NATRILIX SR 1.5MG 30 TABLETS

1. Name of the medicinal product
Natrilix SR 1.5 mg Tablets
2. Qualitative and quantitative composition
One prolonged-release film-coated tablet contains 1.5 mg indapamide.
Excipient with known effect: 124.5 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Prolonged-release tablet.
White, round, film-coated tablet.
4. Clinical particulars
4.1 Therapeutic indications
Natrilix SR is indicated in essential hypertension in adults.
4.2 Posology and method of administration
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.
Special populations
Renal impairment (see sections 4.3 and 4.4):
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.
Hepatic impairment (see sections 4.3 and 4.4):
In severe hepatic impairment, treatment is contraindicated.
Elderly (see section 4.4):
In the elderly, the plasma creatinine must be adjusted in relation to age, weight and gender. Elderly patients can be treated with Natrilix SR when renal function is normal or only minimally impaired.
Paediatric population:
The safety and efficacy of Natrilix SR in children and adolescents have not been established. No data are available.
Method of administration
Oral use
4.3 Contraindications
- Hypersensitivity to the active substance, to other sulfonamides or to any of the excipients listed in section 6.1.
- Severe renal failure.
- Hepatic encephalopathy or severe impairment of liver function.
- Hypokalaemia.
4.4 Special warnings and precautions for use
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.
Photosensitivity:
Cases of photosensitivity reactions have been reported with thiazides and thiazide-related diuretics (see section 4.8). 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 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. The fall in plasma sodium may be asymptomatic initially and regular monitoring is therefore essential, and should be even more frequent in the elderly and cirrhotic patients (see sections 4.8 and 4.9). Any diuretic treatment may cause hyponatraemia, sometimes with very serious consequences. Hyponatraemia with hypovolaemia may be responsible of 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.
The risk of onset of hypokalaemia (< 3.4 mmol/l) must be prevented in certain high risk populations, i.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.
• 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.
- Renal function and diuretics:
Thiazide and related diuretics are fully effective only when renal function is normal or only minimally impaired (plasma creatinine below levels of the order of 25 mg/l, i.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.
-INTRODUCTIONNatrilix SR Tablet is a diuretic (water pill) medicine used to treat hypertension (high blood pressure). It also reduces excess fluid levels in the body and treats edema (fluid overload) associated with heart, liver, kidney, or lung disease.Natrilix SR Tablet makes you lose excess water through urine. It may be used alone or in combination with other medicines. This medicine should be taken only during day time to avoid frequent urination at night. You must take this medicine in the dose and duration as advised by the doctor and never stop it abruptly without consulting the doctor. Most people with high blood pressure do not feel ill, but if you stop taking this medicine, your condition could get worse.It is important to have your blood pressure checked regularly. This medicine is only one part of a treatment program which should also include a healthy diet, regular exercise, smoking cessation, moderation of alcohol intake, and weight reduction. You can eat normally while taking this medicine, but try to reduce your salt intake.Common side effects of this medicine include headache, nausea, and dizziness. Consult your doctor if these side effects bother you. Before taking this medicine, it is better to let your