Инструкция по применению IRBESARTAN TSENTIVA
Содержание инструкции
- Irbesartan Zentiva 75 mg tablets
- Irbesartan Zentiva 150 mg tablets
- Irbesartan Zentiva 300 mg tablets
- Irbesartan Zentiva 75 mg film-coated tablets
- Irbesartan Zentiva 150 mg film-coated tablets
- Irbesartan Zentiva 300 mg film-coated tablets
Irbesartan Zentiva 75 mg tablets
irbesartan
Read this leaflet carefully before you start taking this medicine as it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may be harmful to people even if their symptoms are the same as yours.
- If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What Irbesartan Zentiva is and what it is used for
- 2. What you need to know before you take Irbesartan Zentiva
- 3. How to take Irbesartan Zentiva
- 4. Possible side effects
- 5. How to store Irbesartan Zentiva
- 6. Contents of the pack and other information
1. What is Irbesartan Zentiva and what it is used for
Irbesartan Zentiva 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 Zentiva prevents angiotensin-II from binding to these receptors, allowing blood vessels to dilate and blood pressure to decrease.
Irbesartan Zentiva slows the decline of kidney function in patients with high blood pressure and type 2 diabetes.
Irbesartan Zentiva 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 Zentiva
Do not take Irbesartan Zentiva:
- if you are allergicto 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 Zentiva even in the early stages of pregnancy - see section Pregnancy)
- if you suffer from diabetes or your kidney function is impairedand you are being treated with a medicine that lowers blood pressure, containing aliskiren
Warnings and precautions
Talk to your doctor before taking Irbesartan Zentiva if you are in any of the following
conditions:
- excessive vomiting or diarrhea
- if you suffer from kidney problems
- if you suffer from heart problems
- if you are taking Irbesartan Zentiva for diabetic kidney disorders. In this case, your doctor may prescribe regular blood tests, especially to measure serum potassium levels if you have poor kidney function, if you develop low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, tremor, headache, flushing or paleness, numbness, rapid and pounding heartbeat), especially if you are being treated for diabetes
- if you are to undergo surgery(surgical) or receive anesthetics
- if you are taking any of the following medicines used to treat high blood pressure:
- an "ACE inhibitor" (for example enalapril, lisinopril, ramipril), especially if you suffer from kidney problems related to diabetes.
- aliskiren
The doctor may check your kidney function, blood pressure, and the amount of
electrolytes (e.g. potassium) in your blood at regular intervals.
See also what is stated in the section "Do not take Irbesartan Zentiva”
You should inform your doctor if you think you may be pregnant (or if there is a possibility of
starting a pregnancy). Irbesartan Zentiva is not recommended in early
pregnancy and should not be taken if you are more than 3 months pregnant, as it may
cause serious harm to the baby if taken during this period (see section Pregnancy).
Children and adolescents
This medicine should not be used in children and adolescents as safety
and efficacy have not been fully established.
Other medicines and Irbesartan Zentiva
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 the sections: "Do not
take Irbesartan Zentiva” 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 some painkillers, called non-steroidal anti-inflammatory drugs,
the effectiveness of irbesartan may be reduced.
Irbesartan Zentiva with food and drink
Irbesartan Zentiva can be taken with or without food.
Pregnancy and breastfeeding
Pregnancy
You should inform your doctor if you think you may be pregnant (or if there is a possibility of
starting a pregnancy); your doctor will usually advise you to stop taking
Irbesartan Zentiva before starting a pregnancy or as soon as you find out you are
pregnant and will advise you to take another medicine instead of Irbesartan
Zentiva. Irbesartan Zentiva is not recommended in early pregnancy and should not be
taken if you are more than 3 months pregnant as it may cause serious harm to the baby
if taken after the third month of pregnancy.
Breastfeeding
Tell your doctor if you are breastfeeding or are about to start breastfeeding. Irbesartan Zentiva is not
recommended for women who are breastfeeding and your doctor may choose another treatment
if you wish to breastfeed, especially if the baby is newborn or premature.
Driving and using machines
It is unlikely that Irbesartan Zentiva 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 machines.
Irbesartan Zentiva contains lactose. If your doctor has diagnosed you with intolerance to
some sugars, contact him before taking this medicine.
Irbesartan Zentiva contains sodium. This medicine contains less than 1 mmol of sodium (23
mg) per tablet, i.e. it is essentially “sodium-free”.
3. How to take Irbesartan Zentiva
Take this medicine following exactly the instructions of your doctor. If you have doubts
consult your doctor or pharmacist.
Method of administration
Irbesartan Zentiva is for oral use. Swallow the tablets with a sufficient amount of fluids
(e.g.: a glass of water). You can take Irbesartan Zentiva with or without food. Try to
take the medicine every day at the same time. The treatment should be continued as long as the
doctor deems it necessary.
- Patients with high blood pressureThe usual dose is 150 mg once a day (two tablets a day). The dosage may be increased to 300 mg (four tablets a day) once a day depending on the reduction in blood pressure levels.
- Patients with high blood pressure and type 2 diabetes with kidney diseaseIn patients with high blood pressure and type 2 diabetes, the indicated maintenance dose is 300 mg (four tablets a day) 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 in hemodialysis, or in patients over 75 years of age.
The maximum antihypertensive effect should be achieved 4-6 weeks after the start of
therapy.
Use in children and adolescents
Irbesartan Zentiva should not be given to children under 18 years of age. If a child
ingests tablets, contact your doctor immediately.
If you take more Irbesartan Zentiva than you should
If you accidentally take too many tablets, contact your doctor immediately.
If you forget to take Irbesartan Zentiva
If you accidentally forget to take a dose, continue the therapy normally. 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 (redness, urticaria) 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 Zentiva and contact your doctor immediately.
The frequency of the side effects listed below is defined using the following convention:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
The side effects reported in clinical studies for patients treated with Irbesartan Zentiva
were:
- 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). 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.
Since Irbesartan Zentiva has been marketed, some side effects have been reported.
Side effects with unknown frequency are: feeling of spinning, 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 concerning the skin (a 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 .
You can also report side effects directly through the national reporting system detailed in Appendix V .
By reporting side effects you can help provide more information on the
safety of this medicine.
5. How to store Irbesartan Zentiva
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after
Exp. The expiry date refers to the last day of the month.
Do not store at a temperature above 30°C.
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. Package contents and other information
What Irbesartan Zentiva contains
- The active ingredient is irbesartan. Each Irbesartan Zentiva 75 mg tablet contains 75 mg of irbesartan.
- The excipients are: microcrystalline cellulose, sodium carboxymethyl cellulose, lactose monohydrate, magnesium stearate, hydrated colloidal silica, pregelatinized corn starch and poloxamer 188. See section 2 “Irbesartan Zentiva contains lactose”.
Description of the appearance of Irbesartan Zentiva and package contents
Irbesartan Zentiva 75 mg tablets are white to almost white, biconvex, oval-shaped with a heart engraved on one side and the number 2771 imprinted on the other side.
Irbesartan Zentiva 75 mg tablets are available in packs of 14, 28, 56 or 98 tablets in blisters. Unit-dose blisters of 56 x 1 tablet for hospital use are also available.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Zentiva k.s.
U kabelovny 130
102 37 Prague 10
Czech Republic
Manufacturer:
Sanofi Winthrop Industrie
1 Rue de la vierge
Ambarès et Lagrave
33 565 Carbon Blanc cedex
France
Sanofi Winthrop Industrie
30-36 Avenue Gustave Eiffel
37 100 Tours
France
For further information on this medicinal product, contact the local representative of the marketing authorisation holder:
België/Belgique/Belgien
Zentiva, k.s.
Tél/Tel: +32 280 86 420
[email protected]
Lietuva
Zentiva, k.s.
Tel: +370 52152025
[email protected]
България
Zentiva, k.s.
Тел: +35924417136
[email protected]
Luxembourg/Luxemburg
Zentiva, k.s.
Tél/Tel: +352 208 82330
[email protected]
Česká republika
Zentiva, k.s.
Tel: +420 267 241 111
[email protected]
Magyarország
Zentiva Pharma Kft.
Tel.: +36 1 299 1058
[email protected]
Danmark
Zentiva Denmark ApS
Tlf: +45 787 68 400
[email protected]
Malta
Zentiva, k.s.
Tel: +356 277 82 052
[email protected]
Deutschland
Zentiva Pharma GmbH
Tel: +49 (0) 800 53 53 010
[email protected]
Nederland
Zentiva, k.s.
Tel: +31 202 253 638
[email protected]
Eesti
Zentiva, k.s.
Tel: +372 52 70308
[email protected]
Norge
Zentiva Denmark ApS
Tlf: +47 219 66 203
[email protected]
Ελλάδα
Zentiva, k.s.
Τηλ: +30 211 198 7510
[email protected]
Österreich
Zentiva, k.s.
Tel: +43 720 778 877
[email protected]
España
Zentiva, k.s.
Tel: +34 931 815 250
[email protected]
Polska
Zentiva Polska Sp. z o.o.
Tel: + 48 22 375 92 00
[email protected]
France
Zentiva France
Tél: +33 (0) 800 089 219
[email protected]
Portugal
Zentiva Portugal, Lda
Tel: +351210601360
[email protected]
Hrvatska
Zentiva d.o.o.
Tel: +385 1 6641 830
[email protected]
Ireland
Zentiva, k.s.
Tel: +353 766 803 944
[email protected]
România
ZENTIVA S.A.
Tel: +4 021 304 7597
[email protected]
Slovenija
Zentiva, k.s.
Tel: +386 360 00 408
[email protected]
Ísland
Zentiva Denmark ApS
Sími: +354 539 0650
[email protected]
Slovenská republika
Zentiva, a.s.
Tel: +421 2 3918 3010
[email protected]
Italia
Zentiva Italia S.r.l.
Suomi/Finland
Zentiva Denmark AoS
Puh/Tel: +358 942 598 648
[email protected]
+39-02-38598801
[email protected]
Κύπρος
Zentiva, k.s.
Τηλ: +357 240 30 144
[email protected]
Sverige
Zentiva Denmark ApS
Tel: +46 840 838 822
[email protected]
Latvija
Zentiva, k.s.
Tel: +371 67893939
[email protected]
United Kingdom (Northern Ireland)
Zentiva, k.s.
Tel: +44 (0) 800 090 2408
[email protected]
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/
Irbesartan Zentiva 150 mg 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. It may be harmful for people other than you, even if their symptoms are the same as yours.
- If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What Irbesartan Zentiva is and what it is used for
- 2. What you need to know before you take Irbesartan Zentiva
- 3. How to take Irbesartan Zentiva
- 4. Possible side effects
- 5. How to store Irbesartan Zentiva
- 6. Contents of the pack and other information
1. What is Irbesartan Zentiva and what it is used for
Irbesartan Zentiva 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 Zentiva prevents angiotensin-II from binding to these receptors, allowing blood vessels to dilate and blood pressure to decrease.
Irbesartan Zentiva slows the decline of kidney function in patients with high blood pressure and type 2 diabetes.
Irbesartan Zentiva 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 Zentiva
Do not take Irbesartan Zentiva:
- if you are allergicto 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 Zentiva even in the early stages of pregnancy - see section Pregnancy)
- if you suffer from diabetes or your kidney function is impairedand you are being treated with a medicine that lowers blood pressure, containing aliskiren
Warnings and precautions
Talk to your doctor before taking Irbesartan Zentiva if you are in any of the following
conditions:
- excessive vomiting or diarrhea
- if you suffer from kidney problems
- if you suffer from heart problems
- if you are taking Irbesartan Zentiva for diabetic kidney disorders. In this case, your doctor may prescribe regular blood tests, especially to measure serum potassium levels if you have poor kidney function, if you develop low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, tremor, headache, flushing or paleness, numbness, rapid and pounding heartbeat), especially if you are being treated for diabetes
- if you are to undergo surgery(surgical) or receive anesthetics
- if you are taking any of the following medicines used to treat high blood pressure:
- an "ACE inhibitor" (for example enalapril, lisinopril, ramipril), especially if you suffer from kidney problems related to diabetes.
- aliskiren 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 Zentiva”
You must tell your doctor if you think you may be pregnant (or if there is a possibility of
becoming pregnant). Irbesartan Zentiva is not recommended in early
pregnancy and should not be taken if you are pregnant for more than 3 months, as it may
cause serious harm to the baby if taken during this period (see section Pregnancy).
Children and adolescents
This medicine should not be used in children and adolescents as safety
and efficacy have not been fully established.
Other medicines and Irbesartan Zentiva
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 under: "Do not
take Irbesartan Zentiva” 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 taking some painkillers, called non-steroidal anti-inflammatory drugs,
the effectiveness of irbesartan may be reduced.
Irbesartan Zentiva with food and drink
Irbesartan Zentiva can be taken with or without food.
Pregnancy and breastfeeding
Pregnancy
You must tell 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 Zentiva before becoming pregnant or as soon as you find out you are
pregnant and advise you to take another medicine instead of Irbesartan
Zentiva. Irbesartan Zentiva is not recommended in early pregnancy and should not be
taken if you are pregnant for more than 3 months as it may 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 Zentiva is not
recommended for women who are breastfeeding and your doctor may choose another treatment
if you wish to breastfeed, especially if the baby is newborn or premature.
Driving and using machines
It is unlikely that Irbesartan Zentiva 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 machines.
Irbesartan Zentiva contains lactose. If your doctor has told you that you have an intolerance to
some sugars, contact him before taking this medicine.
Irbesartan Zentiva contains sodium.This medicine contains less than 1 mmol of sodium (23
mg) per tablet, i.e. it is essentially “sodium-free”.
3. How to take Irbesartan Zentiva
Take this medicine following exactly the instructions of your doctor. If you have doubts
consult your doctor or pharmacist.
Method of administration
Irbesartan Zentiva is for oral use. Swallow the tablets with a sufficient amount of fluids
(e.g.: a glass of water). You can take Irbesartan Zentiva 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 pressureThe usual dose is 150 mg once a day. The dosage may be increased to 300 mg (two tablets a day) once a day depending on the reduction in blood pressure levels.
- Patients with high blood pressure and type 2 diabetes with kidney diseaseIn patients with high blood pressure and type 2 diabetes, the indicated maintenance dose is 300 mg (two tablets a day) 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 in hemodialysis, or in patients over 75 years of age.
The maximum antihypertensive effect should be achieved 4-6 weeks after the start of
therapy.
Use in children and adolescents
Irbesartan Zentiva should not be given to children under 18 years of age. If a child
ingests tablets, contact your doctor immediately.
If you take more Irbesartan Zentiva than you should
If you accidentally take too many tablets, contact your doctor immediately.
If you forget to take Irbesartan Zentiva
If you accidentally forget to take a dose, continue the therapy normally. 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 (redness, 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 Zentiva and contact your doctor immediately.
The frequency of the side effects listed below is defined using the following convention:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
The side effects reported in clinical studies for patients treated with Irbesartan Zentiva
were:
- 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). 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.
Since Irbesartan Zentiva was marketed, some side effects have been reported.
Side effects with unknown frequency are: feeling of spinning, 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 (a 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, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects
directly through the national reporting system listed in Annex V.
By reporting side effects you can help provide more information on the
safety of this medicine.
5. How to store Irbesartan Zentiva
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after
Exp. The expiry date refers to the last day of the month.
Do not store at a temperature above 30°C.
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. OTHER INFORMATION
What Irbesartan Zentiva contains
- The active ingredient is irbesartan. Each Irbesartan Zentiva 150 mg tablet contains 150 mg of irbesartan.
- The excipients are: microcrystalline cellulose, sodium carboxymethyl cellulose, lactose monohydrate, magnesium stearate, hydrated colloidal silica, pregelatinized maize starch and poloxamer 188. See section 2 “Irbesartan Zentiva contains lactose”.
Description of the appearance of Irbesartan Zentiva and contents of the pack
Irbesartan Zentiva 150 mg tablets are from white to almost white, biconvex, oval shaped with a heart engraved on one side and the number 2772 imprinted on the other side.
Irbesartan Zentiva 150 mg tablets are available in packs of 14, 28, 56 or 98 tablets in blisters. Also available are single-dose blisters of 56 x 1 tablet for hospital use.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Zentiva k.s.
U kabelovny 130
102 37 Prague 10
Czech Republic
Manufacturer:
Sanofi Winthrop Industrie
1 Rue de la vierge
Ambarès et Lagrave
33 565 Carbon Blanc cedex
France
Sanofi Winthrop Industrie
30-36 Avenue Gustave Eiffel
37 100 Tours
France
For further information on this medicinal product, contact the local representative of the marketing authorisation holder:
België/Belgique/Belgien
Zentiva, k.s.
Tél/Tel: +32 280 86 420
[email protected]
Lietuva
Zentiva, k.s.
Tel: +370 52152025
[email protected]
България
Zentiva, k.s.
Тел: +359 244 17 136
[email protected]
Luxembourg/Luxemburg
Zentiva, k.s.
Tél/Tel: +352 208 82330
[email protected]
Česká republika
Zentiva, k.s.
Tel: +420 267 241 111
[email protected]
Magyarország
Zentiva Pharma Kft.
Tel.: +36 1 299 1058
[email protected]
Danmark
Zentiva Denmark ApS
Tlf: +45 787 68 400
[email protected]
Malta
Zentiva, k.s.
Tel: +356 277 82 052
[email protected]
Deutschland
Zentiva Pharma GmbH
Tel: +49 (0) 800 53 53 010
[email protected]
Nederland
Zentiva, k.s.
Tel: +31 202 253 638
[email protected]
Eesti
Zentiva, k.s.
Tel: +372 52 70308
[email protected]
Norge
Zentiva Denmark ApS
Tlf: +47 219 66 203
[email protected]
Ελλάδα
Zentiva, k.s.
Τηλ: +30 211 198 7510
[email protected]
Österreich
Zentiva, k.s.
Tel: +43 720 778 877
[email protected]
España
Zentiva, k.s.
Tel: +34 931 815 250
[email protected]
Polska
Zentiva Polska Sp. z o.o.
Tel: + 48 22 375 92 00
[email protected]
France
Zentiva France
Tél: +33 (0) 800 089 219
[email protected]
Portugal
Zentiva Portugal, Lda
Tel: +351210601360
[email protected]
Hrvatska
Zentiva d.o.o.
Tel: +385 1 6641 830
[email protected]
Ireland
Zentiva, k.s.
Tel: +353 766 803 944
[email protected]
România
ZENTIVA S.A.
Tel: +4 021 304 7597
[email protected]
Slovenija
Zentiva, k.s.
Tel: +386 360 00 408
[email protected]
Ísland
Zentiva Denmark ApS
Sími: +354 539 0650
[email protected]
Slovenská republika
Zentiva, a.s.
Tel: +421 2 3918 3010
[email protected]
Italia
Zentiva Italia S.r.l.
+39-02-38598801
[email protected]
Suomi/Finland
Zentiva, k.s.
Puh/Tel: +358 942 598 648
[email protected]
Κύπρος
Zentiva, k.s.
Τηλ: +357 240 30 144
[email protected]
Sverige
Zentiva Denmark ApS
Tel: +46 840 838 822
[email protected]
United Kingdom (Northern Ireland)
Zentiva, k.s.
Tel: +44 (0) 800 090 2408
[email protected]
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/
Latvija
Zentiva, k.s.
Tel: +371 67893939
[email protected]
Irbesartan Zentiva 300 mg tablets
irbesartan
Read this leaflet carefully before you start taking this medicinebecause it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may be harmful for people other than you, even if their symptoms are the same as yours.
- If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What Irbesartan Zentiva is and what it is used for
- 2. What you need to know before you take Irbesartan Zentiva
- 3. How to take Irbesartan Zentiva
- 4. Possible side effects
- 5. How to store Irbesartan Zentiva
- 6. Contents of the pack and other information
1. What is Irbesartan Zentiva and what it is used for
Irbesartan Zentiva 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 Zentiva prevents angiotensin-II from binding to these receptors, allowing blood vessels to dilate and blood pressure to decrease.
Irbesartan Zentiva slows the decline of kidney function in patients with high blood pressure and type 2 diabetes.
Irbesartan Zentiva 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 Zentiva
Do not take Irbesartan Zentiva:
- if you are allergicto 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 Zentiva even in the early stages of pregnancy - see section Pregnancy)
- if you suffer from diabetes or your kidney function is impairedand you are being treated with a medicine that lowers blood pressure, containing aliskiren
Warnings and precautions
Talk to your doctor before taking Irbesartan Zentiva if you are in any of the following
conditions:
- excessive vomiting or diarrhea
- if you suffer from kidney disorders
- if you suffer from heart disorders
- if you are taking Irbesartan Zentiva for diabetic kidney disorders. In this case, your doctor may prescribe regular blood tests, especially to measure serum potassium levels if you have poor kidney function, if you develop low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, tremor, headache, flushing or paleness, numbness, fast and pounding heartbeat), especially if you are being treated for diabetes
- if you are to undergo surgery(surgical) or receive anesthetics
- if you are taking any of the following medicines used to treat high blood pressure:
- an "ACE inhibitor" (for example enalapril, lisinopril, ramipril), especially if you suffer from kidney problems related to diabetes.
- aliskiren 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 Zentiva"
You must inform your doctor if you think you may be pregnant (or if there is a possibility of
becoming pregnant). Irbesartan Zentiva is not recommended in early
pregnancy and should not be taken if you are pregnant for more than 3 months, as it may
cause serious harm to the baby if taken during this period (see section Pregnancy).
Children and adolescents
This medicine should not be used in children and adolescents as safety
and efficacy have not been fully established.
Other medicines and Irbesartan Zentiva
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 under: "Do not
take Irbesartan Zentiva” and "Warnings and precautions”)
You may need blood tests if you are using:
- potassium supplements
- potassium-containing salt substitutes
- potassium-sparing medicines (such as some diuretics)
- medicines containing lithium
- repaglinide (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.
Irbesartan Zentiva with food and drink
Irbesartan Zentiva can be taken with or without food.
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 Zentiva before becoming pregnant or as soon as you find out you are
pregnant and will advise you to take another medicine instead of Irbesartan
Zentiva. Irbesartan Zentiva is not recommended in early pregnancy and should not be
taken if you are pregnant for more than 3 months as it may 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 Zentiva is not
recommended for women who are breastfeeding and your doctor may choose another treatment
if you wish to breastfeed, especially if the baby is newborn or premature.
Driving and using machines
It is unlikely that Irbesartan Zentiva 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 machines.
Irbesartan Zentiva contains lactose. If your doctor has told you that you have an intolerance to
some sugars, contact him before taking this medicine.
Irbesartan Zentiva contains sodium.This medicine contains less than 1 mmol of sodium (23
mg) per tablet, i.e. it is essentially “sodium-free”.
3. How to take Irbesartan Zentiva
Take this medicine following exactly the instructions of your doctor. If you have doubts, you should consult your doctor or pharmacist.
Method of administration
Irbesartan Zentiva is for oral use. Swallow the tablets with a sufficient amount of fluids
(e.g., a glass of water). You can take Irbesartan Zentiva with or without food. Try to
take the medicine every day at the same time. The treatment should be continued as long as the
doctor considers it necessary.
- Patients with high blood pressureThe usual dose is 150 mg once a day. The dosage 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 diseaseIn 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 in hemodialysis, or in patients over 75 years of age.
The maximum antihypertensive effect should be achieved 4-6 weeks after the start of
therapy.
Use in children and adolescents
Irbesartan Zentiva should not be given to children under 18 years of age. If a child
ingests tablets, contact your doctor immediately.
If you take more Irbesartan Zentiva than you should
If you accidentally take too many tablets, contact your doctor immediately.
If you forget to take Irbesartan Zentiva
If you accidentally forget to take a dose, continue with therapy as normal. 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 will experience them.
Some of these effects may be serious and may require medical attention.
As with similar medicines, rare cases of allergic skin reactions (redness, 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 Zentiva and contact your doctor immediately.
The frequency of the side effects listed below is defined using the following convention:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
The side effects reported in clinical studies for patients treated with Irbesartan Zentiva
were:
- 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). In patients with high blood pressure and type 2 diabetes with kidney disease, dizziness when standing up from a lying or sitting position, low blood pressure when 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.
Since Irbesartan Zentiva was marketed, some side effects have been reported.
Side effects with unknown frequency are: feeling of spinning, 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 (a 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 experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist .
You can also report side effects directly through the national reporting system as indicated in Annex V .
By reporting side effects you can help provide more information on the
safety of this medicine.
5. How to store Irbesartan Zentiva
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after
Exp. The expiry date refers to the last day of the month.
Do not store at a temperature above 30°C.
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 Zentiva contains
- The active ingredient is irbesartan. Each Irbesartan Zentiva 300 mg tablet contains 300 mg of irbesartan.
- The excipients are: microcrystalline cellulose, sodium carboxymethyl cellulose, anhydrous lactose, magnesium stearate, hydrated colloidal silica, pregelatinized starch and poloxamer 188. See section 2 “Irbesartan Zentiva contains lactose”.
Description of the appearance of Irbesartan Zentiva and package contents
Irbesartan Zentiva 300 mg tablets are white to almost white, biconvex, oval-shaped with a heart engraved on one side and the number 2773 imprinted on the other side.
Irbesartan Zentiva 300 mg tablets are available in packs of 14, 28, 56 or 98 tablets in blisters. Unit-dose blisters of 56 x 1 tablet for hospital use are also available.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Zentiva k.s.
U kabelovny 130
102 37 Prague 10
Czech Republic
Manufacturer:
Sanofi Winthrop Industrie
1 Rue de la vierge
Ambarès et Lagrave
33 565 Carbon Blanc cedex
France
Sanofi Winthrop Industrie
30-36 Avenue Gustave Eiffel
37 100 Tours
France
For further information on this medicinal product, contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien
Zentiva, k.s.
Tél/Tel: +32 280 86 420
[email protected]
Lietuva
Zentiva, k.s.
Tel: +370 52152025
[email protected]
България
Zentiva, k.s.
Тел: +359 244 17 136
[email protected]
Luxembourg/Luxemburg
Zentiva, k.s.
Tél/Tel: +352 208 82330
[email protected]
Česká republika
Zentiva, k.s.
Tel: +420 267 241 111
[email protected]
Magyarország
Zentiva Pharma Kft.
Tel.: +36 1 299 1058
[email protected]
Danmark
Zentiva Denmark ApS
Tlf: +45 787 68 400
[email protected]
Malta
Zentiva, k.s.
Tel: +356 277 82 052
[email protected]
Deutschland
Zentiva Pharma GmbH
Tel: +49 (0) 800 53 53 010
[email protected]
Nederland
Zentiva, k.s.
Tel: +31 202 253 638
[email protected]
Eesti
Zentiva, k.s.
Tel: +372 52 70308
[email protected]
Norge
Zentiva Denmark ApS
Tlf: +47 219 66 203
[email protected]
Ελλάδα
Zentiva, k.s.
Τηλ: +30 211 198 7510
[email protected]
Österreich
Zentiva, k.s.
Tel: +43 720 778 877
[email protected]
España
Zentiva, k.s.
Tel: +34 931 815 250
[email protected]
Polska
Zentiva Polska Sp. z o.o.
Tel: + 48 22 375 92 00
[email protected]
France
Zentiva France
Tél: +33 (0) 800 089 219
[email protected]
Portugal
Zentiva Portugal, Lda
Tel: +351210601360
[email protected]
Hrvatska
Zentiva d.o.o.
Tel: +385 1 6641 830
[email protected]
Ireland
Zentiva, k.s.
Tel: +353 766 803 944
[email protected]
România
ZENTIVA S.A.
Tel: +4 021 304 7597
[email protected]
Slovenija
Zentiva, k.s.
Tel: +386 360 00 408
[email protected]
Ísland
Zentiva Denmark ApS
Sími: +354 539 0650
[email protected]
Slovenská republika
Zentiva, a.s.
Tel: +421 2 3918 3010
[email protected]
Italia
Zentiva Italia S.r.l.
Suomi/Finland
Zentiva Denmark ApS
Puh/Tel: +358 942 598 648
[email protected]
+39-02-38598801
[email protected]
Κύπρος
Zentiva, k.s.
Τηλ: +357 240 30 144
[email protected]
Sverige
Zentiva Denmark ApS
Tel: +46 840 838 822
[email protected]
Latvija
Zentiva, k.s.
Tel: +371 67893939
[email protected]
United Kingdom (Northern Ireland)
Zentiva, k.s.
Tel: +44 (0) 800 090 2408
[email protected]
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/
Irbesartan Zentiva 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. It may be harmful for people other than you, even if their symptoms are the same as yours.
- If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What Irbesartan Zentiva is and what it is used for
- 2. What you need to know before you take Irbesartan Zentiva
- 3. How to take Irbesartan Zentiva
- 4. Possible side effects
- 5. How to store Irbesartan Zentiva
- 6. Contents of the pack and other information
1. What is Irbesartan Zentiva and what it is used for
Irbesartan Zentiva 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 Zentiva prevents angiotensin-II from binding to these receptors, allowing blood vessels to dilate and blood pressure to decrease.
Irbesartan Zentiva slows the decline of kidney function in patients with high blood pressure and type 2 diabetes.
Irbesartan Zentiva 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 renal dysfunction in laboratory tests.
2. What you need to know before taking Irbesartan Zentiva
Do not take Irbesartan Zentiva:
- if you are allergicto 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 better to avoid taking Irbesartan Zentiva even in the early stages of pregnancy - see section Pregnancy)
- if you suffer from diabetes or your kidney function is impairedand you are being treated with a medicine that lowers blood pressure, containing aliskiren
Warnings and precautions
Talk to your doctor before taking Irbesartan Zentiva if you are in any of the following
conditions:
- excessive vomiting or diarrhoea
- if you suffer from kidney problems
- if you suffer from heart problems
- if you are taking Irbesartan Zentiva for diabetic kidney disorders. In this case, your doctor may prescribe regular blood tests, especially to measure serum potassium levels in case of poor kidney function
- 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 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 suffer from kidney problems related to diabetes.
- aliskiren
The doctor may check your kidney function, blood pressure, and the amount of
electrolytes (e.g. potassium) in your blood at regular intervals.
See also what is stated under "Do not take Irbesartan Zentiva”
You must tell your doctor if you think you may be pregnant (or if there is a possibility of
becoming pregnant). Irbesartan Zentiva is not recommended in early pregnancy and should not be taken if you are more than 3 months pregnant, as it may
cause serious harm to the baby if taken during this period (see section Pregnancy).
Children and adolescents
This medicine should not be used in children and adolescents as safety
and efficacy have not yet been fully established.
Other medicines and Irbesartan Zentiva
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 under: "Do not
take Irbesartan Zentiva” and "Warnings and precautions”)
You may need blood tests if you are using:
- potassium supplements
- potassium-containing salt substitutes
- potassium-sparing medicines (such as some diuretics)
- medicines containing lithium
- repaglinide (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.
Irbesartan Zentiva with food and drink
Irbesartan Zentiva can be taken with or without food.
Pregnancy and breastfeeding
Pregnancy
You must tell 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 Zentiva before becoming pregnant or as soon as you find out you are
pregnant and will advise you to take another medicine instead of Irbesartan
Zentiva. Irbesartan Zentiva is not recommended in early pregnancy and should not be
taken if you are more than 3 months pregnant as it may 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 Zentiva is not
recommended for women who are breastfeeding and your doctor may choose another treatment
if you wish to breastfeed, especially if the baby is newborn or premature.
Driving and using machines:
It is unlikely that Irbesartan Zentiva 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 Zentiva contains lactose.If you have been diagnosed with an intolerance to
certain sugars, contact your doctor before taking this medicine.
Irbesartan Zentiva contains sodium.This medicine contains less than 1 mmol of sodium (23
mg) per tablet, i.e. it is essentially “sodium-free”.
3. How to take Irbesartan Zentiva
Take this medicine following exactly the instructions of your doctor. If you have doubts
consult your doctor or pharmacist.
Method of administration
Irbesartan Zentiva is for oral use. Swallow the tablets with a sufficient amount of fluids
(e.g., a glass of water). You can take Irbesartan Zentiva with or without food. Try to
take the medicine every day at the same time. The treatment should be continued as long as the
doctor considers it necessary.
- Patients with high blood pressureThe usual dose is 150 mg once a day (two tablets a day). The dosage may then be increased to 300 mg (four tablets a day) once a day depending on the reduction of blood pressure levels.
- Patients with high blood pressure and type 2 diabetes with kidney diseaseIn patients with high blood pressure and type 2 diabetes, the indicated maintenance dose is 300 mg (four tablets a day) 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 in hemodialysis, or in patients over 75 years of age.
The maximum antihypertensive effect should be achieved 4-6 weeks after the start of
therapy.
Use in children and adolescents
Irbesartan Zentiva should not be given to children under 18 years of age. If a child
ingests tablets, contact your doctor immediately.
If you take more Irbesartan Zentiva than you should
If you accidentally take too many tablets, contact your doctor immediately.
If you forget to take Irbesartan Zentiva
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 (redness, 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 Zentiva and contact your doctor immediately.
The frequency of the side effects listed below is defined using the following convention:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
The side effects reported in clinical studies for patients treated with Irbesartan Zentiva
were:
- 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). 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 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.
Since Irbesartan Zentiva was marketed, some side effects have been reported.
Side effects with unknown frequency are: 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, impaired kidney function, inflammation of small blood vessels
mainly affecting the skin (a 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 .
You can also report side effects directly through the national reporting system detailed in Appendix V .
By reporting side effects you can help provide more information on the
safety of this medicine.
5. How to store Irbesartan Zentiva
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after
Exp. The expiry date refers to the last day of the month.
Do not store at a temperature above 30°C.
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. Package contents and other information
What Irbesartan Zentiva contains
- The active ingredient is irbesartan. Each Irbesartan Zentiva 75 mg tablet contains 75 mg of irbesartan.
- The excipients are: lactose monohydrate, microcrystalline cellulose, sodium carboxymethylcellulose, hypromellose, silicon dioxide, magnesium stearate, titanium dioxide, macrogol 3000, carnauba wax. See section 2 “Irbesartan Zentiva contains lactose”.
Description of the appearance of Irbesartan Zentiva and package contents
Irbesartan Zentiva 75 mg film-coated tablets are white to almost white,
biconvex, oval-shaped with a heart engraved on one side and the number 2871 imprinted on the other
side.
Irbesartan Zentiva 75 mg film-coated tablets are available in packs of 14, 28, 30,
56, 84, 90 and 98 film-coated tablets in blisters. Unit-dose blisters
of 56 x 1 film-coated tablet for hospital use are also available.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Zentiva k.s.
U kabelovny 130
102 37 Prague 10
Czech Republic
Manufacturer:
Sanofi Winthrop Industrie
1 Rue de la vierge
Ambarès et Lagrave
33 565 Carbon Blanc cedex
France
Sanofi Winthrop Industrie
30-36 Avenue Gustave Eiffel
37 100 Tours
France
Zentiva k.s.
U kabelovny 130
102 37 Prague 10
Czech Republic
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:
België/Belgique/Belgien
Zentiva, k.s.
Tél/Tel: +32 280 86 420
[email protected]
Lietuva
Zentiva, k.s.
Tel: +370 52152025
[email protected]
България
Zentiva, k.s.
Тел: +359 244 17 136
[email protected]
Luxembourg/Luxemburg
Zentiva, k.s.
Tél/Tel: +352 208 82330
[email protected]
Česká republika
Zentiva, k.s.
Tel: +420 267 241 111
[email protected]
Magyarország
Zentiva Pharma Kft.
Tel.: +36 1 299 1058
[email protected]
Danmark
Zentiva Denmark ApS
Tlf: +45 787 68 400
[email protected]
Malta
Zentiva, k.s.
Tel: +356 277 82 052
[email protected]
Deutschland
Zentiva Pharma GmbH
Tel: +49 (0) 800 53 53 010
[email protected]
Nederland
Zentiva, k.s.
Tel: +31 202 253 638
[email protected]
Eesti
Zentiva, k.s.
Tel: +372 52 70308
[email protected]
Norge
Zentiva Denmark ApS
Tlf: +47 219 66 203
[email protected]
Ελλάδα
Zentiva, k.s.
Τηλ: +30 211 198 7510
[email protected]
Österreich
Zentiva, k.s.
Tel: +43 720 778 877
[email protected]
España
Zentiva, k.s.
Tel: +34 931 815 250
[email protected]
Polska
Zentiva Polska Sp. z o.o.
Tel: + 48 22 375 92 00
[email protected]
France
Zentiva France
Tél: +33 (0) 800 089 219
[email protected]
Portugal
Zentiva Portugal, Lda
Tel: +351210601360
[email protected]
Hrvatska
Zentiva d.o.o.
Tel: +385 1 6641 830
[email protected]
Ireland
Zentiva, k.s.
Tel: +353 766 803 944
[email protected]
România
ZENTIVA S.A.
Tel: +4 021 304 7597
[email protected]
Slovenija
Zentiva, k.s.
Tel: +386 360 00 408
[email protected]
Ísland
Zentiva Denmark ApS
Sími: +354 539 0650
[email protected]
Slovenská republika
Zentiva, a.s.
Tel: +421 2 3918 3010
[email protected]
Italia
Zentiva Italia S.r.l.
Suomi/Finland
Zentiva Denmark ApS
Puh/Tel: +358 942 598 648
[email protected]
+39-02-38598801
[email protected]
Κύπρος
Zentiva, k.s.
Τηλ: +357 240 30 144
[email protected]
Sverige
Zentiva Denmark ApS
Tel: +46 840 838 822
[email protected]
Latvija
Zentiva, k.s.
Tel: +371 67893939
[email protected]
United Kingdom (Northern Ireland)
Zentiva, k.s.
Tel: +44 (0) 800 090 2408
[email protected]
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu/
Irbesartan Zentiva 150 mg film-coated tablets
irbesartan
Read this leaflet carefully before you start taking this medicine as it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may be harmful for people other than you, even if their symptoms are the same as yours.
- If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What Irbesartan Zentiva is and what it is used for
- 2. What you need to know before you take Irbesartan Zentiva
- 3. How to take Irbesartan Zentiva
- 4. Possible side effects
- 5. How to store Irbesartan Zentiva
- 6. Contents of the pack and other information
1. What is Irbesartan Zentiva and what it is used for
Irbesartan Zentiva 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 Zentiva prevents angiotensin-II from binding to these receptors, allowing blood vessels to dilate and blood pressure to decrease.
Irbesartan Zentiva slows the decline of kidney function in patients with high blood pressure and type 2 diabetes.
Irbesartan Zentiva is used in adult patients
- to treat high blood pressure levels ( 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 Zentiva
Do not take Irbesartan Zentiva:
- if you are allergicto 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 better to avoid taking Irbesartan Zentiva even in the early stages of pregnancy - see section Pregnancy)
- if you suffer from diabetes or your kidney function is impairedand you are being treated with a medicine that lowers blood pressure, containing aliskiren
Warnings and precautions
Talk to your doctor before taking Irbesartan Zentiva if you are in any of the following
conditions:
- excessive vomiting or diarrhoea
- if you suffer from kidney disorders
- if you suffer from heart disorders
- if you are taking Irbesartan Zentiva for diabetic kidney disorders. In this case, your doctor may prescribe regular blood tests, especially to measure serum 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 paleness, numbness, fast and 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 suffer from kidney problems related to diabetes.
- aliskiren
The doctor may check your kidney function, blood pressure, and the amount of
electrolytes (e.g. potassium) in your blood at regular intervals.
See also what is stated under "Do not take Irbesartan Zentiva”
You must tell your doctor if you think you may be pregnant (or if there is a possibility of
becoming pregnant). Irbesartan Zentiva is not recommended in early pregnancy and must not be taken if you are more than 3 months pregnant, as it may
cause serious harm to the baby if taken during this period (see section Pregnancy).
Children and adolescents
This medicine should not be used in children and adolescents as safety
and efficacy have not yet been fully established.
Other medicines and Irbesartan Zentiva
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 under: "Do not
take Irbesartan Zentiva” 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 some painkillers, called non-steroidal anti-inflammatory drugs,
the effectiveness of irbesartan may be reduced.
Irbesartan Zentiva with food and drink
Irbesartan Zentiva can be taken with or without food.
Pregnancy and breastfeeding
Pregnancy
You must tell 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 Zentiva before becoming pregnant or as soon as you find out you are
pregnant and will advise you to take another medicine instead of Irbesartan
Zentiva. Irbesartan Zentiva is not recommended in early pregnancy and must not be
taken if you are more than 3 months pregnant as it may cause serious harm to 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 Zentiva is not
recommended for women who are breastfeeding and your doctor may choose another treatment
if you wish to breastfeed, especially if the baby is newborn or premature.
Driving and using machines:
It is unlikely that Irbesartan Zentiva 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 Zentiva contains lactose.If you have been diagnosed with
intolerance to some sugars, contact your doctor before taking this medicine.
Irbesartan Zentiva contains sodium.This medicine contains less than 1 mmol of sodium (23
mg) per tablet, i.e. it is essentially “sodium-free”.
3. How to take Irbesartan Zentiva
Take this medicine following the instructions of your doctor exactly. If you have any doubts
consult your doctor or pharmacist.
Method of administration
Irbesartan Zentiva is for oral use. Swallow the tablets with a sufficient amount of fluids
(e.g., a glass of water). You can take Irbesartan Zentiva with or without food. Try to
take the medicine every day at the same time. The treatment should be continued as long as the
doctor considers it necessary.
- Patients with high blood pressureThe usual dose is 150 mg once a day. The dosage may then be increased to 300 mg (two tablets a day) once a day depending on the reduction in blood pressure levels.
- Patients with high blood pressure and type 2 diabetes with kidney diseaseIn patients with high blood pressure and type 2 diabetes, the indicated maintenance dose is 300 mg (two tablets a day) 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 in hemodialysis, or in patients over 75 years of age.
The maximum antihypertensive effect should be achieved 4-6 weeks after the start of
therapy.
Use in children and adolescents
Irbesartan Zentiva should not be given to children under 18 years of age. If a child
swallows tablets, contact your doctor immediately.
If you take more Irbesartan Zentiva than you should
If you accidentally take too many tablets, contact your doctor immediately.
If you forget to take Irbesartan Zentiva
If you accidentally forget to take a dose, continue with therapy as normal. Do not
take a double dose to make up for a 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 (redness, 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 Zentiva and contact your doctor immediately.
The frequency of the side effects listed below is defined using the following convention:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
The side effects reported in clinical studies for patients treated with Irbesartan Zentiva were:
- 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). 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.
Since Irbesartan Zentiva was marketed, some side effects have been reported.
Side effects with unknown frequency are: 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
paleness), 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 .
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 Zentiva
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after
Exp. The expiry date refers to the last day of the month.
Do not store at a temperature above 30°C.
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. Contents of the pack and other information
What Irbesartan Zentiva contains
- The active ingredient is irbesartan. Each Irbesartan Zentiva 150 mg tablet contains 150 mg of irbesartan.
- The excipients are: lactose monohydrate, microcrystalline cellulose, sodium carboxymethylcellulose, hypromellose, silicon dioxide, magnesium stearate, titanium dioxide, macrogol 3000, carnauba wax. See section 2 “Irbesartan Zentiva contains lactose”.
Description of the appearance of Irbesartan Zentiva and contents of the pack
The film-coated tablets of Irbesartan Zentiva 150 mg are from white to almost white,
biconvex, oval shaped with a heart engraved on one side and the number 2872 imprinted on the other
side.
Irbesartan Zentiva 150 mg film-coated tablets are available in packs of 14, 28,
30, 56, 84, 90 and 98 film-coated tablets in blisters. Also available are unit-dose blisters of 56 x 1 film-coated tablet for hospital use.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Zentiva k.s.
U kabelovny 130
102 37 Prague 10
Czech Republic
Manufacturer:
Sanofi Winthrop Industrie
1 Rue de la vierge
Ambarès et Lagrave
33 565 Carbon Blanc cedex
France
Sanofi Winthrop Industrie
30-36 Avenue Gustave Eiffel
37 100 Tours
France
Zentiva k.s.
U kabelovny 130
102 37 Prague 10
Czech Republic
Sanofi-Aventis, S.A.
Ctra. C-35 (La Batlloria-Hostalric), km. 63.09
17404 Riells i Viabrea (Girona)
Spain
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:
België/Belgique/Belgien
Zentiva, k.s.
Tél/Tel: +32 280 86 420
[email protected]
Lietuva
Zentiva, k.s.
Tel: +370 52152025
[email protected]
България
Zentiva, k.s.
Тел: +359 244 17 136
[email protected]
Luxembourg/Luxemburg
Zentiva, k.s.
Tél/Tel: +352 208 82330
[email protected]
Česká republika
Zentiva, k.s.
Tel: +420 267 241 111
[email protected]
Magyarország
Zentiva Pharma Kft.
Tel.: +36 1 299 1058
[email protected]
Danmark
Zentiva Denmark ApS
Tlf: +45 787 68 400
[email protected]
Malta
Zentiva, k.s.
Tel: +356 277 82 052
[email protected]
Deutschland
Zentiva Pharma GmbH
Tel: +49 (0) 800 53 53 010
[email protected]
Nederland
Zentiva, k.s.
Tel: +31 202 253 638
[email protected]
Eesti
Zentiva, k.s.
Tel: +372 52 70308
[email protected]
Norge
Zentiva Denmark ApS
Tlf: +47 219 66 203
[email protected]
Ελλάδα
Zentiva, k.s.
Τηλ: +30 211 198 7510
[email protected]
Österreich
Zentiva, k.s.
Tel: +43 720 778 877
[email protected]
España
Zentiva, k.s.
Tel: +34 931 815 250
[email protected]
Polska
Zentiva Polska Sp. z o.o.
Tel: + 48 22 375 92 00
[email protected]
France
Zentiva France
Tél: +33 (0) 800 089 219
[email protected]
Portugal
Zentiva Portugal, Lda
Tel: +351210601360
[email protected]
Hrvatska
Zentiva d.o.o.
Tel: +385 1 6641 830
[email protected]
Ireland
Zentiva, k.s.
Tel: +353 766 803 944
[email protected]
România
ZENTIVA S.A.
Tel: +4 021 304 7597
[email protected]
Slovenija
Zentiva, k.s.
Tel: +386 360 00 408
[email protected]
Ísland
Zentiva Denmark ApS
Sími: +354 539 0650
[email protected]
Slovenská republika
Zentiva, a.s.
Tel: +421 2 3918 3010
[email protected]
Italia
Zentiva Italia S.r.l.
+39-02-38598801
[email protected]
Suomi/Finland
Zentiva Denmark ApS
Puh/Tel: +358 942 598 648
[email protected]
Κύπρος
Zentiva, k.s.
Τηλ: +357 240 30 144
[email protected]
Sverige
Zentiva Denmark ApS
Tel: +46 840 838 822
[email protected]
United Kingdom (Northern Ireland)
Zentiva, k.s.
Tel: +44 (0) 800 090 2408
[email protected]
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu/
Latvija
Zentiva, k.s.
Tel: +371 67893939
[email protected]
Irbesartan Zentiva 300 mg film-coated tablets
irbesartan
Read this leaflet carefully before you start taking this medicine as it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may be harmful to people other than you, even if their symptoms are the same as yours.
- If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What Irbesartan Zentiva is and what it is used for
- 2. What you need to know before you take Irbesartan Zentiva
- 3. How to take Irbesartan Zentiva
- 4. Possible side effects
- 5. How to store Irbesartan Zentiva
- 6. Contents of the pack and other information
1. What is Irbesartan Zentiva and what is it used for
Irbesartan Zentiva 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 Zentiva prevents angiotensin-II from binding to these receptors, allowing blood vessels to dilate and blood pressure to decrease.
Irbesartan Zentiva slows the decline of kidney function in patients with high blood pressure and type 2 diabetes.
Irbesartan Zentiva 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 Zentiva
Do not take Irbesartan Zentiva:
- if you are allergicto 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 Zentivaeven in the early stages of pregnancy - see section Pregnancy)
- if you suffer from diabetes or your kidney function is impairedand you are being treated with a medicine that lowers blood pressure, containing aliskiren
Warnings and precautions
Talk to your doctor before taking Irbesartan Zentiva if you are in any of the following
conditions:
- excessive vomiting or diarrhoea
- if you suffer from kidney problems
- if you suffer from heart problems
- if you are taking Irbesartan Zentiva for diabetic kidney disorders. In this case, your doctor may prescribe regular blood tests, especially to measure serum 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 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 suffer from 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 in the section "Do not take Irbesartan Zentiva”
You must tell your doctor if you think you may be pregnant (or if there is a possibility of
becoming pregnant). Irbesartan Zentiva is not recommended in early pregnancy and must not be taken if you are pregnant for more than 3 months, as it may
cause serious harm to the baby if taken during this period (see section Pregnancy).
Children and adolescents
This medicine should not be used in children and adolescents as safety and efficacy have not been fully established.
Other medicines and Irbesartan Zentiva
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 "Do not
take Irbesartan Zentiva” 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 certain painkillers, called non-steroidal anti-inflammatory drugs,
the effectiveness of irbesartan may be reduced.
Irbesartan Zentiva with food and drink
Irbesartan Zentiva can be taken with or without food.
Pregnancy and breastfeeding
Pregnancy
You must tell 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 Zentiva before becoming pregnant or as soon as you find out you are
pregnant and will advise you to take another medicine instead of Irbesartan
Zentiva. Irbesartan Zentiva is not recommended in early pregnancy and must not be
taken if you are pregnant for more than 3 months as it may 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 Zentiva is not
recommended for women who are breastfeeding and your doctor may choose another treatment
if you wish to breastfeed, especially if the baby is newborn or premature.
Driving and using machines:
It is unlikely that Irbesartan Zentiva 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 machines.
Irbesartan Zentiva contains lactose.If you have been diagnosed with an intolerance to
some sugars, contact your doctor before taking this medicine.
Irbesartan Zentiva contains sodium.This medicine contains less than 1 mmol of sodium (23
mg) per tablet, i.e. it is essentially “sodium-free”.
3. How to take Irbesartan Zentiva
Take this medicine following exactly the instructions of your doctor. If you have doubts
consult your doctor or pharmacist.
Method of administration
Irbesartan Zentiva is for oral use. Swallow the tablets with a sufficient amount of fluids
(e.g.: a glass of water). You can take Irbesartan Zentiva with or without food. Try to
take the medicine every day at the same time. The treatment should be continued as long as the
doctor considers it necessary.
- Patients with high blood pressureThe usual dose is 150 mg once a day. The dosage may then 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 diseaseIn 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 in hemodialysis, or in patients over 75 years of age.
The maximum antihypertensive effect should be achieved 4-6 weeks after the start of
therapy.
Use in children and adolescents
Irbesartan Zentiva should not be given to children under 18 years of age. If a child
ingests tablets, contact your doctor immediately.
If you take more Irbesartan Zentiva than you should
If you accidentally take too many tablets, contact your doctor immediately.
If you forget to take Irbesartan Zentiva
If you accidentally forget to take a dose, continue normally with the therapy. Do not
take a double dose to make up 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 everyone will experience them.
Some of these effects may be serious and may require medical attention.
As with similar medicines, rare cases of allergic skin reactions (redness, 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 Zentiva and contact your doctor immediately.
The frequency of the side effects listed below is defined using the following convention:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
The side effects reported in clinical studies for patients treated with Irbesartan Zentiva
were:
- 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 elevated 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). 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 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.
Since the marketing of Irbesartan Zentiva, some side effects have been reported.
Side effects with unknown frequency are: 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 paleness), reduced number of platelets, abnormal liver function, increased levels of
potassium in the blood, kidney function disorders, inflammation of small blood vessels
mainly concerning 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 experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist .
You can also report side effects directly through the national reporting system as indicated in Annex V .
By reporting side effects you can help provide more information on the
safety of this medicine.
5. How to store Irbesartan Zentiva
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after
Exp. The expiry date refers to the last day of the month.
Do not store at a temperature above 30°C.
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. Package contents and other information
What Irbesartan Zentiva contains
- The active ingredient is irbesartan. Each Irbesartan Zentiva 300 mg tablet contains 300 mg of irbesartan.
- The excipients are: lactose monohydrate, microcrystalline cellulose, sodium carboxymethylcellulose, hypromellose, silicon dioxide, magnesium stearate, titanium dioxide, macrogol 3000, carnauba wax. See section 2 “Irbesartan Zentiva contains lactose”.
Description of the appearance of Irbesartan Zentiva and package contents
The film-coated tablets of Irbesartan Zentiva 300 mg are from white to almost white,
biconvex, oval-shaped with a heart engraved on one side and the number 2873 imprinted on the other
side.
Irbesartan Zentiva 300 mg film-coated tablets are available in packs of 14, 28,
30, 56, 84, 90 and 98 film-coated tablets in blisters. Unit-dose blisters of 56 x 1 film-coated tablet are also available for hospital use.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Zentiva k.s.
U kabelovny 130
102 37 Prague 10
Czech Republic
Manufacturer:
Sanofi Winthrop Industrie
1 Rue de la vierge
Ambarès et Lagrave
33 565 Carbon Blanc cedex
France
Sanofi Winthrop Industrie
30-36 Avenue Gustave Eiffel
37 100 Tours
France
Zentiva k.s.
U kabelovny 130
102 37 Prague 10
Czech Republic
Sanofi-Aventis, S.A.
Ctra. C-35 (La Batlloria-Hostalric), km. 63.09
17404 Riells i Viabrea (Girona)
Spain
For further information on this medicinal product, contact the local representative of the marketing authorisation holder:
België/Belgique/Belgien
Zentiva, k.s.
Tél/Tel: +32 280 86 420
[email protected]
Lietuva
Zentiva, k.s.
Tel: +370 52152025
[email protected]
България
Zentiva, k.s.
Тел: +359 244 17 136
[email protected]
Luxembourg/Luxemburg
Zentiva, k.s.
Tél/Tel: +352 208 82330
[email protected]
Česká republika
Zentiva, k.s.
Tel: +420 267 241 111
[email protected]
Magyarország
Zentiva Pharma Kft.
Tel.: +36 1 299 1058
[email protected]
Danmark
Zentiva Denmark ApS
Tlf: +45 787 68 400
[email protected]
Malta
Zentiva, k.s.
Tel: +356 277 82 052
[email protected]
Deutschland
Zentiva Pharma GmbH
Tel: +49 (0) 800 53 53 010
[email protected]
Nederland
Zentiva, k.s.
Tel: +31 202 253 638
[email protected]
Eesti
Zentiva, k.s.
Tel: +372 52 70308
[email protected]
Norge
Zentiva Denmark ApS
Tlf: +47 219 66 203
[email protected]
Ελλάδα
Zentiva, k.s.
Τηλ: +30 211 198 7510
[email protected]
Österreich
Zentiva, k.s.
Tel: +43 720 778 877
[email protected]
España
Zentiva, k.s.
Tel: +34 931 815 250
[email protected]
Polska
Zentiva Polska Sp. z o.o.
Tel: + 48 22 375 92 00
[email protected]
France
Zentiva France
Tél: +33 (0) 800 089 219
[email protected]
Portugal
Zentiva Portugal, Lda
Tel: +351210601360
[email protected]
Hrvatska
Zentiva d.o.o.
Tel: +385 1 6641 830
[email protected]
România
ZENTIVA S.A.
Tel: +4 021 304 7597
[email protected]
Ireland
Zentiva, k.s.
Tel: +353 766 803 944
[email protected]
Slovenija
Zentiva, k.s.
Tel: +386 360 00 408
[email protected]
Ísland
Zentiva Denmark ApS
Sími: +354 539 0650
[email protected]
Slovenská republika
Zentiva, a.s.
Tel: +421 2 3918 3010
[email protected]
Italia
Zentiva Italia S.r.l.
Suomi/Finland
Zentiva Denmark ApS
Puh/Tel: +358 942 598 648
[email protected]
+39-02-38598801
[email protected]
Κύπρος
Zentiva, k.s.
Τηλ: +357 240 30 144
[email protected]
Sverige
Zentiva Denmark ApS
Tel: +46 840 838 822
[email protected]
Latvija
Zentiva, k.s.
Tel: +371 67893939
[email protected]
United Kingdom (Northern Ireland)
Zentiva, k.s.
Tel: +44 (0) 800 090 2408
[email protected]
More detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/
- Страна регистрации
- Форма выпускаTablet, 75 MG
- Код АТХC09CA04
- Действующее вещество
- Отпускается по рецептуДа
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги IRBESARTAN TSENTIVAФорма выпуска: Coated tablet, 75 MGДействующее вещество: ИрбесартанПроизводитель: SANOFI WINTHROP INDUSTRIEОтпускается по рецептуФорма выпуска: Film-coated tablet, 75 MGДействующее вещество: ИрбесартанПроизводитель: KRKA D.D. NOVO MESTOОтпускается по рецептуФорма выпуска: Film-coated tablet, 75 MGДействующее вещество: ИрбесартанПроизводитель: ACCORD HEALTHCARE, S.L.U.Отпускается по рецепту
Аналоги IRBESARTAN TSENTIVA в других странах
Лекарства с тем же действующим веществом, доступные в других странах.
Аналог IRBESARTAN TSENTIVA в Испания
Аналог IRBESARTAN TSENTIVA в Польша
Аналог IRBESARTAN TSENTIVA в Украина
Врачи онлайн по IRBESARTAN TSENTIVA
Обсудите применение IRBESARTAN TSENTIVA и возможные следующие шаги — по оценке врача.
Получите рецепт на IRBESARTAN TSENTIVA онлайн
Заполните форму за 2 минуты
Расскажите о симптомах, истории болезни и нужном препарате.
Выберите врача или мы назначим
Выберите специалиста или мы подберём ближайшего доступного врача.
Врач рассматривает ваш случай
Обычно в течение 30 минут. Может задать уточняющие вопросы в чате.
Получите в любой аптеке
Электронный рецепт отправляется на вашу почту — действителен по всей Польше.
Часто задаваемые вопросы
IRBESARTAN TSENTIVA требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество IRBESARTAN TSENTIVA — Ирбесартан. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
IRBESARTAN TSENTIVA производится компанией ZENTIVA K.S.. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
Врачи, включая Семейные врачи, Психиатры, Дерматологи, Кардиологи, Эндокринологи, Гастроэнтерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Инфекционисты, Аллергологи, Гериатры, Педиатры, Онкологи, могут оценить целесообразность применения IRBESARTAN TSENTIVA с учетом вашей ситуации и местных правил. Вы можете записаться на онлайн-консультацию, чтобы обсудить возможные варианты.
Польша имеет хорошо развитую систему здравоохранения в крупных городах, таких как Варшава, Краков, Вроцлав и Гданьск. Аптеки широко доступны и работают в соответствии с действующим законодательством, обеспечивая доступ к рецептурным препаратам.
Вы можете купить IRBESARTAN TSENTIVA в Варшаве, Кракове, Вроцлаве или Гданьске в любой аптеке при наличии действующего рецепта.
Чтобы получить рецепт, вы можете воспользоваться Oladoctor:
Другие лекарства с тем же действующим веществом (Ирбесартан) включают APROVEL, IFIRMASTA, IRBESARTAN AKKORD. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.








