TELMISARTAN ACTAVIS 20 mg TABLETS

Introduction

Package Leaflet: Information for the User

Telmisartan Actavis 20mg tabletsEFG

telmisartan

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What is Telmisartan Actavis and what is it used for
2. What you need to know before you take Telmisartan Actavis
3. How to take Telmisartan Actavis
4. Possible side effects
5. Storing Telmisartan Actavis
6. Contents of the pack and other information

1. What is Telmisartan Actavis and what is it used for

Telmisartan Actavis 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 Actavis blocks the effect of angiotensin II, so that the blood vessels relax and your blood pressure is reduced.

Telmisartan Actavis is used to treat high blood pressure (essential hypertension) 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 various organs such as the heart, kidneys, brain and eyes. This could lead to a heart attack, heart or kidney failure, stroke, or blindness. Usually, high blood pressure does not produce any symptoms before damage occurs. Therefore, it is important to regularly measure the blood pressure to verify if it is within the normal range.

Telmisartan Actavis is also used to reduce the risk of cardiovascular events (e.g. 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 a high risk of having diabetes. Your doctor will have determined whether you have a high risk of having these events.

2. What you need to know before you take Telmisartan Actavis

Do not take Telmisartan Actavis

• 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 Telmisartan Actavis 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 or kidney impairment and you are treated with an ACE inhibitor or aliskiren.

If any of these apply to you, tell your doctor or pharmacist before taking Telmisartan Actavis.

Warnings and precautions

Tell your doctor if you have ever had any of the following conditions or if you develop them during treatment with Telmisartan Actavis:

• Kidney disease or kidney transplant.
• Narrowing of the arteries that supply blood to the kidneys (renal artery stenosis).
• Liver disease.
• Heart problems.
• High levels of aldosterone in your blood (water and salt retention in your body combined with imbalance of various minerals in your blood).

Low blood pressure (hypotension) that may be caused by a low blood volume, salt depletion, or because of a treatment with diuretics, low salt diet, diarrhea, or vomiting.

• High levels of potassium in your blood.
• Diabetes.

Tell your doctor before taking Telmisartan Actavis:

• if you are taking digoxin.
• if you are taking any of the following medicines used to treat high blood pressure:

an angiotensin-converting enzyme inhibitor (e.g. enalapril, lisinopril, ramipril), in particular if you have kidney problems connected with diabetes.

• aliskiren.

Your doctor may check your kidney function, blood pressure, and the levels of electrolytes (e.g. potassium) in your blood at regular intervals.

See also information under the heading “Do not take Telmisartan Actavis”.

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. It is not recommended to take Telmisartan Actavis during the first 3 months of pregnancy (see section on pregnancy). In case of planned pregnancy, it is recommended to switch to an alternative medicine to treat your high blood pressure before you become pregnant. If you become pregnant while taking Telmisartan Actavis, inform your doctor immediately.

In case of surgery or anesthesia, inform your doctor that you are taking Telmisartan Actavis.

Telmisartan Actavis may be less effective in lowering the blood pressure in black patients.

Children and adolescents

Telmisartan Actavis is not recommended for children and adolescents under 18 years.

Using other medicines with Telmisartan Actavis

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Your doctor may need to change the dose of these medicines or take other precautions. In some cases, it may be necessary to stop taking one of the medicines. This is especially important for the following medicines when taken with Telmisartan Actavis:

• Medicines that contain lithium for the treatment of some types of depression.
• Medicines that may increase potassium levels in the blood, such as potassium-sparing diuretics, potassium supplements, or salt substitutes containing potassium.

Diuretics, especially when used in combination with Telmisartan Actavis, may cause excessive loss of body water and low blood pressure (hypotension).

• if you are taking an angiotensin-converting enzyme inhibitor (e.g. enalapril, lisinopril, ramipril) or aliskiren (see also information under the headings “Do not take Telmisartan Actavis” and “Warnings and precautions”)

digoxin.

The effect of Telmisartan Actavis may be reduced when you take non-steroidal anti-inflammatory medicines (e.g. aspirin, ibuprofen) or corticosteroids.

Telmisartan Actavis may increase the effect of other medicines used to lower the blood pressure or increase the effect of medicines that can lower the blood pressure (e.g. baclofen, amifostine). Furthermore, low blood pressure may be aggravated by alcohol, barbiturates, narcotics, or antidepressants. You may notice this as dizziness when standing up. You should consult your doctor if you need to adjust the dose of your other medicines while taking Telmisartan Actavis.

Pregnancy and breast-feeding

Pregnancy

Do not take Telmisartan Actavis if you are pregnant or if you think you might be pregnant. If you become pregnant while taking Telmisartan Actavis, inform your doctor immediately. Your doctor will normally advise you to stop taking Telmisartan Actavis before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Telmisartan Actavis. Telmisartan Actavis should not be used during the first 3 months of pregnancy and should not be used at all after the third month of pregnancy because it can cause serious harm to your baby.

Breast-feeding

Do not take Telmisartan Actavis if you are breast-feeding. If you are planning to breast-feed, ask your doctor or pharmacist for advice. Your doctor will decide whether you can take Telmisartan Actavis or whether you can take another medicine to treat your high blood pressure while you are breast-feeding. This is especially important if your baby is a newborn or was born prematurely.

Driving and using machines

Some people feel dizzy or tired when taking Telmisartan Actavis. If you feel dizzy or tired, do not drive or operate machinery.

Telmisartan Actavis contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e. essentially “sodium-free”.

3. How to take Telmisartan Actavis

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

For the 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. Your doctor has prescribed a lower dose of one 20 mg tablet per day. Telmisartan Actavis may also be used in combination with diuretics such as hydrochlorothiazide which has been shown to have an additive blood pressure lowering effect with telmisartan.

For the reduction of cardiovascular events, the usual dose of Telmisartan Actavis is one 80 mg tablet once a day. At the start of treatment for the prevention with Telmisartan Actavis 80 mg, blood pressure should be monitored regularly.

If you have liver problems, the usual dose should not exceed 40 mg once a day.

If you have kidney problems, the recommended starting dose is 20 mg.

Try to take the tablet at the same time each day. You can take Telmisartan Actavis with or without food. The tablets should be swallowed with a little water. It is important to take Telmisartan Actavis every day to control your blood pressure.

If you take more Telmisartan Actavis than you should

Take the correct dose as prescribed by your doctor. If you accidentally take too many tablets, contact your doctor, pharmacist, or hospital emergency department immediately.

The most common symptoms of overdose are low blood pressure (hypotension) and rapid heartbeat (tachycardia). Other symptoms may include slow heartbeat (bradycardia), dizziness, high levels of creatinine in the blood, and acute kidney failure.

If you forget to take Telmisartan Actavis

If you forget to take a dose, take it as soon as you remember on the same day. 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 stop taking Telmisartan Actavis

Take Telmisartan Actavis every day for as long as your doctor prescribes it to keep your blood pressure controlled. If you have the impression that the effect of Telmisartan Actavis is too strong or too weak, talk to your doctor or pharmacist.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects can be serious and require immediate medical attention:

If you experience any of the following symptoms, you should contact your doctor or go to the hospital straight away:

sepsis* (often called “blood poisoning”, is a severe infection that involves an inflammatory reaction throughout the body), rapid swelling of the skin and mucous membranes (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 side effects are not treated, they may be fatal.

Common side effects of telmisartan:

Common side effects (may affect up to 1 in 10 people) Low blood pressure (hypotension) in users treated for cardiovascular event reduction.

Uncommon side effects (may affect up to 1 in 100 people)

Urinary tract infections, upper respiratory tract infections (e.g. sore throat, sinusitis, common cold), anemia, high levels of potassium, insomnia, depression, syncope, vertigo, bradycardia, hypotension, orthostatic hypotension, shortness of breath, cough, abdominal pain, diarrhea, abdominal discomfort, abdominal distension, vomiting, itching, increased sweating, drug rash, back pain, muscle cramps, muscle pain, renal impairment including acute renal failure, chest pain, and high levels 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 that involves an inflammatory reaction throughout the body and can be life-threatening), eosinophilia (a high level of a certain type of white blood cell in the blood), thrombocytopenia (low platelet count), anaphylactic reaction (severe allergic 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), anxiety, somnolence, vision disturbance, tachycardia, dry mouth, gastrointestinal irritation, taste disturbance, abnormal liver function (Japanese patients are more likely to experience this side effect), angioedema (rapid swelling of the skin and mucous membranes), eczema (a skin disorder), erythema (redness of the skin), urticaria (hives), severe drug rash, arthralgia (joint pain), pain in the extremities, tendon pain, pseudogrip syndrome, decrease in hemoglobin (a protein in the blood), increase in blood urea, increase in liver 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)**.

• This may have been a chance finding or related to an unknown mechanism.

** Cases of progressive scarring of lung tissue have been reported during telmisartan treatment. 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 the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Telmisartan Actavis

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.

Al/Al blisters:

Store in the original package in order to protect from light.

HDPE tablet container:

Keep the container tightly closed in order to protect from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Package Contents and Additional Information

Composition of Telmisartán Actavis

• The active ingredient is telmisartan. Each tablet contains 20 mg of telmisartan.
• The other ingredients are magnesium stearate, sodium croscarmellose, mannitol, povidone, potassium hydroxide granules.

Appearance of Telmisartán Actavis and Package Contents

The 20 mg tablets are white, round, flat with the logo T on one side

Package sizes:

Al/Al blister packs: 14, 28, 30, 56, 84, 90, 98 and 100 tablets.

Tablet pack: 30 and 250 tablets.

The tablet pack contains a desiccant that should not be ingested.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78

220 Hafnarfjörður

Iceland

Manufacturer

Actavis Ltd.

BLB 016

Bulebel Industrial Estate

Zejtun

Malta

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Date of the Last Revision of this Leaflet:

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu/.