Diary

https://believeanyway.wordpress.com/2021/07/17/link-arms-at-the-campfire/

Kate is right, “there is always someone in your corner”. She says: “Go to the campfires where the loving people are.” – “Sit beside them. Link arms. Laugh until your sides hurt. Sing with them. Listen.” –

I am waiting for the time when my ‘tribe’ can come to visit and share with me the beautiful deck that very dear young Aaron has crafted at the back of my house. It is a huge deck. I imagine a lot of people can one day use it for a beautiful get-together.

Yes, I believe that these dreams of mine can one day become true. Never mind the Coronavirus with this Delta variant, which is rather scary right now. But we are going to be watchful. So, I do believe, I still have a chance of dying of ‘old age’ rather than of this infectious virus . . . .

How lucky am I really, that the deck and a lot of other improvements could be finished before all these ‘hard’ lockdowns started! And Aaron was able to buy from Bunnings all the material that was needed before the prices went up!

A far as these lockdowns are concerned, well, they cannot last forever, can they now?

I wonder, what Christmas is going to be like this year, the second Christmas without Peter . . . .

David Gulpilil takes centre stage to tell his incredible life story in intimate documentary My Name is Gulpilil

https://www.abc.net.au/news/2021-05-26/david-gulpilil-documentary-my-name-is-gulpilil/100156218

ABC Arts / 

By Annabel Brady-BrownPosted Wed 26 May 2021 at 4:37amWednesday 26 May 2021 at 4:37am, updated Wed 26 May 2021 at 3:42pmWednesday 26 May 2021 at 3:42pm

Actor David Gulpilil, an older Yolngu man in shearling coat taking off his akubra, in the documentary My Name is Gulpilil
The film homes in on Gulpilil’s magnetic performances, from his breakout role in Walkabout to his turns in critically acclaimed films, including Rabbit Proof Fence.(Supplied: ABCG Film)

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In early 2017, when the legendary actor David Gulpilil was diagnosed with stage-four lung cancer and advised that he had only months to live, he told filmmakers Molly Reynolds and Rolf de Heer that he wanted to make one more film.

He wasn’t well enough to appear as planned in Stephen Maxwell Johnson’s revisionary western, High Ground — he requested that his role be taken by Yothu Yindi’s Witiyana Marika, who is a close relative.

But the three decided “that the best way we could go forward was to do his life story, right until the end,” Reynolds says.

The result is My Name is Gulpilil, an intimate documentary about the actor squaring with the end of his life.

Actor David Gulpilil, an older Yolngu man standing in a hospital corridoor, in the documentary My Name is Gulpilil
Gulpilil has been living more than 3,000 kilometres from home in Arnhem Land, as he receives treatment for lung cancer and emphysema.(Supplied: ABCG Film)

“This film is about me. This is my story of my story,” he says at the outset.

Moving between hospital visits and scenic excursions through the South Australian landscape, the film interweaves footage of Gulpilil speaking direct-to-camera with news archives and clips from his movies, reliving his astonishing half-century on screen.

“I like to show my face to remember,” he says.

Viewers are taken on a bittersweet journey — from his debut in the 1971 Australian New Wave classic Walkabout, through some of the country’s most popular and critically acclaimed films, including Storm Boy, Mad Dog Morgan, Crocodile Dundee and Rabbit Proof Fence.

Refreshingly, the movie clips are presented without title cards that name the directors, as the documentary instead homes in on Gulpilil’s magnetic performances.

‘I’m an actor, I’m a dancer, I’m a singer and also a painter.’

My Name is Gulpilil is likely the final entry in a fruitful, two-decade collaboration between Gulpilil and the white Australian filmmaker Rolf de Heer and his partner Reynolds, which started with the Yolngu actor’s phenomenal lead role — his first — in The Tracker in 2002.

Play Audio. Duration: 15 minutes 57 seconds
Listen: David Gulpilil and Rolf de Heer

Over the four films they’ve made since then — which are widely held up as examples of best-practice collaborative filmmaking — Gulpilil has increasingly asserted creative control over his story.

He initiated and narrated Ten Canoes (2006) — the first Australian feature entirely in Indigenous language — and co-wrote and starred in the semi-autobiographical drama Charlie’s Country (2013) and the follow-up essay-documentary Another Country (2015).

Actor David Gulpilil, an older Yolngu man in a white singlet out in the forest on 2013 film Charlie's Country
Charlie’s Country won Gulpilil the Best Actor award at Cannes’s Un Certain Regard section and the AACTA Awards in 2015.(Supplied: ABCG Film)

It’s fitting, then, that My Name is Gulpilil sees him occupy centre stage.

“It’s like, ‘Over to you, David,'” says Reynolds, who directed the film. 

“It’s a fabulous progression, for all of us really.”

Reminiscing direct to camera, Gulpilil recounts his youth as a tribal man from the Arafura Swamp region in Central Arnhem Land, and how it was his talent as a ceremonial dancer that led the British director Nicolas Roeg to “discover” him as a teen and cast him in the biblical desert horror Walkabout.

The experience ignited Gulpilil’s love for cinema and his abiding diva-like delight in front of the camera.

As he said in his 2004 one-man stage show, “Acting came natural to me. Piece of piss. I know how to walk across the land in front of a camera, because I belong there.”

Walkabout toured the world, which took the Yolngu teenager out of his ancestral home and catapulted him into the European film world — and Hollywood-level excess.

Actor David Gulpilil, an young Yolngu man in traditional paint dancing, in the 1971 film Walkabout
At the time Gulpilil was cast in Walkabout, non-Indigenous actors were still being cast as Indigenous characters. (Supplied: ABCG Film)

He amusingly relates some of his adventures: dining with the Queen, carousing with Dennis Hopper, partying with Muhammad Ali and getting high for the first time with Bob Marley. It was the start of a lifelong balancing act for Gulpilil — straddling two worlds, Yolngu and Balanda — and the documentary emphasises the great personal toll this took.

He’s sober these days, but he speaks openly about his well-publicised substance abuse and his time living in the long grass in Darwin.

“Drinking all this grog, smoking all this tobacco, smoking all this ganja. I ended up good in prison every day in Darwin,” he says.

The film uses audio clips from news reports that run through his numerous convictions, including one for domestic violence in 2011, after he broke his wife’s arm.

“I forgot about her,” he says. “Because I was a drunken, drunken man.

“I’m a drug and alcoholic.”

‘No one else can do the life of me, it’s only me. I can do the life about me.’

Unlike other biographic treatments, such as Darlene Johnson’s 2002 documentary Gulpilil: One Red Blood, or Derek Rielly’s 2020 book Gulpilil, there are no other interviewees or talking heads.

“People, usually whitefellas, sort of speak for or about David,’ says Reynolds, explaining the reasoning behind the “clear choices” that she and David made about how to present the documentary.

“David is the consummate performer, the consummate artist, actor. I thought, ‘What happens if he just spoke for himself?’

“I knew David’s capacity to deliver. I thought, ‘He can hold the screen,'” she says. 

Filmmaker Molly Reynolds,  a white woman in red hat and glasses, and David Gulpilil, the Yolgnu actor and dancer in an akubra
“The terrific thing was that throughout this project we developed a real affection, love and regard for one another,” says Reynolds.(Supplied: ABCG Film/Bonnie Paku)

“David really embraced that, because there were no intermediaries at all. He could just look straight down the lens, and speak it as he saw it. 

“Having said that, he’s also an actor and he likes having a director to support his work.”

Needing to stay close to doctors and hospitals, and too sick to travel to Arnhem Land, Gulpilil is observed living in a modest house — kitted out with posters of his films — in Murray Bridge, east of Adelaide, with his indefatigable carer Mary Hood.

Before each shooting session, Reynolds and Gulpilil would discuss what he wanted to talk about that day.

“I quickly learned to be a different director to what I’d normally be,” she says, describing her role as “sort of the brains trust who holds the information”.

“I was there to support his performance, even though his performance was really him.”

The interviews would run for hours. 

“Then he’d just conclude somehow so poetically, and ‘boom’, we’ve got it.”

Tying the film together into effectively one long interview, the unhurried monologues allow the viewer to really listen, and to sink into the rhythm of Gulpilil’s storytelling.

‘I like to make a film, it’s a history. I like it because it won’t rub out.’

Gulpilil’s role extended far beyond being the star interviewee.

“One day he called me up,” recounts Reynolds. “‘Molly, Molly,’ he said. ‘What I’d like to do is, I want you to wrap me in our film, in my cemetery box.'”

She had to break the news to him: “David, we’re shooting digital, not 35mm … but I got the image he was evoking, and that was really poetic, so we did end up shooting it,” she says.

The shot shows Gulpilil lying inside a coffin with his eyes closed, resting on a bed of unfurled analogue film – one of several dreamy images that appear in the documentary to suggest he is confronting his own mortality, and which often foreground his connection with the land.

“He’s got a true sense of cinema,” says Reynolds.

Actor David Gulpilil, an older Yolngu man standing on empty train tracks, in the documentary My Name is Gulpilil
The film is in English and Mandhalpingu and was filmed and produced on Ngarrindjeri, Kaurna and Andyamathana Lands.(Supplied: ABCG Film)

The new film sees Gulpilil credited for the first time in his career as a producer — alongside de Heer and his Ten Canoes co-director Peter Djigirr.

Reynolds describes Djigirr as “critical to everything we do with the Yolngu mob up there… He’s been involved in every single film we’ve made in Ramingining.”

Acting as a kind of “pivot point” between the filmmakers and the community, Djigirr also ensured that everything was done in accord with cultural protocols and traditions.

There was another crucial, if sombre, reason for his involvement, says Reynolds: “There was the expectation that David would be dead by the time we finished. So we wanted someone who … would be able to look at the film and determine how David would feel about it.”

That Gulpilil is still alive to see the finished film, walking the red carpet at the Adelaide Festival for the premiere in March, is a surprise twist ending.

“It felt so right that it worked out this way,” says Reynolds.

“One thing that pleases me about the film, for David, is that I think it has cemented his legacy,” she says. 

“It’s the culmination of all that he has done.”

‘This film will remember to generation to generation.’

In 2002, academic and cultural commentator Marcia Langton said: “David has been absolutely critical to both representing Aboriginal people in modern Australia in the cinema … and also, in his own ironic and charismatic way, undermining the stereotypes that were forced on him. He’s a tremendously important person to us culturally.”

Reflecting on this important role, Reynolds says, “I don’t think Australia yet appreciates [David’s contribution] enough.”

“And I really, really do hope that, on behalf of all of us, whitefellas and blackfellas alike, that we do get to that point.

“My Name Is Gulpilil may just be a reference to help us get there.”https://www.youtube.com/embed/vK1DLvEkvtA?feature=oembedYOUTUBEMy Name is Gulpilil trailer

Taronga Park Zoo

https://www.abc.net.au/news/2021-07-10/covid-live-updates-coronavirus-press-conference-sydney-lockdown/100282612

https://taronga.org.au/taronga-tv

Taronga Zoo Sydney is temporarily closed. Taronga Western Plains Zoo Dubbo is still operating. Read more.

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Coronavirus Outbreak

COVID live updates: NSW braces for more community transmission, as police checkpoints set up along Victorian border

By Bridget Judd and Jessica RigaPosted 46m ago46 minutes ago

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ABC News Channel live stream

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New South Wales is bracing for more locally acquired cases of COVID-19 and the prospect of a longer lockdown as authorities work to get the outbreak under control.

Stay up-to-date on the coronavirus outbreak

It comes as police checkpoints are set up along the Victorian border to ensure those returning from school holidays are carrying the correct permits.

Follow all of Saturday’s COVID-19 updates in the live blog below. 

Key events

The Coronavirus and Me

In a few weeks I am going to be 87. So, it is very likely, that sooner or later I am going to die anyway, isn’t it? I just hope that I can die at home and not in hospital. And I also hope, that my family can be amply prepared for my death.

I maintain ‘Social Distancing’ with each and everyone. I want to avoid to be vaccinated and hope, that this is possible. I mean, why should a very old person be afraid of dying?

Diary

Monika is on a week’s holiday now. She was able to see me yesterday and take me to the Medical Centre. I already mentioned all the medical procedure that went on yesterday. I have now another appointment to see Dr.Krish again on Monday, the 28th at 12,10pm, so that she can tell me the result of the tests.

Monika and I had a late lunch yesterday. We had Chinese Tea and shared a lunch special: Boiled rice and vegies with a sauce that contained cashews among other things. It was the perfect lunch for us. So many different vegies, a real lot of them, and very tasty! Later on Tashi came, and she volunteered to do my shopping for me at ALDIs. In the meantime Monika took me home. No rest for the wicked! Some Internet Banking had to be done. It took Monika a while to set it up properly. I had to talk to the bank, so that my identity could be established. Then Monika just transferred the money that had to be transferred.

The backyard deck is already finished and paid for now. But a few other things still need doing. It is going to look very good in the end!

Uta’s Diary

I looked up: AND (Allow Natural Death)

https://en.wikipedia.org/wiki/Allow_natural_death

Allow natural death

From Wikipedia, the free encyclopediaJump to navigationJump to search

Allow Natural Death (AND) is a medical term defining the use of life-extending measures such as cardiopulmonary resuscitation (CPR). These orders emphasize patient comfort and pain management instead of life extension.[1] Currently, American medical communities utilize “do not resuscitate,” (DNR) orders to define patients’ medical wishes. Those who propose to replace DNR with AND posit that DNR orders are ambiguous and require complex understanding between several parties, while AND orders are clearer.[1][2]

DNR orders range from solely prohibiting the use of resuscitation to prohibiting any action seen as life extending. Because there are many parties involved in a patient’s end of life care – significant others, family, personal doctors, specialists and nurses – DNR orders are not always completely clear, leaving open possible violation of the patient’s wishes.[1] “DNR orders may lead to conflict, unnecessary suffering, and inappropriate care at the EOL [end of life.]” Those who propose to replace DNR orders with AND orders posit that AND are less ambiguous, clearly instructing medical personnel to not use any artificial, life extending measures. This would be especially helpful in regards to emergency care, when medical personnel who are unfamiliar with the patient must decide what medical practices should be used. Furthermore, proponents of AND claim that because it contains “death” in the title it is more clear to the patient and family exactly what the patient is agreeing to.

Critics of AND claim it is simply the replacement of one ambiguous term with another. Just as DNR particulars vary so too would AND particulars vary. Thus, the change would be ineffective.[3]

See also[edit]

References[edit]

  1. Jump up to:a b c Schlairet, Maura C. “Allow-Natural-Death (AND) Orders: Legal, Ethical, And Practical Considerations”. HEC ForumPMID 22752437.
  2. ^ Venneman, S.S. (2008). “‘Allow Natural Death’ Versus ‘Do Not Resuscitate’: Three Words That Can Change A Life”. Journal of Medical Ethics34 (1): 2–6. doi:10.1136/jme.2006.018317PMID 18156510S2CID 7414134.
  3. ^ Chen, Y-Y (2008). “‘Allow Natural Death’ Is Not Equivalent To ‘Do Not Resuscitate’: A Response”. Journal of Medical Ethics34 (12): 887–888. doi:10.1136/jme.2008.024570PMID 19065754S2CID 26867470.

Categories

Furosemide and Colecalciferol Capsules

Furosemide is used to reduce extra fluid in the body (edema) caused by conditions such as heart failure, liver disease, and kidney disease. This can lessen symptoms such as shortness of breath and swelling in your arms, legs, and abdomen. This drug is also used to treat high blood pressure.

https://www.nhs.uk/medicines/furosemide/

Colecalciferol is a form of vitamin D used in the prevention and treatment of vitamin D deficiency conditions. It may also be prescribed for certain bone conditions, such as thinning of the bone (osteoporosis) when it will be given to you with other medicines.

https://www.medicines.org.uk/emc/product/7247/pil#gref

Yesterday, I had a doctor’s appointment. Since Wednesday, the 16th of June, I think it was the third time that I saw Dr. Krish (Nidja Krishnamurthy). Monika came with me to see the doctor. Monika questioned that I had to have more and more antibiotics.

Dr. Krish then prescribed Furosemide and Colecalciferol Capsules. {See above for information)

She also sent me to two different tests: First a blood test and then a test to check for blood clots in my right leg!

Monika further mentioned that geriatric Counselling might help. I found the following online:

https://www.mywellnesshub.in/blog/online-counselling-for-elderly-people-geriatric-psychotherapy/

Counseling for Elderly people, also called as geriatric counseling, is usually not given much importance. But this is the stage of life, where they need a great support. After having a life full of friends, relatives and well-wishers with whom they would be hanging around till a few years back, this stage of life halts them and has some unwanted gifts like health issues and loneliness. To deal with such unavoidable issues and to get on with the remaining life, accepting what it is like, one needs a word of support. More than any kind of other supports, providing psychological help is the main need. Either the children or the caretakers should extend a psychological supporting shoulder for their mental illness like stress, anxiety, loneliness, depression etc.

Issues like missing the children, a chronic disease or death of the spouse or the demise of a closely-knit family member, suffering a prolonged illness or having the mental illness that occur with age etc. could bother a lot by ceasing their mental peace. Empty nest syndrome could be nerve-wrenching for the elderly people to handle. Leading a miserable life giving up all the peace as if the life itself has been a big burden is a real problem that needs to be attended. Geriatric counseling helps the elderly people to lead a peaceful life, focusing on the positive aspects making them to treat life like a blessing.

Why should you respect Elderly people?

It is an undeniable fact that none can escape old age and death. But being in a circle of self-concern and self-appreciation and self-engagement, the younger generation often neglect the yesterday’s generation. While being full-flown adults, we engage in different works and get socially connected with many around us, wondering how we should behave and what they would think of us, we often forget an underlying truth of the world. “At age 20, we worry about what others think of us. At age 40, we don’t care what they think of us. At age 60, we discover they haven’t been thinking of us at all” surprisingly true!! All the age we spent solving the problems of others or the family and showing love, care and affection towards others, sometimes even forgetting what we really want. We tend to be good to others and think what they would think. But suddenly at an elder age, we realize that we are left alone.

Someone once said, “RESPECT the elderly when you are YOUNG, HELP the weak when you are STRONG, ADMIT your mistakes when you are WRONG. Because one day, when you will grow OLD, become WEAK and expect others to show you some RESPECT.” How true that everyone becomes old. Everyone need to come to that stage of age and can’t escape. Then why not show some concern today?

What they truly need?

People into old age, need an ear to listen. They need someone to spend some time with. They should be felt understood, supported and valued. The losses of aging, increased dependency, anticipation of further deterioration of health or death, other physical illnesses etc. bother them very much and they should get a psychological support to make them feel calm.

They need someone by their side to

  • Restore their self-confidence and self-esteem
  • Help them re-establish the continuity with their positive view of themselves
  • Help them dealing with the loss of their loved ones
  • Help them coping with the loneliness
  • Support and make them feel their worth

When someone who has gone through a lot of psychological turmoil in the past days, try to adjust with the present, they will have numerous issues running in their minds. The feelings of overwhelming anger, humiliation, helplessness, fear of loss of control over body and environment, feelings of vulnerability and fear of abandonment etc. are the ones that won’t let them live peacefully.

Empty Nest Syndrome

Apart from all the other factors, the loneliness is the major factor that affects the elder people a lot. Children having flown to far off places for their careers and settlement, relatives and friends getting restricted to their houses and boundaries, having the spouse left the world, a lonely being in a lone house is the most difficult thing a human being could face. Being in an old age, the fear of sudden and unexpected illness haunts them wanting to be with someone who would care for them. But the walls of self esteem prevent them from being there at the mercy of someone for some food and shelter. Hence they restrict themselves to the four walls of their own house. Fighting with all these, the person gets depressed and mentally ill. Such a state could be termed as Empty nest syndrome.

Some fight this back bravely making themselves an engaging daily routine, like from morning walk to evening meet, creating a nice environment for them with neighbors and new friends. But the people with some physical illness who could not go out on themselves or the ones who are introverts and don’t have much friends, have to face a lot of difficulties.

Other problems of the Elderly

Along with the issues that are most common, elderly people suffer from a lot of physical and psychological issues. Geriatric patients could deny the existence of their problems considering it a shame to their self esteem.

Many of them feel so lost experiencing the issues like

  • Loss of youth and vigor
  • Financial dependency
  • Mobility dependency
  • Chronic illness
  • Disability
  • Hearing impairment
  • Loss/ blur of vision
  • Dementia
  • Delirium
  • Alzheimer’s disease
  • Feelings of anxiety, depression and hopelessness
  • Insomnia
  • Cognitive impairment
  • Being alone
  • Loss of loved ones etc.

Combining with the mental disorders like stress, anxiety, depression and loneliness etc. the physical and psychological issues make the elderly people feebler. Each disorder has its severity. A simple reactive sadness could turn slowly into a deep grief being in depressed state. Such severity could result in the thoughts of ending their lives. Risk of suicidal idealization in elderly people especially in such cases cannot be overlooked. We are recently witnessing many cases of suicides by elderly people who are taking such extreme step in the pain of loneliness.

People who choose suicide want to end their pain, not their lives. It is unfortunate that they select a permanent solution to a temporary problem. From common people to celebrities, everyone has feelings that are to be heard and the problems that are to be solved. Elderly celebrity deaths remind us that no one, no matter how revered or celebrated, is immune to depression and the associated feelings of isolation, emptiness, heartbreak and hopelessness. Life is precious. We should tell people how much they mean to us, all the more so when they are alive.

Need of Counselling

The counsellor does not diagnose or label the client, but does his or her best to listen to the client and work with the client to find the best ways to understand and resolve the client’s problem. The counseling or psychotherapy makes them heard, express all the feelings and receive that validation of all the pressures and problems they had faced in their life time. Counselors should be able to understand the client’s feelings without rupturing their self esteem and by restoring a positive sense of self.

Counselling services are offered by psychologists and psychiatrists. They are certified and trained professionals to provide such sessions as they have experience in using the different methods of counselling for specific problems of clients. A counsellor possesses the unique qualities of enjoying helping others and being non-judgmental. In addition, the counsellor has good communication skills, can build rapport, accept, empathize, solve problems and enhance the self-awareness of the people seeking help. In short, the counsellor is trained to help people make decisions and clarify their feelings in order to solve problems.

Counselling is for anyone who needs help with their problems. All of us must have experienced the benefits of counseling in the form of advice and suggestions given by family members and friends when we had to resolve our problems. In fact, we may even have experienced a sense of relief that there is somebody just to listen to us.  However, at times we feel that objective analyses and feedback is necessary and this is provided by professional counsellor.

Professional counseling, on the other hand, works on a higher level since the counselor is trained to help people cope with stress, anxiety, depression, grief, panic attacks and other relationship related issues. Counselling is for people who want more joy, peace of mind, marital harmony and improved work performance

Online Counseling for Elderly people

We at Wellness Hub provide all the help needed for such elderly people suffering any sort of mental issue. There’s no need to come down all the way for an expert help. Online counseling has been a boon for such help seekers who can connect from any place around the globe to seek a solution. Online counseling for elderly people is a real gift, you could offer at this golden phase of life.

Category: Diary

https://auntyuta.com/category/diary//

Under the category ‘Diary’ you can find a lot of my diary blogs.

On the 26th of May 2021 I wrote the following in my diary:

First thing as always in the morning I had my AMLODIPINE APOTEX 10 mg tablet with a glass of water. I also had 1000 mg of Vitamin C! Then I made myself a large cup of instant coffee with quite a lot of reduced fat milk. In the grill section of the oven I heated some buns. I like to eat these with butter and some marmalade. Later on I am also going to eat a banana and a kiwi fruit as well as some avocado.

I am now on some different blood pressure tablets.

Brand name

APO-Telmisartan

This is mentioned in the leaflet about these tablets:

Telmisartan belongs to a group of medicines called angiotensin II receptor antagonists. Angiotensin II is a substance in the body which causes blood vessels to narrow, thus increasing blood pressure.

Telmisartan works by blocking the effect of angiotensin II. When the effect of angiotensin II is blocked, the blood vessels relax and your blood pressure goes down.

Telmisartan may be used either alone or in combination with other medicines used to treat high blood pressure.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.

This medicine is available only with a doctor’s prescription.

There is no evidence that this medicine is addictive.

There is not enough information to recommend the use of this medicine for children under the age of 18 years.

Before you take this medicine

When you must not take it

Do not take this medicine if you have an allergy to:

  • any medicine containing telmisartan
  • any of the ingredients listed at the end of this leaflet

Some of the symptoms of an allergic reaction may include:

  • shortness of breath
  • wheezing or difficulty breathing
  • swelling of the face, lips, tongue or other parts of the body
  • rash, itching or hives on the skin

Do not take this medicine if you have or have had any of the following medical conditions:

  • severe liver disease (severe hepatic impairment)
  • biliary obstructive disorders (problems with the flow of bile from the gall bladder)
  • diabetes or kidney problems and you are taking aliskiren (a medicine used to treat high blood pressure)

Do not take this medicine if you are pregnant or are planning to become pregnant. Telmisartan may affect your developing baby if you take it during pregnancy.

Do not take this medicine if you are breastfeeding or are planning to breastfeed. Telmisartan may pass into human breast milk.

Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to take it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have or have had any of the following medical conditions:

  • kidney problems
  • liver problems
  • heart problems
  • diabetes
  • a condition known as primary hyperaldosteronism (raised aldosterone levels, also known as Conn’s syndrome)
  • recent severe diarrhoea or vomiting

Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding. Your doctor can discuss with you the risks and benefits involved.

Tell your doctor if you are following a very low salt diet.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interact with telmisartan. These include:

  • other medicines used to treat high blood pressure or heart problems, such as ACE inhibitors (e.g. ramipril).
  • potassium supplements or potassium-containing salt substitutes
  • medicines or salt-substitutes which may increase your potassium levels
  • diuretics or fluid tablets, medicines used to help the kidneys get rid of salt and water by increasing the amount of urine produced (e.g. spironolactone or frusemide)
  • nonsteroidal anti-inflammatory agents (NSAIDs) – medicines used to relieve pain, swelling and other symptoms of inflammation (including arthritis), such as aspirin or ibuprofen
  • lithium, used to treat certain mental illnesses
  • digoxin, used to treat heart failure
  • trimethoprim, used to treat bacterial infections
  • heparin, used to thin your blood
  • corticosteroids, medicines used to treat inflammatory conditions
  • immunosuppressants, such as ciclosporin or tacrolimus, used to prevent organ rejection after transplantation

These medicines may be affected by telmisartan or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

How to take this medicine

Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.

If you do not understand the directions, ask your doctor or pharmacist for help.

How much to take

Your doctor will tell you how much of this medicine you should take. This will depend on your condition and whether you are taking any other medicines.

For the treatment of high blood pressure (hypertension):
The usual dose for adults is one 40 mg tablet, once a day.

If your blood pressure is still too high after 4-8 weeks of starting treatment, your doctor may increase your dose to 80 mg.

For the prevention of cardiovascular complications, including death due to cardiovascular causes:
The usual dose is one 80 mg tablet, once a day.

Depending on how you respond to the treatment, your doctor may suggest a higher or lower dose.

How to take it

Swallow the tablet whole with a full glass of water.

When to take it

Take your medicine at about the same time each day. Taking it at the same time each day will have the best effect. It will also help you remember when to take it.

It does not matter if you take it before, with or after food.

How long to take it for

Continue taking your medicine for as long as your doctor tells you.

Telmisartan helps to control your high blood pressure, and/or prevents you from developing cardiovascular complications, but does not cure it. It is important to keep taking telmisartan every day, even if you feel well.

People who have high blood pressure often feel well and do not notice any symptoms.

If you forget to take it

If it is almost time to take your next dose, skip the dose you missed and take your next dose when you are meant to.

Otherwise, take it as soon as you remember, and then go back to taking your medicine as you would normally.

Do not take a double dose to make up for missed doses. This may increase the chance of you experiencing side effects.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much of this medicine. Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

If you take too much telmisartan you may feel dizzy, light-headed or faint. Your heartbeat may be faster or lower than usual and you may experience rapid, shallow breathing or cold, clammy skin. This is because your blood pressure is too low.

While you are taking this medicine

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking this medicine.

Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.

If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine. It may affect other medicines used during surgery.

If you become pregnant or start to breastfeed while taking this medicine, tell your doctor immediately.

If you are about to have any blood tests, tell your doctor that you are taking this medicine. It may interfere with the results of some tests.

Keep all your doctor’s appointments so that your progress can be checked. Your doctor may do some tests from time to time to make sure the medicine is working and to prevent unwanted side effects.

Things you must not do

Do not take this medicine to treat any other complaints unless your doctor tells you to.

Do not give your medicine to anyone else, even if they have the same condition as you.

Do not stop taking your medicine or lower the dosage without checking with your doctor.

Things to be careful of

Be careful when driving or operating machinery until you know how this medicine affects you. Like other medicines used to treat high blood pressure, telmisartan may cause sleepiness, dizziness or light headedness in some people.

If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.

You may feel dizzy or light-headed when you begin to take telmisartan, especially if you are also taking a diuretic (or fluid tablet) or if you are dehydrated.

If this medicine makes you feel dizzy or light-headed, be careful when getting up from a sitting or lying position. Standing up slowly, especially when you get up from a bed or chair, will help your body get used to the change in position and blood pressure. If this problem continues or gets worse, talk to your doctor.

If you exercise, sweat or if the weather is hot, you should drink plenty of water.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking this medicine.

All medicines can have side effects. Sometimes they are serious but most of the time they are not.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Tell your doctor if you notice any of the following and they worry you:

  • headache
  • dizziness, spinning sensation or fainting
  • dizziness or light-headedness when you stand up, especially when getting up from a sitting or lying position
  • tiredness or weakness
  • diarrhoea
  • indigestion
  • stomach pain or discomfort
  • wind or excessive gas in the stomach or bowel (flatulence)

Tell your doctor as soon as possible if you notice any of the following:

  • chest pain
  • ‘flu-like’ symptoms
  • upper respiratory tract infections
  • back pain
  • aching muscles not caused by exercise (myalgia)
  • painful joints (arthralgia)
  • tendon pain or tendinitis-like symptoms
  • urinary tract infections (including cystitis)
  • trouble sleeping (insomnia)
  • feeling anxious
  • depression
  • shortness of breath
  • muscle spasms, leg cramps or leg pain
  • fast or slow heart beats
  • visual disturbances
  • increased sweating
  • dry mouth
  • allergic skin reactions including skin rash, itchiness and redness of the skin
  • signs of anaemia such as tiredness, being short of breath when exercising, dizziness and looking pale
  • changes in your red or white blood cell levels – usually only detected through blood tests

If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

  • symptoms that may indicate low blood sugar levels, such as sweating, weakness, hunger, dizziness, trembling, headache or numbness (especially in diabetic patients)
  • abnormal liver function
  • symptoms that may indicate a worsening of the kidney function, such as passing little or no urine, drowsiness, nausea, vomiting, breathlessness, loss of appetite and weakness
  • symptoms that may indicate high potassium levels in the blood, such as nausea, diarrhoea, muscle weakness and changes in heart rhythm
  • bleeding or bruising more easily than normal (thrombocytopenia)
  • symptoms that may indicate an infection of the blood, such as high fever, chills, headache, confusion and rapid breathing
  • symptoms of an allergic reaction including cough, shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue, throat or other parts of the body; rash, itching or hives on the skin

The above list includes very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are very rare.

Tell your doctor or pharmacist if you notice anything that is making you feel unwell.

Other side effects not listed above may occur in some patients.

Some of these side effects can only be found when your doctor does tests from time to time to check your progress.

Storage and disposal

Storage

Keep your medicine in its original packaging until it is time to take it. If you take your medicine out of its original packaging it may not keep well.

Keep your medicine in a cool dry place where the temperature will stay below 30°C. Protect from light and moisture.

Do not store your medicine, or any other medicine, in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.

Keep this medicine where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Product description

What APO-Telmisartan looks like

40 mg Tablet
White to off-white colour, oval shape, biconvex, uncoated tablets debossed with L203 on one side and plain on other side. AUST R 209336.

Blister packs of 28 tablets.

80 mg Tablet
White to off-white colour, oval shape, biconvex, uncoated tablets debossed with L204 on one side and plain on other side. AUST R 209334.

Blister packs of 28 tablets.

*Not all strengths may be available.

Ingredients

Each tablet contains (40 mg or 80 mg) of telmisartan as the active ingredient.

It also contains the following inactive ingredients:

  • Povidone
  • Mannitol
  • Meglumine
  • Magnesium stearate
  • Sodium hydroxide
  • Sodium stearylfumarate

This medicine is gluten-free, lactose-free, sucrose-free, tartrazine-free and free of other azo dyes.

Sponsor

Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park, NSW 2113
Australia
Tel: (02) 8877 8333
Web: www1.apotex.com/au

Blood creatinine increased.

A 0.5 mg/dL rise or greater in creatinine was observed in 0.4% telmisartan patients compared with 0.3% placebo patients. One telmisartan treated patient discontinued therapy due to increases in creatinine and blood urea nitrogen.

Hepatic enzymes increased.

Occasional elevations of liver chemistries occurred in patients treated with telmisartan; all marked elevations occurred at a higher frequency with placebo. No telmisartan treated patients discontinued therapy due to abnormal hepatic function.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Other interactions of clinical significance have not been identified. Coadministration of telmisartan did not result in a clinically significant interaction with digoxin, warfarin, hydrochlorothiazide, glibenclamide, ibuprofen, paracetamol, simvastatin and amlodipine.
When telmisartan was coadministered with digoxin, an increase in digoxin AUC (22%), Cmax (50%), and Cmin (13%) values was observed. It is recommended that digoxin levels be monitored when initiating, adjusting, and discontinuing telmisartan to avoid possible over or under digitalisation.
In one study, the coadministration of telmisartan 80 mg once daily and ramipril 10 mg once daily to healthy subjects increases steady-state Cmax and AUC of ramipril 2.3 and 2.1-fold, respectively, and Cmax and AUC of ramiprilat 2.4 and 1.5-fold, respectively. In contrast, Cmax and AUC of telmisartan decrease by 31% and 16% respectively. The clinical relevance of this observation is not fully known. When coadministering telmisartan and ramipril, the response may be greater because of the possibly additive pharmacodynamics effects of the combined drugs and also because of the increased exposure to ramipril and ramiprilat in the presence of telmisartan. Combining telmisartan with ramipril in the ONTARGET trial resulted in a significantly higher incidence of hyperkalaemia, renal failure, hypotension and syncope compared to telmisartan alone or ramipril alone (also see Section 5.1 Pharmacodynamic Properties, Clinical trials). Concomitant use of telmisartan and ramipril is therefore not recommended in patients with already controlled blood pressure and should be limited to individually defined cases with close monitoring of renal function (also see Section 4.4 Special Warnings and Precautions for Use).
As with other medicinal products acting on the renin-angiotensin-aldosterone system, telmisartan may provoke hyperkalaemia (see Section 4.4 Special Warnings and Precautions for Use). The risk may increase in case of treatment combination with other medicinal products that may also provoke hyperkalaemia (salt substitutes containing potassium, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, non-steroidal anti-inflammatory medicinal products (NSAIDs, including selective COX-2 inhibitors, heparin, immunosuppressives (ciclosporin or tacrolimus), and trimethoprim.
The occurrence of hyperkalaemia depends on associated risk factors. The risk is increased in case of the above mentioned treatment combinations. The risk is particularly high in combination with potassium sparing-diuretics, and when combined with salt substitutes containing potassium. A combination with ACE inhibitors or NSAIDs, for example, presents a lesser risk provided that precautions for use are strictly followed.

Concomitant use not recommended.

Potassium sparing diuretics or potassium supplements.

Angiotensin II receptor antagonists such as telmisartan, attenuate diuretic induced potassium loss. Potassium sparing diuretics e.g. spironolactone, eplerenone, triamterene, or amiloride, potassium supplements, or potassium-containing salt substitutes may lead to a significant increase in serum potassium. If concomitant use is indicated because of documented hypokalaemia they should be used with caution and with frequent monitoring of serum potassium.

Lithium.

Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors and with angiotensin II receptor antagonists including telmisartan. If use of the combination proves necessary, careful monitoring of serum lithium levels is recommended.

Concomitant use requiring caution.

Non-steroidal anti-inflammatory medicinal products.

NSAIDs (i.e. aspirin at anti-inflammatory dosage regimens, COX-2 inhibitors and non-selective NSAIDs) may reduce the antihypertensive effect of angiotensin II receptor antagonists. In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function), the co-administration of angiotensin II receptor antagonists and agents that inhibit cyclo-oxygenase may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible. Therefore, the combination should be administered with caution, especially in the elderly. Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy and periodically thereafter.

Diuretics (thiazide or loop diuretics).

Prior treatment with high dose diuretics such as frusemide (loop diuretic) and hydrochlorothiazide (thiazide diuretic) may result in volume depletion and in a risk of hypotension when initiating therapy with telmisartan.

To be taken into account with concomitant use.

Other antihypertensive agents.

The blood pressure lowering effect of telmisartan can be increased by concomitant use of other antihypertensive medicinal products.
Clinical trial data has shown that dual blockade of the renin-angiotensin-aldosterone-system (RAAS) through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure) compared to the use of a single RAAS-acting agent (see Section 4.3 Contraindications; Section 4.4 Special Warnings and Precautions for Use; Section 5.1 Pharmacodynamic Properties).
Based on their pharmacological properties it can be expected that the following medicinal products may potentiate the hypotensive effects of all antihypertensives including telmisartan: baclofen, amifostine. Furthermore, orthostatic hypotension may be aggravated by alcohol, barbiturates, narcotics or antidepressants.

Corticosteroids (systemic route).

Reduction of the antihypertensive effect.
Telmisartan is not metabolised by the cytochrome P450 system and had no effects in vitro on cytochrome P450 enzymes, except for some inhibition of CYP2C19. Telmisartan is not expected to interact with drugs that inhibit, or are metabolised by, cytochrome P450 enzymes.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No studies on fertility in humans have been performed. Fertility of male and female rats was unaffected at oral telmisartan doses up to 100 mg/kg/day.
(Category D)
Angiotensin II receptor antagonists should not be initiated during pregnancy. The use of angiotensin II receptor antagonists is not recommended during the first trimester of pregnancy. When pregnancy is diagnosed, treatment with angiotensin II receptor antagonists should be stopped immediately, and, if appropriate, alternative therapy should be started. The use of angiotensin II receptor antagonists is contraindicated during the second and third trimester of pregnancy.
Although there is no clinical experience with telmisartan in pregnant women, in utero exposure to drugs that act directly on the renin angiotensin system can cause fetal and neonatal morbidity and even death. Several dozen cases have been reported in the world literature in patients who were taking angiotensin converting enzyme inhibitors. Therefore, when pregnancy is detected, telmisartan should be discontinued as soon as possible.
Preclinical studies with telmisartan do not indicate teratogenic effect, but have shown fetotoxicity. Angiotensin II receptor antagonists exposure during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia). Oligohydramnios reported in this setting, presumably resulting from decreased fetal renal function, has been associated with fetal limb contractures, craniofacial deformation, and hypoplastic lung development. Prematurity, intrauterine growth retardation, and patent ductus arteriosus have also been reported, although it is not clear whether these occurrences were due to exposure to the drug.
These adverse effects do not appear to occur when drug exposure has been limited to the first trimester. Mothers whose embryos and fetuses are exposed to an angiotensin II receptor antagonist only during the first trimester should be so informed. Women of childbearing age should be warned of the potential hazards to their fetus should they become pregnant.
Unless continued angiotensin II receptor antagonist therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with angiotensin II receptor antagonists should be stopped immediately, and, if appropriate, alternative therapy should be started.
Should exposure to angiotensin II receptor antagonists have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended. Infants whose mothers have taken angiotensin II receptor antagonists should be closely observed for hypotension, oliguria and hyperkalaemia.
Telmisartan has been shown to cross the placenta in rats. There were no teratogenic effects when telmisartan was administered orally to rats and rabbits during the period of organogenesis at doses up to 50 and 45 mg/kg/day, respectively. However, fetal resorptions were observed at the highest dose level in rabbits. Administration of 50 mg/kg/day telmisartan to rats during pregnancy and lactation caused a decrease in birth weight and suppression of postnatal growth and development of the offspring.
The no effect dose level in rabbits was 15 mg/kg/day, and corresponded to a plasma AUC value that was about 9 times higher than that anticipated in women at the highest recommended dose. Plasma drug levels were not measured at the high dose level in rats, but data from other studies suggest that they would have been similar to those in women at the maximum recommended dose.
Telmisartan is contraindicated during lactation since it is not known whether it is excreted in human milk. Animal studies have shown excretion of telmisartan in breast milk. No clinical trials have been carried out in lactating women. Therefore, lactating women should either not be prescribed telmisartan or should discontinue breastfeeding, if telmisartan is administered.
Telmisartan is excreted in the milk of lactating rats. When administered orally to lactating rats at 50 mg/kg/day, telmisartan suppressed postnatal growth and development of the offspring.

4.8 Adverse Effects (Undesirable Effects)

Adverse reactions have usually been mild and transient in nature and have only infrequently required discontinuation of therapy. The incidence of adverse reactions was not dose related and showed no correlation with gender, age or race of the patients.

Treatment of hypertension.

The overall incidence of adverse reactions reported with telmisartan was comparable to placebo in placebo controlled trials involving 1041 patients treated with various doses of telmisartan (20-160 mg) for up to 12 weeks. Therefore, the following information refers to adverse events irrespective of their causal relationship.
Adverse events with an incidence of 1% or more in telmisartan treated patients and greater than placebo are shown in Table 1. The frequency of these adverse events was not significantly different between the telmisartan treated and placebo patients.
In addition, the following adverse events occurred in more than 1% of the 3455 patients treated in all trials with telmisartan although causal association of these events with telmisartan could not be established: bronchitis, insomnia, arthralgia, anxiety, depression, palpitation, muscle spasms (cramps in legs) and rash.
In addition to those listed above, adverse events that occurred in less than 1% but more than 0.3% of 3500 patients treated with telmisartan monotherapy in controlled or open trials are listed below. It cannot be determined whether these events were causally related to telmisartan tablets.

Infections and infestations.

Upper respiratory tract infections (including rhinitis), bronchitis, urinary tract infections (including cystitis), infection, fungal infection, abscess, otitis media.

Immune system disorders.

Allergy.

Metabolism and nutrition disorders.

Gout, hypercholesterolaemia, diabetes mellitus.

Psychiatric disorders.

Anxiety, insomnia, depression, nervousness.

Nervous system disorders.

Somnolence, migraine, paraesthesia, hypoaesthesia.

Eye disorders.

Visual disturbance, conjunctivitis.

Ear and labyrinth disorders.

Vertigo, tinnitus, earache.

Cardiac disorders.

Tachycardia, palpitation, angina pectoris.

Vascular disorders.

Flushing, cerebrovascular disorder.

Respiratory disorders.

Dyspnoea, asthma, epistaxis.

Gastrointestinal disorders.

Dry mouth, flatulence, stomach discomfort, vomiting, constipation, gastritis, haemorrhoids, gastroenteritis, enteritis, gastroesophageal reflux, toothache.

Skin and subcutaneous tissue disorders.

Eczema, pruritus, hyperhidrosis, rash, dermatitis.

Musculoskeletal, connective tissue and bone disorders.

Arthralgia, involuntary muscle contractions or muscle spasms (cramps in legs) or pain in extremity (leg pain), arthritis.

Renal and urinary tract disorders.

Micturition frequency.

Reproductive system and breast disorders.

Impotence.

General disorders and administration site conditions.

Malaise, fever, leg oedema, dependent oedema.

Investigations.

Abnormal ECG.

Prevention of cardiovascular morbidity and mortality.

Because common adverse reactions were well characterised in studies of telmisartan in hypertension, only adverse events leading to discontinuation and serious adverse events were recorded in subsequent studies of telmisartan in the prevention of cardiovascular morbidity and mortality.
The safety profile of telmisartan in patients treated for the prevention of cardiovascular morbidity and mortality was consistent with that obtained in hypertensive patients.
In ONTARGET (N = 25,620, 4.5 years mean duration of follow-up), discontinuations due to adverse events were 8.7% on telmisartan, 11.0% on ramipril and 12.4% on combination of telmisartan and ramipril.
In TRANSCEND (N = 5926, 4 years and 8 months of follow-up), discontinuations due to adverse events were 8.4% on telmisartan and 7.6% on placebo.
In PRoFESS (N = 20,332, 2.5 years follow-up), discontinuations due to adverse events were 14.5% on telmisartan and 11.2% on placebo. Because of the factorial design of the PRoFESS trial, the discontinuation rates observed in the telmisartan and placebo groups could also be due in part to the concomitant administration of either antiplatelet study medication (clopidogrel or aspirin + dipyridamole).
Adverse events in TRANSCEND occurring at least 1% more common in telmisartan treated patients than in placebo treated patients are shown in Table 2. Additionally for these events the incidences from ONTARGET are also presented. The data is derived from all serious adverse events reported during the study.
Combining telmisartan with ramipril in the ONTARGET study resulted in a higher incidence of hyperkalemia, renal failure, hypotension and syncope compared to telmisartan or ramipril alone.
In clinical studies with patients at high risk of developing major cardiovascular events, cases of sepsis, including some with fatal outcomes, have been reported. In the PRoFESS trial, an increased incidence of sepsis was noted for telmisartan compared with placebo, 0.70% versus 0.49%; the incidence of fatal sepsis cases was increased for patients taking telmisartan (0.33%) versus patients taking placebo (0.16%). The observed increased occurrence rate of sepsis associated with the use of telmisartan may be either a chance finding or related to a mechanism not currently known.

Postmarketing experience.

In addition, the following have also been reported since the introduction of telmisartan in the market.

Blood and lymphatic system disorders.

Uncommon: anaemia.
Rare: eosinophilia, thrombocytopenia.

Immune system disorders.

Rare: anaphylactic reaction, hypersensitivity.

Metabolism and nutrition disorders.

Uncommon: hyperkalaemia.
Rare: hypoglycaemia (in diabetic patients).

Nervous system disorders.

Uncommon: syncope (faint).

Cardiac disorders.

Uncommon: bradycardia.

Vascular disorders.

Uncommon: hypotension, orthostatic hypotension.

Hepatobiliary disorders.

Rare: hepatic function abnormal/ liver disorder*.
* Most cases of hepatic function abnormal/ liver disorder from postmarketing experience with telmisartan occurred in patients in Japan, who are more likely to experience these adverse reactions.

Skin and subcutaneous tissue disorders.

Rare: angioedema (with fatal outcome), erythema, urticaria, drug eruption, toxic skin eruption.

Musculoskeletal, connective tissue and bone disorders.

Rare: tendon pain (tendinitis like symptoms).

Renal and urinary tract disorders.

Uncommon: renal impairment including acute renal failure (see Section 4.4 Special Warnings and Precautions for Use).

General disorders and administration site conditions.

Uncommon: asthenia (weakness).

Investigations.

Rare: blood uric acid increased, blood creatine phosphokinase (CPK) increased.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at http://www.tga.gov.au/reporting-problems and contact Apotex Medical Information Enquiries/Adverse Drug Reaction Reporting on 1800 195 055.

4.2 Dose and Method of Administration

Telmisartan is available as tablets for oral administration.
Telmisartan may be administered with or without food.

Dosage.

Treatment of hypertension.

Adults.

The recommended dose is 40 mg once daily. In cases where the target blood pressure is not achieved, telmisartan dose can be increased to 80 mg once daily. Telmisartan may be used in combination with thiazide type diuretics such as hydrochlorothiazide which has been shown to have an additive blood pressure lowering effect with telmisartan. When considering raising the dose, it must be borne in mind that, while reduction in blood pressure is achieved after the first dose, the maximum antihypertensive effect is generally attained four to eight weeks after the start of treatment.

Prevention of cardiovascular morbidity and mortality.

The recommended dose is 80 mg once daily. It is not known whether doses lower than 80 mg of telmisartan are effective in preventing cardiovascular morbidity and mortality.
When initiating telmisartan therapy for the prevention of cardiovascular morbidity and mortality, monitoring of blood pressure is recommended, and if appropriate, adjustment of medications that lower blood pressure may be necessary.

Elderly.

No dosing adjustment is necessary.

Renal impairment.

No dose adjustment is required for patients with renal impairment, including those on haemodialysis. Telmisartan is not removed from blood by haemofiltration.

Hepatic impairment.

In patients with mild to moderate hepatic impairment, the dosage should not exceed 40 mg once daily (see Section 4.4 Special Warnings and Precautions for Use).

4.7 Effects on Ability to Drive and Use Machines

There are no data to suggest that telmisartan affects the ability to drive and use machines. However, when driving or operating machinery it should be taken into account that with antihypertensive therapy, occasionally dizziness or drowsiness may occur.

4.9 Overdose

Symptoms.

Limited information is available with regard to overdose in humans. The most prominent manifestations of telmisartan overdose were hypotension and tachycardia; bradycardia also occurred.

Treatment.

If symptomatic hypotension should occur, supportive treatment should be instituted. Telmisartan is not removed by haemodialysis.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

7 Medicine Schedule (Poisons Standard)

S4.

6 Pharmaceutical Particulars

6.1 List of Excipients

Povidone, meglumine, sodium hydroxide , mannitol, sodium stearylfumarate, magnesium stearate.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 30°C. Protect from light and moisture.
Telmisartan tablets should not be removed from their foil pack until required for administration.

6.5 Nature and Contents of Container

APO-Telmisartan tablets.

40 mg tablets.

Blister Pack (Al/Al) of 28 tablets (AUST R 209336).

80 mg tablets.

Blister Pack (Al/Al) of 28 tablets (AUST R 209334).
APO is a registered trade mark of Apotex Inc.
Not all strengths may be available.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

Summary Table of Changes

PAGE SECTIONS

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Date published: 01 September 2019

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Pipe laying for Waterboard in 1960

Peter and Eberhard were laying sewerage pipes in Wollongong for Waterboard in 1960. Some time ago Peter wrote a story about ‘Billy Boy’. In the story he says: Billy had befriended us at work, where he was our ‘Billy Boy’ providing us with hot water for tea and for washing ourselves. He also helped us with our English. Bill told us to call in at his place when we were in Picton. The story goes under the title:

The ‘Billy Boy’ and His Girls

https://berlioz1935.wordpress.com/2012/07/10/the-billy-boy-and-his-girls/

“Come on in, boys,” said Bill with a big smile as he opened the door. We, my friend from work and me, did not consider ourselves boys, but he was close to fifty years older than we were. From his point of view we were just some youngsters blown in by the trade winds from another continent.

“Did you have any trouble finding the place?” he asked. His face had a reddish, weather beaten complexion. Large furrows and wrinkles criss crossed his face like the legendary canals on Mars, bearing witness to a long outdoor life. He had seen much of Australia as a train driver during the war years. Supplies were taken up to Darwin by train and from there by ship to the troops fighting in the Pacific.

He had befriended us at work, where he was our ‘Billy Boy’ providing us with hot water for tea and for washing ourselves. He also helped us with our English. Bill told us to call in at his place when we were in Picton.

“Saturday would be fine,” said Bill .

“And you will get to meet the girls,” he added with a friendly smile.

We heard ‘girls’ and thought it was about time we got acquainted with some females in Australia. We had not been in Australia for long and all was pretty new to us. I had bought an old Austin A 40. My  friend and I took the car for the half an hour’s drive to see Bill and the girls; probably his granddaughters as he was already past seventy.

We accepted his invitation and went inside his house, a large double story stone building at the edge of town. It was dark inside. He lead us into the dining room.

“The girls will be coming down soon to say ‘Hello’ “, Bill said.

The dining room was dark too. Thick, heavy curtains blocked out any daylight. We could just make out some furniture. As Bill started to draw back the curtains, revealing a beautiful table and eight chairs all made from red cedar, we saw a large cabinet with glass doors and behind them some Royal Dalton and Wedgwood tableware. On the wall was a painting of a stern looking couple. We felt transported into the nineteenth century.

“You know, we haven’t used the dining room since 1935,” Bill said.

“That’s over twenty five years ago, Bill,” I said to him.

“There you are, it shows you how time flies,” he answered.

He went to the door from time to time to look up the stairs where he expected the girls to come down from.

“Have a seat while I’ll put the kettle on. The girls should be down very shortly. You know how it is? They want to look their best,” Bill said with a wink. ‘They have never met Germans in their lives.”

Bill wasn’t gone long when he came back and announced, “Here they come!” and motioned us to the door.

“Aren’t they beautiful?’ Bill whispered, so the girls would not be embarrassed.

There was an electric light on now in the hallway and what we saw, were three women, of advanced years ― of very advanced years, I thought. They were dressed in dark frocks, which nearly touched the floor, white blouses and short black jackets. On their heads they wore small, round hats. They were holding on to the beautiful carved bannister as they carefully stepped from the nineteenth to the twentieth century. They gave me the impression they had been found in a tomb. Their faces looked old and wrinkly too, as the heat and the harsh wind in Australia had not been kind to them.

After we exchanged a few “Pleased to meet you” and “How are you?” we all took seats at the table. I noticed now that they wore long sleeved gloves. Bill, his face beaming, arrived with a pot of tea from the kitchen and took out the tea cups from the cabinet. He did all the work, if one could call it work, and served us and the ‘girls’. He explained that they were his sisters and much older than him. They reminded me of Daisy Bates, of whom I had seen some pictures.

“I was the baby of the family,” Bill said with a wink, “and now I have to look after them.”

Bill had such a great personality and he was full of life and always had a sparkle in his eyes. He seemed so proud that he was able to introduce his new friends and his sisters to each other. At the time we did not know that Australians called women of any age ‘girls’. We still had to learn a lot as newcomers to this great country