INDAPAMIDE

5mg Indapamide, to be taken daily in the morning 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. 5mg of 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. 5) 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 the elderly, the plasma creatinine must be adjusted in relation to age, weight and gender. Elderly patients can be treated with Indapamide when renal function is normal or only minimally impaired.

4) In severe hepatic impairment, treatment is contraindicated.

Children and adolescents:

Indapamide tablet is not recommended for use in children and adolescents due to lack of data on safety and efficacy.

Administration:

Route of administration: Oral.

Summary of safety profile The most commonly reported adverse reactions are 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 effects 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, <1/10); uncommon (>1/1000, <1/100); rare (>1/10000, <1/1000), very rare (<1/10000), not known (cannot be estimated from the available data).

4) Elevated liver enzyme levels 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.

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Special Warnings:

When liver function is impaired, thiazide-related diuretics may cause hepatic encephalopathy particularly in case of electrolyte imbalance. Administration of the diuretic must be stopped immediately if this occurs or there are signs of increasing renal insufficiency.

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

Excipients:

Patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption of sucrase-isomaltase insufficiency 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 diuretics 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.

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 the origin 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 de pointes.

Hypersensitivity to indapamide, to other sulphonamides or to any of the excipients. Severe renal failure. Hepatic encephalopathy or severe impairment of liver function. Hypokalaemia. Porphyria Addison’s disease Refractory hypokalaemia, hyponatraemia, hypercalcaemia