Prestarium 5 mg

Leaflet attached to the packaging: patient information

Prestarium 5 mg

5 mg, coated tablets

Perindopril arginine

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

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

Table of contents of the leaflet:

• 1. What is Prestarium 5 mg and what is it 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 packaging and other information

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

Prestarium 5 mg is an angiotensin-converting enzyme inhibitor (ACE inhibitor). It works by widening the blood vessels, making it easier for the heart to pump blood. Prestarium 5 mg is used:

• to treat high blood pressure(hypertension);
• to treat heart failure(a condition where the heart is not able to pump enough blood to meet the body's needs);
• to reduce the risk of heart events, such as heart attackin patients with stable coronary artery diseasewho have had a heart attack and/or a procedure to improve blood flow to the heart (stable coronary artery disease is a condition where the blood flow to the heart is reduced or blocked).

2. Important information before taking Prestarium 5 mg

When not to take Prestarium 5 mg:

• if you are allergic to perindopril or any of the other ingredients of this medicine (listed in section 6), or to any other ACE inhibitor;
• if you have had symptoms such as wheezing, swelling of the face, lips, tongue or throat, intense itching or severe skin rash during previous treatment with an ACE inhibitor;

or if you or a member of your family have had these symptoms in other circumstances (a condition called angioedema);

• if you are more than 3 months pregnant (it is also recommended to avoid taking Prestarium 5 mg in early pregnancy - see section on pregnancy);
• if you have diabetes or kidney problems and are taking a blood pressure-lowering medicine containing aliskiren;
• if you are having dialysis or haemofiltration (a type of blood filtration);
• if you have kidney problems that reduce blood flow to the kidneys (renal artery stenosis);
• if you have taken a medicine called sacubitril/valsartan (used to treat heart failure), as the risk of angioedema (rapid swelling of the tissues under the skin, especially around the eyes, lips, tongue or throat) is increased (see "Warnings and precautions" and "Prestarium 5 mg with other medicines").

Warnings and precautions

Before taking Prestarium 5 mg, tell your doctor or pharmacist if any of the following apply to you:

• you have a narrowing of the main blood vessel that carries blood from the heart (aortic stenosis), hypertrophic cardiomyopathy (a heart muscle disease) or a narrowing of the blood vessels that supply the kidneys (renal artery stenosis);
• you have any other heart problems;
• you have liver problems;
• you have kidney problems or are having dialysis;
• you have an increased level of a hormone called aldosterone in your blood (primary aldosteronism);
• you have a collagen disease (such as systemic lupus erythematosus or scleroderma);
• you have diabetes;
• you are on a low-salt diet or taking potassium-sparing diuretics or potassium supplements;
• you are going to have an anaesthetic or surgery;
• you are going to have LDL apheresis (a procedure to remove cholesterol from the blood using a special machine);
• you are going to have desensitization treatment to reduce your allergic reactions to bee or wasp stings;
• you have recently had diarrhoea or vomiting or are dehydrated;
• you have been told that you have an intolerance to some sugars;
• you are taking any of the following medicines used to treat high blood pressure:
• an angiotensin receptor blocker (ARB) (also known as sartans - e.g. valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes;
• aliskiren. Your doctor may monitor your kidney function, blood pressure and electrolyte levels (such as potassium) regularly. See also the information under "When not to take Prestarium 5 mg" and "Warnings and precautions".
• if you are black, there is a higher risk of angioedema and this medicine may be less effective at lowering your blood pressure than in patients of other races.
• if you are taking any of the following medicines, the risk of angioedema is increased:
• racecadotril (used to treat diarrhoea);
• sirolimus, everolimus, temsirolimus and other medicines known as mTOR inhibitors (used to prevent transplant rejection and to treat cancer).

mTOR inhibitors (used to prevent transplant rejection and to treat cancer).

• sacubitril (available in a combination medicine containing sacubitril and valsartan), used to treat chronic heart failure;
• linagliptin, saxagliptin, sitagliptin, vildagliptin and other medicines known as gliptins (used to treat diabetes).

Angioedema
Patients taking ACE inhibitors, including Prestarium 5 mg, have reported angioedema (a severe allergic reaction; symptoms include swelling of the face, lips, tongue or throat, difficulty swallowing or breathing). This reaction can occur at any time during treatment. If you experience these symptoms, stop taking Prestarium 5 mg and contact your doctor immediately. See also section 2 "Warnings and precautions".
If you are pregnant or think you may be pregnant, tell your doctor. Prestarium 5 mg is not recommended in early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Children and adolescents

Prestarium 5 mg is not recommended for children and adolescents under 18 years of age.

Prestarium 5 mg with other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken or might take.
Some medicines can affect the way Prestarium 5 mg works, or Prestarium 5 mg can affect the way other medicines work. Your doctor may need to change the dose or take other precautions when you are taking:

• other medicines used to treat high blood pressure, including ARBs, aliskiren (see also the information under "When not to take Prestarium 5 mg" and "Warnings and precautions") or diuretics;
• potassium-sparing diuretics (e.g. triamterene, amiloride), potassium supplements or salt substitutes containing potassium, other medicines that can increase potassium levels in the body (such as heparin, a medicine used to thin the blood to prevent clots; trimethoprim and cotrimoxazole, also known as a combination medicine containing trimethoprim and sulfamethoxazole, used to treat bacterial infections);
• potassium-sparing diuretics used to treat heart failure: eplerenone and spironolactone at doses of 12.5 mg to 50 mg per day;
• lithium (used to treat mania or depression);
• non-steroidal anti-inflammatory drugs (e.g. ibuprofen) used to relieve pain or high doses of aspirin, a substance found in many medicines used to relieve pain and reduce 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 conditions such as multiple sclerosis);
• medicines used to treat mental disorders, such as depression, anxiety, schizophrenia, etc. (e.g. tricyclic antidepressants, antipsychotics);
• immunosuppressants (medicines that reduce the body's immune response) used to treat autoimmune disorders or used after transplants (e.g. cyclosporine, tacrolimus);
• trimethoprim (used to treat bacterial infections);
• estramustine (used to treat cancer);
• medicines commonly used to treat diarrhoea (racecadotril) or to prevent transplant rejection (sirolimus, everolimus, temsirolimus and other mTOR inhibitors). See "Warnings and precautions";

Prestarium 5 mg with food and drink

It is recommended to take Prestarium 5 mg before a meal.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Women who are pregnant or think they may be pregnant should tell their doctor. Normally, your doctor will advise you to stop taking Prestarium 5 mg before you become pregnant or as soon as you know you are pregnant, and will advise you to take a different medicine instead of Prestarium 5 mg. Prestarium 5 mg is not recommended in early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breastfeeding

Women who are breastfeeding or wish to breastfeed should tell their doctor. Prestarium 5 mg is not recommended for mothers who are breastfeeding, and your doctor may choose a different treatment if you want to breastfeed, especially if your 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 due to low blood pressure. In this case, the ability to drive and use machines may be impaired.

Prestarium 5 mg contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your 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 that it is essentially "sodium-free".

3. How to take Prestarium 5 mg

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Swallow the tablet with a glass of water, preferably at the same time each day, in the morning before breakfast. Your doctor will determine the dose that is right for you.
The recommended doses are as follows:
Hypertension: the usual starting and maintenance dose is 5 mg, taken once a day. After one month of treatment, the dose may be increased to 10 mg once a day if necessary. The maximum recommended dose is 10 mg once a day in hypertension.
In patients over 65 years of age, the usual starting dose is 2.5 mg, taken once a day. After one month of treatment, the dose may be increased to 5 mg once a day, and then to 10 mg once a day if necessary.
Heart failure: the usual starting dose is 2.5 mg, taken once a day. After two weeks of treatment, the dose may be increased to 5 mg once a day. This is the maximum recommended dose in heart failure.
Stable coronary artery disease: the usual starting dose is 5 mg, taken once a day. After two weeks of treatment, the dose may be increased to 10 mg once a day. This is the maximum recommended dose in this indication.
In patients over 65 years of age, the usual starting dose is 2.5 mg, taken once a day. After one week of treatment, the dose may be increased to 5 mg once a day, and then to 10 mg once a day after another week.

Use in children and adolescents

Prestarium 5 mg is not recommended for children and adolescents.

Overdose

If you have taken more tablets than you should, contact your 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 this case, it is helpful to lay the patient down with their legs raised.

Missed dose

It is important to take your medicine regularly, as this will help you get the most benefit from it.
Take the missed dose as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for a forgotten dose.

Stopping treatment

Because treatment with Prestarium 5 mg is long-term, do not stop taking your medicine without consulting your doctor first.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, Prestarium 5 mg can cause side effects, although not everybody gets them.

Stop taking Prestarium 5 mg and contact your doctor immediately if you experience any of the following serious side effects:

any of the following serious side effects, which may be serious:

• 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 can 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 can cause severe abdominal pain and very poor general health (very rare - may affect up to 1 in 10,000 people);
• yellowing of the skin or eyes (jaundice), which can be a sign of liver inflammation (very rare - may affect up to 1 in 10,000 people);
• rash, often starting with red, itchy patches on the face, arms or legs (erythema multiforme; very rare - may affect up to 1 in 10,000 people).

Tell your doctor if you experience any of the following side effects:

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

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

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

• depression,
• mood changes,
• sleep disturbances,
• dry mouth,
• intense itching or severe rash,
• formation of blisters on the skin,
• kidney problems,
• impotence,
• sweating,
• increased levels of eosinophils (a type of white blood cell),
• drowsiness,
• fainting,
• palpitations,
• tachycardia,
• vasculitis,
• photosensitivity reaction (increased sensitivity of the skin to sunlight),
• joint pain,
• muscle pain,
• chest pain,
• malaise,
• peripheral oedema,
• fever,
• falls,
• abnormal laboratory test results: high levels of potassium in the blood, transient after stopping treatment, low levels of sodium, hypoglycaemia (very low blood sugar levels) in diabetic patients, increased levels of urea in the blood, increased levels of creatinine in the blood;

rare (may affect up to 1 in 1,000 people):

• acute renal failure,
• dark urine, nausea or vomiting, muscle cramps, disorientation and seizures. These may be signs of a condition called SIADH (inappropriate antidiuretic hormone secretion).
• reduced or absent urine production,
• sudden reddening of the face and neck,
• worsening of psoriasis,
• abnormal laboratory test results: increased liver enzyme activity, high levels of bilirubin in the blood;

very rare (may affect up to 1 in 10,000 people):

• disorientation,
• eosinophilic pneumonia (a rare type of pneumonia),
• nasal congestion (swelling or discharge from the nose),
• blood test abnormalities, such as decreased white blood cell count, decreased red blood cell count, decreased haemoglobin, decreased platelet count.

If you experience any of these symptoms, contact your doctor immediately.
Frequency not known (frequency cannot be estimated from the available data): cyanosis, numbness and pain in the fingers and toes (Raynaud's phenomenon).

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly to the national reporting system via the Medicines and Healthcare products Regulatory Agency (MHRA) Yellow Card Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Prestarium 5 mg

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after "EXP" (the expiry date is the last day of the month stated).
The packaging is labelled with a "Lot" number, which is the batch number of the medicine.
Keep the container tightly closed to protect from moisture.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the packaging and other information

What Prestarium 5 mg contains

• The active substance is perindopril arginine. Each coated tablet contains 3.395 mg of perindopril (which corresponds to 5 mg of perindopril arginine).
• The other ingredients of the tablet core are: lactose monohydrate, magnesium stearate, maltodextrin, hydrophobic colloidal silica, sodium carboxymethylcellulose (type A); the coating ingredients are: glycerol, hypromellose, chlorophyllin copper complex, macrogol 6000, magnesium stearate, titanium dioxide (E171).

What Prestarium 5 mg looks like and contents of the pack

Prestarium 5 mg is a light green, elongated, coated tablet with a score line on both sides. The tablet can be divided into two equal doses.
The tablets are available in packs of 30, 60 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
ANPHARM Przedsiębiorstwo Farmaceutyczne S.A.
ul. Annopol 6B
03-236 Warszawa

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 oblozene tablete
Sweden
COVERSYL NOVUM 5 mg
United Kingdom
(Northern Ireland)
COVERSYL Arginine 5 mg
To obtain more detailed information, contact the representative of the marketing authorisation holder:
Servier Polska Sp. z o.o.
Phone: (22) 594-90-00

Date of last revision of the leaflet: