Prestilol

Leaflet accompanying the packaging: patient information

Prestilol

5 mg + 5 mg, film-coated tablets

Bisoprolol fumarate + 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.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. 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 this leaflet, tell your 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 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 stable chronic heart failure (a condition where the heart is not able to pump enough blood to meet the body's needs, leading to shortness of breath and swelling), 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 flow to the heart by widening the blood vessels that supply it.

Instead of taking bisoprolol fumarate and perindopril arginine in separate tablets, the patient takes only one Prestilol tablet, which contains both active substances in the same amounts.

2. Important information before taking Prestilol

When not to take Prestilol:

Warnings and precautions

Before starting treatment with Prestilol, discuss with your doctor or pharmacist if:

• you have diabetes;
• you have kidney problems (including patients who have had a kidney transplant) or are undergoing dialysis;
• you have liver problems;
• you have a narrowing of the aortic or mitral valve (narrowing of the main blood vessel leading out of the heart), hypertrophic cardiomyopathy (a disease of the heart muscle), or narrowing of the renal arteries (the arteries that supply the kidneys with blood);
• you have an abnormally high level of a hormone called aldosterone in your blood (primary aldosteronism);
• you have heart failure or any other heart condition, such as arrhythmias or severe chest pain at rest (Prinzmetal's angina);
• you have a collagen disease (a disease of the connective tissue), such as systemic lupus erythematosus or scleroderma;
• you are on a low-salt diet or taking salt substitutes that contain potassium (high levels of potassium in the blood can cause changes in heart rate);
• you have recently had diarrhea or vomiting, or are dehydrated (Prestilol can cause a drop in blood pressure);
• you are undergoing LDL apheresis (removal of cholesterol from the blood using a special machine);
• you are undergoing desensitization treatment to reduce allergic reactions to bee or wasp stings;
• you are fasting or on a diet;
• you are undergoing anesthesia and/or surgery;
• you have circulatory problems in your limbs;
• you have asthma or COPD;
• you have (or have had) psoriasis;
• you have an adrenal gland tumor (pheochromocytoma);
• you have thyroid problems (Prestilol can mask the symptoms of hyperthyroidism);
• you experience 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 you experience these symptoms, stop taking Prestilol and contact your doctor immediately.
• if you are of black African origin, there is a higher risk of angioedema, and this medicine may be less effective in lowering blood pressure than in patients of other races.
• you are 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 you have kidney problems related to diabetes;
• aliskiren. Your doctor may monitor your kidney function, blood pressure, and electrolyte levels (e.g., potassium) at regular intervals. See also the information under "When not to take Prestilol" and "Warnings and precautions".
• you are 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 transplant rejection and treat cancer);
• sacubitril (available in a combination medicine containing sacubitril and valsartan, used to treat chronic heart failure). See sections "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.

If you are pregnant or think you may be pregnant, tell your doctor. Prestilol is not recommended in early pregnancy and should not be taken if you are pregnant for more than 3 months, as it may cause serious harm to the baby if taken after the third month of pregnancy (see section "Pregnancy").

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.

Prestilol can interact with other medicines, or other medicines can affect the way Prestilol works. This type of interaction can make one or both medicines less effective or increase the risk or severity of side effects.

Tell your doctor if you are taking any of the following medicines:

• 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 the information under "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 transplant rejection (sirolimus, everolimus, temsirolimus, and other medicines belonging to the group of medicines 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 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 (antipsychotics);
• 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 applied 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 given 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 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

Tell your doctor if you think you are (or might be) pregnant. Normally, your doctor will advise you to stop taking Prestilol before you become pregnant or as soon as you find out you are pregnant and will prescribe a different medicine instead of Prestilol. Prestilol is not recommended in early pregnancy and should not be taken if you are pregnant for more than 3 months, as it may cause serious harm to the baby if taken after the third month of pregnancy.

Breastfeeding

Tell your doctor if you are breastfeeding or plan to breastfeed. Prestilol 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

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

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, your doctor may recommend half a tablet of Prestilol once a day, in the morning before a meal.

Patients with kidney disease

If you have moderate kidney disease, your doctor may recommend half a tablet of Prestilol.

Prestilol is not recommended for patients with severe kidney disease.

Use in children and adolescents

Prestilol is not recommended for children and adolescents.

If you take more Prestilol than you should

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

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

If you forget to take Prestilol

It is important to take the medicine regularly, every day, for it to work better. However, 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 Prestilol 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.

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, 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:

any of the following 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 heartbeats, 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);
• pancreatitis, which can cause severe abdominal pain and very poor general condition (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).

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

Tell your doctor or pharmacist immediately 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;
• central dizziness;
• vestibular dizziness;
• taste disturbances;
• 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 food, diarrhea, constipation;
• allergic reactions, such as rash, itching;
• muscle cramps;
• fatigue;
• weakness.

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

• mood changes;
• sleep disorders;
• 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 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;
• general malaise;
• 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) in diabetic patients, 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 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 similar to 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 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, 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 you experience any of these symptoms, contact your doctor as soon as possible.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

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 after "EXP" (the expiry date stated on the packaging). The expiry date refers to the last day of the month stated.

The word "Lot" on the packaging means the batch number of the medicine.

There are no special precautions for storage of the medicinal product.

After opening the container with 30 film-coated tablets, Prestilol should be used within 60 days.

After opening the container with 100 film-coated tablets, Prestilol should be used within 100 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 5 mg of perindopril arginine, equivalent to 3.395 mg of perindopril.
• The other ingredients are: microcrystalline cellulose PH 102, calcium carbonate, maize starch, sodium carboxymethylcellulose (type A), colloidal anhydrous silica, magnesium stearate, croscarmellose sodium, glycerol, hypromellose, macrogol 6000, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).

What Prestilol looks like and contents of the pack

Prestilol is a pink-beige, elongated, bilayer, film-coated tablet with a score line to facilitate breaking, with the marking "
" on one side and the marking "5/5" on the other side of the tablet.

The tablet can be divided into two halves.

Tablets are available in containers of 30, 90 (3 containers of 30 each), or 100 tablets, packaged in cardboard boxes.

Not all pack sizes may be marketed.

Marketing authorization 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), Moneylands, 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

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

Belgium: Bipressil 5 mg/5 mg comprimé pelliculé; Bulgaria: Prestilol 5 mg/5 mg филмирани таблетки; Croatia: Prestilol 5 mg/5 mg filmom obložene tablete; Cyprus: Cosyrel 5 mg/5 mg επικαλυμμένα με λεπτό υμένιο δισκία; Czech Republic: Cosyrel 5 mg/5 mg, potahované tablety; Estonia: Prestilol; Finland: Cosyrel 5 mg/5 mg Tabletti, kalvopäällysteinen; France: Cosimprel 5 mg/5 mg, comprimé pelliculé; Greece: Cosyrel 5 mg/5 mg επικαλυμμένα με λεπτό υμένιο δισκία; Hungary: Cosyrel 5 mg/5 mg filmtabletta; Ireland: Cosimprel 5 mg/5 mg film-coated tablet; Italy: Cosyrel; Latvia: Prestilol 5 mg/5 mg apvalkotās tabletes; Lithuania: Cosimprel 5 mg/5 mg plėvele dengtos tabletės; Luxembourg: Bipressil 5 mg/5 mg comprimé pelliculé; Netherlands: Cosimprel 5 mg/5 mg filmomhulde tabletten; Poland: Prestilol; Portugal: Cosyrel 5 mg/5 mg; Romania: Cosyrel 5 mg/5 mg comprimate filmate; Slovakia: Prestilol 5 mg/5 mg filmom obalené tablety; Slovenia: Cosyrel 5 mg/5 mg filmsko obložene tablete

Date of last revision of the leaflet: 02/2023