Prestarium 2.5 mg

Package leaflet: Information for the patient

Prestarium 2.5 mg
2.5 mg, film-coated tablets
Perindopril arginine
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

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

Leaflet contents:

1. What Prestarium 2.5 mg is and what it is used for
2. What you need to know 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 pack and other information

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

Prestarium 2.5 mg is an angiotensin-converting enzyme (ACE) inhibitor. It works by widening blood vessels, which helps the heart pump blood more easily.
Prestarium 2.5 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 previous heart attack and/or a procedure to improve blood supply to the heart (stable coronary artery disease is a condition in which blood supply 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 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 angioedema (a type of swelling) occurred during previous treatment with an ACE inhibitor, 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 ever had such symptoms under other circumstances (a condition known as hereditary angioedema);
• if the patient is more than 3 months pregnant (it is also better to avoid using Prestarium 2.5 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 another form of blood filtration. Depending on the equipment used, Prestarium 2.5 mg may not be suitable for the patient;
• if the patient has kidney problems causing reduced 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, because this increases the risk of angioedema (rapid swelling of tissues under the skin, particularly around the throat) (see "Warnings and precautions" and "Prestarium 2.5 mg and other medicines").

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

• if the patient has 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);
• if the patient has any other heart diseases;
• if the patient has liver disease;
• if the patient has kidney disease or is undergoing dialysis;
• if the patient has abnormally high levels of a hormone called aldosterone in the blood (primary hyperaldosteronism);
• if the patient has collagenosis (a connective tissue disease), such as systemic lupus erythematosus or scleroderma;
• if the patient has diabetes;
• if the patient is on a low-salt diet or uses salt substitutes containing potassium;
• if the patient is undergoing anaesthesia and/or surgery;
• if the patient is undergoing LDL apheresis (removal of cholesterol from the blood using a special device);
• if the patient is undergoing desensitisation treatment to reduce allergic reactions to bee or wasp stings;
• if the patient has recently had diarrhoea or vomiting, or is dehydrated;
• if the patient has been diagnosed with intolerance to certain sugars;
• if the patient is taking any of the following medicines used to treat high blood pressure:
  • an angiotensin II receptor antagonist (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 blood electrolyte levels (e.g. potassium) at regular intervals. See also information under the heading "When not to take Prestarium 2.5 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 2.5 mg. This reaction may occur at any time during treatment. If such symptoms occur, stop taking Prestarium 2.5 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 2.5 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 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 2.5 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 2.5 mg. Your 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 2.5 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 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 to treat heart failure: 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, as well as for preventing blood clots;
• medicines used to treat diabetes (such as insulin or metformin);
• baclofen, used to treat muscle stiffness in conditions 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 organ transplants (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 take Prestarium 2.5 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, noradrenaline or adrenaline);
• gold salts, particularly when administered intravenously (used to treat symptoms of rheumatoid arthritis).

Prestarium 2.5 mg with food and drink
It is recommended to take Prestarium 2.5 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 taking 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 2.5 mg before pregnancy or as soon as pregnancy is confirmed, and will recommend an alternative medicine instead of Prestarium 2.5 mg. Prestarium 2.5 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
Inform your doctor if you are breastfeeding or plan to breastfeed. Prestarium 2.5 mg is not recommended for mothers who are breastfeeding. The doctor may choose another treatment if the patient wishes to breastfeed, especially if the baby is a newborn or was born prematurely.

Driving and operating machinery
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 or operate machinery may be impaired.

Prestarium 2.5 mg contains lactose
If the patient has been told by a doctor that they have an intolerance to certain sugars, they should consult their 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, meaning the medicine is considered "sodium-free".

3. How to use Prestarium 2.5 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 starting 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 daily is the highest recommended dose for hypertension.
In patients aged 65 years or older, the usual starting 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 starting 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 for heart failure.
Stable coronary artery disease: the usual starting 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 starting 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 2.5 mg than recommended
If too many tablets are taken, 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 lay the patient down with their legs raised.
Missing a dose of Prestarium 2.5 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 Prestarium 2.5 mg
Since treatment with Prestarium 2.5 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 effects

Like all medicines, this medicine can cause adverse effects, although not everybody will get them.
Stop taking this medicine and contact your doctor immediately if any of the following adverse 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 pectoris) or heart attack (very rare - may occur in up to 1 in 10,000 patients);
• sudden 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);
• inflammation of the pancreas, 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);
• rash, often starting with red, itchy spots on the face, arms or legs (erythema multiforme; very rare - may occur in up to 1 in 10,000 patients).

Inform your doctor if any of the following adverse effects occur in the patient:

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 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 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 potassium levels in blood, transient and resolving upon 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-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),
• decreased or absence of urine output,
• sudden redness of the face and neck,
• worsening of psoriasis,
• abnormal laboratory test results: increased liver enzyme activity, high bilirubin levels in serum;

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; nasal swelling or discharge),
• blood count changes such as decreased number of white and red blood cells, decreased haemoglobin levels, decreased platelet count.

If any of these symptoms occur, 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 effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Prestarium 2.5 mg

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after the word "EXP"
(the abbreviation used to describe the expiry date). The expiry date refers to the last day of the stated month.
The word "Lot" on the packaging indicates the batch number of the medicine.
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 in use. Such measures help protect the environment.

6. Contents of the pack and other information

What Prestarium 2.5 mg contains

• The active substance is perindopril with arginine. One coated tablet contains 1.6975 mg of perindopril (equivalent to 2.5 mg of perindopril arginine).
• Other components of the tablet core: lactose monohydrate, magnesium stearate, maltodextrin, colloidal anhydrous silica, sodium carboxymethyl starch (type A); coating components: 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, convex coated tablet. Tablets are available in cartons containing 30 or 90 tablets.
Marketing Authorisation 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 authorised in the European Economic Area countries 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
Slovak Republic PRESTARIUM A 2.5 mg
Slovenia BIOPREXANIL 2.5 mg filmsko oblozene tablete
Sweden COVERSYL NOVUM 2.5 mg
United Kingdom COVERSYL Arginine 2.5 mg
(Northern Ireland)
For further information, please contact the representative of the marketing authorisation holder:
Servier Polska Sp. z o.o.
Telephone number: (22) 594-90-00