PRESTARIUM 2.5 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Prestarium 2.5 mg
3. 5 mg, film-coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
4. What is Prestarium 2.5 mg and what is it used for
5. Important information before taking Prestarium 2.5 mg
   1. When not to take Prestarium 2.5 mg:
   2. Warnings and precautions
   3. Pregnancy and breastfeeding
   4. Pregnancy
   5. Breastfeeding
   6. Driving and using machines
   7. Prestarium 2.5 mg contains lactose
   8. Prestarium 2.5 mg contains sodium
6. How to take Prestarium 2.5 mg
   1. Use in children and adolescents
   2. Taking a larger dose than recommended of Prestarium 2.5 mg
   3. Missing a dose of Prestarium 2.5 mg
   4. Stopping treatment with Prestarium 2.5 mg
7. Possible side effects
   1. Stop taking the medicine and contact your doctor immediately if you experience any of the following serious side effects:
   2. Tell your doctor if you experience any of the following side effects:
   3. Reporting side effects
8. How to store Prestarium 2.5 mg
9. Contents of the packaging and other information
   1. What Prestarium 2.5 mg contains
   2. What Prestarium 2.5 mg looks like and contents of the pack
   3. Marketing authorization holder:
   4. Manufacturer:
   5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   6. Cyprus
   7. Denmark
   8. Finland
   9. France
   10. Germany
   11. Greece
   12. Ireland
   13. Italy
   14. Lithuania
   15. Netherlands
   16. Norway
   17. Poland
   18. Slovakia
   19. Slovenia
   20. Sweden
   21. United Kingdom
   22. To obtain more detailed information, contact the representative of the marketing authorization holder:
   23. Date of last revision of the leaflet:

Leaflet attached to the packaging: patient information

Prestarium 2.5 mg

2.5 mg, film-coated tablets

Perindopril arginine

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• Consult your doctor, pharmacist, or nurse if you have any further questions.
• This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Prestarium 2.5 mg and what is it used for
• 2. Important information before taking Prestarium 2.5 mg
• 3. How to take Prestarium 2.5 mg
• 4. Possible side effects
• 5. How to store Prestarium 2.5 mg
• 6. Contents of the packaging and other information

1. What is Prestarium 2.5 mg and what is it used for

Prestarium 2.5 mg is an angiotensin-converting enzyme inhibitor (ACE inhibitor). It works by widening the blood vessels, making it easier for the heart to pump blood.

Prestarium 2.5 mg is used:

• to treat high blood pressure(hypertension);
• to treat heart failure(a condition where the heart is not able to pump enough blood to meet the body's needs);
• to reduce the risk of heart attacks in patients with stable coronary artery diseasewho have had a heart attack and/or have undergone a procedure to improve blood flow to the heart (stable coronary artery disease is a condition where the blood flow to the heart is reduced or blocked).

2. Important information before taking Prestarium 2.5 mg

When not to take Prestarium 2.5 mg:

• if you are allergic to perindopril or any of the other ingredients of this medicine (listed in section 6), or to any other ACE inhibitor;
• if you have had symptoms such as wheezing, swelling of the face, lips, tongue, or throat, intense itching, or severe skin rashes during previous treatment with an ACE inhibitor;

if you or a member of your family has had these symptoms in other circumstances (a condition called angioedema);

• if you are pregnant over 3 months (it is also recommended to avoid taking Prestarium 2.5 mg in early pregnancy - see the section on pregnancy);
• if you have diabetes or kidney problems and are taking a blood pressure-lowering medicine containing aliskiren;
• if you are undergoing dialysis or blood filtration using a machine. Depending on the machine used, Prestarium 2.5 mg may not be suitable for you;
• if you have kidney problems that reduce blood flow to the kidneys (renal artery stenosis);
• if you have taken or are currently taking a combination medicine containing sacubitril and valsartan, used to treat heart failure, as the risk of angioedema (rapid swelling of the tissues under the skin in the area of the throat) increases (see "Warnings and precautions" and "Prestarium 2.5 mg with other medicines").

Warnings and precautions

Before taking Prestarium 2.5 mg, discuss with your doctor or pharmacist if any of the following apply to you:

• you have a narrowing of the aorta (the main blood vessel leading from the heart), hypertrophic cardiomyopathy (a heart muscle disease), or a narrowing of the renal arteries (the arteries that supply blood to the kidneys);
• you have any other heart problems;
• you have liver problems;
• you have kidney problems or are undergoing dialysis;
• you have an increased level of a hormone called aldosterone in your blood (primary aldosteronism);
• you have a collagen disease, such as systemic lupus erythematosus or scleroderma;
• you have diabetes;
• you are on a low-salt diet or taking salt substitutes that contain potassium;
• you are undergoing anesthesia and/or surgery;
• you are undergoing LDL apheresis (a procedure to remove cholesterol from the blood using a special machine);
• you are undergoing desensitization treatment to reduce allergic reactions to bee or wasp stings;
• you have recently had diarrhea or vomiting or are dehydrated;
• you have been told that you have an intolerance to certain sugars;
• you are taking any of the following medicines used to treat high blood pressure:
• an angiotensin receptor blocker (ARB) (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 electrolyte levels (e.g., potassium) regularly. See also the information under "When not to take Prestarium 2.5 mg".
• if you are black, there is a higher risk of angioedema, and this medicine may be less effective in lowering blood pressure than in patients of other races.
• if you are taking any of the following medicines, the risk of angioedema increases:
• racecadotril (used to treat diarrhea);
• sirolimus, everolimus, temsirolimus, and other medicines belonging to the group of medicines called mTOR inhibitors (used to prevent organ rejection and treat cancer);

Angioedema

In patients treated with ACE inhibitors, including Prestarium 2.5 mg, angioedema (a severe allergic reaction; symptoms include swelling of the face, lips, tongue, or throat, difficulty swallowing or breathing) has been reported. This reaction can occur at any time during treatment. If you experience these symptoms, stop taking Prestarium 2.5 mg and contact your doctor immediately. See also section 4.

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, 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. Normally, your doctor will advise you to stop taking Prestarium 2.5 mg before you become pregnant or as soon as you know you are pregnant and will advise you to take a different medicine instead of Prestarium 2.5 mg. Prestarium 2.5 mg is not recommended in early pregnancy and must not be taken if you are pregnant over 3 months, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. Prestarium 2.5 mg is not recommended for mothers who are breastfeeding, and your doctor may choose a different treatment if you want to breastfeed, especially if your baby is a newborn or was born prematurely.

Driving and using machines

Prestarium 2.5 mg usually does not affect alertness, but some patients may experience dizziness or weakness due to low blood pressure. In such cases, the ability to drive and use machines may be impaired.

Prestarium 2.5 mg contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Prestarium 2.5 mg contains sodium

Prestarium 2.5 mg contains less than 1 mmol of sodium (23 mg) per tablet, which means it is essentially "sodium-free".

3. How to take Prestarium 2.5 mg

Always take this medicine exactly as your doctor or pharmacist has told you.

In case of doubt, consult your doctor or pharmacist.

Swallow the tablet with a glass of water, preferably at the same time each day, in the morning before breakfast. The dose will be determined by your doctor.

The recommended doses are as follows:

Hypertension: the usual starting and maintenance dose is 5 mg, taken once a day. After one month of treatment, the dose may be increased to 10 mg, taken once a day. The dose of 10 mg once a day is the maximum recommended dose in hypertension.

In patients over 65 years of age, the usual starting dose is 2.5 mg, taken once a day. After one month of treatment, the dose may be increased to 5 mg once a day, and then to 10 mg once a day if necessary.

Heart failure: the usual starting dose is 2.5 mg, taken once a day. After two weeks of treatment, the dose may be increased to 5 mg, taken once a day. This is the maximum recommended dose in heart failure.

Stable coronary artery disease: the usual starting dose is 5 mg, taken once a day. After two weeks of treatment, the dose may be increased to 10 mg, taken once a day. This is the maximum recommended dose in this indication.

In patients over 65 years of age, the usual starting dose is 2.5 mg, taken once a day. After one week of treatment, the dose may be increased to 5 mg once a day, and then to 10 mg once a day after another week.

Use in children and adolescents

Use in children and adolescents under 18 years of age is not recommended.

Taking a larger dose than recommended of Prestarium 2.5 mg

If you have taken more tablets than recommended, contact your doctor or go to the hospital immediately.

The most likely symptom of overdose is low blood pressure, which can cause dizziness and fainting. In such cases, it is helpful to lay the patient down with their legs raised.

Missing a dose of Prestarium 2.5 mg

It is important to take the medicine regularly for it to work best.

Take the missed dose as soon as possible, unless it is almost time for the next dose. Do not take a double dose to make up for a forgotten dose.

Stopping treatment with Prestarium 2.5 mg

Since treatment with Prestarium 2.5 mg is long-term, consult your doctor before stopping treatment.

If you have any further questions on the use of this medicine, ask 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 you experience any of the following serious side effects:

any of the following serious side effects,which 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);
• very fast or irregular heartbeat, chest pain (angina pectoris), or heart attack (very rare - may affect up to 1 in 10,000 people);
• weakness of the arms or legs or difficulty speaking, which may be a sign of a stroke (very rare - may affect up to 1 in 10,000 people);
• sudden onset of wheezing, chest pain, shortness of breath, or difficulty breathing (bronchospasm; uncommon - may affect up to 1 in 100 people);
• pancreatitis, which can cause severe abdominal pain and very serious illness (very rare - may affect up to 1 in 10,000 people);
• yellowing of the skin or eyes (jaundice), which may be a sign of liver inflammation (very rare - may affect up to 1 in 10,000 people);
• rash, often starting with red, itchy patches on the face, arms, or legs (erythema multiforme; very rare - may affect up to 1 in 10,000 people).

Tell your doctor if you experience any of the following side effects:

common (may affect up to 1 in 10 people):

• headache,
• dizziness,
• tingling sensation,
• vision disturbances,
• tinnitus (ringing in the ears),
• cough,
• shortness of breath,
• gastrointestinal disturbances (nausea, vomiting, abdominal pain, taste disturbances, indigestion, or difficulty digesting food, diarrhea, constipation),
• allergic reactions (such as rash, itching),
• muscle cramps,
• feeling weak;

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

• depression,
• mood changes,
• sleep disturbances,
• dry mouth,
• intense itching or severe skin rashes,
• formation of blisters on the skin,
• kidney problems,
• impotence,
• sweating,
• increased eosinophil count (a type of white blood cell),
• drowsiness,
• fainting,
• palpitations,
• tachycardia,
• vasculitis,
• photosensitivity reaction (increased skin sensitivity to sunlight),
• joint pain,
• muscle pain,
• chest pain,
• feeling unwell,
• peripheral edema,
• fever,
• falls,
• abnormal laboratory test results: high potassium levels in the blood, transient after stopping treatment, low sodium levels, hypoglycemia (very low blood sugar levels) in diabetic patients, increased urea levels in the blood, increased creatinine levels in the blood;

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

• acute kidney failure,
• dark urine, nausea, or vomiting, muscle cramps, disorientation, and seizures. These may be symptoms of a condition called SIADH (inappropriate antidiuretic hormone secretion).
• reduced or absent urine production,
• sudden reddening of the face and neck,
• worsening of psoriasis,
• abnormal laboratory test results: increased liver enzyme activity, high bilirubin levels in the blood;

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

• disorientation,
• eosinophilic pneumonia (a rare type of pneumonia),
• nasal mucositis (swelling or discharge from the nose),
• blood test abnormalities, such as decreased white blood cell count, decreased red blood cell count, decreased hemoglobin levels, decreased platelet count.

If you experience any of these symptoms, contact your doctor immediately.

Frequency not known (frequency cannot be estimated from the available data): cyanosis, numbness, and pain in the fingers of the hands or feet (Raynaud's phenomenon).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products

Al. Jerozolimskie 181C

02-222 Warsaw

Phone: +48 22 49 21 301

Fax: +48 22 49 21 309

Website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Prestarium 2.5 mg

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

Do not use this medicine after the expiry date stated on the packaging after "EXP" (the expiry date stated on the packaging).

The expiry date refers to the last day of the month stated.

The "Lot" number on the packaging refers to the batch number of the medicine.

Store the container tightly closed to protect from moisture.

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 packaging and other information

What Prestarium 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 other ingredients of the tablet core are: lactose monohydrate, magnesium stearate, maltodextrin, colloidal anhydrous silica, sodium carboxymethylcellulose (type A); the ingredients of the coating are: glycerol, hypromellose, macrogol 6000, magnesium stearate, titanium dioxide (E171).

What Prestarium 2.5 mg looks like and contents of the pack

Prestarium 2.5 mg is a white, round, biconvex film-coated tablet. The tablets are available in boxes of 30 or 90 tablets.

Marketing authorization holder:

Les Laboratoires Servier

50, rue Carnot

92284 Suresnes cedex

France

Manufacturer:

Les Laboratoires Servier Industrie (LSI)

905 route de Saran

45520 Gidy

France

Servier (Ireland) Industries Ltd (SII)

Gorey Road - Arklow - Co. Wicklow

Ireland

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

Cyprus

COVERSYL 2.5 mg

Denmark

COVERSYL NOVUM 2,5 mg

Finland

COVERSYL NOVUM 2,5 mg

France

COVERSYL 2,5 mg pelliculé

Germany

COVERSUM Arginin 2.5 mg

Greece

COVERSYL 2,5 mg/tab

Ireland

COVERSYL Arginine 2.5 mg film-coated tablets

Italy

COVERSYL 2.5 mg

Lithuania

PRESTARIUM 2.5 mg

Netherlands

COVERSYL arg 2,5 mg

Norway

PERINDOPRILARGININ SERVIER 2,5 mg

Poland

Prestarium 2,5 mg

Slovakia

PRESTARIUM A 2.5 mg

Slovenia

BIOPREXANIL 2.5 mg filmsko oblozene tablete

Sweden

COVERSYL NOVUM 2,5 mg

United Kingdom

(Northern Ireland)

COVERSYL Arginine 2.5 mg

To obtain more detailed information, contact the representative of the marketing authorization holder:

Servier Polska Sp. z o.o.

Phone: (22) 594-90-00

Date of last revision of the leaflet: