Roxampex 20/10/8mg 30 tablets

Form

tableti saghech i

Dosage mg

20+10+8

Pack

30

ROXAMPEX® 20 mg/10 mg/8 mg film-coated tablets Rosuvastatin/Amlodipine/Perindopril tert-butylamine Read the package leaflet carefully before you start taking this medicine because it contains important information for you. - Keep the package 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 signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4. What is in this leaflet: 1. What ROXAMPEX® is and what it is used for 2. What you need to know before you take ROXAMPEX® 3. How to take ROXAMPEX® 4. Possible side effects 5. How to store ROXAMPEX® 6. Contents of the pack and other information 1. What ROXAMPEX® is and what it is used for ROXAMPEX® is a combination of three active ingredients: rosuvastatin, perindopril and amlodipine. Rosuvastatin belongs to a group of medicines known as statins. Perindopril is an ACE (angiotensin-converting enzyme) inhibitor. Amlodipine belongs to a group of medicines known as calcium channel blockers. Rosuvastatin helps to control high cholesterol levels: - Rosuvastatin is used to treat high cholesterol if you are at risk of heart attack or stroke. - Rosuvastatin is used if changes to your diet and more physical activity were not enough to correct your cholesterol levels. While you are taking rosuvastatin, you should continue your cholesterol-lowering diet and physical activity. Perindopril and amlodipine help to control high blood pressure (hypertension). ROXAMPEX® is prescribed for adult patients to treat high blood pressure (hypertension) and high cholesterol levels at the same time. Patients who are already taking separate tablets of rosuvastatin, perindopril and amlodipine can take one ROXAMPEX® tablet containing all three ingredients. 2. What you need to know before you take ROXAMPEX® Do not take ROXAMPEX®: - if you are allergic to rosuvastatin, perindopril or any other ACE inhibitor, amlodipine or any other calcium channel blocker or any of the other ingredients of ROXAMPEX® (listed in section 6); - if you have experienced symptoms such as shortness of breath, swelling of your face or tongue, severe itching or severe skin reactions previously when taking an ACE inhibitor, or if a member of your family has had similar symptoms in any circumstances (a condition called angioedema); - if you have diabetes or kidney impairment and you are treated with an aliskiren-containing medicine for high blood pressure; - if you have serious low blood pressure (hypotension); - if you have a narrowing of your aortic valve (aortic stenosis) or cardiogenic shock (a condition where your heart cannot supply the body with enough blood); - if you have heart failure after a heart attack; - if you have severe kidney disease; - if you have liver disease; - if you have recurrent or unexplained muscle pain; - if you are taking ciclosporin (used, for example, after organ transplantation); - if you are pregnant or breastfeeding. If you become pregnant while taking ROXAMPEX®, stop taking it immediately and tell your doctor. - if you are undergoing dialysis or any other type of blood filtration. Depending on the machine used, ROXAMPEX® may not be suitable for you, - if you have kidney problems where blood supply to the kidneys is reduced (renal artery stenosis), - if you have taken or are currently taking sacubitril/valsartan, a medicine used for long-term (chronic) heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin, such as of the throat). Warnings and precautions Before taking ROXAMPEX®, talk to your doctor or pharmacist: - if you have recently had a heart attack; - if you have aortic valve stenosis (narrowing of the main blood vessel leaving the heart) or hypertrophic cardiomyopathy (a disease of the heart muscle) or renal artery stenosis (narrowing of the artery supplying blood to the kidney); - if you have heart failure or other heart problems; - if you have kidney problems or if you are on dialysis; - if you have liver problems; - if you have a collagen disease (a connective tissue disease) such as systemic lupus erythematosus or scleroderma; - if you experience swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema), which may occur during treatment, stop treatment immediately and contact your doctor straight away; - if you are on a salt-restricted diet or use salt substitutes containing potassium; - if you are taking lithium or potassium-sparing diuretics (spironolactone, triamterene), as their use with ROXAMPEX® should be avoided (see 'Other medicines and ROXAMPEX®'); - if you are elderly; - if you have high levels of the hormone aldosterone in your blood (primary aldosteronism); - if you have diabetes; - if you are to undergo anaesthesia and/or surgery; - if you are to undergo LDL apheresis (which involves removing cholesterol from your blood using a machine), - if you are to undergo desensitisation treatment to reduce the effects of bee or wasp stings, - if you have recently had diarrhoea or vomiting, or are dehydrated, - if your doctor has told you that you have an intolerance to some sugars, - if your thyroid gland is not working properly; - if you are of Asian origin – Japanese, Chinese, Filipino, Vietnamese, Korean and Indian. - Your doctor will choose the correct starting dose of ROXAMPEX® for you. - if you are of Black African origin, as you may have an increased risk of angioedema and this medicine may be less effective in lowering your blood pressure than in non-Black African patients; - if you have had recurrent or unexplained muscle pain, a personal or family history of muscle problems or previous muscle problems when taking other cholesterol-lowering medicines. Tell your doctor immediately if you have unexplained muscle pain, especially if you feel unwell or have a fever. Also tell your doctor if you have persistent muscle weakness. - if you are taking other medicines, such as fibrates to lower cholesterol. Please read this leaflet carefully, even if you have taken other cholesterol-lowering medicines before. - if you are taking medicines for HIV infection, e.g. ritonavir with lopinavir and/or atazanavir, please see section 'Other medicines and ROXAMPEX®', - if you regularly drink large quantities of alcohol; - if you are taking any of the following medicines to treat high blood pressure: - Angiotensin II receptor blockers (also known as sartans - for example, valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes, - Aliskiren. - Women should avoid becoming pregnant while taking ROXAMPEX® using effective contraception. Your doctor may check your kidney function, blood pressure and the amount of electrolytes (e.g. potassium) in your blood at regular intervals. See also information in the section 'Do not take ROXAMPEX®'. If you are taking, or have recently taken, or might take, fusidic acid (a medicine for bacterial infection) orally or by injection. Combination of fusidic acid and rosuvastatin can cause serious muscle problems (rhabdomyolysis), see 'Other medicines and ROXAMPEX®'. If you are taking any of the following medicines, the risk of angioedema may be increased: - racecadotril (used to treat diarrhoea); - sirolimus, everolimus, temsirolimus and other medicines belonging to the class of so-called mTOR inhibitors (used to prevent the rejection of transplanted organs); - vildagliptin, a medicine used to treat diabetes. Angioedema Angioedema (acute allergic reaction with swelling of the face, lips, mouth or throat causing difficulty in breathing or swallowing) has been reported in patients treated with ACE inhibitors, including ROXAMPEX®. This can occur at any time during treatment. If you experience these symptoms, stop taking ROXAMPEX® and contact your doctor immediately. See also section 4. In a small number of people, statins can affect the liver, which can be detected by a simple test that checks for increased levels of liver enzymes in the blood. For this reason, your doctor will perform this blood test (liver function test) before and during treatment with ROXAMPEX®. During treatment with this medicine, your doctor will monitor your condition if you have diabetes or are at risk of developing diabetes. You are at risk of developing diabetes if you have high blood sugar and fat levels, are overweight and have high blood pressure. Children and adolescents ROXAMPEX® is not intended for use in children and adolescents. Other medicines and ROXAMPEX® Tell your doctor or pharmacist if you are currently taking, have recently taken or might take any other medicines. Treatment with ROXAMPEX® may be affected by other medicines. Tell your doctor if you are taking any of the following medicines, as special precautions may be needed: - Other medicines used to treat high blood pressure, including angiotensin II receptor blockers, aliskiren (see also information in the sections 'Do not take ROXAMPEX®' and 'Warnings and precautions') or diuretics (medicines that increase the amount of urine produced by your kidneys); - Potassium-sparing diuretics (e.g. triamterene, amiloride), potassium supplements (including salt substitutes) and other medicines that increase the amount of potassium in your blood (e.g. trimethoprim and co-trimoxazole for bacterial infections; ciclosporin or tacrolimus, immunosuppressants used to prevent rejection of transplanted organs; and heparin, a medicine used to prevent blood clots by thinning the blood), - Potassium-sparing medicines used to treat heart failure: eplerenone and spironolactone in doses of 12.5 mg to 50 mg per day, - Lithium to treat mania or depression, - Non-steroidal anti-inflammatory drugs (e.g. ibuprofen) or high doses of salicylates (e.g. aspirin); - Medicines for diabetes (such as insulin or metformin), - Baclofen (to treat muscle stiffness that occurs in diseases such as multiple sclerosis); - Medicines for psychiatric disorders such as depression, anxiety, schizophrenia, etc. (e.g. tricyclic antidepressants, antipsychotics), - Trimethoprim (to treat infections), - Estramustine (used in cancer therapy), - Medicines most commonly used to treat diarrhoea (racecadotril) or to prevent rejection of transplanted organs (sirolimus, everolimus, temsirolimus and other medicines belonging to the class of so-called mTOR inhibitors). See section 'Warnings and precautions', - Allopurinol (to treat gout), - Procainamide (to treat irregular heartbeats), - Vasodilators, including nitrates (products that widen blood vessels), - Heparin (a blood-thinning agent), - Medicines used to treat low blood pressure, shock or asthma (e.g. ephedrine, noradrenaline or adrenaline), - Gold salts, especially injectable gold (used to treat symptoms of rheumatoid arthritis), - Warfarin or clopidogrel (or any other medicine used to thin the blood), - Fibrates (such as gemfibrozil, fenofibrate) or any other cholesterol-lowering medicine (such as ezetimibe), - Medicines for indigestion (used to neutralise stomach acid). - Rifampicin, erythromycin, clarithromycin (antibiotics); - Oral contraceptives (pills) or hormone replacement therapy; - Antiviral medicines such as ritonavir with lopinavir and/or atazanavir or simeprevir (used to treat infections, including HIV or Hepatitis C infection - please see Warnings and precautions); - Hypericum perforatum (St. John's Wort); - Verapamil, diltiazem (heart medicines) - Dantrolene (infusion for severe body temperature regulation disorders) - Simvastatin (cholesterol-lowering medicine) If you need to take fusidic acid orally to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will tell you when it is safe to restart it. Use with fusidic acid has rarely caused muscle weakness or pain (rhabdomyolysis). See more information about rhabdomyolysis in section 4. Your doctor may change your dose and/or take other precautions: - if you are taking an angiotensin II receptor blocker or aliskiren (see also information in the sections 'Do not take ROXAMPEX®' and 'Warnings and precautions'). Taking ROXAMPEX® with food and drink It is best to take ROXAMPEX® before a meal. Pregnancy and breast-feeding Do not take ROXAMPEX® if you are pregnant or breastfeeding. Ask your doctor or pharmacist for advice before taking this medicine. Pregnancy Tell your doctor if you think you are pregnant (or could become pregnant). If you become pregnant while taking ROXAMPEX®, stop taking it immediately and contact your doctor. Your doctor will usually advise you to stop ROXAMPEX® before pregnancy or as soon as you know you are pregnant and will prescribe another medicine instead of ROXAMPEX®. Women should avoid becoming pregnant while taking ROXAMPEX® using effective contraception. Breast-feeding Tell your doctor if you are breastfeeding or are about to start breastfeeding. ROXAMPEX® is contraindicated in breastfeeding mothers and your doctor may choose another treatment if you wish to breastfeed, especially if your baby is newborn or premature. Driving and using machines ROXAMPEX® may affect your ability to drive or operate machinery. It is advisable to refrain from driving or operating machinery until you know how ROXAMPEX® affects you. If you experience nausea, dizziness or fatigue, or headache when taking the tablets, do not drive or operate machinery and contact your doctor immediately. 3. How to take ROXAMPEX® Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is one tablet once a day. It is best to take the tablet in the morning and before a meal. The tablet should be swallowed with a glass of water. Your doctor will decide the correct dose for you. ROXAMPEX® is prescribed for patients who are already taking rosuvastatin, perindopril and amlodipine in separate tablets. If you take more ROXAMPEX® than you should If you take too many tablets, contact your doctor or go to the nearest hospital emergency department immediately. In case of overdose, low blood pressure is most likely to occur. If significant low blood pressure occurs (symptoms such as dizziness or fainting), lie down and raise your legs. If you forget to take ROXAMPEX® It is important to take the medicine every day, as regular treatment is more effective. However, if you forget to take ROXAMPEX®, take your next dose at the usual time. Do not take a double dose to make up for a forgotten dose. If you stop taking ROXAMPEX® As treatment for high blood pressure usually lasts a lifetime, consult your doctor before stopping 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, this medicine can cause side effects, although not everybody gets them. Stop taking this medicine and contact your doctor immediately if you experience the following side effects, which may be serious: - Swelling of the face, lips, mouth, tongue or throat, difficulty in swallowing (angioedema) (see section 2 'Warnings and precautions') (uncommon - may affect up to 1 in 100 people), - Severe dizziness or fainting due to low blood pressure (common - may affect up to 1 in 10 people), - Unusually fast or irregular heartbeat, chest pain (angina) or heart attack (very rare - may affect up to 1 in 10,000 people), - Weakness in your arms or legs, or problems with your speech, which could be signs of a stroke (very rare - may affect up to 1 in 10,000 people), - Sudden wheezing, chest pain, shortness of breath, or difficulty breathing (bronchospasm) (uncommon - may affect up to 1 in 100 people), - Inflammation of the pancreas, which can cause severe pain in the abdomen and back, making you feel sick (rare - may affect up to 1 in 1,000 people), - Yellowing of the skin or eyes (jaundice), which may be a sign of hepatitis (very rare - may affect up to 1 in 10,000 people), - A skin rash that starts with red itchy spots on the face, arms and legs (erythema multiforme) (very rare - may affect up to 1 in 10,000 people), - Severe skin rash (Stevens-Johnson syndrome, toxic epidermal necrolysis), this may appear as reddish-purple spots or round patches often with central blisters, peeling of the skin, sores on the mouth, throat, nose, ears and genitals and may be preceded by fever and flu-like symptoms (very rare - may affect up to 1 in 10,000 people). In addition, stop taking ROXAMPEX® and contact your doctor immediately if you experience unusual muscle pain that lasts longer than expected. Muscle-related symptoms are more common in children and adolescents than in adults. As with other statins, a very small number of people have experienced unpleasant muscle effects which have rarely progressed to potentially life-threatening muscle damage called rhabdomyolysis. Side effects, in order of decreasing frequency, may be: Very common (may affect more than 1 in 10 people): - Oedema (fluid retention) Common (may affect up to 1 in 10 people): - Diabetes (more likely if you have high blood sugar and fat levels, are overweight and have high blood pressure; your doctor will monitor your condition during treatment with this medicine); - Dizziness, headache, vertigo, tingling sensation, drowsiness; - Palpitations (feeling your heart beat); - Low blood pressure, flushing; - Cough, shortness of breath; - Gastrointestinal disorders (taste disturbances, dyspepsia or indigestion, vomiting, abdominal pain, nausea, diarrhoea, constipation); - Allergic reactions (such as skin rash, itching); - Visual disturbances (including double vision); - Tinnitus (ringing in the ears); - Muscle pain, cramps; - Feeling tired, fatigue. Uncommon (may affect up to 1 in 100 people): - Increase in eosinophils (a type of white blood cell); - Mood changes, sleep disturbances, depression, insomnia; - Tremor, numbness or tingling in the extremities, loss of sensation of pain, fainting; - Heart rhythm disturbances, tachycardia; - Inflammation of blood vessels; - Bronchospasm (tightness in the chest, wheezing and shortness of breath), sneezing/runny nose caused by inflammation of the nasal lining (rhinitis); - Dry mouth; - Angioedema (symptoms - wheezing, swelling of the face or tongue); - Kidney problems; - Severe itching or skin rash, blistering of the skin, hair loss, increased sweating, itching of the skin, red patches on the skin, skin discolouration; - Photosensitivity reaction (increased sensitivity of the skin to the sun); - Joint pain; - Back pain; - Urinary disorders, increased need to urinate at night, increased frequency of urination; - In men, erectile dysfunction, discomfort or enlargement of the breasts; - Chest pain, pain, weakness, peripheral oedema, fever; - Changes in laboratory parameters: high potassium levels in the blood, which is reversible on discontinuation, low sodium levels, hypoglycaemia (very low blood sugar levels) in diabetic patients, increased blood urea and increased blood creatinine; - Weight gain or loss; - Falls. Rare (may affect up to 1 in 1,000 people): - Changes in laboratory parameters: increased levels of liver enzymes, high levels of bilirubin in the serum, reduced platelet count in the blood; - Confusion, nerve damage in the arms and legs (such as numbness), memory loss; - Severe abdominal pain (inflammation of the pancreas); - Severe allergic reaction - signs include swelling of the face, lips, tongue and/or throat, difficulty swallowing and breathing, severe itching of the skin (with raised lumps). If you think you are having an allergic reaction, stop taking ROXAMPEX® and seek medical help immediately; - Lupus-like disease syndrome (including rash, joint disorders and effects on blood cells); - Muscle damage in adults, muscle rupture - as a precaution, stop taking ROXAMPEX® and contact your doctor immediately if you experience unusual muscle pain that may last longer than expected. Very rare (may affect up to 1 in 10,000 people): - Changes in blood values, such as a decrease in the number of white and red blood cells, reduced haemoglobin; - Excess sugar in the blood (hyperglycaemia); - Nerve damage in the arms and legs (such as numbness); - Memory loss; - Cardiovascular disorders (angina and heart attack); - Increased muscle tone; - Eosinophilic pneumonia (a rare type of pneumonia), rhinitis; - Bloating (gastritis); - Swollen gums; - Liver dysfunction, liver inflammation (hepatitis), jaundice (yellowing of the skin and eyes); - Erythema multiforme (a skin rash that starts with red itchy spots on the face, arms or legs); - Stevens-Johnson syndrome (severe blistering on the skin, in the mouth, eyes and genitals), - Blood in urine, severe kidney problems. Concentrated urine (dark-coloured), nausea or vomiting, muscle spasms, confusion and seizures, which may be due to inappropriate secretion of antidiuretic hormone when taking ACE inhibitors. Not known (frequency cannot be estimated from the available data): - Sleep disturbances, including insomnia and nightmares; - Tendon damage, muscle weakness that is persistent; - Redness and peeling of the skin over large areas of the body; - Angioneurotic oedema; - Severe skin reaction (toxic epidermal necrolysis); - Colour changes, numbness and pain in the fingers or toes (Raynaud's phenomenon). Blood, kidney, liver or pancreatic disorders and changes in laboratory parameters (blood tests) may occur. Your doctor may perform blood tests to monitor your condition. 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 package leaflet. By reporting side effects you can help provide more information on the safety of this medicine. 5. How to store ROXAMPEX® Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton after "EXP". The expiry date refers to the last day of that month. - Keep in the original container in order to protect from light. - This medicine does not require any special storage conditions regarding temperature. - Do not throw away medicines via wastewater or household rubbish. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6. Contents of the pack and other information What ROXAMPEX® contains - The active substances are rosuvastatin, amlodipine and perindopril tert-butylamine. ROXAMPEX® 20 mg/10 mg/8 mg film-coated tablets - Each film-coated tablet contains 20 mg of rosuvastatin, equivalent to 20.79 mg of rosuvastatin calcium, 10 mg of amlodipine, equivalent to 13.87 mg of amlodipine besilate, and 8 mg of perindopril tert-butylamine, equivalent to 6.676 mg of perindopril. - The other ingredients are microcrystalline cellulose (type 200), microcrystalline cellulose (type 112), crospovidone (type A) colloidal anhydrous silica and magnesium stearate in the tablet core and polyvinyl alcohol, macrogol 3350, titanium dioxide (E171) and talc in the film coating. Description and contents of the pack ROXAMPEX® 20 mg/10 mg/8 mg film-coated tablets are yellow, round, slightly biconvex, film-coated tablets with bevelled edges, engraved with the mark PAR6 on one side of the tablet (tablet diameter: approx. 11 mm). ROXAMPEX® is available in packs of 30, 60, 90 and 100 film-coated tablets in blisters. Not all pack sizes may be marketed. ROXAMPEX® dispensing category Group II pharmaceutical product, dispensed with prescription form №3.