1. what irbesartan/hydrochlorothiazide tablets is and what it is 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 to treat high blood pressure , when treatment with irbesartan or hydrochlorothiazide alone did not provide adequate control of your bloodpressure.

2. what you need to know before you take irbesartan / hydrochlorothiazide tablets

Do not take Irbesartan/Hy­drochlorothia­zide Tablets

• ifyou are allergic to irbesartan or any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to hydrochlorothiazide or any other sulfonamide-derived medicines
• if you are more than 3 months pregnant. (It is also better to avoid Irbesartan/ Hydrochlorothiazide Tablets in early pregnancy – see pregnancy 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 or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.

Warnings and precautions

Talk to your doctor before taking Irbesartan/Hy­drochlorothia­zide Tablets and if any of the following apply to you :

• 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 ofthe 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.

• if you have had skin cancer or if you develop an unexpected skin lesion during the treatment. Treatment with Hydrochlorothi­azide, particularly long term use with high doses, may increase the risk of some types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Irbesartan/ Hydrochlorothiazide Tablets

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 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
• 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 Tablets)
• 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 experience a decrease in vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase of pressure in your eye and can happen within hours to weeks of taking irbesartan/ hydrochlorothi­azide. This can lead to permanent vision loss, if not treated. If you earlier have had a penicillin or sulfonamide allergy, you can be at higher risk of developing this. You should discontinue irbesartan/hy­drochlorothia­zide treatment and seek medical attention

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

Children and adolescents

Irbesartan/Hy­drochlorothia­zide Tablets should 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.

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”).

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 lllUllltltlTI
• 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 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, breast-feeding and fertility

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 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 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 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

Driving and using machines

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.

Irbesartan/Hy­drochlorothia­zide Tablets 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.

Irbesartan/Hy­drochlorothia­zide Tablets contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‚sodium-free‘.

3. how to take irbesartan/hydrochlorothiazide tablets

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 Tablets is one or two tablets a day. Irbesartan/Hy­drochlorothia­zide Tablets will usually be prescribed by your doctor when your previous treatment did not reduce your blood pressure enough. 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.

Children should not take-<invented name>

Irbesartan/Hy­drochlorothia­zide Tablets 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 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.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects could be very serious and may require medical attention: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 the above symptoms or get short of breath , stop IIIIIUIHHI taking <invented name> and contact your doctor immediately.

The frequency of the side effects listed below is defined using the

following convention:

Common: may affect up to 1 in 10 people

Uncommon: may affect up to 1 in 100 people

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

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

• 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).

If any of these side effects causes you problems, talk to your doctor.

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

• diarrhoea
• low blood pressure
• fainting
• heart rate increased
• flushing
• swelling
• sexual dysfunction (problems with sexual performance)
• blood tests may show lowered levels of potassium and sodium in your blood.

If any of these side effects causes you problems, talk to your doctor.

Side effects reported since the launch of irbesartan/hy­drochlorothia­zide Tablets

Some undesirable effects have been reported since the marketing of irbesartan and 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 of the eyes) have also been reported.

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, severe allergic reactions (anaphylactic shock) and decrease in the number of platelets (a blood cell essential for the clotting of the blood) have 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 of the eyes); inflammation of the pancreas characterised by severe upper stomach pain, often with nausea and vomiting; sleep disorders; depression; blurred vision; decrease in vision or pain in your eyes due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angleclosure glaucoma), 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 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.

Not Known (frequency can not be estimated from the available data Skin and lip cancer (Non-melanoma skin cancer)

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. You can also report side effects directly via. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store irbesartan/hydrochlorothiazide tablets

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 on the blister after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Do not throw away any medicines via wastewater. 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 Tablets contains

The active substances are irbesartan and hydrochlorothi­azide. Each film-coated tablet contains 150 mg irbesartan and 12.5 mg hydrochlorothi­azide.

The other ingredients are

Core: Carboxymethyl­cellulose Calcium (ECG-505), Colloidal silicon dioxide (Aerosil 200), Povidone (PVP K29/32), Sodium Starch Glycolate Type A (Glycolys), Talc & Magnesium Stearate. Coating: Hypromellose 15 cp (E464), Lactose monohydrate, Titanium Dioxide (E171) & Polyethylene glycol 3000, Iron oxide red (E172) & Iron oxide yellow (E172)

What Irbesartan/Hydrochlorothiazide Tablets looks like and contents of the pack

Irbesartan/Hy­drochlorothia­zide 150 mg/12.5 mg tablets are peach coloured, oval, film coated tablets debossed with “ML 34” on one side and plain on other side.

Irbesartan/Hy­drochlorothia­zide 150 mg/12.5 mg tablets are supplied in blister packs of 28 tablets, 56 tablets and 98 tablets.

Not all pack sizes may be marketed.

nUCLEOS^

lllllllllllll­lllllllllllllll

Marketing Authorisation Holder

Macleods Pharma UK Limited,

Wynyard Park House,

Wynyard Avenue,

Wynyard, Billingham,

TS22 5TB, United Kingdom

Manufacturer

Mawdsleys Brooks and Co Ltd.

Unit 22, Quest Park, Wheatley Hall Road,

Doncaster, DN2 4LT, United Kingdom

PL 34771/0088

This medicinal product is authorised in the Member States under the following names:

United Kingdom: Irbesartan/Hy­drochlorothia­zide 150 mg/12.5 mg tablets

Germany: Irbesartan/Hy­drochlorothia­zid Heumann 150 mg/12,5 mg

filmtabletten

Italy: Irbesartan e Idroclorotiazide Macleods Pharma 150 mg/12,5 mg

compresse rivestite con film

Spain: Irbesartan/Hi­droclorotiazi­da Viso Farmaceutica 150 mg/12,5 mg

comprimidos recubiertos con pelfcula EFG

This leaflet was last revised in 12/2020

lllllllllll

1. what irbesartan/hydrochlorothiazide tablets is and what it is 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 to treat high blood pressure , when treatment with irbesartan or hydrochlorothiazide alone did not provide adequate control of your bloodpressure.

2. what you need to know before you take irbesartan / hydrochlorothiazide tablets

Do not take Irbesartan/Hy­drochlorothia­zide Tablets

• 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 any other sulfonamide-derived medicines
• if you are more than 3 months pregnant. (It is also better to avoid Irbesartan/ Hydrochlorothiazide Tablets in early pregnancy – see pregnancy 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 or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.

Warnings and precautions

Talk to your doctor before taking Irbesartan/Hy­drochlorothia­zide Tablets and if any of the following apply to you :

• 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.

• if you have had skin cancer or if you develop an unexpected skin lesion during the treatment. Treatment with Hydrochlorothi­azide, particularly long term use with high doses, may increase the risk of some types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Irbesartan/ Hydrochlorothiazide Tablets

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 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
• 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 Tablets)
• 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 experience a decrease in vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase of pressure in your eye and can happen within hours to weeks of taking irbesartan/ hydrochlorothi­azide. This can lead to permanent vision loss, if not treated. If you earlier have had a penicillin or sulfonamide allergy, you can be at higher risk of developing this. You should discontinue irbesartan/hy­drochlorothia­zide treatment and seek medical attention

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

Children and adolescents

Irbesartan/Hy­drochlorothia­zide Tablets should 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.

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”).

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 lllUllltltlTI
• 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 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, breast-feeding and fertility

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 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 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 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

Driving and using machines

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.

Irbesartan/Hy­drochlorothia­zide Tablets 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.

Irbesartan/Hy­drochlorothia­zide Tablets contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‚sodium-free‘.

3. how to take irbesartan/hydrochlorothiazide tablets

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 Tablets is one or two tablets a day. Irbesartan/Hy­drochlorothia­zide Tablets will usually be prescribed by your doctor when your previous treatment did not reduce your blood pressure enough. 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.

Children should not take-<invented name>

Irbesartan/Hy­drochlorothia­zide Tablets 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 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.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects could be very serious and may require medical attention: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 the above symptoms or get short of breath , stop IIIIIUIHHI taking <invented name> and contact your doctor immediately.

The frequency of the side effects listed below is defined using the

following convention:

Common: may affect up to 1 in 10 people

Uncommon: may affect up to 1 in 100 people

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

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

• 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).

If any of these side effects causes you problems, talk to your doctor.

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

• diarrhoea
• low blood pressure
• fainting
• heart rate increased
• flushing
• swelling
• sexual dysfunction (problems with sexual performance)
• blood tests may show lowered levels of potassium and sodium in your blood.

5. how to store irbesartan/hydrochlorothiazide tablets

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 on the blister after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Do not throw away any medicines via wastewater. 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 Tablets contains

The active substances are irbesartan and hydrochlorothi­azide. Each film-coated tablet contains 150 mg irbesartan and 12.5 mg hydrochlorothi­azide.

The other ingredients are

Core: Carboxymethyl­cellulose Calcium (ECG-505), Colloidal silicon dioxide (Aerosil 200), Povidone (PVP K29/32), Sodium Starch Glycolate Type A (Glycolys), Talc & Magnesium Stearate. Coating: Hypromellose 15 cp (E464), Lactose monohydrate, Titanium Dioxide (E171) & Polyethylene glycol 3000, Iron oxide red (E172) & Iron oxide yellow (E172)

What Irbesartan/Hydrochlorothiazide Tablets looks like and contents of the pack

Irbesartan/Hy­drochlorothia­zide 150 mg/12.5 mg tablets are peach coloured, oval, film coated tablets debossed with “ML 34” on one side and plain on other side.

Irbesartan/Hy­drochlorothia­zide 150 mg/12.5 mg tablets are supplied in blister packs of 28 tablets, 56 tablets and 98 tablets.

Not all pack sizes may be marketed.

nUCLEOS^

lllllllllllll­lllllllllllllll

Marketing Authorisation Holder

Macleods Pharma UK Limited,

Wynyard Park House,

Wynyard Avenue,

Wynyard, Billingham,

TS22 5TB, United Kingdom

Manufacturer

Mawdsleys Brooks and Co Ltd.

Unit 22, Quest Park, Wheatley Hall Road,

Doncaster, DN2 4LT, United Kingdom

PL 34771/0088

This medicinal product is authorised in the Member States under the following names:

United Kingdom: Irbesartan/Hy­drochlorothia­zide 150 mg/12.5 mg tablets

Germany: Irbesartan/Hy­drochlorothia­zid Heumann 150 mg/12,5 mg

filmtabletten

Italy: Irbesartan e Idroclorotiazide Macleods Pharma 150 mg/12,5 mg

compresse rivestite con film

Spain: Irbesartan/Hi­droclorotiazi­da Viso Farmaceutica 150 mg/12,5 mg

comprimidos recubiertos con pelfcula EFG

This leaflet was last revised in 12/2020

lllllllllll

ARTWORK CODE 12

PACKAGE LEAFLET: INFORMATION FOR THE USER

Irbesartan/Hy­drochlorothia­zide 150 mg/12.5 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.

• – 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

What is in this leaflet :

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

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

• 3. How to take Irbesartan/Hy­drochlorothia­zide Tablets

• 4. Possible side effects

• 5. How to store Irbesartan/Hy­drochlorothia­zide Tablets

• 6. Contents of the pack and other information

1. what irbesartan/hy­drochlorothia­zide tablets is and what it is 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 to treat high blood pressure , when treatment with irbesartan or hydrochlorothiazide alone did not provide adequate control of your bloodpressure.

2. what you need to know before you take irbesartan / hydrochlorothiazide tablets

Do not take Irbesartan/Hy­drochlorothia­zide Tablets

• 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 any other sulfonamide-derived medicines
• if you are more than 3 months pregnant. (It is also better to avoid Irbesartan/ Hydrochlorothiazide Tablets in early pregnancy – see pregnancy 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 or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.

Warnings and precautions

Talk to your doctor before taking Irbesartan/Hy­drochlorothia­zide Tablets and if any of the following apply to you :

• 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.

• if you have had skin cancer or if you develop an unexpected skin lesion during the treatment. Treatment with Hydrochlorothi­azide, particularly long term use with high doses, may increase the risk of some types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Irbesartan/ Hydrochlorothiazide Tablets

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 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
• 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 Tablets)
• 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 experience a decrease in vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase of pressure in your eye and can happen within hours to weeks of taking irbesartan/ hydrochlorothi­azide. This can lead to permanent vision loss, if not treated. If you earlier have had a penicillin or sulfonamide allergy, you can be at higher risk of developing this. You should discontinue irbesartan/hy­drochlorothia­zide treatment and seek medical attention

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

Children and adolescents

Irbesartan/Hy­drochlorothia­zide Tablets should 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.

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”).

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 lllUllltltlTI
• 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 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, breast-feeding and fertility

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 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 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 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

Driving and using machines

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.

Irbesartan/Hy­drochlorothia­zide Tablets 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.

Irbesartan/Hy­drochlorothia­zide Tablets contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‚sodium-free‘.

3. how to take irbesartan/hy­drochlorothia­zide tablets

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 Tablets is one or two tablets a day. Irbesartan/Hy­drochlorothia­zide Tablets will usually be prescribed by your doctor when your previous treatment did not reduce your blood pressure enough. 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.

Children should not take-<invented name>

Irbesartan/Hy­drochlorothia­zide Tablets 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 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.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects could be very serious and may require medical attention: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 the above symptoms or get short of breath , stop IIIIIUIHHI taking <invented name> and contact your doctor immediately.

The frequency of the side effects listed below is defined using the

following convention:

Common: may affect up to 1 in 10 people

Uncommon: may affect up to 1 in 100 people

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

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

• 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).

If any of these side effects causes you problems, talk to your doctor.

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

• diarrhoea
• low blood pressure
• fainting
• heart rate increased
• flushing
• swelling
• sexual dysfunction (problems with sexual performance)
• blood tests may show lowered levels of potassium and sodium in your blood.