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NOLIPREL ARGININE PERINDOPRIL ARGININE/INDAPAMIDE film-coated tablets Read this leaflet carefully before you start taking this medicine because 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 or pharmacist. · 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: 1. What NOLIPREL ARGININE is and what it is used for 2. What you need to know before you take NOLIPREL ARGININE 3. How to take NOLIPREL ARGININE 4. Possible side effects 5. How to store NOLIPREL ARGININE 6. Contents of the pack and other information 1. What NOLIPREL ARGININE is and what it is used for NOLIPREL ARGININE is a combination of two active substances, perindopril and indapamide. It is an antihypertensive medicine used to treat high blood pressure (hypertension) in adults. Perindopril belongs to a class of medicines called ACE inhibitors. It works by widening the blood vessels, which makes it easier for your heart to pump blood. Indapamide is a diuretic. Diuretics increase the amount of urine produced by the kidneys. However, indapamide differs from other diuretics because it only slightly increases the amount of urine produced by the kidneys. Each active substance lowers blood pressure and together they control your blood pressure. 2. What you need to know before you take NOLIPREL ARGININE Do not take NOLIPREL ARGININE: · if you are allergic to perindopril, any other ACE inhibitor, indapamide, any sulfonamide or any of the other ingredients of this medicine (listed in section 6), · if you or any of your relatives have previously experienced symptoms such as wheezing, swelling of the face or tongue, intense itching or skin rash (angioneurotic oedema) when taking another ACE inhibitor or in other circumstances, · if you have diabetes or impaired kidney function and you are taking a blood pressure lowering medicine containing aliskiren, · if you have severe liver disease or hepatic encephalopathy (a degenerative disease of the brain), · if you have severe kidney disease with reduced blood flow to the kidneys (renal artery stenosis), · if you are undergoing dialysis or other filtration procedures. Depending on the type of membrane used, NOLIPREL ARGININE may be unsuitable for you, · if you have low levels of potassium in your blood, · if you suspect you have untreated decompensated heart failure (serious fluid retention, difficulty breathing), · if you are pregnant and more than 3 months pregnant (it is also best to avoid NOLIPREL ARGININE in early pregnancy – see section ‘Pregnancy’), · if you were taking or are currently taking sacubitril and valsartan (medicines used to treat heart failure) as this increases the risk of Quincke's oedema (rapid swelling of the tissues under the skin, e.g. in the throat) (see sections ‘Warnings and precautions’ and ‘Other medicines and NOLIPREL ARGININE’). Warnings and precautions Talk to your doctor or pharmacist before taking NOLIPREL ARGININE: · if you have aortic stenosis (narrowing of the main artery leaving the heart), hypertrophic cardiomyopathy (heart muscle disease) or renal artery stenosis (narrowing of the arteries supplying the kidneys), · if you have heart failure, or any other heart disease, · if you have kidney disease or are undergoing dialysis, · if you have muscle disorders, including muscle pain, tenderness or weakness, or muscle cramps, · if you have abnormally high levels of the hormone aldosterone in your blood (primary hyperaldosteronism), · if you have kidney disease, · if you have impaired liver function, · if you have a collagen-vascular disease (skin disease) such as systemic lupus erythematosus or scleroderma, · if you have atherosclerosis (hardening of the arteries), · if you have hyperparathyroidism (overactive parathyroid gland), · if you have gout, · if you have diabetes, · if you are on a low-salt diet or use salt substitutes containing potassium, · if you are taking lithium or potassium-sparing drugs (spironolactone, triamterene), or potassium supplements, as they cannot be taken together with NOLIPREL ARGININE (see ‘Other medicines and NOLIPREL ARGININE’), · if you are elderly, · if you have experienced photosensitivity reactions, · if you have experienced serious allergic reactions, with swelling of the face, tongue, mouth, throat, which may make it difficult to swallow or breathe (angioneurotic oedema). This can occur at any time during treatment. If you develop such symptoms, you should stop taking the medicine and seek immediate medical attention. · if you are taking any of the following blood pressure lowering medicines: - an angiotensin II receptor blocker (ARB) (also known as sartans, e.g. valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes, - aliskiren. · if you experience a decrease in vision or eye pain. These could be symptoms of fluid build-up in the vascular layer of the eye (choroidal effusion) or an increase in intraocular pressure – these can occur from hours to weeks after taking NOLIPREL ARGININE. Without treatment, this can lead to irreversible vision loss. If you have had an allergic reaction to penicillin or sulfonamide in the past, you may be at higher risk of developing this. Your doctor may monitor your kidney function, blood pressure, and the level of electrolytes (e.g. potassium) in your blood regularly. Also see information in the section ‘Do not take NOLIPREL ARGININE’. · if you are of African descent, as you may have a higher risk of angioneurotic oedema and this medicine may be less effective in lowering your blood pressure than in patients of non-African descent, · if you are undergoing dialysis with high-flux membranes, · if you are taking any of the following medicines, the risk of angioneurotic oedema may be increased: - racecadotril (used to treat diarrhoea), - sirolimus, everolimus, temsirolimus and other medicines belonging to the class of mTOR inhibitors (used to prevent rejection of transplanted organs and to treat cancer). - sacubitril (in fixed combination with valsartan), used to treat chronic heart failure. - linagliptin, saxagliptin, sitagliptin, vildagliptin and other medicines belonging to the class of gliptins (used to treat diabetes). Angioneurotic oedema: Cases of angioneurotic oedema (serious allergic reactions with swelling of the face, lips, tongue or throat, difficulty swallowing or breathing) have been reported in patients treated with ACE inhibitors, including NOLIPREL ARGININE. These reactions may occur at any time during treatment. If you develop these symptoms, you must stop taking NOLIPREL ARGININE immediately and seek medical attention. See also section 4. You must tell your doctor if you think you are pregnant (or might become pregnant). NOLIPREL ARGININE is not recommended in early pregnancy. You should not take the medicine if you are more than 3 months pregnant, as it could cause serious harm to your baby (see section ‘Pregnancy and breastfeeding’). When you are taking NOLIPREL ARGININE, you must also inform your doctor or medical staff if: · you are scheduled for anaesthesia and/or major surgery, · you have recently suffered from diarrhoea, vomiting or dehydration, · you need to undergo dialysis or are undergoing LDL apheresis (mechanical removal of cholesterol from your blood), · you are going to have desensitisation treatment to reduce allergy to bee or wasp stings, · you are undergoing a medical examination that requires the injection of iodinated contrast media (substances that make internal organs, e.g. kidneys or stomach, visible on X-rays). · you experience a change in vision or pain in your eyes. This could be a sign of fluid build-up in the vascular layer of the eye (choroidal effusion) or increased eye pressure from angle-closure glaucoma. You should stop treatment and seek medical advice. Athletes should be aware that NOLIPREL ARGININE contains an active substance (indapamide) which may give a positive result in doping control tests. Children and adolescents NOLIPREL ARGININE must not be prescribed to children and adolescents. Other medicines and NOLIPREL ARGININE Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Avoid taking NOLIPREL ARGININE together with: · lithium (used to treat mania or depression), · aliskiren (a medicine for high blood pressure), unless you have diabetes or impaired kidney function, · potassium-sparing diuretics (e.g. triamterene, amiloride), potassium salts and other medicines that increase the level of potassium in your body (e.g. heparin for thinning the blood, preventing blood clots, trimethoprim and co-trimoxazole, also known as trimethoprim/sulfamethoxazole, used to treat bacterial infections), · estramustine (used to treat cancer), · other medicines for high blood pressure: ACE inhibitors and angiotensin receptor blockers. The use of other medicines may affect the treatment with NOLIPREL ARGININE. Your doctor may need to change your dose and/or take other precautions. Be sure to tell your doctor if you are taking any of the following medicines, as special care may be needed: · medicines used to treat high blood pressure, including angiotensin II receptor blockers (ARBs) or aliskiren (also see information in the sections ‘Do not take NOLIPREL ARGININE’ and ‘Warnings and precautions’) or diuretics (medicines that increase the amount of urine produced by the kidneys), · potassium-sparing drugs used in heart failure: eplerenone and spironolactone, at doses from 12.5 mg to 50 mg per day, · medicines more commonly used to treat diarrhoea (racecadotril) or to prevent rejection of transplanted organs (sirolimus, everolimus, temsirolimus and other medicines belonging to the class of mTOR inhibitors) see section ‘Warnings and precautions’, · sacubitril and valsartan (used to treat chronic heart failure) see sections ‘Do not take NOLIPREL ARGININE’ and ‘Warnings and precautions’, · anaesthetic drugs, · iodinated contrast media, · antibiotics to treat bacterial infections (e.g. moxifloxacin, sparfloxacin, injectable erythromycin), · methadone (used to treat drug addiction), · procainamide (to treat irregular heart rhythm), · allopurinol (to treat gout), · antihistamines to treat allergic reactions, such as hay fever (e.g. mizolastine, terfenadine, astemizole), · corticosteroids used to treat various conditions, including severe asthma or rheumatoid arthritis, · immunosuppressants used to treat autoimmune disorders or to prevent rejection of transplanted organs after surgery (e.g. ciclosporin, tacrolimus), · halofantrine (used to treat certain forms of malaria), · pentamidine (used to treat pneumonia), · injectable gold preparations (used to treat rheumatoid polyarthritis) · vincamine (used in the elderly for symptomatic treatment of cognitive impairment, including memory loss), · bepridil (used to treat angina), · medicines for heart rhythm disorders (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, digoxin, bretylium), · cisapride, difenmanil (used to treat gastrointestinal disorders), · digoxin or other cardiac glycosides (to treat heart diseases), · baclofen (to treat muscle rigidity occurring in diseases such as multiple sclerosis), · medicines for diabetes, such as insulin, metformin or gliptins, · calcium, including calcium supplements, · stimulant laxatives (e.g. senna), · non-steroidal anti-inflammatory drugs (e.g. ibuprofen) and high doses of salicylates (acetylsalicylic acid, a substance found in many medicines used to relieve pain and reduce fever, and also to prevent blood clots), · amphotericin B (injection) (to treat serious fungal infections), · medicines for mental disorders such as depression, anxiety, schizophrenia, etc. (e.g. tricyclic antidepressants, neuroleptics (such as amisulpride, sulpiride, sultopride, tiapride, haloperidol, droperidol)), · tetracosactide (to treat Crohn's disease), · trimethoprim (to treat infection), · vasodilators, including nitrates (medicines that widen blood vessels), · medicines used to treat low blood pressure, shock or asthma (e.g. ephedrine, noradrenaline or adrenaline). NOLIPREL ARGININE with food and drink NOLIPREL ARGININE 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 If you think you are pregnant (or might become pregnant), you must tell your doctor. Your doctor will usually advise you to stop taking NOLIPREL ARGININE before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead. NOLIPREL ARGININE is not recommended in early pregnancy. You must not take the medicine if you are more than 3 months pregnant, as it could cause serious harm to your baby’s health. Breastfeeding NOLIPREL ARGININE is not recommended during breastfeeding. If you are breastfeeding or plan to breastfeed, tell your doctor immediately. Contact your doctor immediately. Driving and using machines NOLIPREL ARGININE does not affect alertness, but some patients may experience various reactions, such as dizziness or weakness, due to a drop in blood pressure. As a result, your ability to drive or operate machinery may be impaired. NOLIPREL ARGININE contains lactose monohydrate. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine. NOLIPREL ARGININE contains sodium Each tablet of NOLIPREL ARGININE contains less than 1 mmol of sodium (23 mg), meaning it is essentially ‘sodium-free’. 3. How to take NOLIPREL ARGININE Always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, ask your doctor or pharmacist. The recommended starting dose is 1 tablet per day. Your doctor may decide to increase the dose to 2 tablets per day or change the dosage regimen if you have impaired kidney function. It is best to take the tablets in the morning, before a meal. Swallow the tablet with a glass of water. The score line is not intended for dividing the tablet. If you take more NOLIPREL ARGININE than you should: If you have taken too many tablets, contact the nearest emergency department or inform your doctor immediately. The most likely effect of an overdose is a drop in blood pressure. If your blood pressure drops (with symptoms such as nausea, vomiting, low blood pressure, cramps, dizziness, drowsiness, confusion and a change in the amount of urine produced by the kidneys), lie down and raise your legs; this will help to alleviate the situation. If you forget to take NOLIPREL ARGININE 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 NOLIPREL ARGININE, take the next dose at the usual time. Do not double the dose to make up for a forgotten dose. If you stop taking NOLIPREL ARGININE Treatment for high blood pressure usually lasts a lifetime. You must consult your doctor before stopping treatment with this medicine. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, NOLIPREL ARGININE can cause side effects, although not everybody gets them. Stop taking the medicine immediately and contact your doctor straight away if you experience any of the following side effects, which may be serious: · Severe dizziness or fainting due to low blood pressure (common – affects less than 1 in 10 people), · Bronchospasm (feeling of chest tightness, wheezing and shortness of breath) (uncommon – affects less than 1 in 100 people), · Swelling of the face, lips, mouth, tongue or throat, difficulty breathing (angioneurotic oedema) (uncommon – affects less than 1 in 100 people) (see section 2 ‘Warnings and precautions’), · Severe skin reactions including intense rash, redness all over the body, severe itching, blistering, peeling and swelling of the skin, inflammation of mucous membranes (Stevens-Johnson syndrome) or other allergic reactions (very rare – affects less than 1 in 10,000 people), · Cardiovascular disorders (unusually fast or irregular heartbeat, chest pain, pain in the jaw and back, caused by physical exertion (angina), heart attack) (very rare – affects less than 1 in 10,000 people), · Weakness in arms or legs or speech problems, which could be signs of a possible stroke (very rare – affects less than 1 in 10,000 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 and whites of the eyes (jaundice), which may be a sign of hepatitis (very rare – affects less than 1 in 10,000 people), · Life-threatening arrhythmia (frequency unknown), · Brain disease caused by liver dysfunction (hepatic encephalopathy) (frequency unknown). · Muscle weakness, cramps, tenderness or muscle pain, especially if you feel unwell or have a fever at the same time; this may be caused by abnormal breakdown of muscle tissue (frequency unknown). With decreasing frequency, the following side effects may occur: · Common (affects less than 1 in 10 people): low potassium in the blood, skin reactions, in patients predisposed to allergic and asthmatic reactions, headache, dizziness, vertigo, tingling sensation in the extremities, visual disturbances, tinnitus (ringing in the ears), cough, shortness of breath (dyspnoea), digestive disorders (nausea, vomiting, abdominal pain, taste disturbances, dyspepsia or difficulty digesting, diarrhoea, constipation), allergic reactions (such as rash, itching), muscle cramps, feeling of tiredness. · Uncommon (may affect up to 1 in 100 people): mood changes, sleep disturbances, hives, purpura (red spots on the skin), blistering on the skin, kidney function impairment, impotence (inability to achieve or maintain an erection), increased sweating, excess eosinophils (a type of white blood cell). Changes in laboratory parameters: high potassium in the blood, which is reversible upon discontinuation of treatment, low sodium in the blood, which can lead to dehydration and low blood pressure, drowsiness, fainting, palpitations, tachycardia (rapid heartbeat), hypoglycaemia (very low blood sugar) in diabetic patients, vasculitis (inflammation of blood vessels), dry mouth, photosensitivity reactions (increased skin sensitivity to the sun), arthralgia (joint pain), myalgia (muscle pain), chest pain, malaise, peripheral oedema, fever, increased blood urea and creatinine levels, falls. · Rare (affects less than 1 in 1,000 people): worsening of psoriasis, changes in laboratory parameters: low chloride in the blood, low magnesium in the blood, increased liver enzymes, high bilirubin levels in the blood serum, fatigue, facial flushing, reduced or stopped urine output, acute kidney failure. Dark urine, nausea or vomiting, muscle cramps, confusion and seizures. These may all be symptoms of a condition called SIADH (Syndrome of Inappropriate Antidiuretic Hormone Secretion). · Very rare (affects less than 1 in 10,000 people): confusion, eosinophilic pneumonia (a rare type of pneumonia), rhinitis (stuffy or runny nose), severe kidney disease, blood disorders such as reduced number of white blood cells and red blood cells, reduced haemoglobin, reduced number of platelets, high calcium in the blood, impaired liver function. · Frequency not known (cannot be estimated from the available data): deviation from normal on electrocardiogram (ECG), changes in some laboratory parameters: increased uric acid and increased blood glucose levels, myopia (nearsightedness), blurred vision, visual impairment, change in skin colour. Numbness and pain in fingers and toes (Raynaud's syndrome), decreased vision or eye pain due to high pressure (possible signs of fluid build-up in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma). If you have systemic lupus erythematosus (a type of collagen disease), your condition may worsen. Disorders of the blood, kidneys, liver or pancreas and changes in laboratory parameters (blood tests) may occur. Your doctor may order blood tests to monitor your condition. If you develop such symptoms, seek medical attention immediately. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. 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 NOLIPREL ARGININE Keep this medicine out of the sight and reach of children. Store at a temperature not exceeding 30°C. Shelf life: 36 months Do not use this medicine after the expiry date which is stated on the carton and container. The expiry date refers to the last day of that month. Packaging Keep the container tightly closed, 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 need. These measures will help protect the environment. 6. Contents of the pack and other information What NOLIPREL ARGININE contains - The active substances are: perindopril arginine and indapamide. One film-coated tablet contains 2.5 mg of perindopril arginine (equivalent to 1.6975 mg perindopril) and 0.625 mg of indapamide. - The other ingredients in the tablet core are: lactose monohydrate, magnesium stearate (E470B), maltodextrin, colloidal anhydrous silica (E551), sodium starch glycolate (Type A); the film coating contains: glycerol (E422), hypromellose (E464), macrogol 6000, magnesium stearate (E470B), titanium dioxide (E171). What NOLIPREL ARGININE looks like and contents of the pack NOLIPREL ARGININE is a white, oblong film-coated tablet with a score line on both sides. One film-coated tablet contains 2.5 mg of perindopril arginine and 0.625 mg of indapamide. The tablets are available in containers containing 30 tablets. Dispensing conditions: Pharmaceutical product group II, dispensed with prescription form №3
