Prestarium 10 mg

Package leaflet: Information for the user

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!
Prestarium 10 mg (Coversyl 10 mg)
10 mg, film-coated tablets
Perindoprilum argininum
Prestarium 10 mg and Coversyl 10 mg are different trade names for the same medicine.
Please read this leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• Consult your doctor, pharmacist, or nurse if you have any further questions.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

1. What Prestarium 10 mg is and what it is 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 pack and other information

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

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

• for the treatment of high blood pressure (hypertension);
• to reduce the risk of cardiovascular events such as heart attack in patients with stable coronary artery disease who have had a previous heart attack and/or undergone a procedure to improve blood supply to the heart by widening the blood vessels (stable coronary artery disease is a condition in which blood supply to the heart is reduced or blocked).

2. Important information before using Prestarium 10 mg

When not to use 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 angiotensin-converting enzyme (ACE) inhibitor;
• if during previous treatment with an ACE inhibitor the patient experienced symptoms such as: wheezing, swelling of the face, tongue or throat, severe itching or severe skin rashes, or if the patient or a family member has ever had such symptoms under other circumstances (a condition known as angioedema);
• if the patient is more than 3 months pregnant (it is also better to avoid using 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 by another 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 supply 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, because this increases the risk of angioedema (rapid swelling of tissues under the skin in the throat area) (see "Warnings and precautions" and "Prestarium 10 mg and other medicines").

Warnings and precautions
Before taking Prestarium 10 mg, discuss with your doctor or pharmacist if any of the following situations apply to you:

• the patient has been diagnosed with aortic stenosis (narrowing of the main blood vessel leading from the heart), hypertrophic cardiomyopathy (a heart muscle disease), or renal artery stenosis (narrowing of the arteries supplying blood to the kidneys);
• the patient has any other heart diseases;
• the patient has liver diseases;
• the patient has kidney diseases or is undergoing dialysis;
• the patient has abnormally high levels of a hormone called aldosterone in the blood (primary hyperaldosteronism);
• the patient has collagenosis (a connective tissue disease), such as systemic lupus erythematosus or scleroderma;
• the patient has diabetes;
• the patient is on a low-salt diet or uses salt substitutes containing potassium;
• the patient is undergoing anaesthesia and/or surgery;
• the patient is undergoing LDL apheresis (removal of cholesterol from the blood using a special device);
• the patient is undergoing desensitisation treatment to reduce allergic reactions to bee or wasp stings;
• the patient has recently had diarrhoea 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:
  • an angiotensin II receptor antagonist (ARB) (also known as sartans - e.g. valsartan, telmisartan, irbesartan), especially if the patient has kidney problems related to diabetes;
  • aliskiren. The treating doctor may monitor kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals. See also information under the heading "When not to use Prestarium 10 mg".
• patients of black race have a higher risk of developing 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 diarrhoea);
  • sirolimus, everolimus, temsirolimus, and other medicines belonging to a group called mTOR inhibitors (used to prevent rejection of transplanted organs and in cancer treatment);
  • sacubitril (available in a combination medicine containing sacubitril and valsartan), used to treat chronic heart failure.
• linagliptin, saxagliptin, sitagliptin, vildagliptin, and other medicines belonging to a group called gliptins (used to treat diabetes).

Angioedema
In patients treated with ACE inhibitors, including Prestarium 10 mg, cases of angioedema (a severe allergic reaction; symptoms include swelling of the face, lips, tongue or throat, difficulty swallowing or breathing) have been reported. This reaction may occur at any time during treatment. If such symptoms occur, the patient should stop taking Prestarium 10 mg immediately and contact a doctor without delay. See also section 4.
The patient must inform the doctor if she thinks she is (or might be) pregnant. Prestarium 10 mg is not recommended during early pregnancy and must not be taken if the patient is more than 3 months pregnant, as the medicine may cause serious harm to the unborn child when used during this period (see section on pregnancy).

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

Prestarium 10 mg and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Other medicines may affect treatment with Prestarium 10 mg. The treating doctor may need to adjust the dose and/or take additional precautions regarding medicines such as:

• other medicines used to treat high blood pressure, including angiotensin II receptor antagonists (ARBs), aliskiren (see also information under "When not to use Prestarium 10 mg" and "Warnings and precautions"), or diuretics (medicines that increase urine production by the kidneys);
• potassium-sparing medicines (e.g. triamterene, amiloride), potassium supplements, or salt substitutes containing potassium, and other medicines that may increase potassium levels in the body (such as heparin, a medicine used to thin the blood to prevent clots; trimethoprim and co-trimoxazole, also known as a combination medicine containing trimethoprim and sulfamethoxazole, used to treat bacterial infections);
• potassium-sparing medicines used in heart failure treatment: eplerenone and spironolactone at doses from 12.5 mg to 50 mg per day;
• lithium, used in mania or depression;
• non-steroidal anti-inflammatory drugs (e.g. ibuprofen) used for pain relief, or high doses of acetylsalicylic acid, a substance found in many medicines used for pain and fever relief, and also for preventing 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 (reducing the body's immune response) used to treat autoimmune disorders or after organ transplantation (e.g. cyclosporine, tacrolimus);
• trimethoprim (used to treat infections);
• estramustine (used to treat cancer);
• medicines most commonly used to treat diarrhoea (racecadotril) or to prevent rejection of transplanted organs (sirolimus, everolimus, temsirolimus, and other medicines belonging to a group 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 use Prestarium 10 mg" and "Warnings and precautions";
• allopurinol (used to treat gout);
• procainamide (used to treat heart rhythm disorders);
• vasodilating medicines, including nitrates;
• medicines used to treat low blood pressure, shock, or asthma (e.g. ephedrine, noradrenaline, or adrenaline);
• gold salts, particularly when administered 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, suspects she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
The patient must inform her doctor if she thinks she is (or might be) pregnant. Usually, the doctor will advise stopping Prestarium 10 mg before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine instead of Prestarium 10 mg. Prestarium 10 mg is not recommended during early pregnancy and must not be taken if the patient is more than 3 months pregnant, as the medicine may cause serious harm to the unborn child when used after the third month of pregnancy.

Breastfeeding
Inform the doctor if the patient is breastfeeding or starts breastfeeding. Prestarium 10 mg is not recommended for mothers who are breastfeeding, and the doctor may choose another treatment method if the patient wishes to breastfeed, especially if the baby is a newborn or was born prematurely.

Driving and operating machinery
Prestarium 10 mg usually does not affect alertness, but some patients may experience dizziness or weakness related to low blood pressure. In such cases, the ability to drive or operate machinery may be impaired.

Prestarium 10 mg contains lactose monohydrate
If the patient has been informed by a doctor that they have an intolerance to certain sugars, they should consult 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, meaning the medicine is considered "sodium-free".

3. How to use Prestarium 10 mg

This medicine should always be taken exactly as directed by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
The tablet should be swallowed with a glass of water, preferably at the same time each day, in the morning before food.
The appropriate dose for the patient is determined by the doctor.
Recommended doses are as follows:
Hypertension: the usual initial and maintenance dose is 5 mg once daily. After one month of treatment, if necessary, the dose may be increased to 10 mg once daily. A dose of 10 mg daily is the highest recommended dose for hypertension.
In patients aged 65 years or older, the usual initial dose is 2.5 mg once daily. After one month of treatment, the dose may be increased to 5 mg once daily, and then, if necessary, to 10 mg once daily.
Stable angina pectoris: the usual initial dose is 5 mg once daily. After two weeks of treatment, the dose may be increased to 10 mg once daily. This is the highest recommended dose for this indication.
In patients aged 65 years or older, the usual initial dose is 2.5 mg once daily. After one week of treatment, the dose may be increased to 5 mg once daily, and after another week, to 10 mg once daily.

Use in children and adolescents
Prestarium 10 mg is not recommended for use in children and adolescents.

If you take more Prestarium 10 mg tablets than you should
If you take too many tablets, contact your doctor immediately or go to the nearest hospital emergency department.
The most likely symptom of overdose is low blood pressure, which may cause dizziness and fainting. In such a case, it is helpful to lie the patient down with their legs raised.

If you forget to take a dose of Prestarium 10 mg
It is important to take the medicine regularly, as this ensures optimal effectiveness.
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 missed dose.

Stopping Prestarium 10 mg
Since treatment with Prestarium 10 mg is long-term, you should consult your doctor before stopping the medication.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You must stop taking this medicine and contact your doctor immediately if
any of the following adverse reactions occur, as they may be serious:

• swelling of the face, lips, mouth, tongue or throat, difficulty breathing (angioedema; see section 2 "Warnings and precautions") (not common – may occur in up to 1 in 100 patients);
• severe dizziness or fainting caused by low blood pressure (common – may occur in up to 1 in 10 patients);
• extremely rapid or irregular heartbeat, chest pain (angina) or heart attack (very rare – may occur in up to 1 in 10,000 patients);
• weakness in the arms or legs, or difficulty speaking, which may be signs of stroke (very rare – may occur in up to 1 in 10,000 patients);
• sudden onset of wheezing, chest pain, shortness of breath or difficulty breathing (bronchospasm; not common – may occur in up to 1 in 100 patients);
• pancreatitis, which may cause severe upper abdominal pain radiating to the back and general malaise (very rare – may occur in up to 1 in 10,000 patients);
• yellowing of the skin or eyes (jaundice), which may be a sign of liver inflammation (very rare – may occur in up to 1 in 10,000 patients);
• skin rash, often starting with red, itchy patches on the face, arms or legs (erythema multiforme; very rare – may occur in up to 1 in 10,000 patients).

You should inform your doctor if any of the following adverse reactions occur in the patient:
common (may occur in up to 1 in 10 patients):

• headache,
• dizziness,
• tingling sensation,
• visual disturbances,
• tinnitus (perception of ringing or other sounds in the ears),
• cough,
• shortness of breath,
• gastrointestinal disturbances (nausea, vomiting, abdominal pain, taste disturbances, indigestion or difficulty digesting, diarrhoea, constipation),
• allergic reactions (such as rash, itching),
• muscle cramps,
• feeling of weakness;

not common (may occur in up to 1 in 100 patients):

• depression,
• mood changes,
• sleep disturbances,
• dry mouth,
• severe itching or severe rash,
• formation of clusters of blisters on the skin,
• kidney function disorders,
• 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,
• malaise,
• peripheral oedema,
• fever,
• falls,
• abnormal laboratory test results: high potassium levels in blood, which resolve after discontinuation of treatment, low sodium levels, hypoglycaemia (very low blood sugar levels) in diabetic patients, increased blood urea levels, increased creatinine levels in blood;

rare (may occur in up to 1 in 1,000 patients):

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

very rare (may occur in up to 1 in 10,000 patients):

• confusion,
• eosinophilic pneumonia (a rare type of lung inflammation),
• rhinitis (nasal mucosa inflammation – swelling or nasal discharge),
• blood count changes such as reduced white blood cell and red blood cell counts, reduced haemoglobin levels, reduced platelet count.

If any of these symptoms occur, you should contact your doctor as soon as possible.
Frequency not known (frequency cannot be estimated from available data): cyanosis (bluish discoloration),
numbness and pain in fingers or toes (Raynaud's phenomenon).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Prestarium 10 mg

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

6. Contents of the pack and other information

What Prestarium 10 mg contains

• The active substance is perindopril with arginine. One coated tablet contains 10 mg of perindopril arginine, equivalent to 6.79 mg of perindopril.
• Other ingredients in the tablet are: lactose monohydrate, magnesium stearate, maltodextrin, colloidal anhydrous silica, sodium carboxymethyl starch (type A); coating ingredients: glycerol, hypromellose, copper chlorophyllin complex, polyethylene glycol 6000, magnesium stearate, titanium dioxide.

What Prestarium 10 mg looks like and contents of the pack
Prestarium 10 mg is a green, round, biconvex coated tablet with the imprint

on one side and on the other side.
Packaging: PP container with a PE membrane, dosing opening, and a PE cap containing a desiccant, packed in a cardboard box.
The medicine is available in boxes containing 30 coated tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation Holder in France, the country of export:
Les Laboratoires Servier
50, Rue Carnot
92284 Suresnes Cedex
France
Manufacturer:
Les Laboratoires Servier Industrie
905 Route de Saran
45520 Gidy
France
Servier Ireland Industries Ltd
Gorey Road
Arklow, Co. Wicklow
Ireland
Anpharm Przedsiębiorstwo Farmaceutyczne S.A.
ul. Annopol 6B
03-236 Warsaw
Poland
Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorisation number in France, country of export: 34009 366 603 0 4
366 603-0
34009 366 607 6 2
366 607-6
Parallel import authorisation number: 112/21
This medicinal product is authorised for marketing in the European Economic Area under the following trade 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 COVERSYL Arginine 10 mg
(Northern Ireland)