Patient leaflet - Irbesartan Zentiva (previously Irbesartan Winthrop)
■ If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in 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 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 in the body which binds to receptors in blood vessels causing them to tighten. This results in an increase in blood pressure. Irbesartan Zentiva prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. Irbesartan Zentiva slows the decrease 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 hypertension )
-
■ to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory evidence of impaired kidney function.
2. What you need to know before you take Irbesartan Zentiva
Do not take Irbesartan Zentiva
-
■ if you are allergic to irbesartan or any other ingredients of this medicine (listed in section 6)
-
■ if you are more than 3 months pregnant. (It is also better to avoid Irbesartan Zentiva in early
pregnancy – see pregnancy section)
-
■ if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
Warning and precautions
Talk to your doctor before taking Irbesartan Zentiva and if any of the following apply to you:
■ ■ ■ ■
if you get excessive vomiting or diarrhoea
if you suffer from kidney problems
if you suffer from heart problems
if you receive Irbesartan Zentiva for diabetic kidney disease. In this case your doctor may perform regular blood tests, especially for measuring blood 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, having a fast, pounding heart beat), particularly if you are being treated for diabetes.
-
■ if you are going to have an operation (surgery) or be given anaesthetics
-
■ if you are taking any of the following medicines used to treat high blood pressure:
o an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.
o 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 information under the heading “Do not take Irbesartan Zentiva”.
You must tell your doctor if you think you are (or might become) 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 your baby if used at that stage (see pregnancy section).
Children and adolescents
This medicinal product should not be used in children and adolescents because the 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 change your dose and/or to take other precautions.
If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Irbesartan Zentiva ” and “Warnings and precautions”).
You may need to have blood checks if you take:
-
■ potassium supplements
-
■ salt substitutes containing potassium
-
■ potassium-sparing medicines (such as certain diuretics)
-
■ medicines containing lithium
-
■ repaglinide (medication used for lowering blood sugar levels)
If you take certain painkillers, called non-steroidal anti-inflammatory drugs, the effect of irbesartan may be reduced.
Irbesartan Zentiva with food and drink
Irbesartan Zentiva can be taken with or without food.
Pregnancy and breast-feeding
Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Irbesartan Zentiva before you become pregnant or as soon as you know 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 when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Irbesartan Zentiva is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Driving and using machines
Irbesartan Zentiva is unlikely to affect your ability to drive or use machines. However, occasionally dizziness or weariness may occur during treatment of high blood pressure. If you experience these, talk to your doctor before attempting to drive or use machines.
Irbesartan Zentiva contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Irbesartan Zentiva contains sodium. This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
3. How to take Irbesartan Zentiva
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Method of administration
Irbesartan Zentiva is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water). You can take Irbesartan Zentiva with or without food. Try to take your daily dose at about the same time each day. It is important that you continue to take Irbesartan Zentiva until your doctor tells you otherwise.
-
■ Patients with high blood pressure
The usual dose is 150 mg once a day (two tablets a day). The dose may later be increased to 300 mg (four tablets a day) once daily depending on blood pressure response.
-
■ Patients with high blood pressure and type 2 diabetes with kidney disease
In patients with high blood pressure and type 2 diabetes, 300 mg (four tablets a day) once daily is the preferred maintenance dose for the treatment of associated kidney disease.
The doctor may advise a lower dose, especially when starting treatment in certain patients such as those on haemodialysis , or those over the age of 75 years.
The maximal blood pressure lowering effect should be reached 4–6 weeks after beginning treatment.
Use in children and adolescents
Irbesartan Zentiva should not be given to children under 18 years of age. If a child swallows some 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 daily dose, just take the next dose as normal. Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some of these effects may be serious and may require medical attention.
As with similar medicines, rare cases of allergic skin reactions (rash, urticaria), as well as localised swelling of the face, lips and/or tongue have been reported in patients taking irbesartan. If you get any of these symptoms or get short of breath, 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
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 an increased level of potassium.
Common (may affect up to 1 in 10 people): dizziness, feeling sick/vomiting, fatigue and blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase enzyme). In patients with high blood pressure and type 2 diabetes with kidney disease, dizziness when getting up from a lying or sitting position, low blood pressure when getting up from a lying or sitting position, pain in joints or muscles and decreased levels of a protein in the red blood cells (haemoglobin) were also reported.
Uncommon (may affect up to 1 in 100 people): heart rate increased, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain.
Some undesirable effects have been reported since marketing of Irbesartan Zentiva. Undesirable effects where the frequency is not known are: feeling of spinning, headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, decreased number of red blood cells (anaemia – symptoms may include tiredness, headaches, being short of breath when exercising, dizziness and looking pale), reduced number of platelets, abnormal liver function, increased blood potassium levels, impaired kidney function, inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis), severe allergic reactions (anaphylactic shock) and low blood sugar levels. Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in 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 on the blister after EXP. The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Irbesartan Zentiva contains
-
■ The active substance is irbesartan. Each tablet of Irbesartan Zentiva 75 mg contains 75 mg irbesartan.
-
■ The other ingredients are microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, magnesium stearate, colloidal hydrated silica, pregelatinised maize starch, and poloxamer 188. Please see section 2 “Irbesartan Zentiva contains lactose”.
What Irbesartan Zentiva looks like and contents of the pack
Irbesartan Zentiva 75 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2771 engraved on the other side.
Irbesartan Zentiva 75 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets. Unidose blister packs of 56 × 1 tablet for delivery in hospitals 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 any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
| Belgie/Belgique/Belgien Zentiva, k.s. Tél/Tel: +32 280 86 420 | Lietuva Zentiva, k.s. Tel: +370 52152025 |
| Etnrapua Zentiva, k.s. Ten: +35924417136 | Luxembourg/Luxemburg Zentiva, k.s. Tel/Tel: +352 208 82330 |
| Česká republika Zentiva, k.s. Tel: +420 267 241 111 | Magyarorszag Zentiva Pharma Kft. Tel.: +36 1 299 1058 |
| Danmark Zentiva Denmark ApS Tlf: +45 787 68 400 | Malta Zentiva, k.s. Tel: +356 277 82 052 |
| Deutschland Zentiva Pharma GmbH Tel: +49 (0) 800 53 53 010 | Nederland Zentiva, k.s. Tel: +31 202 253 638 |
| Eesti Zentiva, k.s. | Norge Zentiva Denmark ApS |
| Tel: +372 52 70308 | Tlf: +47 219 66 203 |
| EXÀàôa Zentiva, k.s. TnX: +30 211 198 7510 | Österreich Zentiva, k.s. Tel: +43 720 778 877 |
| España Zentiva, k.s. Tel: +34 931 815 250 | Polska Zentiva Polska Sp. z o.o. Tel: + 48 22 375 92 00 |
| France Zentiva France Tél: +33 (0) 800 089 219 | Portugal Zentiva Portugal, Lda Tel: +351210601360 |
| Hrvatska Zentiva d.o.o. Tel: +385 1 6641 830 | România ZENTIVA S.A. Tel: +4 021 304 7597 |
| Ireland Zentiva, k.s. Tel: +353 766 803 944 | Slovenija Zentiva, k.s. Tel: +386 360 00 408 |
| Ísland Zentiva Denmark ApS Sími: +354 539 0650 | Slovenská republika Zentiva, a.s. Tel: +421 2 3918 3010 |
| Italia Zentiva Italia S.r.l. Tel: +39–02–38598801 | Suomi/Finland Zentiva Denmark ApS Puh/Tel: +358 942 598 648 |
| Kùnpoç Zentiva, k.s. TnX: +357 240 30 144 | Sverige Zentiva Denmark ApS Tel: +46 840 838 822 |
| Latvija Zentiva, k.s. Tel: +371 67893939 | United Kingdom (Northern Ireland) Zentiva, k.s. Tel: +44 (0) 800 090 2408 |
This leaflet was last revised in
Detailed information on this medicine is available on the European Medicines Agency web site: