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Bipreterax

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Indications:

It is used to treat adults with mild to moderate high blood pressure.

Contraindications:

this medicine should not be used by anyone who: * is allergic to perindopril, indapamide, or to any of the ingredients of the medication * is allergic to sulfa (sulfonamide) medications (e.g., sulfamethoxazole) * is pregnant * cannot pass urine or has progressive or severe decrease in urine production * has had angioedema (a serious allergic reaction which causes the area around the throat and tongue to swell) after taking any ACE inhibitors (e.g., captopril, ramipril) * has severely decreased function of the liver accompanied by coma

Adverse reactions:

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you experience any of the following, stop taking the medicinal product at once and tell your doctor immediately: * swelling of the face, lips, mouth, tongue or throat, difficulty in breathing, * severe dizziness or fainting, * unusual fast or irregular heart beat. In decreasing order of frequency, side effects can include: * Common (occur in fewer than 1 in 10 users but in more than 1 in 100 users): headache, feelings of dizziness, vertigo, pins and needles, vision disturbances, tinnitus (sensation of noises in the ears), light-headedness due to low blood pressure, cough, shortness of breath, 4 gastro-intestinal disorders (nausea, epigastric pain, anorexia, vomiting, abdominal pain, taste disturbances, dry mouth, dyspepsia or difficulty of digestion, diarrhoea, constipation), allergic reactions (such as skin rashes, itching), cramps, feeling of tiredness, * Uncommon (occur in fewer than 1 in 100 users but in more than 1 in 1000 users): mood swings, sleep disturbances, bronchospasm (tightening of the chest, wheezing and shortness of breath), angioedema (symptoms such as wheezing, swelling of the face or tongue), urticaria, purpura (red pinpoints on skin), kidney problems, impotence, sweating, * Very rare (occur in fewer than 1 in 10,000 users): confusion, cardiovascular disorders (irregular heart beat, angina, heart attack), eosinophilic pneumonia (a rare type of pneumonia), rhinitis (blocked up or runny nose), severe skin manifestations such as erythema multiforme. If you suffer from systemic lupus erythematosus (a type of collagen disease), this might get worse. Cases of photosensitivity reactions (change in skin appearance) after exposure to the sun or artificial UVA have also been reported. Disorders of the blood, kidney, liver or pancreas and changes in laboratory parameters (blood tests) can occur. Your doctor may need to give you blood tests to monitor your condition. In cases of hepatic insufficiency (liver problems), there is a possibility of onset of hepatic encephalopathy (degenerative disease in the brain). If any of the side effects gets serious, or

Interactions:

You should avoid this medicine with: * lithium (used to treat depression), * potassium-sparing diuretics (spironolactone, triamterene), potassium salts. Treatment with this medicine 5mg/1.25mg can be affected by other medicines. Make sure to tell your doctor if you are taking any of the following medicines as special care may be required: * other medicines for treating high blood pressure, * procainamide (for the treatment of an irregular heart beat), * allopurinol (for the treatment of gout), * terfenadine or astemizole (antihistamines for hay fever or allergies), * corticosteroids used to treat various conditions including severe asthma and rheumatoid arthritis, * immunosuppressants used for the treatment of auto-immune disorders or following transplant surgery to prevent rejection (e.g. ciclosporin), * medicines for the treatment of cancer, * erythromycin by injection (an antibiotic), * halofantrine (used to treat certain types of malaria), * pentamidine (used to treat pneumonia), * injectable gold (used to treat rhumatoid polyarthritis), * vincamine (used to treat symptomatic cognitive disorders in elderly including memory loss), * bepridil (used to treat angina pectoris), * sultopride (for the treatment of psychoses), * medicines used for heart rhythm problems (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol), * digoxin or other cardiac glycosides (for the treatment of heart problems), * baclofen (to treat muscle stiffness occurring in diseases such as multiple sclerosis), * medicines to treat diabetes such as insulin or metformin, * calcium including calcium supplements, * stimulant laxatives (e.g. senna), * non-steroidal anti-inflammatory drugs (e.g. ibuprofen) or high dose salicylates (e.g. aspirin), * amphotericin B by injection (to treat severe fungal disease), * medicines to treat mental disorders such as depression, anxiety, schizophrenia…(e.g. tricyclic antidepressants, neuroleptics), * tetracosactide (to treat Crohn’s disease).

Warnings:

Take special care with this medicine If any of the following apply to you please talk to your doctor before taking this medicine: * if you have aortic stenosis (narrowing of the main blood vessel leading from the heart) or hypertrophic cardiomyopathy (heart muscle disease) or renal artery stenosis (narrowing of the artery supplying the kidney with blood), * if you have any other heart problems or problems with your kidneys, * if you have liver problems, * if you suffer from a collagen disease (skin disease) such as systemic lupus erythematosus or scleroderma, * if you have atherosclerosis (hardening of the arteries), PACKAGE LEAFLET: INFORMATION FOR THE USER Read all of this leaflet carefully before you start taking this medicine. • 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. perindopril arginine / indapamide Film-coated tablets 2 * if you suffer from hyperparathyroidism (overactive parathyroid gland), * if you suffer from gout, * if you have diabetes, * if you are on a salt restricted diet or use salt substitutes which contain potassium, * if you take lithium or potassium-sparing diuretics (spironolactone, triamterene) as their use with this medicine should be avoided (see “Taking other medicines”). You must tell your doctor if you think that you are (or might become) pregnant. this medicine is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see “Pregnancy and Breast-feeding”). When you are taking this medicine, you should also inform your doctor or the medical staff: * if you are to undergo anaesthesia and/or surgery, * if you have recently suffered from diarrhoea or vomiting, or are dehydrated, * if you are to undergo dialysis or LDL apheresis (which is removal of cholesterol from your blood by a machine), * if you are going to have desensitisation treatment to reduce the effects of an allergy to bee or wasp stings, * if you are to undergo a medical test that requires injection of an iodinated contrast agent (a substance that makes organs like kidney or stomach visible on an X-ray) Athletes should be aware that this medicine contains an active ingredient (indapamide) which may give a positive reaction in drug tests. this medicine should not be given to children.

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