Brand name Telmisartan Actavis

Form tablets

Active substance / Dosage

TELMISARTAN

Prescription type Prescription only

ATC code

C09CA07

Registration number 041007

Manufacturer ACTAVIS GROUP PTC EHF

Table of Contents

Package leaflet: Information for the user
Telmisartan Actavis 20 mg tablets
1. What is Telmisartan Actavis and what is it used for?
2. What you should 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
Package leaflet: information for the user
Telmisartan Actavis 40 mg tablets
1. What Telmisartan Actavis is 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
Package leaflet: information for the user
Telmisartan Actavis 80 mg tablets
1. What is Telmisartan Actavis and what is it 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

Package leaflet: Information for the user

Telmisartan Actavis 20 mg tablets

telmisartan
Generic medicine
Please 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 questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Never give it to others. It may be harmful to other people, even if their symptoms are the same as yours.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Telmisartan Actavis is and what it is used for
What you need to know before taking Telmisartan Actavis
How to take Telmisartan Actavis
Possible side effects
How to store Telmisartan Actavis
Contents of the pack and other information

1. What is Telmisartan Actavis and what is it 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 that causes blood vessels to narrow, thereby increasing blood pressure. Telmisartan Actavis blocks the effect of angiotensin II, resulting in relaxation of blood vessels and consequently lowering blood pressure.
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 other conditions.
If left untreated, high blood pressure can damage blood vessels in various organs and may sometimes lead to heart attack, heart or kidney failure, stroke, or blindness. High blood pressure usually does not cause symptoms until such damage occurs. Therefore, it is important to have your blood pressure checked regularly to ensure 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 of reduced or blocked blood flow to the heart or legs, or who have had a stroke or have high-risk diabetes. Your doctor can determine whether you are at high risk for these events.

2. What you should know before taking Telmisartan Actavis

Do not take Telmisartan Actavis

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

If you are in any of the above conditions, inform your doctor or pharmacist before taking
Telmisartan Actavis.
Warnings and precautions
Talk to your doctor if you have or have ever had any of the following conditions or diseases:

Kidney disease or kidney transplant.
Renal artery stenosis (narrowing of the blood vessels to one or both kidneys).
Liver diseases.
Heart problems.
Increased levels of aldosterone (retention of water and salt in the body with 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 salt deficiency due to diuretic therapy ("diuretics"), a low-salt diet, diarrhoea 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" (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
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 the section "Do not take Telmisartan Actavis"
Talk to your doctor if, after taking Telmisartan Actavis, you experience abdominal pain, nausea,
vomiting or diarrhoea. Your doctor will decide whether treatment should continue. Do not stop
taking Telmisartan Actavis on your own.
You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming
pregnant). Telmisartan Actavis is not recommended during early pregnancy and must not
be taken if you are more than 3 months pregnant, as it may cause serious harm to the
foetus if taken during this period (see section Pregnancy).
If you are undergoing surgery or receiving anaesthetics, 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 origin.
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
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicine. Your doctor may decide to change the dose of these other medicines or
take other precautions. In some cases, it may be necessary to discontinue one of
these medicines. This particularly applies to the following medicines taken
concomitantly with Telmisartan Actavis:

Medicines containing lithium used to treat certain types of depression.
Medicines that may increase potassium levels in the blood, such as potassium-containing salt substitutes, potassium-sparing diuretics (some "diuretics"), ACE inhibitors (angiotensin-converting enzyme inhibitors, to reduce blood pressure), angiotensin II receptor antagonists, NSAIDs (non-steroidal anti-inflammatory drugs, e.g. aspirin or ibuprofen), heparin (a medicine to thin the blood), immunosuppressants (e.g. ciclosporin or tacrolimus) and the antibiotic trimethoprim.
Diuretics, especially when taken at high doses with Telmisartan Actavis, may cause excessive loss of body water and low blood pressure (hypotension).
If you are taking an ACE inhibitor or aliskiren (see also sections: "Do not take Telmisartan Actavis" and "Warnings and precautions").
Digoxin.

The effect of Telmisartan Actavis may be reduced when taking NSAIDs (non-steroidal anti-inflammatory drugs, e.g. aspirin or ibuprofen) or corticosteroids.
Telmisartan Actavis may enhance the effect of other medicines used to lower blood pressure or medicines that may potentially lower blood pressure (e.g. baclofen, amifostine). In addition, lowering of blood pressure may be worsened by alcohol, barbiturates, narcotics or antidepressants. You may experience this drop in blood pressure as dizziness when standing up. Consult your doctor if you need to adjust the dose of other medicines while taking Telmisartan Actavis.
Pregnancy and breastfeeding
Pregnancy
You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). Usually, your doctor will advise you to stop taking Telmisartan Actavis before becoming pregnant or as soon as you find out you are pregnant, and will recommend another medicine instead of Telmisartan Actavis.
Telmisartan Actavis is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the foetus if taken after the third month of pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or are planning to breastfeed. 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 a newborn or was born prematurely.
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, i.e. it is essentially “sodium-free”.

3. How to take Telmisartan Actavis

Take this medicine exactly as directed by your doctor. 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 over a 24-hour period. However, your doctor may prescribe a lower dose of 20 mg or a higher dose of 80 mg. Telmisartan Actavis may also be used in combination with diuretics such as hydrochlorothiazide, with which it has demonstrated an additive effect in reducing blood pressure.
For reduction of cardiovascular events, the usual dose of Telmisartan Actavis is one 80 mg tablet once daily. At the start of preventive treatment with Telmisartan Actavis 80 mg, blood pressure should be monitored frequently.
If your liver is not functioning properly, the usual dose should not exceed 40 mg daily.
If your kidneys are not functioning properly, an initial lower dose of 20 mg is recommended.
Try to take the tablet at the same time each day. You may take Telmisartan Actavis with or without food. The tablets should be swallowed with a glass of water or other non-alcoholic beverage.
It is important that you take Telmisartan Actavis every day unless otherwise instructed by your doctor. 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 dose prescribed by your doctor. If you have accidentally taken too many tablets, contact your doctor or go to the nearest hospital emergency department immediately.
The most common symptoms of telmisartan overdose are low blood pressure (hypotension) and increased heart rate (tachycardia). A decrease in heart rate (bradycardia), dizziness, increased blood creatinine levels, and sudden worsening of renal function have also been reported.

If you forget to take Telmisartan Actavis
If you forget to take your dose, take it as soon as you remember on the same day. If you miss a day's dose, take your usual dose the next day. Do not take a double dose to make up for the forgotten dose.

If you stop taking Telmisartan Actavis
Take Telmisartan Actavis every day for as long as your doctor prescribes it, in order to maintain controlled blood pressure levels.
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 questions about how to use Telmisartan Actavis, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Some side effects can be serious and require immediate medical treatment:
You must contact your doctor immediately if you experience any of the following symptoms:
Sepsis* (often called "blood infection" – a severe infection causing a systemic inflammatory response throughout the body), 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. Patients must stop taking the medicine and consult their doctor immediately. If these effects are not treated, they may 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 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 (anaemia), high levels of potassium in the blood, difficulty falling asleep, feeling of sadness (depression), fainting (syncope), sensation of dizziness (vertigo), slow heart rate (bradycardia), low blood pressure (hypotension) in patients treated for high blood pressure, feeling of instability upon standing (orthostatic hypotension), shortness of breath, abdominal pain, diarrhoea, abdominal discomfort, bloating, vomiting, itching, increased sweating, drug-related skin 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” – a severe infection with systemic inflammatory response of the entire organism which may lead to death), increase in certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), severe allergic reaction (anaphylactic reaction), allergic reaction (e.g. rash, skin eruption, itching, difficulty breathing, wheezing, facial swelling or low blood pressure), low blood sugar levels (in diabetic patients), feeling of anxiety, drowsiness, vision disturbances, rapid heartbeat (tachycardia), dry mouth, stomach upset, altered taste (dysgeusia), altered liver function (patients of Japanese origin are more likely to experience this side effect)**, rapid swelling of the skin and mucous membranes which may also be fatal (angioedema, including fatal outcome), eczema (skin disorder), skin redness, urticaria, severe drug-related skin rash, joint pain (arthralgia), pain in extremities, tendon pain, influenza-like illness, decreased haemoglobin (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)**.

Frequency “not known” (frequency cannot be estimated from the available data):
Intestinal angioedema: following the use of similar products, swelling in the intestine has been reported, presenting with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

*The event may have occurred by chance or could be related to a mechanism currently unknown.
** Cases of progressive scarring of lung tissue have been reported during treatment with telmisartan. However, it is not known whether telmisartan was the cause.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 stated on the carton, bottle or blister after
"Exp.". The expiry date refers to the last day of the month.
Al/Al blisters:
Store in the original packaging to protect the medicine from light.
HDPE bottle:
Keep the bottle tightly closed to protect the medicine from light.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Telmisartan Actavis contains

The active substance 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.
Pack sizes:
Al/Al blisters: 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 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 on this medicinal product, please contact the local representative of the Marketing Authorization Holder.

België/Belgique/Belgien Lietuva
Teva Pharma Belgium N.V./S.A./AG UAB Teva Baltics
Tél/Tel: +32 38207373 Tel: +370 52660203

България Luxembourg/Luxemburg
Тева Фарма ЕАД Teva Pharma Belgium N.V./S.A./AG
Teл.: +359 24899585 Belgique/Belgien
Tél/Tel: +32 38207373

Česká republika Magyarország
Teva Pharmaceuticals CR, s.r.o. Teva Gyógyszergyár Zrt.
Tel: +420 251007111 Tel.: +36 12886400

Danmark Malta
Teva Denmark A/S Teva Pharmaceuticals Ireland
Tlf.: +45 44985511 Ireland
Tel: +44 2075407117

Deutschland Nederland
ratiopharm GmbH Teva Nederland B.V.
Tel: +49 73140202 Tel: +31 8000228400

Eesti Norge
UAB Teva Baltics Eesti filiaal Teva Norway AS
Tel: +372 6610801 Tlf: +47 66775590

Ελλάδα Österreich
TEVA HELLAS A.E. ratiopharm Arzneimittel Vertriebs-GmbH
Τηλ: +30 2118805000 Tel: +43 1970070

España Polska
Teva Pharma, S.L.U. Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +34 913873280 Tel.: +48 223459300

France Portugal
Teva Santé Teva Pharma - Produtos Farmacêuticos, Lda.
Tél: +33 155917800 Tel: +351 214767550

Hrvatska România
Pliva Hrvatska d.o.o. Teva Pharmaceuticals S.R.L.
Tel: +385 13720000 Tel: +40 212306524

Ireland Slovenija
Teva Pharmaceuticals Ireland Pliva Ljubljana d.o.o.
Tel: +44 2075407117 Tel: +386 15890390

Ísland Slovenská republika
Teva Pharma Iceland ehf. TEVA Pharmaceuticals Slovakia s.r.o.
Sími: +354 5503300 Tel: +421 257267911

Italia Suomi/Finland
Teva Italia S.r.l. Teva Finland Oy
Tel: +39 028917981 Puh/Tel: +358 201805900

Κύπρος Sverige
TEVA HELLAS A.E. Teva Sweden AB
Greece Tel: +46 42121100
Τηλ: +30 2118805000

Latvija
UAB Teva Baltics filiāle Latvijā
Tel: +371 67323666

More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/

Package leaflet: information for the user

Telmisartan Actavis 40 mg tablets

telmisartan
Generic medicine
Please read this entire leaflet carefully before 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. Never give it to others. It could be harmful to other people, even if their symptoms are the same as yours.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Telmisartan Actavis is and what it is used for
What you need to know before taking Telmisartan Actavis
How to take Telmisartan Actavis
Possible side effects
How to store Telmisartan Actavis
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 that causes blood vessels to narrow, thereby increasing blood pressure. Telmisartan Actavis blocks the effect of angiotensin II, resulting in relaxation of blood vessels and consequently lowering blood pressure.
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 other conditions.
If left untreated, high blood pressure can damage blood vessels in many organs and may sometimes lead to heart attack, heart or kidney failure, stroke, or blindness. High blood pressure usually does not cause symptoms until such damage has occurred. Therefore, it is important to have your blood pressure checked regularly to ensure 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 of reduced or blocked blood flow to the heart or legs, or who have had a stroke or have high-risk diabetes. Your doctor can determine whether you are at high risk for these events.

2. What you need to know before taking Telmisartan Actavis

Do not take Telmisartan Actavis

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

If you are in any of the above conditions, inform your doctor or pharmacist before taking
Telmisartan Actavis.
Warnings and precautions
Talk to your doctor if you have or have ever had any of the following conditions or diseases:

Kidney disease or kidney transplant.
Renal artery stenosis (narrowing of the blood vessels to one or both kidneys).
Liver diseases.
Heart problems.
Elevated levels of aldosterone (water and salt retention in the body with imbalance of various minerals in the blood).
Low blood pressure (hypotension), which is more likely if you are dehydrated (excessive loss of water from the body) or have salt deficiency due to diuretic therapy ("diuretics"), a low-salt diet, diarrhoea 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" (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
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 the information under the heading "Do not take Telmisartan Actavis".
Talk to your doctor if, after taking Telmisartan Actavis, you experience abdominal pain, nausea,
vomiting or diarrhoea. Your doctor will decide whether treatment should continue. Do not stop
taking Telmisartan Actavis on your own.
You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming
pregnant). Telmisartan Actavis is not recommended during early pregnancy and must not
be taken if you are more than 3 months pregnant, as it may cause serious harm to the
unborn baby if taken during this period (see section Pregnancy).
If undergoing surgery or receiving anaesthetics, 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
descent.
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
Inform your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including those without a prescription. Your doctor may decide to
adjust 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 particularly applies to the
following medicines when taken together with Telmisartan Actavis:

Medicines containing lithium used to treat certain types of depression.
Medicines that may increase potassium levels in the blood such as potassium-containing salt substitutes, potassium-sparing diuretics (some "diuretics"), ACE inhibitors (angiotensin-converting enzyme inhibitors, to reduce blood pressure), angiotensin II receptor antagonists, NSAIDs (non-steroidal anti-inflammatory drugs, e.g. aspirin or ibuprofen), heparin (a medicine to thin the blood), immunosuppressants (e.g. cyclosporine or tacrolimus), and the antibiotic trimethoprim.
Diuretics, especially when taken at high doses together with Telmisartan Actavis, may 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 taking NSAIDs (non-steroidal anti-inflammatory
drugs, e.g. aspirin or ibuprofen) or corticosteroids.
Telmisartan Actavis may enhance the effect of other medicines used to lower blood pressure
or medicines that may potentially lower blood pressure (e.g. baclofen,
amifostine). In addition, lowering of blood pressure may be worsened by alcohol,
barbiturates, narcotics or antidepressants. You may experience this drop in blood pressure as
dizziness when standing up. Consult your doctor if you need to adjust the dose of other
medicines while taking Telmisartan Actavis.
Pregnancy and breast-feeding
Pregnancy
You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming
pregnant). Usually, your doctor will advise you to stop taking Telmisartan
Actavis before becoming pregnant or as soon as you find out you are pregnant, and will recommend
another medicine instead of Telmisartan Actavis.
Telmisartan Actavis is not recommended during early pregnancy and must not be taken if you are
more than 3 months pregnant, as it may cause serious harm to the unborn baby if taken after
the third month of pregnancy.
Breast-feeding
Inform your doctor if you are breast-feeding or about to start breast-feeding. Telmisartan Actavis is not
recommended for women who are breast-feeding, and your doctor may choose another treatment
for you if you wish to breast-feed, especially if the baby is a newborn or was born prematurely.
Driving and using machines
Some patients may experience dizziness or drowsiness when taking Telmisartan Actavis. If these
effects occur, 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. is essentially
"sodium-free".

3. How to take Telmisartan Actavis

Take this medicine exactly as your doctor has told you. If you are unsure, 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 over a 24-hour period.
However, sometimes your doctor may recommend a lower dose of 20 mg daily or a higher dose of 80 mg. Alternatively, Telmisartan Actavis may also be used in combination with diuretics such as hydrochlorothiazide, with which it has demonstrated an additive effect in lowering blood pressure.
For the reduction of cardiovascular events, the usual dose of Telmisartan Actavis is one 80 mg tablet once daily. At the beginning of preventive treatment with Telmisartan Actavis 80 mg, blood pressure should be monitored frequently.
If your liver is not functioning properly, the usual dose should not exceed 40 mg daily.
If your kidneys are not functioning adequately, a lower starting dose of 20 mg is recommended.
Try to take the tablet at the same time each day. You may take Telmisartan Actavis with or without food. The tablets should be swallowed with a glass of water or other non-alcoholic beverage.
It is important that you take Telmisartan Actavis every day unless otherwise instructed by your doctor. If you feel that the effect of Telmisartan Actavis is too strong or too weak, speak 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 taken too many tablets by mistake, contact your doctor or go to the nearest hospital emergency department immediately.
The most common symptoms of telmisartan overdose are low blood pressure (hypotension) and increased heart rate (tachycardia). Decreased heart rate (bradycardia), dizziness, increased blood creatinine levels, and sudden worsening of kidney function have also been reported.

If you forget to take Telmisartan Actavis
If you forget to take your dose, take it as soon as you remember on the same day. If you miss a day's dose, take your normal dose the next day. Do not take a double dose to make up for the forgotten dose.

If you stop taking Telmisartan Actavis
Take Telmisartan Actavis every day for as long as your doctor prescribes it in order to maintain controlled blood pressure levels.
If you feel that the effect of Telmisartan Actavis is too strong or too weak, speak to your doctor or pharmacist.

If you have any doubts about how to use Telmisartan Actavis, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Some side effects may be serious and require immediate medical treatment:
You must contact your doctor immediately if you experience any of the following symptoms:
Sepsis* (often called "blood infection" – a severe infection with an inflammatory response throughout the whole body), 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 must stop taking the medicine and consult a doctor immediately. If these effects are not treated, they may be fatal.

Possible side effects of telmisartan:
Common side effects (may affect up to 1 in 1,000 people):
Low blood pressure (hypotension) in patients treated to reduce 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 (anaemia), high levels of potassium in the blood, difficulty falling asleep, feeling of sadness (depression), fainting (syncope), sensation of dizziness (vertigo), slow heart rate (bradycardia), low blood pressure (hypotension) in patients treated for high blood pressure, feeling of instability upon standing (orthostatic hypotension), shortness of breath, cough, abdominal pain, diarrhoea, abdominal discomfort, bloating, vomiting, itching, increased sweating, drug-related skin rash, back pain, muscle cramps, muscle pain (myalgia), kidney impairment including acute kidney 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” – a severe infection with an inflammatory response throughout the whole body that may 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, facial swelling or low blood pressure), low blood sugar levels (in diabetic patients), feeling of anxiety, drowsiness, visual disturbances, rapid heartbeat (tachycardia), dry mouth, stomach upset, altered taste (dysgeusia), altered liver function (Japanese patients are more predisposed to experience this side effect)**, rapid swelling of the skin and mucous membranes which may also lead to death (angioedema, including fatal outcome), eczema (skin disorder), skin redness, urticaria, severe drug-related skin rash, joint pain (arthralgia), pain in the extremities, tendon pain, influenza-like illness, decreased haemoglobin (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)**.

Frequency “not known” (frequency cannot be estimated from the available data):
Intestinal angioedema: following the use of similar products, swelling in the intestine has been reported, presenting with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.
This event may have occurred by chance or could be related to a currently unknown mechanism.
** Cases of progressive scarring of lung tissue have been reported during treatment with telmisartan. However, it is not known whether telmisartan was the cause.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 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 packaging 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 via 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 substance 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 package contents
The 40 mg tablets are white, oval, biconvex, with a score line and the logo T imprinted on one side. The tablet can be divided into two equal halves.
Pack sizes:
Al/Al blisters: 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 about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien Lietuva
Teva Pharma Belgium N.V./S.A./AG UAB Teva Baltics
Tél/Tel: +32 38207373 Tel: +370 52660203

България Luxembourg/Luxemburg
Тева Фарма ЕАД Teva Pharma Belgium N.V./S.A./AG
Teл.: +359 24899585 Belgique/Belgien
Tél/Tel: +32 38207373

Česká republika Magyarország
Teva Pharmaceuticals CR, s.r.o. Teva Gyógyszergyár Zrt.
Tel: +420 251007111 Tel.: +36 12886400

Danmark Malta
Teva Denmark A/S Teva Pharmaceuticals Ireland
Tlf.: +45 44985511 L-Irlanda
Tel: +44 2075407117