Irbesartan Zentiva: detailed information

Package leaflet: Information for the patient

Irbesartan Zentiva 75 mg tablets

irbesartan
Read this leaflet carefully before taking this medicine because it contains
important information for you.

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

Contents of this leaflet:

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

1. What Irbesartan Zentiva is 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 leads to 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 in 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 kidneys in hypertensive patients with high blood pressure, type 2 diabetes, and evidence of kidney dysfunction shown by laboratory tests.

2. What you should know before taking irbesartan zentiva

Do not take Irbesartan Zentiva:

if you are allergic to irbesartan or to any of the other ingredients of this medicine (listed in section 6)
if you are more than 3 months pregnant (it is best to avoid taking Irbesartan Zentiva even during early pregnancy – see section Pregnancy)
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine 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 have kidney problems
if you have heart problems
if you are taking Irbesartan Zentiva for diabetic kidney disorders. In this case, your doctor may prescribe regular blood tests, especially to monitor serum potassium levels in case of poor kidney function, or if you develop low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, tremor, headache, flushing or pallor, numbness, rapid or pounding heartbeat), particularly if you are being treated for diabetes
if you are scheduled for surgery or require anaesthetics
if you are taking any of the following medicines used to treat high blood pressure:
- an "ACE inhibitor” (e.g. enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
- aliskiren

Your doctor may check your kidney function, blood pressure, and levels of
electrolytes (e.g. potassium) in your blood at regular intervals.
See also the information under the heading "Do not take Irbesartan Zentiva"
Contact your doctor if, after taking Irbesartan Zentiva, you experience abdominal pain, nausea,
vomiting, or diarrhoea. Your doctor will decide whether treatment should continue. Do not
stop taking Irbesartan Zentiva on your own.
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 during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn baby if taken during this period (see section Pregnancy).
Children and adolescents
This medicine should not be used in children and adolescents, as its 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 consider it necessary to adjust your 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 taking:

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

When taking certain painkillers known as non-steroidal anti-inflammatory drugs (NSAIDs), 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 normally advise you to stop taking Irbesartan Zentiva before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine. Irbesartan Zentiva is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn baby if taken after the third month of pregnancy.
Breast-feeding
Inform your doctor if you are breast-feeding or planning to breast-feed. Irbesartan Zentiva is not recommended for women who are breast-feeding, and your doctor may choose an alternative treatment if you wish to breast-feed, especially if the baby is a newborn or was born prematurely.
Driving and using machines
It is unlikely that Irbesartan 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 your doctor has diagnosed you with an intolerance to certain 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 exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.
Method of administration
Irbesartan Zentiva is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g., a glass of water). You may take Irbesartan Zentiva with or without food. Try to take the medicine at the same time each day. Treatment should be continued as long as your doctor considers it necessary.

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

Your doctor may decide to use lower doses, especially at the beginning of treatment, in particular patients such as those on haemodialysis, or in patients over 75 years of age.
The maximum antihypertensive effect should be achieved within 4–6 weeks after starting treatment.
Use in children and adolescents
Irbesartan Zentiva must not be given to children under 18 years of age. If a child takes any 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 miss a dose, continue with your next dose as normal. Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some of these side effects can be serious and may require medical attention.
As with similar medicines, rare cases of skin allergic reactions (rash, urticaria) as well as localized swelling of the face, lips and/or tongue have been reported in patients treated with irbesartan. If you experience any of these symptoms or have difficulty breathing, stop taking Irbesartan 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
Rare: may affect up to 1 in 1,000 people

The side effects reported in clinical studies in patients treated with Irbesartan Zentiva are:

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

Additional side effects have been reported since Irbesartan Zentiva has been marketed.
Side effects with unknown frequency include: dizziness, headache, taste disturbances, ringing in the ears, muscle cramps, joint and muscle pain, reduced number of red blood cells (anaemia – symptoms may include tiredness, headache, shortness of breath during physical activity, dizziness and pale appearance), reduced platelet count, abnormal liver function, increased blood potassium levels, impaired kidney function, inflammation of the small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis), severe allergic reactions (anaphylactic shock) and low blood sugar levels. Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) and rare cases of intestinal angioedema (swelling in the intestine presenting with symptoms such as abdominal pain, nausea, vomiting and diarrhoea) have also been reported.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system listed in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Irbesartan Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after
Exp. The expiry date refers to the last day of the month.
Do not store above 30°C.
Do not dispose of medicines 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 substance is irbesartan. Each tablet of Irbesartan Zentiva 75 mg contains 75 mg of irbesartan.
The excipients are: microcrystalline cellulose, cross-linked sodium carmellose, monohydrate lactose, 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 75 mg tablets are white to almost white, biconvex, oval-shaped tablets with a heart-shaped logo 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 blister packs. Single-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 about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Zentiva, k.s. Zentiva, k.s.
Tél/Tel: +32 (78) 700 112 Tel: +370 52152025
[email protected] [email protected]

България Luxembourg/Luxemburg
Zentiva, k.s. Zentiva, k.s.
Тел: +35924417136 Tél/Tel: +352 208 82330
[email protected] [email protected]

Česká republika Magyarország
Zentiva, k.s. Zentiva Pharma Kft.
Tel: +420 267 241 111 Tel.: +36 1 299 1058
[email protected] [email protected]

Danmark Malta
Zentiva Denmark ApS Zentiva, k.s.
Tlf: +45 787 68 400 Tel: +356 2034 1796
[email protected] [email protected]

Deutschland Nederland
Zentiva Pharma GmbH Zentiva, k.s.
Tel: +49 (0) 800 53 53 010 Tel: +31 202 253 638
[email protected] [email protected]

Eesti Norge
Zentiva, k.s. Zentiva Denmark ApS
Tel: +372 52 70308 Tlf: +45 787 68 400
[email protected] [email protected]

Ελλάδα Österreich
Zentiva, k.s. Zentiva, k.s.
Τηλ: +30 211 198 7510 Tel: +43 720 778 877
[email protected] [email protected]

España Polska
Zentiva Spain S.L.U. Zentiva Polska Sp. z o.o.
Tel: +34 671 365 828 Tel: + 48 22 375 92 00
[email protected] [email protected]

France Portugal
Zentiva France Zentiva Portugal, Lda
Tél: +33 (0) 800 089 219 Tel: +351210601360
[email protected] [email protected]

Hrvatska România
Zentiva d.o.o. ZENTIVA S.A.
Tel: +385 1 6641 830 Tel: +4 021 304 7597
[email protected] [email protected]

Ireland Slovenija
Zentiva, k.s. Zentiva, k.s.
Tel: +353 818 882 243 Tel: +386 360 00 408
[email protected] [email protected]

Ísland Slovenská republika
Zentiva Denmark ApS Zentiva, a.s.
Sími: +354 539 5025 Tel: +421 2 3918 3010
[email protected] [email protected]

Italia Suomi/Finland
Zentiva Italia S.r.l. Zentiva Denmark AoS
+39 800081631 Puh/Tel: +358 942 598 648
[email protected] [email protected]

Κύπρος Sverige
Zentiva, k.s. Zentiva Denmark ApS
Τηλ: +30 211 198 7510 Tel: +46 840 838 822
[email protected] [email protected]

Latvija
Zentiva, k.s.
Tel: +371 67893939
[email protected]

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

Patient Information Leaflet

Irbesartan Zentiva 150 mg tablets

irbesartan
Read this entire leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others. It may be harmful to other people, even if their symptoms are the same as yours.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

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

2. What you need to know before taking Irbesartan Zentiva

Do not take Irbesartan Zentiva:

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

Warnings and precautions
Talk to your doctor before taking Irbesartan Zentiva if you are in any of the following
conditions:

excessive vomiting or diarrhoea
if you have kidney problems
if you have heart problems
if you are taking Irbesartan Zentiva for diabetic kidney disorders. In this case, your doctor may prescribe regular blood tests, especially to monitor serum potassium levels in case of poor kidney function, or if you develop low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, tremor, headache, flushing or pallor, numbness, rapid and pounding heartbeat), particularly if you are being treated for diabetes
if you are due to have surgery or are receiving anaesthetics
if you are taking any of the following medicines used to treat high blood pressure:
- an "ACE inhibitor" (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
- aliskiren. Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals.

See also information under the section "Do not take Irbesartan Zentiva".
Talk to your doctor if, after taking Irbesartan Zentiva, you experience abdominal pain, nausea,
vomiting or diarrhoea. Your doctor will decide whether treatment should continue. Do not
stop taking Irbesartan Zentiva on your own.
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 during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn child when 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 consider it necessary to adjust your dose and/or take other precautions:
If you are taking an ACE inhibitor or aliskiren (see also information under "Do not take Irbesartan Zentiva" and "Warnings and precautions").
You may need blood tests if you are taking:

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

If you are taking certain painkillers called non-steroidal anti-inflammatory drugs (NSAIDs), the effectiveness of irbesartan may be reduced.
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 pregnancy is confirmed, and will recommend an alternative medicine. Irbesartan Zentiva is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn child if taken after the third month of pregnancy.
Breast-feeding
Inform your doctor if you are breast-feeding or planning to breast-feed. Irbesartan Zentiva is not recommended for women who are breast-feeding, and your doctor may choose a different treatment if you wish to breast-feed, especially if the baby is a newborn or was born prematurely.
Driving and using machines
It is unlikely that Irbesartan Zentiva will affect your ability to drive or use machines.
However, occasionally, dizziness or fatigue may occur during treatment for high blood pressure. If this happens, talk to your doctor before driving or using machines.
Irbesartan Zentiva contains lactose. If you have been diagnosed by your doctor 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

Always take this medicine exactly as instructed by your doctor. 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 liquid (e.g.: a glass of water). You may take Irbesartan Zentiva with or without food. Try to take the medicine at the same time each day. Treatment should be continued for as long as your doctor considers it necessary.

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

Your doctor may decide to use lower doses, especially at the beginning of treatment, in particular patients such as those on haemodialysis, or in patients over 75 years of age.
Maximum antihypertensive effect should be achieved within 4–6 weeks after starting treatment.
Use in children and adolescents
Irbesartan Zentiva must not be given to children under 18 years of age. If a child swallows any 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 your next dose as usual. Do not take a double dose to make up for the forgotten dose.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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
Rare: may affect up to 1 in 1,000 people

Side effects reported in clinical studies for patients treated with Irbesartan Zentiva include:

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

Additional side effects have been reported since Irbesartan Zentiva has been marketed.
Side effects with unknown frequency include: dizziness, headache, taste disturbances, ringing in the ears, muscle cramps, joint and muscle pain, reduced number of red blood cells (anaemia - symptoms may include tiredness, headache, shortness of breath during physical activity, dizziness and pale appearance), reduced platelet count, abnormal liver function, increased potassium levels in the blood, impaired kidney function, inflammation of the small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis), severe allergic reactions (anaphylactic shock), and low blood sugar levels. Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) and rare cases of intestinal angioedema (swelling in the intestine presenting with symptoms such as abdominal pain, nausea, vomiting and diarrhoea) have also been reported.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Irbesartan Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after
Exp. The expiry date refers to the last day of the month.
Do not store above 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. OTHER INFORMATION

What Irbesartan Zentiva contains

The active substance is irbesartan. Each Irbesartan Zentiva 150 mg tablet contains 150 mg of irbesartan.
The other ingredients are: microcrystalline cellulose, sodium carboxymethyl starch, lactose monohydrate, magnesium stearate, colloidal anhydrous silica, pregelatinized maize starch and poloxamer 188. See section 2 “Irbesartan Zentiva contains lactose”.

What Irbesartan Zentiva looks like and contents of the pack
Irbesartan Zentiva 150 mg tablets are white to almost white, biconvex, oval-shaped tablets with a heart-shaped symbol 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. Single-dose blisters containing 56 x 1 tablet for hospital use are also available.
Not all pack sizes may be marketed.

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

België/Belgique/Belgien Lietuva
Zentiva, k.s. Zentiva, k.s.
Tél/Tel: +32 (78) 700 112 Tel: +370 52152025
[email protected] [email protected]

България Luxembourg/Luxemburg
Zentiva, k.s. Zentiva, k.s.
Тел: +359 244 17 136 Tél/Tel: +352 208 82330
[email protected] [email protected]