IRBESARTAN 75 mg Film-Coated Tablets

Зміст інструкції

1. Irbesartan Teva 75 mg film-coated tablets
   1. What is Irbesartan Teva and what it is used for
   2. What you need to know before taking Irbesartan Teva
   3. How to use Irbesartan Teva
   4. Possible side effects
   5. How to store Irbesartan Teva
   6. Package contents and other information
2. Irbesartan Teva 150 mg film-coated tablets
   1. What is Irbesartan Teva and what it is used for
   2. What you need to know before you take Irbesartan Teva
   3. How to use Irbesartan Teva
   4. Possible side effects
   5. How to store Irbesartan Teva
   6. Contents of the pack and other information
3. Irbesartan Teva 300 mg film-coated tablets
   1. What is Irbesartan Teva and what it is used for
   2. What you need to know before taking Irbesartan Teva
   3. How to use Irbesartan Teva
   4. Possible side effects
   5. How to store Irbesartan Teva
   6. Contents of the pack and other information

Irbesartan Teva 75 mg film-coated tablets

Irbesartan

Read this leaflet carefully before 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, even if their symptoms are the same as yours, as it could be harmful.
• 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 Irbesartan Teva is and what it is used for
• 2. What you need to know before you use Irbesartan Teva
• 3. How to use Irbesartan Teva
• 4. Possible side effects
• 5. How to store Irbesartan Teva
• 6. Contents of the pack and other information

1. What is Irbesartan Teva 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 an increase in 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 kidney in hypertensive patients with high blood pressure, type 2 diabetes and with evidence of renal dysfunction in laboratory tests.

2. What you need to know before taking Irbesartan Teva

Do not use Irbesartan Teva

• If you are allergic to irbesartan 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 Irbesartan Teva even in the early stages of pregnancy - see section Pregnancy).
• 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.

Irbesartan Teva should not be given to children and adolescents (under 18 years of age).

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

• If you have excessive vomiting or diarrhoea.
• If you have problems with your kidneys.
• If you have problems with your heart.
• If you are taking Irbesartan Teva for diabetic kidney disease. In this case, your doctor may prescribe regular blood tests, especially to measure potassium levels in the blood if you have poor kidney function.
• If you develop low blood sugar levels (symptoms can include sweating, weakness, hunger, dizziness, tremor, headache, flushing or paleness, numbness, fast or pounding heartbeat), especially if you are being treated for diabetes.
• If you are to undergo surgery (surgical) or receive anaesthetics.
• 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 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 what is stated under "Do not take Irbesartan Teva".
You must tell your doctor if you think you may be pregnant (or if there is a possibility of becoming
pregnant). Irbesartan Teva is not recommended in early 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 section Pregnancy).

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

Other medicines and Irbesartan Teva
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, or if you
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 what is stated under: "Do not
Irbesartan Teva" and "Warnings and precautions”).
You may need blood tests if you are using:

• potassium supplements
• salt substitutes containing potassium
• potassium-sparing medicines (such as some diuretics)
• medicines containing lithium
• repaglinide (a medicine used to lower blood sugar levels).

If you take some painkillers, called non-steroidal anti-inflammatory drugs,
the effectiveness of irbesartan may be reduced.

Pregnancy and breastfeeding
Pregnancy
Tell your doctor if you think you may be pregnant (or if there is a possibility of becoming
pregnant). Normally your doctor will advise you to stop taking Irbesartan Teva
before becoming pregnant or as soon as you find out you are pregnant and will
advise you to take another medicine instead of Irbesartan Teva. Irbesartan Teva is not
recommended in early 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 planning to start breastfeeding. Irbesartan Teva 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
It is unlikely that Irbesartan Teva will affect your ability to drive or operate machinery. However,
occasionally, dizziness or
tiredness 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, which is
essentially ‘sodium-free’.

3. How to use Irbesartan Teva

Take this medicine following always exactly the instructions of the doctor. If you have doubts, consult
the doctor or the pharmacist.
Method of administration
Irbesartan Teva is for oral use. Swallow the tablets with a sufficient amount of fluids (e.g. a
glass of water). You can take Irbesartan Teva with or without food. Try to take the medicine
every day at the same time. The treatment must be continued as long as the doctor deems it necessary.

• Patients with high blood pressure The usual dose is 150 mg once a day. The dose may be increased to 300 mg once a day depending on the reduction of 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 indicated maintenance dose is 300 mg once a day for the treatment of associated kidney disease.

The doctor may decide to use lower doses, especially at the beginning of the treatment, in
particular patients such as those in hemodialysis, or in patients over 75 years of age.
The maximum antihypertensive effect should be reached 4-6 weeks after the start of 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 forget to take a dose, continue normally with the therapy. Do not take
a double dose to compensate for the missed dose.
If you have any doubts about the use of this medicine, consult 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 effects may be serious and may require medical attention.
As with similar medicines, rare cases of allergic skin reactions (rash, hives) 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 if you 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 suffer from 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 an increase in the 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 when getting up from a lying or sitting position, low blood pressure when getting up from a lying or sitting position, joint or muscle pain and a decrease in the levels of a protein in red blood cells (hemoglobin) have also been reported.
• Uncommon (may affect up to 1 in 100 people): increased heart rate, flushing, cough, diarrhea, indigestion/heartburn, sexual dysfunction (problems related to sexual performance), chest pain.

Not known (the frequency cannot be estimated from the available data): feeling of
dizziness, headache, taste disturbances, ringing in the ears, muscle cramps, joint and muscle pain, decreased number of red blood cells (anemia - symptoms may
include fatigue, headache, shortness of breath during physical activity, dizziness and pale appearance), reduced number of platelets, abnormal liver function, increased levels of potassium
in the blood, kidney function disorders, inflammation of small blood vessels mainly affecting
the skin (condition known as leucocytoclastic 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 get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.
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 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 particular storage conditions.
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 Irbesartan Teva contains

• The active ingredient is irbesartan. Each film-coated tablet of Irbesartan Teva 75 mg contains 75 mg of irbesartan.
• The other ingredients are: Tablet core: povidone, pregelatinized starch (corn), 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
Irbesartan Teva 75 mg film-coated tablets are capsule-shaped and range in colour from white
to almost white. The number ”93” is engraved on one side of the tablet. The number “7464” is
engraved on the other side of the tablet.
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 packs of 28 film-coated tablets in non-perforated calendar blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Teva B.V.
Swensweg 5
2031GA Haarlem
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
Netherlands
For further information on this medicine, contact the local representative of the Marketing Authorisation
Holder:

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

България
Teva Pharma EAD
Tel: +359 24899585

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

Magyarország
Teva Gyógyszergyár Zrt.
Tel: +36 12886400

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

Malta
Teva Pharmaceuticals Ireland
Ireland
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.
Greece
Tel: +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
Tel: +33 155917800

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

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

Ireland
Teva Pharmaceuticals Ireland
Tel: +44 2075407117

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

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

Ísland
Teva Finland Oy
Finland
Sími: +358 201805900

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

Sverige
Teva Sweden AB
Tel: +46 42121100

Κύπρος
Specifar A.B.E.E.
Greece
Tel: +30 2118805000

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

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 medicine is available on the website of the European Medicines
Agency: http://www.ema.europa.eu/

Irbesartan Teva 150 mg film-coated tablets

Irbesartan

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, even if their symptoms are the same as yours, as it could be harmful.
• 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 Irbesartan Teva is and what it is used for
• 2. What you need to know before you take Irbesartan Teva
• 3. How to take Irbesartan Teva
• 4. Possible side effects
• 5. How to store Irbesartan Teva
• 6. Contents of the pack and other information

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

Irbesartan Teva belongs to a group of medicines known as angiotensin II receptor blockers. Angiotensin-II is a substance produced by the body that binds to receptors in blood vessels, causing them to constrict. This results in an increase in 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 hypertension)
• to protect the kidney in hypertensive patients with high blood pressure, type 2 diabetes and evidence of kidney dysfunction in laboratory tests.

2. What you need to know before you take 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 pregnant for more than 3 months (it is best to avoid taking Irbesartan Teva even in the early stages of pregnancy - see section Pregnancy).
• If you develop low blood sugar levels (symptoms can include sweating, weakness, hunger, dizziness, tremor, headache, flushing or paleness, numbness, fast or pounding heartbeat), especially if you are being treated for diabetes
• If you have diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren.

Warnings and precautions
Tell your doctor before taking Irbesartan Teva if you have 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 measure potassium levels in your blood if you have poor kidney function
• If you are going to have surgery or receive anaesthetics
• 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 have kidney problems related to diabetes;
• aliskiren.

Your doctor may check your kidney function, blood pressure, and the amount of electrolytes
(for example potassium) in your blood at regular intervals.
See also the section "Do not take Irbesartan Teva".
You must tell your doctor if you think you might be pregnant (or if there is a possibility of becoming
pregnant). Irbesartan Teva 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 section Pregnancy).

Children and adolescents
This medicine should not be given to children under the age of 18 years as safety and
efficacy have not 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 need to change your 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 using:

• potassium supplements
• salt substitutes containing potassium
• potassium-sparing medicines (such as some diuretics)
• medicines containing lithium
• repaglinide (a medicine used to lower blood sugar levels).

If you take some pain relievers, called non-steroidal anti-inflammatory drugs,
the effectiveness of irbesartan may be reduced.

Pregnancy and breastfeeding
Pregnancy
You must tell your doctor if you think you might be pregnant (or if there is a possibility of becoming
pregnant). Your doctor will normally advise you to stop taking Irbesartan Teva
before becoming pregnant or as soon as you find out you are pregnant and
will advise you to take another medicine instead of Irbesartan Teva. Irbesartan Teva 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 planning to start breastfeeding. Irbesartan Teva 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
It is unlikely that Irbesartan Teva will affect your ability to drive or operate machinery. However,
occasionally, dizziness or tiredness 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, which is
essentially ‘sodium-free’.

3. How to use Irbesartan Teva

Take this medicine following exactly the instructions of 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 fluids (e.g. a
glass of water). You can take Irbesartan Teva with or without food. Try to take the medicine
every day at the same time. The treatment should be continued as long as your doctor considers it necessary.

• Patients with high blood pressure The usual dose is 150 mg once a day. The dose may be increased to 300 mg once a day 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 indicated maintenance dose is 300 mg once a day for the treatment of associated kidney disease.

The doctor may decide to use lower doses, especially at the beginning of treatment, in
particular patients such as those on hemodialysis, or in patients over 75 years of age.
The maximum antihypertensive effect should be reached 4-6 weeks after the start of 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 forget to take a dose, continue normally with the therapy. Do not take
a double dose to compensate for the missed dose.
If you have any doubts 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 allergic skin reactions (rash, hives) have been reported in patients
treated with irbesartan, as well as localized swelling of the face, lips and/or tongue. 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 suffer from 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 an increase in the 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 a lying or sitting position, low blood pressure upon standing up from a lying or sitting
  position, joint or muscle pain, and decreased levels of a protein in red blood cells (hemoglobin) have also
  been reported.
• Uncommon (may affect up to 1 in 100 people): increased heart rate, flushing, cough, diarrhea,
  indigestion/heartburn, sexual dysfunction (problems related to sexual performance), chest pain.

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please 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 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 particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Irbesartan Teva contains

• The active ingredient is irbesartan. Each film-coated tablet of Irbesartan Teva 150 mg contains 150 mg of irbesartan.
• The other ingredients are: Tablet core: povidone, pregelatinized starch (corn), 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 contents of the pack
Irbesartan Teva 150 mg film-coated tablets are capsule-shaped and range in colour from
white to almost white. The number “93” is embossed on one side of the tablet. The number “7465” is embossed on the other side of the
tablet.
Irbesartan Teva is available in pack sizes 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 packs of 28 film-coated tablets in non-perforated calendar blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Teva B.V.
Swensweg 5
2031GA Haarlem
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
Netherlands
For further information on this medicinal product, please contact the local representative of the Marketing
Authorisation Holder:

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

България
Тева Фарма ЕАД
Тел: +359 24899585

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

Magyarország
Teva Gyógyszergyár Zrt.
Tel: +36 12886400

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

Malta
Teva Pharmaceuticals Ireland
L-Irlanda
Τel: +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

Ireland
Teva Pharmaceuticals Ireland
Tel: +44 2075407117

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

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

Ísland
Teva Finland Oy
Finnland
Sími: +358 201805900

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

Sverige
Teva Sweden AB
Tel: +46 42121100

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

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

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 medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu/

Irbesartan Teva 300 mg film-coated tablets

Irbesartan

Read this leaflet carefully before 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, even if their symptoms are the same as yours, as it could be harmful.
• 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 Irbesartan Teva is and what it is used for
• 2. What you need to know before you use Irbesartan Teva
• 3. How to use Irbesartan Teva
• 4. Possible side effects
• 5. How to store Irbesartan Teva
• 6. Contents of the pack and other information

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

Irbesartan Teva belongs to a group of medicines known as angiotensin II receptor blockers. Angiotensin-II is a substance produced by the body that binds to receptors in blood vessels, causing them to constrict. This results in an increase in 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 kidney in hypertensive patients with high blood pressure, type 2 diabetes and evidence of kidney dysfunction in laboratory tests.

2. What you need to know before taking Irbesartan Teva

Do not use Irbesartan Teva

• If you are allergic to irbesartan 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 Irbesartan Teva even in the early stages of pregnancy - see section Pregnancy).
• If you have diabetes or your kidney function is impaired and are being treated with a medicine that lowers blood pressure, 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 diarrhea.
• If you have problems with your kidneys.
• If you have problems with your heart.
• If you are taking Irbesartan Teva for diabetic kidney disease. In this case, your doctor may prescribe you regular blood tests, especially to measure potassium levels in the blood if you have poor kidney function.
• If you are going to have surgery or receive anesthetics
• If you develop low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, trembling, headache, flushing or paleness, numbness, fast 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), especially if you have kidney problems related to diabetes.
• aliskiren.

Your 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 in the section "Do not take Irbesartan Teva".
You must tell your doctor if you think you may be pregnant (or if there is a possibility of starting
a pregnancy). Irbesartan Teva is not recommended in the early stages of pregnancy and should 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 section Pregnancy).

Children and adolescents
This medicine should not be given to children under 18 years of age as safety and
efficacy have not yet been fully established. If a child swallows 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 the dose and/or take other precautions:
If you are taking an ACE inhibitor or aliskiren (see also what is stated in the sections: "Do not take
Irbesartan Teva" and "Warnings and precautions”).
You may need blood tests if you are using:

• potassium supplements
• salt substitutes containing potassium
• potassium-sparing medicines (such as some diuretics)
• medicines containing lithium
• repaglinide (medicine used to lower blood sugar levels).

If you take certain painkillers, called non-steroidal anti-inflammatory drugs,
the effectiveness of irbesartan may be reduced.

Pregnancy and breastfeeding
Pregnancy
Tell your doctor if you think you may be pregnant (or if there is a possibility of starting
a pregnancy). Usually your doctor will advise you to stop taking Irbesartan Teva
before becoming pregnant or as soon as you find out you are pregnant and
will advise you to take another medicine instead of Irbesartan Teva. Irbesartan Teva is not
recommended in the early stages of pregnancy and should 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 planning to start breastfeeding. Irbesartan Teva 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 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 operating machinery

Irbesartan Teva contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which is
essentially ‘sodium-free’.

3. How to use Irbesartan Teva

Take this medicine following exactly the instructions of 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 fluids (e.g. a
glass of water). You can take Irbesartan Teva with or without food. Try to take the medicine
every day at the same time. The treatment should be continued as long as your doctor deems it necessary.

• Patients with high blood pressure The usual dose is 150 mg once a day. The dose may be increased to 300 mg once a day 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 indicated maintenance dose is 300 mg once a day for the treatment of associated kidney disease.

The doctor may decide to use lower doses, especially at the beginning of treatment, in
particular patients such as those undergoing hemodialysis, or in patients over 75 years of age.
The maximum antihypertensive effect should be reached 4-6 weeks after the start of 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 forget to take a dose, continue normally with the therapy. Do not take
a double dose to compensate for the missed dose.
If you have any doubts about the use of this medicine, consult 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 effects may be serious and may require medical attention.
As with similar medicines, rare cases of allergic skin reactions (rash, hives) 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 suffer from 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 an increase in the 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 when getting up from a lying or sitting position, low blood pressure when getting up from a lying or sitting position, joint or muscle pain, and decreased levels of a protein in red blood cells (hemoglobin) have also been reported.
• Uncommon (may affect up to 1 in 100 people): increased heart rate, flushing, cough, diarrhea, indigestion/heartburn, sexual dysfunction (problems related to sexual performance), chest pain.

Not known (frequency cannot be estimated from available data): headache, taste disturbances, ringing in the ears, muscle cramps, joint and muscle pain, decreased number of red blood cells (anemia - symptoms may include fatigue, headache, shortness of breath during physical activity, dizziness and pale appearance), reduced number of platelets, abnormal liver (liver) function, increased levels of potassium in the blood, kidney function disorders, inflammation of small blood vessels mainly affecting the skin (condition known as leucocytoclastic 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
talk to 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 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 particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Irbesartan Teva contains

• The active ingredient is irbesartan. Each film-coated tablet of Irbesartan Teva 300 mg contains 300 mg of irbesartan.
• The other ingredients are: Tablet core: povidone, pregelatinized starch (corn), 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 contents of the pack
Irbesartan Teva 300 mg film-coated tablets are capsule-shaped and range in colour from
white to almost white. The number “93” is embossed on one side of the tablet. The number “7466” is
embossed on the other side of the tablet.
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 packs of 28 film-coated tablets in non-perforated calendar blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Teva B.V.
Swensweg 5
2031GA Haarlem
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
Netherlands
For further information on this medicine, contact the local representative of the Marketing Authorisation
Holder:

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

България
Тева Фарма ЕАД
Tel: +359 24899585

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

Magyarország
Teva Gyógyszergyár Zrt.
Tel: +36 12886400

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

Malta
Teva Pharmaceuticals Ireland
Ireland
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.
Greece
Tel: +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
Tel: +33 155917800

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

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

Ireland
Teva Pharmaceuticals Ireland
Tel: +44 2075407117

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

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

Ísland
Teva Finland Oy
Finland
Sími: +358 201805900

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

Sverige
Teva Sweden AB
Tel: +46 42121100

Κύπρος
Specifar A.B.E.E.
Greece
Tel: +30 2118805000

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

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 medicine is available on the website of the European Medicines
Agency: http://www.ema.europa.eu/