Irbesartan Teva: detailed information

Package leaflet: Information for the user

Irbesartan Teva 75 mg film-coated tablets

Irbesartan
Please read this 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. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Irbesartan Teva and what is it used for

Irbesartan Teva belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced by the body that binds to receptors in blood vessels, causing them to narrow. This results in increased blood pressure. Irbesartan Teva prevents angiotensin-II from binding to these receptors, allowing blood vessels to relax and blood pressure to decrease. Irbesartan Teva slows the decline in kidney function in patients with high blood pressure and type 2 diabetes.
Irbesartan Teva is used in adult patients

to treat high blood pressure (essential arterial hypertension)
to protect the kidneys in hypertensive patients with high blood pressure, type 2 diabetes, and evidence of kidney dysfunction shown by laboratory tests.

2. What you need to know before taking Irbesartan Teva

Do not use Irbesartan Teva

If you are allergic to irbesartan or to any of the excipients of this medicine (listed in section 6).
If you are more than 3 months pregnant (it is better to avoid taking Irbesartan Teva even in the early stages of pregnancy – see section Pregnancy).
If you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

Irbesartan Teva must not be administered to children and adolescents (under 18 years of age).
Warnings and precautions
Tell your doctor before taking Irbesartan Teva if you are in any of the following conditions:

If you have excessive vomiting or diarrhoea.
If you have kidney problems.
If you have heart problems.
If you are taking Irbesartan Teva for diabetic kidney disease. In this case, your doctor may prescribe regular blood tests, especially to monitor potassium levels in case of poor kidney function.
If you develop low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, tremor, headache, flushing or pallor, numbness, rapid and pounding heartbeat), especially if you are being treated for diabetes.
If you are due to undergo surgery or receive anaesthetics.
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 blood electrolyte levels
(e.g. potassium) at regular intervals.
See also the section "Do not take Irbesartan Teva".
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Irbesartan Teva 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).
Children and adolescents
This medicine must not be given to children under 18 years of age, as safety and efficacy have not yet been fully established. If a child accidentally swallows any tablets, contact your doctor immediately.
Other medicines and Irbesartan Teva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Your doctor may need to adjust your dose and/or take other precautions:
If you are taking an ACE inhibitor or aliskiren (see also sections: "Do not take Irbesartan Teva" and "Warnings and precautions").
You may need blood tests if you are taking:

Potassium supplements
Potassium-containing salt substitutes
Potassium-sparing medicines (such as certain diuretics)
Medicines containing lithium
Repaglinide (a medicine used to lower blood sugar levels).

If you are taking certain painkillers called non-steroidal anti-inflammatory drugs (NSAIDs), the effectiveness of irbesartan may be reduced.
Pregnancy and breastfeeding
Pregnancy
Inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking Irbesartan Teva before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine. Irbesartan Teva 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 planning to breast-feed. Irbesartan Teva is not recommended for women who are breast-feeding, and your doctor may choose an alternative treatment if you wish to breast-feed, especially if the baby is a newborn or was born prematurely.
Driving and using machines
It is unlikely that Irbesartan Teva will affect your ability to drive or operate machinery. However, occasionally, dizziness or fatigue may occur during treatment for high blood pressure. If this happens, talk to your doctor before driving or using machinery.
Irbesartan Teva contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. essentially 'sodium-free'.

3. How to use Irbesartan Teva

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Method of administration
Irbesartan Teva is for oral use. Swallow the tablets with sufficient fluid (e.g. a glass of water). You may take Irbesartan Teva with or without food. Try to take the medicine at the same time each day. Treatment should be continued for as long as your doctor considers it necessary.

Patients with high blood pressure: The usual dose is 150 mg once daily. The dose may be increased to 300 mg once daily, depending on the reduction in blood pressure levels.
Patients with high blood pressure and type 2 diabetes with kidney disease: In patients with high blood pressure and type 2 diabetes, the recommended maintenance dose is 300 mg once daily for the treatment of associated kidney disease.

Your doctor may decide to use lower doses, especially at the beginning of treatment, in particular patients such as those undergoing haemodialysis, or in patients over 75 years of age.
Maximum antihypertensive effect should be achieved within 4–6 weeks after starting therapy.
If you take more Irbesartan Teva than you should
If you accidentally take too many tablets, contact your doctor immediately.
If you forget to take Irbesartan Teva
If you accidentally miss a dose, continue with your regular dosing schedule. Do not take a double dose to make up for the missed dose.
If you have any questions about 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 of these side effects can be serious and may require medical attention.
As with similar medicines, rare cases of skin allergic reactions (rash, urticaria) as well as localized swelling of the face, lips and/or tongue have been reported in patients treated with irbesartan. If you experience any of these symptoms or have difficulty breathing, stop taking Irbesartan Teva and contact your doctor immediately.

List of side effects

Very common (may affect more than 1 in 10 people): if you have high blood pressure and type 2 diabetes with kidney disease, blood tests may show high levels of potassium.
Common (may affect more than 1 in 10 people): dizziness, feeling unwell/vomiting, fatigue and blood tests may show increased levels of an enzyme that measures muscle and heart function (creatine kinase enzyme). In patients with high blood pressure and type 2 diabetes with kidney disease, dizziness upon standing up from lying or sitting position, low blood pressure upon standing up from lying or sitting position, joint or muscle pain and decreased levels of a protein in red blood cells (haemoglobin) have also been reported.
Uncommon (may affect up to 1 in 100 people): increased heart rate, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems related to sexual performance), chest pain.

Not known (frequency cannot be estimated from the available data): sensation of spinning dizziness, headache, taste disturbances, ringing in the ears, muscle cramps, joint and muscle pain, decreased number of red blood cells (anaemia - symptoms may include tiredness, headache, shortness of breath during physical activity, dizziness and pale appearance), reduced platelet count, abnormal liver function, increased potassium levels in the blood, kidney function disorders, inflammation of the small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis), severe allergic reactions (anaphylactic shock) and low blood sugar levels. Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported.

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 detailed in Annex V.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Irbesartan Teva

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 outer packaging or on the
blister after Exp. The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Do not dispose of medicines 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 Irbesartan Teva contains

The active substance is irbesartan. Each 75 mg film-coated tablet of Irbesartan Teva contains 75 mg of irbesartan.
The other components are:
Tablet core: povidone, pregelatinized starch (maize), poloxamer 188, microcrystalline cellulose, sodium croscarmellose, hydrated colloidal silica and magnesium stearate.
Tablet coating: polydextrose, titanium dioxide, hypromellose and macrogol 4000.

Description of the appearance of Irbesartan Teva and package contents
The 75 mg film-coated tablets of Irbesartan Teva are capsule-shaped, white to almost white in colour. On one side of the tablet, the number "93" is engraved; on the other side, the number "7464" is engraved.
Irbesartan Teva is available in packs of 7, 14, 28, 30, 56, 60, 80, 84, 90, 98 and 100 film-coated tablets in non-perforated blisters; packs of 50 x 1 and 56 x 1 film-coated tablet in unit dose blister packs; and a pack of 28 film-coated tablets in non-perforated calendar blister packs.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Teva B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands

Manufacturers:
Teva Operations Poland Sp. z o.o.
ul. Mogilska 80
31-546 Kraków
Poland
Teva Pharmaceutical Works Private Limited Company
Pallagi út 13
Debrecen H-4042
Hungary
Pharmachemie B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

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

България
Тева Фарма ЕАД
Teл: +359 24899585

Magyarország
Teva Gyógyszergyár Zrt.
Tel: +36 12886400

Česká republika Malta
Teva Pharmaceuticals CR, s.r.o.
Tel: +420 251007111
Teva Pharmaceuticals Ireland
L-Irlanda
Tel: +44 2075407117

Danmark
Teva Denmark A/S
Tlf: +45 44985511

Nederland
Teva Nederland B.V.
Tel: +31 8000228400

Deutschland
TEVA GmbH
Tel: +49 73140208

Norge
Teva Norway AS
Tlf: +47 66775590

Eesti
UAB Teva Baltics Eesti filiaal
Tel: +372 6610801

Österreich
ratiopharm Arzneimittel Vertriebs-GmbH
Tel: +43 1970070

Ελλάδα
Specifar A.B.E.E.
Τηλ: +30 2118805000

Polska
Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +48 223459300

España
Teva Pharma, S.L.U.
Tel: +34 913873280

Portugal
Teva Pharma - Produtos Farmacêuticos, Lda.
Tel: +351 214767550

France
Teva Santé
Tél: +33 155917800

România
Teva Pharmaceuticals S.R.L.
Tel: +40 212306524

Hrvatska
Pliva Hrvatska d.o.o.
Tel: +385 13720000

Slovenija
Pliva Ljubljana d.o.o.
Tel: +386 15890390

Ireland
Teva Pharmaceuticals Ireland
Tel: +44 2075407117

Slovenská republika
TEVA Pharmaceuticals Slovakia s.r.o.
Tel: +421 257267911

Ísland
Teva Finland Oy
Sími: +358 201805900

Suomi/Finland
Teva Finland Oy
Puh/Tel: +358 201805900

Italia
Teva Italia S.r.l.
Tel: +39 028917981

Sverige
Teva Sweden AB
Tel: +46 42121100

Κύπρος
Specifar A.B.E.E.
Ελλάδα
Τηλ: +30 2118805000

United Kingdom (Northern Ireland)
Teva Pharmaceuticals Ireland
Ireland
Tel: +44 2075407117

Latvija
UAB Teva Baltics filiāle Latvijā
Tel: +371 67323666

Lietuva
UAB Teva Baltics
Tel: +370 52660203

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

Package leaflet: information for the user

Irbesartan Teva 150 mg film-coated tablets

Irbesartan
Please read this 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. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
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 Irbesartan Teva is and what it is used for
What you need to know before taking Irbesartan Teva
How to take Irbesartan Teva
Possible side effects
How to store Irbesartan Teva
Contents of the pack and other information

1. What Irbesartan Teva is and what it is used for

Irbesartan Teva belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced by the body that binds to receptors in blood vessels, causing them to constrict. This results in increased blood pressure. Irbesartan Teva prevents angiotensin-II from binding to these receptors, allowing blood vessels to widen and blood pressure to decrease. Irbesartan Teva slows the decline in kidney function in patients with high blood pressure and type 2 diabetes.
Irbesartan Teva is used in adult patients

to treat high blood pressure (essential hypertension)
to protect the kidneys in hypertensive patients with type 2 diabetes and evidence of kidney dysfunction shown by laboratory tests.

2. What you need to know before taking Irbesartan Teva

Do not use Irbesartan Teva

If you are allergic to irbesartan 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 Irbesartan Teva even in the early stages of pregnancy – see Pregnancy section).
If you develop low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, trembling, headache, flushing or paleness, numbness, rapid and pounding heartbeat), especially if you are being treated for diabetes.
If you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions
Tell your doctor before taking Irbesartan Teva if you are in any of the following conditions:

If you have excessive vomiting or diarrhoea.
If you have kidney problems.
If you have heart problems.
If you are taking Irbesartan Teva for diabetic kidney disease. In this case, your doctor may prescribe regular blood tests, especially to monitor potassium levels in case of poor kidney function.
If you are due to undergo surgery or receive anaesthetics.
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 blood levels of electrolytes (such as potassium) at regular intervals.
See also the information under the section "Do not take Irbesartan Teva".
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Irbesartan Teva 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).

Children and adolescents
This medicine must not be given to children under 18 years of age, as safety and efficacy have not yet been fully established. If a child swallows any tablets, contact your doctor immediately.

Other medicines and Irbesartan Teva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Your doctor may consider it necessary to adjust the dose and/or take other precautions:
If you are taking an ACE inhibitor or aliskiren (see also the sections "Do not take Irbesartan Teva" and "Warnings and precautions").

You may need blood tests if you are taking:

Potassium supplements
Potassium-containing salt substitutes
Potassium-sparing medicines (such as certain diuretics)
Medicines containing lithium
Repaglinide (a medicine used to lower blood sugar levels)

If you are taking certain painkillers called non-steroidal anti-inflammatory drugs (NSAIDs), the effectiveness of irbesartan may be reduced.

Pregnancy and breastfeeding
Pregnancy
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking Irbesartan Teva before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of Irbesartan Teva. Irbesartan Teva 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. Irbesartan Teva 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
It is unlikely that Irbesartan Teva will affect your ability to drive or use machines. However, occasionally dizziness or fatigue may occur during treatment for high blood pressure. If this happens, talk to your doctor before driving or using machines.

Irbesartan Teva contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. essentially 'sodium-free'.

3. How to use Irbesartan Teva

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Route of administration
Irbesartan Teva is for oral use. Swallow the tablets with sufficient fluid (e.g. a glass of water). You may take Irbesartan Teva with or without food. Try to take the medicine at the same time each day. Treatment should be continued for as long as your doctor considers it necessary.

Patients with high blood pressure
The usual dose is 150 mg once daily. The dose may be increased to 300 mg once daily depending on the reduction in blood pressure levels.
Patients with high blood pressure and type 2 diabetes with kidney disease
In patients with high blood pressure and type 2 diabetes, the recommended maintenance dose is 300 mg once daily for the treatment of associated kidney disease.

Your doctor may decide to use lower doses, especially at the beginning of treatment, in certain patients such as those on haemodialysis or patients over 75 years of age.
Maximum antihypertensive effect should be achieved within 4–6 weeks after starting therapy.

If you take more Irbesartan Teva than you should
If you accidentally take too many tablets, contact your doctor immediately.

If you forget to take Irbesartan Teva
If you accidentally miss a dose, continue your treatment as usual. Do not take a double dose to make up for the missed dose.

If you have any questions about 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 everyone experiences them. Some of these side effects may be serious and may require medical attention.
As with similar medicines, rare cases of skin allergic reactions (rash, urticaria) as well as localized swelling of the face, lips and/or tongue have been reported in patients treated with irbesartan. If you experience any of these symptoms or have difficulty breathing, stop taking Irbesartan Teva and contact your doctor immediately.

List of side effects:

Very common (may affect more than 1 in 10 people): if you have high blood pressure and type 2 diabetes with kidney disease, blood tests may show high potassium levels.
Common (may affect up to 1 in 10 people): dizziness, feeling unwell/nausea, fatigue, and blood tests may show increased levels of an enzyme that measures muscle and heart function (creatine kinase enzyme). In patients with high blood pressure and type 2 diabetes with kidney disease, dizziness upon standing up from lying or sitting position, low blood pressure upon standing up from lying or sitting position, joint or muscle pain, and decreased levels of a protein in red blood cells (haemoglobin) have also been reported.
Uncommon (may affect up to 1 in 100 people): increased heart rate, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems related to sexual performance), chest pain.

Not known (frequency cannot be estimated from the available data): sensation of dizziness, headache, taste disturbances, ringing in the ears, muscle cramps, joint and muscle pain, decreased number of red blood cells (anaemia - symptoms may include tiredness, headache, shortness of breath during physical activity, dizziness and pale appearance), reduced platelet count, abnormal liver function, increased blood potassium levels, disturbances in kidney function, inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis), severe allergic reactions (anaphylactic shock), and low blood sugar levels.
Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported.

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 Irbesartan Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer packaging or blister after Exp. The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
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 Irbesartan Teva Contains

The active substance is irbesartan. Each film-coated tablet of Irbesartan Teva 150 mg contains 150 mg of irbesartan.
The other components are:
Tablet core: povidone, pregelatinized maize starch, poloxamer 188, microcrystalline cellulose, sodium croscarmellose, colloidal hydrated silica, and magnesium stearate.
Tablet coating: polydextrose, titanium dioxide, hypromellose, and macrogol 4000.

Description of the Appearance of Irbesartan Teva and Contents of the Pack
Irbesartan Teva 150 mg film-coated tablets are capsule-shaped, white to almost white. The number "93" is imprinted on one side of the tablet and the number "7465" on the other side.
Irbesartan Teva is available in packs of 7, 14, 28, 30, 56, 60, 80, 84, 90, 98, and 100 film-coated tablets in non-perforated blisters; packs of 50 x 1 and 56 x 1 film-coated tablet in unit dose blisters; and a pack of 28 film-coated tablets in a non-perforated calendar blister.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Teva B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands

For further information about this medicine, please contact the local representative of the Marketing Authorization Holder:

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

България
Тева Фарма ЕАД
Teл: +359 24899585

Magyarország
Teva Gyógyszergyár Zrt.
Tel: +36 12886400

Česká republika Malta
Teva Pharmaceuticals CR, s.r.o. Teva Pharmaceuticals Ireland
Tel: +420 251007111 L-Irlanda
Τel: +44 2075407117

Danmark Nederland
Teva Denmark A/S Teva Nederland B.V.
Tlf: +45 44985511 Tel: +31 8000228400

Deutschland Österreich
TEVA GmbH ratiopharm Arzneimittel Vertriebs-GmbH
Tel: +49 73140208 Tel: +43 1970070

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

Ελλάδα Polska
Specifar A.B.E.E. Teva Pharmaceuticals Polska Sp. z o.o.
Τηλ: +30 2118805000 Tel: +48 223459300

España Portugal
Teva Pharma, S.L.U. Teva Pharma - Produtos Farmacêuticos, Lda.
Tel: +34 913873280 Tel: +351 214767550

France România
Teva Santé Teva Pharmaceuticals S.R.L.
Tél: +33 155917800 Tel: +40 212306524

Hrvatska Slovenija
Pliva Hrvatska d.o.o. Pliva Ljubljana d.o.o.
Tel: +385 13720000 Tel: +386 15890390

Ireland Slovenská republika
Teva Pharmaceuticals Ireland TEVA Pharmaceuticals Slovakia s.r.o.
Tel: +44 2075407117 Tel: +421 257267911

Ísland Suomi/Finland
Teva Finland Oy
Sími: +358 201805900
Finnland Puh/Tel: +358 201805900

Italia Sverige
Teva Italia S.r.l. Teva Sweden AB
Tel: +39 028917981 Tel: +46 42121100

Κύπρος United Kingdom (Northern Ireland)
Specifar A.B.E.E. Teva Pharmaceuticals Ireland
Ελλάδα Ireland
Τηλ: +30 2118805000 Tel: +44 2075407117

Latvija
UAB Teva Baltics filiāle Latvijā
Tel: +371 67323666

Lietuva
UAB Teva Baltics
Tel: +370 52660203

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

Package leaflet: Information for the user

Irbesartan Teva 300 mg film-coated tablets

Irbesartan
Read this entire 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 give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Irbesartan Teva is and what it is used for

Irbesartan Teva belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced by the body that binds to receptors in blood vessels, causing them to constrict. This results in increased blood pressure. Irbesartan Teva prevents angiotensin-II from binding to these receptors, allowing blood vessels to dilate and blood pressure to decrease. Irbesartan Teva slows the decline in kidney function in patients with high blood pressure and type 2 diabetes.
Irbesartan Teva is used in adult patients

to treat high blood pressure (essential arterial hypertension)
to protect the kidneys in hypertensive patients with high blood pressure, type 2 diabetes, and evidence of kidney dysfunction shown by laboratory tests.

2. What you need to know before taking Irbesartan Teva

Do not use Irbesartan Teva

If you are allergic to irbesartan or to any of the other ingredients of this medicine (listed in section 6).
If you are more than 3 months pregnant (it is best to avoid taking Irbesartan Teva even in the early stages of pregnancy – see Pregnancy section).
If you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions
Tell your doctor before taking Irbesartan Teva if you are in any of the following conditions:

If you have severe vomiting or diarrhoea.
If you have kidney problems.
If you have heart problems.
If you are taking Irbesartan Teva for diabetic kidney disease. In this case, your doctor may prescribe regular blood tests, especially to monitor blood potassium levels in case of poor kidney function.
If you are scheduled for surgery or to receive anaesthetics.
If you develop low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, trembling, headache, flushing or paleness, numbness, rapid or pounding heartbeat), especially if you are being treated for diabetes.
If you are taking any of the following medicines used to treat high blood pressure:
- an "ACE inhibitor" (for example enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
- aliskiren.

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals.
See also the section "Do not take Irbesartan Teva".
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Irbesartan Teva 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).

Children and adolescents
This medicine must not be given to children under 18 years of age, as its safety and efficacy have not yet been fully established. If a child accidentally swallows any tablets, contact your doctor immediately.

Other medicines and Irbesartan Teva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Your doctor may consider it necessary to adjust your dose and/or take additional precautions if you are taking an ACE inhibitor or aliskiren (see also sections "Do not take Irbesartan Teva" and "Warnings and precautions").

You may need blood tests if you are taking:

Potassium supplements
Potassium-containing salt substitutes
Potassium-sparing medicines (such as certain diuretics)
Medicines containing lithium
Repaglinide (a medicine used to lower blood sugar levels)

The effectiveness of irbesartan may be reduced if you take certain painkillers called non-steroidal anti-inflammatory drugs (NSAIDs).

Pregnancy and breastfeeding
Pregnancy
Inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking Irbesartan Teva before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of Irbesartan Teva. Irbesartan Teva 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 planning to start breast-feeding. Irbesartan Teva 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
It is unlikely that Irbesartan Teva will affect your ability to drive or use machinery. However, occasionally, dizziness or fatigue may occur during treatment for high blood pressure. If this happens, talk to your doctor before driving or operating machinery.

Irbesartan Teva contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. essentially 'sodium-free'.

3. How to use Irbesartan Teva

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Method of administration
Irbesartan Teva is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. a glass of water). You may take Irbesartan Teva with or without food. Try to take the medicine at the same time each day. Treatment should be continued for as long as your doctor considers it necessary.

Patients with high blood pressure: The usual dose is 150 mg once daily. The dose may be increased to 300 mg once daily, depending on the reduction in blood pressure levels.
Patients with high blood pressure and type 2 diabetes with kidney disease: In patients with high blood pressure and type 2 diabetes, the recommended maintenance dose is 300 mg once daily for the treatment of associated kidney disease.

Your doctor may decide to use lower doses, especially at the beginning of treatment, in certain patients such as those undergoing haemodialysis, or in patients over 75 years of age.
Maximum antihypertensive effect should be achieved within 4–6 weeks after starting therapy.
If you take more Irbesartan Teva than you should
If you accidentally take too many tablets, contact your doctor immediately.
If you forget to take Irbesartan Teva
If you accidentally miss a dose, continue with your next dose as usual. Do not take a double dose to make up for the missed dose.
If you have any questions about 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 everyone gets them. Some of these effects may be serious and may require medical attention.
As with similar medicines, rare cases of skin allergic reactions (rash, urticaria) as well as localized swelling of the face, lips and/or tongue have been reported in patients treated with irbesartan. If you experience any of these symptoms or have difficulty breathing, stop taking Irbesartan Teva and contact your doctor immediately.

List of side effects:
Very common (may affect more than 1 in 10 people): If you have high blood pressure and type 2 diabetes with kidney disease, blood tests may show high levels of potassium.

Common (may affect up to 1 in 10 people): dizziness, feeling unwell/vomiting, fatigue, and blood tests may show increased levels of an enzyme that measures muscle and heart function (creatine kinase enzyme). In patients with high blood pressure, type 2 diabetes and kidney disease, dizziness upon standing up from lying or sitting position, low blood pressure upon standing up from lying or sitting position, joint or muscle pain, and decreased levels of a protein in red blood cells (haemoglobin) have also been reported.

Uncommon (may affect up to 1 in 100 people): increased heart rate, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems related to sexual performance), chest pain.

Not known (frequency cannot be estimated from the available data): headache, taste disturbances, ringing in the ears, muscle cramps, joint and muscle pain, decreased number of red blood cells (anaemia – symptoms may include tiredness, headache, shortness of breath during physical activity, dizziness and pale appearance), reduced number of platelets, abnormal liver function, increased blood potassium levels, impaired kidney function, inflammation of the small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis), severe allergic reactions (anaphylactic shock) and low blood sugar levels. Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported.

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 Irbesartan Teva

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 outer packaging or on the
blister after Exp. The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Irbesartan Teva contains

The active substance is irbesartan. Each film-coated tablet of Irbesartan Teva 300 mg contains 300 mg of irbesartan.
The other components are:
Tablet core: povidone, pregelatinized maize starch, poloxamer 188, microcrystalline cellulose, sodium croscarmellose, colloidal hydrated silica, magnesium stearate.
Tablet coating: polydextrose, titanium dioxide, hypromellose, macrogol 4000.

Description of the appearance of Irbesartan Teva and contents of the pack
The film-coated tablets of Irbesartan Teva 300 mg are capsule-shaped, white to almost white. On one side of the tablet, the number "93" is printed. On the other side, the number "7466" is printed.
Irbesartan Teva is available in packs of 7, 14, 28, 30, 56, 60, 80, 84, 90, 98 and 100 film-coated tablets in non-perforated blisters; packs of 50 x 1 and 56 x 1 film-coated tablet in unit dose blisters; and a pack of 28 film-coated tablets in non-perforated calendar blister packs.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Teva B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

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

България
Тева Фарма ЕАД
Teл: +359 24899585

Magyarország
Teva Gyógyszergyár Zrt.
Tel: +36 12886400

Česká republika Malta
Teva Pharmaceuticals CR, s.r.o. Teva Pharmaceuticals Ireland
Tel: +420 251007111 L-Irlanda
Τel: +44 2075407117

Danmark
Teva Denmark A/S
Tlf: +45 44985511

Deutschland
TEVA GmbH
Tel: +49 73140208

Eesti
UAB Teva Baltics Eesti filiaal
Tel: +372 6610801

Ελλάδα
Specifar A.B.E.E.
Τηλ: +30 2118805000

España
Teva Pharma, S.L.U.
Tel: +34 913873280

France
Teva Santé
Tél: +33 155917800

Hrvatska
Pliva Hrvatska d.o.o
Tel: +385 13720000

Ireland
Teva Pharmaceuticals Ireland
Tel: +44 2075407117

Ísland
Teva Finland Oy
Sími: +358 201805900

Italia
Teva Italia S.r.l.
Tel: +39 028917981

Κύπρος
Specifar A.B.E.E.
Ελλάδα
Τηλ: +30 2118805000

Latvija
UAB Teva Baltics filiāle Latvijā
Tel: +371 67323666

Lietuva
UAB Teva Baltics
Tel: +370 52660203

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

Magyarország
Teva Gyógyszergyár Zrt.
Tel: +36 12886400

Malta
Teva Pharmaceuticals Ireland
L-Irlanda
Τel: +44 2075407117

Nederland
Teva Nederland B.V.
Tel: +31 8000228400

Norge
Teva Norway AS
Tlf: +47 66775590

Österreich
ratiopharm Arzneimittel Vertriebs-GmbH
Tel: +43 1970070

Polska
Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +48 223459300

Portugal
Teva Pharma - Produtos Farmacêuticos, Lda.
Tel: +351 214767550

România
Teva Pharmaceuticals S.R.L.
Tel: +40 212306524

Slovenija
Pliva Ljubljana d.o.o.
Tel: +386 15890390

Slovenská republika
Teva Pharmaceuticals Slovakia s.r.o.
Tel: +421 257267911

Suomi/Finland
Teva Finland Oy
Puh/Tel: +358 201805900

Sverige
Teva Sweden AB
Tel: +46 42121100

United Kingdom (Northern Ireland)
Teva Pharmaceuticals Ireland
Tel: +44 2075407117

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