TELMISARTAN 20 mg Таблетка

Содержание инструкции

1. Telmisartan Actavis 20 mg tablets
   1. What is Telmisartan Actavis and what it is used for
   2. What you need to know before taking Telmisartan Actavis
   3. How to take Telmisartan Actavis
   4. Possible side effects
   5. How to store Telmisartan Actavis
   6. Package contents and other information
2. Telmisartan Actavis 40 mg tablets
   1. What is Telmisartan Actavis and what it is used for
   2. What you need to know before taking Telmisartan Actavis
   3. How to take Telmisartan Actavis
   4. Possible side effects
   5. How to store Telmisartan Actavis
   6. Package contents and other information
3. Telmisartan Actavis 80 mg tablets
   1. What is Telmisartan Actavis and what it is used for
   2. What you need to know before taking Telmisartan Actavis
   3. How to take Telmisartan Actavis
   4. Possible side effects
   5. How to store Telmisartan Actavis
   6. Package contents and other information

Telmisartan Actavis 20 mg tablets

telmisartan

Generic medicine

Read 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may be harmful to people even if their symptoms are the same as yours.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of 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 is Telmisartan Actavis and what it is used for

Telmisartan Actavis contains the active ingredient telmisartan, which belongs to a class of medicines
known as angiotensin II receptor antagonists.
Angiotensin II is a substance produced in your body that causes the constriction of blood vessels,
thus increasing blood pressure. Telmisartan Actavis blocks the effect of angiotensin II,
causing a relaxation of the blood vessels and thus reducing blood pressure.
Telmisartan Actavis tablets are used for the treatment of essential hypertension (high blood
pressure) in adults. “Essential” means that the high blood pressure is not caused by other
conditions.
High blood pressure, if left untreated, can damage blood vessels in many organs, which can
sometimes cause heart attack, heart failure or kidney failure, stroke or blindness. Normally, high blood
pressure does not give symptoms before such damage occurs. Therefore, it is important to have your
blood pressure measured regularly to check if it is within the normal range.
Telmisartan Actavis is also used to reduce cardiovascular events (e.g. heart attack or
stroke) in adults who are at risk because their blood supply to the heart or legs is reduced or
blocked or have had a stroke or have high-risk diabetes. Your doctor can tell you if you are
at high risk of these events.

2. What you need to know before taking Telmisartan Actavis

Do not take Telmisartan Actavis

• if you are allergic (hypersensitive) to telmisartan or any of the other ingredients of Telmisartan Actavis
• if you are pregnant for more than 3 months (it is best to avoid taking Telmisartan Actavis even in the early stages of pregnancy - see the Pregnancy section).
• if you suffer from severe liver problems such as cholestasis or biliary obstruction (problems with the drainage of bile from the liver and gallbladder) or any other serious liver disease.
• if you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren.

If you are in any of the conditions listed above, tell your doctor or pharmacist before taking
Telmisartan Actavis.

Warnings and precautions
Talk to your doctor if you suffer from 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 of one or both kidneys).
• Liver diseases.
• Heart problems.
• Increased levels of aldosterone (retention of water and salt in the body with an imbalance of various minerals in the blood).
• Low blood pressure (hypotension), which is more likely to occur if you are dehydrated (excessive loss of water from the body) or have a salt deficiency due to diuretic therapy (“diuretics”), a low-salt diet, diarrhea or vomiting.
• High levels of potassium in the 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), especially if you suffer from kidney problems related to diabetes.
• aliskiren

The doctor may check your kidney function, blood pressure, and the amount of electrolytes
(for example potassium) in your blood at regular intervals.
See also what is stated under "Do not take Telmisartan Actavis”
You must tell your doctor if you think you may be pregnant (or if there is a possibility of starting
a pregnancy). Telmisartan Actavis is not recommended in the early stages of pregnancy and must not
be taken if you are pregnant for more than 3 months, as it can cause serious harm to
the baby if taken during this period (see the Pregnancy section).
In case of surgery or administration of anesthetics, you must inform the doctor that you are
taking Telmisartan Actavis.
Telmisartan Actavis may be less effective in lowering blood pressure in patients of African
ethnicity.

Children and adolescents
The use of Telmisartan Actavis in children and adolescents up to 18 years of age 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,. The doctor may decide to change the dose of these other medicines or
take other precautions. In some cases, it may be necessary to stop taking one of
these medicines. This applies especially to the medicines listed below, taken
simultaneously with Telmisartan Actavis:

• Medicines containing lithium to treat some types of depression.
• Medicines that can increase potassium levels in the blood such as potassium-containing salt substitutes, potassium-sparing diuretics (some “diuretics”), ACE inhibitors (angiotensin converting enzyme inhibitors, to lower blood pressure), angiotensin II receptor antagonists, NSAIDs (non-steroidal anti-inflammatory drugs, e.g. aspirin or ibuprofen), heparin (medicine to thin the blood), immunosuppressants (e.g. cyclosporine or tacrolimus) and the antibiotic trimethoprim.
• Diuretics, especially if taken in high doses with Telmisartan Actavis, can induce excessive loss of body water and low blood pressure (hypotension).
• If you are taking an ACE inhibitor or aliskiren (see also what is stated under: "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 can increase the effect of other medicines used to lower blood pressure
or of medicines that can potentially lower blood pressure (e.g. baclofen,
amifostine). In addition, the lowering of blood pressure may be aggravated by alcohol,
barbiturates, narcotics or antidepressants. You may feel this lowering of blood pressure as
dizziness when getting up. Consult your doctor if you need to change the dose of other
medicines while taking Telmisartan Actavis.

Pregnancy and breastfeeding

Pregnancy
You must tell your doctor if you think you may be pregnant (or if there is a possibility of starting
a pregnancy). As a rule, your doctor will advise you to stop taking Telmisartan
Actavis before starting a pregnancy or as soon as you find out you are pregnant and will advise you to take another medicine instead of Telmisartan Actavis.
Telmisartan Actavis is not recommended in the early stages of pregnancy and must not be taken if you are
pregnant for more than 3 months as it can cause serious harm to the baby if taken after
the third month of pregnancy.

Breastfeeding
Tell your doctor if you are breastfeeding or are about to start breastfeeding. Telmisartan Actavis is not
recommended for women who are breastfeeding and your doctor may choose another treatment
for you if you wish to breastfeed, especially if the baby is newborn or premature

Driving and using machines
Some patients may experience dizziness or drowsiness when taking Telmisartan Actavis. If you
experience these effects, do not drive or use machines.

Telmisartan Actavis contains sodium.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially
“sodium-free”.

3. How to take Telmisartan Actavis

Take this medicine always exactly as your doctor has instructed. If you have any doubts, consult your
doctor or pharmacist.
For the treatment of high blood pressure, the recommended dose of Telmisartan Actavis for most
patients is one 40 mg tablet daily to control blood pressure for a period of 24 hours. However, your
doctor may advise a lower dose of 20 mg or a higher dose of 80 mg. Telmisartan Actavis can also be used
in association with diuretics such as hydrochlorothiazide, for which an additive effect has been
demonstrated with the association with telmisartan in terms of blood pressure reduction.
For the reduction of cardiovascular events, the usual dose of Telmisartan Actavis is one 80 mg tablet
once a day. At the beginning of preventive therapy with Telmisartan Actavis 80 mg, blood pressure
should be checked frequently.
If your liver is not functioning properly, the usual dose of 40 mg per day should not be exceeded.
If your kidney is not functioning properly, a lower initial 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 beverages.
It is important that you take Telmisartan Actavis every day unless your doctor instructs otherwise. If you
feel 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 take the same dose prescribed by your doctor. If you have accidentally taken too
many tablets, ask your doctor what to do, or contact the emergency room of the nearest hospital.
The most common symptoms of telmisartan overdose are low blood pressure (hypotension) and an
increased heart rate (tachycardia). A decrease in heart rate (bradycardia), dizziness, an increase in
blood creatinine levels and a sudden worsening of kidney function have also been reported.

If you forget to take Telmisartan Actavis
If you forget to take the medicine, take it as soon as you remember on the same day. If you miss
the dose of one day, take the normal dose the next day. Do not take a double dose to make up for
the missed dose.

If you stop taking Telmisartan Actavis
Take Telmisartan Actavis every day until your doctor prescribes it in order to keep your blood
pressure values under control.
If you feel that the effect of Telmisartan Actavis is too strong or too weak, talk to your doctor or
pharmacist.
If you have any doubts about the use of Telmisartan Actavis, 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 require immediate medical attention:
You should see a doctor immediately if you experience any of the following symptoms:
Sepsis* (often called "blood infection" is a serious infection with inflammatory response of the
entire organism), rapid swelling of the skin and mucous membranes (angioedema); these side
effects are rare (may affect up to 1 in 1000 people), but extremely serious and patients should stop
taking the medicine and consult a doctor immediately. If these effects are not treated they can be fatal.

Possible side effects of telmisartan:
Common side effects (may affect up to 1 in 10 people):
Low blood pressure (hypotension) in patients treated for the 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, sinusitis,
common cold), reduced red blood cells (anemia), high levels of potassium in the blood, difficulty
falling asleep, feeling sad (depression), fainting (syncope), feeling dizzy (vertigo), slowed heartbeat
(bradycardia), low blood pressure (hypotension) in patients treated for high blood pressure, feeling
unstable when standing up (orthostatic hypotension), shortness of breath, abdominal pain, diarrhea,
abdominal discomfort, swelling, vomiting, itching, increased sweating, drug-related skin rash, back
pain, muscle cramps, muscle pain (myalgia), impaired kidney function including acute renal failure, chest
pain, feeling of weakness, increased levels of creatinine in the blood.
Rare side effects (may affect up to 1 in 1000 people):
Sepsis* (often called “blood infection” is a serious infection with inflammatory response of the
entire organism that can lead to death), increased number of 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, drowsiness, vision changes,
fast heartbeat (tachycardia), dry mouth, stomach discomfort, altered taste (dysgeusia), altered liver
function (liver), (Japanese patients are more prone to experience this side effect)**, rapid swelling of
the skin and mucous membranes which can also lead to death (angioedema, even with fatal outcome),
eczema (skin disorder), skin redness, urticaria, severe drug-related skin rash, joint pain (arthralgia),
pain in the extremities, tendon pain, flu-like illness, decreased hemoglobin (a blood protein), increased
levels of uric acid, increased liver 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 occurred by chance or may be related to a currently unknown mechanism.
** Cases of progressive scarring of lung tissue have been reported during the intake of
telmisartan. However, it is not known whether telmisartan was the cause.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can
also report side effects directly through the national reporting system listed in Annex 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 pack, bottle or blister after
“Exp.”. The expiry date refers to the last day of the month.
Al/Al blisters:
Store in the original package to protect the medicine from light.
HDPE bottle:
Keep the bottle tightly closed to protect the medicine from light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Telmisartan Actavis contains

• The active ingredient is telmisartan. Each tablet contains 20 mg of telmisartan.
• The excipients are magnesium stearate, sodium croscarmellose, mannitol, povidone, potassium hydroxide in pellets.

Description of the appearance of Telmisartan Actavis and package contents
The 20 mg tablets are white, round, flat with the logo T imprinted on one side
Packages:
Al/Al blister: 14, 28, 30, 56, 84, 90, 98 and 100 tablets
Bottle: 30 and 250 tablets.
The bottle contains a desiccant, do not swallow it.
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 further information on this medicinal product, contact the local representative of the marketing
authorisation holder.

België/Belgique/Belgien
Teva Pharma Belgium N.V./S.A./AG
Tél/Tel: +32 38207373

Lietuva
UAB Teva Baltics
Tel: +370 52660203

България
Тева Фарма ЕАД
Teл.: +359 24899585

Luxembourg/Luxemburg
Teva Pharma Belgium N.V./S.A./AG
Belgique/Belgien
Tél/Tel: +32 38207373

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

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 257267911

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

United Kingdom (Northern Ireland)
Teva Pharmaceuticals Ireland
Ireland
Tel: +44 2075407117
More detailed information on this medicinal product is available on the website of the European Medicines
Agency: http://www.ema.europa.eu/

Telmisartan Actavis 40 mg tablets

telmisartan

Generic medicine

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may be harmful to people even if their symptoms are the same as yours.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of 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
• 6. How to store Telmisartan Actavis
• 6. Contents of the pack and other information

1. What is Telmisartan Actavis and what it is used for

Telmisartan Actavis contains the active ingredient telmisartan, which belongs to a class of medicines
known as angiotensin II receptor antagonists.
Angiotensin II is a substance produced in your body that causes the constriction of blood vessels,
thus increasing blood pressure. Telmisartan Actavis blocks the effect of angiotensin II,
causing a relaxation of blood vessels and thus reducing blood pressure.
Telmisartan Actavis tablets are used for the treatment of essential hypertension (high blood
pressure) in adults. “Essential” means that the high blood pressure is not caused by other
conditions.
High blood pressure, if left untreated, can damage blood vessels in many organs, which can
sometimes cause heart attack, heart or kidney failure, stroke or blindness. Normally, high blood
pressure does not give symptoms before such damage occurs. Therefore, it is important to have your
blood pressure measured regularly to check if it is within the normal range.
Telmisartan Actavis is also used to reduce cardiovascular events (e.g. heart attack or
stroke) in adults who are at risk because their blood supply to the heart or legs is reduced or
blocked or have had a stroke or have high-risk diabetes. Your doctor can tell you if you are
at high risk of these events.

2. What you need to know before taking Telmisartan Actavis

Do not take Telmisartan Actavis

• if you are allergic to telmisartan or any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant for more than 3 months (it is best to avoid taking Telmisartan Actavis even in the early stages of pregnancy - see the Pregnancy section).
• if you suffer from severe liver problems such as cholestasis or biliary obstruction (problems with the drainage of bile from the liver and gallbladder) or any other serious liver disease.
• if you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren

If you are in any of the conditions listed above, tell your doctor or pharmacist before taking
Telmisartan Actavis.

Warnings and precautions
Talk to your doctor if you suffer from 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 of one or both kidneys).
• Liver diseases.
• Heart problems.
• Increased levels of aldosterone (retention of water and salt in the body with an imbalance of various minerals in the blood).
• Low blood pressure (hypotension), which is more likely to occur if you are dehydrated (excessive water loss from the body) or have a salt deficiency due to diuretic therapy (“diuretics”), a low-salt diet, diarrhea or vomiting.
• High levels of potassium in the 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), especially if you suffer from kidney problems related to diabetes.
• aliskiren

The doctor may check your kidney function, blood pressure, and the amount of electrolytes
(e.g. potassium) in the blood at regular intervals.
See also what is stated in the section "Do not take Telmisartan Actavis”.
You must tell your doctor if you think you may be pregnant (or if there is a possibility of starting
a pregnancy). Telmisartan Actavis is not recommended in the early stages of pregnancy and must not
be taken if you are pregnant for more than 3 months, as it can cause serious harm to
the baby if taken during this period (see the Pregnancy section).
In case of surgery or administration of anesthetics, you must inform your doctor that you are
taking Telmisartan Actavis.
Telmisartan Actavis may be less effective in lowering blood pressure in patients of African
ethnicity

Children and adolescents
The use of Telmisartan Actavis in children and adolescents up to 18 years of age 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 medicine, including those available without a prescription. Your doctor may decide to
change the dose of these other medicines or take other precautions. In some cases it may be
necessary to stop taking one of these medicines. This is particularly true for
the medicines listed below, taken at the same time as Telmisartan Actavis:

• Medicines containing lithium for treating some types of depression.
• Medicines that can increase potassium levels in the blood such as potassium-containing salt substitutes, potassium-sparing diuretics (some “diuretics”), ACE inhibitors (angiotensin converting enzyme inhibitors, to lower blood pressure), angiotensin II receptor antagonists, NSAIDs (non-steroidal anti-inflammatory drugs, e.g. aspirin or ibuprofen), heparin (medicine to thin the blood), immunosuppressants (e.g. cyclosporine or tacrolimus) and the antibiotic trimethoprim.
• Diuretics, especially if taken at high doses with Telmisartan Actavis, can cause excessive loss of body water and low blood pressure (hypotension).
• If you are taking an ACE inhibitor or aliskiren (see also the sections: "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 can increase the effect of other medicines used to lower blood pressure
or of medicines that can potentially lower blood pressure (e.g. baclofen,
amifostine). Furthermore, the lowering of blood pressure may be aggravated by alcohol,
barbiturates, narcotics or antidepressants. You may feel this lowering of blood pressure as
dizziness when getting up. Consult your doctor if you need to change the dose of other
medicines while taking Telmisartan Actavis.

Pregnancy and breastfeeding

Pregnancy
You must tell your doctor if you think you may be pregnant (or if there is a possibility of starting
a pregnancy). As a rule, your doctor will advise you to stop taking Telmisartan
Actavis before starting a pregnancy or as soon as you find out you are pregnant and will advise you to take another medicine instead of Telmisartan Actavis.
Telmisartan Actavis is not recommended in the early stages of pregnancy and must not be taken if you are
pregnant for more than 3 months as it can cause serious harm to the baby if taken after
the third month of pregnancy.

Breastfeeding
Tell your doctor if you are breastfeeding or are about to start breastfeeding. Telmisartan Actavis is not
recommended for women who are breastfeeding and your doctor may choose another treatment
for you if you wish to breastfeed, especially if the baby is newborn or premature

Driving and using machines
Some patients may experience dizziness or drowsiness when taking Telmisartan Actavis. If
these effects occur, do not drive or operate machinery.

Telmisartan Actavis contains sodium.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially
“sodium-free”.

3. How to take Telmisartan Actavis

Take this medicine always exactly as your doctor has instructed. If you have any doubts, ask your
doctor or pharmacist.
For the treatment of high blood pressure, the recommended dose of Telmisartan Actavis for most
patients is one 40 mg tablet daily to control blood pressure for a period of 24 hours.
However, sometimes your doctor may advise a lower dose of 20 mg daily or a higher dose of 80 mg. Alternatively, Telmisartan Actavis can also be used in association with
diuretics such as hydrochlorothiazide, for which an additive effect has been demonstrated with
combination with telmisartan in terms of blood pressure reduction.
For the reduction of cardiovascular events, the usual dose of Telmisartan Actavis is one 80 mg tablet
once a day. At the beginning of preventive therapy with Telmisartan Actavis 80 mg, blood pressure
should be checked frequently.
If your liver is not functioning properly, the usual dose of 40 mg per day should not be exceeded.
If your kidneys are not functioning properly, a lower initial 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 beverages.
It is important that you take Telmisartan Actavis every day unless your doctor instructs otherwise. If you feel 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 take the same dose prescribed by your doctor. If you have accidentally taken
too many tablets, ask your doctor what to do, or contact the emergency room of the nearest hospital.
The most common symptoms of telmisartan overdose are low blood pressure (hypotension)
and an increased heart rate (tachycardia). A decrease in heart rate (bradycardia), dizziness, an increase
in blood creatinine levels and a sudden worsening of kidney function have also been reported.

If you forget to take Telmisartan Actavis
If you forget to take the medicine, take it as soon as you remember on the same day. If you miss
the dose of one day, take the normal dose the next day. Do not take a double dose to
make up for a missed dose.

If you stop taking Telmisartan Actavis
Take Telmisartan Actavis every day until your doctor prescribes it in order to
keep your blood pressure values under control.
If you feel 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 Telmisartan Actavis, 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 require immediate medical attention:
You should see a doctor immediately if you experience any of the following symptoms:
Sepsis* (often called "blood infection" is a serious infection with an inflammatory response
throughout the body), rapid swelling of the skin and mucous membranes (angioedema); these effects
are rare (may affect up to 1 in 1,000 people), but extremely serious and patients should stop taking the
medicine and consult a doctor immediately. If these effects are not treated, they can be fatal.

Possible side effects of telmisartan:
Common side effects (may affect up to 1 in 10 people):
Low blood pressure (hypotension) in patients treated for the reduction of cardiovascular
events.
Uncommon side effects (may affect up to 1 in 100 people) may include
Urinary tract infections, upper respiratory tract infections (e.g. sore throat, sinusitis,
common cold), reduced red blood cells (anemia), high levels of potassium in the blood, difficulty
falling asleep, feeling sad (depression), fainting (syncope), feeling dizzy (vertigo), slowed heartbeat
(bradycardia), low blood pressure (hypotension) in patients treated for high blood pressure, feeling
unstable when standing up (orthostatic hypotension), shortness of breath, cough, abdominal pain,
diarrhea, abdominal discomfort, swelling, vomiting, itching, increased sweating, drug rash,
back pain, muscle cramps, muscle pain (myalgia), impaired kidney function including acute
renal failure, chest pain, feeling weak, increased creatinine levels in the blood.
Rare side effects (may affect up to 1 in 1,000 people):
Sepsis* (often called “blood infection” is a serious infection with an inflammatory response
throughout the body that can lead to death), increased 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, drowsiness, changes in
vision, fast heartbeat (tachycardia), dry mouth, stomach discomfort, altered taste (dysgeusia), altered
liver function (the liver), (Japanese patients are more likely to experience this side effect)**, rapid
swelling of the skin and mucous membranes which can also lead to death (angioedema, even with
fatal outcome), eczema (skin disorder), skin redness, urticaria, severe drug rash, joint pain
(arthralgia), pain in the extremities, tendon pain, flu-like illness, decreased hemoglobin (a blood
protein), increased uric acid levels, increased liver 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 occurred by chance or may be related to a currently unknown mechanism.
** Cases of progressive scarring of lung tissue have been reported during the intake of
telmisartan. However, it is not known whether telmisartan was the cause

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can
also report side effects directly through the national reporting system listed in Annex 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 bottle or blister pack after
“Exp.”. The expiry date refers to the last day of that month.
Al/Al blisters:
Store in the original package to protect the medicine from light.
HDPE bottle:
Keep the bottle tightly closed to protect the medicine from light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Telmisartan Actavis contains

• The active ingredient is telmisartan. Each tablet contains 40 mg of telmisartan.
• The excipients are magnesium stearate, sodium croscarmellose, mannitol, povidone, potassium hydroxide in pellets.

Description of the appearance of Telmisartan Actavis and contents of the pack
The 40 mg tablets are white, oval, biconvex, with a fracture line and the logo T imprinted on
one side. The tablet can be divided into two equal halves
Packs:
Al/Al blister: 14, 28, 30, 56, 84, 90, 98 and 100 tablets.
Bottle: 30 and 250 tablets.
The bottle contains a desiccant, do not swallow it.
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 further information on this medicinal product, contact the local representative of the marketing
authorisation holder.

België/Belgique/Belgien
Teva Pharma Belgium N.V./S.A./AG
Tél/Tel: +32 38207373

Lietuva
UAB Teva Baltics
Tel: +370 52660203

България
Тева Фарма ЕАД
Teл.: +359 24899585

Luxembourg/Luxemburg
Teva Pharma Belgium N.V./S.A./AG
Belgique/Belgien
Tél/Tel: +32 38207373

Magyarország
Teva Gyógyszergyár Zrt.
Tel.: +36 12886400

Danmark
Teva Denmark A/S
Tlf.: +45 44985511

Česká republika
Teva Pharmaceuticals CR, s.r.o.
Tel: +420 251007111

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

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 257267911

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

United Kingdom (Northern Ireland)
Teva Pharmaceuticals Ireland
Ireland
Tel: +44 2075407117
More detailed information on this medicinal product is available on the website of the European Medicines
Agency: http://www.ema.europa.eu/.

Telmisartan Actavis 80 mg tablets

telmisartan

Generic medicine

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may be harmful for people other than you, even if their symptoms are the same as yours.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of 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 is Telmisartan Actavis and what it is used for

Telmisartan Actavis contains the active ingredient telmisartan, which belongs to a class of medicines
known as angiotensin II receptor antagonists.
Angiotensin II is a substance produced in your body that causes blood vessels to constrict,
thus increasing blood pressure. Telmisartan Actavis blocks the effect of angiotensin II,
causing blood vessels to relax and thus reducing blood pressure.
Telmisartan Actavis tablets are used for the treatment of essential hypertension (high blood
pressure) in adults. “Essential” means that the high blood pressure is not caused by other
conditions.
High blood pressure, if left untreated, can damage blood vessels in many organs, which can
sometimes cause heart attack, heart failure or kidney failure, stroke or blindness. Normally, high blood
pressure does not give symptoms before such damage occurs. Therefore, it is important to have your
blood pressure measured regularly to check if it is within the normal range.
Telmisartan Actavis is also used to reduce cardiovascular events (e.g. heart attack or
stroke) in adults who are at risk because their blood supply to the heart or legs is reduced or
blocked or have had a stroke or have high-risk diabetes. Your doctor can tell you if you are
at high risk of these events.

2. What you need to know before taking Telmisartan Actavis

Do not take Telmisartan Actavis

• if you are allergic to telmisartan or any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant for more than 3 months (it is best to avoid taking Telmisartan Actavis even in the early stages of pregnancy - see the Pregnancy section).
• if you suffer from severe liver problems such as cholestasis or biliary obstruction (problems with the drainage of bile from the liver and gallbladder) or any other serious liver disease
• if you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren.

If you are in any of the conditions listed above, tell your doctor or pharmacist before taking
Telmisartan Actavis.

Warnings and precautions
Talk to your doctor if you suffer from or have ever suffered from any of the following conditions or diseases:

• Kidney disease or kidney transplant.
• Renal artery stenosis (narrowing of the blood vessels of one or both kidneys).
• Liver diseases.
• Heart problems.
• Increased levels of aldosterone (retention of water and salt in the body with an imbalance of various minerals in the blood).
• Low blood pressure (hypotension), which is more likely to occur if you are dehydrated (excessive loss of water from the body) or have a salt deficiency due to diuretic therapy (“diuretics”), a low-salt diet, diarrhea or vomiting.
• High levels of potassium in the 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), especially if you suffer from kidney problems related to diabetes.
• aliskiren

The doctor may check your kidney function, blood pressure, and the amount of electrolytes
(e.g. potassium) in the blood at regular intervals.
See also what is stated in the section "Do not take Telmisartan Actavis”.
You must tell your doctor if you think you may be pregnant (or if there is a possibility of starting
a pregnancy). Telmisartan Actavis is not recommended in the early stages of pregnancy and must not
be taken if you are pregnant for more than 3 months, as it can cause serious harm to the
child if taken during this period (see the Pregnancy section).
In case of surgery or administration of anesthetics, you must inform the doctor that you are
taking Telmisartan Actavis.
Telmisartan Actavis may be less effective in reducing blood pressure in patients of African
ethnicity

Children and adolescents
The use of Telmisartan Actavis in children and adolescents up to 18 years of age 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 medicine. The doctor may decide to change the dose of these other medicines or
take other precautions. In some cases it may be necessary to stop taking one of
these medicines. This applies especially to the medicines listed below, taken
simultaneously with Telmisartan Actavis:

• Medicines containing lithium to treat some types of depression.
• Medicines that can increase potassium levels in the blood such as salt substitutes containing potassium, potassium-sparing diuretics (some “diuretics”), ACE inhibitors (angiotensin converting enzyme inhibitors, to lower blood pressure), angiotensin II receptor antagonists, NSAIDs (non-steroidal anti-inflammatory drugs, e.g. aspirin or ibuprofen), heparin (medicine to thin the blood), immunosuppressants (e.g. cyclosporine or tacrolimus) and the antibiotic trimethoprim.
• Diuretics, especially if taken at high doses with Telmisartan Actavis, can induce excessive loss of body water and low blood pressure (hypotension).
• If you are taking an ACE inhibitor or aliskiren (see also the sections: "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 effect of other medicines used to lower blood pressure
or of medicines that can potentially lower blood pressure (e.g. baclofen,
amifostine). In addition, the lowering of blood pressure may be aggravated by alcohol,
barbiturates, narcotics or antidepressants. You may feel this lowering of blood pressure as
dizziness when getting up. Consult your doctor if you need to change the dose of other
medicines while taking Telmisartan Actavis.

Pregnancy and breastfeeding

Pregnancy
You must tell your doctor if you think you may be pregnant (or if there is a possibility of starting
a pregnancy). As a rule, your doctor will advise you to stop taking Telmisartan
Actavis before starting a pregnancy or as soon as you become aware of being pregnant and will advise you to take another medicine instead of Telmisartan Actavis.
Telmisartan Actavis is not recommended in the early stages of pregnancy and must not be taken if you are
pregnant for more than 3 months as it can cause serious harm to the child if taken after the
third month of pregnancy.

Breastfeeding
Tell your doctor if you are breastfeeding or are about to start breastfeeding. Telmisartan Actavis is not
recommended for women who are breastfeeding and your doctor may choose another treatment
for you if you wish to breastfeed, especially if the baby is newborn or premature.

Driving and using machines
Some patients may experience dizziness or drowsiness while taking Telmisartan Actavis. If you
experience these effects, do not drive or use machines.

Telmisartan Actavis contains sodium.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially
“sodium-free”.

3. How to take Telmisartan Actavis

Take this medicine always exactly as your doctor has told you. If you have doubts, ask your doctor or pharmacist.
For the treatment of high blood pressure, the recommended dose of Telmisartan Actavis for most patients is one 40 mg tablet daily to control blood pressure for a period of 24 hours. However, sometimes your doctor may advise a lower dose of 20 mg daily or a higher dose of 80 mg.
Alternatively, Telmisartan Actavis can also be used in association with diuretics such as hydrochlorothiazide, for which an additive effect has been demonstrated with the association with telmisartan in terms of blood pressure reduction.
For the reduction of cardiovascular events, the usual dose of Telmisartan Actavis is one 80 mg tablet once a day. At the beginning of prevention therapy with Telmisartan Actavis 80 mg, blood pressure should be checked frequently.
If your liver is not functioning properly, the usual dose of 40 mg per day should not be exceeded.
If your kidney is not functioning properly, a lower initial 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 a little water or other non-alcoholic beverages.
It is important that you take Telmisartan Actavis every day unless your doctor instructs otherwise. If you feel 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 take the same dose prescribed by your doctor. If you have accidentally taken too many tablets, ask your doctor what to do, or contact the emergency room of the nearest hospital.
The most common symptoms of telmisartan overdose are low blood pressure (hypotension) and an increased heart rate (tachycardia). A decrease in heart rate (bradycardia), dizziness, an increase in blood creatinine levels and a sudden worsening of kidney function have also been reported.

If you forget to take Telmisartan Actavis
If you forget to take the medicine, take it as soon as you remember on the same day. If you skip the dose of one day, take the normal dose the next day. Do not take a double dose to make up for a missed dose.

If you stop taking Telmisartan Actavis
Take Telmisartan Actavis every day until your doctor prescribes it to maintain controlled blood pressure values.
If you feel that the effect of Telmisartan Actavis is too strong or too weak, talk to your doctor or pharmacist.
If you have any doubts about the use of Telmisartan Actavis, 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 require immediate medical attention:
You should see a doctor immediately if you experience any of the following symptoms:
Sepsis* (often called "blood infection" is a serious infection with inflammatory response of the
entire organism), rapid swelling of the skin and mucous membranes (angioedema); these side
effects are rare (may affect up to 1 in 1,000 people), but extremely serious and patients should stop
taking the medicine and consult a doctor immediately. If these effects are not treated they can be fatal.

Possible side effects of telmisartan:
Common side effects (may affect up to 1 in 10 people): may include:
Low blood pressure (hypotension) in patients treated for the 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, sinusitis,
common cold), reduced red blood cells (anemia), high levels of potassium in the blood, difficulty
falling asleep, feeling sad (depression), fainting (syncope), feeling dizzy (vertigo), slowed heartbeat
(bradycardia), low blood pressure (hypotension) in patients treated for high blood pressure, feeling
unstable when standing up (orthostatic hypotension), shortness of breath, abdominal pain, diarrhea,
abdominal discomfort, swelling, vomiting, itching, increased sweating, drug rash, back pain,
muscle cramps, muscle pain (myalgia), kidney impairment including acute renal failure, chest pain,
feeling of weakness, increased levels of creatinine in the blood.
Rare side effects (may affect up to 1 in 1,000 people):
Sepsis* (often called “blood infection” is a serious infection with inflammatory response of the
entire organism that can lead to death), increased number of 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, drowsiness, changes in
vision, fast heartbeat (tachycardia), dry mouth, stomach upset, altered taste (dysgeusia), altered
liver function (liver), (Japanese patients are more likely to experience this side effect)**, rapid
swelling of the skin and mucous membranes which can also be fatal (angioedema, including fatal
outcome), eczema (skin disorder), skin redness, urticaria, severe drug rash, joint pain (arthralgia),
pain in the extremities, tendon pain, flu-like illness, decreased hemoglobin (a blood protein),
increased levels of uric acid, increased liver 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 occurred by chance or may be related to a currently unknown mechanism.
** Cases of progressive scarring of lung tissue have been reported during the intake of
telmisartan. However, it is not known whether telmisartan was the cause

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can
also report side effects directly through the national reporting system listed in Annex 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 package, bottle or blister pack after
“Exp.”. The expiry date refers to the last day of the month.
Al/Al blisters:
Store in the original package to protect the medicine from light.
HDPE bottle:
Keep the bottle tightly closed to protect the medicine from light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Telmisartan Actavis contains

• The active ingredient is telmisartan. Each tablet contains 80 mg of telmisartan.
• The excipients are magnesium stearate, sodium croscarmellose, mannitol, povidone, potassium hydroxide in pellets.

Description of the appearance of Telmisartan Actavis and package contents
The 80 mg tablets are white, oval, biconvex with the T1 logo imprinted on one side
Packages:
Al/Al blister: 14, 28, 30, 56, 84, 90, 98 and 100 tablets.
Bottle: 30 and 250 tablets.
The bottle contains a desiccant, do not swallow it.
Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Actavis Group PTC ehf.
Dalshraun 1
220 Hafnarfjörður
Iceland

Manufacturer
Actavis Ltd
BLB015-016
Bulebel Industrial Estate
Zejtun ZTN 3000
Malta
For further information about this medicinal product, contact the local representative of the marketing
authorization holder.

België/Belgique/Belgien
Teva Pharma Belgium N.V./S.A./AG
Tél/Tel: +32 38207373

Lietuva
UAB Teva Baltics
Tel: +370 52660203

България
Тева Фарма ЕАД
Teл.: +359 24899585

Luxembourg/Luxemburg
Teva Pharma Belgium N.V./S.A./AG
Belgique/Belgien
Tél/Tel: +32 38207373

Magyarország
Teva Gyógyszergyár Zrt.
Tel.: +36 12886400

Danmark
Teva Denmark A/S
Tlf.: +45 44985511

Česká republika
Teva Pharmaceuticals CR, s.r.o.
Tel: +420 251007111

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

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 257267911

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

United Kingdom (Northern Ireland)
Teva Pharmaceuticals Ireland
Ireland
Tel: +44 2075407117
More detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/