Irbesartan Zentiva (previously Irbesartan Winthrop)
irbesartan
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
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 Irbesartan Zentiva is and what it is used for
What you need to know before you take Irbesartan Zentiva
How to take Irbesartan Zentiva
Possible side effects
How to store Irbesartan Zentiva
Contents of the pack and other information
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.
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)
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:
an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.
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 (ormightbecome) 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).
This medicinal product should not be used in children and adolescents because the safety and efficacy have not yet been fully established.
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”).
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 can be taken with or without food.
You must tell your doctor if you think you are (ormightbecome) 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.
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.
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.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
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.
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.
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.
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 accidentally take too many tablets, contact your doctor immediately.
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.
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 thenationalreportingsystem listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
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.
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”.
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 x 1 tablet for delivery in hospitals are also available.
Not all pack sizes may be marketed.
Zentiva k.s.
U kabelovny 130
102 37 Prague 10 Czech Republic
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.
Zentiva, k.s.
Tél/Tel: +32 280 86 420
Zentiva, k.s.
Tel: +370 52152025
Zentiva, k.s.
Тел: +35924417136
Zentiva, k.s.
Tél/Tel: +352 208 82330
Zentiva, k.s.
Tel: +420 267 241 111
Zentiva Denmark ApS Tlf: +45 787 68 400
Zentiva, k.s.
Tel: +356 277 82 052
Zentiva Pharma GmbH Tel: +49 (0) 800 53 53 010
Zentiva, k.s.
Tel: +31 202 253 638
Zentiva, k.s.
Zentiva Denmark ApS
Tel: +372 52 70308
Tlf: +47 219 66 203
Zentiva, k.s.
Τηλ: +30 211 198 7510
Zentiva, k.s.
Tel: +43 720 778 877
Zentiva, k.s.
Tel: +34 931 815 250
Zentiva Polska Sp. z o.o. Tel: + 48 22 375 92 00
Zentiva France
Tél: +33 (0) 800 089 219
Zentiva Portugal, Lda Tel: +351210601360
Zentiva d.o.o.
Tel: +385 1 6641 830
Zentiva, k.s.
Tel: +353 766 803 944
ZENTIVA S.A.
Tel: +4 021 304 7597
Zentiva, k.s.
Tel: +386 360 00 408
Zentiva Denmark ApS Sími: +354 539 0650
Zentiva, a.s.
Tel: +421 2 3918 3010
Zentiva Italia S.r.l. Tel: +39-02-38598801
Zentiva Denmark ApS Puh/Tel: +358 942 598 648
Zentiva, k.s.
Τηλ: +357 240 30 144
Zentiva Denmark ApS Tel: +46 840 838 822
Zentiva, k.s.
Tel: +371 67893939
Zentiva, k.s.
Tel: +44 (0) 800 090 2408