PROPAPTAN

PACKAGE LEAFLET: INFORMATION FOR THE USER

Procaptan 2.5 mg film-coated tablets

perindopril arginine
Please 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 questions, ask your doctor or pharmacist or nurse.
• 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, tell your doctor or pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What Procaptan is and what it is used for

Procaptan is an angiotensin-converting enzyme (ACE) inhibitor. ACE inhibitors work by dilating blood vessels, making it easier for the heart to pump blood through them. Procaptan is used:

• to treat high blood pressure (hypertension),
• to treat heart failure (a condition in which the heart is unable to pump enough blood to meet the body’s needs),
• to reduce the risk of heart events, such as heart attack, in patients with stable coronary artery disease (a condition involving reduced or blocked blood flow to the heart) who have already had a heart attack and/or a procedure to improve blood supply to the heart by widening the vessels that supply it.

2. What you need to know before taking Procaptan

Do not take Procaptan

• if you are allergic to perindopril or to any of the other ingredients of this medicine (listed in section 6), or to any other ACE inhibitor,
• if you have experienced symptoms such as breathlessness, swelling of the face, tongue or throat, severe itching or serious skin rashes related to a previous treatment with ACE inhibitors, or if you or a family member has ever had such symptoms under any circumstances (a condition called angioedema),
• if you are more than three months pregnant (it is better to avoid Procaptan even in the early stages of pregnancy – see section “Pregnancy”),
• if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren,
• if you are undergoing dialysis or any type of blood filtration. Depending on the equipment used, treatment with Procaptan may not be suitable for you,
• if you have kidney problems causing reduced blood flow to the kidneys (renal artery stenosis),
• if you are being treated with sacubitril/valsartan, a medicine used to treat heart failure (see information under “Warnings and precautions” and “Other medicines and Procaptan”).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Procaptan if any of the following apply to you:

• you have aortic stenosis (narrowing of the main artery leaving the heart), hypertrophic cardiomyopathy (a disease of the heart muscle), or renal artery stenosis (narrowing of the artery supplying blood to the kidneys),
• you suffer from other heart conditions,
• you have liver problems,
• you have kidney problems or are on dialysis,
• you have abnormally high levels in the blood of a hormone called aldosterone (primary hyperaldosteronism),
• you have a collagen vascular disease (connective tissue disease) such as systemic lupus erythematosus or scleroderma,
• you have diabetes,
• you are on a low-salt diet or use potassium-containing salt substitutes,
• you are due to undergo anaesthesia and/or surgery,
• you are due to undergo LDL apheresis (blood purification to remove cholesterol using a machine),
• you are due to undergo desensitisation treatment to reduce the effects of an allergy to bee or wasp stings,
• you have recently had diarrhoea, vomiting, or are dehydrated,
• your doctor has diagnosed you with an intolerance to certain sugars,
• you are taking any of the following medicines used to treat high blood pressure:
• an "angiotensin II receptor antagonist" (AIIRA) (also known as sartans – for example valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.
• aliskiren. Your doctor may check your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals. See also section "Do not take Procaptan".
• you are of Black origin, as you may have a higher risk of angioedema, and this medicine may be less effective in lowering blood pressure compared to non-Black patients,
• you are taking any of the following medicines, which increase the risk of angioedema:
• racecadotril (used to treat diarrhoea)
• sirolimus, everolimus, temsirolimus and other medicines belonging to the class of so-called mTOR inhibitors (used to prevent organ transplant rejection)
• sacubitril (available as a fixed-dose combination with valsartan), used for long-term treatment of heart failure.

Angioedema
In patients treated with ACE inhibitors, including Procaptan, angioedema (a severe allergic reaction with swelling of the face, lips, tongue or throat, causing difficulty in swallowing or breathing) has been reported. This may occur at any time during treatment. If you develop such symptoms, you must stop taking Procaptan and contact a doctor immediately. See also section 4.
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Procaptan is not recommended during early pregnancy and must not be taken if you are more than three months pregnant, as it may cause severe harm to the unborn child if taken during this period (see section “Pregnancy”).

Children and adolescents
The use of perindopril is not recommended in children and adolescents under 18 years of age.

Other medicines and Procaptan
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Treatment with Procaptan may be affected by other medicines. Your doctor may need to adjust your dose and/or take other precautions. These include:

• other blood pressure medicines, including an angiotensin II receptor antagonist (AIIRA), aliskiren (see also section "Do not take Procaptan" and "Warnings and precautions"), or diuretics (medicines that increase the amount of urine produced by the kidneys),
• potassium-sparing agents (e.g. triamterene, amiloride), potassium supplements or potassium-containing salt substitutes, other medicines that may increase potassium levels in the blood (such as heparin and co-trimoxazole, also known as trimethoprim/sulfamethoxazole),
• potassium-sparing agents used to treat heart failure: eplerenone and spironolactone at doses between 12.5 mg and 50 mg per day,
• lithium, used to treat mania or depression,
• non-steroidal anti-inflammatory drugs (e.g. ibuprofen) for pain relief or high doses of aspirin,
• medicines for diabetes (such as insulin or metformin),
• baclofen (used to treat muscle stiffness in conditions such as multiple sclerosis),
• medicines used to treat mental disorders such as depression, anxiety, schizophrenia, etc. (e.g. tricyclic antidepressants, antipsychotics),
• immunosuppressants (medicines that reduce the body’s defence mechanisms) used to treat autoimmune diseases or after surgical organ transplantation (e.g. cyclosporine, tacrolimus),
• trimethoprim (used to treat infections),
• estramustine (used in cancer therapy),
• medicines used mainly to treat diarrhoea (racecadotril) or to prevent organ transplant rejection (sirolimus, everolimus, temsirolimus and other medicines belonging to the class of so-called mTOR inhibitors). See section “Warnings and precautions”,
• sacubitril/valsartan (used for long-term treatment of heart failure). See section “Do not take Procaptan” and “Warnings and precautions”,
• allopurinol (used to treat gout),
• procainamide (used to treat irregular heartbeat),
• vasodilators including nitrates (substances that dilate blood vessels),
• medicines used to treat hypotension, shock or asthma (e.g. ephedrine, noradrenaline or adrenaline),
• gold salts, especially when administered intravenously (used to treat symptoms of rheumatoid arthritis).

Procaptan with food and drink
It is preferable to take Procaptan before meals.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, or think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking Procaptan before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine.
Procaptan is not recommended during early pregnancy and must not be taken if you are more than three months pregnant, as it may cause severe harm to the unborn child if taken after the third month of pregnancy.

Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed.
Procaptan is not recommended for women who are breastfeeding. Your doctor may choose an alternative treatment if you wish to breastfeed, especially if your baby is a newborn or was born prematurely.

Driving and using machines
Procaptan usually does not affect alertness. However, in some patients, side effects such as dizziness or fatigue may occur due to lowered blood pressure. If you experience such symptoms, your ability to drive or operate machinery may be impaired.

Procaptan contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Procaptan

Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Take the tablet with a glass of water, preferably at the same time each day, in the morning, before a meal. Your doctor will determine the appropriate dose for you.
The recommended doses are as follows:
Hypertension: the usual starting and maintenance dose is 5 mg once daily. After one month,
this dose may be increased to 10 mg once daily, if needed. 10 mg per day
is the maximum recommended dose for the treatment of high blood pressure.
If you are over 65 years old, the usual starting dose is 2.5 mg once daily. After one month, this
dose may be increased to 5 mg once daily, and if necessary to 10 mg once daily.
Heart failure: the usual starting dose is 2.5 mg once daily. After two weeks,
this dose may be increased to 5 mg once daily, which is the maximum recommended dose for heart failure.
Stable coronary artery disease: the usual starting dose is 5 mg once daily. After two weeks,
this dose may be increased to 10 mg once daily, which represents the maximum recommended dose for this indication.
If you are over 65 years old, the usual starting dose is 2.5 mg once daily. After one week,
this dose may be increased to 5 mg once daily, and after another week to 10 mg once daily.
Use in children and adolescents
Procaptan is not recommended for use in children and adolescents.
If you take more Procaptan than you should
If you have taken an excessive amount of tablets, go immediately to the nearest emergency department or consult your doctor. The most likely effect of an overdose is a drop in blood pressure, which may cause dizziness or fainting. In such a case, lying down with your legs raised may be helpful.
If you forget to take Procaptan
It is important to take the medicine every day, as regular treatment is more effective. However, if you forget to take a dose of Procaptan, take the next dose as usual.
Do not take a double dose to make up for the missed dose.
If you stop taking Procaptan
Since treatment with Procaptan is usually lifelong, you must speak with your doctor before stopping this medicine.
If you have any questions about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.

Stop taking the medicine and immediately inform your doctor if any of the following side effects occur,
as they may be serious:

• swelling of the face, lips, mouth, tongue or throat, difficulty breathing (angioedema) (See section 2 “Warnings and precautions”) (uncommon – may affect up to 1 in 100 people),
• severe dizziness or fainting due to low blood pressure (common – may affect up to 1 in 10 people),
• unusually fast or irregular heartbeat, chest pain (angina) or heart attack (very rare – may affect up to 1 in 10,000 people),
• weakness in arms or legs or difficulty speaking, which could be signs of a possible stroke (very rare – may affect up to 1 in 10,000 people),
• sudden shortness of breath, chest pain, breathlessness or difficulty breathing (bronchospasm) (uncommon – may affect up to 1 in 100 people),
• inflamed pancreas which may cause severe abdominal pain and back pain accompanied by a general feeling of severe illness (very rare – may affect up to 1 in 10,000 people),
• yellowing of the skin or eyes (jaundice), which could be a sign of hepatitis (very rare – may affect up to 1 in 10,000 people),
• skin rashes that often begin as red, itchy spots on the face, arms or legs (erythema multiforme) (very rare – may affect up to 1 in 10,000 people).

Tell your doctor if you notice any of the following side effects:
Common (may affect up to 1 in 10 people):

• headache,
• dizziness,
• vertigo,
• tingling sensations,
• visual disturbances,
• tinnitus (ringing or noise in the ears),
• cough,
• shortness of breath (dyspnea),
• gastrointestinal disturbances (nausea, vomiting, abdominal pain, altered taste, indigestion or difficulty digesting, diarrhea, constipation),
• allergic reactions (such as skin rash, itching),
• muscle cramps,
• feeling of fatigue.

Uncommon (may affect up to 1 in 100 people):

• mood changes,
• sleep disorders,
• dry mouth,
• intense itching or severe skin rashes,
• formation of clusters of blisters on the skin,
• kidney problems,
• impotence,
• sweating,
• elevated eosinophil count (a type of white blood cell),
• somnolence (drowsiness),
• fainting,
• palpitations,
• tachycardia,
• vasculitis (inflammation of blood vessels),
• photosensitivity reactions (increased skin sensitivity to sunlight),
• arthralgia (joint pain),
• myalgia (muscle pain),
• chest pain,
• malaise,
• peripheral edema,
• fever,
• risk of falls,
• changes in laboratory parameters: high potassium levels in blood (reversible upon discontinuation of treatment), low sodium levels, hypoglycemia (very low blood sugar levels) in diabetic patients, increased plasma urea and increased plasma creatinine.

Rare (may affect up to 1 in 1,000 people):

• worsening of psoriasis,
• changes in laboratory parameters: increased liver enzymes, elevated serum bilirubin.

Very rare (may affect up to 1 in 10,000 people):

• confusion,
• eosinophilic pneumonia (a rare type of pneumonia),
• rhinitis (stuffy or runny nose),
• acute kidney failure,
• changes in blood values such as decreased white blood cell and red blood cell counts, decreased hemoglobin, decreased platelet count.

With the use of ACE inhibitors, very concentrated urine (dark-colored), sensation or state of malaise, muscle cramps, confusion and seizures may occur, probably due to inappropriate secretion of ADH (antidiuretic hormone). If you experience these symptoms, contact your doctor immediately.

Frequency not known (frequency cannot be estimated from the available data):

• abnormal color, numbness and pain in the fingers of hands or feet (Raynaud's phenomenon).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via the national reporting system at the following address
.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Procaptan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the bottle. The expiry date refers to the last day of the month.
Keep the container tightly closed to protect the product from moisture.
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. Package contents and other information

What Procaptan 2.5 mg contains

• The active substance is perindopril arginine. One film-coated tablet contains 1.6975 mg of perindopril (equivalent to 2.5 mg of perindopril arginine).
• The excipients in the tablet core are: monohydrate lactose, magnesium stearate, maltodextrin, colloidal anhydrous silica, sodium starch glycolate (type A), and in the film coating: glycerol, hypromellose, macrogol 6000, magnesium stearate, titanium dioxide.

Description of the appearance of Procaptan 2.5 mg and package contents
Procaptan 2.5 mg tablets are white, round, film-coated tablets, convex in shape.
The tablets are available in boxes containing 5, 10, 14, 20, 28, 30, 50, 60 (60 or 2 containers of 30), 84 (84 or 3 containers of 28), 90 (90 or 3 containers of 30), 100 (100 or 2 containers of 50), 120 (120 or 4 containers of 30), or 500 tablets (500 or 10 containers of 50).
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
I.F.B. STRODER S.r.l.
Via Luca Passi, 85
00166 Rome, Italy

Manufacturer
Les Laboratoires Servier Industrie
905 route de Saran
45520 Gidy - France
and
Servier (Ireland) Industries Ltd
Gorey Road
Arklow - Co. Wicklow – Ireland

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

INSTRUCTION LEAFLET: INFORMATION FOR THE USER

Procaptan 5 mg film-coated tablets

perindopril arginine
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 or nurse.
• 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, contact your doctor or pharmacist or nurse. See section 4.

Contents of this leaflet:

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

2. What Procaptan is and what it is used for

Procaptan is an angiotensin-converting enzyme (ACE) inhibitor.
ACE inhibitors work by dilating blood vessels, making it easier for the heart to pump blood through them.
Procaptan is used:

• to treat high blood pressure (hypertension),
• to treat heart failure (a condition in which the heart is unable to pump enough blood to meet the body's needs),
• to reduce the risk of heart events, such as heart attack, in patients with stable coronary artery disease (a condition causing reduced or blocked blood flow to the heart) who have already had a heart attack and/or undergone a procedure to improve blood supply to the heart by widening the vessels that supply it.

4. What you need to know before taking Procaptan

Do not take Procaptan

• if you are allergic to perindopril or to any of the other ingredients of this medicine (listed in section 6), or to any other ACE inhibitor,
• if you have previously experienced symptoms such as breathlessness, swelling of the face, tongue or throat, severe itching or severe skin rashes related to prior treatment with ACE inhibitors, or if you or a family member have ever had such symptoms under any circumstances (a condition called angioedema),
• if you are more than three months pregnant (Procaptan should also be avoided during early pregnancy – see section “Pregnancy”),
• if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren,
• if you are undergoing dialysis or any type of blood filtration. Depending on the equipment used, treatment with Procaptan may not be suitable for you,
• if you have kidney problems causing reduced blood flow to the kidneys (renal artery stenosis),
• if you are being treated with sacubitril/valsartan, a medicine used to treat heart failure (see section “Warnings and precautions” and “Other medicines and Procaptan”).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Procaptan if any of the following apply to you:

• you have aortic stenosis (narrowing of the main artery leaving the heart), hypertrophic cardiomyopathy (a heart muscle disease), or renal artery stenosis (narrowing of the artery supplying blood to the kidneys),
• you have other heart problems,
• you have liver problems,
• you have kidney problems or are on dialysis,
• you have abnormally high levels of a hormone called aldosterone in your blood (primary aldosteronism),
• you have a collagen vascular disease (connective tissue disease) such as systemic lupus erythematosus or scleroderma,
• you have diabetes,
• you are on a low-salt diet or use potassium-containing salt substitutes,
• you are due to undergo anaesthesia and/or surgery,
• you are scheduled for LDL apheresis (blood purification to remove cholesterol using a machine),
• you are undergoing desensitisation treatment to reduce allergic reactions to bee or wasp stings,
• you have recently had diarrhoea or vomiting, or are dehydrated,
• your doctor has diagnosed you with an intolerance to certain sugars,
• you are taking any of the following medicines used to treat high blood pressure:
• an "angiotensin II receptor antagonist" (AIIRA) (also known as sartans – e.g. valsartan, telmisartan, irbesartan), especially 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 section "Do not take Procaptan".
• you are of Black origin, as you may have a higher risk of angioedema and this medicine may be less effective in lowering blood pressure compared to non-Black patients,
• you are taking any of the following medicines, which increase the risk of angioedema:
• racecadotril (used to treat diarrhoea),
• sirolimus, everolimus, temsirolimus and other medicines belonging to the class of so-called mTOR inhibitors (used to prevent organ transplant rejection),
• sacubitril (available as a fixed-dose combination with valsartan), used for long-term treatment of heart failure.

Angioedema
Angioedema (a serious allergic reaction with swelling of the face, lips, tongue or throat causing difficulty in swallowing or breathing) has been reported in patients treated with ACE inhibitors, including Procaptan. This may occur at any time during treatment. If you develop such symptoms, you must stop taking Procaptan and seek immediate medical advice. See also section 4.
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Procaptan is not recommended during early pregnancy, and must not be taken if you are more than three months pregnant, as it may cause severe harm to the unborn baby if taken during this period (see section “Pregnancy”).

Children and adolescents
The use of perindopril is not recommended in children and adolescents under 18 years of age.

Other medicines and Procaptan
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Treatment with Procaptan may be affected by other medicines. Your doctor may need to adjust your dose and/or take other precautions. These include:

• other medicines for high blood pressure, including an angiotensin II receptor antagonist (AIIRA), aliskiren (see also sections "Do not take Procaptan" and "Warnings and precautions"), or diuretics (medicines that increase urine production by the kidneys),
• potassium-sparing agents (e.g. triamterene, amiloride), potassium supplements, or potassium-containing salt substitutes, and other medicines that may increase potassium levels in the blood (such as heparin and co-trimoxazole, also known as trimethoprim/sulfamethoxazole),
• potassium-sparing agents used to treat heart failure: eplerenone and spironolactone at doses between 12.5 mg and 50 mg daily, lithium for the treatment of mania or depression,
• non-steroidal anti-inflammatory drugs (e.g. ibuprofen) for pain relief, or high-dose aspirin,
• medicines for diabetes (such as insulin or metformin),
• baclofen (used to treat muscle stiffness in conditions such as multiple sclerosis),
• medicines used to treat mental disorders such as depression, anxiety, schizophrenia, etc. (e.g. tricyclic antidepressants, antipsychotics),
• immunosuppressants (medicines that reduce the body's immune defences) used to treat autoimmune diseases or after organ transplantation (e.g. cyclosporine, tacrolimus),
• trimethoprim (for treating infections),
• estramustine (used in cancer therapy),
• medicines used mainly to treat diarrhoea (racecadotril) or to prevent transplant rejection (sirolimus, everolimus, temsirolimus and other medicines belonging to the class of so-called mTOR inhibitors). See section “Warnings and precautions”,
• sacubitril/valsartan (used for long-term treatment of heart failure). See section “Do not take Procaptan” and “Warnings and precautions”,
• allopurinol (for treating gout),
• procainamide (for treating irregular heartbeat),
• vasodilators including nitrates (substances that dilate blood vessels),
• medicines used to treat hypotension, shock or asthma (e.g. ephedrine, noradrenaline or adrenaline),
• gold salts, especially when administered intravenously (used to treat symptoms of rheumatoid arthritis).

Procaptan with food and drink
It is preferable to take Procaptan before meals.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, or think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.

Pregnancy
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking Procaptan before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of Procaptan.
Procaptan is not recommended during early pregnancy, and must not be taken if you are more than three months pregnant, as it may cause severe harm to the unborn baby if taken after the third month of pregnancy.

Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed.
Procaptan is not recommended for women who are breastfeeding. Your doctor may choose an alternative treatment if you wish to breastfeed, especially if your baby is a newborn or was born prematurely.

Driving and using machines
Procaptan usually does not affect alertness. However, in some patients, side effects such as dizziness or fatigue may occur due to lowering of blood pressure. If you experience such symptoms, your ability to drive or operate machinery may be impaired.

Procaptan contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

5. How to take Procaptan

Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Take the tablet with a glass of water, preferably at the same time each day, in the morning, before a meal. Your doctor will determine the appropriate dose for you.
The recommended dose is as follows:
Hypertension: The usual starting and maintenance dose is 5 mg once daily. After one month, this dose may be increased to 10 mg once daily, if required. 10 mg per day is the maximum recommended dose for the treatment of high blood pressure.
If you are over 65 years old, the usual starting dose is 2.5 mg once daily. After one month, this dose may be increased to 5 mg once daily, and if necessary, to 10 mg once daily.
Heart failure: The usual starting dose is 2.5 mg once daily. After two weeks, this dose may be increased to 5 mg once daily, which is the maximum recommended dose for heart failure.
Stable coronary artery disease: The usual starting dose is 5 mg once daily. After two weeks, this dose may be increased to 10 mg once daily, which is the maximum recommended dose for this indication.
If you are over 65 years old, the usual starting dose is 2.5 mg once daily. After one week, this dose may be increased to 5 mg once daily, and after another week, to 10 mg once daily.
Use in children and adolescents
Use in children and adolescents is not recommended.
If you take more Procaptan than you should
If you have taken an excessive amount of tablets, go immediately to the nearest emergency room or contact your doctor. The most likely effect of an overdose is a drop in blood pressure, which may cause dizziness or fainting. In this case, it may help to lie down with your legs raised.
If you forget to take Procaptan
It is important to take the medicine every day, as regular treatment is more effective. However, if you forget to take a dose of Procaptan, take the next dose at your usual time.
Do not take a double dose to make up for the missed dose.
If you stop taking Procaptan
Since treatment with Procaptan is usually lifelong, you must speak with your doctor before stopping this medicine.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Stop taking the medicine and inform your doctor immediately if any of the following side effects occur,
as they may be serious:

• swelling of the face, lips, mouth, tongue or throat, difficulty breathing (angioedema) (See section 2 “Warnings and precautions”) (uncommon – may affect up to 1 in 100 people),
• severe dizziness or fainting due to low blood pressure (common – may affect up to 1 in 10 people),
• unusually fast or irregular heartbeat, chest pain (angina) or heart attack (very rare – may affect up to 1 in 10,000 people),
• weakness in arms or legs or speech problems which could be signs of a possible stroke (very rare – may affect up to 1 in 10,000 people),
• sudden shortness of breath, chest pain, breathlessness or difficulty breathing (bronchospasm) (uncommon – may affect up to 1 in 100 people),
• inflamed pancreas which may cause severe abdominal pain and back pain accompanied by a general feeling of severe illness (very rare – may affect up to 1 in 10,000 people),
• yellowing of the skin or eyes (jaundice) which could be a sign of hepatitis (very rare – may affect up to 1 in 10,000 people),
• skin rashes which often begin with red, itchy spots on the face, arms or legs (erythema multiforme) (very rare – may affect up to 1 in 10,000 people).

Tell your doctor if you notice any of the following side effects:
Common (may affect up to 1 in 10 people):

• headache,
• dizziness,
• vertigo,
• tingling,
• vision disturbances,
• tinnitus (ringing or noise in the ears),
• cough,
• shortness of breath (dyspnea),
• gastrointestinal disturbances (nausea, vomiting, abdominal pain, taste disturbances, indigestion or difficulty digesting, diarrhea, constipation),
• allergic reactions (such as skin rashes, itching),
• muscle cramps,
• feeling of fatigue.

Uncommon (may affect up to 1 in 100 people):

• mood changes,
• sleep disturbances,
• dry mouth,
• intense itching or severe skin rashes,
• formation of clusters of blisters on the skin,
• kidney problems,
• impotence,
• sweating,
• elevated eosinophil count (a type of white blood cells),
• drowsiness,
• fainting,
• palpitations,
• tachycardia,
• vasculitis (inflammation of blood vessels),
• photosensitization reactions (increased skin sensitivity to sunlight),
• arthralgia (joint pain),
• myalgia (muscle pain),
• chest pain, malaise,
• peripheral edema, fever,
• risk of falls,
• changes in laboratory parameters: high potassium levels in blood (reversible upon discontinuation of treatment), low sodium levels, hypoglycemia (very low blood sugar levels) in diabetic patients, increased plasma urea and increased plasma creatinine.

Rare (may affect up to 1 in 1,000 people):

• worsening of psoriasis,
• changes in laboratory parameters: increased liver enzymes, elevated serum bilirubin.

Very rare (may affect up to 1 in 10,000 people):

• confusion,
• eosinophilic pneumonia (a rare type of pneumonia),
• rhinitis (stuffy or runny nose),
• acute kidney failure,
• changes in blood values such as decreased white blood cell and red blood cell counts, decreased hemoglobin, decreased platelet count.

With the use of ACE inhibitors, highly concentrated urine (dark-colored), sensation or state of malaise, muscle cramps, confusion and seizures may occur, probably due to inappropriate secretion of ADH (antidiuretic hormone). If you experience these symptoms, contact your doctor immediately.

Frequency not known (frequency cannot be estimated from the available data):

• abnormal color, numbness and pain in fingers of hands or feet (Raynaud's phenomenon).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via the national reporting system at the website
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 Procaptan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the bottle. The expiry date refers to the last day of the month.
Keep the container tightly closed to protect the product from moisture.
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. Package contents and other information

What Procaptan 5 mg contains

• The active substance is perindopril arginine. One film-coated tablet contains 3.395 mg of perindopril (equivalent to 5 mg of perindopril arginina).
• The excipients in the tablet core are: monohydrate lactose, magnesium stearate, maltodextrin, colloidal anhydrous silica, sodium starch glycolate (type A), and in the film coating: glycerol, hypromellose, copper chlorophyllin complexes, macrogol 6000, magnesium stearate, titanium dioxide.

Description of the appearance of Procaptan 5 mg and package contents
Procaptan 5 mg tablets are film-coated, light green in colour, elongated in shape, with a logo engraved on one side and scored on both sides. The tablet
can be divided into two equal parts.
The tablets are available in packs of 5, 10, 14, 20, 28, 30, 50, 60 (60 or 2 packs of 30), 84 (84 or 3 packs of 28), 90 (90 or 3 packs of 30), 100 (100 or 2 packs of 50), 120 (120 or 4 packs of 30) or 500 tablets (500 or 10 packs of 50).
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
I.F.B. STRODER S.r.l.
Via Luca Passi, 85
00166 Rome, Italy

Manufacturers
Les Laboratoires Servier Industrie
905 route de Saran
45520 Gidy - France
and
Servier (Ireland) Industries Ltd
Gorey Road
Arklow - Co. Wicklow – Ireland
and
EGIS Pharmaceuticals Private Limited Company
Mátyás király u. 65
9900 Körmend – Hungary

This medicinal product is authorized in the European Economic Area Member States under the following names:

PATIENT LEAFLET: INFORMATION FOR THE USER

Procaptan 10 mg film-coated tablets

perindopril arginine
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, pharmacist, or nurse.
• 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, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

3. What Procaptan is and what it is used for

Procaptan is an angiotensin-converting enzyme (ACE) inhibitor. ACE inhibitors work by dilating blood vessels, making it easier for the heart to pump blood through them.
Procaptan is used:

• to treat high blood pressure (hypertension),
• to reduce the risk of heart events such as heart attack, in patients with stable coronary artery disease (a condition causing reduced or blocked blood supply to the heart) who have already had a heart attack and/or undergone a procedure to improve blood supply to the heart by widening the vessels that supply it.

6. What you need to know before taking Procaptan

Do not take Procaptan

• if you are allergic to perindopril or to any of the other ingredients of this medicine (listed in section 6), or to any other ACE inhibitor,
• if you have previously experienced symptoms such as breathlessness, swelling of the face, tongue or throat, severe itching or serious skin rashes related to prior treatment with ACE inhibitors, or if you or a family member have ever had such symptoms under any circumstances (a condition called angioedema),
• if you are more than three months pregnant (it is better to avoid Procaptan even in the early stages of pregnancy – see section “Pregnancy”),
• if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren,
• if you are undergoing dialysis or any type of blood filtration. Depending on the equipment used, treatment with Procaptan may not be suitable for you,
• if you have kidney problems causing reduced blood flow to the kidneys (renal artery stenosis),
• if you are being treated with sacubitril/valsartan, a medicine used to treat heart failure (see information under “Warnings and precautions” and “Other medicines and Procaptan”).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Procaptan if any of the following apply to you:

• you have aortic stenosis (narrowing of the main artery arising from the heart), hypertrophic cardiomyopathy (a disease of the heart muscle), or renal artery stenosis (narrowing of the artery supplying blood to the kidneys),
• you suffer from other heart problems,
• you have liver problems,
• you have kidney problems or are on dialysis,
• you have abnormally high levels in the blood of a hormone called aldosterone (primary aldosteronism),
• you have a collagen vascular disease (connective tissue disease) such as systemic lupus erythematosus or scleroderma,
• you have diabetes,
• you are on a low-salt diet or use potassium-containing salt substitutes,
• you are due to undergo anaesthesia and/or surgery,
• you are scheduled for LDL apheresis (blood purification to remove cholesterol using a machine),
• you are scheduled for desensitisation treatment to reduce allergic reactions to bee or wasp stings,
• you have recently had diarrhoea, vomiting, or are dehydrated,
• your doctor has diagnosed you with an intolerance to certain sugars,
• you are taking any of the following medicines used to treat high blood pressure:
• an "angiotensin II receptor antagonist" (AIIRA), also known as sartans (e.g. valsartan, telmisartan, irbesartan), 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 section "Do not take Procaptan".
• you are of Black African or African-Caribbean origin, as you may have a higher risk of angioedema, and this medicine may be less effective in lowering blood pressure compared to non-Black patients,
• you are taking any of the following medicines, which increase the risk of angioedema:
• racecadotril (used to treat diarrhoea)
• sirolimus, everolimus, temsirolimus, and other medicines belonging to the class of so-called mTOR inhibitors (used to prevent organ transplant rejection)
• sacubitril (available as a fixed-dose combination with valsartan), used for long-term treatment of heart failure.

Angioedema
Angioedema (a severe allergic reaction with swelling of the face, lips, tongue or throat, causing difficulty in swallowing or breathing) has been reported in patients treated with ACE inhibitors, including Procaptan. This may occur at any time during treatment. If you develop such symptoms, stop taking Procaptan immediately and contact a doctor without delay. See also section 4.
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Procaptan is not recommended during early pregnancy, and must not be taken if you are more than three months pregnant, as it may cause severe harm to the unborn child if taken during this period (see section “Pregnancy”).

Children and adolescents
The use of perindopril is not recommended in children and adolescents under 18 years of age.

Other medicines and Procaptan
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
Treatment with Procaptan may be affected by concomitant use of other medicines. Your doctor may need to adjust your dose and/or take other precautions. These include:

• other medicines for high blood pressure, including angiotensin II receptor antagonists (AIIRAs), aliskiren (see also sections "Do not take Procaptan" and "Warnings and precautions"), or diuretics (medicines that increase urine production by the kidneys),
• potassium-sparing agents (e.g. triamterene, amiloride), potassium supplements, or potassium-containing salt substitutes, and other medicines that may increase blood potassium levels (such as heparin and co-trimoxazole, also known as trimethoprim/sulfamethoxazole),
• potassium-sparing agents used to treat heart failure: eplerenone and spironolactone at doses between 12.5 mg and 50 mg daily,
• lithium, used to treat mania or depression,
• non-steroidal anti-inflammatory drugs (e.g. ibuprofen) for pain relief, or high-dose aspirin,
• medicines for diabetes (such as insulin or metformin),
• baclofen (used to treat muscle stiffness in conditions such as multiple sclerosis),
• medicines used to treat mental disorders such as depression, anxiety, schizophrenia, etc. (e.g. tricyclic antidepressants, antipsychotics),
• immunosuppressants (medicines that reduce the body's defence mechanisms) used to treat autoimmune diseases or after surgical organ transplantation (e.g. cyclosporine, tacrolimus),
• trimethoprim (used to treat infections),
• estramustine (used in cancer therapy),
• medicines used mainly to treat diarrhoea (racecadotril) or to prevent organ transplant rejection (sirolimus, everolimus, temsirolimus and other medicines belonging to the class of so-called mTOR inhibitors). See section “Warnings and precautions”,
• sacubitril/valsartan (used for long-term treatment of heart failure). See information under “Do not take Procaptan” and “Warnings and precautions”,
• allopurinol (used to treat gout),
• procainamide (used to treat irregular heartbeat),
• vasodilators including nitrates (substances that dilate blood vessels),
• medicines used to treat hypotension, shock or asthma (e.g. ephedrine, noradrenaline or adrenaline),
• gold salts, especially when administered intravenously (used to treat symptoms of rheumatoid arthritis).

Procaptan with food and drink
It is preferable to take Procaptan before meals.

Pregnancy and breastfeeding
If you are pregnant, breastfeeding, suspect you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking Procaptan before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine instead of Procaptan.
Procaptan is not recommended during early pregnancy, and must not be taken if you are more than three months pregnant, as it may cause severe harm to the unborn child if taken after the third month of pregnancy.

Breastfeeding
Inform your doctor if you are breastfeeding or are planning to breastfeed.
Procaptan is not recommended for women who are breastfeeding. Your doctor may choose an alternative treatment if you wish to breastfeed, especially if your baby is a newborn or was born prematurely.

Driving and using machines
Procaptan usually does not affect alertness, but in some patients dizziness or fatigue may occur due to lowered blood pressure. If you experience such symptoms, your ability to drive or operate machinery may be impaired.

Procaptan contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, consult him or her before taking this medicine.

7. How to take Procaptan

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Swallow the tablet with a glass of water, preferably at the same time each day, in the morning, before a
meal. Your doctor will determine the appropriate dose for you.
The recommended dose is as follows:
Hypertension: the usual starting and maintenance dose is 5 mg once daily. After one month,
this dose may be increased to 10 mg once daily, if required. 10 mg per day
is the maximum recommended dose for the treatment of high blood pressure.
If you are over 65 years old, the usual starting dose is 2.5 mg once daily. After one month, this
dose may be increased to 5 mg once daily, and if necessary to 10 mg once daily.
Stable coronary artery disease: the usual starting dose is 5 mg once daily. After two weeks,
this dose may be increased to 10 mg once daily, which is the maximum recommended
dose for this indication.
If you are over 65 years old, the usual starting dose is 2.5 mg once daily. After one week,
this dose may be increased to 5 mg once daily, and after another week to 10 mg once
daily.
Use in children and adolescents
Procaptan is not recommended for use in children and adolescents.
If you take more Procaptan than you should
If you have taken an excessive amount of tablets, go immediately to the nearest emergency room or
consult your doctor. The most likely effect in case of overdose is a drop in blood pressure which may
cause dizziness or fainting. In this case, it may help to lie down with your legs raised.
If you forget to take Procaptan
It is important to take the medicine every day, as regular treatment is more effective. However, if
you forget to take a dose of Procaptan, take the next dose as usual.
Do not take a double dose to make up for the missed dose.
If you stop taking Procaptan
Since treatment with Procaptan is usually lifelong, you must speak to your doctor before
stopping this medicine.
If you have any questions about the use of this medicine, consult your doctor, pharmacist, or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking the medicine and contact your doctor immediately if any of the following side effects occur,
as they may be serious:

• swelling of the face, lips, mouth, tongue or throat, difficulty breathing (angioedema) (See section 2 “Warnings and precautions”) (uncommon – may affect up to 1 in 100 people),
• severe dizziness or fainting due to low blood pressure (common – may affect up to 1 in 10 people),
• unusually fast or irregular heartbeat, chest pain (angina) or heart attack (very rare – may affect up to 1 in 10,000 people),
• weakness in the arms or legs or difficulty speaking, which could be signs of a possible stroke (very rare – may affect up to 1 in 10,000 people),
• sudden shortness of breath, chest pain, breathlessness or difficulty breathing (bronchospasm) (uncommon – may affect up to 1 in 100 people),
• inflamed pancreas which may cause severe abdominal pain and back pain accompanied by a general feeling of severe illness (very rare – may affect up to 1 in 10,000 people),
• yellowing of the skin or eyes (jaundice), which could be a sign of hepatitis (very rare – may affect up to 1 in 10,000 people),
• skin rashes that often begin with red, itchy spots on the face, arms or legs (erythema multiforme) (very rare – may affect up to 1 in 10,000 people).

Contact your doctor if you notice any of the following side effects:
Common (may affect up to 1 in 10 people):

• headache,
• dizziness,
• vertigo,
• tingling sensations,
• vision disturbances,
• tinnitus (ringing or noise in the ears),
• cough,
• shortness of breath (dyspnea),
• gastrointestinal disorders (nausea, vomiting, abdominal pain, altered taste, dyspepsia or indigestion, diarrhea, constipation),
• allergic reactions (such as skin rash, itching),
• muscle cramps,
• feeling of fatigue.

Uncommon (may affect up to 1 in 100 people):

• mood changes,
• sleep disorders,
• dry mouth,
• intense itching or severe skin rashes,
• formation of clusters of blisters on the skin,
• kidney problems,
• impotence,
• sweating,
• elevated eosinophil count (a type of white blood cells),
• drowsiness,
• fainting,
• palpitations,
• tachycardia,
• vasculitis (inflammation of blood vessels),
• photosensitivity reactions (increased skin sensitivity to sunlight),
• arthralgia (joint pain),
• myalgia (muscle pain),
• chest pain,
• malaise,
• peripheral edema,
• fever,
• risk of falls,
• changes in laboratory parameters: high potassium levels in blood (reversible upon discontinuation of treatment), low sodium levels, hypoglycemia (very low blood sugar levels) in diabetic patients, increased plasma urea and increased plasma creatinine.

Rare (may affect up to 1 in 1,000 people):

• worsening of psoriasis,
• changes in laboratory parameters: increased liver enzymes, elevated serum bilirubin levels.

Very rare (may affect up to 1 in 10,000 people):

• confusion,
• eosinophilic pneumonia (a rare type of pneumonia),
• rhinitis (stuffy or runny nose),
• acute kidney failure,
• changes in blood values such as decreased white blood cell and red blood cell counts, decreased hemoglobin, decreased platelet count.

With the use of ACE inhibitors, very concentrated (dark-coloured) urine, sensation or state of malaise, muscle cramps, confusion and seizures may occur, probably due to inappropriate ADH (antidiuretic hormone) secretion. If you experience these symptoms, contact your doctor immediately.

Frequency not known (frequency cannot be estimated from the available data):

• abnormal colour, numbness and pain in fingers or toes (Raynaud's phenomenon).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at the following website:
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 Procaptan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and vial. The expiry date refers to the last day of the month.
Store the container tightly closed to protect the product from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Procaptan 10 mg contains

• The active substance is perindopril arginine. One film-coated tablet contains 6.790 mg of perindopril (equivalent to 10 mg of perindopril arginina).
• The excipients in the tablet core are: monohydrate lactose, magnesium stearate, maltodextrin, colloidal anhydrous silica, sodium starch glycolate (type A), and in the film coating: glycerol, hypromellose, copper complexes of chlorophyllins, macrogol 6000, magnesium stearate, titanium dioxide.

Description of the appearance of Procaptan 10 mg and package contents
Procaptan 10 mg tablets are green, round, film-coated

biconvex tablets, with impressed mark on one side and the logo on the other.

The tablets are available in boxes containing 5, 10, 14, 20, 28, 30, 50, 60 (60 or 2 packs of 30), 84 (84 or 3 packs of 28), 90 (90 or 3 packs of 30), 100 (100 or 2 packs of 50), 120 (120 or 4 packs of 30), or 500 tablets (500 or 10 packs of 50).
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
I.F.B. STRODER S.r.l.
Via Luca Passi, 85
00166 Rome, Italy

Manufacturers
Les Laboratoires Servier Industrie
905 route de Saran
45520 Gidy - France
and
Servier (Ireland) Industries Ltd
Gorey Road
Arklow - Co. Wicklow – Ireland
and
EGIS Pharmaceuticals Private Limited Company
Mátyás király u. 65
9900 Körmend – Hungary

This medicinal product is authorized in the European Economic Area countries under the following names: