Prestarium 5 mg

Package leaflet: Information for the patient

Warning! Keep the leaflet! Information on the immediate packaging is in a foreign language.
Prestarium 5 mg (Prestarium Neo)
5 mg, film-coated tablets
Perindoprilum argininum
Prestarium 5 mg and Prestarium Neo are different trade names for the same medicinal product.
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for possible future reference.
• 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. It may harm someone else, 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:

1. What Prestarium 5 mg is and what it is used for
2. Important information 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, thereby making it easier for the heart to pump blood.
Prestarium 5 mg is used:

• for the treatment of high blood pressure (hypertension);
• for 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 cardiovascular events such as heart attack in patients with stable coronary artery disease who have had a 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 5 mg

When not to use 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 the patient has previously experienced symptoms such as wheezing, facial, tongue or throat swelling, severe itching, or severe skin rash while being treated with an ACE inhibitor;
• if the patient or a family member has ever experienced 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 5 mg in early pregnancy - see section on pregnancy);
• if the patient has diabetes or kidney function disorders and is being treated with a blood pressure-lowering drug containing aliskiren;
• if the patient is undergoing dialysis or another form of blood filtration. Depending on the device used, Prestarium 5 mg may not be suitable for the patient;
• if the patient has kidney disorders 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, as this increases the risk of angioedema (rapid swelling of tissues under the skin around the throat) (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 collagenosis (connective tissue disease), such as systemic lupus erythematosus or scleroderma;
• the patient has diabetes;
• the patient is on a low-salt diet or uses potassium-containing salt substitutes;
• 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 desensitization therapy 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 disorders 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 5 mg".
• patients of black race have a higher risk of developing angioedema, and this medicine may be less effective in lowering blood pressure compared to 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
Angioedema (a severe allergic reaction; symptoms include swelling of the face, lips, tongue or throat, difficulty 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, stop taking Prestarium 5 mg immediately and contact your 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 section on pregnancy).

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
Inform 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. Your 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 the headings "When not to use 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 clotting; 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 in 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 responses) 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 the 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 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 plans to become pregnant, 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 using another medicine instead of Prestarium 5 mg. Prestarium 5 mg is not recommended in 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 after the third month of pregnancy.

Breastfeeding
Inform the doctor if the patient is breastfeeding or plans to breastfeed. Prestarium 5 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 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 informed by a doctor of an intolerance to certain sugars, they should consult the doctor before using this medicine.

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

3. How to use Prestarium 5 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 a meal.
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 daily dose of 10 mg 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 subsequently, if necessary, to 10 mg once daily.
Heart failure: the usual initial dose is 2.5 mg once daily. After two weeks of treatment, the dose may be increased to 5 mg once daily. This is the maximum recommended dose in heart failure.
Stable coronary artery disease: 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 maximum 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
Use in children and adolescents is not recommended.

Taking more Prestarium 5 mg than recommended
If too many tablets have been 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, placing the patient in a lying position with legs elevated may be helpful.

Missing a dose of Prestarium 5 mg
It is important to take the medicine regularly, as this ensures optimal effectiveness.
If a dose is missed, it should be taken 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 treatment with Prestarium 5 mg
Since treatment with Prestarium 5 mg is long-term, do not stop taking the medicine without consulting your doctor.
If you have any further 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 will experience them.
You must stop taking this 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 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);
• muscle weakness in 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 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 side effects 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 rashes, 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 rashes,
• 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 potassium levels in blood, transient after discontinuation of 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 urine, nausea or vomiting, muscle cramps, disorientation and convulsions. 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,
• exacerbation 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):

• disorientation,
• eosinophilic pneumonia (a rare type of lung inflammation),
• rhinitis (nasal mucosa inflammation; swelling or nasal discharge),
• blood count abnormalities, such as decreased number of white blood cells and red blood cells, decreased haemoglobin concentration, 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 fingers of hands or feet (Raynaud's phenomenon).

Reporting of side effects
If any side effects occur, including any side effects not listed in this leaflet, inform your doctor,
pharmacist or nurse. Side effects can also be reported directly to the Department for Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Poland, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting side effects 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 container. 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. Such measures will help protect the environment.

6. Contents of the pack and other information

What Prestarium 5 mg contains

• The active substance is perindopril arginine. One coated tablet contains 5 mg of perindopril arginine (equivalent to 3.395 mg of perindopril).
• Other ingredients in the tablet are: monohydrate lactose, magnesium stearate, maltodextrin, colloidal anhydrous silica, sodium carboxymethyl starch (type A); coating ingredients: glycerol, hypromellose, chlorophyllin copper 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 coated tablet, marked on one side and with a score line on both sides to facilitate splitting. The tablet may be divided into halves.
Prestarium 5 mg is available in boxes containing 30, 60 or 90 coated tablets.
For further information, please contact the marketing authorisation holder or the parallel importer.

Marketing authorisation holder in the Czech Republic, country of export:
Les Laboratoires Servier, 50, rue Carnot, 92284 Suresnes cedex, France

Manufacturers:
Anpharm Przedsiębiorstwo Farmaceutyczne S.A., ul. Annopol 6B, 03-236 Warszawa, Poland
Les Laboratoires Servier Industrie
905 route de Saran, 45520 Gidy, France
Servier (Ireland) Industries Ltd
Gorey Road, Arklow - Co. Wicklow, Ireland

Parallel importer:
InPharm Sp. z o.o., ul. Strumykowa 28/11, 03-138 Warszawa

Repackaged in:
InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warszawa

Marketing authorisation number in the Czech Republic, country of export: 58/162/05-C
Parallel import authorisation number: 306/20

Translation of weekday symbols appearing on the immediate packaging:
PO - Monday
ÚT - Tuesday
ST - Wednesday
ČT - Thursday
PÁ - Friday
SO - Saturday
NE - Sunday

This medicinal product is authorised for sale in 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 oblozene tablete
Sweden COVERSYL NOVUM 5 mg
United Kingdom (Northern Ireland) COVERSYL Arginine 5 mg