Irbesartan Macleods Pharma

Patient Information Leaflet

Irbesartan Macleods Pharma 75 mg film-coated tablets

Irbesartan
Generic medicine
Please read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Irbesartan Macleods Pharma is and what it is used for
2. What you need to know before taking Irbesartan Macleods Pharma
3. How to take Irbesartan Macleods Pharma
4. Possible side effects
5. How to store Irbesartan Macleods Pharma
6. Contents of the pack and other information

1. WHAT IS IRBESARTAN MACLEODS PHARMA AND WHAT IS IT USED FOR

Irbesartan Macleods Pharma 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 located in blood vessels, causing them to narrow. This results in increased blood pressure. Irbesartan Macleods Pharma prevents angiotensin-II from binding to these receptors, causing blood vessels to relax and blood pressure to decrease. Irbesartan Macleods Pharma slows the decline in kidney function in patients with high blood pressure and type 2 diabetes.
Irbesartan Macleods Pharma is used in adult patients for:

• treating high blood pressure (essential hypertension)
• protecting the kidneys in patients with high blood pressure, type 2 diabetes, and laboratory evidence of impaired kidney function.

2. WHAT YOU NEED TO KNOW BEFORE TAKING IRBESARTAN MACLEODS PHARMA

Do not take Irbesartan Macleods Pharma

• if you are allergic to irbesartan or to any of the excipients of this medicine (listed in section 6)
• if you are more than 3 months pregnant. (Irbesartan Macleods Pharma is also advised to be avoided at the beginning of pregnancy: see Pregnancy section)
• if you have diabetes mellitus or renal failure and are being treated with aliskiren (another medicine used to treat high blood pressure)

Warnings and precautions
Tell your doctor before taking Irbesartan if you are in any of the following conditions:

• You have excessive vomiting or diarrhoea
• You suffer from kidney problems
• You suffer from heart problems
• You are receiving Irbesartan Macleods Pharma for diabetic kidney disease. In this case, your doctor may carry out regular blood tests, especially to monitor serum potassium levels if kidney function is impaired.
• You are due to undergo surgery or to receive anaesthetics.
• If you are taking any of the following medicines used to treat high blood pressure:
  – an ACE inhibitor (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes
  – aliskiren

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels
(e.g. potassium) at regular intervals.
See also the information in the section “Do not take Irbesartan Macleods Pharma”.
Inform your doctor if you think you are pregnant (or planning a pregnancy). Irbesartan
Macleods Pharma is not recommended during early pregnancy and must not be taken after the third
month of pregnancy, as it may cause severe harm to the unborn baby (see Pregnancy section).

Children and adolescents
This medicine should not be used in children and adolescents, as its safety and
efficacy have not yet been fully established.

Other medicines and Irbesartan
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines.
Your doctor may need to adjust your dose and/or take additional precautions:
If you are taking an ACE inhibitor or aliskiren (also see information in the sections “Do not take
Irbesartan Macleods Pharma” and “Warnings and precautions”).

You may need blood tests if you are taking:

• Potassium supplements
• Potassium-containing salt substitutes
• Potassium-sparing medicines (such as certain diuretic tablets)
• Medicines containing lithium

If you take certain painkillers called non-steroidal anti-inflammatory drugs (NSAIDs), the effect of irbesartan may be reduced.

Irbesartan Macleods Pharma with food and drink
Irbesartan Macleods Pharma can be taken with or without food.

Pregnancy and breastfeeding
Pregnancy
Inform your doctor if you think you are pregnant (or planning to become pregnant). Your doctor will
usually advise you to stop taking Irbesartan Macleods Pharma before you become pregnant or as soon as
you know you are pregnant, and will recommend an alternative treatment. Irbesartan Macleods Pharma is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the unborn baby if taken beyond the third month.

Breast-feeding
Inform your doctor if you are breast-feeding or planning to breast-feed. Irbesartan Macleods Pharma
is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breast-feed, especially if your baby is newborn or was born prematurely.

Driving and using machines
It is unlikely that Irbesartan Macleods Pharma will affect your ability to drive or use machines. However, occasionally during treatment for high blood pressure, you may experience dizziness or fatigue. If this occurs, talk to your doctor before driving or operating machinery.

Irbesartan Macleods Pharma contains lactose. If your doctor has informed you that you have an intolerance to certain sugars (e.g. lactose), contact your doctor before taking this medicine.

3. HOW TO TAKE IRBESARTAN MACLEODS PHARMA

Always take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Method of administration
Irbesartan Macleods Pharma is for oral use. Swallow the tablets with a sufficient amount of liquid (e.g. a glass of water). You may take Irbesartan Macleods Pharma with or without food.
Try to take the medicine at the same time each day. It is important to continue taking Irbesartan Macleods Pharma unless otherwise instructed by your doctor.

• Patients with high blood pressure: The usual dose is 150 mg once daily (two tablets per day). Subsequently, the dose may be increased to 300 mg (four tablets per day) once daily, depending on the blood pressure response.
• Patients with high blood pressure and type 2 diabetes with kidney disease: In patients with high blood pressure and type 2 diabetes, the recommended maintenance dose for treating associated kidney disease is 300 mg (four tablets per day) once daily. Your doctor may recommend a lower dose, especially at the beginning of treatment in certain patients, such as those undergoing haemodialysis or with age over 75 years.

Maximum antihypertensive effect should be achieved within 4–6 weeks after starting treatment.
Use in children and adolescents
Irbesartan must not be given to children under 18 years of age. If a child accidentally ingests any tablets, contact your doctor immediately.
If you take more Irbesartan Macleods Pharma than you should:
If you accidentally take too many tablets, contact your doctor immediately.
If you forget to take Irbesartan Macleods Pharma:
If you accidentally miss a daily dose, simply take your next dose at the usual time. Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them. Some of these effects may be serious and may require medical attention.
As with similar medicines, rare cases of skin allergic reactions (rash, urticaria), as well as localized swelling of the face, lips and/or tongue, have been reported in patients taking irbesartan. If you experience any of these symptoms or have difficulty breathing, stop taking Irbesartan Macleods Pharma and contact your doctor immediately.
The frequency of adverse reactions is defined using the following convention:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people

The adverse reactions reported in clinical studies for patients treated with Irbesartan Macleods Pharma were:

• Very common (may affect more than 1 in 10 people): If you have high blood pressure and type 2 diabetes with kidney disease, blood tests may show increased levels of potassium.
• Common (may affect up to 1 in 10 people): Dizziness, nausea/vomiting, fatigue. Blood tests may show increased levels of an enzyme that measures muscle and heart function (creatine kinase enzyme). In patients with high blood pressure and type 2 diabetes with kidney disease, dizziness or low blood pressure upon standing from a sitting or lying position, joint or muscle pain, and reduced levels of a protein found in red blood cells (haemoglobin) have also been reported.
• Uncommon (may affect up to 1 in 100 people): Increased heart rate, facial flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain.

From post-marketing experience with Irbesartan Macleods Pharma, additional adverse reactions have been reported. Adverse reactions with unknown frequency include: sensation of dizziness, headache, taste disturbances, ringing in the ears, muscle cramps, joint and muscle pain, reduced platelet count, abnormal liver function, increased potassium levels in the blood, impaired kidney function, inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis), and severe allergic reaction (anaphylactic shock). Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE IRBESARTAN MACLEODS PHARMA

Keep this medicine out of the sight and reach of children.
Do not use Irbesartan Macleods Pharma after the expiry date stated on the cardboard box and blister pack after EXP. The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What Irbesartan Macleods Pharma contains
The active substance is irbesartan. Each tablet contains 75 mg of irbesartan.
The other ingredients are
Core: calcium carboxymethylcellulose, colloidal anhydrous silica, povidone, sodium starch glycolate Type A, talc and magnesium stearate.
Coating: hypromellose 15 cP (E171), lactose monohydrate, titanium dioxide (E171) and Macrogol 3000.
Description of the appearance of Irbesartan Macleods Pharma and pack contents
Film-coated tablets, oval-shaped, white to off-white, imprinted with "ML 94" on one side (approximate size: 10.8 x 5.7 mm).
The tablets are supplied in blisters containing 28 tablets, 56 tablets and 98 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
MACLEODS PHARMA ESPANA S.L.U
AVENIDA DIAGONAL, 468, 6° PUERTA A, 08006 BARCELONA, SPAIN.
Manufacturer
Mawdsleys Brooks and Co Ltd.
Unit 22, Quest Park, Wheatley Hall Road,
Doncaster, DN2 4LT, United Kingdom
Synoptis Industrial Sp. z o.o.
ul. Rabowicka 15
62-020 Swarzędz, Poland
This medicinal product is authorized in the European Economic Area Member States under the following names:
United Kingdom: Irbesartan 75 mg film-coated tablets
Germany: Irbesartan Heumann 75 mg Filmtabletten
Italy: Irbesartan Macleods Pharma 75 mg film-coated tablets
Spain: Irbesartán Viso Farmacéutica 75 mg film-coated tablets EFG
This summary of product characteristics was last approved on

Package leaflet: Information for the user

Irbesartan Macleods Pharma 150 mg film-coated tablets

Irbesartan
Generic medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Irbesartan Macleods Pharma is and what it is used for
2. What you need to know before taking Irbesartan Macleods Pharma
3. How to take Irbesartan Macleods Pharma
4. Possible side effects
5. How to store Irbesartan Macleods Pharma
6. Contents of the pack and other information

1. WHAT IRBESARTAN MACLEODS PHARMA IS AND WHAT IT IS USED FOR

Irbesartan Macleods Pharma 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 located in blood vessels, causing them to narrow. This results in increased blood pressure. Irbesartan Macleods Pharma prevents angiotensin II from binding to these receptors, causing blood vessels to relax and blood pressure to decrease. Irbesartan Macleods Pharma slows the decline in kidney function in patients with high blood pressure and type 2 diabetes.
Irbesartan Macleods Pharma is used in adult patients to:

• treat high blood pressure (essential hypertension)
• protect the kidneys in patients with high blood pressure, type 2 diabetes, and laboratory evidence of impaired kidney function.

2. WHAT YOU NEED TO KNOW BEFORE TAKING IRBESARTAN MACLEODS PHARMA

Do not take Irbesartan Macleods Pharma

• if you are allergic to irbesartan or any of the excipients of this medicine (listed in section 6)
• if you are more than 3 months pregnant. (It is also advised to avoid Irbesartan Macleods Pharma in early pregnancy: see Pregnancy section)
• if you have diabetes mellitus or renal failure and are being treated with aliskiren (another medicine used to treat high blood pressure)

Warnings and precautions
Tell your doctor before taking Irbesartan if you are in any of the following conditions:

• You have excessive vomiting or diarrhoea
• You suffer from kidney disorders
• You suffer from heart disorders
• You are receiving Irbesartan Macleods Pharma for diabetic kidney disease. In this case, your doctor may carry out regular blood tests, especially to monitor serum potassium levels if kidney function is impaired.
• You are due to undergo surgery or receive anaesthetics.
• If you are taking any of the following medicines used to treat high blood pressure: or an ACE inhibitor (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes, or aliskiren.

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels
(e.g. potassium) at regular intervals.
See also the information in section “Do not take Irbesartan Macleods Pharma”.
Inform your doctor if you think you may be pregnant (or are planning a pregnancy). Irbesartan
Macleods Pharma is not recommended during early pregnancy and must not be taken after the third
month of pregnancy, as it may cause severe harm to the unborn baby (see Pregnancy section).

Children and adolescents
This medicine must not be used in children and adolescents, as its safety and efficacy have not yet been fully established.

Other medicines and Irbesartan
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Your doctor may need to adjust the dose and/or take additional precautions:
If you are taking an ACE inhibitor or aliskiren (see also information in sections “Do not take
Irbesartan Macleods Pharma” and “Warnings and precautions”).

You may need blood tests if you are taking:

• Potassium supplements
• Potassium-containing salt substitutes
• Potassium-sparing medicines (such as certain diuretic tablets)
• Medicines containing lithium

If you take certain painkillers called non-steroidal anti-inflammatory drugs (NSAIDs), the effect of irbesartan may be reduced.

Irbesartan Macleods Pharma with food and drink
Irbesartan Macleods Pharma can be taken with or without food.

Pregnancy and breastfeeding
Pregnancy
Inform your doctor if you think you may be pregnant (or are planning to become pregnant). Your doctor will usually advise stopping treatment with Irbesartan Macleods Pharma before you become pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Irbesartan Macleods Pharma is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the unborn baby if taken beyond this point.

Breast-feeding
Inform your doctor if you are breast-feeding or planning to breast-feed. Irbesartan Macleods Pharma is not recommended for nursing mothers, and your doctor may choose an alternative treatment if you wish to breast-feed, especially if your baby is newborn or was born prematurely.

Driving and using machines
It is unlikely that Irbesartan Macleods Pharma will affect your ability to drive or use machines. However, occasionally during treatment for hypertension, you may experience dizziness or fatigue. If this occurs, discuss it with your doctor before driving or operating machinery.

Irbesartan Macleods Pharma contains lactose. If your doctor has informed you that you have an intolerance to certain sugars (e.g. lactose), contact your doctor before taking this medicine.

3. HOW TO TAKE IRBESARTAN MACLEODS PHARMA

Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Method of administration
Irbesartan Macleods Pharma is for oral use. Swallow the tablets with a sufficient amount of liquid (e.g. a glass of water). You may take Irbesartan Macleods Pharma with or without food.
Try to take the medicine at the same time every day. It is important to continue taking Irbesartan Macleods Pharma unless otherwise instructed by your doctor.

• Patients with high blood pressure: The usual dose is 150 mg once daily. Subsequently, the dose may be increased to 300 mg (two tablets once daily) depending on the blood pressure response.
• Patients with high blood pressure and type 2 diabetes with kidney disease: In patients with high blood pressure and type 2 diabetes, the recommended maintenance dose for the treatment of associated kidney disease is 300 mg (two tablets once daily).

Your doctor may recommend a lower dose, especially at the beginning of treatment in certain patients, such as those undergoing haemodialysis or those over 75 years of age.
Maximum antihypertensive effect should be achieved within 4–6 weeks after starting treatment.
Use in children and adolescents
Irbesartan must not be given to children under 18 years of age. If a child swallows any tablets, contact your doctor immediately.
If you take more Irbesartan Macleods Pharma than you should:
If you accidentally take too many tablets, contact your doctor immediately.
If you forget to take Irbesartan Macleods Pharma:
If you accidentally miss a daily dose, simply take the next dose at the usual time. Do not take a double dose to make up for the missed dose.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them. Some of these side effects can be serious and may require medical attention.
As with similar medicines, rare cases of skin allergic reactions (rash, urticaria), as well as localized swelling of the face, lips and/or tongue, have been reported in patients taking irbesartan. If you experience any of these symptoms or have difficulty breathing, stop taking Irbesartan Macleods Pharma and contact your doctor immediately.
The frequency of side effects is defined using the following convention:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people

The side effects reported in clinical studies for patients treated with Irbesartan Macleods Pharma were:

• Very common (may affect more than 1 in 10 people): If you have high blood pressure and type 2 diabetes with kidney disease, blood tests may show increased potassium levels.
• Common (may affect up to 1 in 10 people): Dizziness, feeling unwell/nausea, fatigue. Blood tests may show increased levels of an enzyme that measures muscle and heart function (creatine kinase enzyme). In patients with high blood pressure and type 2 diabetes with kidney disease, dizziness or low blood pressure upon standing from a sitting or lying position, joint or muscle pain, and reduced levels of a protein in red blood cells (haemoglobin) have also been reported.
• Uncommon (may affect up to 1 in 100 people): Increased heart rate, facial flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain.

Additional side effects have been reported since the marketing of Irbesartan Macleods Pharma. Side effects with unknown frequency include: sensation of dizziness, headache, taste disturbances, ringing in the ears, muscle cramps, joint and muscle pain, reduced platelet count, abnormal liver function, increased potassium levels in the blood, impaired kidney function, inflammation of the small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis), and severe allergic reaction (anaphylactic shock). Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE IRBESARTAN MACLEODS PHARMA

Keep this medicine out of the sight and reach of children.
Do not use Irbesartan Macleods Pharma after the expiry date stated on the cardboard box and on the
blister after EXP. The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Irbesartan Macleods Pharma contains
The active substance is irbesartan. Each tablet contains 150 mg of irbesartan.
The excipients are
Core: calcium carboxymethylcellulose, colloidal anhydrous silica, povidone, sodium starch glycolate Type
A, talc and magnesium stearate.
Coating: hypromellose 15 cP (E171), lactose monohydrate, titanium dioxide (E171) and Macrogol 3000.
Description of the appearance of Irbesartan Macleods Pharma and contents of the pack
Film-coated tablets, oval-shaped, white to off-white, imprinted with "ML 95" on one side (size approximately 13.6 x 7.2 mm).
The tablets are supplied in blisters containing 28, 56 or 98 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
MACLEODS PHARMA ESPANA S.L.U
AVENIDA DIAGONAL, 468, 6° PUERTA A, 08006 BARCELONA, SPAIN.
Manufacturer
Mawdsleys Brooks and Co Ltd.
Unit 22, Quest Park, Wheatley Hall Road,
Doncaster, DN2 4LT, United Kingdom
Synoptis Industrial Sp. z o.o.
ul. Rabowicka 15
62-020 Swarzędz, Poland
This medicinal product is authorised in the Member States of the European Economic Area under the
following names:
United Kingdom: Irbesartan 150 mg film-coated tablets
Germany: Irbesartan Heumann 150 mg Filmtabletten
Italy: Irbesartan Macleods Pharma 150 mg film-coated tablets
Spain: Irbesartán Viso Farmacéutica 150 mg film-coated tablets EFG
This summary of product characteristics was last approved on

Package leaflet: Information for the user

Irbesartan Macleods Pharma 300 mg film-coated tablets

Irbesartan
Generic medicine
Please read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Irbesartan Macleods Pharma is and what it is used for
2. What you need to know before taking Irbesartan Macleods Pharma
3. How to take Irbesartan Macleods Pharma
4. Possible side effects
5. How to store Irbesartan Macleods Pharma
6. Contents of the pack and other information

1. WHAT IRBESARTAN MACLEODS PHARMA IS AND WHAT IT IS USED FOR

Irbesartan Macleods Pharma 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 located in blood vessels, causing them to narrow. This results in increased blood pressure. Irbesartan Macleods Pharma prevents angiotensin-II from binding to these receptors, causing blood vessels to relax and blood pressure to decrease. Irbesartan Macleods Pharma slows the decline in kidney function in patients with high blood pressure and type 2 diabetes.
Irbesartan Macleods Pharma is used in adult patients for:

• treating high blood pressure (essential hypertension)
• protecting the kidneys in patients with high blood pressure, type 2 diabetes, and laboratory evidence of impaired kidney function.

2. WHAT YOU SHOULD KNOW BEFORE TAKING IRBESARTAN MACLEODS PHARMA

Do not take Irbesartan Macleods Pharma

• If you are allergic to irbesartan or any of the excipients of this medicine (listed in section 6)
• If you are more than 3 months pregnant. (It is also advised to avoid Irbesartan Macleods Pharma in early pregnancy: see section Pregnancy)
• If you have diabetes mellitus or renal failure and are being treated with aliskiren (another medicine used to treat high blood pressure)

Warnings and precautions
Tell your doctor before taking Irbesartan if you are in any of the following conditions:

• You have excessive vomiting or diarrhoea
• You have kidney problems
• You have heart problems
• You are receiving Irbesartan Macleods Pharma for diabetic kidney disease. In this case, your doctor may perform regular blood tests, especially to monitor serum potassium levels if kidney function is impaired.
• You are due to undergo surgery or receive anaesthetics.
• You are taking any of the following medicines for high blood pressure: an ACE inhibitor (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes, or aliskiren.

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels
(e.g. potassium) at regular intervals.
See also the information in section “Do not take Irbesartan Macleods Pharma”.
Inform your doctor if you think you may be pregnant (or are planning a pregnancy). Irbesartan
Macleods Pharma is not recommended during early pregnancy and must not be taken after the third
month of pregnancy, as it may cause severe harm to the unborn baby (see section Pregnancy).

Children and adolescents
This medicine must not be used in children and adolescents, as safety and efficacy have not yet been fully established.

Other medicines and Irbesartan
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Your doctor may need to adjust your dose and/or take additional precautions:
If you are taking an ACE inhibitor or aliskiren (also see information in sections “Do not take
Irbesartan Macleods Pharma” and “Warnings and precautions”).

You may need blood tests if you are taking:

• Potassium supplements
• Potassium-containing salt substitutes
• Potassium-sparing medicines (such as certain diuretic tablets)
• Medicines containing lithium

If you take certain painkillers known as non-steroidal anti-inflammatory drugs (NSAIDs), the effect of irbesartan may be reduced.

Irbesartan Macleods Pharma with food and drink
Irbesartan Macleods Pharma can be taken with or without food.

Pregnancy and breastfeeding
Pregnancy
Inform your doctor if you think you may be pregnant (or are planning a pregnancy). Your doctor will usually advise you to stop taking Irbesartan Macleods Pharma before you become pregnant or as soon as you know you are pregnant, and will recommend another medicine instead of Irbesartan Macleods Pharma. Irbesartan Macleods Pharma is not recommended in early pregnancy and must not be taken after the third month of pregnancy, as it may cause severe harm to the unborn baby if taken beyond the third month.

Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Irbesartan Macleods Pharma is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if your baby is newborn or was born prematurely.

Driving and using machines
It is unlikely that Irbesartan Macleods Pharma will affect your ability to drive or operate machinery. However, occasionally during treatment for hypertension, you may experience dizziness or tiredness. If this occurs, discuss it with your doctor before driving or operating machinery.

Irbesartan Macleods Pharma contains lactose. If your doctor has told you that you have an intolerance to certain sugars (e.g. lactose), contact your doctor before taking this medicine.

3. HOW TO TAKE IRBESARTAN MACLEODS PHARMA

Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Method of administration
Irbesartan Macleods Pharma is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. a glass of water). You may take Irbesartan Macleods Pharma with or without food.
Try to take the medicine at the same time every day. It is important to continue taking Irbesartan Macleods Pharma unless otherwise instructed by your doctor.

• Patients with high blood pressure: The usual dose is 150 mg once daily. Subsequently, the dose may be increased to 300 mg once daily, depending on blood pressure response.
• Patients with high blood pressure and type 2 diabetes with kidney disease: In patients with high blood pressure and type 2 diabetes, the recommended maintenance dose for treating associated kidney disease is 300 mg once daily.

Your doctor may recommend a lower dose, especially at the beginning of treatment in certain patients, such as those undergoing haemodialysis or those over 75 years of age.
Maximum antihypertensive effect should be achieved within 4–6 weeks after starting treatment.
Use in children and adolescents
Irbesartan must not be given to children under 18 years of age. If a child ingests any tablets, contact your doctor immediately.
If you take more Irbesartan Macleods Pharma than you should:
If you accidentally take too many tablets, contact your doctor immediately.
If you forget to take Irbesartan Macleods Pharma:
If you accidentally miss a daily dose, simply take your next dose at the usual time. Do not take a double dose to make up for the missed dose.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE ADVERSE EFFECTS

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. Some of these effects may be serious and may require medical attention.
As with similar medicines, rare cases of allergic skin reactions (rash, urticaria), as well as localized swelling of the face, lips and/or tongue, have been reported in patients taking irbesartan. If you experience any of these symptoms or have difficulty breathing, stop taking Irbesartan Macleods Pharma and contact your doctor immediately.
The frequency of adverse effects is defined using the following convention:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people

The adverse effects reported in clinical studies for patients treated with Irbesartan Macleods Pharma were:

• Very common (may affect more than 1 in 10 people): If you have high blood pressure, type 2 diabetes and kidney disease, blood tests may show increased levels of potassium.
• Common (may affect up to 1 in 10 people): Dizziness, feeling unwell/nausea or vomiting, fatigue. Blood tests may show increased levels of an enzyme that measures muscle and heart function (creatine kinase enzyme). In patients with high blood pressure, type 2 diabetes and kidney disease, dizziness or low blood pressure upon standing from a sitting or lying position, joint or muscle pain, and reduced levels of a protein found in red blood cells (haemoglobin) have also been reported.
• Uncommon (may affect up to 1 in 100 people): Increased heart rate, facial flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain. From post-marketing experience with Irbesartan Macleods Pharma, additional adverse effects have been reported. Adverse effects with unknown frequency include: sensation of dizziness, headache, taste disturbances, ringing in the ears, muscle cramps, joint and muscle pain, reduced platelet count, abnormal liver function, increased blood potassium levels, renal function impairment, inflammation of the small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis), and severe allergic reaction (anaphylactic shock). Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported.

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You can also report adverse effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE IRBESARTAN MACLEODS PHARMA

Keep this medicine out of the sight and reach of children.
Do not use Irbesartan Macleods Pharma after the expiry date stated on the cardboard box and blister pack after EXP. The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. PACKAGING CONTENTS AND OTHER INFORMATION

What Irbesartan Macleods Pharma contains
The active substance is irbesartan. Each tablet contains 300 mg of irbesartan.
The excipients are
Core: calcium carboxymethylcellulose, anhydrous colloidal silica, povidone, sodium starch glycolate Type A, talc and magnesium stearate.
Coating: hypromellose 15 cP (E171), lactose monohydrate, titanium dioxide (E171) and Macrogol 3000.
Description of the appearance of Irbesartan Macleods Pharma and packaging contents
Film-coated oval white to off-white tablets, imprinted with "ML 95" on one side (dimensions approximately 17.2 x 9.2 mm).
The tablets are supplied in blisters containing 28, 56 or 98 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
MACLEODS PHARMA ESPANA S.L.U
AVENIDA DIAGONAL, 468, 6° PUERTA A, 08006 BARCELONA, SPAIN.
Manufacturer
Mawdsleys Brooks and Co Ltd.
Unit 22, Quest Park, Wheatley Hall Road,
Doncaster, DN2 4LT, United Kingdom
Synoptis Industrial Sp. z o.o.
ul. Rabowicka 15
62-020 Swarzędz, Poland
This medicinal product is authorised in the European Economic Area countries under the following names:
United Kingdom: Irbesartan 300 mg film-coated tablets
Germany: Irbesartan Heumann 300 mg Filmtabletten
Italy: Irbesartan Macleods Pharma 300 mg film-coated tablets
Spain: Irbesartán Viso Farmacéutica 300 mg film-coated tablets EFG
This patient information leaflet was last approved on