Prestarium 5 mg

Package leaflet: Information for the patient

Warning! Keep the leaflet. The information on the immediate packaging is in a foreign language.
Prestarium 5 mg (Coversyl Arginine)
5 mg, film-coated tablets
Perindoprilum argininum
Prestarium 5 mg and Coversyl Arginine are different trade names for the same medicine.
Please read this leaflet carefully before using 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 another person, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet:

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

1. What Prestarium 5 mg is and what it is used for

Prestarium 5 mg is an angiotensin-converting enzyme (ACE) inhibitor. It works by dilating blood vessels, which helps the heart pump blood more easily.
Prestarium 5 mg is used:

• in the treatment of high blood pressure (hypertension);
• in the treatment of 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 cardiac events, such as heart attack, in patients with stable ischaemic heart disease who have had a previous heart attack and/or undergone a procedure to improve blood supply to the heart (stable ischaemic heart disease is a condition in which blood supply to the heart is reduced or blocked).

2. Important information before taking Prestarium 5 mg

When not to take Prestarium 5 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 rash, or if the patient or a family member has had such symptoms under other circumstances (a condition called angioedema);
• if the patient is more than 3 months pregnant (it is also better to avoid using Prestarium 5 mg in early pregnancy – see pregnancy section);
• 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 5 mg may not be suitable for the patient;
• if the patient has kidney problems causing reduced 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 5 mg and other medicines").

Warnings and precautions
Before taking Prestarium 5 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 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 connective tissue disease (collagenosis), 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 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 – for example, 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 take Prestarium 5 mg".
• in black patients, there is 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 the group of drugs known as mTOR inhibitors (used to prevent rejection of transplanted organs and in cancer treatment);
• sacubitril (available in a combination medicine containing sacubitril and valsartan), used in the treatment of chronic heart failure;
• linagliptin, saxagliptin, sitagliptin, vildagliptin and other medicines belonging to the group of drugs known as gliptins (used in the treatment of diabetes).

Angioedema
Angioedema (a serious allergic reaction; symptoms include swelling of the face, lips, tongue or throat, difficulty in swallowing or breathing) has been reported in patients treated with ACE inhibitors, including Prestarium 5 mg. This reaction may occur at any time during treatment. If such symptoms occur, the patient should stop taking Prestarium 5 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 5 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 if used during this period (see pregnancy section).

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

Prestarium 5 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 5 mg. The treating doctor may need to adjust the dose and/or take additional precautions with 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 take Prestarium 5 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 potassium-containing salt substitutes, and 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 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 of 12.5 mg to 50 mg per day;
• lithium, used in the treatment of 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 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 in the treatment of cancer);
• medicines most commonly used to treat diarrhoea (racecadotril) or to prevent rejection of transplanted organs (sirolimus, everolimus, temsirolimus and other medicines belonging to the group of drugs known as mTOR inhibitors). See section "Warnings and precautions";
• a combination medicine containing sacubitril and valsartan (used in the treatment of chronic heart failure). See sections "When not to take Prestarium 5 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 5 mg with food and drink
It is recommended to take Prestarium 5 mg before a meal.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
The patient must inform the doctor if she thinks she is (or might be) pregnant. Usually, the doctor will advise stopping Prestarium 5 mg before becoming pregnant or as soon as pregnancy is confirmed, and will recommend another medicine instead. Prestarium 5 mg is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as the medicine may cause serious harm to the unborn child if used beyond the third month of pregnancy.

Breastfeeding
The patient should inform the doctor if she is breastfeeding or intends to breastfeed. Prestarium 5 mg is not recommended for breastfeeding mothers, 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 using machines
Prestarium 5 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 5 mg contains lactose monohydrate
If the patient has been told by a doctor that he or she has an intolerance to certain sugars, consult the doctor before taking this medicine.

Prestarium 5 mg contains sodium
Prestarium 5 mg contains less than 1 mmol of sodium (23 mg) per tablet, which means the medicine is considered "sodium-free".

3. How to use Prestarium 5 mg

This medicine should always be taken exactly as directed by the physician or pharmacist.
In case of 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 dose appropriate for the patient is determined by the doctor.
Recommended doses are as follows:
Hypertension: the usual initial and maintenance dose is 5 mg, taken once daily. After one month of treatment, if necessary, the dose may be increased to 10 mg once daily. A dose of 10 mg per day is the highest recommended dose in hypertension.
In patients aged 65 years or older, the usual initial dose is 2.5 mg, taken once daily. After one month of treatment, the dose may be increased to 5 mg once daily, and subsequently, if necessary, to 10 mg once daily.
Heart failure: the usual initial dose is 2.5 mg, taken once daily. After two weeks of treatment, the dose may be increased to 5 mg once daily. This is the highest recommended dose in heart failure.
Stable coronary artery disease: the usual initial dose is 5 mg, taken 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 taken 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
Use in children and adolescents is not recommended.
Taking more Prestarium 5 mg than recommended
If too many tablets are taken, contact a 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 lay the patient down with elevated legs.
Missed dose of Prestarium 5 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 5 mg
Since treatment with Prestarium 5 mg is long-term, do not discontinue treatment without consulting your doctor.
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 should 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")(uncommon - 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; uncommon - may occur in up to 1 in 100 patients);
• pancreatitis, which may cause severe upper abdominal pain radiating to the back and severe 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 beginning with red, itchy spots 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:
common (may occur in up to 1 in 10 patients):

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

uncommon (may occur in up to 1 in 100 patients):

• depression,
• mood changes,
• sleep disturbances,
• dry mouth,
• severe itching or severe skin rash,
• formation of clusters of blisters on the skin,
• kidney function disorders,
• impotence,
• sweating,
• increased number of eosinophils (a type of white blood cells),
• 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 blood potassium levels, which resolve after stopping treatment, low sodium levels, hypoglycaemia (very low blood sugar levels) in patients with diabetes, increased blood urea levels, increased blood creatinine levels;

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

• acute kidney failure,
• dark-coloured 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, high serum bilirubin levels;

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

• confusion,
• eosinophilic pneumonia (a rare type of pneumonia),
• rhinitis (nasal mucosa inflammation - swelling or nasal discharge),
• blood test abnormalities such as decreased number of white and red blood cells, decreased haemoglobin levels, decreased 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,
numbness and pain in the fingers or toes (Raynaud's phenomenon).
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, you should inform your doctor, pharmacist or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, 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 provide more information on the safety of this medicine.

5. How to store Prestarium 5 mg

Keep this 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 from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Prestarium 5 mg contains

• The active substance is perindopril with arginine. One coated tablet contains 3.395 mg of perindopril (equivalent to 5 mg of perindopril arginine).
• Other ingredients of the tablet core: monohydrate lactose, magnesium stearate, maltodextrin, colloidal anhydrous silica, sodium carboxymethyl starch (type A); coating ingredients: glycerol, hypromellose, copper chlorophyllin complex, macrogol 6000, magnesium stearate, titanium dioxide (E 171).

What Prestarium 5 mg looks like and contents of the pack
Prestarium 5 mg is a light green, elongated, film-coated tablet, marked on one side and with a score line on both sides to facilitate division. The tablet may be divided into halves.
Tablets are available in cardboard packs containing 30 tablets.
For more detailed information, please contact the responsible party or parallel importer.
Marketing Authorisation Holder in Ireland, 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:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź, Poland
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź, Poland
Marketing Authorisation number in Ireland, country of export: PA 0568/002/005
Parallel Import Authorisation Number: 55/20
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Austria Coversum-Arginin 5 mg-Filmtabletten
Belgium COVERSYL 5 mg
Cyprus COVERSYL 5 mg
Czech Republic Prestarium Neo
Denmark COVERSYL NOVUM 5 mg
Estonia Prestarium Arginine 5 mg
Finland COVERSYL NOVUM 5 mg
France COVERSYL 5 mg comprimé pelliculé sécable
Germany COVERSUM Arginin 5 mg
Greece COVERSYL 5 mg
Iceland COVERSYL NOVUM 5 mg
Ireland COVERSYL Arginine 5 mg film-coated tablets
Italy COVERSYL 5 mg
Latvia PRESTARIUM 5 mg
Lithuania PRESTARIUM 5 mg
Luxembourg COVERSYL 5 mg
Malta COVERSYL 5 mg
Netherlands COVERSYL arg 5 mg
Norway PERINDOPRILARGININ SERVIER 5 mg
Poland Prestarium 5 mg
Portugal COVERSYL 5 mg
Slovakia PRESTARIUM A 5 mg
Slovenia BIOPREXANIL 5 mg filmsko obložene tablete
Sweden COVERSYL NOVUM 5 mg
United Kingdom (Northern Ireland) COVERSYL Arginine 5 mg
Translation of the symbols for days of the week appearing on the container:
MON - Monday
TUE - Tuesday
WED - Wednesday
THU - Thursday
FRI - Friday
SAT - Saturday
SUN - Sunday