Telmisartan Teva
telmisartan
telmisartan
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.
What Telmisartan Teva is and what it is used for
What you need to know before you take Telmisartan Teva
How to take Telmisartan Teva
Possible side effects
How to store Telmisartan Teva
Contents of the pack and other information
Medicinal product no longer authorised
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) 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 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.
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 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.
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:
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”.
Medicinal product no longer authorised
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. Telmisartan Teva may be less effective in lowering the blood pressure in black patients.
The use of Telmisartan Teva in children and adolescents up to the age of 18 years is not recommended.
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.
If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Telmisartan Teva” and “Warnings and precautions”).
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).
Digoxin.
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
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.
Medicinal product no longer authorised
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.
Some people feel dizzy or tired when taking Telmisartan Teva. If you feel dizzy or tired, do not drive or
operate machinery.
This medicine contains 21.4 mg sorbitol in each tablet.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
Always take Telmisartan Teva 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 a day. 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.
For treament of high blood pressure, 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 lower dose of one 20 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.
For reduction of cardiovascular events, the usual dose of Telmisartan Teva is one 80 mg tablet once a day. At the beginning of the preventive therapy 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 a day.
If you accidentally take too many tablets, contact your doctor, pharmacist, or your nearest hospital emergency department immediately.
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.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should see your doctor immediately if you experience any of the following symptoms:
Medicinal product no longer authorised
Sepsis (often called "blood poisoning", is a severe infection with whole-body inflammatory response usually accompanied by high fevers, hot, flushed skin, elevated heart rate, rapid breathing, altered mental status, swelling, and low blood pressure), 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.
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):
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), 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).
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.
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.
Medicinal product no longer authorised
The active substance is telmisartan. Each Telmisartan Teva tablet contains 20 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
Telmisartan Teva 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 is provided in peelable perforated unit-dose aluminium-aluminium blisters and perforated unit-dose aluminium-aluminium blisters containing 14x1, 28x1, 30x1, 40x1, 56x1, 60x1, 84x1, 90x1, 98x1, 100x1 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.
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 út 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
Teva Pharma Belgium N.V./S.A./AG
Tel/Tél: +32 38207373
UAB Teva Baltics
Tel: +370 52660203
Тева Фарма ЕАД
Teл: +359 24899585
Teva Pharma Belgium N.V./S.A./AG
Belgien/Belgique Tél/Tel: +32 38207373
Teva Pharmaceuticals CR, s.r.o.
Tel: +420 251007111
Teva Gyógyszergyár Zrt.
Tel.: +36 12886400
Medicinal product no longer authorised
Teva Denmark A/S
Tlf: +45 44985511
Teva Pharmaceuticals Ireland
L-Irlanda
Tel: +353 19127700
Teva GmbH
Tel: +49 73140208
Teva Nederland B.V.
Tel: +31 800 0228400
UAB Teva Baltics Eesti filiaal Tel: +372 661 0801
Teva Norway AS Tlf: +47 66775590
Specifar A.B.E.E.
Τηλ: +30 2118805000
ratiopharm Arzneimittel Vertriebs-GmbH
Tel: +43 197007
Teva Pharma, S.L.U
Tél: +(34) 91 387 32 80
Teva Pharmaceuticals Polska Sp. z o.o.
Tel.: +48 223459300
Teva Santé
Tél: +33 155917800
Teva Pharma - Produtos Farmacêuticos, Lda
Tel: +351 214767550
Pliva Hrvatska d.o.o Tel: + 385 13720000
Teva Pharmaceuticals S.R.L. Tel: +40 212306524
Teva Pharmaceuticals Ireland
Tel: +353 19127700
Pliva Ljubljana d.o.o.
Tel: +386 15890390
Teva Finland Oy
Finnland
Sími: +358 201805900
Teva Pharmaceuticals Slovakia s.r.o.
Tel: +421 257267911
Teva Italia S.r.l.
Tel: +39 028917981
Teva Finland Oy
Puh/Tel: +358 201805900
Specifar A.B.E.E.
Ελλάδα
Τηλ: +30 2118805000
Teva Sweden AB Tel: +46 42121100
UAB Teva Baltics filiāle Latvijā
Tel: +371 67323666
Medicinal product no longer authorised