Irbesartan/hydrochlorothiazide Teva 300 mg/25 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Irbesartán/Hydrochlorothiazide Teva 300mg/25mg film-coated tablets EFG

irbesartan / hydrochlorothiazide

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

• Keep this leaflet as 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, since it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are 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 constrict. This leads to an increase in blood pressure. Irbesartan prevents angiotensin-II from binding to these receptors, relaxing blood vessels and thereby lowering blood pressure. Hydrochlorothiazide belongs to a group of medicines (called thiazide diuretics) that reduce 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 either irbesartan or hydrochlorothiazide alone does not provide adequate control of blood pressure.

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

Do not take Irbesartan/Hydrochlorothiazide Teva

• if you are allergic to irbesartan or to 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 Pregnancy section)
• 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 an antihypertensive medicine containing aliskiren.

Warnings and precautions

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

• if you have excessive vomiting or 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 related to excessive production of the hormone aldosterone, causing sodium retention and consequently increased blood pressure)

• if you are taking any of the following medicines for 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 cancer 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 serious harm to your baby (see Pregnancy section).

You should also tell your doctor:

• if you are on a low-salt diet
• if you experience any of the following symptoms: feeling thirsty, dry mouth, general 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 develop increased skin sensitivity to sunlight with symptoms of sunburn (such as redness, itching, swelling, blisters) occurring more quickly than usual
• if you are going to have surgery or will be receiving 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 the eyes. You should stop treatment with Irbesartan/Hydrochlorothiazide Teva and seek medical help immediately.

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

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

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take 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 medicines to lower blood pressure, steroids, cancer treatments, painkillers, medicines for arthritis, or cholestyramine or colestipol resins to reduce 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 likelihood of dizziness when standing up, 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 usually advise you to stop taking Irbesartan/Hydrochlorothiazide Teva before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative antihypertensive medicine. Irbesartan/Hydrochlorothiazide Teva is not recommended during pregnancy and must not be administered from the third month of pregnancy onwards, as it may cause serious harm to your baby when used from that stage.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to breastfeed, as Irbesartan/Hydrochlorothiazide Teva is not recommended for women during this period. Your doctor may decide to prescribe a treatment more suitable for breastfeeding, 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 operating machinery.

Irbesartan/Hydrochlorothiazide Teva contains sodium

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

3. How to take Irbesartan/Hydrochlorothiazide Teva

Follow exactly the instructions given by your doctor for taking this medicine. 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.

Administration method

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.

The 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 at telephone 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 the missed dose.

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 experiences 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 difficulty breathing, stop taking Irbesartan/Hydrochlorothiazide Teva and contact your doctor immediately.

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

Frequent 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
• tachycardia
• flushing
• swelling due to fluid retention (oedema)
• sexual dysfunction (disturbances 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 (ringing in the ears), cough, taste disturbances, 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 medicinal products, 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 are:

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]; lack of white blood cells, 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 during exertion, dizziness and pallor; 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 disorder 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; weakness and muscle cramps; 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; elevated levels of uric acid in the blood, which may cause gout.

Frequency “not known”: 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 type of 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 carton and on the blister after EXP. The expiry date refers to the last day of the month indicated.

Irbesartan/Hydrochlorothiazide Teva in PVC/PVdC/White opaque aluminium blisters: do not store above 30°C.

Irbesartan/Hydrochlorothiazide Teva in aluminium-aluminium blisters: this medicine requires no special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging 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/25 mg contains 300 mg of irbesartan and 25 mg of hydrochlorothiazide.

• The other components are:

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

Film coating for the 300 mg/25 mg strength: hypromellose, titanium dioxide, polyethylene glycol 6000 (macrogol), polyethylene glycol 400 (macrogol), red iron oxide, indigotine (aluminium lake of indigo carmine FD&C Blue #2), and black iron oxide.

Nature of the medicine and pack contents

Irbesartan/Hydrochlorothiazide Teva 300 mg/25 mg are film-coated tablets, pink to dark pink in colour and capsule-shaped. One side of the tablet is marked with the number “93”. The other side is marked with the number “7469”.

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; packs of 50x1 film-coated tablet in single-dose blisters and packs of 28 film-coated tablets in non-perforated calendar blisters.

Only certain pack sizes may be commercially available.

Marketing Authorization 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 medicinal product, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

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