TELMISARTAN ACTAVIS 40 mg TABLETS

Introduction

Package Leaflet: Information for the User

Telmisartan Actavis 40 mg Tablets EFG

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, causing the blood vessels to relax and your blood pressure to lower.

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 various organs, which could lead, in some cases, to heart attacks, heart failure, stroke, or kidney damage. Usually, high blood pressure does not produce symptoms before damage occurs. Therefore, it is important to regularly measure blood pressure to check if it is within the normal range.

Telmisartan Actavis is also used to reduce cardiovascular events (such as heart attacks or strokes) in adults who are at risk because their blood supply to the heart or legs is reduced, or who have had a stroke or have a high risk of developing diabetes. Your doctor will tell you if you are at 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. (In any case, it is better to avoid taking Telmisartan Actavis at the start of pregnancy - see section Pregnancy.)
• if you have severe liver problems, such as cholestasis or biliary obstruction (problems with the drainage of 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 are suffering from or have ever suffered from any of the following conditions or diseases:

• 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 (a hormone that helps control blood pressure) in your blood.

Low blood pressure (hypotension) that may be caused by:

• Dehydration (excessive loss of body water) or low salt levels in the blood due to diuretic therapy, low salt diet, diarrhea, or vomiting.
• High levels of potassium in the 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:

such as an ACE inhibitor (e.g. enalapril, lisinopril, ramipril), in particular if you have kidney problems associated with diabetes, or aliskiren (see also the information under the headings “Do not take Telmisartan Actavis” and “Warnings and precautions”).

• Digoxin.

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

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

If you are pregnant, think you might be pregnant, or are planning to become pregnant, you must tell your doctor. It is not recommended to take Telmisartan Actavis during the first 3 months of pregnancy (see section Pregnancy) and it must not be taken after the third month of pregnancy as it may cause serious harm to your baby (see section Pregnancy).

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

Telmisartan Actavis may be less effective in lowering 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 containing lithium for the treatment of certain mood disorders.
• Medicines that may increase potassium levels in the blood, such as potassium-sparing diuretics, potassium supplements, or salt substitutes containing potassium; ACE inhibitors (e.g. enalapril, lisinopril, ramipril); angiotensin II receptor blockers (e.g. telmisartan, losartan); non-steroidal anti-inflammatory drugs (NSAIDs) (e.g. aspirin, ibuprofen); heparin; immunosuppressants (e.g. cyclosporin or tacrolimus); or the antibiotic trimethoprim.

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

The effect of Telmisartan Actavis may be reduced when you take NSAIDs (e.g. aspirin, ibuprofen) or corticosteroids.

Telmisartan Actavis may increase the effect of other medicines used to lower blood pressure or medicines that may lower blood pressure as a side effect (e.g. baclofen, amifostine). Additionally, low blood pressure may be worsened 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 breastfeeding

Pregnancy

Must inform your doctor if you are pregnant, think you might be pregnant, or are planning to become pregnant. 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. It is not recommended to take Telmisartan Actavis during the first 3 months of pregnancy and it must not be taken after the third month of pregnancy as it may cause serious harm to your baby.

Breastfeeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. It is not recommended to take Telmisartan Actavis while breast-feeding, and your doctor may prescribe a different treatment if you want to breast-feed, especially if your baby is a newborn or premature.

Driving and using machines

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

Telmisartan Actavis contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

3. How to take Telmisartan Actavis

Always take this medicine exactly as your doctor 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.

However, your 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 such as hydrochlorothiazide, which has been shown to have an additive blood pressure-lowering effect with telmisartan.

For the reduction of cardiovascular events, the recommended daily dose of Telmisartan Actavis is one 80 mg tablet.

At the start of treatment with Telmisartan Actavis 80 mg, blood pressure should be monitored frequently.

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

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 or another non-alcoholic drink.

It is important to take Telmisartan Actavis every day until your doctor tells you to stop.

If you think that the effect of Telmisartan Actavis is too strong or too weak, talk to your doctor or pharmacist.

If you take more Telmisartan Actavis than you should

It is important to follow the doctor’s prescription. If you accidentally take too many tablets, contact your doctor, pharmacist, or the nearest hospital emergency department immediately.

The most common symptoms of telmisartan overdose are low blood pressure (hypotension) and rapid heartbeat (tachycardia). Slow heartbeat (bradycardia), dizziness, high levels of creatinine in the blood, and sudden kidney failure have also been reported.

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 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 think 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 immediately:

Sepsis* (often called “blood infection”, a serious infection that involves an inflammatory reaction of the whole 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 contact their doctor immediately. If these side effects are not treated, they can be fatal.

Other possible 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 (low red blood cell count), high levels of potassium in the blood, insomnia (difficulty falling asleep), depression (feeling sad), fainting (syncope), dizziness (vertigo), slow heartbeat (bradycardia), low blood pressure (hypotension) in users treated for high blood pressure, dizziness when standing up (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 (myalgia), kidney failure including sudden kidney 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 infection”, a serious infection that involves an inflammatory reaction of the whole body and can cause death), increased levels of certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), severe allergic reaction (anaphylactic reaction), allergic reaction (e.g. rash, itching, difficulty breathing, wheezing, low blood pressure), low blood sugar levels (in diabetic patients), anxiety, somnolence, vision disturbances, rapid heartbeat (tachycardia), dry mouth, stomach upset, taste disturbances (dysgeusia), abnormal liver function (Japanese patients show a higher tendency to experience this side effect), sudden swelling of the skin and mucous membranes that can cause death (angioedema including fatal outcome), eczema (a skin disorder), redness of the skin, hives (urticaria), severe drug rash, joint pain (arthralgia), pain in the limbs, tendon pain, flu-like illness, increased levels of uric acid in the blood, increased levels of 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 treatment with 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 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 to protect from light.

HDPE tablet container:

Keep the container tightly closed 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 40 mg of telmisartan.
• The other ingredients are magnesium stearate, sodium croscarmellose, mannitol, povidone, potassium hydroxide granules.

Appearance of Telmisartán Actavis and Package Contents

The 40 mg tablets are white, oval, biconvex with a score line and the logo T on one side. The tablet can be divided into two equal halves.

Package sizes:

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

Tablet container: 30 and 250 tablets.

The tablet container 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 medicine by contacting the local representative of the marketing authorization holder:

Date of the Last Revision of this Leaflet:

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