Prestilol 5 mg. / 5 mg. 30 tablets

What is Prestilol and what it is used for

Prestilol contains the two active ingredients - bisoprolol fumarate and perindopril arginine in one tablet:

Bisoprolol fumarate belongs to a group of medicines called beta-blockers. Beta-blockers slow down heartbeat and make it more efficient to pump blood from the heart to the body.
Perindopril arginine is an angiotensin converting enzyme (ACE) inhibitor. It works by expanding the blood vessels, making it easier for your heart to pump blood through them.
Prestilol is used to treat high blood pressure (hypertension) and / or stable chronic heart failure (a condition where the heart is unable to pump enough blood to meet the body's needs, resulting in shortness of breath and swelling); / or to reduce the risk of heart attacks, such as myocardial infarction, in patients with stable coronary artery disease (a condition where the blood supply to the heart is reduced or blocked) and who have already had myocardial infarction and / or surgery to improve is blood flow to the heart by widening the vessels that supply it with blood.

Instead of taking bisoprolol fumarate and perindopril arginine as separate tablets, you will take one Prestilol tablet containing both ingredients in the same amount.

2. What you need to know before you take Prestilol

Do not take Prestilol:

if you are allergic to bisoprolol or any other beta-blocker to perindopril or any other ACE inhibitor or any of the other ingredients listed in section 6;
if you have heart failure that has suddenly worsened and / or may require treatment in a hospital;
if you have a cardiogenic shock (serious heart condition caused by very low blood pressure);
if you have heart disease characterized by slow or irregular heart rhythm (second or third degree cardiac block, sinoatrial block, sinus node syndrome);
if you have a slow heartbeat;
if you have too low blood pressure;
if you have severe asthma or severe chronic lung disease;
if you have severe blood circulation problems in your limbs (such as Raynaud's syndrome) that may cause fingers or toes to get faded or pale or bluish;
if you have an untreated pheochromocytoma that is a rare tumor of the adrenal gland (medulla);
if you have metabolic acidosis, a condition where you have too much acid in your blood;
if you have experienced symptoms such as whistling, swelling of the face, tongue or throat, severe pruritus or severe skin rashes with previous ACE inhibitor treatment, or if you or a member of your family have had such symptoms under other circumstances (a condition called angioneurotic edema);
if you are pregnant after the 3rd month (in addition, it is preferable to avoid Prestilol in the early stages of pregnancy - see section on pregnancy);
if you have diabetes or have impaired kidney function and are being treated with a blood pressure lowering medication containing aliskiren.
Warnings and precautions
Talk to your doctor or pharmacist before taking Prestilol if:

you have diabetes;
have kidney problems (including kidney transplantation) or if you are on dialysis treatment;
you have a liver problem;
have aortic and mitral stenosis (narrowing of the main blood vessel coming out of the heart) or hypertrophic cardiomyopathy (heart muscle disease) or renal artery stenosis (narrowing of the artery that supplies the kidney with blood);
if you suffer from heart failure or other heart problems, such as mild heart rhythm abnormalities or severe chest pain at rest (Princeton's type of angina pectoris);
suffer from collagen vascular disease (connective tissue disease), such as systemic lupus erythematosus or scleroderma;
adhere to a diet with limited intake of salt or use potassium salt substitutes that contain potassium (increased amounts of potassium in the blood may cause changes in heart rate);
if you have recently had diarrhea or vomiting or if you are dehydrated (Prestilol may cause a fall in blood pressure);
you must be subjected to LDL apheresis (which is removal of your blood cholesterol by machine);
You are currently undergoing anti-allergic treatment or are going to be subjected to desensitization treatment to reduce the allergic effects to bee or axle stings;
strict fasting or heavy diet;
you are going to be subjected to anesthesia and / or major surgery;
you have blood circulation problems in your limbs;
have asthma or chronic lung disease;
you have (or have had) psoriasis;
if you have a tumor of the adrenal gland (pheochromocytoma);
you have a thyroid disorder (Prestilol can mask the symptoms of an overactive thyroid);
have angioedema (severe allergic reaction with swelling of the face, lips, tongue or throat accompanied by difficulty in swallowing or breathing). This can happen at any time during the course of treatment. If you develop such symptoms, you should stop taking Prestilol and go to a doctor immediately;
you are of black background because you may have a greater risk of angioedema and this medicine may be less effective in lowering your blood pressure than in non-black people;
take any of the following medicines used to treat high blood pressure:
angiotensin II receptor blocker (ARB) (also known as sartan - for example valsartan, telmisartan, irbesartan) and in particular - if you have kidney problems associated with diabetes;
aliskiren.
Your doctor may periodically check renal function, blood pressure and the amount of electrolytes (eg potassium) in your blood. See also the information titled "Do not take Prestilol".

the risk of angioedema is increased if you are taking any of the following medicines:
racemacotril (used to treat diarrhea);
sirolimus, everolimus, temsirolimus and other medicines belonging to a class of medicines called mTOR inhibitors (used to prevent transplanted organ rejection).
Do not stop taking Prestilol taken abruptly, as this may cause a severe worsening of your heart disease. Treatment should not be abruptly discontinued, especially in patients with coronary heart disease.
You must tell your doctor if you think you are pregnant (or you may become pregnant). Pristolol is not recommended in the early stages of pregnancy and should not be taken if you are pregnant after the third month as it may cause serious harm to your baby if used during this period (see pregnancy point).

Children and adolescents
Prestilol is not intended for use in children and adolescents under the age of 18 years.

Other Drugs and Prestilol
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

There are medicines that can change the effect of Prestilol or whose effects may change from Prestilol. This type of interaction may reduce the effectiveness of either or both drugs. Alternatively, it may increase the risk of side effects or their severity.

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

(eg amiodarone, amlodipine, clonidine, digitalis glycosides, diltiazem, disopyramide, felodipine, flecainide, lidocaine, methyldopa, moxonidine, procainamide, propafenone, quinidine, rilmenidine, verapamil);
other medicines to treat high blood pressure, including angiotensin II receptor blockers (ARB), aliskiren (see also "Do not take Prestilol" and "Warnings and precautions for use") or diuretics (medicines that increase the amount of urine, produced by the kidneys);
potassium-sparing medicines (e.g., triamterene, amiloride), potassium supplements or potassium-containing salt substitutes;
potassium-sparing medicines used to treat heart failure, spleenone and spironolactone at doses ranging from 12.5 mg to 50 mg per day;
sympathomimetic agents for the treatment of clinical shock (adrenaline, noradrenaline, dobutamine, isoprenaline, ephedrine);
estramustine - used in the treatment of cancer;
medicines most commonly used to treat diarrhea (racemacotril) or to avoid the rejection of transplanted organs (sirolimus, everolimus, temsirolimus and other medicines belonging to a class of medicinal product called mTOR inhibitors). See "Warnings and precautions for use" section;
lithium - used to treat manias and depressions;
some medicines used to treat depression, such as imipramine, amitriptyline, monoamine oxidase inhibitors (MAO) (except MAO-B inhibitors);
some medicines used to treat schizophrenia (antipsychotics);
some medicines used to treat epilepsy (phenytoin, barbiturates like phenobarbital);
anesthesia medicinal products used in surgical procedures;
vasodilators, including nitrates (preparations that lead to blood vessel enlargement);
trimethoprim used to treat infections;
heparin used to treat blood clotting;
immunosuppressants (medicines that reduce
Refined with food, drinks and alcohol
Prestolol should preferably be taken before a meal.

Pregnancy and breastfeeding
If you are pregnant or are breast-feeding, think you may be pregnant or plan to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
You must tell your doctor if you think you are pregnant (or you may become pregnant). Your doctor will usually advise you to stop taking Prestilol before getting pregnant or as soon as you know that you are pregnant and will advise you instead of taking Prestilol to take other medicines. Prestilol is not recommended in the early stages of pregnancy and should not be used if you are pregnant after the third month as it may cause serious harm to your baby if used after the third trimester of pregnancy.

Breastfeeding
Tell your doctor if you are breast-feeding or intend to breast-feed. Prestilol is not recommended for mothers who are breast-feeding and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn or premature.

Driving and using machines
Prestilol has no direct effect on attention concentration but some patients may experience dizziness or weakness associated with low blood pressure, especially at the beginning of treatment, when switching to treatment, and when used in conjunction with alcohol. If you are affected this way, your ability to drive or operate machinery may be impaired.

3. How to take Prestilol

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

The recommended starting dose is one tablet once a day. Swab the tablet with a glass of water in the morning before eating.

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

Patients with renal disease
Prestilol is not recommended if you suffer from moderate and severe kidney disease.

Use in children and adolescents
Use in children and adolescents is not recommended.

If you take more Prestilol than you should
If you take more tablets than you prescribed, contact your doctor or pharmacist immediately.
The most likely effect in case of overdose is low blood pressure, which may cause dizziness or diminish (if this occurs, it may help to lie down and set your legs high), severe difficulty breathing, trembling ( due to reduced blood sugar levels) and heart rate delays.

If you forget to take Prestilol
It is important to take your medicine every day, as regular treatment is more effective. However, if you have forgotten to take a dose of Prestilol, take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

If you stop taking Prestilol
Do not interrupt abruptly taking Prestilol and do not change the dose without consulting your doctor as this may cause a severe worsening of your heart disease. Treatment should not be abruptly discontinued, especially in patients with coronary heart disease.

If you have any further questions on the use of this medicine, please ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

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

severe dizziness or fainting due to low blood pressure (common - may affect up to 1 in 10 people);
worsening of heart failure which causes 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 in breathing (angioedema) (uncommon - may affect up to 1 in 100 people);
sudden breathing, chest pain, shortness of breath or difficulty in breathing (bronchospasm) (uncommon - may affect up to 1 in 100 people);
abnormally fast or irregular heartbeat, chest pain (angina pectoris) or heart attack (very rare - may affect up to 1 in 10,000 people);
hand or leg shakes or speech problems, which may indicate a possible stroke (very rare - may affect up to 1 in 10,000 people);
an inflamed pancreas that can cause severe abdominal pain and back pain accompanied by a feeling of being very unwell (very rare - may affect up to 1 in 10,000 people);
yellowing of the skin or eyes (jaundice), which could be a sign of hepatitis (very rare - may affect up to 1 in 10,000 people;
skin rash, which often begins with the appearance of red itchy spots on the face, arms or legs (erythema multiforme) (very rare - may affect up to 1 in 10,000 people).
Prestilol is usually well tolerated,
How to Store Prestilol

Keep out of the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Upon opening, Prestilol should be used for up to 20 days for tablet packs of 10 film-coated tablets; 60 days for tablet packs of 30 film-coated tablets and 100 days for tablet packs of 100 film-coated tablets.

Do not dispose of medicines in the sewage system or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

6. Package Contents and Additional Information

What Prestilol contains

The active substances are: bisoprolol fumarate and perindopril arginine. One film-coated tablet Prestilol 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: cellulose, microcrystalline PH 102 (E460), calcium carbonate (E170), corn starch, pregelatinised, sodium starch glycolate type A (E468), colloidal silicon dioxide, anhydrous E551, magnesium stearate (Liga E572), croscarmellose Sodium (E468), glycerol (E422), hypromellose (E464), macrogol 6000, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172) and purified water.
What Prestilol looks like and what the package contains
He has a pink-beige, elongated, double-layered, scored film-coated tablet on one side of which is engraved '5/5'. The tablet can be divided into two equal doses.

The tablets are supplied in cartons of 10, 30, 90 (3 packs of 30 tablets), 100 and 120 (4 packs of 30 tablets) film-coated tablets.

Not all pack sizes may be marketed.

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