TELMISARTAN TEVA PHARMA 20 mg TABLETS

Introduction

Package Leaflet: Information for the User

Telmisartan Teva Pharma 20 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 Teva Pharma and what is it used for
2. What you need to know before you take Telmisartan Teva Pharma
3. How to take Telmisartan Teva Pharma
4. Possible side effects
5. Storage of Telmisartan Teva Pharma
6. Contents of the pack and other information

1. What is Telmisartan Teva Pharma and what is it used for

Telmisartan Teva Pharma belongs to a group 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 Teva Pharma blocks the effect of angiotensin II, causing the blood vessels to relax and your blood pressure to decrease.

Telmisartan Teva Pharma is used to treat essential hypertension (high blood pressure). "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 failure, kidney failure, stroke, or blindness. Usually, high blood pressure does not produce any symptoms before damage occurs. Therefore, it is important to regularly measure your blood pressure to check if it is within the normal range.

Telmisartan Teva is also used to reduce cardiovascular events (e.g., heart attack or stroke) in patients at risk because their blood supply to the heart or legs is reduced or blocked, or they have had a stroke or have a high risk of developing diabetes. Your doctor will inform you if you are at high risk of having these events.

2. What you need to know before you take Telmisartan Teva Pharma

Do not take Telmisartan Teva Pharma

• 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 Teva Pharma at the beginning 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 insufficiency and are treated with medicines that lower blood pressure and contain aliskiren.

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

Warnings and precautions

Consult your doctor if you are suffering or have ever suffered from any of the following conditions or diseases:

• Kidney disease or kidney transplant
• Renal artery stenosis (narrowing of the blood vessels to one or both kidneys)
• Liver disease
• Heart problems
• High levels of aldosterone (water and salt retention in the body along with an imbalance of various minerals in the blood)
• Low blood pressure (hypotension), which may occur if you are dehydrated (excessive loss of water from the body) or have low salt levels due to treatment with diuretics, low-salt diet, diarrhea, or vomiting
• High levels of potassium in the blood
• Diabetes

Consult your doctor before taking Telmisartan Teva Pharma:

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

• an ACE inhibitor (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
• aliskiren.

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

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

If you think you might be pregnant (or might become pregnant), tell your doctor. The use of Telmisartan Teva Pharma is not recommended at the beginning of pregnancy and should 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 Teva Pharma.

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

Children and adolescents

The use of Telmisartan Teva Pharma is not recommended in children and adolescents up to 18 years.

Other medicines and Telmisartan Teva Pharma

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 medicines or take other precautions. In some cases, you may need to stop taking one of the medicines. This is especially applicable to the following medicines when taken with Telmisartan Teva Pharma:

• Medicines containing lithium for treating some types of depression.
• Medicines that may increase potassium levels in the blood, such as potassium-sparing diuretics, potassium supplements, ACE inhibitors, angiotensin II receptor antagonists, NSAIDs (e.g., aspirin or ibuprofen), heparin, immunosuppressants (e.g., cyclosporine or tacrolimus), and the antibiotic trimethoprim.
• Diuretics, especially when taken in high doses with Telmisartan Teva Pharma, may cause excessive loss of water from the body and low blood pressure (hypotension).
• If you are taking an ACE inhibitor or aliskiren (see also the information under the heading “Do not take Telmisartan Teva Pharma” and “Warnings and precautions”).
• Digoxin.

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

Telmisartan Teva Pharma may increase the blood-lowering effect of other medicines used to treat high blood pressure.

If you have a condition called “orthostatic hypotension” (a drop in blood pressure when standing up from sitting or lying down, resulting in dizziness or fainting), your condition may worsen if you take Telmisartan Teva Pharma in combination with:

• Other medicines used to treat high blood pressure
• Baclofen (a muscle relaxant)
• Amifostine (a protective medicine during radiation therapy for cancer treatment)
• Alcohol
• Barbiturates (strong sleeping pills)
• Narcotics (strong painkillers)
• Antidepressants

Pregnancy and breastfeeding

Pregnancy

Tell your doctor if you think you might be pregnant (or might become pregnant). Your doctor will normally advise you to stop taking Telmisartan Teva Pharma before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Telmisartan Teva Pharma. The use of Telmisartan Teva Pharma is not recommended during the first trimester of pregnancy and should 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 will start breast-feeding. It is not recommended to take Telmisartan Teva Pharma while breast-feeding, and your doctor may decide to 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 may feel dizzy or tired when taking Telmisartan Teva. If you feel dizzy or tired, do not drive or use machines.

Telmisartan Teva Pharma contains sorbitol

This medicine contains 21.4 mg of sorbitol in each tablet.

Telmisartan Teva Pharma 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 Teva Pharma

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

The recommended dose of Telmisartan Teva is one tablet per day. Try to take the tablet at the same time each day. You can take Telmisartan Teva Pharma with or without food. The tablets should be swallowed with a little water or another non-alcoholic drink. It is important that you take Telmisartan Teva Pharma every day until your doctor tells you to stop. If you think that the effect of Telmisartan Teva Pharma is too strong or too weak, talk to your doctor or pharmacist.

For the treatment of high blood pressure, the usual dose of Telmisartan Teva Pharma for most patients is 40 mg once daily to control blood pressure over 24 hours. Your doctor has prescribed a lower dose of one 20 mg tablet daily. Alternatively, Telmisartan Teva Pharma may be used in combination with diuretics such as hydrochlorothiazide, which have been shown to have an additive blood pressure-lowering effect with Telmisartan Teva Pharma.

For the reduction of cardiovascular events, the usual dose of Telmisartan Teva is one 80 mg tablet once daily. At the start of treatment with Telmisartan Teva 80 mg, 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 Telmisartan Teva Pharma than you should

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

If you forget to take Telmisartan Teva Pharma

If you forget to take a dose, do not worry. Take it as soon as you remember and then continue as before. 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 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.

Possible side effects of Telmisartan

Common side effects (may affect up to 1 in 10 people):

Low blood pressure (hypotension) in patients treated for cardiovascular events

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), decreased red blood cells (anemia), high levels of potassium, difficulty falling asleep (insomnia), feeling sad (depression), fainting (syncope), spinning sensation (vertigo), slow heart rate (bradycardia), low blood pressure (hypotension) in patients treated for high blood pressure, difficulty breathing, cough, abdominal pain, diarrhea, abdominal discomfort, abdominal distension, vomiting, itching, increased sweating, drug rash, back pain, muscle cramps, muscle pain (myalgia), kidney failure including acute kidney failure, chest pain, and symptoms of weakness 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 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), feeling anxious, drowsiness, vision disturbance, increased heart rate (tachycardia), dry mouth, stomach upset, abnormal liver function (this is more likely to occur in Japanese patients), sudden swelling of the skin and mucous membranes that can cause death (angioedema including fatal outcome), hives (urticaria), severe drug rash, joint pain (arthralgia), pain in the limbs, pain in the tendons, flu-like illness, increased levels of uric acid, increased 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 an isolated case or related to an unknown mechanism.

**There have been reports of progressive scarring of lung tissue 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. Storage of Telmisartan Teva Pharma

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 and blister after “EXP”. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

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 Telmisartan Teva Pharma

• The active ingredient is telmisartan. Each Telmisartan Teva Pharma tablet contains 20 mg of telmisartan.
• The other components are microcrystalline cellulose (Avicel PH 102), sodium glycolate starch (Type A), poloxamers, meglumine, povidone (PVP K-30), sorbitol (E420), magnesium stearate.

Appearance of the product and container contents

Telmisartan Teva Pharma 20 mg tablets are white to off-white, oval-shaped tablets; one side of the tablet is engraved with the number “93”. The other side of the tablet is engraved with the number “7458”.

Telmisartan Teva Pharma is supplied in aluminum-aluminum blisters with a separable sheet of unit doses precut and aluminum-aluminum blisters of unit doses precut containing 14, 28, 30, 40, 56, 60, 84, 90, 98, 100 tablets per each type of blister pack, although only some pack sizes may be marketed.

Keep in mind that the instructions on how to remove the tablet from the blister strip are given on the outer carton of the blisters with a separable sheet.

Telmisartan Teva Pharma is also supplied in aluminum-aluminum blisters of pack size 28 and 30 tablets

Marketing authorization holder and manufacturer

The marketing authorization holder is:

Teva B.V.

Swensweg 5

2031GA Haarlem

Netherlands

The manufacturer is:

TEVA Pharmaceutical Works Private Limited Company

H-4042 Debrecen,

Pallagi út 13,

Hungary

Or:

Pharmachemie B.V.

Swensweg 5,

2031 GA, Haarlem,

Netherlands

For more information about this medicinal product, please contact the local representative of the marketing authorization holder:

Date of the last revision of this leaflet: {month/YYYY}.

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