Telmisartan Teva 80 mg tablets

Telmisartan Teva belongs to a class of medicines known as angiotensin-II receptor antagonists. Angiotensin II is a substance occurring in the body, which causes your blood vessels to narrow, thus increasing your blood pressure. Telmisartan Teva blocks this effect of angiotensin II so that the blood vessels relax, and your blood pressure is lowered.

Telmisartan Teva 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 several organs, which could lead sometimes to heart attacks, heart or kidney failure, strokes 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.

Do not take Telmisartan Teva

• if you are allergic (hypersensitive) to telmisartan or any other ingredients included in Telmisartan Teva tablets (see section Further information for a list of other ingredients)
• if you are more than 3 months pregnant (It is also better to avoid Telmisartan Teva 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 any of the above applies to you, tell your doctor or pharmacist before taking Telmisartan Teva.

Take special care with Telmisartan Teva

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 that you are ( or might become) pregnant. Telmisartan Teva 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 Telmisartan Teva.

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

As with all other angiotensin II receptor antagonists, Telmisartan Teva may be less effective in lowering the blood pressure in black patients.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. 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 taken at the same time with Telmisartan Teva.

• 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 antagonists, NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen), heparin, immunosuppressives (e.g. cyclosporin or tacrolimus), and the antibiotic trimethoprim.
• Diuretics (?water tablets?), especially if taken in high doses together with Telmisartan Teva, may lead to excessive loss of body water and low blood pressure (hypotension).

As with other blood pressure lowering medicines, the effect of Telmisartan Teva may be reduced when you take NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen) or corticosteroids.

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

If you suffer from a condition called ?orthostatic hypotension? (a drop in blood pressure on standing up from a sitting or lying position resulting in dizziness or faintness) your condition may worsen if you take Telmisartan Teva in combination with:

• Other medicines used to treat high blood pressure
• Baclofen (a muscle relaxant)
• Amifostine (a protective medicine during radiotherapy for cancer treatment)
• Alcohol
• Barbiturates (strong sleeping tablets)
• Narcotics (strong pain killers)
• Antidepressants

Taking Telmisartan Teva with food and drink
You can take Telmisartan Teva with or without food.

Pregnancy and breast-feeding

Pregnancy

You must tell your doctor if you think you are ( or might become) pregnant. Your doctor will normally advise you to stop taking Telmisartan Teva 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. Telmisartan Teva 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. Telmisartan Teva 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
No information is available on the effect of Telmisartan Teva on the ability to drive or operate machinery. Some people feel dizzy or tired when they are treated for high blood pressure. If you feel dizzy or tired, do not drive or operate machinery.

Important information about some of the ingredients of Telmisartan Teva tablets

Telmisartan Teva contains sorbitol.
If you are intolerant to some sugars, contact your doctor before taking Telmisartan Teva.

Always take Telmisartan Teva exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Try to take the tablet at the same time each day. You can take Telmisartan Teva with or without food. The tablets should be swallowed with some water or other non-alcoholic drink. It is important that you take Telmisartan Teva every day until your doctor tells you otherwise. If you have the impression that the effect of Telmisartan Teva is too strong or too weak, talk to your doctor or pharmacist.

The usual dose of Telmisartan Teva for most patients is 40 mg once a day to control your blood pressure over the 24-hour period. Your doctor has recommended a higher dose of one 80 mg tablet daily. Alternatively, Telmisartan Teva may be used in combination with diuretics (?water? tablets) such as hydrochlorothiazide which has been shown to have an additive blood pressure lowering effect with Telmisartan Teva.

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

Please follow these steps to remove the tablet from the blister strip:

1. Separate one individual blister cell from the rest of the strip by gently tearing along the perforations around it

2. Carefully peel off the top paper layer

3. Push the tablet through the exposed foil

4. Put the tablet in your mouth and swallow with water or a suitable liquid

If you take more Telmisartan Teva 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 Telmisartan Teva
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 forgotten individual doses.

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

Like all medicines, Telmisartan Teva can cause side effects, although not everybody gets them. These side effects may occur with certain frequencies, which are defined as follows:
very common: affects more than 1 user in 10
common: affects 1 to 10 users in 100
uncommon: affects 1 to 10 users in 1,000
rare: affects 1 to 10 users in 10,000
very rare: affects less than 1 user in 10,000
not known: frequency cannot be estimated from the available data

Uncommon side effects:
High potassium levels, fainting (syncope), difficulty falling asleep, feeling of spinning (vertigo), low blood pressure (hypotension), shortness of breath, abdominal pain, diarrhoea, dry mouth, discomfort in the abdomen, bloating, increased sweating, itching, muscle pain (myalgia), kidney impairment including acute kidney failure, and pain in the chest.

Rare side effects:
Upper respiratory tract infection (e.g. sore throat, inflamed sinuses, common cold), deficiency in red blood cells (anaemia), low platelet count (thrombocytopenia), feeling anxious, feeling sad (depression), impaired vision, fast heart beat (tachycardia), dizziness on standing up (orthostatic hypotension), upset stomach, vomiting, abnormal liver function, redness of skin, rapid swelling of the skin and mucosa (angioedema), hives (urticaria), joint pain (arthralgia), back pain, muscle cramps, pain in extremity, symptoms of weakness, flu-like-illness, increased levels of uric acid, creatinine, hepatic enzymes or creatine phosphokinase in the blood.

Side effects of unknown frequency:
Urinary tract infections, increase in certain white blood cells (eosinophilia), allergic reaction (e.g. rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), slow heart rate (bradycardia), drug rash, eczema (a skin disorder), inflammation of the tendons, ineffectiveness of Telmisartan Teva, decreased haemoglobin (a blood protein),sepsis* (often called ?blood poisoning?, is a severe infection with whole-body inflammatory response which can lead to death).

*In a long-term study involving more than 20,000 patients, more patients treated with telmisartan experienced sepsis compared with patients who received no telmisartan. The event may have happened by chance or could be related to a mechanism currently not known.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not use Telmisartan Teva after the expiry date which is stated on the carton and blister after ?EXP?. The expiry date refers to the last day of that month.

This medicinal product 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 to protect the environment.

What Telmisartan Teva contains

• The active substance is telmisartan. Each Telmisartan Teva tablet contains 80 mg telmisartan.
• The other ingredients are microcrystalline cellulose (Avicel PH 102), sodium starch glycolate (Type

A), poloxamers, meglumine, povidone (PVP K-30), sorbitol (E420), magnesium stearate

What Telmisartan Teva looks like and contents of the pack

Telmisartan Teva 80 mg tablets are white to off white, oval shaped tablets; one side of the tablet is debossed with the number "93". The other side of the tablet is debossed with the number "7460".

Telmisartan Teva is provided in blisters containing 14x1, 28x1, 30x1, 40x1, 56x1, 60x1, 84x1, 90x1, 98x1, 100x1 tablet, although not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation Holder is:

Teva Pharma B.V.,
Computerweg 10,
3542 DR Utrecht,
The Netherlands

The manufacturer is:

TEVA Pharmaceutical Works Private Limited Company
H-4042 Debrecen,
Pallagi út 13,
Hungary

Or:

TEVA Pharmaceutical Works Private Limited Company
H-2100 Gödöll-,
Táncsics Mihály út 82
Hungary

Or:

TEVA UK Ltd
Brampton Road,
Hampden Park,
Eastbourne,
East Sussex,
BN22 9AG
United Kingdom

Or:

Pharmachemie B.V.
Swensweg 5,
2031 GA, Haarlem,
The Netherlands

Or:

TEVA Santé SA,
Rue Bellocier,
89107 Sens,
France

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder

BelgiëBelgiqueBelgien Teva Pharma Belgium N.V.S.A. TelTél 32 3 820 73 73 LuxembourgLuxemburg Teva Pharma Belgium S.A. TélTel 32 3 820 73 73

Te 359 2 489 95 82 Magyarország Teva Magyarország Zrt Tel. 36 1 288 64 00

eská republika Teva Pharmaceuticals CR, s.r.o. Tel 420 251 007 111 Malta Teva .. el 30 210 72 79 099

Danmark Teva Denmark AS Tlf 45 44 98 55 11 Nederland Teva Nederland B.V. Tel 31 0 800 0228400

Deutschland Teva Generics GmbH Tel 49 351 834 0 Norge Teva Sweden AB Tlf 46 42 12 11 00

Österreich Teva Generics GmbH Tel 49 351 834 0 Eesti Teva Eesti esindus UAB Sicor Biotech Eesti filiaal Tel 372 611 2409

Teva .. 30 210 72 79 099 Polska Teva Pharmaceuticals Polska Sp. z o.o. Tel. 48 22 345 93 00

España Teva Genéricos Española, S.L.U Tél 34 91 387 32 80 Portugal Teva Pharma - Produtos Farmacêuticos Lda Tel 351 214 235 910

France Teva Santé Tél 33 1 55 91 7800 România Teva Pharmaceuticals S.R.L Tel 4021 230 65 24

Ireland Teva Pharmaceuticals Ireland Tel 353 042 9395 892 Slovenija Pliva Ljubljana d.o.o. Tel 386 1 58 90 390

Ísland Teva UK Limited Sími 44 1323 501 111. Slovenská republika Teva Pharmaceuticals Slovakia s.r.o. Tel 421 2 5726 7911

Italia Teva Italia S.r.l. Tel 39 0289179805 SuomiFinland Teva Sweden AB PuhTel 46 42 12 11 00

Teva .. 30 210 72 79 099 Sverige Teva Sweden AB Tel 46 42 12 11 00

Latvija UAB Sicor Biotech filile Latvij Tel 371 67 784 980 United Kingdom Teva UK Limited Tel 44 1323 501 111

Lietuva

UAB ?Sicor Biotech?
Tel: +370 5 266 02 03

This leaflet was last approved in {MM/YYYY}.