Properties
What is it?
PRESTARIU M® 5mg, perindopril arginine also see Prestarium- PRESTARIU M 10mg 30 tablets Read this leaflet carefully before you start taking this medicine as it contains important information for you. · 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 notice any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4. This leaflet contains the following information: 1. What PRESTARIU M® is and what it is used for 2. What you need to know before taking PRESTARIU M® 3. How to take PRESTARIU M® 4. Possible side effects 5. How to store PRESTARIU M® 6. What PRESTARIU M® contains and other information 1. What PRESTARIU M® is and what it is used for PRESTARIU M® is an angiotensin-converting enzyme (ACE) inhibitor. It has a blood vessel dilating effect, which lowers blood pressure. PRESTARIU M® is used for the following conditions: · Treatment of high blood pressure (hypertension), · Treatment of heart failure (a condition where the heart no longer supplies the body with enough blood); · To reduce the risk of heart complications, such as heart attack, in patients with stable ischemic heart disease (a condition where the blood supply to the heart is reduced or blocked) and in patients who have already had a heart attack and/or surgery to improve blood supply to the heart by widening its supplying blood vessels. See blog: Prestarium - when to take it and what to know about the medicine? 2. What you need to know before taking PRESTARIU M® Do not take PRESTARIU M® · If you are allergic to perindopril or any of the other ingredients of this medicine (listed in section 6), or any other ACE inhibitor · If you or any member of your family have previously had symptoms such as wheezing, swelling of the face, tongue or throat, severe itching or skin rash (angioedema) when taking other ACE inhibitors or in other circumstances, · If you are pregnant and your pregnancy is more than 3 months advanced (you should also avoid taking PRESTARIU M® in early pregnancy – see section <<Pregnancy>>), · If you have diabetes and impaired kidney function, or if you are taking aliskiren-containing medicine to lower blood pressure · If you are undergoing dialysis or other haemofiltration procedures. Depending on the apparatus used, PRESTARIU M® may not be suitable for you, · If you have kidney disease with reduced blood flow to the kidneys (renal artery stenosis). · If you are taking or have recently taken sacubitril and valsartan – a medicine for heart failure, because of the increased risk of Quincke's edema (rapid swelling of the subcutaneous tissue, e.g. in the throat area) (see sections <<Be especially careful>> and <<Taking PRESTARIU M® with other medicines>>). Be especially careful in the following cases: Consult your doctor, pharmacist or nurse before taking PRESTARIU M® if any of the following apply to you: · If you have aortic stenosis (narrowing of the main blood vessel leaving the heart), hypertrophic cardiomyopathy (heart muscle disease) or renal artery stenosis (narrowing of the artery supplying blood to the kidneys), · If you have other heart disease, · If you have impaired liver function, · If you have impaired kidney function or are on dialysis, · You have abnormally high levels of the hormone aldosterone in your blood (primary hyperaldosteronism), · If you have a collagen-vascular disease, such as systemic lupus erythematosus or scleroderma (connective tissue disease), · If you have diabetes, · If you are on a low-salt diet or are taking salt substitutes containing potassium, · If you are scheduled for anesthesia and/or major surgery, · If you are undergoing LDL apheresis (mechanical removal of cholesterol from the blood), · If you are undergoing treatment to reduce allergic reactions to bee or wasp stings, · If you have recently had diarrhea, vomiting, or dehydration, · If your doctor has told you that you have an intolerance to some sugars, · If you are taking any of the following blood pressure-lowering medicines: - Angiotensin II receptor blockers (ARBs) (also known as sartans, e.g. valsartan, telmisartan, irbesartan), especially if you have diabetic kidney disease, - Aliskiren Your doctor may carry out regular monitoring of your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium). Also see the information in the section "Do not take PRESTARIU M®" - if you are of African descent, as you may be at a higher risk of angioedema, and this medicine may be less effective in lowering blood pressure in patients of African descent compared to patients of other ethnicities. · If you are taking any of the following medicines, the risk of angioedema may increase: - racecadotril (used to treat diarrhea), - sirolimus, everolimus, temsirolimus and other medicines belonging to the so-called mTOR inhibitors class (used to prevent rejection of transplanted organs and to treat cancer), - sacubitril (available in fixed combination with valsartan), used for chronic heart failure. - linagliptin, saxagliptin, sitagliptin, vildagliptin and other medicines belonging to the so-called gliptins (used to treat diabetes). Angioedema Cases of angioedema (a serious allergic reaction with swelling of the face, lips, tongue or throat, difficulty swallowing or breathing) have been reported in patients taking ACE inhibitors, including PRESTARIU M®. These reactions can occur at any time during treatment. If you develop these symptoms, you should stop taking PRESTARIU M® immediately and consult your doctor. See also section 4. You must inform your doctor if you think you are pregnant (or planning a pregnancy). Taking PRESTARIU M® is not recommended in early pregnancy. The medicine should not be taken after 3 months of pregnancy, as it can cause serious harm to the baby's health (see section <<Pregnancy>>). Children and adolescents The use of perindopril in children and adolescents under 18 years of age is not recommended. Taking PRESTARIU M® with other medicines If you are taking, have recently taken or might take any other medicines, tell your doctor or pharmacist. Treatment with PRESTARIU M® may be affected by other medicines. Your doctor may need to change your dose and/or take other precautions. These medicines include: · Other medicines for high blood pressure, including angiotensin II receptor blockers (ARBs), aliskiren (see also information in the section <<Do not take PRESTARIU M®>> and <<Be especially careful in the following cases>>) or diuretics (medicines that increase the volume of urine excreted by the kidneys), · Potassium-sparing drugs (e.g. triamterene, amiloride), potassium supplements or salt substitutes containing potassium, other medicines that increase potassium levels in the body (e.g. heparin, a medicine used to thin the blood and prevent clot formation; trimethoprim and co-trimoxazole, also known as trimethoprim/sulfamethoxazole), · Potassium-sparing drugs for heart failure: eplerenone and spironolactone, at doses of 12.5 mg to 50 mg per day, · Lithium, for mania or depression, · Non-steroidal anti-inflammatory drugs (e.g. ibuprofen) for pain relief or high doses of acetylsalicylic acid, substances found in many medicines used to relieve pain and reduce fever, as well as to prevent clot formation, · Medicines for diabetes (e.g. insulin or metformin), · Baclofen (used to treat muscle stiffness in conditions such as multiple sclerosis), · Medicines for mental disorders such as depression, anxiety, schizophrenia, etc. (e.g. tricyclic antidepressants, antipsychotics), · Immunosuppressants (medicines that lower the body's defenses) used in autoimmune disorders or after transplantation (e.g. ciclosporin, tacrolimus), · Trimethoprim (for treating infections), · Estramustine (used in cancer therapy) · Medicines most commonly used to treat diarrhea (racecadotril) or to prevent rejection of transplanted organs (sirolimus, everolimus, temsirolimus and other medicines belonging to the so-called mTOR inhibitors class see section <<Be especially careful in the following cases>>); · Sacubitril and valsartan (used to treat chronic heart failure) see sections <<Do not take PRESTARIU M®>> and <<Be especially careful in the following cases>>; · Allopurinol (for treating gout), · Procainamide (for treating irregular heart rhythm), · Vasodilators, including nitrates (medicines that cause blood vessels to widen); · Medicines for low blood pressure, shock and asthma (e.g. ephedrine, noradrenaline and adrenaline); · Sodium aurothiomalate, especially when given intravenously (used to treat symptoms of rheumatoid arthritis). Taking PRESTARIU M® with food and drink PRESTARIU M® is best 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 You must inform your doctor if you think you are pregnant (or if you are planning a pregnancy). Your doctor will usually advise you to stop taking PRESTARIU M® before you become pregnant or as soon as you confirm you are pregnant and will prescribe another medicine instead. Taking PRESTARIU M® is not recommended in early pregnancy. The medicine must not be taken after 3 months of pregnancy, as it can cause serious harm to the baby's health. Breastfeeding If you are breastfeeding or planning to breastfeed, tell your doctor. PRESTARIU M® is not recommended for breastfeeding mothers. If you wish to continue breastfeeding, your doctor may prescribe another treatment for you, especially if the baby is newborn or premature. Driving and using machines PRESTARIU M® usually does not affect your ability to concentrate, but some patients may experience dizziness or weakness due to low blood pressure. In such cases, your ability to drive or operate machinery may be impaired. PRESTARIU M® contains lactose If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine. PRESTARIU M® contains sodium PRESTARIU M® contains less than 1 mmol of sodium (23 mg) per tablet, meaning it is essentially sodium-free. 3. How to take PRESTARIU M® Always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, ask your doctor or pharmacist. The tablets are recommended to be taken once a day, in the morning, before breakfast, with a glass of water, preferably at the same time each day. Your doctor will decide the appropriate dose for you. Recommended doses: High blood pressure: The usual starting and maintenance dose is 5 mg once a day. If necessary, the dose can be increased to 10 mg once a day after one month of treatment. The maximum recommended dose for high blood pressure is 10 mg per day. If you are 65 years or older, the usual starting dose is 2.5 mg once a day. After one month of starting treatment, the dose can be increased to 5 mg once a day, and then, if necessary, to 10 mg once a day. Heart failure: The usual starting dose is 2.5 mg once a day. After 2 weeks of starting treatment, the dose can be increased to 5 mg once a day, which is the maximum recommended dose for heart failure. Stable ischemic heart disease: The usual starting dose is 5 mg once a day. After 2 weeks of starting treatment, the dose can be increased to 10 mg once a day, which is the maximum recommended dose for this indication. If you are 65 years or older, the usual starting dose is 2.5 mg once a day. After one week of starting treatment, the dose can be increased to 5 mg once a day, and then, after another week, to 10 mg once a day. Use in children and adolescents The use of the medicine in children and adolescents is not recommended. If you take more PRESTARIU M® than you should If you have taken too many tablets, go to the nearest emergency department or tell your doctor immediately. The most likely effect of an overdose is a drop in blood pressure, which may make you feel dizzy or faint. If this happens, lie down with your legs raised, which may help your condition. If you forget to take PRESTARIU M® It is important to take the medicine every day, as regular intake makes the treatment more effective. However, if you forget to take a dose of PRESTARIU M®, take the next dose at the usual time. Do not double the dose to make up for a forgotten dose. If you stop taking PRESTARIU M® Since treatment with PRESTARIU M® is usually lifelong, you should consult your doctor before stopping the medication. If you have any further questions about the use of this medicine, ask your doctor, pharmacist or nurse. 4. Possible side effects Like all medicines, PRESTARIU M® can cause side effects, although not everybody gets them. Stop taking this medicine immediately and contact your doctor if you experience any of the following side effects, which may be serious: · Swelling of the face, lips, mouth, tongue or throat, difficulty breathing (angioedema) (see section 2 "Be especially careful in the following cases") (uncommon, affects less than 1 in 100 people), · Severe dizziness or fainting caused by low blood pressure (common – affects less than 1 in 10 people), · Unusually fast or irregular heartbeat, chest pain (angina) or heart attack (very rare – affects less than 1 in 10,000 people), · Weakness in arms or legs, speech problems, which may be signs of a stroke (very rare – affects less than 1 in 10,000 people), · Sudden wheezing, chest pain, shortness of breath or difficulty breathing (bronchospasm) (uncommon – affects less than 1 in 100 people), · Inflammation of the pancreas, which can cause severe abdominal and back pain accompanied by feeling unwell (very rare – affects less than 1 in 10,000 people) · Yellowing of the skin or whites of the eyes (jaundice), which may be a sign of hepatitis (very rare – affects less than 1 in 10,000 people), · Skin rash, often starting on the face, hands and feet with red itchy spots (erythema multiforme) (very rare - affects less than 1 in 10,000 people). If you experience any of the following side effects, tell your doctor: Common (affects less than 1 in 10 people): - Headache, - Dizziness, - Vertigo, - Tingling sensation in the limbs, - Visual disturbances, - Ringing in the ears (tinnitus), - Cough - Shortness of breath (dyspnea), - Digestive tract disorders (nausea, vomiting, abdominal pain, taste disturbance, dyspepsia or indigestion, diarrhea, constipation), - Allergic reactions (such as skin rash, itching), - Muscle cramps, - Feeling of weakness. Uncommon (affects less than 1 in 100 people): - Depression, - Mood swings, - Sleep disturbances, - Dry mouth, - Severe itching or widespread skin rash, - Formation of blisters on the skin, - Impaired kidney function, - Sexual impotence, - Sweating, - Increased eosinophil count (a type of white blood cell), - Drowsiness, - Fainting, - Palpitations, - Tachycardia, - Vasculitis (inflammation of blood vessels), - Photosensitivity reactions (increased skin sensitivity to the sun) - Arthralgia (joint pain), - Myalgia (muscle pain), - Chest pain, - Feeling of discomfort, - Peripheral edema, - Fever, - Falls, - Changes in laboratory parameters: high potassium levels in the blood, which decrease upon discontinuation of therapy, low sodium levels, hypoglycemia (very low blood sugar levels) in patients with diabetes, increased blood urea and creatinine levels. Rare (affects less than 1 in 1,000 people): - Acute kidney failure - Dark urine, feeling unwell (nausea or vomiting), muscle cramps, confusion, seizures. This may be a symptom of a disorder called SIADH (syndrome of inappropriate secretion of antidiuretic hormone) - Reduced or absent urine output - Hot flushes - Worsening of psoriasis - Changes in laboratory parameters: increased liver enzyme levels, high bilirubin levels in the blood. Very rare (affects less than 1 in 10,000 people): - Confusion, - Eosinophilic pneumonia (a rare type of pneumonia), - Rhinitis (stuffy or runny nose), - Blood disorders, such as a decrease in the number of white blood cells and red blood cells, a decrease in hemoglobin levels, a decrease in the number of platelets. If you develop any of these symptoms, consult your doctor immediately. Frequency not known (cannot be estimated from available data): Change in skin color, numbness and pain in fingers and toes (Raynaud's syndrome) Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. By reporting side effects, you can help provide more information on the safety of this medicine. 5. How to store PRESTARIU M® Keep out of the reach and sight of children. Store at a temperature not exceeding 30°C. Do not use this medicine after the expiry date which is stated on the carton and bottle. The expiry date refers to the last day of that month. Keep the bottle tightly closed to protect from moisture. Do not dispose of medicines down the drain or into household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6. What PRESTARIU M® contains and other information What PRESTARIU M® 5mg contains: · The active substance is perindopril arginine. One film-coated tablet contains 3.395 mg of perindopril (equivalent to 5 mg of perindopril arginine). · Other ingredients: Tablet core: lactose monohydrate, magnesium stearate, maltodextrin, colloidal anhydrous silica, sodium starch glycolate (Type A); Film coating: glycerol, hypromellose, copper chlorophyllin, macrogol 6000, magnesium stearate, titanium dioxide. What PRESTARIU M® 10mg contains: · The active substance is perindopril arginine. One film-coated tablet contains 6.790 mg of perindopril (equivalent to 10 mg of perindopril arginine). · Other ingredients: Tablet core: lactose monohydrate, magnesium stearate, maltodextrin, colloidal anhydrous silica, sodium starch glycolate (Type A); Film coating: glycerol, hypromellose, copper chlorophyllin, macrogol 6000, magnesium stearate, titanium dioxide (E171). What PRESTARIU M® looks like and contents of the pack PRESTARIU M® 5mg: Light green, elongated, film-coated tablets with an embossed mark on one side and a dividing line on each side. The tablet can be divided into equal halves. PRESTARIU M® 10mg: Green, round, biconvex, film-coated tablets with an embossed mark on one side and a mark on the other side. The tablets are available in cartons containing 30 tablets. Dispensing category Pharmaceutical product group II, dispensed with prescription form No. 3 For the treatment of arterial hypertension you can see the blog.
