INDAPAMIDE

5mg indapamide hemihydrate, to be taken daily in the morning. The action of indapamide is progressive and the reduction of blood pressure may continue and not reach a maximum until several months after the start of therapy. 5mg indapamide daily is not recommended, as there is no appreciable additional anti-hypertensive 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 anti-hypertensive agent may be added such as beta- blockers, ACE inhibitors, methyldopa, clonidine and other adrenergic blocking agents.

The co-administration of indapamide with diuretics which may cause hypokalaemia is not recommended. There is no evidence of rebound hypertension on withdrawal of indapamide. 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 Indapamide SR when renal function is normal or only minimally impaired. 5mg 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.

Tabulated summary of adverse reactions The following undesirable effects have been observed with indapamide during treatmentranked 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 (≥1/100,000 to <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 hepatic encephalopathy, particularly in case of electrolyte imbalance which can progress to hepatic coma. Administration of the diuretic must be stopped immediately if this occurs or there are signs of renal insufficiency.

A slight weight loss has been reported in some patients taking Indapamide.

Excipients (Lactose Monohydrate and Sucrose):

Patients with rare hereditary problems of fructose intolerance, galactose intolerance, the total lactase deficiency or glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medicine. 8). If photosensitivity reaction occurs during treatment, it is recommended to stop the treatment.

’ Special precautions for use: • Water and electrolyte balance: - Plasma Sodium: This must be measured before starting treatment, then at regular intervals subsequently. Any diuretics treatment may cause hyponatraemia, sometimes with very serious consequences.

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.

Hypokalaemia may cause muscle disorders. Cases of Rhabdomyolysis have been reported, mainly in the context of severe hypokalaemia. e. the elderly, malnourished and / or poly-medicated, cirrhotic patients with oedema and ascites, coronary artery disease and cardiac failure patients.

In this latter 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 theorigin is congenital or iatrogenic. Hypokalaemia, as well as bradycardia, is then a pre- disposing factor to the onset of severe arrhythmias, in particular, potentially fatal torsades depointes.

Severe renal failure. Hepatic encephalopathy or severe impairment of liver function. Hypokalaemia. Hypersensitivity to Indapamide, Sulphonamide derivatives, and any of the ingredients.