INDAPAMIDE HEMIHYDRATE

For oral administration. 5mg indapamide hemihydrate, daily to be taken in the morning. The action of indapamide is progressive and the reduction in blood pressure may reach a maximum until several months after the start of therapy. 5mg daily is not recommended as there is no appreciable additional antihypertensive effect, but a diuretic effect may become apparent.

If one indapamide tablet daily 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.

Co- administration of indapamide with diuretics may cause hypokalaemia and, therefore, is not recommended. There is no evidence of rebound hypertension following 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 Tablets 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.

Thiazide-related diuretics, including indapamide, may cause the following undesirable effects 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), frequency 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), Hepatitis. 4) Renal and urinary disorders: Very rare: renal failure. 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.

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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.

Lactose:

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Sucrose:

Patients with rare hereditary problems of fructose intolerance, glucose- galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Sodium:

This medicine contains less than 1mmol (23mg) of sodium in each tablet, that is to say essentially sodium-free.

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.

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 preexisting renal insufficiency. - 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.

- 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.

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

1 • Severe renal failure. • Hepatic encephalopathy or severe impairment of liver function. • Hypokalaemia.