Prestilol

Package Leaflet: Information for the Patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Prestilol (Cosyrel), 5 mg + 10 mg, Film-Coated Tablets

Bisoprolol Fumarate + Perindopril Arginine
Prestilol and Cosyrel are different trade names for the same medicine.

Before Taking the Medicine, Carefully Read the Contents of the Leaflet, as it Contains Important Information for the Patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

• 1. What is Prestilol and what is it used for
• 2. Important information before taking Prestilol
• 3. How to take Prestilol
• 4. Possible side effects
• 5. How to store Prestilol
• 6. Contents of the pack and other information

1. What is Prestilol and what is it used for

Prestilol contains two active substances in one tablet: bisoprolol fumarate and perindopril arginine.

• Bisoprolol fumarate belongs to a group of medicines called beta-blockers. Beta-blockers slow the heart rate and make the heart more efficient at pumping blood throughout the body.
• Perindopril arginine is an angiotensin-converting enzyme inhibitor (ACE inhibitor). It works by widening blood vessels, making it easier for the heart to pump blood.

Prestilol is used to treat high blood pressure (hypertension) and/or to reduce the risk of heart events, such as heart attack, in patients with stable coronary artery disease (a condition where the blood supply to the heart is reduced or blocked) who have had a heart attack and/or have undergone a surgical procedure to improve blood supply to the heart by widening the blood vessels that supply it.

2. Important information before taking Prestilol

When not to take Prestilol:

• if the patient is allergic to bisoprolol or any other beta-blocker, to perindopril or any other ACE inhibitor, or to any of the other ingredients of this medicine (listed in section 6);
• if the patient has heart failure that is worsening and requires hospital treatment;
• if the patient has cardiogenic shock (a serious heart condition that causes very low blood pressure);

if the patient has a heart condition characterized by slow or irregular heartbeats (second- or third-degree atrioventricular block, sinoatrial block, sick sinus syndrome);

• if the patient has a slow heart rate;
• if the patient has very low blood pressure;
• if the patient has severe asthma or severe chronic obstructive pulmonary disease (COPD);
• if the patient has severe circulatory problems in the limbs (such as Raynaud's syndrome), which can cause tingling or blanching or cyanosis of the fingers and toes;
• if the patient has an untreated pheochromocytoma (a rare tumor of the adrenal gland);
• if the patient has metabolic acidosis, a condition where the blood contains too much acid;
• if the patient has experienced symptoms such as wheezing, facial swelling, tongue or throat swelling, difficulty swallowing or breathing during previous treatment with an ACE inhibitor, or if such symptoms have occurred in a family member in any other circumstances (a condition called angioedema);
• if the patient is pregnant for more than 3 months (it is also recommended to avoid taking Prestilol during early pregnancy - see "Pregnancy");
• if the patient has diabetes or kidney problems and is taking a blood pressure-lowering medicine containing aliskiren;
• if the patient is undergoing dialysis or blood filtration by another method. Depending on the device used, Prestilol may not be suitable for the patient;
• if the patient has kidney problems that reduce 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, as the risk of angioedema (rapid swelling of tissues under the skin in the area of the throat) increases (see "Warnings and precautions" and "Prestilol and other medicines").

Warnings and precautions

Before starting to take Prestilol, discuss it with your doctor or pharmacist if:

• the patient has diabetes;
• the patient has kidney problems (including patients who have had a kidney transplant) or is undergoing dialysis;
• there are liver problems;
• the patient has a narrowing of the aortic or mitral valve and aortic stenosis (narrowing of the main blood vessel leading from the heart), hypertrophic cardiomyopathy (a heart muscle disease), or narrowing of the renal arteries (arteries that supply the kidneys with blood);
• the patient has abnormally high levels of a hormone called aldosterone in the blood (primary aldosteronism);
• the patient has heart failure or other heart diseases, such as arrhythmias or severe chest pain at rest (Prinzmetal's angina);
• the patient has collagenosis (a disease of connective tissue), such as systemic lupus erythematosus or scleroderma;
• the patient is on a low-salt diet or uses salt substitutes containing potassium (high potassium levels in the blood can cause changes in heart rate);
• the patient has recently had diarrhea or vomiting, or is dehydrated (Prestilol can cause a drop in blood pressure);
• the patient is undergoing LDL apheresis (removal of cholesterol from the blood using a special device);
• the patient is undergoing desensitization treatment to reduce allergic reactions to bee or wasp stings;
• the patient is fasting or on a diet;
• the patient is undergoing anesthesia and/or surgery;
• the patient has circulatory problems in the limbs;
• the patient has asthma or COPD;
• the patient has (or has had) psoriasis;
• the patient has an adrenal gland tumor (pheochromocytoma);
• the patient has thyroid problems (Prestilol may mask symptoms of hyperthyroidism);
• angioedema (a severe allergic reaction characterized by swelling of the face, lips, tongue, or throat, difficulty swallowing or breathing). This reaction can occur at any time during treatment. If the patient experiences such symptoms, they should stop taking Prestilol and contact their doctor immediately;
• in black patients, there is a higher risk of angioedema, and this medicine may be less effective in lowering blood pressure than in patients of other races.
• the patient is taking any of the following medicines used to treat high blood pressure:
• angiotensin II receptor antagonist (ARB) (also known as sartans - e.g., valsartan, telmisartan, irbesartan), especially if the patient has diabetic kidney problems;
• aliskiren. The doctor may monitor kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood at regular intervals. See also the information under the heading "When not to take Prestilol" and "Warnings and precautions".
• the patient is taking any of the following medicines, which increase the risk of angioedema:
• racecadotril (used to treat diarrhea);
• sirolimus, everolimus, temsirolimus, and other medicines belonging to the group of medicines called mTOR inhibitors (used to prevent rejection of transplanted organs and to treat cancer);
• sacubitril (available in a combination medicine containing sacubitril and valsartan), used to treat chronic heart failure. See points "When not to take Prestilol" and "Warnings and precautions";
• linagliptin, saxagliptin, sitagliptin, wildagliptin, and other medicines belonging to the group of medicines called gliptins (used to treat diabetes).

Do not stop taking Prestilol suddenly, as this can cause severe worsening of heart function. Treatment should not be stopped suddenly, especially in patients with coronary artery disease.

Children and adolescents

Prestilol is not recommended for children and adolescents under 18 years of age.

Prestilol and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take.

• medicines used to control blood pressure or heart diseases (such as amiodarone, amlodipine, clonidine, digitalis glycosides, diltiazem, disopyramide, felodipine, flecainide, lidocaine, methyldopa, moxonidine, procainamide, propafenone, quinidine, rilmenidine, verapamil);
• other medicines used to treat high blood pressure, including angiotensin II receptor antagonists (ARBs), aliskiren (see also the information under the heading "When not to take Prestilol" and "Warnings and precautions"), or diuretics (medicines that increase urine production);
• potassium-sparing medicines (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 clotting, trimethoprim, and cotrimoxazole, also known as a combination medicine containing trimethoprim and sulfamethoxazole, used to treat bacterial infections);

Prestilol is usually taken before a meal.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.

3. How to take Prestilol

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

The recommended dose is one tablet once a day. The tablet should be swallowed with a glass of water, in the morning before a meal.

In some cases, the doctor may recommend taking half a tablet of Prestilol once a day, in the morning before a meal.

Patients with kidney disease

Prestilol is not recommended for patients with moderate or severe kidney disease.

Overdose

If you have taken more tablets than you should, contact your doctor or pharmacist immediately.

Missed dose

It is important to take the medicine regularly, every day, for it to work better. If you miss a dose of Prestilol, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

Stopping treatment

Do not stop taking Prestilol suddenly or change the dose without consulting your doctor, as this can cause significant worsening of heart function. Do not stop treatment suddenly, especially in patients with coronary artery disease.

4. Possible side effects

Like all medicines, Prestilol can cause side effects, although not everybody gets them.

Stop taking the medicine and contact your doctor immediately if you experience any of the following side effects:

serious side effects:

• severe dizziness or fainting due to low blood pressure (common - may affect up to 1 in 10 people);
• worsening of heart failure, causing severe shortness of breath and/or fluid retention (common - may affect up to 1 in 10 people);
• swelling of the face, lips, mouth, tongue, or throat, difficulty breathing (angioedema; uncommon - may affect up to 1 in 100 people);
• sudden onset of wheezing, chest pain, shortness of breath, or difficulty breathing (bronchospasm; uncommon - may affect up to 1 in 100 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 may be a sign of a stroke (very rare - may affect up to 1 in 10,000 people);
• pancreatitis, which can cause severe abdominal pain, radiating to the back, and very poor general condition (very rare - may affect up to 1 in 10,000 people);
• jaundice (yellowing of the skin or eyes), which can be a sign of liver inflammation (very rare - may affect up to 1 in 10,000 people);
• a 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).

Prestilol is usually well-tolerated, but like other medicines, it can cause side effects, especially at the beginning of treatment.

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

very common (may affect more than 1 in 10 people):

• slow heart rate.

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

• headache;
• dizziness;
• disturbances of taste;
• tingling;
• numbness of the arms or legs;
• visual disturbances;
• tinnitus (ringing in the ears);
• feeling of coldness in the arms or legs;
• cough;
• shortness of breath;
• gastrointestinal disorders, such as nausea, vomiting, abdominal pain, indigestion, or difficulty digesting, diarrhea, constipation;
• allergic reactions, such as rash, itching;
• muscle cramps;
• feeling of fatigue;
• weakness.

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

• mood changes;
• sleep disturbances;
• depression;
• dry mouth;
• increased itching or severe skin rash;
• formation of blisters on the skin;
• increased sensitivity of the skin to light (photosensitivity reaction);
• sweating;
• kidney disease;
• impotence;
• increased eosinophil count (a type of white blood cell);
• drowsiness;
• fainting;
• palpitations;
• tachycardia;
• irregular heart rhythm (conduction disorders);
• vasculitis;
• orthostatic hypotension;
• muscle weakness;
• joint pain;
• muscle pain;
• chest pain;
• general feeling of being unwell;
• peripheral edema;
• fever;
• falls;
• changes in laboratory test results: high potassium levels in the blood, transient after stopping treatment, low sodium levels, hypoglycemia (very low blood sugar) in patients with diabetes, increased urea levels in the blood, increased creatinine levels in the blood.

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

• acute kidney failure;
• dark urine, nausea, or vomiting, muscle cramps, disorientation, and seizures. These may be symptoms of a condition called SIADH (inappropriate antidiuretic hormone secretion);
• reduced or absent urine production;
• sudden flushing of the face and neck;
• nightmares, hallucinations;
• reduced tear production (dry eyes);
• hearing problems;
• liver inflammation, which can cause yellowing of the skin or eyes;
• allergic rhinitis, sneezing;
• reactions resembling allergy: itching, flushing, rash;
• worsening of psoriasis;
• changes in laboratory test results: increased liver enzyme activity, high bilirubin levels in the blood, abnormal lipid levels in the blood.

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

• disorientation;
• irritation and redness of the eyes (conjunctivitis);
• eosinophilic pneumonia (a rare type of pneumonia);
• pancreatitis (which can cause severe abdominal pain, radiating to the back);
• hair loss;
• onset or worsening of psoriasis, psoriasiform rash;
• changes in blood test results, such as decreased white blood cell count, decreased red blood cell count, decreased hemoglobin levels, decreased platelet count.

frequency not known (cannot be estimated from the available data):

• blue discoloration, numbness, and pain in the fingers and toes (Raynaud's phenomenon).

If you experience any of these symptoms, contact your doctor as soon as possible.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring 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.

5. How to store Prestilol

Keep this medicine out of the 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 month stated.

No special precautions for storage are necessary.

After first opening the container with 30 film-coated tablets of Prestilol, use within 60 days.

Medicines should 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 Prestilol contains

• The active substances are bisoprolol fumarate and perindopril arginine. Each Prestilol tablet contains 5 mg of bisoprolol fumarate, equivalent to 4.24 mg of bisoprolol, and 10 mg of perindopril arginine, equivalent to 6.790 mg of perindopril.
• The other ingredients are: tablet core: microcrystalline cellulose PH 102, calcium carbonate, maize starch, sodium carboxymethylcellulose (type A), colloidal anhydrous silica, magnesium stearate, croscarmellose sodium; tablet coating: glycerol, hypromellose, macrogol 6000, magnesium stearate, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172).

What Prestilol looks like and contents of the pack

Prestilol is a pink-beige, elongated, biconvex, film-coated tablet with a score line, engraved with "
" on one side and "5/10" on the other side of the tablet.

The tablet can be divided into two equal doses.

The tablets are available in a container containing 30 tablets, packed in a cardboard box.

For more information, contact the Marketing Authorization Holder or the Parallel Importer.

Marketing Authorization Holder in the Czech Republic, the country of export:

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)

Moneylands - Gorey Road – Arklow

Co. Wicklow

Ireland

Anpharm Pharmaceutical Company S.A.

Annopol 6b

03-236 Warsaw

Poland

EGIS Pharmaceuticals PLC

H-9900 Körmend, Mátyás király u.65

Hungary

Parallel Importer:

InPharm Sp. z o.o.

Strumykowa 28/11

03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.

Chełmżyńska 249

04-458 Warsaw

Marketing Authorization Number in the Czech Republic, the country of export:58/564/15-C

Parallel Import Authorization Number:396/21

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Belgium

Bipressil 5 mg/10 mg film-coated tablets

Bulgaria

Prestilol 5 mg/10 mg film-coated tablets

Croatia

Prestilol 5 mg/10 mg film-coated tablets

Cyprus

Cosyrel 5 mg/10 mg film-coated tablets

Czech Republic

Cosyrel 5 mg/10 mg film-coated tablets

Estonia

Prestilol

Finland

Cosyrel 5 mg/10 mg film-coated tablets

France

Cosimprel 5 mg/10 mg film-coated tablets

Greece

Cosyrel 5 mg/10 mg film-coated tablets

Hungary

Cosyrel 5 mg/10 mg film-coated tablets

Ireland

Cosimprel 5 mg/10 mg film-coated tablets

Italy

Cosyrel+c

Latvia

Prestilol 5 mg/10 mg film-coated tablets

Lithuania

Cosimprel 5 mg/10 mg film-coated tablets

Luxembourg

Bipressil 5 mg/10 mg film-coated tablets

Netherlands

Cosimprel 5 mg/10 mg film-coated tablets

Poland

Prestilol

Portugal

Cosyrel 5 mg/10 mg

Romania

Cosyrel 5 mg/10 mg film-coated tablets

Slovakia

Prestilol 5 mg/10 mg film-coated tablets

Slovenia

Cosyrel 5 mg/10 mg film-coated tablets

Date of approval of the leaflet: 26.04.2023

[Information about the trademark]