Irbesartan Hydrochlorothiazide 150mg/12.5mg, 300mg/12.5mg and 300mg/25mg Film-coated Tablets

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 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. See section 4.

•    The full name of this product is Irbesartan Hydrochlorothiazide 150mg/12.5mg, 300mg/12.5mg and 300mg/25mg Film-coated Tablets but within the leaflet it will be referred to as Irbesartan Hydrochlorothiazide tablets.

What is in this leaflet:

T| What Irbesartan Hydrochlorothiazide tablets are and what they are used for What you need to know before you take How to take ^ Possible side effects How to store

Contents of the pack and other information

j What Irbesartan Hydrochlorothiazide tablets are and what they are used for

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

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

What you need to know before you take

Do not take Irbesartan Hydrochlorothiazide tablets if you

•    are allergic to irbesartan or hydrochlorothiazide, or any of the other ingredients of this medicine (listed in section 6), or to medicines chemically related to sulfonamide (ask your doctor or pharmacist for further clarification).

•    are more than 3 months pregnant. (It is also better to avoid Irbesartan Hydrochlorothiazide tablets in early pregnancy - see Warnings and precaution sand Pregnancy section).

•    have severe liver or kidney problems.

•    have difficulty in producing urine.

•    have a condition which is associated with persistently high calcium or low potassium levels in your blood.

•    have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren

Warnings and precautions

Talk to your doctor before using Irbesartan Hydrochlorothiazide tablets:

•    if you get excessive vomiting or diarrhoea

•    if you suffer from kidney problems, or have 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 blood pressure).

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

•    an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.

•    aliskiren.

Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.

See also information under the heading "Do not take Irbesartan Hydrochlorothiazide tablets”

You must tell your doctor if you think that you are (or might become) pregnant. Irbesartan Hydrochlorothiazide tablets 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

•    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 tablets)

•    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

•    are going to have an operation (surgery) or be given anaesthetics

•    have changes in your vision or pain in one or both of your eyes while taking Irbesartan Hydrochlorothiazide tablets. This could be a sign that you are developing glaucoma, increased pressure in your eye(s). You should discontinue Irbesartan Hydrochlorothiazide tablets treatment and seek medical attention.

Hydrochlorothiazide contained in this medicine could produce a positive result in an anti-doping test.

Children and adolescents

Irbesartan hydrochlorothiazide shoud not be given to children and adolescents ( under 18 years).

Other medicines and Irbesartan Hydrochlorothiazide tablets

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 tablets may have an effect on other medicines. Preparations containing lithium should not be taken with Irbesartan Hydrochlorothiazide tablets 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, colestyramine and colestipol resins to reduce cholesterol in your blood, nondepolarizing skeletal muscle relaxants (e.g. tubocurarine), anticholinergic agents (e.g. atropine, beperiden) or amantadine.

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

•    If you are taking an ACE-inhibitor or aliskiren (see also information under the headings "Do not take Irbesartan Hydrochlorothiazide tablets” and "Warnings and precautions”)

Irbesartan Hydrochlorothiazide tablets with food, drink and alcohol

Irbesartan Hydrochlorothiazide tablets can be taken with or without food.

Due to the hydrochlorothiazide contained in Irbesartan Hydrochlorothiazide tablets, if you drink alcohol while on treatment with this medicine, you may have an increased feeling of dizziness on standing up, especially when getting up from a sitting position.

Pregnancy and breast-feeding

Pregnancy

You must tell your doctor if you think that you are (or might become) pregnant. Your doctor will normally advise you to stop taking Irbesartan Hydrochlorothiazide tablets 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 tablets. Irbesartan Hydrochlorothiazide tablets is not recommended during 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 breastfeeding. Irbesartan Hydrochlorothiazide tablets 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.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed. Irbesartan Hydrochlorothiazide tablets 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.

How to take

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 is one 150mg/12.5mg, 300mg/12.5mg or 300mg/25mg tablet a day or two 150mg/12.5mg tablets a day. Irbesartan Hydrochlorothiazide tablets 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 tablets.

Method of administration

Irbesartan Hydrochlorothiazide tablets is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water).

You can take Irbesartan Hydrochlorothiazide tablets 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 tablets until your doctor tells you otherwise.

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

Use in children and adolescents

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

If you take more Irbesartan Hydrochlorothiazide tablets than you should

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

If you forget to take Irbesartan Hydrochlorothiazide tablets

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.

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; dizziness at hight; numbness, tingling or pins and needles; light-headedness; restlessness; electrolyte imbalance (including hypokalaemia and hyponatraemia); changes in vision or pain in one or both eyes.

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

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. Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at www.mhra.gov. uk/yellowcard. Alternatively you can call Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from your local pharmacy.

How to store

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 tablet container, carton and on the blister after EXP. The expiry date refers to the last day of that month.

Al/PVDC/PVC blister packaging: Do not store above 25°C

HDPE tablet containers with desiccant: This medicinal product does

not require any special storage conditions.

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.

Contents of the pack and other information What Irbesartan Hydrochlorothiazide tablets contain

•    The active substances are irbesartan and hydrochlorothiazide.

Each Irbesartan Hydrochlorothiazide 150mg/12.5mg film-coated tablet contains 150mg of irbesartan and 12.5mg hydrochlorothiazide. Each Irbesartan Hydrochlorothiazide 300mg/12.5mg film-

coated tablet contains 300mg of irbesartan and 12.5mg of hydrochlorothiazide.

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

The other ingredients are:

•    Tablet core: mannitol (E421), povidone (K29-32 or equivalent), microcrystalline cellulose, croscarmellose sodium, silica colloidal anhydrous, magnesium stearate.

•    Film-coat: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, iron oxide yellow (E172), iron oxide red (E172).

Irbesartan Hydrochlorothiazide 300mg/12.5mg and 300mg/25mg film-coated tablets also contain iron oxide black (E172).

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.

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 tablets and contact your doctor immediately.

Side effects reported in clinical studies for patients treated with Irbesartan Hydrochlorothiazide tablets were:

•    Common (may affect up to 1 in 10 people): 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 (may affect up to 1 in 100 people): 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, yellowing of the skin and/or whites of the eyes (jaundice).

•    Not known (frequency cannot be estimated from the available data): headache, ringing in the ears, cough, taste disturbance, indigestion, pain in joints and muscles, liver function abnormal, inflammation of the liver causing yellowing of the skin or eyes, impaired kidney function, kidney failure, increased level of potassium in your blood and allergic reactions such as rash, hives, swelling of the face, lips, mouth, tongue or throat.

What Irbesartan Hydrochlorothiazide tablets looks like and contents of the pack

Irbesartan Hydrochlorothiazide 150mg/12.5mg film-coated tablets are pink, biconvex, oval-shaped, 6.5 x 12.7mm film-coated tablet with a H engraved on one side and I on the other side.

Irbesartan Hydrochlorothiazide 300mg/12.5mg film-coated tablets are pink, biconvex, oval-shaped, 8.2 x 16.0mm film-coated tablet with a H engraved on one side and I on the other side.

Irbesartan Hydrochlorothiazide 300mg/25mg film-coated tablets are dark pink, biconvex, oval-shaped, 8.2 x 16.0mm film-coated tablet with a H engraved on one side and I on the other side.

Pack sizes: 28 film-coated tablets

Marketing Authorisation Holder

Actavis Group PTC ehf.

Reykjavikurvegi 76-78 220 Hafnarfjordur Iceland

Manufacturer

Actavis Group PTC ehf Reykjavikurvegi 78 220 Hafnarfjordur Iceland

Balkanpharma - Dupnitsa AD 3 Samokovsko Shosse Str.,

Dupnitsa 2600,

Bulgaria

This leaflet was last revised in August 2014

Irbesartan Hydrochlorothiazide 150mg/12.5mg, 300mg/12.5mg and 300mg/25mg Film-coated Tablets

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 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.

See section 4.

•    The full name of this product is Irbesartan Hydrochlorothiazide 150mg/12.5mg, 300mg/12.5mg and 300mg/25mg Film-coated Tablets but within the leaflet it will be referred to as Irbesartan Hydrochlorothiazide tablets.

What is in this leaflet:

J What Irbesartan Hydrochlorothiazide tablets are and what they are used for What you need to know before you take _3| How to take

Possible side effects _5| How to store

Contents of the pack and other information

_T| What Irbesartan Hydrochlorothiazide tablets are and what they are used for

Irbesartan Hydrochlorothiazide tablets 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 tablets work together to lower blood pressure further than if either was given alone. Irbesartan Hydrochlorothiazide tablets is used in the treatment of high blood pressure (essential hypertension), when treatment with irbesartan or hydrochlorothiazide alone did not provide adequate control of your blood pressure.

What you need to know before you take

Do not take Irbesartan Hydrochlorothiazide tablets if you

•    are allergic to irbesartan or hydrochlorothiazide, or any of the other ingredients of this medicine (listed in section 6), or to medicines chemically related to sulfonamide (ask your doctor or pharmacist for further clarification).

•    are more than 3 months pregnant. (It is also better to avoid Irbesartan Hydrochlorothiazide tablets in early pregnancy - see Warnings and precautions and Pregnancy section).

•    have severe liver or kidney problems.

•    have difficulty in producing urine.

•    have a condition which is associated with persistently high calcium or low potassium levels in your blood.

•    have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren

Warnings and precautions

Talk to your doctor before using Irbesartan Hydrochlorothiazide tablets

•    if you get excessive vomiting or diarrhoea

•    if you suffer from kidney problems, or have 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 blood pressure).

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

•an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.

• aliskiren.

Your doctor may check your kidney function, blood pressure, and the amount

of electrolytes (e.g. potassium) in your blood at regular intervals.

See also information under the heading"Do not take Irbesartan Hydrochlorothiazide tablets"

You must tell your doctor if you think that you are (or might become) pregnant. Irbesartan Hydrochlorothiazide tablets 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

•    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 tablets)

•    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

•    are going to have an operation (surgery) or be given anaesthetics

•    have changes in your vision or pain in one or both of your eyes while taking Irbesartan Hydrochlorothiazide tablets. This could be a sign that you are developing glaucoma, increased pressure in your eye(s). You should discontinue Irbesartan Hydrochlorothiazide tablets treatment and seek medical attention.

Hydrochlorothiazide contained in this medicine could produce a positive result in an anti-doping test.

Children and adolescents

Irbesartan hydrochlorothiazide shoud not be given to children and adolescents ( under 18 years).

Other medicines and Irbesartan Hydrochlorothiazide tablets

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 tablets may have an effect on other medicines. Preparations containing lithium should not be taken with Irbesartan Hydrochlorothiazide tablets 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, colestyramine and colestipol resins to reduce cholesterol in your blood, nondepolarizing skeletal muscle relaxants (e.g. tubocurarine), anticholinergic agents (e.g. atropine, beperiden) or amantadine.

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

•    If you are taking an ACE-inhibitor or aliskiren (see also information under the headings "Do not take Irbesartan Hydrochlorothiazide tablets" and "Warnings and precautions")

Irbesartan Hydrochlorothiazide tablets with food, drink and alcohol

Irbesartan Hydrochlorothiazide tablets can be taken with or without food.

Due to the hydrochlorothiazide contained in Irbesartan Hydrochlorothiazide tablets, if you drink alcohol while on treatment with this medicine, you may have an increased feeling of dizziness on standing up, especially when getting up from a sitting position.

Pregnancy and breast-feeding

Pregnancy

You must tell your doctor if you think that you are (or might become) pregnant. Your doctor will normally advise you to stop taking Irbesartan Hydrochlorothiazide tablets 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 tablets. Irbesartan Hydrochlorothiazide tablets is not recommended during 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 tablets 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.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed. Irbesartan Hydrochlorothiazide tablets 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.

How to take

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 is one 150mg/12.5mg, 300mg/12.5mg or 300mg/25mg tablet a day or two 150mg/12.5mg tablets a day. Irbesartan Hydrochlorothiazide tablets 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 tablets.

Method of administration

Irbesartan Hydrochlorothiazide tablets is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water). You can take Irbesartan Hydrochlorothiazide tablets 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 tablets until your doctor tells you otherwise.

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

Use in children and adolescents

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

If you take more Irbesartan Hydrochlorothiazide tablets than you should

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

If you forget to take Irbesartan Hydrochlorothiazide tablets

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.

increased sensitivity of the skin to the sun; inflammation of blood vessels; a skin disease characterised 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; dizziness at height; numbness; tingling or pins and needles; light-headedness; restlessness; electrolyte imbalance (including hypokalaemia and hyponatraemia); changes in vision or pain in one or both eyes.

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

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. Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at www.mhra.gov.uk/yellowcard. Alternatively you can call Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from your local pharmacy.

How to store

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 tablet container, carton and on the blister after EXP. The expiry date refers to the last day of that month.

Al/PVDC/PVC blister packaging: Do not store above 25°C

HDPE tablet containers with desiccant: This medicinal product does not require

any special storage conditions.

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.

Contents of the pack and other information

What Irbesartan Hydrochlorothiazide tablets contain

• The active substances are irbesartan and hydrochlorothiazide.

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

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

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

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

^ 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.

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 tablets and contact your doctor immediately.

Side effects reported in clinical studies for patients treated with Irbesartan Hydrochlorothiazide tablets were:

•    Common (may affect up to 1 in 10 people): 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 (may affect up to 1 in 100 people): 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, yellowing of the skin and/or whites of the eyes (jaundice).

•    Not known (frequency cannot be estimated from the available data):

headache, ringing in the ears, cough, taste disturbance, indigestion, pain in joints and muscles, liver function abnormal, inflammation of the liver causing yellowing of the skin or eyes, impaired kidney function, kidney failure, 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, the following has also been reported

•    Uncommon (may affect up to 1 in 100 people): chest pain .

Additional side effects associated with the other component of Irbesartan Hydrochlorothiazide tablets (hydrochlorothiazide) alone are:

•    Not known (frequency cannot be estimated from the available data):

loss of appetite; stomach irritation; diarrhoea; 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; yellow 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;

continued top of next column AAAH1543

The other ingredients are:

•    Tablet core: mannitol (E421), povidone (K29-32 or equivalent), microcrystalline cellulose, croscarmellose sodium, silica colloidal anhydrous, magnesium stearate.

•    Film-coat: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, iron oxide yellow (E172), iron oxide red (E172).

Irbesartan Hydrochlorothiazide 300mg/12.5mg and 300mg/25mg film-coated tablets also contain iron oxide black (E172).

What Irbesartan Hydrochlorothiazide tablets looks like and contents of the pack

Irbesartan Hydrochlorothiazide 150mg/12.5mg film-coated tablets are pink, biconvex, oval-shaped, 6.5 x 12.7mm film-coated tablet with a H engraved on one side and I on the other side.

Irbesartan Hydrochlorothiazide 300mg/12.5mg film-coated tablets are pink, biconvex, oval-shaped, 8.2 x 16.0mm film-coated tablet with a H engraved on one side and I on the other side.

Irbesartan Hydrochlorothiazide 300mg/25mg film-coated tablets are dark pink, biconvex, oval-shaped, 8.2 x 16.0mm film-coated tablet with a H engraved on one side and I on the other side.

Pack sizes: 28 film-coated tablets

Marketing Authorisation Holder

Actavis Group PTC ehf.

Reykjavikurvegi 76-78 220 Hafnarfjordur Iceland

Manufacturer

Actavis Group PTC ehf Reykjavikurvegi 78 220 Hafnarfjordur Iceland

This leaflet was last revised in August 2014

If you would like a leaflet with larger text, please contact 01271 385257.

(factavis

Actavis, Barnstaple, EX32 8NS, UK