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%), C_max (50%), and C_min (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 C_max and AUC of ramipril 2.3 and 2.1-fold, respectively, and C_max and AUC of ramiprilat 2.4 and 1.5-fold, respectively. In contrast, C_max 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

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Date published: 01 September 2019

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