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INDAPAMIDE TEVA is a brand name for Indapamide. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Indapamide Teva 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 action of indapamide is not enhanced but the saluretic effect is increased. 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. 4) In the elderly, the plasma creatinine must be adjusted in relation to age, weight and gender.
Elderly patients can be treated with Cardide SR when renal function is normal or only minimally impaired. Paediatric population The safety and efficacy of Cardide SR in children and adolescents have not been established. No data are available.
Method of administration Oral use.
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.
The majority of adverse reactions concerning clinical or laboratory parameters are dose-dependent. 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 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
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.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Special warnings When liver function is impaired, thiazide-related diuretics may cause particularly in case of electrolyte imbalance hepatic encephalopathy which can progress to hepatic coma. 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 the diuretic is deemed necessary, it is recommended to protect exposed areas to the sun or to artificial UVA.
Excipient:
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. Special precautions for use Water and electrolyte balance Plasma sodium This must be measured before starting treatment, then at regular intervals subsequently.
9). Any diuretic treatment may cause hyponatraemia, sometimes with very serious consequences. Hyponatraemia with hypovolaemia may be responsible for 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 Potassium depletion with hypokalaemia is the major risk of thiazide and related diuretics. Hypokalaemia may cause muscle disorders. Cases of rhabdomyolysis have been reported, mainly in the context of severe hypokalaemia.
e. the elderly, malnourished and/or polymedicated, cirrhotic patients with oedema and ascites, coronary artery disease and cardiac failure patients. In this situation, hypokalaemia increases the cardiac toxicity of digitalis preparations and the risks of arrhythmias.
Individuals 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 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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More frequent monitoring of plasma potassium is required in all the situations indicated above. The first measurement of plasma potassium should be obtained during the first week following the start of treatment. Detection of hypokalaemia requires its correction.
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.
Frank hypercalcaemia may be due to previously unrecognised hyperparathyroidism. Treatment 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 an adult). 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 transitory functional renal insufficiency is of no consequence in individuals with normal renal function but may worsen pre-existing renal insufficiency. 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. Athletes The attention of athletes is drawn to the fact that this medicinal product contains a drug substance, which may give a positive reaction in doping tests.