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INDAPRES XL is a brand name for Indapamide. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Indapres XL is indicated in essential hypertension in adults.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology One tablet per 24 hours, preferably in the morning, to be swallowed whole with water and not chewed. At higher doses the antihypertensive effect of indapamide is not enhanced but the excretion of salt is increased (saluretic effect).
Special populations Elderly In the elderly, this plasma creatinine must be adjusted in relation to age, weight and gender. Elderly patients can be treated with Indapres XL when renal function is normal or only minimally impaired. 4): In severe renal failure (creatinine clearance below 30 ml/min), treatment is contraindicated.
Thiazide and related diuretics are fully effective only when renal function is normal or only minimally impaired. 4): In severe hepatic impairment, treatment is contraindicated. Paediatric population The safety and efficacy of Indapres XL in children and adolescents have not been established.
No data are available. Method of administration Indapamide is administered orally.
Summary of safety profile The most commonly reported adverse reactions are hypokalaemia, hypersensitivity reactions, mainly dermatological, in subjects with a predisposition to allergic and asthmatic reactions and maculopapular rashes.
Tabulated summary of adverse reactions The following undesirable effects have been observed with indapamide during treatment ranked under the following frequency: Very common (> 1/10), Common (≥ 1/100, < 1/10), Uncommon (≥ 1/1000, < 1/100), Rare (≥ 1/10,000, < 1/1000), Very Rare (< 1/10,000), not known (cannot be estimated from the available data).
Blood and the lymphatic system disorders Very rare: thrombocytopenia, leucopenia, agranulocytosis, aplastic anaemia, haemolytic anaemia. 4). 4). Rare: hypochloraemia, hypomagnesaemia. Very rare: hypercalcaemia. Nervous system disorders Rare: vertigo, fatigue, headache, paraesthesia.
Not known: syncope. Eye disorders Not known: myopia, blurred vision, visual impairment, acute angle-closure glaucoma, choroidal effusion. 5) Vascular disorders Very rare: hypotension. Gastrointestinal disorders Uncommon: vomiting. Rare: nausea, constipation, dry mouth.
Very rare: pancreatitis. Hepato-biliary disorders Very rare: abnormal hepatic function. 4), hepatitis. Skin and subcutaneous tissue disorders Common: hypersensitivity reactions, maculopapular rashes. Uncommon: purpura. Very rare: angioneurotic oedema, urticaria, toxic epidermic necrolysis, Steven Johnson syndrome.
4). Renal and urinary disorders Very rare: renal failure. Musculoskeletal and connective tissue disorders Not known: muscle spasms, muscular weakness, myalgia, rhabdomyolysis Reproductive system and breast disorders Uncommon: erectile dysfunction.
4), elevated liver enzyme levels. 2 mmol/l in 4 % of patients after 4 to 6 weeks treatment. 23 mmol/l. 2 mmol/l in 10 % of patients after 4 to 6 weeks treatment. 41 mmol/l. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Special warnings In patients with impaired liver function, thiazide-related diuretics may cause hepatic encephalopathy which can progress to hepatic coma, particularly in case of electrolyte imbalance. Administration of the diuretic must be stopped immediately if this occurs.
8). If photosensitivity reaction occurs during treatment, it is recommended to stop the treatment. If a re- administration of indapamide is deemed necessary, it is recommended to protect exposed areas to the sun or to artificial UVA.
Special precautions for use Water and electrolyte balance Plasma sodium This must be measured before starting treatment, then at regular intervals subsequently. The fall in plasma sodium may be asymptomatic initially and regular monitoring is therefore essential.
9). Any diuretic treatment may cause hyponatraemia, sometimes with very serious consequences. Hyponatraemia with hypovolaemia may be responsible of dehydration and orthostatic hypotension. Concomitant loss of chloride ions may lead to secondary compensatory metabolic alkalosis: the incidence and degree of this effect are slight.
Plasma potassium The major risk of treatment with thiazide and related diuretics is hypokalaemia. Hypokalaemia may cause muscle disorders. Cases of Rhabdomyolysis have been reported, mainly in the context of severe hypokalaemia. e. patients that are malnourished and/or are taking several drugs concomitantly, the elderly, cirrhotic patients with oedema and ascites, patients with coronary artery disease and cardiac failure.
In these patients, hypokalaemia increases the cardiotoxicity of digitalis preparations and the risks of arrhythmias. Patients with a long QT interval are also at risk, whether the origin is congenital or iatrogenic. Hypokalaemia (as well as bradycardia) is then a predisposing factor to the onset of severe arrhythmias, in particular, potentially fatal heart rhythm disorders of the type “torsades de pointes”.
1; - severe renal failure; - hepatic encephalopathy or severe impairment of liver function; - hypokalaemia.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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In these patients, more frequent monitoring of plasma potassium is required. The first measurement of plasma potassium should be obtained during the first week of treatment. If low potassium levels are detected, correction is required.
Hypokalaemia found in association with low serum magnesium concentration can be refractory to treatment unless serum magnesium is corrected. 8). Plasma calcium Thiazide and related diuretics may decrease urinary calcium excretion and cause a slight and transitory rise in plasma calcium.
Evident hypercalcaemia may be due to previously unrecognised hyperparathyroidism. Treatment with the diuretic should be withdrawn before the investigation of parathyroid function. Blood glucose Monitoring of blood glucose is important in diabetics, in particular in the presence of hypokalaemia.
Uric acid Tendency to gout attacks may be increased in hyperuricaemic patients. e. 220 μmol/l in adults). In the elderly, this plasma creatinine must be adjusted in relation to age, weight and gender. Hypovolaemia, secondary to the loss of water and sodium induced by the diuretic at the start of treatment causes a reduction in glomerular filtration.
This may lead to an increase in blood urea and plasma creatinine. This transient renal dysfunction has no consequences in patients with normal renal function but it may deteriorate the existing renal insufficiency. Athletes The attention of athletes is drawn to the fact that this product contains an active substance which may cause a positive reaction in doping tests.
Choroidal effusion, acute myopia and secondary angle-closure glaucoma:
Sulfonamide or sulfonamide derivative drugs can cause an idiosyncratic reaction resulting in choroidal effusion with visual field defect, transient myopia and acute angle-closure glaucoma. Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation.
Untreated acute angle-closure glaucoma can lead to permanent vision loss. The primary treatment is to discontinue drug intake as rapidly as possible. Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled.
Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy. Lactose This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.