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Telmisartan Actavis (telmisartan) – Package leaflet - C09CA07

Updated on site: 10-Oct-2017

Medication nameTelmisartan Actavis
ATC CodeC09CA07
Substancetelmisartan
ManufacturerActavis Group PTC ehf

Package leaflet: Information for the user

Telmisartan Actavis 20 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 in 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. ‘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 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.

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 (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 Actavis:

-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 Actavis”.

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 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.

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.

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. Telmisartan 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 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 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 infections (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 this 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 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 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

-The active substance is telmisartan. Each tablet contains 20 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

20 mg tablets are white, round, flat with 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. 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:

België/Belgique/Belgien

Lietuva

Aurobindo Pharma B.V.

UAB “Actavis Baltics”

Nederland / Pays-Bas / Niederlande

Tel: +370 5 260 9615

Tél/Tel: +31 (0)35 542 99 33

 

България

Luxembourg/Luxemburg

Актавис ЕАД

Aurobindo Pharma B.V.

Teл.: +359 2 9321 861

Pays-Bas / Niederlande

 

Tél/Tel: +31 (0)35 542 99 33

Česká republika

Magyarország

Actavis CZ a.s.

Actavis Hungary Kft.

Tel: +420251 113 002

Tel.: +36 1 501 7001

Danmark

Malta

Actavis A/S

Actavis Ltd.

Tlf: +45 72 22 30 00

Tel: +35621693533

Deutschland

Nederland

PUREN Pharma GmbH & Co. KG

Aurobindo Pharma B.V.

Tel.: +49-89-558-9090

Tel: +31 (0)35 542 99 33

Eesti

Norge

UAB “Actavis Baltics” Eesti Filiaal

Actavis Norway AS

Tel: +372 6100 565

Tlf: +47 815 22 099

Ελλάδα

Österreich

Specifar ABEE

Actavis GmbH

Τηλ: +30 210 5401500

Tel: +43 (0)662 435 235 00

España

Polska

Aurovitas Spain, S.A.U.

Actavis Export Int. Ltd., Malta

Tfno.: +34 91 630 86 45

Kontakt w Polsce:

 

Tel.: (+48 22) 512 29 00

France

Portugal

Arrow Génériques

Aurovitas, Unipessoal, Lda

Tél: +33 4 72 72 60 72

Tel: +351 214 185 104

Hrvatska

România

PharmaVigil d.o.o.

Actavis SRL

Tel: +385(1)3890676

Tel: +40 21 318 17 77

Ireland

Slovenija

Actavis Ireland Limited

Apta Medica Internacional d.o.o.

Tel: +353 (0)21 4619040

Tel: +386 51 615 015

Ísland

Slovenská republika

Actavis Group PTC ehf.

Actavis s.r.o.

Sími: +354 550 3300

Tel: +421 2 3255 3800

Italia

Suomi/Finland

Aurobindo Pharma (Italia) s.r.l.

Actavis Oy

Tel: +39 0296392601

Puh/Tel: +358 (0)9 348 233

Κύπρος

Sverige

A. Potamitis Medicare Ltd

Actavis AB

Τηλ: +357 22583333

Tel: +46 8 13 63 70

Latvija

United Kingdom

UAB “Actavis Baltics” Latvijas filiāle

Actavis UK Limited

Tel: +371 67304300

Tel: +44 1271 385257

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: 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 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 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. ‘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 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.

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 Actavis:

-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 Actavis”.

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 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.

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.

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 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 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 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 infections (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 this 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 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 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

-The active substance is telmisartan. Each tablet contains 40 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

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. 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:

België/Belgique/Belgien

Lietuva

Aurobindo Pharma B.V.

UAB “Actavis Baltics”

Nederland / Pays-Bas / Niederlande

Tel: +370 5 260 9615

Tél/Tel: +31 (0)35 542 99 33

 

България

Luxembourg/Luxemburg

Актавис ЕАД

Aurobindo Pharma B.V.

Teл.: +359 2 9321 861

Pays-Bas / Niederlande

 

Tél/Tel: +31 (0)35 542 99 33

Česká republika

Magyarország

Actavis CZ a.s.

Actavis Hungary Kft.

Tel: +420251 113 002

Tel.: +36 1 501 7001

Danmark

Malta

Actavis A/S

Actavis Ltd.

Tlf: +45 72 22 30 00

Tel: +35621693533

Deutschland

Nederland

PUREN Pharma GmbH & Co. KG

Aurobindo Pharma B.V.

Tel.: +49-89-558-9090

Tel: +31 (0)35 542 99 33

Eesti

Norge

UAB “Actavis Baltics” Eesti Filiaal

Actavis Norway AS

Tel: +372 6100 565

Tlf: +47 815 22 099

Ελλάδα

Österreich

Specifar ABEE

Actavis GmbH

Τηλ: +30 210 5401500

Tel: +43 (0)662 435 235 00

España

Polska

Aurovitas Spain, S.A.U.

Actavis Export Int. Ltd., Malta

Tfno.: +34 91 630 86 45

Kontakt w Polsce:

 

Tel.: (+48 22) 512 29 00

France

Portugal

Arrow Génériques

Aurovitas, Unipessoal, Lda

Tél: +33 4 72 72 60 72

Tel: +351 214 185 104

Hrvatska

România

PharmaVigil d.o.o.

Actavis SRL

Tel: +385(1)3890676

Tel: +40 21 318 17 77

Ireland

Slovenija

Actavis Ireland Limited

Apta Medica Internacional d.o.o.

Tel: +353 (0)21 4619040

Tel: +386 51 615 015

Ísland

Slovenská republika

Actavis Group PTC ehf.

Actavis s.r.o.

Sími: +354 550 3300

Tel: +421 2 3255 3800

Italia

Suomi/Finland

Aurobindo Pharma (Italia) s.r.l.

Actavis Oy

Tel: +39 0296392601

Puh/Tel: +358 (0)9 348 233

Κύπρος

Sverige

A. Potamitis Medicare Ltd

Actavis AB

Τηλ: +357 22583333

Tel: +46 8 13 63 70

Latvija

United Kingdom

UAB “Actavis Baltics” Latvijas filiāle

Actavis UK Limited

Tel: +371 67304300

Tel: +44 1271 385257

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: 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 in 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. ‘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 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.

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 Actavis:

-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 Actavis”.

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 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 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.

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.

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 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 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 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 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 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 infections (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 this 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 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 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

-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

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. 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:

België/Belgique/Belgien

Lietuva

Aurobindo Pharma B.V.

UAB “Actavis Baltics”

Nederland / Pays-Bas / Niederlande

Tel: +370 5 260 9615

Tél/Tel: +31 (0)35 542 99 33

 

България

Luxembourg/Luxemburg

Актавис ЕАД

Aurobindo Pharma B.V.

Teл.: +359 2 9321 861

Pays-Bas / Niederlande

 

Tél/Tel: +31 (0)35 542 99 33

Česká republika

Magyarország

Actavis CZ a.s.

Actavis Hungary Kft.

Tel: +420251 113 002

Tel.: +36 1 501 7001

Danmark

Malta

Actavis A/S

Actavis Ltd.

Tlf: +45 72 22 30 00

Tel: +35621693533

Deutschland

Nederland

PUREN Pharma GmbH & Co. KG

Aurobindo Pharma B.V.

Tel.: +49-89-558-9090

Tel: +31 (0)35 542 99 33

Eesti

Norge

UAB “Actavis Baltics” Eesti Filiaal

Actavis Norway AS

Tel: +372 6100 565

Tlf: +47 815 22 099

Ελλάδα

Österreich

Specifar ABEE

Actavis GmbH

Τηλ: +30 210 5401500

Tel: +43 (0)662 435 235 00

 

España

Polska

Aurovitas Spain, S.A.U.

Actavis Export Int. Ltd., Malta

Tfno.: +34 91 630 86 45

Kontakt w Polsce:

 

Tel.: (+48 22) 512 29 00

France

Portugal

Arrow Génériques

Aurovitas, Unipessoal, Lda

Tél: +33 4 72 72 60 72

Tel: +351 214 185 104

Hrvatska

România

PharmaVigil d.o.o.

Actavis SRL

Tel: +385(1)3890676

Tel: +40 21 318 17 77

Ireland

Slovenija

Actavis Ireland Limited

Apta Medica Internacional d.o.o.

Tel: +353 (0)21 4619040

Tel: +386 51 615 015

Ísland

Slovenská republika

Actavis Group PTC ehf.

Actavis s.r.o.

Sími: +354 550 3300

Tel: +421 2 3255 3800

Italia

Suomi/Finland

Aurobindo Pharma (Italia) s.r.l.

Actavis Oy

Tel: +39 0296392601

Puh/Tel: +358 (0)9 348 233

Κύπρος

Sverige

A. Potamitis Medicare Ltd

Actavis AB

Τηλ: +357 22583333

Tel: +46 8 13 63 70

Latvija

United Kingdom

UAB “Actavis Baltics” Latvijas filiāle

Actavis UK Limited

Tel: +371 67304300

Tel: +44 1271 385257

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/.

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