IRBESARTAN/HYDROCHLOROTHIAZIDE TEVA 150 MG/12.5 MG FILM-COATED TABLETS

2. What you need to know before you take 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 medicine belonging to the sulphonamide group.
• if you are more than 3 months pregnant (in any case, it is recommended to avoid taking this medicine during pregnancy – see section Pregnancy).
• if you have severe liver or kidney problems.
• if you have difficulty urinating.
• if your doctor detects that you have persistently high calcium or low potassium levels in your blood.
• if you have diabetes or kidney impairment and are being treated with a blood pressure 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 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 lupus erythematosus (also known as lupus or LES).
• if you have primary aldosteronism (a condition related to high production of the hormone aldosterone, leading to sodium retention and increased blood pressure).
• if you are taking any of the following medicines used to treat high blood pressure:

• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g. enalapril, lisinopril, ramipril), especially 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 skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure 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, think you may be pregnant, or are planning to become pregnant, inform your doctor.

Irbesartan/Hydrochlorothiazide Teva is not recommended during pregnancy and should not be taken after the third month of pregnancy as it may cause serious harm to your baby (see section Pregnancy).

You must also inform your doctor:

• if you are on a low-salt diet.
• if you experience any of the following signs: feeling thirsty, dry mouth, weakness, feeling sleepy, muscle cramps, nausea, vomiting, or rapid heartbeat, as these may indicate an excessive effect of hydrochlorothiazide (contained in Irbesartan/Hydrochlorothiazide Teva).
• if you experience increased sensitivity of your skin to the sun with symptoms of sunburn (such as redness, itching, swelling, blistering) that occurs more quickly than usual.
• if you are going to have surgery (including dental surgery) or if you are going to be given anaesthetics.
• if you experience changes in your vision or pain in one or both eyes when 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 taking Irbesartan/Hydrochlorothiazide Teva and seek medical attention.

The amount of hydrochlorothiazide in this medicine may cause positive results in doping tests.

Children and adolescents

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

In case a child swallows several tablets, contact your doctor immediately.

Using Irbesartan/Hydrochlorothiazide Teva with other medicines

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

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

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

Diuretics, such as hydrochlorothiazide contained in Irbesartan/Hydrochlorothiazide Teva, may have an effect on other medicines. You should not take preparations containing lithium together with Irbesartan/Hydrochlorothiazide Teva without the supervision of your doctor.

You may need to have a blood test if you take:

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

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

Taking Irbesartan/Hydrochlorothiazide Teva with alcohol

Due to the hydrochlorothiazide contained in Irbesartan/Hydrochlorothiazide Teva, if you drink alcohol while taking this medicine, you may have a greater feeling of dizziness when standing up, especially when getting up from a sitting or lying down position.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you are pregnant, think you may be pregnant, or are planning to 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 to treat your high blood pressure.

Irbesartan/Hydrochlorothiazide Teva is not recommended during pregnancy and should not be taken after the third month of pregnancy as it may cause serious harm to your baby.

Breastfeeding

Inform your doctor if you are going to start or are breastfeeding. Irbesartan/Hydrochlorothiazide Teva is not recommended for use during breastfeeding. Your doctor may decide to prescribe a different treatment if you want to breastfeed, especially if you are breastfeeding a newborn or premature baby.

Driving and using machines

Irbesartan/Hydrochlorothiazide Teva is unlikely to affect your ability to drive or use machines. However, during treatment of high blood pressure, dizziness or fatigue may occasionally occur. If you experience these symptoms, consult your doctor before driving or using machines.

Irbesartan/Hydrochlorothiazide Teva contains sodium

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

3. How to take Irbesartan/Hydrochlorothiazide Teva

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Dose

The recommended dose of Irbesartan/Hydrochlorothiazide Teva is one or two tablets a day. In general, your doctor will prescribe Irbesartan/Hydrochlorothiazide Teva when previous treatments you have received for high blood pressure have not provided adequate control of your blood pressure. Your doctor will tell you how to switch from your previous treatment to Irbesartan/Hydrochlorothiazide Teva.

Method of administration

Irbesartan/Hydrochlorothiazide Teva is taken orally. The tablets should be swallowed with a sufficient amount of liquid (e.g. a glass of water). You can 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 to take Irbesartan/Hydrochlorothiazide Teva until your doctor tells you to stop.

The maximum blood pressure-lowering effect should be achieved after 6-8 weeks of 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. Telephone 91 562 04 20, or go to the Emergency Department of the nearest hospital.

If you forget to take Irbesartan/Hydrochlorothiazide Teva

If you accidentally miss a dose, simply take your normal dose when it is due. Do not take a double dose to make up for a forgotten dose.

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

4. Possible side effects

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

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

The side effects reported in clinical studies for patients treated with Irbesartan/Hydrochlorothiazide Teva were:

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

• nausea/vomiting
• urination abnormalities
• fatigue
• dizziness (including dizziness when 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 (urea, creatinine in the blood).

If any of these side effects get serious, talk to your doctor.

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

• diarrhoea
• low blood pressure
• fainting
• rapid heartbeat
• flushing
• swelling due to fluid retention (oedema)
• sexual dysfunction (impotence)
• blood tests may show low sodium and potassium levels in the blood.

If any of these side effects get serious, talk to your doctor.

Some side effects have been reported since the marketing of Irbesartan/Hydrochlorothiazide Teva, but the frequency of these is unknown. The side effects of unknown frequency are: headache, ringing in the ears, cough, altered taste, indigestion, muscle and joint pain, liver function disorders, and kidney failure, high potassium levels in the blood, and allergic reactions such as skin 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 combinations of two active substances, it cannot be excluded that side effects associated with each of the individual substances may occur.

Side effects associated with irbesartan:

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

Side effects associated with hydrochlorothiazide in monotherapy are:

Lack of appetite; stomach upset; stomach cramps; constipation; jaundice (yellowing of the skin and/or whites of the eyes); pancreatitis characterized by severe upper stomach pain, often with nausea and vomiting; sleep disorders; depression; blurred vision; decreased vision or eye pain due to increased pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or glaucoma]; low white blood cell count, which can lead to frequent infections, fever; decreased platelet count (a blood cell essential for blood clotting), decreased red blood cell count (anaemia) characterized by tiredness, headaches, shortness of breath when exercising, dizziness, and paleness; kidney disease; lung disorders including pneumonia or fluid accumulation in the lungs; increased sensitivity of the skin to the sun; blood vessel inflammation; a skin disease characterized by peeling of the skin all over the body; cutaneous lupus erythematosus, which is identified by a rash that can appear on the face, neck, and scalp; allergic reactions; weakness and muscle spasms; irregular heartbeat; low blood pressure after changing body position; swelling of the salivary glands; high blood sugar levels; sugar in the urine; increased levels of certain fats in the blood; high uric acid levels in the blood, which can cause gout.

Frequency “not known”: skin and lip cancer (non-melanoma skin cancer).

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

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side 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 which is stated on the carton and blister after EXP. The expiry date refers to the last day of the month shown.

Irbesartan/Hydrochlorothiazide Teva packaged in PVC/PVdC/Aluminium white opaque blisters: do not store above 30°C.

Irbesartan/Hydrochlorothiazide Teva packaged in aluminium-aluminium blisters: this medicine 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 protect the environment.

6. Package Contents and Additional Information

Composition of Irbesartan/Hydrochlorothiazide Teva

• The active ingredients are irbesartan and hydrochlorothiazide.

Each film-coated tablet of Irbesartan/Hydrochlorothiazide Teva 150 mg/12.5 mg contains 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide.

• The other ingredients are:

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

Tablet coating for the 150 mg/12.5 mg dose: 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 Package Contents

Irbesartan/Hydrochlorothiazide Teva 150 mg/12.5 mg are film-coated tablets, pale red to red in color, and capsule-shaped. One side of the tablet is marked with the number "93" and the other side of the tablet is marked with the number "7238".

Irbesartan/Hydrochlorothiazide is available in the following formats: 7, 14, 15, 20, 28, 30, 56, 60, 84, 90, 98, and 100 film-coated tablets in non-perforated blisters: packages of 50x1 film-coated tablet in unit-dose blisters and packages of 28 film-coated tablets in non-perforated calendar blisters.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Teva B.V.

Swensweg 5

2031GA Haarlem

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

Netherlands

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet:

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