Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg film-coatedtablets

USED FOR

Irbesartan/Hydrochlorothiazide Teva 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 Teva work together to lower blood pressure further than if either was given alone.

Irbesartan/Hydrochlorothiazide Teva is used in the treatment of high blood pressure in adults (essential hypertension), when treatment with irbesartan or hydrochlorothiazide alone did not provide adequate control of your blood pressure.

Do not takeIrbesartan/Hydrochlorothiazide Teva

• If you are allergic (hypersensitive) to irbesartan and hydrochlorothiazide, or any of the other ingredients of Irbesartan/Hydrochlorothiazide Teva or to medicines chemically related to sulfonamide (ask your doctor or pharmacist for further clarification).
• If you are more than 3 months pregnant (it is also better to avoid Irbesartan/Hydrochlorothiazide Teva in early pregnancy ? see pregnancy section).
• If you have severe liver or kidney problems.
• If you have difficulty in producing urine.
• If you have a condition which is associated with persistently high calcium or low potassium levels in your blood.

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

Take special care with Irbesartan/Hydrochlorothiazide Teva

Tell your doctor if any of the following apply to you:

• If you get excessive diarrhoea or vomiting.
• If you suffer from kidney problems, including kidney transplantation.
• 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 your 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 Teva 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 Teva).
• 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 to have an operation (surgery) or be given anaesthetics

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/Hydrochlorothiaizde Teva may have an effect on other medicines. Preparations containing lithium should not be taken with Irbesartan/Hydrochlorothiaizde Teva 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.

TakingIrbesartan/Hydrochlorothiazide Teva with food and drink
Irbesartan/Hydrochlorothiazide Teva can be taken with or without food.

Due to the hydrochlorothiazide contained in Irbesartan/Hydrochlorothiazide Teva, 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 Teva 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 Teva. Irbesartan/Hydrochlorothiazide Teva 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 Teva 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.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
No studies on the effects on the ability to drive and use machines have been performed. Irbesartan/Hydrochlorothiazide Teva 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 Irbesartan/Hydrochlorothiazide Teva 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 Teva is one or two tablets a day. Irbesartan/Hydrochlorothiazide Teva will usually be prescribed by your doctor when your previous treatment for high blood pressure did not provide appropriate blood pressure reduction. Your doctor will instruct you how to switch from the previous treatment to Irbesartan/Hydrochlorothiazide Teva.

Method of administration

Irbesartan/Hydrochlorothiazide Teva is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water). You can take Irbesartan/Hydrochlorothiazide Teva 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 Teva 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 Teva than you should
If you accidentally take too many tablets, contact your doctor immediately.

Children should not takeIrbesartan/Hydrochlorothiazide Teva
Irbesartan/Hydrochlorothiazide Teva 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 Teva
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/Hydrochlorothiazide Teva 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/Hydrochlorothiazide Teva and contact your doctor immediately.

The frequency of the side effects listed below is defined using the following convention: Common: affects 1 to 10 users in 100
Uncommon: affects 1 to 10 users in 1,000
Not known: frequency cannot be estimated from the available data.

Side effects reported in clinical studies for patients treated with the combination of irbesartan and hydrochlorothiazide were:

• Common: nausea/vomiting, abnormal urination, fatigue and dizziness (including when getting up from a lying or sitting position) and 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).
• Uncommon: diarrhoea, low blood pressure, fainting, heart rate increased, flushing, swelling and sexual dysfunction (problems with sexual performance). Blood tests may show lowered levels of potassium and sodium in your blood.

Some undesirable effects have been reported since the marketing of the combination of irbesartan and hydrochlorothiazide but the frequency for them to occur 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. In patients taking irbesartan alone, in addition to the side effects listed above, chest pain has also been reported.

Additional side effects associated with the use of hydrochlorothiazide alone are: loss of appetite; stomach irritation; stomach cramps; constipation; jaundice seen as 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 get 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/Hydrochlorothiazide Teva after the expiry date that is stated on the outer carton or foil. The expiry date refers to the last day of that month.

For Irbesartan/Hydrochlorothiazide Teva packaged in white opaque PVC-PVdC - aluminium blisters: Do not store above 30°C.

For Irbesartan/Hydrochlorothiazide Teva packaged in aluminium ? aluminium blisters: This medicinal

product does not require any special storage conditions.

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/Hydrochlorothiazide Teva contains

• The active ingredients are irbesartan and hydrochlorothiazide. Each Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg film-coated tablet contains 300 mg irbesartan and 12.5 mg hydrochlorothiazide.
• The other ingredients are: Tablet core: povidone, pregelatinized starch (maize), poloxamer 188, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica and magnesium stearate. Tablet coating for 300 mg/12.5 mg strength: hypromellose, titanium dioxide, polyethylene glycol 6000 (macrogol), polyethylene glycol 400 (macrogol), iron oxide red, iron oxide yellow and iron oxide black.

What Irbesartan/Hydrochlorothiazide Teva looks like and contents of the pack

Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg film-coated tablets are light pink to pink, film coated capsule shaped tablets. One side of the tablet is debossed with the number "93" and the other side of the tablet is debossed with the number "7239".

Irbesartan/Hydrochlorothiazide Teva is available in pack sizes of 7, 14, 15, 20, 28, 30, 56, 60, 90, 98 and 100 film-coated tablets and perforated unit dose blister 50x1 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
Teva Pharma B.V.
Computerweg 10
3542 DR Utrecht
The Netherlands

Manufacturers:
TEVA Kutno SA
Sienkiewicza Str. 25
99-300 Kutno
Poland

Teva Pharmaceutical Works Private Limited Company
Pallagi út 13

Debrecen H-4042
Hungary

TEVA Pharmaceutical Works Private Limited Company

H-2100 Gödöllö

Táncsics Mihály út 82

Hungary

TEVA UK Ltd
Brampton Road
Hampden Park

Eastbourne, East Sussex

BN22 9AG UK

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

TEVA Santé SA

Rue Bellocier

89107 Sens

France

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

BelgiëBelgiqueBelgien Teva Pharma Belgium N.V.S.A. TelTél 32 3 820 73 73 LuxembourgLuxemburg Teva Pharma Belgium S.A. TélTel 32 3 820 73 73

Magyarország Teva Magyarország Zrt Tel. 36 1 288 64 00 Te 359 2 489 95 82

eská republika Teva Pharmaceuticals CR, s.r.o. Tel 420 251 007 111 Malta Teva .. el 30 210 72 79 099

Danmark Teva Denmark AS Tlf 45 44 98 55 11 Nederland Teva Nederland B.V. Tel 31 0 800 0228400

Deutschland Teva Generics GmbH Tel 49 351 834 0 Norge Teva Sweden AB Tlf 46 42 12 11 00

Österreich Teva Generics GmbH Tel 49 351 834 0 Eesti Teva Eesti esindus UAB Sicor Biotech Eesti filiaal Tel 372 611 2409

Teva .. Polska Teva Pharmaceuticals Polska Sp. z o.o.

30 210 72 79 099 Tel. 48 22 345 93 00

España Teva Genéricos Española, S.L.U Tél 34 91 387 32 80 Portugal Teva Pharma - Produtos Farmacêuticos Lda Tel 351 214 235 910

France Teva Santé Tél 33 1 55 91 7800 România Teva Pharmaceuticals S.R.L Tel 4021 230 65 24

Ireland Teva Pharmaceuticals Ireland Tel 353 042 9395 892 Slovenija Pliva Ljubljana d.o.o. Tel 386 1 58 90 390

Ísland Teva UK Limited Sími 44 1323 501 111. Italia Teva Italia S.r.l. Tel 39 0289179805 Slovenská republika Teva Pharmaceuticals Slovakia s.r.o. Tel 421 2 5726 7911 SuomiFinland Teva Sweden AB PuhTel 46 42 12 11 00

Teva .. 30 210 72 79 099 Sverige Teva Sweden AB Tel 46 42 12 11 00

Latvija UAB Sicor Biotech filile Latvij Tel 371 67 784 980 United Kingdom Teva UK Limited Tel 44 1323 501 111

Lietuva
UAB ?Sicor Biotech?
Tel: +370 5 266 02 03

This leaflet was last approved in {MM/YYYY}.