Natrixam Tablet (Modified Release)

This is indicated as substitution therapy for treatment of essential hypertension in patients already controlled with indapamide and amlodipine given concurrently at the same dose level.

Indapamide is a sulphonamide derivative with an indole ring, pharmacologically related to thiazide diuretics, which acts by inhibiting the reabsorption of sodium in the cortical dilution segment. It increases the urinary excretion of sodium and chlorides and, to a lesser extent, the excretion of potassium and magnesium, thereby increasing urine output and having an antihypertensive action.

Amlodipine is a calcium ion influx inhibitor of the dihydropyridine group (slow channel blocker or calcium ion antagonist) and inhibits the transmembrane influx of calcium ions into cardiac and vascular smooth muscle. The mechanism of the antihypertensive action of amlodipine is due to a direct relaxant effect on vascular smooth muscle.

One tablet per day as single dose, preferably to be taken in the morning, to be swallowed whole with water and not chewed. The fixed dose combination is not suitable for initiation therapy. If a change of the posology is required, titration should be done with the individual components.

Pediatric population: The safety and efficacy of this medicine in children and adolescents have not been established. No data are available.

Patients with renal impairment: In severe renal impairment (creatinine clearance below 30 ml/min), treatment is contraindicated. In patients with mild to moderate renal impairment, no dose adjustment is needed. Older people can be treated with this medicine according to renal function.

Patients with hepatic impairment: In severe hepatic impairment, treatment is contraindicated. Dosage recommendations of amlodipine have not been established in patients with mild to moderate hepatic impairment; therefore dose selection should be cautious and should start at the lower end of the dosing range

• hypersensitivity to the active substances, to other sulphonamides, to dihydropyridine derivatives or to
• any of the excipients
• severe renal failure (creatinine clearance below 30 ml/min)
• hepatic encephalopathy or severe impairment of liver function
• hypokalaemia
• lactation
• severe hypotension
• shock (including cardiogenic shock)
• obstruction of the outflow tract of the left ventricle (e.g., high-grade aortic stenosis)
• hemodynamically unstable heart failure after acute myocardial infarction

The most commonly reported adverse reactions with indapamide and amlodipine given separately are somnolence, dizziness, headache, palpitations, flushing, abdominal pain, nausea, ankle swelling, oedema and fatigue.

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. This medicine is not recommended during pregnancy. When a pregnancy is planned or confirmed, the switch to an alternative treatment should be initiated as soon as possible. You must not take this medicine if you are breastfeeding. Tell your doctor immediately if you are breastfeeding or about to start breastfeeding.

You should inform your doctor if you have or have had any of the following conditions:

• recent heart attack,
• if you have heart failure, any heart rhythm problems, if you have coronary artery disease (heart disease caused by poor blood flow in the blood vessels of the heart),
• if you have problems with your kidneys,
• severe increase in blood pressure (hypertensive crisis),
• you are elderly and your dose needs to be increased,
• if you take other medicines,
• if you are malnourished,
• if you have liver problems,
• if you have diabetes,
• if you suffer from gout,
• if you need to have a test to check how well your parathyroid gland is working,
• if you had photosensitivity reactions.

Combined antihypertensive preparations

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.