Telmisartan Actavis – Package Leaflet: InfoCons – Consumer Protection presents, in an accessible format, the official package leaflet of the medicine Telmisartan Actavis, as authorised in the European Union and published in the Union Register of medicinal products.
Before anything else
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.
What is i n this leaflet :
1. What Telmisartan Actavis is and what it is used for 2. What you need to know before you take Telmisartan Actavis 3. How to take Telmisartan Actavis 4. Possible side effects 5. How to store Telmisartan Actavis 6. Contents of the pack and other information 1. What Telmisartan Actavis is and what it is used for 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 . ‘Essen tial’ 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 with in the normal range .
Telmisartan Actavis 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 Actavis
Do not take Telmisartan Actavis
- 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 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 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 Actavis.
44 Warning 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 (excessi ve 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 Actavis:
- if you are taking d igoxin.
- 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 Actavis” .
Talk to your doctor if you experienc e abdominal pain, nausea, vomiting or diarrhoea after taking Telmisartan Actavis. Your doctor will decide on further treatment. Do not stop taking Telmisartan Actavis on your own.
You must tell your doctor if you think you are ( or might become ) pregnant. Telmisartan Actavis 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 Actavis.
Telmisartan Actavis may be less effective in lowering the blood pressure in black patients.
Children and adolescents
The use of Telmisartan Actavis in children and adolescents up to the age of 18 years is not recommended .
Other medicines and Telmisartan Actavis
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 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 45 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).
- If you are taking an ACE -inhibitor or aliskiren (see also informati on under the headings “ Do not take Telmisartan Actavis” and “ Warnings and precautions ”).
- Digoxin.
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 or of medicines with blood pressure lowering potential (e.g. baclofen, amifostine) .
Furthermore, low blood pressure may be aggravated by alcohol , barbiturates, narcotics or antidepressants. You may notice this as dizziness when standing up. You should consult with your doctor if you need to adjust the dose of your other medicine while taking Telmisartan Actavis.
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
Some people feel dizzy or tired when taking Telmisartan Actavis. If you feel dizzy or tired, do not drive or use machines.
Telmisartan Actavis 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 Actavis Always take this medicine exactly as your doctor has told you. 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. Your doctor has recommended a lower dose of one 20 mg tablet daily. Telm isartan Actavis may also 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 dai ly.
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 immediatel y.
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 a forgotten dose.
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 que stions 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 t hey could be fatal.
Possible side effects of telmisartan:
Common side effects (may affect up to 1 in 10 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 s (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, discomfor t 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 th e 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 re sponse which can lead to death), increase in certain white blood cells (eosinophilia), l ow 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), feeli ng 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 th is side effect) , rapid swelling of the skin and muco sa 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 (i nterstitial lung disease)**.
Frequency ‘not known’ (frequency cannot be estimated from the available data):
Intestinal angioedema: A swelling in the gut presenting with symptoms like abdominal pain, nausea, vomiting and diarrhoea have been reported after the use of similar products.
- The event may have happened by chance or could be related to a way that telmisartan works that is currently not known.
**Cases of progressive scarring of lung tissue have been reported during intake of telmisartan.
However, it is not known whether telmi sartan 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 s afety of this medicine .
5. How to store Telmisartan Actavis 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 , 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.
Do not throw away any medicines via wastewater or hou sehold 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 Actavis contains
- The active substance is telmisartan. Each tablet contains 20 mg telmisartan.
48 – The other ingredients are magnesium stearate, croscarmellose sodium, mannitol, povidone, potassium hydroxide pellets.
What Telmisartan Actavis looks like and contents of the pack
20 mg tablets are white, round, flat w ith logo T on one side Pack sizes:
Al/Al blister packs: 14, 28, 30, 56, 84, 90, 98 and 100 tablets .
Tablet container : 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.
Dalshraun 1 220 Hafnarfjörður Iceland
Manufacturer
Actavis Ltd BLB 015-0 16 Bulebel Industrial Estate Zejtun ZTN 3000 Malta For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Teva Pharma Belg ium N.V./S.A./AG Tél/Tel: +32 382073 73 Lietuva UAB Teva Baltics Tel: +370 5 2660203 България Тева Фарма ЕАД Teл.: +359 2 4899585 Luxembourg/Luxemburg Teva Pharma Belgium N.V./S.A./AG Belgique/Belgien Tél/Tel: +32 382073 73 Česká republika Teva Pharmaceuticals CR, s.r.o.
Tel: +420 251007111 Magyarország Teva Gyógyszergyár Zrt.
Tel.: +36 12886400 Danmark Teva Denmark A/S Tlf.: +45 44985511 Malta Teva Pharmaceuticals Ireland L-Irlanda Tel: +44 2075407117 Deutschland ratiopharm GmbH Tel: +49 73140202 Nederland Teva Nederland B.V.
Tel: +31 8000228400 Eesti UAB Teva Baltics Eesti filiaal Tel: +372 6610801 Norge Teva Norway AS Tlf: +47 66775590 49 Ελλάδα TEVA HELLAS A.E.
Τηλ: +30 2118805000 Österreich ratiopharm Arzneimittel Vertriebs -GmbH Tel: +43 1970070 España Teva Pharma, S.L.U. Tel: +34 913873280 Polska Teva Pharmaceuticals Polska Sp. z o.o.
Tel.: +48 223459300 France Teva Santé Tél: +33 155917800 Portugal Teva Pharma – Produtos Farmacêuticos, Lda.
Tel: +351 214767550 Hrvatska Pliva Hrvatska d.o.o.
Tel: +385 13720000 România Teva Pharmaceuticals S.R.L .
Tel: + 40 212306524 Ireland Teva Pharmaceuticals Ireland Tel: +44 2075407117 Slovenija Pliva Ljubljana d.o.o.
Tel: +386 15890390 Ísland Teva Pharma Iceland ehf.
Sími: +354 5503300 Slovenská republika TEVA Pharmaceuticals Slovakia s.r.o.
Tel: +421 2 57267911 Italia Teva Italia S.r.l. Tel: +39 028917981 Suomi/Finland Teva Finland Oy Puh/Tel: +358 201805900 Κύπρος TEVA HELLAS A.E.
Ελλάδα Τηλ: + 30 2118805000 Sverige Teva Sweden AB Tel: +46 42121100 Latvija UAB Teva Baltics filiāle Latvijā Tel: +371 67323666
This leaflet was last revised in
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu /.
50 Package leaflet: Information for the user Telmisartan Actavis 40 mg tablets 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 effect s talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is i n this leaflet :
1. What Telmisartan Actavis is and what it is used for 2. What you need to know before you take Telmisartan Actavis 3. How to take Telmisartan Actavis 4. Possible side effects 5. How to store Telmisartan Actavis 6. Contents of the pack and o ther information 1. What Telmisartan Actavis is and what it is used for 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 usual ly 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 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 Actavis
Do not take Telmisartan Actavis
- 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 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 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 Actavis.
51 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 defici ency 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 Actavis:
- if you are taking d igoxin.
- 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 pressur e, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.
See also information under the heading “ Do not take Telmisartan Actavis”.
Talk to your doctor if you experience abdominal pain, nausea, vomiting or diarrhoea after taking Telmisartan Actavis. Your doctor will decide on further treatment. Do not stop taking Telmisartan Actavis on your own.
You must tell your doctor if you think you are ( or might become ) pregnant. Telmisartan Actavis 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 Actavis.
Telmisartan Actavis may be less effective in lowering the blood pressure in black patients.
Children and adolescents
The use of Telmisartan Actavis in children and adolescents up to the age of 18 years is not recommended .
Other medicines and Telmisartan Actavis
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 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 52 or ibuprofen), heparin (a medicine for thinning the blood), immunosuppressives (e.g. cyclosporin or t acrolimus), 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).
- If you are taking an ACE -inhib itor or aliskiren (see also information under the headings “Do not take Telmisartan Actavis” and “ Warnings and precautions ”).
- Digoxin.
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 or of medicines with blood pressure lowering potential (e.g. baclofen, amifostine) .
Furtherm ore, low blood pressure may be aggravated by alcohol , barbiturates, narcotics or antidepressants. You may notice this as dizziness when standing up. You should consult with your doctor if you need to adjust the dose of your other medicine while taking Telm isartan Actavis.
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
Some people feel dizzy or tired when taking Telmisartan Actavis. If you feel dizzy or tired, do not drive or use machines.
Telmisartan Actavis 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 Actavis Always take this medicine exactly as your doctor has told you. 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 20 mg or a higher dose of 80 mg.
Alternatively, Telmisartan Actavis may be used in combi nation 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.
53 In patients with liver problems the usual dose should not exceed 40 mg once daily.
In patie nts 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 Telmisarta n 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 a forgotten dose.
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 Act avis 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.
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 in 10 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 s (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 c ramps, 54 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 re sponse which can lead to death), i ncrease in certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), severe allergic reaction ( anaphylactic reaction), allergic reactio n (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 th is side effect) , 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 th e blood.
Very rare side effects (may affect up to 1 in 10,000 people)
Progressive scarring of lung tissue (i nterstitial lung disease)**.
Frequency ‘not known’ (frequency cannot be estimated from the available data):
Intestinal angioedema: A swelling in the gut presenting with symptoms like abdominal pain, nausea, vomiting and diarrhoea have been reported after the use of similar products. *The event may have happened by chance or could be related to a way that telmisartan works that is 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 Actavis 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, 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.
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 Actavis contains
55 – The active substance is telmisartan. Each tablet contains 40 mg telmisartan .
- The o ther ingredients are m agnesium stearate, croscarmellose sodium, mannitol, povidone, potassium hydroxide pellets.
What Telmisartan Actavis looks like and contents of the pack
40 mg tablets are white, oval, biconvex, with a break line and logo T on one side. The tablet can be divided into equal halves.
Pack sizes:
Al/Al blister packs: 14, 28, 30, 56, 84, 90, 98 and 100 tablets .
Tablet container : 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.
Dalshraun 1 220 Hafnarfjörður Iceland
Manufacturer
Actavis Ltd BLB015-016 Bulebel Industrial Estate Zejtun ZTN 3000 Malta For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Teva Pharma Belg ium N.V./S.A./AG Tél/Tel: +32 382073 73 Lietuva UAB Teva Baltics Tel: +370 5 2660203 България Тева Фарма ЕАД Teл.: +359 2 4899585 Luxembourg/Luxemburg Teva Pharma Belgium N.V./S.A./AG Belgique/Belgien Tél/Tel: +32 382073 73 Česká republika Teva Pharmaceuticals CR, s.r.o.
Tel: +420 251007111 Magyarország Teva Gyógyszergyár Zrt.
Tel.: +36 12886400 Danmark Teva Denmark A/S Tlf.: +45 44985511 Malta Teva Pharmaceuticals Ireland L-Irlanda Tel: +44 2075407117 Deutschland ratiopharm GmbH Tel: +49 73140202 Nederland Teva Nederland B.V.
Tel: +31 8000228400 56 Eesti UAB Teva Baltics Eesti filiaal Tel: +372 6610801 Norge Teva Norway AS Tlf: +47 66775590 Ελλάδα TEVA HELLAS A.E.
Τηλ: +30 2118805000 Österreich ratiopharm Arzneimittel Vertriebs -GmbH Tel: +43 1970070 España Teva Pharma, S.L.U.
Tel: +34 913873280 Polska Teva Pharmaceuticals Polska Sp. z o.o.
Tel.: +48 223459300 France Teva Santé Tél: +33 155917800 Portugal Teva Pharma – Produtos Farmacêuticos, Lda.
Tel: +351 214767550 Hrvatska Pliva Hrvatska d.o.o.
Tel: +385 13720000 România Teva Pharmaceuticals S.R.L .
Tel: + 40 212306524 Ireland Teva Pharmaceuticals Ireland Tel: +44 2075407117 Slovenija Pliva Ljubljana d.o.o.
Tel: +386 15890390 Ísland Teva Pharma Iceland ehf.
Sími: +354 5503300 Slovenská republika TEVA Pharmaceuticals Slovakia s.r.o.
Tel: +421 2 57267911 Italia Teva Italia S.r.l.
Tel: +39 028917981 Suomi/Finland Teva Finland Oy Puh/Tel: +358 201805900 Κύπρος TEVA HELLAS A.E. Ελλάδα Τηλ: + 30 2118805000 Sverige Teva Sweden AB Tel: +46 42121100 Latvija UAB Teva Baltics filiāle Latvijā Tel: +371 67323666 Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu /.
57 Package leaflet: Information for the user Telmisartan Actavis 80 mg tablets 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.
What is i n this leaflet :
1. What Telmisartan Actavis is and what it is used for 2. What you need to know before you take Telmisartan Actavis 3. How to take Telmisartan Actavis 4. Possible side effects 5. How to store Telmisartan Actavis 6. Contents of the pack and other information
ℹ️ 1. What Telmisartan Actavis is and what it is used for
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 h igh 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 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 Telmisa rtan Actavis
Do not take Telmisartan Actavis
- 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 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 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 Actavis.
58 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 d isease.
- 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 sal t 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 Actavis:
- if you are taking d igoxin.
- 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 Actavis”.
Talk to your doctor if you experience abdominal pain, nausea, vomiting or diarrhoea af ter taking Telmisartan Actavis. Your doctor will decide on further treatment. Do not stop taking Telmisartan Actavis on your own.
You must tell your doctor if you think you are ( or might become ) pregnant. Telmisartan 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 t hat you are taking Telmisartan Actavis.
Telmisartan Actavis may be less effective in lowering the blood pressure in black patients.
Children and adolescents
The use of Telmisartan Actavis in children and adolescents up to the age of 18 years is not recommended .
Other medicines and Telmisartan Actavis
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 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 59 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).
- If you are taking an ACE -inhibitor or aliskiren (see also information under the headings “Do not take Telmisartan Actavis” and “ Warnings and precautions ”).
- Digoxin.
The effect of Telmisartan Actavis may be reduced when you take NSAIDs (non steroidal anti-inflammatory drugs , e.g. aspirin or ibuprofen) or corticosteroids .
Telmi sartan Actavis may increase the blood pressure lowering effect of other medicines used to treat high blood pressure or of medicines with blood pressure lowering potential (e.g. baclofen, amifostine) .
Furthermore, low blood pressure may be aggravated by alcohol , barbiturates, narcotics or antidepressants. You may notice this as dizziness when standing up. You should consult with your doctor if you need to adjust the dose of your other medicine while taking Telmisartan Actavis.
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
Some people feel dizzy or tired when taking Telmisartan Actavis. If you feel dizzy or tired, do not drive or use machines.
Telmisartan Actavis 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 Actavis
Always take this medicine exactly as your doctor has told you. 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 cardiovasc ular 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.
60 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 a forgotten dose.
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 que stions 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 in1,000 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 telmisa rtan:
Common side effects (may affect up to 1 in 10 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 s (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, 61 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 re sponse which can lead to death), i ncrease in certain white blood cells (eosinophilia) , low platelet count (thrombocytopenia), severe allergic reacti on (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 th is side effect) , 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, in creased 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 (i nterstitial lung disease)**.
Frequency ‘not known’ (frequency cannot be estimated from the available data):
Intestinal angioedema: A swelling in the gut presenting with symptoms like abdominal pain, nausea, vomiting and diarrhoea have been reported after the use of similar products.
- The event may have happened by chance or could be relate d to a way that telmisartan works that is 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 Actavis
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, 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.
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 Actavis contains
62 – The active substance is telmisartan. Each tablet contains 80 mg telmisartan .
- The other ingredients are m agnesium 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 Pack sizes:
Al/Al blister packs: 14, 28, 30, 56, 84, 90, 98 and 100 tablets .
Tablet container : 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.
Dalshraun 1 220 Hafnarfjörður Iceland
Manufacturer
Actavis Ltd BLB015-016 Bulebel Industrial Estate Zejtun ZTN 3000 Malta For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Teva Pharma Belg ium N.V./S.A./AG Tél/Tel: +32 382073 73 Lietuva UAB Teva Baltics Tel: +370 5 2660203 България Тева Фарма ЕАД Teл.: +359 2 4899585 Luxembourg/Luxemburg Teva Pharma Belgium N.V./S.A./AG Belgique/Belgien Tél/Tel: +32 382073 73 Česká republika Teva Pharmaceuticals CR, s.r.o.
Tel: +420 251007111 Magyarország Teva Gyógyszergyár Zrt.
Tel.: +36 12886400 Danmark Teva Denmark A/S Tlf.: +45 44985511 Malta Teva Pharmaceuticals Ireland L-Irlanda Tel: +44 2075407117 Deutschland ratiopharm GmbH Tel: +49 73140202 Nederland Teva Nederland B.V.
Tel: +31 8000228400 63 Eesti UAB Teva Baltics Eesti filiaal Tel: +372 6610801 Norge Teva Norway AS Tlf: +47 66775590 Ελλάδα TEVA HELLAS A.E.
Τηλ: +30 2118805000 Österreich ratiopharm Arzneimittel Vertriebs -GmbH Tel: +43 1970070 España Teva Pharma, S.L.U.
Tel: +34 913873280 Polska Teva Pharmaceuticals Polska Sp. z o.o.
Tel.: +48 223459300 France Teva Santé Tél: +33 155917800 Portugal Teva Pharma – Produtos Farmacêuticos, Lda.
Tel: +351 214767550 Hrvatska Pliva Hrvatska d.o.o.
Tel: +385 13720000 România Teva Pharmaceuticals S.R.L .
Tel: + 40 212306524 Ireland Teva Pharmaceuticals Ireland Tel: +44 2075407117 Slovenija Pliva Ljubljana d.o.o.
Tel: +386 15890390 Ísland Teva Pharma Iceland ehf.
Sími: +354 5503300 Slovenská republika TEVA Pharmaceuticals Slovakia s.r.o.
Tel: +421 2 57267911 Italia Teva Italia S.r.l. Tel: +39 028917981 Suomi/Finland Teva Finland Oy Puh/Tel: +358 201805900 Κύπρος TEVA HELLAS A.E. Ελλάδα Τηλ: + 30 2118805000 Sverige Teva Sweden AB Tel: +46 42121100 Latvija UAB Teva Baltics filiāle Latvijā Tel: +371 67323666
This leaflet was last revised in
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu /.
📄 Package Leaflet – official source
This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Telmisartan Actavis (PDF, ec.europa.eu).
You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/10/639).
⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.