What is it and how is it used?

IS USED FOR

Irbesartan Hydrochlorothiazide Winthrop is a combination of two active substances, irbesartan and hydrochlorothiazide.
Irbesartan belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body that binds to receptors in blood vessels causing them to tighten. This results in an increase in blood pressure. Irbesartan prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. Hydrochlorothiazide is one of a group of medicines (called thiazide diuretics) that causes increased urine output and so causes a lowering of blood pressure.
The two active ingredients in Irbesartan Hydrochlorothiazide Winthrop work together to lower blood pressure further than if either was given alone.

Irbesartan Hydrochlorothiazide Winthrop is used to treat high blood pressure, when treatment with irbesartan or hydrochlorothiazide alone did not provide adequate control of your blood pressure.

Table of Contents
What do you have to consider before using it?
How is it used?
What are possible side effects?
How should it be stored?
Further information

What do you have to consider before using it?

Do not take Irbesartan Hydrochlorothiazide Winthrop

if you are allergic (hypersensitive) to irbesartan or any of the other ingredients of Irbesartan Hydrochlorothiazide Winthrop
if you are allergic (hypersensitive) to hydrochlorothiazide or any other sulfonamide-derived medicines
if you are more than 3 months pregnant. (It is also better to avoid Irbesartan Hydrochlorothiazide Winthrop in early pregnancy ? see pregnancy section) if you have severe liver or kidney problems
if you have difficulty in producing urine
if your doctor determines that you have persistently high calcium or low potassium levels in your blood

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

Take special care with Irbesartan Hydrochlorothiazide 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 or have a kidney transplant
if you suffer from heart problems
if you suffer from liver problems
if you suffer from diabetes
if you suffer from lupus erythematosus (also known as lupus or SLE)
if you suffer from primary aldosteronism (a condition related to high production of the hormone aldosterone, which causes sodium retention and, in turn, an increase in blood pressure).

You must tell your doctor if you think you are ( or might become) pregnant. Irbesartan Hydrochlorothiazide 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).

You should also tell your doctor:

if you are on a low-salt diet
if you have signs such as abnormal thirst, dry mouth, general weakness, drowsiness, muscle pain or cramps, nausea, vomiting, or an abnormally fast heart beat which may indicate an excessive effect of hydrochlorothiazide (contained in Irbesartan Hydrochlorothiazide Winthrop) if you experience an increased sensitivity of the skin to the sun with symptoms of sunburn (such as redness, itching, swelling, blistering) occurring more quickly than normal if you are going tohave an operation (surgery) or be given anaesthetics

The hydrochlorothiazide contained in this medicine could produce a positive result in an anti-doping test.

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.

Diuretic agents such as the hydrochlorothiazide contained in Irbesartan Hydrochlorothiazide Winthrop may have an effect on other medicines. Preparations containing lithium should not be taken with Irbesartan Hydrochlorothiazide Winthrop without close supervision by your doctor.

You may need to have blood checks if you take:

potassium supplements
salt substitutes containing potassium
potassium sparing medicines or other diuretics (water tablets)
some laxatives
medicines for the treatment of gout
therapeutic vitamin D supplements
medicines to control heart rhythm
medicines for diabetes (oral agents or insulins)

It is also important to tell your doctor if you are taking other medicines to reduce your blood pressure, steroids, medicines to treat cancer, pain killers, arthritis medicines, or colestyramine and colestipol resins for lowering blood cholesterol.

Taking Irbesartan Hydrochlorothiazide Winthrop with food and drink

Irbesartan Hydrochlorothiazide Winthrop can be taken with or without food.

Due to the hydrochlorothiazide contained in Irbesartan Hydrochlorothiazide Winthrop, if you drink alcohol while on treatment with this medicine, you may have an increased feeling of dizziness on standing up, specially when getting up from a sitting position.

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 Hydrochlorothiazide 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 Hydrochlorothiazide Winthrop. Irbesartan Hydrochlorothiazide 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 Hydrochlorothiazide 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 Hydrochlorothiazide 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 Hydrochlorothiazide Winthrop
Irbesartan Hydrochlorothiazide 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.

How is it used?

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

Dosage

The usual dose of Irbesartan Hydrochlorothiazide Winthrop is one tablet a day. Irbesartan Hydrochlorothiazide Winthrop will usually be prescribed by your doctor when your previous treatment did not reduce your blood pressure enough. Your doctor will instruct you how to switch from the previous treatment to Irbesartan Hydrochlorothiazide Winthrop.

Method of administration

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

The maximal blood pressure lowering effect should be reached 6-8 weeks after beginning treatment.

If you take more Irbesartan Hydrochlorothiazide Winthrop than you should

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

Children should not take Irbesartan Hydrochlorothiazide Winthrop

Irbesartan Hydrochlorothiazide 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 Hydrochlorothiazide 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.

What are possible side effects?

Like all medicines, Irbesartan Hydrochlorothiazide Winthrop can cause side effects, although not everybody gets them.
Some of these effects may be serious and may require medical attention.

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 the above symptoms or get short of breath, stop taking Irbesartan Hydrochlorothiazide Winthrop and contact your doctor immediately.

Side effects reported in clinical studies for patients treated with Irbesartan Hydrochlorothiazide Winthrop were:

Common side effects(affect 1 to 10 users in 100)nausea/vomiting
abnormal urination
fatigue
dizziness (including when getting up from a lying or sitting position)
blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase) or raised levels of substances that measure kidney function (blood urea nitrogen, creatinine).
If any of these side effects causes you problems, talk to your doctor.

Uncommon side effects(affect 1 to 10 users in 1,000)
diarrhoea
low blood pressure
fainting
heart rate increased
flushing
swelling
sexual dysfunction (problems with sexual performance)
blood tests may show lowered levels of potassium and sodium in your blood. If any of these side effects causes you problems, talk to your doctor.

Side effects reported since the launch of Irbesartan Hydrochlorothiazide Winthrop The frequency of these effects is not known. These undesirable effects are: headache, ringing in the ears, cough, taste disturbance, indigestion, pain in joints and muscles, liver function abnormal and impaired kidney function, increased level of potassium in your blood and allergic reactions such as rash, hives, swelling of the face, lips, mouth, tongue or throat.

As for any combination of two active substances, side effects associated with each individual component cannot be excluded.
Side effects associated with irbesartan alone
In addition to the side effects listed above, chest pain has also been reported.
Side effects associated with hydrochlorothiazide alone
Loss of appetite; stomach irritation; stomach cramps; constipation; jaundice (yellowing of the skin and/or whites of the eyes); inflammation of the pancreas characterised by severe upper stomach pain, often with nausea and vomiting; sleep disorders; depression; blurred vision; lack of white blood cells, which can result in frequent infections, fever; decrease in the number of platelets (a blood cell essential for the clotting of the blood), decreased number of red blood cells (anaemia) characterised by tiredness, headaches, being short of breath when exercising, dizziness and looking pale; kidney disease; lung problems including pneumonia or build-up of fluid in the lungs; increased sensitivity of the skin to the sun; inflammation of blood vessels; a skin disease characterized by the peeling of the skin all over the body; cutaneous lupus erythematosus, which is identified by a rash that may appear on the face, neck, and scalp; allergic reactions; weakness and muscle spasm; altered heart rate; reduced blood pressure after a change in body position; swelling of the salivary glands; high sugar levels in the blood; sugar in the urine; increases in some kinds of blood fat; high uric acid levels in the blood, which may cause gout.

It is known that side effects associated with hydrochlorothiazide may increase with higher doses of hydrochlorothiazide.

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.

How should it be stored?

Keep out of the reach and sight of children.

Do not use Irbesartan Hydrochlorothiazide 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.

Store in the original package in order to protect from moisture.

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.

Further information

What Irbesartan Hydrochlorothiazide Winthrop contains

The active substances are irbesartan and hydrochlorothiazide. Each film-coated tablet of Irbesartan Hydrochlorothiazide Winthrop 300 mg/12.5 mg contains 300 mg irbesartan and 12.5 mg hydrochlorothiazide.
The other ingredients are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, silicon dioxide, magnesium stearate, titanium dioxide, macrogol 3000, red and yellow ferric oxides, carnauba wax.

What Irbesartan Hydrochlorothiazide Winthrop looks like and contents of the pack Irbesartan Hydrochlorothiazide Winthrop 300 mg/12.5 mg film-coated tablets are peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2876 engraved on the other side.

Irbesartan Hydrochlorothiazide Winthrop 300 mg/12.5 mg film-coated tablets are supplied in blister packs of 14, 28, 56, 84 or 98 film-coated tablets. Unit dose 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

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

SANOFI WINTHROP INDUSTRIE
30-36 Avenue Gustave Eiffel
37100 Tours - France

For any information about this medicine, 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

sanofi-aventis Bulgaria EOOD . 359 02 970 53 00 Magyarország sanofi-aventis zrt., Magyarország Tel. 36 1 505 0050

eská republika sanofi-aventis, s.r.o. Tel 420 233 086 111 Malta sanofi-aventis Malta Ltd. Tel 356 21493022

Danmark sanofi-aventis Denmark AS Tlf 45 45 16 70 00 Nederland sanofi-aventis Netherlands B.V. Tel 31 0182 557 755

Deutschland Winthrop Arzneimittel GmbH Tel. 490180 20 200 10 Norge sanofi-aventis Norge AS Tlf 47 67 10 71 00

Eesti sanofi-aventis Estonia OÜ Tel 372 627 34 88 Österreich sanofi-aventis GmbH Tel 43 1 80 185 0

sanofi-aventis AEBE 30 210 900 16 00 Polska sanofi-aventis Sp. z o.o. Tel. 48 22 280 00 00

España sanofi-aventis, S.A. Tel 34 93 485 94 00 Portugal sanofi-aventis - Produtos Farmacêuticos, S.A. Tel 351 21 35 89 400

România sanofi-aventis România S.R.L. Tel 40 0 21 317 31 36 France sanofi-aventis France Tél 0 800 222 555 Appel depuis létranger 33 1 57 63 23 23

Ireland sanofi-aventis Ireland Ltd. Tel 353 0 1 403 56 00 Slovenija sanofi-aventis d.o.o. Tel 386 1 560 48 00

Ísland Vistor hf. Sími 354 535 7000 Slovenská republika sanofi-aventis Pharma Slovakia s.r.o. Tel 421 2 33 100 100

Italia sanofi-aventis S.p.A. Tel 39 02 393 91 SuomiFinland sanofi-aventis Oy PuhTel 358 0 201 200 300

sanofi-aventis Cyprus Ltd. 357 22 871600 Sverige sanofi-aventis AB Tel 46 08 634 50 00

Latvija sanofi-aventis Latvia SIA Tel 371 67 33 24 51 United Kingdom sanofi-aventis Tel 44 0 1483 505 515

Lietuva

UAB sanofi-aventis Lietuva
Tel: +370 5 2755224

This leaflet was last approved in

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