TELMISARTAN ACTAVIS 80 mg TABLETS

Introduction

Package Leaflet: Information for the User

Telmisartan Actavis 80mg 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 your blood vessels relax and your blood pressure is reduced.

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 attack, heart or kidney failure, stroke, or blindness. Usually, high blood pressure does not produce symptoms before damage has occurred. Therefore, it is important to regularly measure your blood pressure to check 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 their blood supply to the heart or legs is reduced or blocked, or who have had a stroke or have a high risk of having 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 takeTelmisartan 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 the section on Pregnancy).
• 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 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 your kidneys (renal artery stenosis).
• Liver disease.
• Heart problems.
• High levels of aldosterone in your blood (water and salt retention in your body combined with an imbalance of various minerals in your blood).
• Low blood pressure (hypotension) that is likely to occur if you are dehydrated (excessive fluid loss) or have low salt levels in your blood due to diuretic treatment, 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), especially if you have kidney problems associated with diabetes.
• aliskiren.

Your doctor may check your kidney function, blood pressure, and levels of electrolytes (e.g., 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, tell your doctor. 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 harm your baby (see the section on 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

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, you may need 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 types of depression.
• Medicines that may increase potassium levels in your blood, such as potassium-sparing diuretics, potassium supplements, or salt substitutes containing potassium.
• Diuretics, especially when taken in high doses with Telmisartan Actavis, may cause excessive loss of body water and low blood pressure (hypotension).
• If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also the 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 drugs (NSAIDs, e.g., aspirin or 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

Tell 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 harm 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 choose a different treatment for you, especially if you are breast-feeding a newborn or premature infant.

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

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

For the treatment of high blood pressure, the usual dose of Telmisartan Actavis 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 regularly.

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

If your kidneys are not working properly, 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 some water or other 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 an overdose of telmisartan are low blood pressure (hypotension) and fast 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 severe infection that involves an inflammatory reaction of the whole body), rapid swelling of your 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.

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, insomnia (difficulty falling asleep), depression, 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 severe 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, swelling of the face or low blood pressure), low blood sugar levels (in diabetic patients), anxiety, somnolence, vision disturbance, fast heartbeat (tachycardia), dry mouth, stomach upset, taste disturbance (dysgeusia), abnormal liver function (Japanese patients are more likely to experience this side effect), sudden swelling of your 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 extremities, tendon pain, pseudogrip syndrome, decrease in hemoglobin (a blood protein), increased levels of uric acid, 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 experience 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 the month stated.

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. Container contents and additional information

Composition of Telmisartán Actavis

• The active ingredient is telmisartan. Each tablet contains 80 mg of telmisartan.
• The other components are magnesium stearate, sodium croscarmellose, mannitol, povidone, potassium hydroxide granules.

Appearance of Telmisartán Actavis and container contents

The 80 mg tablets are white, oval, biconvex with the T1 logo on one side

Container 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 container 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 last revision of this leaflet:

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