Telmisartan Tablets

TELMISARTAN TEVA belongs to a class of medicines known as angiotensin II receptor antagonists. Angiotensin II is a substance produced in your body which causes your blood vessels to narrow, thus increasing your blood pressure. TELMISARTAN TEVA blocks the effect of angiotensin II so that the blood vessels relax, and your blood pressure is lowered. TELMISARTAN TEVA tablets are used for the treatment of high blood pressure in adults. TELMISARTAN TEVA tablets can also be used to reduce cardiovascular events (i.e. heart attack or stroke) and death in patients 55 years or older who are at high risk of cardiovascular disease.

Do not take TELMISARTAN TEVA:

• if you are allergic to telmisartan or any of the other ingredients of TELMISARTAN TEVA (see section 6)
• if you have developed swelling of the face, lips, mouth, tongue or throat and giant wheals on your skin when previously taking medicines called angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) – you should never take these medicines again
• if your doctor has told you that the thickness of your heart muscle is abnormally increased (hypertrophic obstructive cardiomyopathy (HOCM)
• if you suffer from obstruction of blood vessels to your heart or kidneys
• if you have severe kidney function problems
• if you are currently taking potassium sparing diuretics (water tablets) containing spironolactone, triamterene or amiloride
• if you have porphyria (a rare hereditary disease)
• if you are currently taking lithium (used to treat some types of depression)
• do not take TELMISARTAN TEVA if you are pregnant, are considering becoming pregnant or are breastfeeding. A switch to a suitable alternative treatment should be carried out in advance of planned pregnancy
• if you suffer from severe liver disease or biliary obstruction (a problem with the drainage of the bile from the gall bladder)
• if you are currently taking aliskiren-containing products
• if you are taking a fluoroquinolone antibiotic (used to treat a variety of illnesses such as respiratory and urinary tract infections)
• if you have kidney problems or are elderly.

Warnings and precautions:

Take special care with TELMISARTAN TEVA and tell your doctor:

• if you become pregnant while taking TELMISARTAN TEVA. You should stop treatment immediately and contact your doctor to change your medicine.
• if you suffer from kidney disease or have had a kidney transplant
• if your body could be lacking in salt due to a low salt diet, or if you have recently lost a lot of body fluids due to taking diuretic medicines (water tablets), vomiting or diarrhea
• if you are already taking a medicine called an angiotensin-converting enzyme (ACE) inhibitor
• contact your doctor to re-evaluate your treatment if you are treated with Angiotensin-converting enzyme (ACE) inhibitors/Angiotensin receptor blockers (ARBs) together with a fluoroquinolone antibiotic
• if you have been told previously that you have raised aldosterone levels
• if you have heart problems
• if you have diabetes
• if you have high potassium levels in your blood or use salt substitutes containing potassium
• if you have liver problems.

Children and adolescents:

The safety and efficacy of TELMISARTAN TEVA for use in children below 18 years have not been established.

Other medicines and TELMISARTAN TEVA:

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines). Your doctor may need to change the dose of these other medicines or take other precautions. In some cases, you may have to stop taking one of the medicines. This applies especially to the medicines listed below taken at the same time with TELMISARTAN TEVA:

• Digoxin (used to treat various heart conditions)
• Medicines that may increase blood potassium levels such as salt substitutes containing potassium, potassium-sparing diuretics (certain 'water tablets'), ACE inhibitors, angiotensin II receptor antagonists, NSAIDs (non-steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen), heparin, immunosuppressives (e.g. ciclosporin or tacrolimus), and the antibiotic trimethoprim
• Lithium containing medicines (used to treat some types of depression)
• If you are taking an ACE-inhibitor or aliskiren (see also information under the headings Do not take TELMISARTAN TEVA and Warnings and precautions)
• Diuretics (water tablets), especially if taken in high doses together with TELMISARTAN TEVA, may lead to excessive loss of body water and low blood pressure (hypotension).
• The effect of TELMISARTAN TEVA may be reduced when you take NSAIDs (non-steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen) or corticosteroids.
• TELMISARTAN TEVA may increase the blood pressure lowering effect of other medicines used to treat high blood pressure or of medicines with blood pressure lowering potential (e.g. baclofen, amifostine).
• Concomitant use of fluoroquinolones and TELMISARTAN TEVA may precipitate acute kidney injury.
• Furthermore, alcohol, barbiturates, narcotics or antidepressants may aggravate low blood pressure. You may notice this as dizziness when standing up. You should consult with your doctor if you need to adjust the dose of your other medicine while taking TELMISARTAN TEVA.

TELMISARTAN TEVA with food, drink and alcohol:

TELMISARTAN TEVA can be taken with or without food.

Pregnancy, breastfeeding and fertility:

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other healthcare provider for advice before taking TELMISARTAN TEVA. Do not take TELMISARTAN TEVA if you are pregnant, are considering becoming pregnant or are breastfeeding. If you are a woman of childbearing age, you must use effective contraception.

Driving and using machines:

When driving vehicles or operating machinery, it should be taken into account that dizziness or drowsiness may occur when taking blood pressure lowering medication including TELMISARTAN TEVA. You should not engage in the above activities until you are aware of the extent to which TELMISARTAN TEVA affects you.

TELMISARTAN TEVA contains sorbitol. If you have been told that you have an intolerance to some sugars, you should not take TELMISARTAN TEVA.

One dose (tablet) of TELMISARTAN 40 TEVA contains 4,66 mg sodium (found in table salt). This is equivalent to 0,24 % of the recommended maximum daily intake of sodium for an adult. One dose (tablet) of TELMISARTAN 80 TEVA contains 9,31 mg sodium (found in table salt). This is equivalent to 0,48 % of the recommended maximum daily intake of sodium for an adult. To be taken into consideration by patients on a controlled sodium diet.

Do not share medicines prescribed for you with any other person. Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Adults: The usual dose is 40 mg tablet once daily (preferably at about the same time each day) and swallowed with a drink of water. The dose may be increased to 80 mg in cases where the target blood pressure is not achieved. Your doctor may prescribe TELMISARTAN TEVA in combination with other blood pressure lowering medicines.

If you have the impression that the effect of TELMISARTAN TEVA is too strong or too weak, tell your doctor or pharmacist.

If you take more TELMISARTAN TEVA than you should: In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

If you forget to take TELMISARTAN TEVA: Always take TELMISARTAN TEVA as prescribed. If you have missed a dose, take it as soon as you remember. Do not take a double dose of TELMISARTAN TEVA to make up for forgotten individual doses.

If you stop taking TELMISARTAN TEVA: Do not stop taking TELMISARTAN TEVA unless your doctor tells you to.

TELMISARTAN TEVA can have side effects. Not all side effects reported for TELMISARTAN TEVA are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking TELMISARTAN TEVA, please consult your health care provider for advice.

If any of the following happens, stop taking TELMISARTAN TEVA and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of your hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing
• rash or itching
• fainting.

These are all very serious side effects. If you have them, you may have had a serious reaction to TELMISARTAN TEVA. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• severe, life-threatening infection (sepsis, also known as ’blood infection’) with possible fatal outcome
• changes in the way your heart beats, for example, if you notice it is beating faster, slower or irregular
• yellowing of the skin and eyes, dark coloured urine, feeling tired or weak which may be symptoms of liver problems or liver failure
• passing less urine than is normal for you which may be a sign of serious kidney problems or kidney failure.

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• Coughing.

Less frequent side effects:

• urinary tract infections, upper respiratory tract infections (e.g. sore throat, inflamed sinuses, common cold)
• deficiency in red blood cells (anaemia), low platelet count (thrombocytopenia)
• high levels of potassium in your blood
• difficulty falling asleep, feeling sad (depression), feeling anxious
• fainting (syncope), feeling sleepy (somnolence)
• problems with your vision
• feeling of spinning (vertigo)
• low blood pressure (hypotension) in users treated for high blood pressure, dizziness on standing up (orthostatic hypotension)
• shortness of breath, progressive scarring of lung tissue (interstitial lung disease)
• abdominal pain, diarrhoea, discomfort in the abdomen, bloating, vomiting, dry mouth, upset stomach, taste disturbance (dysgeusia)
• increased sweating, itching, drug rash, eczema (a skin disorder) and redness of skin
• back pain, muscle cramps, muscle pain (myalgia), joint pain (arthralgia), pain in extremity
• chest pain, feeling of weakness (asthenia), flu-like illness
• increased level of creatinine in the blood, decreased haemoglobin (a blood protein), increased levels of uric acid, increased hepatic enzymes or creatine phosphokinase in the blood.

Side effects with unknown frequency:

• increase in certain white blood cells (eosinophilia)
• low blood sugar levels (in diabetic patients)
• hives (urticaria)
• tendon pain.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects: If you get side effects, talk to your doctor or pharmacist. You can also report side effects to SAHPRA via the 6.04 Adverse Drug Reaction Reporting Form, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of TELMISARTAN TEVA.

Store all medicines out of reach of children. Store at or below 25 ºC. Store in the original packaging. Do not take after the expiry date stated on the package. Return all unused medicine to your pharmacist. Do not dispose of unused capsules in drains or sewerage systems (e.g. toilets).