Package leaflet: Information for the patient

Irbesartan/Hydrochlorothiazide 150 mg/12.5 mg film-coated tablets Irbesartan/Hydrochlorothiazide 300 mg/12.5 mg film-coated tablets Irbesartan/Hydrochlorothiazide 300 mg/25 mg film-coated tablets

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.

• Ifyouhave any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

What is in this leaflet

1.    What Irbesartan/Hydrochlorothiazide is and what it is used for

2.    What you need to know before you take Irbesartan/Hydrochlorothiazide

3.    How to take Irbesartan/Hydrochlorothiazide

4.    Possible side effects

5.    How to store Irbesartan/Hydrochlorothiazide

6.    Contents of the pack and other information

1.    What Irbesartan/Hydrochlorothiazide is and what it is used for

Irbesartan/Hydrochlorothiazide 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 increases the amount of water you lose in your urine and so causes a lowering of blood pressure.

The two active ingredients in Irbesartan/Hydrochlorothiazide work together to lower blood pressure further than if either was given alone.

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

2.    What you need to know before you take Irbesartan/Hydrochlorothiazide Do not take Irbesartan/Hydrochlorothiazide

•    if you are allergic to irbesartan or to hydrochlorothiazide or to any of the other ingredients of this medicine (listed in section 6)

• if you are allergic to any other sulfonamide-derived medicines

•    if you are more than 3 months pregnant. (It is also better to avoid Irbesartan/Hydrochlorothiazide in early pregnancy - see “Pregnancy and breastfeeding” 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

•    if you have diabetes mellitus or impaired kidney function and you are treated with aliskiren (another medicine to treat high blood pressure)

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

Warnings and precautions

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 had 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 bloodpressure)

•    ifyouare taking aliskiren.

You must tell your doctor if you think you are (or might become) pregnant. Irbesartan/Hydrochlorothiazide 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 and breast-feeding” section).

You should also tell your doctor:

•    ifyouareona low-saltdiet

•    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)

•    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

•    if you have changes in your vision or pain in one or both of your eyes while taking Irbesartan/Hydrochlorothiazide. This could be a sign that you are developing glaucoma, increased pressure in your eye(s). You should discontinue Irbesartan/Hydrochlorothiazide treatment and seek medical attention (see section 4 “Possible side effects”).

Children and adolescents

Irbesartan/Hydrochlorothiazide should not be given to children and adolescents (under 18 years). Ifachild swallows some tablets, contact your doctor immediately.

Other medicines and Irbesartan/Hydrochlorothiazide

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Diuretic agents such as the hydrochlorothiazide contained in Irbesartan/ Hydrochlorothiazide may have an effect on other medicines. Preparations containing lithium should not be taken with Irbesartan/Hydrochlorothiazide 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)

•    carbamazepine (a medicine for the treatment of epilepsy).

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.

Irbesartan/Hydrochlorothiazide with food, drink and alcohol

Irbesartan/Hydrochlorothiazide can be taken with or without food.

Due to the hydrochlorothiazide contained in Irbesartan/Hydrochlorothiazide, 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 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. Irbesartan/Hydrochlorothiazide 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 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 is unlikely to affect your ability to drive or use machines. However, occasionally dizziness or tiredness may occur during treatment of high blood pressure. If you experience these, talk to your doctor before attempting to drive or use machines.

Irbesartan/Hydrochlorothiazide 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.

3. How to take Irbesartan/Hydrochlorothiazide

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Dosage

The recommended dose of Irbesartan/Hydrochlorothiazide is one (150/12.5 mg, 300/12.5 mg or 300/25 mg) or two (150/12.5 mg) tablets a day. Irbesartan/Hydrochlorothiazide will usually be prescribed by your doctor when your previous treatment did not reduce your bloodpressure enough.

Your doctor will instruct you how to switch from the previous treatment to Irbesartan/Hydrochlorothiazide.

Method ofadministration

Irbesartan/Hydrochlorothiazide is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water). You can take Irbesartan/Hydrochlorothiazide with or without food. Try to take your daily dose at about the same time each day.

Duration of treatment

It is important that you continue to take Irbesartan/Hydrochlorothiazide until your doctor tells youotherwise.

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

Use in children and adolescents

Irbesartan/Hydrochlorothiazide should not be given to children under 18 years of age. If a child swallows some tablets, contact your doctor immediately.

If you take more Irbesartan/Hydrochlorothiazide than you should

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

If you forget to take Irbesartan/Hydrochlorothiazide

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 medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, althoughnot 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/ortongue have beenreported in patients taking irbesartan.

If you get any of these symptoms, or get short of breath, stop taking Irbesartan/Hydrochlorothiazide and contact your doctor immediately.

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

Common (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).

Uncommon (affect 1 to 10 users in 1,000)

•    diarrhoea

•    lowbloodpressure

•    fainting

•    increased heart rate

•    flushing

•    swelling

•    sexual dysfunction (problems with sexual performance)

• blood tests may show lowered levels of potassium and sodium in your blood.

Side effects reported since the launch of Irbesartan/Hydrochlorothiazide

Some undesirable effects have been reported since marketing of Irbesartan/Hydrochlorothiazide. Undesirable effects where the frequency is not known 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. Uncommon cases of jaundice (yellowing of the skin and/or whites ofthe eyes) have also beenreported.

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 ofthe eyes); acute shortsightedness; acute increased pressure in the eye leading to a decreased vision; 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 ofthe 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 ofhydrochlorothiazide.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Irbesartan/Hydrochlorothiazide

Keep this medicine out ofthe sight and reach of children.

Do not use this medicine 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 25°C.

Do not throw away any medicines via wastewater or household waste.Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.    Contents of the pack and other information

What Irbesartan/Hydrochlorothiazide contains

•    The active substances are irbesartan and hydrochlorothiazide.

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

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

Each film-coated tablet of Irbesartan/Hydrochlorothiazide 300 mg/25 mg contains 300 mg irbesartan and 25 mg hydrochlorothiazide.

•    The other ingredients are lactose monohydrate, microcrystalline cellulose (E460), pregelatinized starch, croscarmellose sodium, povidone, magnesium stearate (E572), hypromellose, titanium dioxide (E171), macrogol.

The 150/12.5 mg and 300/12.5 mg tablets also contain red and yellow ferric oxide (E172).

The 300/25 mg tablets also contain red and black ferric oxide (E172).

What Irbesartan/Hydrochlorothiazide looks like and contents of the pack

Irbesartan/Hydrochlorothiazide 150 mg/12.5 mg film-coated tablets are peach coloured, biconvex, oval shaped film-coated tablets of 13.7 mm, debossed with '450'on one side and plain on the other side.

Irbesartan/Hydrochlorothiazide 300 mg/12.5 mg film-coated tablets are peach coloured, biconvex, oval shaped film-coated tablets of 17.3 mm, debossed with '451'on one side and plain on the other side.

Irbesartan/Hydrochlorothiazide 300 mg/25 mg film-coated tablets are dark pink coloured, biconvex, oval shaped film-coated tablets of 17.3 mm, debossed with '452'on one side and plain on the other side.

Irbesartan/Hydrochlorothiazide film-coated tablets are supplied in blister packs of 14, 28, 30, 56,84,90 or 98 film-coated tablets.

Not all pack sizes may be marketed.

MarketingAuthorisation Holder and Manufacturer MarketingAuthorisation Holder

Jubilant Pharmaceuticals nv Axxes Business Park Guldensporenpark 22 - Block C 9820 Merelbeke Belgium

Manufacturer

PSI supply nv Axxes Business Park Guldensporenpark 22 - Block C 9820 Merelbeke Belgium

This leaflet was last revised in 10/2013.