INDAPAMIDE HEMIHYDRATE

5 mg indapamide hemihydrate, daily to be taken in the morning. 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 the older people, the plasma creatinine must be adjusted in relation to age, weight and gender. Older people can be treated with indapamide when renal function is normal or only minimally impaired. 4) In severe hepatic impairment, treatment is contraindicated.

Paediatric population Indapamide is not recommended for use in children and adolescents due to a lack of data on safety and efficacy. The action of indapamide is progressive and the reduction in blood pressure may continue and not reach a maximum until several months after the start of therapy.

5 mg indapamide daily is not recommended as there is no appreciable additional antihypertensive effect but a diuretic effect may become apparent. If a single daily tablet of indapamide does not achieve a sufficient reduction in blood pressure, another antihypertensive agent may be added; those which have been used in combination with indapamide include beta-blockers, ACE inhibitors, methyldopa, clonidine and other adrenergic blocking agents.

The co-administration of indapamide with diuretics may cause hypokalaemia and, therefore, is not recommended. There is no evidence of rebound hypertension on withdrawal of indapamide. Method of administration Indapamide tablets are for oral administration only.

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.

2 mmol/l in 10 % of patients after 4 to 6 weeks treatment. 41 mmol/l. 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 frequencies: 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) and not known (cannot be estimated from the available data).

4) Not known 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. 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.

In case of hepatic impairment, thiazide-related diuretics may cause hepatic encephalopathy, 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 the diuretic is deemed necessary, it is recommended to protect exposed areas to the sun or to artificial UVA. Patients likely to be exposed to direct sunlight or ultraviolet light should be advised that photosensitivity leading to exaggerated sunburn may occur and treatment should be discontinued at the first sign of skin erythema.

Angioneurotic oedema Angioneurotic oedema of the face, extremities, lips, tongue, glottis and/or larynx has been reported infrequently in patients receiving treatment with indapamide. In such cases, treatment with indapamide should be stopped immediately and the patient should be monitored until the oedema has disappeared.

Water and electrolyte balance Plasma sodium Plasma sodium must be measured before treatment is initiated and subsequently at regular intervals. Any kind of treatment with diuretics may cause hyponatraemia, sometimes with very serious consequences.

A drop in plasma sodium may be asymptomatic in the beginning. 9). 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 constitutes the greatest risk in the treatment with thiazides and related diuretics. e. 5), cirrhotic patients with oedema and ascites, coronary artery disease, cardiac failure patients, patients with hyperaldosteronism, patients predisposed to or suffering from gout.

g. digoxin) 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.

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 and subsequently at regular intervals, especially in the mentioned risk patients.

4 mmol potassium) is detected, it must be corrected and it should be prevented in risk patients. Hypokalaemia found in association with low serum magnesium concentration can be refractory to treatment unless serum magnesium is corrected.

8). Plasma calcium Thiazides and related diuretics may decrease urinary calcium excretion and cause a slight and transitory increase in plasma calcium. Frank hypercalcaemia may be due to previously unrecognised hyperparathyroidism. Treatment with indapamide hemihydrate should be stopped if hypercalcaemia occurs in patients with hyperparathyroidism.

Treatment should be withdrawn before the investigation of parathyroid function. Blood glucose Monitoring of blood glucose is important in diabetic patients, especially in the presence of hypokalaemia. Uric acid Serum urate should be monitored in patients with gout.

Tendency to gout attacks may be increased in hyperuricaemic patients. Renal function and diuretics Caution should be exercised when administering indapamide hemihydrate to patients with severe renal impairment. However, the drug has been safely given to patients with impaired renal function.

However, if renal insufficiency worsens, treatment should be stopped. e. < 220 μmol/l in an adult). In elderly patients, the plasma creatinine values must be adjusted according to age, body weight and sex. Secondary hypovolaemia, as a result of loss of water and sodium induced by the diuretic at the start of treatment results in reduced glomerular filtration which, may increase plasma concentrations of blood urea and creatinine.

This temporary impairment of renal function is harmless to patients with normal renal function but may exacerbate 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 […]

1. Severe renal failure Hepatic encephalopathy, severe impairment of liver function, severe hepatic failure Hypokalaemia Recent cerebrovascular accident.