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What Presgillol is and what it is used for
Prestilol contains two active ingredients - bisoprolol fumarate and perindopril arginine in one tablet:
Bisoprolol fumarate belongs to a group of drugs called beta-blocker. 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 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) have had a myocardial infarction and / or an operation to improve the blood supply to the heart by expanding blood vessels that supply it.
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 of this medicine (listed in section 6);
if you have heart failure that has suddenly become worse or may require treatment in a hospital;
if you have a cardiogenic shock (a serious heart condition caused by very low blood pressure),
if you have a heart disease that is characterized by slow or irregular heart rhythm (second or third degree ventricular block, sinoatrial block, sinus node syndrome),
if you have a slow heartbeat,
if you have excessive low blood pressure,
if you have severe asthma or severe chronic lung disease,
if you have severe problems with the circulation of your extremities (such as Raynaud's syndrome), which may cause your fingers or toes to get faded or pale or bluish,
if you have an untreated phaeochromocytoma 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 itching or severe skin rashes with previous treatment with ACE inhibitors 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 third month (in addition, it is preferable to avoid Prestilol in the early stages of pregnancy - see section on pregnancy),
if you have diabetes or impaired kidney function and are being treated with a blood pressure lowering medication containing aliskiren,
if you are on dialysis or some other kind of blood filtration. Depending on the device you are using, Prestilol may be inappropriate for you,
if you have kidney problems where the supply of your kidneys with blood is reduced (renal artery stenosis),
if you are being treated with saquitril / valsartan, a medicine used to treat heart failure (see "Warnings and precautions" and "Other medicines and Prestilol").
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);
have abnormally elevated blood levels of the hormone called aldosterone (primary aldosteronism),
if you suffer from heart failure or other heart problems such as mild heart rhythm disturbances or severe chest pain at rest (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 should be subjected to LDL apheresis (which is removal of cholesterol from your blood by machine);
You are currently undergoing anti-allergic treatment or are going to be subjected to a desensitization treatment to reduce the allergic effects to bee or axle stings; strict fasting or heavy diet; you are going to be subjected
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 can change from Prestilol. This type of interaction may lead to reduced efficacy of either or both drugs. Alternatively, it may increase the risk of side effects or their severity.
Be sure to tell your doctor if you are taking any of the following medicines:
(for example, amiodarone, amlodipine, clonidine, digitalis glycosides, diltiazem, disopyramide, felodipine, flecainide, lidocaine, methyldopa, moxonidine, propafenone, quinidine, rilmenidine, verapamil) ;
other medicines for the treatment of 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 (eg triamterene, amiloride), potassium supplements or potassium-containing salt substitutes, other medicines that may increase potassium in the body (such as heparin and co-trimoxazole, also known as trimethoprim / sulfamethoxazole);
potassium-sparing medicines used to treat heart failure: eplerenone 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 that are most commonly used to treat diarrhea (racemacotril) or to avoid rejection of transplanted organs (sirolimus, everolimus, temsirolimus and other medicines belonging to a class of medicines called mTOR inhibitors). See "Warnings and precautions for use",
saquinavir / valsartan (used for long-term treatment of heart failure). See "Do not take Prestilol" and "Warnings and precautions for use".
lithium - used to treat mania and depression,
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;
immunosuppressants (medicines that reduce the body's defense mechanism) like cyclosporin, tacrolimus, used to treat autoimmune disorders or after transplant surgery;
allopurinol used to treat gout;
parasympathomimetic drugs used to treat conditions such as Alzheimer's disease or glaucoma;
topical beta-blockers to treat glaucoma (elevated intraocular pressure);
mefloquine used to treat malaria;
baclofen used to treat muscle stiffness in some diseases such as multiple sclerosis;
gold salts, especially when given intravenously (used to treat rheumatoid arthritis symptoms);
medicines for diabetes such as insulin, metformin, linagliptin, saxagliptin, sitagliptin, vildagliptin;
non-steroidal anti-inflammatory drugs (NSAIDs), e.g. ibuprofen or diclofenac, or high doses of aspirin that are used to treat arthritis, headache, pain or inflammation.
Appreciated with food, drinks and alcohol
Prestolol should preferably be taken before a meal.
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
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 on taking Presgyalol to take other medicines. Presagall 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.
Tell your doctor if you are breast-feeding or intend to breast-feed. Presagilol is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, a special
Prestilol is usually well tolerated, but as with all other medicines, people may experience various side effects, especially during the initial onset of treatment.
If you notice any of the side effects listed below or other side effects not listed in this leaflet, please tell your doctor or pharmacist immediately:
Very common (may affect more than 1 in 10 people):
Common (may affect up to 1 in 10 people):
numbness and depression of the hands and feet,
tinnitus (feeling of tinnitus),
a feeling of cold in the hands and feet,
Lack of air,
gastrointestinal disorders such as nausea, vomiting, abdominal pain, difficulty in digestion or dyspepsia, diarrhea, constipation,
allergic reactions such as skin rashes, pruritus,
Uncommon (may affect up to 1 in 100 people):
intense pruritus or severe skin rashes,
blistering on the surface of the skin,
increased sensitivity of the skin to the sun (photosensitivity reactions),
kidney problems, impotence,
increased number of eosinophils (a type of white blood cell)
non-cardiac arrhythmias (disturbance of AV conduction, inflammation of blood vessels (vasculitis),
dizziness, strained dizziness, muscle weakness, arthralgia (joint pain), myalgia (muscle aches), chest pain,
physical disorientation, localized swelling (peripheral edema), fever, falling,
changes in laboratory performance: increased blood potassium levels, reversible upon discontinuation of administration; decreased levels of sodium, very low blood sugar (hypoglycaemia) in patients with diabetes, increased blood urea, increased creatinine in the blood.
Rare (may affect up to 1 in 1,000 people):
decreased tear (dry eye),
inflammation of the liver which may cause yellowing of the skin or white eyes,
allergic rhinitis, sneezing,
allergic-like reactions such as itching, redness, rash,
worsening of psoriasis,
changes in laboratory performance: elevated liver enzymes, high levels of bilirubin in serum, abnormal fat levels.
Very rare (may affect up to 1 in 10,000 people):
irritation and redness of the eye (conjunctivitis),
eosinophilic pneumonia (a rare type of pneumonia),
inflammation of the pancreas (which causes severe abdominal and back pain),
appearance or worsening of scaly rash (psoriasis), psoriasis-like rash,
acute renal failure,
changes in blood counts, such as a lower number of white and red blood cells, decreased hemoglobin, fewer platelets.
Concentrated urine (dark color), feeling unwell, muscle cramps, confusion and fainting, which may be due to irregular antidiuretic hormone secretion (ADH). If you experience any of these symptoms, contact your doctor as soon as possible. soon.
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 28 or 30 film-coated tablets and 100 days for tablet packs of 100 film-coated tablets.
Do not dispose of medicines in the sewer 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. Contents of the pack and further information What Prestilol contains
- The active substances are bisoprolol fumarate and perindopril arginine. One film-coated tablet Prestilol contains 10 mg of bisoprolol fumarate equivalent to 8.49 mg of bisoprolol and 10 mg of perindopril arginine equivalent to 6.790 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
The pink-beige, elongated, bilayer film-coated tablet engraved on both sides of the tablet is available in cartons of 10, 28, 30, 84 (3 packs of 28 tablets), 90 (3 packs of 30 tablets) 100 and 120 (4 packs)
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