Telmisartan Teva Pharma - patient leaflet, side effects, dosage

- 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.

What is in this leaflet

• 1. What Telmisartan Teva Pharma is and what it is 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. How to store Telmisartan Teva Pharma

• 6. Contents of the pack and other information

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

Telmisartan Teva Pharma 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 Pharma blocks this effect of angiotensin II so that the blood vessels relax, and your blood pressure is lowered.

Telmisartan Teva Pharma 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 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 Teva Pharma is also used to reduce cardiovascular events (i.e. heart attack or stroke) in adults 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.

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 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 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 you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.

If any of the above applies to you, tell your doctor or pharmacist before taking Telmisartan Teva

Pharma.

Warnings and precautions

Talk to 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

Talk to 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 (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.

• – 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 information under the heading “Do not take Telmisartan Teva Pharma”.

You must tell your doctor if you think that you are (or might become) pregnant. Telmisartan Teva Pharma 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 Pharma.

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

Children and adolescents

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

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 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 Pharma.

• 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 Pharma, may lead to excessive loss of body water and low blood pressure (hypotension).
• If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Telmisartan Teva Pharma” and “Warnings and precautions”).
• Digoxin.

The effect of Telmisartan Teva Pharma may be reduced when you take NSAIDs (non steroidal antiinflammatory medicines, e.g. aspirin or ibuprofen) or corticosteroids.

Telmisartan Teva Pharma 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 Pharma 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

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 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. Telmisartan Teva Pharma 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 Pharma 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

Some people feel dizzy or tired when taking Telmisartan Teva Pharma.If you feel dizzy or tired, do not drive or operate machinery.

Telmisartan Teva Pharma contains sorbitol.

This medicine contains 21.4 mg sorbitol in each tablet.

Telmisartan Teva Pharma contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say 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 Pharma is one tablet a 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 some water or other non-alcoholic drink. It is important that you take Telmisartan Teva Pharma every day until your doctor tells you otherwise. If you have the impression that the effect of Telmisartan Teva Pharma is too strong or too weak, talk to your doctor or pharmacist.

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

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

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

If you take more Telmisartan Teva Pharma 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 Pharma

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 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 need immediate medical attention:

You should see your doctor immediately if you experience any of the following symptoms:

Sepsis* (often called „blood poisoning“, is a severe infection with whole-body inflammatory response), rapid swelling of the skin and mucosa (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 see their doctor immediately. If these effects are not treated they could be fatal.

Possible side effects of telmisartan:

Common side effects (may affect up to 1 in10 people):

Low blood pressure (hypotension) in users treated for reduction of cardiovascular events.

Uncommon side effects (may affect up to 1 in 100 people):

Urinary tract infections, upper respiratory tract infection (e.g. sore throat, inflamed sinuses, common cold), deficiency in red blood cells (anaemia), high potassium levels, difficulty falling asleep, feeling sad (depression), fainting (syncope), feeling of spinning (vertigo), slow heart rate (bradycardia), low blood pressure (hypotension) in users treated for high blood pressure, dizziness on standing up (orthostatic hypotension), shortness of breath, cough, abdominal pain, diarrhoea, discomfort in the abdomen, bloating, vomiting, itching, increased sweating, drug rash, back pain, muscle cramps, muscle pain (myalgia), kidney impairment including acute kidney failure, pain in the chest, feeling of weakness, and increased level of creatinine in the blood.

Rare side effects (may affect up to 1 in 1,000 people):

Sepsis* (often called „blood poisoning“, is a severe infection with whole-body inflammatory response which can lead to death), increase in 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), feeling anxious, somnolence, impaired vision, fast heart beat (tachycardia), dry mouth, upset stomach, taste disturbance (dysgeusia), abnormal liver function (Japanese patients are more likely to experience these side effects), rapid swelling of the skin and mucosa which can also lead to death

(angioedema also with fatal outcome), eczema (a skin disorder), redness of skin, hives (urticaria), severe drug rash, joint pain (arthralgia), pain in extremity, tendon pain, flu-like-illness, decreased haemoglobin (a blood protein), increased levels of uric acid, increased hepatic 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).

• * The event may have happened by chance or could be related to a mechanism currently not known.

• Cases of progressive scarring of lung tissue have been reported during intake of 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. How to store Telmisartan Teva

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 that month.

This medicinal product does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Telmisartan Teva Pharma contains

• – The active substance is telmisartan. Each Telmisartan Teva Pharma tablet contains 20 mg telmisartan.

• – The other ingredients are microcrystalline cellulose (Avicel PH 102), sodium starch glycolate (Type

What Telmisartan Teva Pharma looks like and contents of the pack

Telmisartan Teva Pharma 20 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 „7458“.

Telmisartan Teva Pharma is provided in peelable perforated unit-dose aluminium-aluminium blisters and perforated unit-dose aluminium-aluminium blisters containing 14×1, 28×1, 30×1, 40×1, 56×1, 60×1, 84×1, 90×1, 98×1, 100×1 tablets for each type of blister presentation, although not all pack sizes may be marketed. Please note that instructions on how to remove the tablet from the blister strip are given on the outer carton of the peelable blisters.

Telmisartan Teva Pharma is also provided in aluminium-aluminium blister packs of 28 and 30 tablets.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation Holder is:

Teva B.V.

Swensweg 5

2031GA Haarlem

The Netherlands

The manufacturer is:

TEVA Pharmaceutical Works Private Limited Company

H-4042 Debrecen,

Pallagi ut 13,

Hungary

Or:

Pharmachemie B.V.

Swensweg 5,

2031 GA, Haarlem,

The Netherlands

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

Tql: +30 2118805000

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

Detailed information on this medicine is available on the European Medicines Agency web site:.