Telmisartan Actavis 80 mg tablets

Telmisartan Actavis contains the active substance telmisartan which 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 lowered.

Telmisartan Actavis tablets are 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 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.

Telmisartan Actavis is also used toreduce cardiovascular events (i.e. heart attack or stroke) in patients 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 high risk diabetes. Your doctor can tell you if you are at high risk for such events.

Do not take Telmisartan Actavis

• if you are allergic to telmisartan or any other ingredients included in Telmisartan Actavis 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 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 any of the above applies to you, tell your doctor or pharmacist before taking Telmisartan Actavis.

Take special care with Telmisartan Actavis

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.

In case of surgery or anaesthesia, you should tell your doctor that you are taking Telmisartan Actavis.

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

Children

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

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 Actavis

• 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-converting enzyme inhibitors, to treat high blood pressure), angiotensin II receptor antagonists (to treat high blood pressure), NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen), heparin (a medicine for thinning the blood), immunosuppressives (e.g. cyclosporin or tacrolimus), and the antibiotic trimethoprim.
• Diuretics ('water tablets'), especially if taken in high doses together with Telmisartan Actavis, may lead to excessive loss of body water and low blood pressure (hypotension).

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

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

Taking Telmisartan Actavis with food and drink
You can take Telmisartan Actavis 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 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 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 Actavis 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 Actavis on the ability to drive or use machines.
Some people feel dizzy or tired when they are treated for high blood pressure. If you feel dizzy or tired, do not drive or use machines.

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

For 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, sometimes 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 (?water tablets?) such as hydrochlorothiazide which has been shown to have an additive blood pressure lowering effect with telmisartan.

For reduction of cardiovascular events, the usual dose of Telmisartan Actavis is one 80 mg tablet once a day. At the beginning of the preventive therapy with Telmisartan Actavis 80 mg, blood pressure should be frequently monitored.

In patients with liver problems the usual dose should not exceed 40 mg once daily.

In patients with kidney problems a lower starting dose of 20 mg is recommended.

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 that you take Telmisartan Actavis every day until your doctor tells you otherwise. 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 take more Telmisartan Actavis than you should
It is important to keep to the dose as prescribed by your doctor. If you accidentally take too many tablets ask your doctor what to do or contact your nearest hospital emergency department immediately.
The most common symptoms of telmisartan overdose are low blood pressure (hypotension) and fast heart beat (tachycardia). Slow heart beat (bradycardia), dizziness, higher 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 your medicine you should take the dose 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 forgotten individual doses.

If you stop taking Telmisartan Actavis

Take Telmisartan Actavis every day for as long as your doctor prescribes it in order 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.

Like all medicines, Telmisartan Actavis 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 include:

• high potassium levels - fainting (syncope)
• difficulty falling asleep - feeling of spinning (vertigo)
• low blood pressure (hypotension) and - shortness of breath dizziness on standing up (orthostatic hypotension)
• stomach ache - diarrhoea
• upper respiratory tract infection (e.g. sore - heartburn throat, inflamed sinuses, common cold)
• bloating - increased sweating
• itching - back pain
• kidney problems including sudden kidney - pain in the chest failure
• vomiting - urinary tract infections
• deficiency in red blood cells (anaemia) - rash
• feeling sad (depression) - slow heart rate (bradycardia)
• symptoms of weakness - increased levels of creatinine in the blood
• muscle cramps

Rare side effects include:

• low platelet count (thrombocytopenia) - feeling anxious,
• impaired vision - fast heart beat (tachycardia)
• decreased haemoglobin (a blood protein) - upset stomach
• dry mouth - abnormal liver function
• redness of skin - rapid swelling of the skin and mucosa (angioedema)
• flu-like illness - joint pain (arthralgia)
• pain in extremity - increased levels of liver enzymes or creatine phosphokinase in the blood
• increased levels of uric acid in the blood

Side effects of unknown frequency include:

• hives (urticaria) - increase in certain white blood cells (eosinophilia)
• allergic reaction (e.g. rash, itching, - inflammation of the tendons difficulty breathing, wheezing, swelling of the face or low blood pressure)
• 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 (blood poisoning) compared with patients who received no telmisartan. This may have happened by chance or could be related to a way that telmisartan works that is 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 Actavis after the expiry date which is stated on the carton, bottle or blister 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 to protect the environment.

What Telmisartan Actavis contains

• The active substance is telmisartan. Each tablet contains 80 mg telmisartan.
• The other ingredients are magnesium stearate, croscarmellose sodium, mannitol, povidone, potassium hydroxide pellets.

What Telmisartan Actavis looks like and contents of the pack

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

Telmisartan Actavis is provided in blister packs of 14 (2 x 7), 28 (4 x 7), 30 (3 x 10), 56 (8 x 7), 84 (12 x 7), 90 (9 x 10), 98 (14 x 7) or 100 (10 x 10) tablets and tablets containers with 30 and 250 tablets.
The tablet container contains a desiccant, do not eat the desiccant.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Actavis Group PTC ehf.
Reykjavíkurvegi 76-78
220 Hafnarfjörður
Iceland

Manufacturer

Actavis Hf.
Reykjavikurvegi 76-78,
IS-220 Hafnafjordur
ICELAND

Actavis Ltd.
BLB 016

Bulebel Industrial Estate

Zejtun

MALTA

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

BelgiëBelgiqueBelgien ALL-in-1 bvba TélTel 32 032 86 88 88 LuxembourgLuxemburg ALL-in-1 bvba BelgiqueBelgien TélTel 32 032 86 88 88

Te. 359 2 9321 680 Magyarország Actavis Hungary Kft Tel. 3652431-313314

eská republika Actavis CZ a.s. Tel 420251001680 Malta Actavis Ltd. Tel 35621693533

Danmark Actavis AS Tlf 45 72 22 30 00 Nederland Actavis B.V. Tel 035 -54 299 33

Deutschland Actavis Deutschland GmbH Co. KG Telefon 49 021731674 0 Norge Actavis Norway AS Tlf 47 815 22 099

Eesti UAB Actavis Baltics Eesti Filiaal Tel 372 6100 565 Österreich Actavis GmbH Tel 43 0662 435 235 14

Polska Actavis Polska Sp. z o.o Tel. 48 22 512 29 00 PharOS - Pharmaceutical Oriented Services Ltd Tel 30 210 66 64 667 8

España Actavis Spain, S.A. Tfno. 34 91 630 86 45 Portugal Actavis AS Sucursal Tel 351 21 722 06 50

France Actavis France Tél 33 1 40 83 77 77 România Actavis SRL Tel 40 21 318 17 77

Slovenija Sanolabor d.d. phone 386 01 585-4211 Ireland Actavis UK Limited United Kingdom Tel 441271311234

Ísland Actavis Group PTC ehf Sími 354-535 2326 Slovenská republika Actavis s.r.o. Tel 421 2 3255 3800

Italia Actavis Italy S.p.A. Tel 39 0331 583111 SuomiFinland Actavis Oy PuhTel 358 09 348 233

A. Potamitis Medicare Ltd 35722583333 Sverige Actavis AB Tel 46 8 13 63 70

Latvija Actavis Baltics prstvniecba Latvij Tel 371 67067873 United Kingdom Actavis UK Limited Tel 441271311234

Lietuva
UAB ?Actavis Baltics?
Tel: +370 5 260 9615

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