Irbesartan Winthrop 150 mg film-coated tablets

Irbesartan Winthrop 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 Winthrop prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. Irbesartan Winthrop slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes.

Irbesartan Winthrop is used
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.

Do not take Irbesartan Winthrop

if you are allergic (hypersensitive) to irbesartan or any other ingredients of Irbesartan Winthrop if you are more than 3 months pregnant. (It is also better to avoid Irbesartan Winthrop in early pregnancy ? see pregnancy section)

Irbesartan Winthrop should not be given to children and adolescents (under 18 years).

Take special care with Irbesartan Winthrop
Tell your doctor 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 Winthrop 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 are going to have an operation (surgery) or be given anaesthetics
You must tell your doctor if you think you are ( or might become) pregnant. Irbesartan Winthrop 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).

Using other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Irbesartan Winthrop does not usually interact with other medicines.

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

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

Taking Irbesartan Winthrop with food and drink

Irbesartan Winthrop 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 Winthrop before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Irbesartan Winthrop. Irbesartan Winthrop 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 Winthrop 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

No studies on the effects on the ability to drive and use machines have been performed. Irbesartan Winthrop 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.

Important information about some of the ingredients of Irbesartan Winthrop Irbesartan Winthrop contains lactose. If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicine.

Always take Irbesartan Winthrop exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Method of administration

Irbesartan Winthrop is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water). You can take Irbesartan Winthrop 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 Winthrop until your doctor tells you otherwise.

Patients with high blood pressure

The usual dose is 150 mg once a day. The dose may later be increased to 300 mg (two 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 (two 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.

If you take more Irbesartan Winthrop than you should:

If you accidentally take too many tablets, contact your doctor immediately.

Children should not take Irbesartan Winthrop

Irbesartan Winthrop should not be given to children under 18 years of age. If a child swallows some tablets, contact your doctor immediately.

If you forget to take Irbesartan Winthrop:

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 product, ask your doctor or pharmacist.

Like all medicines, Irbesartan Winthrop 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 Winthrop and contact your doctor immediately.

The frequency of the side effects listed below is defined using the following convention: Very common: at least 1 in 10 patients or more
Common: at least 1 in 100 and less than 1 in 10 patients
Uncommon: at least 1 in 1000 and less than 1 in 100 patients

Side effects reported in clinical studies for patients treated with Irbesartan Winthrop were: Very common: if you suffer from high blood pressure and type 2 diabetes with kidney disease, blood tests may show an increased level of potassium.

Common: 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: 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 Winthrop but the frequency for them to occur is not known. These undesirable effects are: headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, abnormal liver function, increased blood potassium levels, impaired kidney function, and inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis).

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not use Irbesartan Winthrop 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.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What Irbesartan Winthrop contains

The active substance is irbesartan. Each tablet of Irbesartan Winthrop 150 mg contains 150 mg irbesartan.
The other ingredients are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, silicon dioxide, magnesium stearate, titanium dioxide, macrogol 3000, carnauba wax.

What Irbesartan Winthrop looks like and contents of the pack

Irbesartan Winthrop 150 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2872 engraved on the other side.

Irbesartan Winthrop 150 mg film-coated tablets are supplied in blister packs of 14, 28, 56, 84 or 98 film-coated tablets. Unidose blister packs of 56 x 1 film-coated tablet for delivery in hospitals are also available.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

SANOFI PHARMA BRISTOL-MYERS SQUIBB SNC
174 avenue de France
F-75013 Paris - France

Manufacturer:

SANOFI WINTHROP INDUSTRIE
1, rue de la Vierge
Ambarès & Lagrave
F-33565 Carbon Blanc Cedex - France

SANOFI SYNTHELABO LIMITED
Edgefield Avenue - Fawdon
Newcastle Upon Tyne, Tyne & Wear NE3 3TT - United Kingdom

SANOFI WINTHROP INDUSTRIE
30-36 Avenue Gustave Eiffel, BP 7166
F-37071 Tours Cedex 2 - France

CHINOIN PRIVATE CO. LTD.
Lévai u.5.
2112 Veresegyház - Hungary

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

BelgiëBelgiqueBelgien sanofi-aventis Belgium TélTel 32 02 710 54 00 LuxembourgLuxemburg sanofi-aventis Belgium TélTel 32 02 710 54 00 BelgiqueBelgien

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Lietuva

UAB sanofi-aventis Lietuva
Tel: +370 5 2755224

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