Perindopril 4 Mg Tablets

Document: leaflet MAH GENERIC_PL 16363-0293 change

Pharmacode position may change as per Supplier's m/c requirement &additional small pharma code may appear on the front / back panel

Package leaflet: Information for the user

Perindopril 2 mg tablets Perindopril 4 mg tablets

Perindopril tert-butylamine

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

Whai is in this leaflet

The name of your medicine is Perindopril 2 mg / 4 mg tablets (referred to as Perindopril Tablets’ throughout this leaflet).

1. What Perindopril Tablets is and what it is used for

2. What you need to know before you take Perindopril Tablets

3. How to take Perindopril Tablets

4. Possible side effects

5. How to store Perindopril Tablets

6. Contents of the pack and other information

1. What Perindopril tablets is and what it is used for

Perindopril Tablets are angiotensin converting enzyme (ACE) inhibitor. These work by widening the blood vessels, which makes it easier for your heart to pump blood through them.

Perindopril Tablets are used:

• to treat high blood pressure (hypertension),

• to treat heart failure (a condition where the heart is unable to pump enough blood to meet the body’s needs),

• to reduce the risk of cardiac events, such as heart attack, in patients with stable coronary artery disease (a condition where the blood supply to the heart is reduced or blocked) and who have already had a heart attack and/or an operation to improve the blood supply to the heart by widening the vessels that supply it.

2. What you need to know before you take Perindopril tablets

Do not take Perindopril Tablets

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

• if you are more than 3 months pregnant. (It is also better to avoid Perindopril Tablets in early pregnancy - see pregnancy section),

• if you have experienced symptoms such as wheezing, swelling of the face, tongue or throat, intense itching or severe skin rashes with previous ACE inhibitor treatment or if you or a member of your family have had these symptoms in any other circumstances (a condition called angioedema),

• 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 or pharmacist before taking Perindopril Tablets

• if you have aortic stenosis (narrowing of the main blood vessel leading from the heart) or hypertrophic cardiomyopathy (heart muscle disease) or renal artery stenosis (narrowing of the artery supplying the kidney with blood),

• if you have any other heart problems,

• if you have liver problems,

• if you have kidney problems or if you are receiving dialysis,

• if you suffer from a collagen vascular disease such as systemic lupus erythematosus or scleroderma,

• if you have diabetes,

• if you are on a salt restricted diet or use salt substitutes which contain potassium,

• if you are going to have a general anaesthetic and/or major surgery,

• if you are to undergo LDL apheresis (which is removal of cholesterol from your blood by a machine),

• if you are going to have desensitisation treatment to reduce the effects of an allergy to bee or wasp stings,

• if you have recently suffered from diarrhoea or vomiting, or are dehydrated,

• if you have been told by your doctor that you have an intolerance to some sugars,

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

- an “angiotensin II receptor blocker” (ARBs) (also known as sartans - for example valsartan, telmisartan, irbesartan),

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 Perindopril Tablets”

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

Children and adolescents

Perindopril Tablets are not recommended for use in children and adolescents.

Other medicines and Perindopril Tablets

Tell your doctor or pharmacist if you are taking have recently taken or might take any other medicines. Treatment with Perindopril Tablets can be affected by other medicines. These include:

• other medicines for high blood pressure, including diuretics (medicines which increase the amount of urine produced by the kidneys),

• potassium-sparing diuretics (spironolactone, triamterene, amiloride), potassium supplements or potassium-containing salt substitutes,

• lithium for mania or depression,

• non-steroidal anti-inflammatory drugs (e.g. ibuprofen) for pain relief or high dose aspirin,

• medicines to treat diabetes (such as insulin or metformine),

• medicines to treat mental disorders such as depression, anxiety, schizophrenia etc (e.g. tricyclic antidepressants, antipsychotics),

• immunosuppressants (medicines which reduce the defence mechanism of the body) used for the treatment of auto-immune disorders or following transplant surgery (e.g. ciclosporin),

• allopurinol (for the treatment of gout),

• procainamide (for the treatment of an irregular heart beat),

• vasodilators including nitrates (products that make the blood vessels become wider),

• heparin (medicines used to thin blood),

• medicines used for the treatment of low blood pressure, shock or asthma (e.g. ephedrine, noradrenaline or adrenaline).

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

If you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also information under the headings “Do not take Perindopril Tablets ” and “Warnings and precautions”)

Perindopril Tablets with food, drink and alcohol

It is preferable to take Perindopril Tablets before a meal.

Pregnancy, breast-feeding and fertility

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.

Pregnancy

You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Perindopril Tablets before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Perindopril Tablets. Perindopril 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 breastfeeding. Perindopril 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

Perindopril Tablets usually does not affect alertness but dizziness or weakness due to low blood pressure may occur in certain patients. If you are affected in this way, your ability to drive or to operate machinery may be impaired.

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Perindopril Tablets contain lactose. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Perindopril tablets

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

Swallow your tablet with a glass of water, preferably at the same time each day, in the morning, before a meal. Your doctor will decide on the correct dose for you.

The recommended dose is as follows:

If you are 65 or older, the usual starting dose is 2 mg once a day. After a month this can be increased to 4 mg once a day and then if necessary to 8 mg once daily.

Heart failure: the usual starting dose is 2 mg once daily. After two weeks, this can be increased to 4 mg once a day, which is the maximum recommended dose for heart failure.

Stable coronary artery disease: the usual starting dose is 4 mg once daily. After two weeks, this can be increased to 8 mg once daily, which is the maximum recommended dose in this indication.

If you are 65 or older, the usual starting dose is 2 mg once a day. After a week this can be increased to 4 mg once a day and after a further week to 8 mg once daily.

If you take more Perindopril Tablets than you should

If you take too many tablets, contact your nearest accident and emergency department or tell your doctor immediately. The most likely effect in case of overdose is low blood pressure which can make you feel dizzy or faint. If this happens, lying down with the legs raised can help.

If you forget to take Perindopril Tablets

It is important to take your medicine every day as regular treatment works better. However, if you forget to take a dose of Perindopril Tablets, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Perindopril Tablets

As the treatment with Perindopril Tablets 2 mg is usually life-long, you should discuss with your doctor before stopping this medicinal product.

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.

If you experience any of the following, stop taking the medicinal

product at once and tell your doctor immediately:

- swelling of the face, lips, mouth, tongue or throat, difficulty in breathing,

- severe dizziness or fainting,

- unusual fast or irregular heart beat.

In decreasing order of frequency, side effects can include:

• Common (occur in fewer than 1 in 10 users but in more than

1 in 100 users): headache, dizziness, vertigo, pins and needles, vision disturbances, tinnitus (sensation of noises in the ears), light-headedness due to low blood pressure, cough, shortness of breath, gastro-intestinal disorders (nausea, vomiting, abdominal pain, taste disturbances, dyspepsia or difficulty of digestion, diarrhoea, constipation), allergic reactions (such as skin rashes, itching), muscle cramps, feeling of weakness,

• Uncommon (occur in fewer than 1 in 100 users but in more than 1 in 1000 users): mood swings, sleep disturbances, bronchospasm (tightening of the chest, wheezing and shortness of breath), dry mouth, angioedema (symptoms such as wheezing, swelling of the face, tongue or throat, intense itching or severe skin rashes), kidney problems, impotence, sweating,

• Very rare (occur in fewer than 1 in 10,000 users): confusion, cardiovascular disorders (irregular heart beat, angina, heart attack and stroke), eosinophilic pneumonia (a rare type of pneumonia), rhinitis (blocked up or runny nose), erythema multiforme, disorders of the blood, pancreas or liver.

• In case of diabetic patients, hypoglycaemia (very low blood sugar level) can occur.

• Vasculitis (inflammation of blood vessels) have been reported.

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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

The United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

5. How to store Perindopril tablets

Keep this medicine out of the sight and reach of children.

Store in the original package in order to protect from moisture and light.

Do not store above 25^oC.

Use within 60 days after first opening the aluminium pouch. Aluminium pouch contains desiccant, do not swallow the desiccant.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month.

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

6. Contents of the pack and other information

What Perindopril Tablets contains

- The active substance is perindopril tert-butylamine.

Each tablet contains 2 mg of perindopril tert-butylamine, equivalent to 1.669 mg perindopril.

Each tablet contains 4 mg of perindopril tert-butylamine, equivalent to 3.338 mg perindopril.

- The other ingredients are: Lactose anhydrous, cellulose, microcrystalline (E460), silica colloidal anhydrous (E551), and magnesium stearate (E572).

What Perindopril Tablets looks like and contents of the pack

Perindopril 2 mg tablets

White to off-white coloured, round biconvex, uncoated tablets with debossing “D" on one side and “57”on the other side.

Perindopril 4mg tablets

White to off-white coloured, capsule shaped, uncoated tablets with debossing “D" on one side and “5" & “8" on either side of the break line on another side. The tablet can be divided into two equal doses.

Perindopril Tablets are available in blister packs of 28, 30, 56, 60, 84, 90, 112 and 120 tablets

The blisters are packed in a foil pouch containing a desiccant. Each foil pouch contains 28 or 30 tablets. Do not swallow desiccant.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Milpharm Limited

Ares Block, Odyssey Business Park West End Road Ruislip HA4 6QD United Kingdom

Manufacturer

APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate, Hal Far,

Birzebbugia, BBG 3000.

Malta

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

France: Perindopril Arrow Lab 2 mg, comprime

Perindopril Arrow Lab 4 mg, comprime secable Malta: Perindopril Aurobindo 2 mg/ 4 mg Tablets

The Netherlands Perindopril tert-butylamine Aurobindo 2 mg/ 4 mg, tabletten Poland Perinor

Spain Perindopril Aurobindo 4 mg comprimidos

United kingdom Perindopril 2 mg/ 4 mg tablets

This leaflet was last revised in 06/2015.

Pharmacode position may change as per Supplier's m/c requirement &additional small pharma code may appear on the front / back panel

■o

Package leaflet: Information for the user

Perindopril 8 mg tablets

Perindopril tert-butylamine

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

The name of your medicine is Perindopril 8 mg tablets (referred to as ‘Perindopril Tablets’ or ‘Perindopril’ throughout this leaflet).

1. What Perindopril tablets is and what it is used for

2. What you need to know before you take Perindopril tablets

3. How to take Perindopril tablets

4. Possible side effects

5. How to store Perindopril tablets

6. Contents of the pack and other information

1. What Perindopril tablets is and what it is used for

Perindopril Tablets is an angiotensin converting enzyme (ACE) inhibitor. These work by widening the blood vessels, which makes it easier for your heart to pump blood through them.

Perindopril Tablets is used:

• to treat high blood pressure (hypertension),

2. What you need to know before you take Perindopril tablets

Do not take Perindopril Tablets

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

• if you are more than 3 months pregnant. (It is also better to avoid Perindopril Tablets in early pregnancy - see pregnancy section),

• 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 or pharmacist before taking Perindopril Tablets

• if you have any other heart problems,

• if you have liver problems,

• if you have kidney problems or if you are receiving dialysis,

• if you suffer from a collagen vascular disease such as systemic lupus erythematosus or scleroderma,

• if you have diabetes,

• if you are on a salt restricted diet or use salt substitutes which contain potassium,

• if you are going to have a general anaesthetic and/or major surgery,

• if you are to undergo LDL apheresis (which is removal of cholesterol from your blood by a machine),

• if you are going to have desensitisation treatment to reduce the effects of an allergy to bee or wasp stings,

• if you have recently suffered from diarrhoea or vomiting, or are dehydrated,

• if you have been told by your doctor that you have an intolerance to some sugars,

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

- an "angiotensin II receptor blocker" (ARBs) (also known as sartans - for example valsartan, telmisartan, irbesartan),

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 Perindopril Tablets" intervals.

Children and adolescents

Perindopril Tablets is not recommended for use in children and adolescents.

Other medicines and Perindopril Tablets

Tell your doctor or pharmacist if you are taking have recently taken or might take any other medicines. Treatment with Perindopril Tablets can be affected by other medicines. These include:

• other medicines for high blood pressure, including diuretics (medicines which increase the amount of urine produced by the kidneys);

• potassium-sparing diuretics (spironolactone, triamterene, amiloride), potassium supplements or potassium-containing salt substitutes,

• lithium for mania or depression,

• inflammatory painkillers (non-steroidal anti-inflammatory drugs e.g. ibuprofen) for pain relief or high dose aspirin,

• medicines to treat diabetes (such as insulin or metformine),

• medicines to treat mental disorders such as depression, anxiety, schizophrenia etc (e.g. tricyclic antidepressants, antipsychotics),

• immunosuppressants (medicines which reduce the defence mechanism of the body) used for the treatment of auto-immune disorders or following transplant surgery (e.g. ciclosporin),

• allopurinol (for the treatment of gout),

• procainamide (for the treatment of an irregular heart beat),

• vasodilators including nitrates

• heparin (medicines used to thin blood),

• medicines used for the treatment of low blood pressure, shock or asthma (e.g. ephedrine, noradrenaline or adrenaline).

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

If you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also information under the headings "Do not take Perindopril Tablets" and "Warnings and precautions")

Perindopril Tablets with food, drink and alcohol

It is preferable to take Perindopril Tablets before a meal.

Pregnancy, breast-feeding and fertility

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

Pregnancy

Breast-feeding

Black

P150XXXX

J

L

Driving and using machines

Perindopril Tablets contains lactose. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Perindopril tablets

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Swallow your tablet with a glass of water, preferably at the same time each day, in the morning, before a meal. Your doctor will decide on the correct dose for you.

The recommended dose isas follows:

High blood pressure: the usual starting and maintenance dose is 4 mg once daily. After one month, this can be increased to 8 mg once a day if required. 8 mg a day is the maximum recommended dose for high blood pressure. If you are 65 or older, the usual starting dose is 2 mg once a day. After a month this can be increased to 4 mg once a day and then if necessary to 8 mg once daily.

Stable coronary artery disease: the usual starting dose is 4 mg once daily. After two weeks, this can be increased to 8 mg once daily, which is the maximum recommended dose in this indication.

If you are 65 or older, the usual starting dose is 2 mg once a day. After a week this can be increased to 4 mg once a day and after a further week to 8 mg once daily.

If you take more Perindopril Tablets than you should

If you forget to take Perindopril Tablets

If you stop taking Perindopril Tablets

As the treatment with Perindopril Tablets is usually life-long, you should discuss with your doctor before stopping this medicinal product.

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.

If you experience any of the following, stop taking the medicinal

product at once and tell your doctor immediately:

- swelling of the face, lips, mouth, tongue or throat, difficulty in breathing,

- severe dizziness or fainting,

- unusual fast or irregular heart beat.

In decreasing order of frequency, side effects can include:

- Common (occur in fewer than 1 in 10 users but in more than

- Uncommon (occur in fewer than 1 in 100 users but in more than 1 in 1000 users): mood swings, sleep disturbances, bronchospasm (tightening of the chest, wheezing and shortness of breath), dry mouth, angioedema (symptoms such as wheezing, swelling of the face, tongue or throat, intense itching or severe skin rashes), kidney problems, impotence, sweating,

- Very rare (occur in fewer than 1 in 10,000 users): confusion, cardiovascular disorders (irregular heart beat, angina, heart attack and stroke), eosinophilic pneumonia (a rare type of pneumonia), rhinitis (blocked up or runny nose), erythema multiforme, disorders of the blood, pancreas or liver.

- In case of diabetic patients, hypoglycaemia (very low blood sugar level) can occur.

- Vasculitis (inflammation of blood vessels) have been reported. Reporting of side effects

The United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

5. How to store Perindopril tablets

Keep this medicine out of the sight and reach of children.

Store in the original package in order to protect from moisture and light.

Do not store above 25^oC.

Use within 60 days after first opening the Aluminium pouch. Aluminium pouch contains desiccant, do not swallow the desiccant.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month.

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

6. Contents of the pack and other information

What Perindopril Tablets contains

- The active substance is perindopril tert-butylamine.

Each tablet contains 8 mg of perindopril tert-butylamine, equivalent to 6.676 mg perindopril.

- The other ingredients are: Lactose anhydrous, silica colloidal anhydrous (E551), cellulose, microcrystalline (E460) and magnesium stearate (E572).

What Perindopril Tablets looks like and contents of the pack

Tablet

Perindopril Tablets 8 mg tablets are white to off-white, coloured round biconvex, uncoated tablets with debossing “D" on one side and “5" & “9" on either side of the break line on another side. The tablet can be divided into two equal doses.

Perindopril Tablets tablets are available in blister packs of 28, 30, 56, 60, 84, 90, 112 and 120 tablets.

The blisters are packed in a foil pouch containing a desiccant. Each foil pouch contains 28 or 30 tablets. Do not swallow desiccant.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Milpharm Limited

Ares Block, Odyssey Business Park West End Road Ruislip HA4 6QD United Kingdom

Manufacturer

APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate, Hal Far,

Birzebbugia, BBG 3000.

Malta

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

France: Perindopril Arrow Lab 8 mg, comprime secable

Malta: Perindopril Aurobindo 8 mg Tablets

The Netherlands Perindopril tert-butylamine Aurobindo 8 mg, tabletten

Poland Perinor

Spain PERINDOPRIL AUROBINDO 8 mg

comprimidos

United kingdom Perindopril 8 mg tablets This leaflet was last revised in 06/2015.