Telmisartan Torrent 80 mg tabletten

[product name] 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. [product name] blocks the effect of angiotensin II so that the blood vessels relax, and your blood pressure is lowered.

[product name] 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.

[product name] 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. Your doctor can tell you if you are at high risk for such events.

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Do not take [product name]

• if you are allergic to telmisartan or any of the other ingredients of this medicine (listed in section 6).
• if you are more than 3 months pregnant. (It is also better to avoid [product name] in early pregnancy – see pregnancy section.)
• if you have severe liver problems such as cholestasis or biliary obstruction (problems with the drainage of the bile from the liver and gall bladder) or any other severe liver disease.
• if you have diabetes mellitus or impaired kidney function and you are treated with aliskiren.

If any of the above applies to you, tell your doctor or pharmacist before taking [product name].

Warnings and precautions

Talk to your doctor or pharmacist before taking [product name].

Please tell your doctor if you are 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 you are dehydrated (excessive loss of body water) or have salt deficiency due to diuretic therapy (‘water tablets’), low-salt diet, diarrhoea, or vomiting.
• Elevated potassium levels in your blood.
• Diabetes.

You must tell your doctor if you think you are (or might become) pregnant. [product name] is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).

In case of surgery or anaesthesia, you should tell your doctor that you are taking [product name].

[product name] may be less effective in lowering the blood pressure in black patients.

Children and adolescents

The use of [product name] in children and adolescents up to the age of 18 years is not recommended.

Other medicines and [product name]

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 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 when taken at the same time with [product name]:

• Lithium containing medicines to treat some types of depression.
• Medicines that may increase blood potassium levels such as salt substitutes containing potassium, potassium-sparing diuretics (certain 'water tablets'), ACE inhibitors, angiotensin II receptor

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antagonists, aliskiren, NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen), heparin, immunosuppressives (e.g. cyclosporin or tacrolimus), the antibiotic trimethoprim.

• Diuretics ('water tablets'), especially if taken in high doses together with [product name], may lead to excessive loss of body water and low blood pressure (hypotension).

The effect of [product name] may be reduced when you take NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen) or corticosteroids.

[product name] may increase the blood pressure lowering effect of other medicines used to treat high blood pressure.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking [product name] before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of [product name]. This medicine is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. [product name] is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.

Driving and using machines

Some people feel dizzy or tired when taking [product name]. If you feel dizzy or tired, do not drive or operate machinery.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Dosage

The recommended dose of [product name] is one tablet a day. Try to take your medicine at the same time each day. You can take [product name] with or without food.

The tablets should be swallowed with some water or other non-alcoholic drink. It is important that you take [product name] every day until your doctor tells you otherwise. If you have the impression that the effect of [product name] is too strong or too weak, talk to your doctor or pharmacist.

For treatment of high blood pressure, the usual dose of [product name] for most patients is one 40 mg tablet once a day to control blood pressure over the 24 hour period. However, your doctor may recommend a lower dose of 20 mg or a higher dose of 80 mg. Alternatively, [product name] may be

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used in combination with diuretics ('water tablets') such as hydrochlorothiazide which has been shown to have an additive blood pressure lowering effect with [product name].

For reduction of cardiovascular events, the usual dose of [product name] is one 80 mg tablet once a day. At the beginning of preventive therapy blood pressure should be frequently monitored.

If your liver is not working properly, the usual dose should not exceed 40 mg once daily.

If you take more [product name] than you should

If you accidentally take too many tablets, contact your doctor, pharmacist, or your nearest hospital emergency department immediately.

If you forget to take [product name]

If you forget to take a dose, do not worry. Take it as soon as you remember then carry on as before. If you do not take your tablet on one day, take your normal dose on the next day. Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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:

You should see your doctor immediately if you experience 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 product and see their doctor immediately. If these effects are not treated they could be fatal.

Possible side effects:

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

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-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

-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 effects)

-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

-increased creatine phosphokinase in the blood.

Very rare side effects (may affect up to 1 in 10,000 people):

- progressive scarring of lung tissue (intesitial lung disease)**.

* The event may have happened by chance or could be related to a mechanism currently not known.

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** Cases of progressive scarring of lung tissue have been reported during intake of telmisartan. However, it is not known whether telmisartan was the cause.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Nederlands Bijwerkingen Centrum Lareb, Website: www.lareb.nl.

By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What [product name] contains

The active substance is telmisartan. Each tablet contains 20 mg telmisartan.

The active substance is telmisartan. Each tablet contains 40 mg telmisartan.

The active substance is telmisartan. Each tablet contains 80 mg telmisartan.

The other ingredients are:

Sodium hydroxide (E524), Meglumine, Povidone (E2101), Mannitol (E421) and Sodium stearyl fumarate (E485).

What [product name] looks like and contents of the pack

[product name] 20 mg tablets are white or off white to yellowish, round, uncoated tablets with a diameter of approx. 7.2 mm, plain on both sides.

[product name] 40 mg tablets are white or off-white to yellowish, oblong, biconvex uncoated tablets, approx. 12.0 x 5.9 mm, with breakline on one side an plain on the other side. The tablet can be divided into equal doses.

[product name] 80 mg tablets are white or off-white to yellowish, oval, biconvex uncoated tablets, approx. 16.3 x 6.9 mm, with breakline on one side and plain on other sides. The tablet can be divided into equal doses.

[product name] is available in blister packs containing 28, 56, or 98 tablets.

Not all pack sizes may be marketed.

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Marketing Authorisation Holder

Torrent Pharma GmbH

Südwestpark 50

90449 Nürnberg

Germany

Manufacturer

Torrent Pharma GmbH

Südwestpark 50

90449 Nürnberg

Germany

or

Heumann Pharma GmbH & Co. Generica KG

Südwestpark 50

90449 Nürnberg

Germany

In het register ingeschreven onder:

RVG 110355 Telmisartan Torrent 20 mg tabletten

RVG 110356 Telmisartan Torrent 40 mg tabletten

RVG 110357 Telmisartan Torrent 80 mg tabletten

This medicinal product is authorised in the Member States of the EEA under the following names:

This leaflet was last revised in November 2013.