Prestilol

Leaflet accompanying the packaging: patient information

Prestilol

5 mg + 10 mg, 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 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 have undergone a surgical procedure to improve blood flow to the heart by widening the blood vessels that supply it.

2. Important information before taking Prestilol

When not to take Prestilol:

• if you are 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 you have heart failure that is worsening and requires hospital treatment;
• if you have cardiogenic shock (a serious heart condition that causes very low blood pressure);
• if you have a heart condition characterized by slow or irregular heartbeats (second- or third-degree atrioventricular block, sinoatrial block, sick sinus syndrome);
• if you have a slow heart rate;
• if you have very low blood pressure;
• if you have severe asthma or severe chronic obstructive pulmonary disease (COPD);
• if you have severe circulatory problems in your limbs (such as Raynaud's syndrome), which may cause tingling or blanching of the fingers or toes;
• if you have an untreated pheochromocytoma (a rare tumor of the adrenal gland);
• if you have metabolic acidosis (a condition where the blood contains too much acid);
• if you have had angioedema (a severe allergic reaction) during previous treatment with an ACE inhibitor;
• if you are pregnant for more than 3 months (it is also recommended to avoid taking Prestilol during early pregnancy - see "Pregnancy");
• if you have diabetes or kidney problems and are taking aliskiren;
• if you are undergoing dialysis or blood filtration using a machine. Depending on the equipment used, Prestilol may not be suitable for you;
• if you have kidney problems that reduce blood flow to the kidneys (renal artery stenosis);
• if you are taking a combination medicine containing sacubitril and valsartan, used to treat heart failure, as the risk of angioedema (rapid swelling of the 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, 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 from the heart) or hypertrophic cardiomyopathy (a heart muscle disease) or renal artery stenosis (narrowing of the blood vessels supplying the kidneys);
• you have an abnormal increase in the level of a hormone called aldosterone in your blood (primary aldosteronism);
• you have heart failure or other heart conditions, such as arrhythmias or severe chest pain at rest (Prinzmetal's angina);
• you have collagenosis (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 device);
• 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 may 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 race, 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 may 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;
• 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 breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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 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 urine production);
• potassium-sparing medicines (e.g., triamterene, amiloride), potassium supplements, or salt substitutes containing potassium, other medicines that may 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 "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 (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;
• topical 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

It is recommended to take Prestilol 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

You must tell your doctor if you are pregnant or think you may 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. Prestilol is not recommended during 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 taken after the third month of pregnancy.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. 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 premature.

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 that the medicine is essentially "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 breakfast.

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

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.

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 help to lay the patient down with their legs raised), severe breathing difficulties, trembling (due to low blood sugar), and slow heart rate.

If you forget to take Prestilol

It is important to take your medicine regularly, every day, as this will make it 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 your dose without consulting your doctor, as this can cause severe 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 Prestilol 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 rare (may affect up to 1 in 10,000 people):

• very fast or irregular heartbeat, chest pain (angina pectoris), or heart attack;
• weakness of the arms or legs, or difficulty speaking, which may be a sign of a stroke;
• pancreatitis, which may cause severe abdominal pain and very poor general condition;
• jaundice (yellowing of the skin or eyes), which may 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 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;
• dizziness due to central or vestibular causes;
• taste disturbances;
• tingling or numbness of the hands or feet;
• visual disturbances;
• tinnitus (ringing in the ears);
• 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;
• allergic reactions, such as rash or itching;
• muscle cramps;
• fatigue;
• weakness.

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

• mood changes;
• sleep disturbances;
• depression;
• dry mouth;
• increased itching or severe skin rash;
• blistering of the skin;
• increased sensitivity of the skin to light;
• 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 hypotension;
• 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 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 renal 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 may 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 affect up to 1 in 10,000 people):

• disorientation;
• eye irritation and redness (conjunctivitis);
• eosinophilic pneumonia (a rare type of pneumonia);
• pancreatitis (which may cause severe abdominal pain and very poor general condition);
• 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):

• cyanosis, 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. You can also report side effects directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products.

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 first opening the container of 30 tablets, Prestilol should be used within 60 days.

After first opening the container of 100 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 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, 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, bi-convex, 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 halves.

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 Pharmaceutical Company S.A.

Annopol 6B

03-236 Warsaw

EGIS Pharmaceuticals PLC

Mátyás király u. 65

H-9900 Körmend

Hungary

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

Servier Polska Sp. z o.o.

Phone: (22) 594 90 00