Prestilol

Leaflet accompanying the packaging: patient information

Prestilol

10 mg + 5 mg, film-coated tablets

Bisoprolol fumarate + Perindopril arginine

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

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, the patient should consult a doctor, pharmacist, or nurse.
• This medication has been prescribed to a specific person. It should not be given to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those 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 medications 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 (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 stable chronic heart failure (a condition where the heart is not able to pump enough blood to meet the body's needs, causing shortness of breath and swelling), 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) who have had a heart attack and/or 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 Prestilol, the patient should discuss the following with their doctor or pharmacist:

• angiotensin receptor blockers (ARBs) (also known as sartans - e.g., valsartan, telmisartan, irbesartan), especially if the patient has diabetic kidney disease;
• 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".
• racecadotril (used to treat diarrhea);
• sirolimus, everolimus, temsirolimus, and other medications belonging to the class of medications called mTOR inhibitors (used to prevent organ rejection and treat cancer);
• sacubitril (available in a combination medication containing sacubitril and valsartan), used to treat chronic heart failure;
• linagliptin, saxagliptin, sitagliptin, wildagliptin, and other medications belonging to the class of medications 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.

The patient should inform their doctor if they think they may be pregnant. Prestilol is not recommended during early pregnancy and should not be taken if the patient is pregnant for more than 3 months, as it may cause serious harm to the fetus if taken after the third month of pregnancy (see "Pregnancy").

Children and adolescents

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

Prestilol and other medications

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

Other medications may affect the action of Prestilol or Prestilol may affect the action of other medications. This type of interaction can cause one or both medications to be less effective or increase the risk or severity of side effects.

The patient should inform their doctor if they are taking any of the following medications:

• medications 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 medications 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 (medications that increase urine production);
• potassium-sparing medications (e.g., triamterene, amiloride), potassium supplements, or salt substitutes that contain potassium, other medications that can increase potassium levels in the body (such as heparin, a medication used to thin the blood and prevent clotting; trimethoprim and cotrimoxazole, also known as a combination medication containing trimethoprim and sulfamethoxazole, used to treat bacterial infections);
• potassium-sparing medications used to treat heart failure: eplerenone and spironolactone in doses of 12.5 mg to 50 mg per day;
• sympathomimetic medications used to treat shock (adrenaline, noradrenaline, dobutamine, isoprenaline, ephedrine);
• estramustine used to treat cancer;
• medications used to treat diarrhea (racecadotril) or prevent organ rejection (sirolimus, everolimus, temsirolimus, and other medications belonging to the class of medications called mTOR inhibitors). See "Warnings and precautions".
• a combination medication 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 medications used to treat depression, such as imipramine, amitriptyline, monoamine oxidase inhibitors (MAOIs; except for MAO-B inhibitors);
• certain medications used to treat schizophrenia (antipsychotic medications);
• certain medications used to treat epilepsy (phenytoin, barbiturates, such as phenobarbital);
• anesthetics used in surgical procedures;
• vasodilators, including nitrates (medications that cause blood vessels to widen);
• trimethoprim used to treat infections;
• immunosuppressive medications (medications 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 medications used to treat conditions such as Alzheimer's disease or glaucoma;
• topically applied beta-blockers used to treat glaucoma (increased eye pressure);
• 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);
• medications used to treat diabetes, such as insulin, metformin, linagliptin, saxagliptin, sitagliptin, wildagliptin;
• nonsteroidal anti-inflammatory medications (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 medication.

Pregnancy

The patient should inform their doctor if they think they may be pregnant. The doctor will usually recommend stopping Prestilol before becoming pregnant or as soon as the patient finds out they are pregnant and prescribe a different medication instead of Prestilol. Prestilol is not recommended during early pregnancy and should not be taken if the patient is pregnant for more than 3 months, as it may cause serious harm to the fetus if taken after the third month of pregnancy.

Breastfeeding

The patient should inform 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 medication 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 the medication is considered "sodium-free".

3. How to take Prestilol

This medication should always be taken as directed 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.

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.

Overdose of Prestilol

In case of overdose, the patient should immediately contact their doctor or pharmacist.

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, tremors (due to low blood sugar), and slow heart rate.

Missed dose of Prestilol

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

Stopping Prestilol treatment

The patient should not stop taking Prestilol suddenly or change the dose without consulting their doctor, as this can cause severe worsening of heart function. Treatment should not be stopped suddenly, especially in patients with coronary artery disease.

If the patient has any further doubts about taking this medication, they should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medications, Prestilol can cause side effects, although not everyone will experience them.

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

any of the following side effects:

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

very rare (may occur in up to 1 in 10,000 patients):

• extremely rapid or irregular heartbeat, chest pain (angina pectoris), or heart attack;
• weakness of arm or leg muscles, or difficulty speaking, which can be a sign of a stroke;
• pancreatitis, which can cause severe abdominal pain, radiating to the back, and severe illness;
• jaundice (yellowing of the skin or eyes), which can be a sign of liver inflammation;
• a rash often starting with red, itchy patches on the face, arms, or legs (erythema multiforme).

Prestilol is usually well-tolerated, but like other medications, 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 occur in more than 1 in 10 patients):

• slow heart rate.

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

• headaches;
• central dizziness;
• vestibular dizziness;
• taste disturbances;
• tingling;
• numbness of hands or feet;
• vision disturbances;
• tinnitus (ringing in the ears);
• feeling of coldness in hands or feet;
• cough;
• shortness of breath;
• gastrointestinal disturbances, such as nausea, vomiting, abdominal pain, indigestion, or diarrhea;
• allergic reactions, such as rash, itching;
• muscle cramps;
• fatigue;
• weakness.

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

• mood changes;
• sleep disturbances;
• depression;
• dry mouth;
• increased itching or severe skin rash;
• blistering of 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 (inflammation of blood vessels);
• orthostatic hypotension (dizziness when standing up);
• 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 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 occur in up to 1 in 1,000 patients):

• 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;
• allergic reactions: 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 occur in 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;
• 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 available data):

• cyanosis, 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 those not listed in this leaflet, they should inform their 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, more information can be collected on the safety of this medication.

5. How to store Prestilol

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

The patient should not take this medication after the expiration date stated on the packaging after "EXP" (the expiration date stated on the packaging). The expiration date refers to the last day of the month stated.

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

There are no special precautions for storing the medication.

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

After opening the container of 100 film-coated tablets, Prestilol should be used within 100 days.

Medications should not be disposed of in wastewater or household waste. The patient should ask their pharmacist how to dispose of medications they no longer use. 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 10 mg of bisoprolol fumarate, equivalent to 8.49 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, round, biconvex, film-coated tablet with the inscription "5" on one side and "10/5" on the other side.

The tablets are available in containers of 30, 90 (3 containers of 30 tablets), 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 Przedsiębiorstwo Farmaceutyczne S.A., ul. Annopol 6B, 03-236 Warsaw, Poland; EGIS Pharmaceuticals PLC, Mátyás király u. 65, H-9900 Körmend, Hungary

To obtain further information, the patient should contact the representative of the marketing authorization holder:

Servier Polska Sp. z o.o., phone: (22) 594 90 00

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

Belgium: Bipressil 10 mg/5 mg comprimé pelliculé

Bulgaria: Prestilol 10 mg/5 mg филмирани таблетки

Cyprus: Cosyrel 10 mg/5 mg επικαλυμμένα με λεπτό υμένιο δισκία

Czech Republic: Cosyrel 10 mg/5 mg, potahované tablety

Estonia: Prestilol

Finland: Cosyrel 10 mg/5 mg Tabletti, kalvopäällysteinen

France: Cosimprel 10 mg/5 mg, comprimé pelliculé

Greece: Cosyrel 10 mg/5 mg επικαλυμμένα με λεπτό υμένιο δισκία

Hungary: Cosyrel 10 mg/5 mg filmtabletta

Ireland: Cosimprel 10 mg/5 mg film-coated tablet

Italy: Cosyrel

Latvia: Prestilol 10 mg/5 mg apvalkotās tabletes

Lithuania: Cosimprel 10 mg/5 mg plėvele dengtos tabletės

Luxembourg: Bipressil 10 mg/5 mg comprimé pelliculé

Netherlands: Cosimprel 10 mg/5 mg filmomhulde tabletten

Poland: Prestilol

Portugal: Cosyrel 10 mg/5 mg

Romania: Cosyrel 10 mg/5 mg comprimate filmate

Slovakia: Prestilol 10 mg/5 mg filmom obalené tablety

Slovenia: Cosyrel 10 mg/5 mg filmsko obložene tablete

Date of last revision of the leaflet: 02/2023