Telmisartan Actavis

Telmisartan Actavis

telmisartan

Manufacturer:

Teva

Distributor:

Zuellig
Full Prescribing Info
Contents
Telmisartan.
Description
The active substance is telmisartan.
Each tablet contains 40 mg or 80 mg telmisartan.
Telmisartan belongs to a class of medicines known as angiotensin II receptor antagonists. Angiotensin II is a substance produced in the body which causes the blood vessels to narrow, thus increasing the blood pressure.
Telmisartan blocks the effect of angiotensin II so that the blood vessels relax, and the blood pressure is lowered.
Excipients/Inactive Ingredients: magnesium stearate, croscarmellose sodium, mannitol, povidone, potassium hydroxide pellets.
Indications/Uses
Telmisartan Actavis is used to treat essential hypertension (high blood pressure) in adults. 'Essential' means that the high blood pressure is not caused by any other condition.
High blood pressure, if not treated, can damage blood vessels in several organs, which could lead sometimes to heart attack, heart or kidney failure, stroke, or blindness. There are usually no symptoms of high blood pressure before damage occurs. Thus it is important to regularly measure blood pressure to verify if it is within the normal range.
Telmisartan Actavis is also used to reduce cardiovascular events (i.e. heart attack or stroke) in adults who are at risk because they have a reduced or blocked blood supply to the heart or legs, or have had a stroke or have high risk diabetes. The doctor can tell if the patient is at high risk for such events.
Dosage/Direction for Use
Always take Telmisartan Actavis exactly as the doctor has told. Check with the doctor or pharmacist if not sure.
The recommended dose of Telmisartan Actavis is one tablet a day. Try to take the tablet at the same time each day.
The patient can take Telmisartan Actavis with or without food. The tablets should be swallowed with some water or other non-alcoholic drink. It is important that the patient takes Telmisartan Actavis every day until the doctor tells otherwise. If the patient has the impression that the effect of Telmisartan Actavis is too strong or too weak, talk to the doctor or pharmacist.
For treatment of high blood pressure, the usual dose of Telmisartan Actavis for most patients is one 40 mg tablet once a day to control blood pressure over the 24 hour period. However, sometimes the doctor may recommend a lower dose of 20 mg or a higher dose of 80 mg. Alternatively, Telmisartan Actavis may be used in combination with diuretics ('water tablets') such as hydrochlorothiazide which has been shown to have an additive blood pressure lowering effect with Telmisartan Actavis.
For reduction of cardiovascular events, the usual dose of Telmisartan Actavis is one 80 mg tablet once a day. At the beginning of the preventive therapy with Telmisartan Actavis 80 mg, blood pressure should be frequently monitored.
If the liver is not working properly, the usual dose should not exceed 40 mg once daily.
If the patient forgets to take Telmisartan Actavis: If the patient forgets to take a dose, do not worry. Take it as soon as remembered then carry on as before. If the patient does not take the tablet on one day, take the normal dose on the next day. Do not take a double dose to make up for forgotten individual doses.
If the patient has any further questions on the use of this medicine, ask the doctor or pharmacist.
Overdosage
If the patient accidentally takes too many tablets, contact the doctor, pharmacist, or the nearest hospital emergency department immediately.
Contraindications
Do not take Telmisartan Actavis: if the patient is allergic to telmisartan or any other ingredients of this medicine (listed Description).
If the patient is more than 3 months pregnant. (It is also better to avoid Telmisartan Actavis in early pregnancy - see Use in Pregnancy & Lactation).
If the patient has severe liver problems such as cholestasis or biliary obstruction (problems with drainage of the bile from the liver and gall bladder) or any other severe liver disease.
If any of these applies, tell the doctor or pharmacist before taking Telmisartan Actavis.
The concomitant use of Telmisartan Actavis with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2).
Special Precautions
Talk to the doctor if the patient is suffering or have ever suffered from any of the following conditions or illnesses: Kidney disease or kidney transplant; renal artery stenosis (narrowing of the blood vessels to one or both kidneys); liver disease; heart trouble; raised aldosterone levels (water and salt retention in the body along with imbalance of various blood minerals); low blood pressure (hypotension), likely to occur if the patient is dehydrated (excessive loss of body water) or have salt deficiency due to diuretic therapy ('water tablet'), low-salt diet, diarrhoea, or vomiting; elevated potassium levels in the blood; diabetes.
Tell the doctor if the patient thinks she is (or might become) pregnant. Telmisartan Actavis is not recommended in early pregnancy, and must not be taken if the patient is more than 3 months pregnant, as it may cause serious harm to the baby if used at that stage (see Use in Pregnancy & Lactation).
In case of surgery or anaesthesia, tell the doctor that the patient is taking Telmisartan Actavis.
Telmisartan Actavis may be less effective in lowering the blood pressure in black patients.
Dual blockade of the renin-angiotensin-aldosterone system (RAAS): There is evidence that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure). Dual blockade of RAAS through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is therefore not recommended.
If dual blockade therapy is considered absolutely necessary, this should only occur under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure.
ACE-inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with diabetic nephropathy.
Children and adolescents: The use of Telmisartan Actavis in children and adolescents up to the age of 18 years is not recommended.
Telmisartan Actavis contains mannitol: If the patient is intolerant to some sugars, consult the doctor before taking Telmisartan Actavis.
Driving and using machines: Some people feel dizzy or tired when taking Telmisartan Actavis. If the patient feels dizzy or tired, do not drive or operate machinery.
Use In Pregnancy & Lactation
Pregnancy: Tell the doctor if the patient thinks she is (or might become) pregnant. The doctor will normally advise the patient to stop taking Telmisartan Actavis before she becomes pregnant or as soon as she knows she is pregnant and will advise to take another medicine instead of Telmisartan Actavis.
Telmisartan Actavis is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to the baby if used after the third month of pregnancy.
Breast-feeding: Tell the doctor if the patient is breast-feeding or about to start breast-feeding. Telmisartan Actavis is not recommended for mothers who are breast-feeding, and the doctor may choose another treatment if the patient wishes to breast-feed, especially if the baby is newborn, or was born prematurely.
Side Effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects can be serious and need immediate medical attention: The patient should see the doctor immediately if he/she experiences any of the following symptoms: Sepsis* (often called "blood poisoning", is a severe infection with whole-body inflammatory response), rapid swelling of the skin and mucosa (angioedema); these side effects are rare (may affect up to 1 in 1,000 people) but are extremely serious and patients should stop taking the medicine and see their doctor immediately. If these effects are not treated they could be fatal.
Possible side effects of Telmisartan: Common side effects (may affect up to 1 in 10 people): Low blood pressure (hypotension) in users treated for reduction of cardiovascular events.
Uncommon side effects (may affect up to 1 in 100 people): Urinary tract infections, upper respiratory tract infections (e.g. sore throat, inflamed sinuses, common cold), deficiency in red blood cells (anaemia), high potassium levels, difficulty falling asleep, feeling sad (depression), fainting (syncope), feeling of spinning (vertigo), slow heart rate (bradycardia), low blood pressure (hypotension) in users treated for high blood pressure, dizziness on standing up (orthostatic hypotension), shortness of breath, cough, abdominal pain, diarrhoea, discomfort in the abdomen, bloating, vomiting, itching, increased sweating, drug rash, back pain, muscle cramps, muscle pain (myalgia), kidney impairment including acute kidney failure, pain in the chest, feeling of weakness, and increased level of creatinine in the blood.
Rare side effects (may affect up to 1 in 1,000 people): Sepsis* (often called "blood poisoning", is a severe infection with whole-body inflammatory response which can lead to death), increase in certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), severe allergic reaction (anaphylactic reaction), allergic reaction (e.g. rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), low blood sugar levels (in diabetic patients), feeling anxious, somnolence, impaired vision, fast heart beat (tachycardia), dry mouth, upset stomach, abnormal liver function (Japanese patients are more likely to experience these side effect), rapid swelling of the skin and mucosa which can also lead to death (angioedema also with fatal outcome), eczema (a skin disorder), redness of skin, hives (urticaria), severe drug rash, joint pain (arthralgia), pain in extremity, tendon pain, flu-like-illness, decreased haemoglobin (a blood protein), increased levels of uric acid, increased hepatic enzymes or creatine phosphokinase in the blood.
Very rare side effects (may affect up to 1 in 10,000 people): Progressive scarring of lung tissue (interstitial lung disease)**.
* The event may have happened by chance or could be related to a mechanism currently not known.
** Cases of progressive scarring of lung tissue have been reported during intake of telmisartan. However, it is not known whether telmisartan was the cause.
If the patient gets any side effects, talk to the doctor or pharmacist. This includes any possible side effects not listed.
Drug Interactions
Tell the doctor or pharmacist if the patient is taking, have recently taken or might take any other medicines. The doctor may need to change the dose of these other medicines or take other precautions. In some cases the patient may have to stop taking one of the medicines. This applies especially to the medicines listed as follows taken at the same time with Telmisartan Actavis: Lithium containing medicines to treat some types of depression.
Medicines that may increase blood potassium levels such as salt substitutes containing potassium, potassiumsparing diuretics (certain 'water tablets'), ACE inhibitors, angiotensin II receptor antagonists, NSAIDs (non steroidal antiinflammatory medicines, e.g. aspirin or ibuprofen), heparin, immunosuppressives (e.g. cyclosporin or tacrolimus), and the antibiotic trimethoprim.
Diuretics ('water tablets'), especially if taken in high doses together with Telmisartan Actavis, may lead to excessive loss of body water and low blood pressure (hypotension).
The effect of Telmisartan Actavis may be reduced when the patient takes NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen) or corticosteroids.
Telmisartan Actavis may increase the blood pressure lowering effect of other medicines used to treat high blood pressure.
Interaction with other medicinal products and other forms of interaction: Clinical trial data has shown that dual blockade of the 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.
Storage
Store this medicine below 30°C.
Store in the original package in order to protect from light.
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines no longer use. These measures will help protect the environment.
Keep this medicine out of the sight and reach of children.
ATC Classification
C09CA07 - telmisartan ; Belongs to the class of angiotensin II receptor blockers (ARBs). Used in the treatment of cardiovascular disease.
Presentation/Packing
FC tab 40 mg (white, oval, biconvex with a break line and logo T on one side) x 30's. 80 mg (white, oval, biconvex with logo T1 on one side) x 30's.
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