Prestilol

Leaflet accompanying the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Prestilol (Cosimprel)

5 mg + 10 mg, coated tablets

Bisoprolol fumarate + Perindopril arginine
Prestilol and Cosimprel are different trade names for the same medicine.

It is essential to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, the patient should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform 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. Package contents 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 down 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 the 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 attacks, in patients with stable coronary artery disease (a condition where the blood supply to the heart is reduced or blocked) and who have had a heart attack and/or 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, perindopril or any other ACE inhibitor, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has heart failure that is worsening rapidly and/or requires hospital treatment;
• if the patient has cardiogenic shock (a severe heart condition that causes very low blood pressure);
• if the patient has a heart condition characterized by slow or irregular heart rhythm (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;
• if the patient has severe circulatory disorders 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 many acids;
• 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;
• if the patient is pregnant for more than 3 months (it is also recommended to avoid taking Prestilol in early pregnancy - see "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 blood filtration using a different 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 treatment with Prestilol, the patient should discuss the following with their doctor or pharmacist:

• if the patient has diabetes;
• if the patient has kidney problems (including patients who have had a kidney transplant) or is undergoing dialysis;
• if the patient has liver problems;
• if the patient has a narrowing of the aortic or mitral valve and/or hypertrophic cardiomyopathy (a heart muscle disease) or renal artery stenosis (narrowing of the arteries that supply the kidneys with blood);
• if the patient has an abnormally high level of a hormone called aldosterone in the blood (primary aldosteronism);
• if the patient has heart failure or other heart conditions, such as arrhythmias or severe chest pain at rest (Prinzmetal's angina);
• if the patient has a connective tissue disease, such as systemic lupus erythematosus or scleroderma;
• if the patient is on a low-salt diet or uses salt substitutes that contain potassium (high levels of potassium in the blood can cause changes in heart rate);
• if the patient has recently experienced diarrhea or vomiting, or is dehydrated (Prestilol can cause a drop in blood pressure);
• if the patient is undergoing LDL apheresis (removal of cholesterol from the blood using a special device);
• if the patient is undergoing desensitization treatment to reduce allergic reactions to bee or wasp stings;
• if the patient is fasting or on a diet;
• if the patient is undergoing anesthesia and/or surgery;
• if the patient has circulatory disorders in the limbs;
• if the patient has asthma or chronic obstructive pulmonary disease;
• if the patient has (or has had) psoriasis;
• if the patient has an adrenal gland tumor (pheochromocytoma);
• if the patient has thyroid problems (Prestilol can mask symptoms of hyperthyroidism);
• if the patient experiences 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.
• if the patient is of black race, as there is a higher risk of angioedema, and the 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 used to treat high blood pressure:
• angiotensin receptor blockers (ARBs) (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 "When not to take Prestilol" and "Warnings and precautions".
• if the patient is taking any of the following medicines, which can 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 "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).

The patient should 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

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

• medicines used to control blood pressure or heart conditions (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 receptor blockers (ARBs), aliskiren (see also "When not to take Prestilol" and "Warnings and precautions"), or diuretics (medicines that increase the amount of urine produced by the kidneys);
• 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);
• potassium-sparing medicines used to treat heart failure: eplerenone and spironolactone at doses of 12.5 mg to 50 mg per day;
• sympathomimetic medicines used to treat shock (adrenaline, noradrenaline, dobutamine, isoprenaline, ephedrine);
• estramustine used to treat cancer;
• medicines used to treat diarrhea (racecadotril) or to prevent rejection of transplanted organs (sirolimus, everolimus, temsirolimus, and other medicines belonging to the group of medicines called mTOR inhibitors). See "Warnings and precautions".
• a combination medicine containing sacubitril and valsartan (used to treat chronic heart failure). See "When not to take Prestilol" and "Warnings and precautions".
• lithium used to treat mania or depression;
• certain medicines used to treat depression, such as imipramine, amitriptyline, monoamine oxidase inhibitors (MAOIs; except MAO-B inhibitors);
• certain medicines used to treat schizophrenia (antipsychotic medicines);
• certain medicines used to treat epilepsy (phenytoin, barbiturates, such as phenobarbital);
• anesthetics used in surgical procedures;
• vasodilators, including nitrates (medicines that cause blood vessels to widen);
• trimethoprim used to treat infections;
• immunosuppressants (medicines that reduce the body's immune response), such as cyclosporine, tacrolimus, used to treat autoimmune disorders or after organ transplantation;
• allopurinol used to treat gout;
• parasympathomimetic medicines used to treat conditions such as Alzheimer's disease or glaucoma;
• topically administered beta-blockers used to treat glaucoma (increased pressure in the eye);
• mefloquine used to prevent or treat malaria;
• baclofen used to treat muscle stiffness in conditions such as multiple sclerosis;
• gold salts, especially when administered intravenously (used to treat symptoms of rheumatoid arthritis);
• medicines used to treat diabetes, such as insulin, metformin, linagliptin, saxagliptin, sitagliptin, wildagliptin;
• non-steroidal anti-inflammatory medicines (NSAIDs), such as ibuprofen, diclofenac, or high doses of acetylsalicylic acid, used to treat arthritis, headache, pain, or inflammation.

Prestilol with food and drink

Prestilol should be taken before a meal.

Pregnancy and breastfeeding

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

Pregnancy

The patient should tell their doctor if they think they are (or may be) pregnant. The doctor will usually advise stopping Prestilol before becoming pregnant or as soon as the patient finds out they are pregnant and will prescribe a different medicine instead of Prestilol. Prestilol is not recommended in early pregnancy and should not be taken if the patient is pregnant for more than 3 months, as the medicine may cause serious harm to the baby if taken after the third month of pregnancy.

Breastfeeding

The patient should tell their doctor if they are breastfeeding or plan to breastfeed. Prestilol is not recommended for breastfeeding mothers, and the doctor may choose a different treatment if the patient wants to breastfeed, especially if the baby is a newborn or was born prematurely.

Driving and using machines

Prestilol usually does not affect alertness, but some patients may experience dizziness or weakness due to low blood pressure, especially at the start of treatment or when changing the medicine or in combination with alcohol. In such cases, the ability to drive or operate machinery may be impaired.

Prestilol contains sodium

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

3. How to take Prestilol

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.

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

In some cases, the doctor may prescribe half a tablet of Prestilol per day, in the morning before a meal.

Patients with kidney disease

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

Use in children and adolescents

Prestilol is not recommended for children and adolescents.

Taking a higher dose of Prestilol than recommended

If the patient has taken more tablets than prescribed, they should contact their doctor or pharmacist immediately.

The most likely symptom of an overdose is a drop in blood pressure, which can cause dizziness or fainting (if this happens, it can be helpful to lay the patient down with their legs raised), severe breathing difficulties, tremors (due to low blood sugar levels), and slow heart rate.

Missing a dose of Prestilol

It is essential to take the medicine regularly, every day, for it to work best. If a dose of Prestilol is missed, the next dose should be taken at the usual time. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Prestilol

The patient should not stop taking Prestilol suddenly or change the dose without consulting their doctor, as this can cause significant worsening of heart function. Treatment should not be stopped 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.

The patient should stop taking Prestilol and contact their doctor immediately if they experience any of the following side effects:

• severe dizziness or fainting due to low blood pressure (very common - may affect up to 1 in 10 patients);
• worsening of heart failure causing severe shortness of breath and/or fluid retention (very common - may affect up to 1 in 10 patients);
• swelling of the face, lips, mouth, tongue, or throat, difficulty breathing (angioedema; uncommon - may affect up to 1 in 100 patients);
• sudden onset of wheezing, chest pain, shortness of breath, or difficulty breathing (bronchospasm; uncommon - may affect up to 1 in 100 patients);
• very fast or irregular heartbeat, chest pain (angina pectoris), or heart attack (very rare - may affect up to 1 in 10,000 patients);
• 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 patients);
• 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 patients);
• 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 patients);
• 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 patients).

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

The patient should inform their doctor or pharmacist immediately if they experience any of the following side effects:

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

• slow heart rate.

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

• headaches;
• central dizziness;
• vestibular dizziness;
• taste disorders;
• tingling;
• numbness of the hands or feet;
• vision disorders;
• tinnitus (a sensation of hearing sounds);
• feeling of coldness in the hands or feet;
• cough;
• shortness of breath;
• gastrointestinal disorders, such as nausea, vomiting, abdominal pain, indigestion, or difficulty digesting food, diarrhea, constipation;
• allergic reactions, such as rashes, itching;
• muscle cramps;
• fatigue;
• weakness.

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

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

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

• acute kidney failure;
• dark urine, nausea, or vomiting, muscle cramps, disorientation, and seizures. These can 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 allergies: 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 patients):

• 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;
• worsening or onset of psoriasis, psoriasis-like 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 or toes (Raynaud's phenomenon).

If the patient experiences any of these symptoms, they should contact their doctor as soon as possible.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their 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

By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Prestilol

The medicine should be stored out of sight and reach of children.

The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the month.

There are no special storage instructions.

After opening the container, Prestilol should be used within 60 days.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents 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: microcrystalline cellulose PH 102, calcium carbonate, maize starch, sodium carboxymethylcellulose (type A), colloidal anhydrous silica, magnesium stearate, sodium croscarmellose, glycerol, hypromellose, macrogol 6000, 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, two-layered, film-coated tablet with a score line to facilitate breaking, with the inscription "
" on one side and the inscription "5/10" on the other side of the tablet.

The tablet can be divided into two halves.

Tablets are available in containers of 30 or 90 (3 containers of 30 tablets each), packaged in cardboard boxes.

For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in France, the 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 Pharmaceutical Company S.A., ul. Annopol 6B, 03-236 Warsaw, Poland

EGIS Pharmaceuticals PLC, Mátyás király u. 65, H-9900 Körmend, Hungary

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Marketing authorization number in France, the country of export: 34009 300 675 5 0

Parallel import authorization number: 182/23

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 tablet

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 tablet

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 tablet

Italy

Cosyrel

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 tablet

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: 30.08.2023

[Information about the trademark]