Prestarium 10 mg

Leaflet accompanying the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Prestarium 10 mg (Coversyl Arginine)

10 mg, coated tablets

Perindoprilum argininum
Prestarium 10 mg and Coversyl Arginine are different trade names for the same medicine.

It is essential to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any further doubts, the patient should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Prestarium 10 mg and what is it used for
• 2. Important information before taking Prestarium 10 mg
• 3. How to take Prestarium 10 mg
• 4. Possible side effects
• 5. How to store Prestarium 10 mg
• 6. Contents of the packaging and other information

1. What is Prestarium 10 mg and what is it used for

Prestarium 10 mg is an angiotensin-converting enzyme inhibitor (ACE inhibitor). It works by dilating blood vessels, making it easier for the heart to pump blood.
Prestarium 10 mg is used:

• to treat high blood pressure(hypertension);
• to reduce the risk of heart events, such as heart attacks in patients with stable coronary artery diseasewho have had a heart attack and/or a procedure to improve blood flow to the heart by widening the blood vessels (stable coronary artery disease is a condition where the blood flow to the heart is reduced or blocked).

2. Important information before taking Prestarium 10 mg

When not to take Prestarium 10 mg:

• if the patient is allergic to perindopril or any of the other ingredients of this medicine (listed in section 6), or to any other ACE inhibitor;
• if the patient has experienced 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 the patient is pregnant over 3 months (it is also recommended to avoid taking Prestarium 10 mg in early pregnancy - see section on pregnancy);
• if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren;
• if the patient is undergoing dialysis or blood filtration using a different method. Depending on the device used, Prestarium 10 mg may not be suitable for the patient.
• if the patient has kidney problems that reduce blood flow to the kidneys (renal artery stenosis);
• if the patient has taken or is currently taking a combination medicine containing sacubitril and valsartan, used to treat heart failure, as the risk of angioedema (rapid swelling of tissues under the skin in the throat area) increases (see "Warnings and precautions" and "Prestarium 10 mg with other medicines").

Warnings and precautions

Before taking Prestarium 10 mg, the patient should discuss the following with their doctor or pharmacist if any of the following apply:

• the patient has 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);
• the patient has other heart diseases;
• the patient has liver diseases;
• the patient has kidney diseases or is undergoing dialysis;
• the patient has an abnormally high level of a hormone called aldosterone in the blood (primary aldosteronism);
• the patient has collagenosis (a disease of the connective tissue), such as systemic lupus erythematosus or scleroderma;
• the patient has diabetes;
• the patient is on a low-salt diet or is taking salt substitutes that contain potassium;
• the patient is undergoing anesthesia and/or surgery;
• the patient is undergoing LDL apheresis (a procedure to remove cholesterol from the blood using a special device);
• the patient is undergoing desensitization treatment to reduce allergic reactions to bee or wasp stings;
• the patient has recently experienced diarrhea or vomiting or is dehydrated;
• the patient has been diagnosed with intolerance to certain sugars;
• the patient is taking any of the following medicines used to treat high blood pressure:
• angiotensin receptor blockers (ARBs) (also known as sartans - e.g., valsartan, telmisartan, irbesartan), especially if the patient has kidney problems related to diabetes;
• aliskiren. The doctor may monitor kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood at regular intervals. See also the information under "When not to take Prestarium 10 mg".
• in black patients, 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 the patient is 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 rejection of transplanted organs and to treat cancer).
• sacubitril (available in a combination medicine containing sacubitril and valsartan), used to treat chronic heart failure. See sections "When not to take Prestarium 10 mg" and "Warnings and precautions".
• linagliptin, saxagliptin, sitagliptin, vildagliptin, and other medicines belonging to the group of medicines called gliptins (used to treat diabetes).

Angioedema
In patients treated with ACE inhibitors, including Prestarium 10 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 the patient experiences such symptoms, they should stop taking Prestarium 10 mg and contact their doctor immediately. See also section 4.
The patient must inform their doctor if they think they are (or may be) pregnant. Prestarium 10 mg is not recommended in early pregnancy and should not be taken if the patient is pregnant over 3 months, as the medicine may cause serious harm to the baby if taken after the third month of pregnancy.

Children and adolescents

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

Prestarium 10 mg with other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Other medicines may affect treatment with Prestarium 10 mg. The doctor may need to change the dose and/or take other precautions regarding such medicines as:

• other medicines used to treat high blood pressure, including angiotensin receptor blockers (ARBs), aliskiren (see also the information under "When not to take Prestarium 10 mg" and "Warnings and precautions"), or diuretics (medicines that increase the amount of urine produced by the kidneys);
• potassium-sparing medicines (e.g., triamterene, amiloride), potassium supplements, or salt substitutes containing potassium, other medicines that may increase potassium levels in the body (such as heparin, a medicine used to thin the blood to prevent blood clots; trimethoprim and cotrimoxazole, also known as a combination medicine containing trimethoprim and sulfamethoxazole, used to treat bacterial infections);
• potassium-sparing medicines used to treat heart failure: eplerenone and spironolactone in doses of 12.5 mg to 50 mg per day;
• lithium used to treat mania or depression;
• non-steroidal anti-inflammatory medicines (e.g., ibuprofen) used to treat pain or high doses of acetylsalicylic acid, a substance found in many medicines, used to treat pain and fever, as well as to prevent blood clots;
• medicines used to treat diabetes (such as insulin or metformin);
• baclofen (used to treat muscle stiffness in diseases such as multiple sclerosis);
• medicines used to treat mental disorders, such as depression, anxiety, schizophrenia, etc. (e.g., tricyclic antidepressants, antipsychotics);
• immunosuppressive medicines (which reduce the body's immune response) used to treat autoimmune disorders or after transplants (e.g., cyclosporine, tacrolimus);
• trimethoprim (used to treat infections);
• estramustine (used to treat cancer);
• medicines commonly used to treat diarrhea (racecadotril) or to prevent rejection of transplanted organs (sirolimus, everolimus, temsirolimus, and other medicines belonging to the group of medicines called mTOR inhibitors). See section "Warnings and precautions";
• a combination medicine containing sacubitril and valsartan (used to treat chronic heart failure). See sections "When not to take Prestarium 10 mg" and "Warnings and precautions".
• allopurinol (used to treat gout);
• procainamide (used to treat heart rhythm disorders);
• vasodilators, including nitrates;
• medicines used to treat low blood pressure, shock, or asthma (e.g., ephedrine, norepinephrine, or epinephrine);
• gold salts, especially when given intravenously (used to treat symptoms of rheumatoid arthritis).

Prestarium 10 mg with food and drink

It is recommended to take Prestarium 10 mg before a meal.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.

Pregnancy

The patient must inform their doctor if they think they are (or may be) pregnant. The doctor will usually advise stopping Prestarium 10 mg before becoming pregnant or as soon as the patient knows they are pregnant and will prescribe a different medicine instead of Prestarium 10 mg. Prestarium 10 mg is not recommended in early pregnancy and should not be taken if the patient is pregnant over 3 months, as the medicine may cause serious harm to the baby if taken after the third month of pregnancy.

Breastfeeding

The patient should inform their doctor if they are breastfeeding or plan to breastfeed. Prestarium 10 mg is not recommended for mothers who are breastfeeding, and the doctor may choose a different treatment if the patient wants to breastfeed, especially if the baby is a newborn or was born prematurely.

Driving and using machines

Prestarium 10 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 operate machines may be impaired.

Prestarium 10 mg contains lactose monohydrate

If the patient has been informed by their doctor that they have an intolerance to some sugars, they should contact their doctor before taking this medicine.

Prestarium 10 mg contains sodium

Prestarium 10 mg contains less than 1 mmol of sodium (23 mg) per tablet, which means that the medicine is considered "sodium-free".

3. How to take Prestarium 10 mg

This medicine should always be taken exactly as prescribed by the doctor or pharmacist.
In case of doubts, the patient should consult their doctor or pharmacist.
The tablet should be swallowed with a glass of water, preferably at the same time every day, in the morning before breakfast. The dose will be determined by the doctor.
The recommended doses are as follows:
Hypertension:the usual initial and maintenance dose is 5 mg, taken once a day. After one month of treatment, the dose may be increased to 10 mg if necessary. The maximum recommended dose is 10 mg per day for hypertension.
In patients over 65 years of age, the usual initial dose is 2.5 mg, taken once a day. After one month of treatment, the dose may be increased to 5 mg per day and then to 10 mg per day if necessary.
Stable coronary artery disease:the usual initial dose is 5 mg, taken once a day. After two weeks of treatment, the dose may be increased to 10 mg per day. This is the maximum recommended dose for this indication.
In patients over 65 years of age, the usual initial dose is 2.5 mg, taken once a day. After one week of treatment, the dose may be increased to 5 mg per day and then to 10 mg per day after another week.

Use in children and adolescents

The use of Prestarium 10 mg in children and adolescents is not recommended.

Overdose of Prestarium 10 mg

In case of taking too many tablets, the patient should contact their doctor or go to the hospital emergency department 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 elevated.

Missed dose of Prestarium 10 mg

It is essential to take the medicine regularly for it to work best.
The patient should take the missed dose as soon as possible, unless it is almost time for the next dose. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Prestarium 10 mg

Since treatment with Prestarium 10 mg is long-term, the patient should consult their doctor before stopping treatment.
In case of any further doubts about taking this medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Prestarium 10 mg can cause side effects, although not everybody gets them.

The patient should stop taking this medicine and contact their doctor immediately if they experience any of the following serious side effects:

which may include:

• 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 may cause severe abdominal pain, radiating to the back, and very poor general condition (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 the appearance of red, itchy patches on the face, arms, or legs (erythema multiforme; very rare - may affect up to 1 in 10,000 people).

The patient should inform their doctor if they experience any of the following side effects:

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

• headache,
• dizziness,
• tingling sensation,
• vision disturbances,
• tinnitus (a sensation of hearing sounds),
• cough,
• shortness of breath,
• gastrointestinal disorders (nausea, vomiting, abdominal pain, taste disturbances, indigestion, or difficulty digesting, diarrhea, constipation),
• allergic reactions (such as rashes, itching),
• muscle cramps,
• feeling of weakness;

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

• depression,
• mood changes,
• sleep disturbances,
• dry mouth,
• intense itching or severe 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 (inflammation of blood vessels),
• photosensitivity reaction (increased skin sensitivity to sunlight),
• joint pain,
• muscle pain,
• chest pain,
• poor general condition,
• peripheral edema,
• fever,
• falls,
• abnormal laboratory test results: high potassium levels in the blood, transient and disappearing after treatment discontinuation, low sodium levels, hypoglycemia (very low blood sugar levels) in patients with diabetes, 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 flushing of the face and neck,
• exacerbation 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 mucosa inflammation (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 such symptoms occur, the patient should contact their doctor as soon as possible.
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 the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych (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
By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Prestarium 10 mg

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
The container should be kept tightly closed to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Prestarium 10 mg contains

• The active substance is perindopril arginine. One coated tablet contains 10 mg of perindopril arginine (which corresponds to 6.790 mg of perindopril).
• 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, copper chlorophyllin complex, macrogol 6000, magnesium stearate, titanium dioxide (E 171).

What Prestarium 10 mg looks like and contents of the pack

Prestarium 10 mg is a green, round, biconvex, coated tablet with a score line on one side and the following markings:

The tablets are available in boxes of 30 tablets.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Ireland, the country of export:

Les Laboratoires Servier
50, rue Carnot, 92284 Suresnes Cedex, France

Manufacturer:

Servier (Ireland) Industries Ltd
Gorey Road
Arklow - Co. Wicklow
Ireland
Les Laboratoires Servier Industrie
905 route de Saran
45520 Gidy, France
ANPHARM Pharmaceutical Company S.A.
ul. Annopol 6B
03-236 Warsaw

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Irish authorization number: PA 658/2/6

Parallel import authorization number: 333/21

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

Austria
Coversum-Arginin 10 mg-Filmtabletten
Belgium
COVERSYL 10 mg
Cyprus
COVERSYL 10 mg
Czech Republic
Prestarium Neo Forte
Denmark
COVERSYL NOVUM 10 mg
Estonia
Prestarium Arginine 10 mg
Finland
COVERSYL NOVUM 10 mg
France
COVERSYL 10 mg
Germany
COVERSUM Arginin 10 mg
Greece
COVERSYL 10 mg
Ireland
COVERSYL Arginine 10 mg film-coated tablets
Italy
COVERSYL 10 mg
Latvia
PRESTARIUM 10 mg
Lithuania
PRESTARIUM 10 mg
Luxembourg
COVERSYL 10 mg
Malta
COVERSYL 10 mg
Netherlands
COVERSYL arg 10 mg
Norway
PERINDOPRILARGININ SERVIER 10 mg
Poland
Prestarium 10 mg
Portugal
COVERSYL 10 mg
Slovakia
PRESTARIUM A 10 mg
Slovenia
BIOPREXANIL 10 mg
Sweden
COVERSYL NOVUM 10 mg
United Kingdom (Northern Ireland)
COVERSYL Arginine 10 mg

Translation of the days of the week on the packaging:

MON -
Monday
TUE

• Tuesday WED - Wednesday THU
• Thursday FRI
• Friday SAT
• Saturday SUN
• Sunday

Date of leaflet approval: 17.03.2022
[Information about the trademark]