Irbesartan/hydrochlorothiazide Teva 300 mg/12.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Irbesartán/Hydrochlorothiazide Teva 300 mg/12.5 mg film-coated tablets EFG

irbesartan / hydrochlorothiazide

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Irbesartán/Hydrochlorothiazide Teva is and what it is used for
2. What you need to know before taking Irbesartán/Hydrochlorothiazide Teva
3. How to take Irbesartán/Hydrochlorothiazide Teva
4. Possible side effects
5. How to store Irbesartán/Hydrochlorothiazide Teva
6. Contents of the pack and other information

1. What Irbesartan/Hydrochlorothiazide Teva is and what it is 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 contract. This leads to an increase in blood pressure. Irbesartan blocks angiotensin-II from binding to these receptors, relaxing the blood vessels and thereby reducing blood pressure. Hydrochlorothiazide belongs to a group of medicines (called thiazide diuretics) that lower blood pressure by increasing the amount of urine produced.

The two active substances in Irbesartan/Hydrochlorothiazide work together to achieve a greater reduction in blood pressure than either substance alone.

Irbesartan/Hydrochlorothiazide Teva is used to treat high blood pressure when treatment with irbesartan or hydrochlorothiazide alone does not provide adequate blood pressure control.

2. What you need to know before taking Irbesartan/Hydrochlorothiazide Teva

Do not take Irbesartan/Hydrochlorothiazide Teva

• if you are allergic to irbesartan or any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to hydrochlorothiazide or to any other sulfonamide-derived medicine
• if you are more than 3 months pregnant (in any case, it is better to avoid taking this medicine also during early pregnancy – see section Pregnancy)
• if you have severe liver or kidney problems
• if you have difficulty passing urine
• if your doctor finds that you have persistently high levels of calcium or low levels of potassium in your blood
• if you have diabetes or renal impairment and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Consult your doctor before starting to take Irbesartan/Hydrochlorothiazide Teva and in any of the following cases:

• if you have vomiting or excessive diarrhoea

• if you have kidney problems or have had a kidney transplant

• if you have heart problems

• if you have liver problems

• if you have diabetes

• if you have systemic lupus erythematosus (also known as lupus or SLE)

• if you have primary hyperaldosteronism (a condition involving excessive production of the hormone aldosterone, leading to sodium retention and consequently increased blood pressure)

• if you are taking any of the following medicines used to treat high blood pressure (hypertension):

• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes

• aliskiren

  • if you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use at high doses, may increase the risk of certain types of non-melanoma skin and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking Irbesartan/Hydrochlorothiazide Teva.

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals.

See also the information under the heading “Do not take Irbesartan/Hydrochlorothiazide Teva”.

If you are pregnant, suspect you may be pregnant, or plan to become pregnant, you must inform your doctor.

Use of Irbesartan/Hydrochlorothiazide Teva is not recommended during early pregnancy and must not be used from the third month of pregnancy onwards, as it may cause severe harm to your baby (see section Pregnancy).

You should also inform your doctor:

• if you are on a low-salt diet
• if you experience any of the following symptoms: feeling thirsty, dry mouth, generalised weakness, drowsiness, muscle pain or cramps, nausea, vomiting, or rapid heartbeat, as these may indicate an excessive effect of hydrochlorothiazide (contained in Irbesartan/Hydrochlorothiazide Teva)
• if you experience increased skin sensitivity to sunlight with symptoms of sunburn (such as redness, itching, swelling, blisters) occurring more quickly than usual
• if you are scheduled for surgery or will receive anaesthetics
• if you experience changes in vision or pain in one or both eyes while taking Irbesartan/Hydrochlorothiazide Teva. This could be a sign of fluid accumulation in the vascular layer of the eye (choroidal effusion) or development of glaucoma, increased pressure in your eyes. You should stop treatment with Irbesartan/Hydrochlorothiazide Teva and seek medical attention.

The amount of hydrochlorothiazide contained in this medicine may lead to positive doping test results.

Children and adolescents

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

If a child accidentally swallows several tablets, contact your doctor immediately.

Taking Irbesartan/Hydrochlorothiazide Teva with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

Your doctor may need to adjust your dose and/or take other precautions:

If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also information under the headings “Do not take Irbesartan/Hydrochlorothiazide Teva” and “Warnings and precautions”).

Diuretics such as hydrochlorothiazide contained in Irbesartan/Hydrochlorothiazide Teva may interact with other medicines. You must not take lithium-containing preparations together with Irbesartan/Hydrochlorothiazide Teva without medical supervision.

You may need to have blood tests if you are taking:

• potassium supplements
• salt substitutes containing potassium
• potassium-sparing medicines or other diuretics (tablets that increase urine production)
• certain laxatives
• medicines used to treat gout
• vitamin D supplements
• medicines to control heart rhythm
• medicines for diabetes (oral agents or insulin)
• carbamazepine (a medicine used to treat epilepsy)

It is also important to inform your doctor if you are taking other blood pressure-lowering medicines, steroids, cancer treatments, painkillers, arthritis medicines, or cholestyramine or colestipol resins to lower blood cholesterol.

Taking Irbesartan/Hydrochlorothiazide Teva with alcohol

Due to the hydrochlorothiazide contained in Irbesartan/Hydrochlorothiazide Teva, drinking alcohol while taking this medicine may increase the sensation of dizziness upon standing, especially when rising from a sitting position.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you are pregnant, suspect you may be pregnant, or plan to become pregnant. Your doctor will generally advise you to stop taking Irbesartan/Hydrochlorothiazide Teva before becoming pregnant or as soon as pregnancy occurs, and will recommend an alternative antihypertensive medicine. Use of Irbesartan/Hydrochlorothiazide Teva during pregnancy is not recommended, and it must not be used from the third month of pregnancy onwards, as it may cause severe harm to your baby when administered from that stage.

Breastfeeding

Inform your doctor if you are planning to breastfeed or are currently breastfeeding, as Irbesartan/Hydrochlorothiazide Teva is not recommended for women during this period. Your doctor may decide to prescribe a more suitable treatment if you intend to breastfeed, especially if the infant is a newborn or premature.

Driving and using machines

It is unlikely that Irbesartan/Hydrochlorothiazide Teva will affect your ability to drive or operate machinery. However, dizziness or fatigue may occasionally occur during antihypertensive treatment. If you experience these symptoms, speak with your doctor before driving or using machines.

Irbesartan/Hydrochlorothiazide Teva contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; this is essentially “sodium-free”.

3. How to take Irbesartan/Hydrochlorothiazide Teva

Follow exactly the instructions for using this medicine as given by your doctor. If you are unsure, consult your doctor or pharmacist again.

Dosage

The recommended dose of Irbesartan/Hydrochlorothiazide Teva is one tablet daily. Your doctor will generally prescribe Irbesartan/Hydrochlorothiazide Teva when previous treatments for high blood pressure have not provided adequate reduction in blood pressure. Your doctor will advise you on how to switch from previous treatments to Irbesartan/Hydrochlorothiazide Teva.

Method of administration

Irbesartan/Hydrochlorothiazide Teva is administered orally. The tablets should be swallowed with a sufficient amount of liquid (e.g. a glass of water). You may take Irbesartan/Hydrochlorothiazide Teva with or without food. Try to take your daily dose at the same time each day. It is important that you continue taking Irbesartan/Hydrochlorothiazide Teva unless your doctor advises otherwise.

Maximum blood pressure-lowering effect should be achieved within 6–8 weeks after starting treatment.

If you take more Irbesartan/Hydrochlorothiazide Teva than you should

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

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Phone number: 91 562 04 20, or go to the nearest hospital emergency department.

If you forget to take Irbesartan/Hydrochlorothiazide Teva

If you accidentally miss a dose, simply take your next dose at the usual time. Do not take a double dose to make up for forgotten doses.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. Some of these effects may be serious and may require immediate medical attention.

Rare cases of skin allergic reactions (rash, urticaria) have been reported in patients treated with irbesartan, as well as localized swelling of the face, lips and/or tongue. If you experience any of the above symptoms or have shortness of breath, stop taking Irbesartan/Hydrochlorothiazide Teva and contact your doctor immediately.

Adverse effects reported in clinical studies for patients treated with Irbesartan/Hydrochlorothiazide were:

Common adverse effects (may affect up to 1 in 10 people):

• nausea/vomiting
• abnormalities in urination
• fatigue
• dizziness (including dizziness upon standing up from a lying or sitting position)
• blood tests may show elevated levels of an enzyme that measures muscle and heart function (creatine kinase) or elevated levels of substances that measure kidney function (blood urea nitrogen, creatinine).

If any of these adverse effects cause you problems, consult your doctor.

Uncommon adverse effects (may affect up to 1 in 100 people):

• diarrhoea
• low blood pressure
• fainting
• palpitations
• flushing
• swelling due to fluid retention (oedema)
• sexual dysfunction (alterations in sexual function)
• blood tests may show low levels of sodium and potassium in the blood.

If any of these adverse effects cause you problems, consult your doctor.

Some adverse effects have been reported since the marketing of Irbesartan/Hydrochlorothiazide Teva, but their frequency is unknown. Adverse effects with unknown frequency include: headache, tinnitus, cough, altered taste, indigestion, joint and muscle pain, liver function abnormalities and kidney failure, elevated levels of potassium in the blood, and allergic reactions such as rash, urticaria, swelling of the face, lips, mouth, tongue or throat. Rare cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been observed.

As with all fixed-combination medicines, adverse effects associated with each individual component cannot be excluded.

Adverse effects associated solely with irbesartan:

In addition to the adverse effects described above, chest pain, severe allergic reactions (anaphylactic shock), and reduced platelet count (a blood cell essential for blood clotting) have also been observed.

Adverse effects associated with hydrochlorothiazide in monotherapy:

Loss of appetite; stomach irritation; stomach cramps; constipation; jaundice (yellowing of the skin and/or whites of the eyes); inflammation of the pancreas characterized by severe upper abdominal pain, often with nausea and vomiting; sleep disorders; depression; blurred vision; visual disturbances or eye pain due to increased pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma]; low white blood cell count, which may lead to frequent infections and fever; reduced platelet count (blood cells essential for blood clotting), reduced red blood cell count (anaemia) characterized by tiredness, headaches, shortness of breath on exertion, dizziness and paleness; kidney disease; lung disorders including pneumonia or fluid accumulation in the lungs; increased sensitivity of the skin to sunlight; inflammation of blood vessels; a skin disease characterized by peeling of the skin over the entire body; cutaneous lupus erythematosus, identified by a rash that may appear on the face, neck and scalp; allergic reactions; muscle weakness and spasms; irregular heartbeat; drop in blood pressure after changing body position; swelling of the salivary glands; high blood sugar levels; sugar in the urine; increases in certain types of blood fats; high levels of uric acid in the blood, which may cause gout.

Frequency “unknown”: Skin and lip cancer (non-melanoma skin cancer)

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system detailed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Irbesartan/Hydrochlorothiazide Teva

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging and on the blister after EXP. The expiry date refers to the last day of the month indicated.

Irbesartan/Hydrochlorothiazide Teva in opaque white aluminium-aluminium blisters: no special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Irbesartan/Hydrochlorothiazide Teva

• The active substances are irbesartan and hydrochlorothiazide.

Each film-coated tablet of Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg contains 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide.

• The other components are:

Tablet core: povidone, pregelatinized starch (maize), poloxamer 188, microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, and magnesium stearate.

Tablet coating for the 300 mg/12.5 mg strength: hypromellose, titanium dioxide, polyethylene glycol 6000 (macrogol), polyethylene glycol 400 (macrogol), red iron oxide, yellow iron oxide, and black iron oxide.

Appearance of the product and pack contents

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

Irbesartan/Hydrochlorothiazide is available in pack sizes of: 7, 14, 15, 20, 28, 30, 56, 60, 84, 90, 98 and 100 film-coated tablets in non-perforated blisters; 50x1 film-coated tablet in single-dose blister packs; and 28 film-coated tablets in non-perforated calendar blister packs.

Only some pack sizes may be marketed.

Marketing Authorisation Holder

Teva B.V.

Swensweg 5

2031GA Haarlem

The Netherlands

Manufacturer:

Teva Operations Poland Sp. z o.o.

ul. Mogilska 80

31-546 Kraków

Poland

Teva Pharmaceutical Works Private Limited Company

Pallagi út 13

Debrecen H-4042

Hungary

TEVA UK Ltd

Brampton Road

Hampden Park

Eastbourne, East Sussex

BN22 9AG UK

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Date of the most recent review of this leaflet:

Detailed information on this medicine is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu/