Natrixam Tablets / Modified Release

Natrixam Tablets / Modified Release is used for: Essential hypertension in patients already controlled with indapamide and amlodipine given concurrently at the same dose.

By mouth, 1 tablet daily in the morning.

CrCl <30 mL/min: Use is contraindicated.

Swallow whole. Do not chew the tablets

Hypersensitivity to amlodipine, indapamide, any of the excipients, sulphonamides, or dihydropyridine derivatives Severe renal impairment (CrCl <30 mL/min) Severe hepatic impairment; Hepatic encephalopathy Hypokalaemia Breastfeeding Severe hypotension Shock Obstruction of the outflow tract of the left ventricle Haemodynamically unstable heart failure after acute myocardial infarction

Hypertensive crisis Elderly patients Malnourished patients Cirrhosis; Oedema; Ascites Severe obstructive coronary artery disease; Cardiac failure Severe aortic stenosis Long QT interval Diabetes

Dantrolene: Concurrent use is contraindicated. Increases risk of cardiovascular collapse. Simvastatin: Significantly increases simvastatin concentrations. When used concurrently, maximum simvastatin dose should be 20mg. Lithium: Increases lithium concentrations. Concurrent use is not recommended, but if necessary, monitor lithium levels closely. Class Ia antiarrhythmics, such as quinidine, hydroquinidine, disopyramide): Increases risk of torsades de pointes and other ventricular arrhythmias, especially in patients with hypokalaemia. Monitor potassium levels, other plasma electrolytes, and ECG. Class III antiarrhythmics, such as amiodarone, sotalol, dofetilide, ibutilide : Increases risk of torsades de pointes and other ventricular arrhythmias, especially in patients with hypokalaemia. Monitor potassium levels, other plasma electrolytes, and ECG. Phenothiazines, such as chlorpromazine, thioridazine, and trifluoperazine: Increases risk of torsades de pointes and other ventricular arrhythmias, especially in patients with hypokalaemia. Monitor potassium levels, other plasma electrolytes, and ECG. Benzamides, such as sulpiride, sultopride: Increases risk of torsades de pointes and other ventricular arrhythmias, especially in patients with hypokalaemia. Monitor potassium levels, other plasma electrolytes, and ECG. Butyrophenones, such as droperidol, haloperidol: Increases risk of torsades de pointes and other ventricular arrhythmias, especially in patients with hypokalaemia. Monitor potassium levels, other plasma electrolytes, and ECG. Other torsades de pointes-inducing drugs, such as bepridil, cisapride, diphemanil, erythromycin IV, halofantrine, mizolastine, pentamidine, sparfloxacin, moxifloxacin, vincamine IV: Increases risk of torsades de pointes and other ventricular arrhythmias, especially in patients with hypokalaemia. Monitor potassium levels and ECG. NSAIDs, salicylic acid (greater than or equal to 3 g/day): May reduce efficacy of indapamide. In dehydrated patients, increases risk of acute renal failure. Monitor renal function and hydrate the patient. ACE inhibitors: Increases risk of sudden hypotension and/or acute renal failure, especially in patients with hyponatraemia. Monitor renal function. Digitalis preparations: Increases risk of digitalis toxicity, especially in patients with hypokalaemia Baclofen: Increases antihypertensive effects. Monitor renal function at the start of therapy and hydrate the patient. Potassium-sparing diuretics, such as amiloride, spironolactone, and triamterene: Concurrent use alters potassium concentrations. Monitor plasma potassium and ECG, especially in patients with diabetes or renal failure. Other compounds causing hypokalaemia: amphotericin B (IV), gluco- and mineralo-corticoids (systemic route), tetracosactide, stimulant laxatives: Increase risk of hypokalaemia. Monitor potassium levels and ECG. Citalopram: Increases risk of hyponatraemia. Metformin: Increases risk of lactic acidosis. Do not use metformin when plasma creatinine exceeds 15 mg/l (135 μmol/l) in men and 12 mg/l (110 μmol/l) in women. Iodinated contrast media: In dehydrated patients, increases risk of acute renal failure. Monitor renal function and hydrate the patient. Imipramine-like antidepressants, neuroleptics: Increases antihypertensive effects and risk of orthostatic hypotension. Calcium (salts): May decrease calcium elimination, therefore increasing the risk of hypercalcaemia Ciclosporin, tacrolimus: Increases risk of elevated serum creatinine. Corticosteroids, tetracosactide (systemic route): May increase water/sodium retention, therefore decreasing the antihypertensive effect. Strong or moderate CYP3A4 inhibitors, such as protease inhibitors, azole antifungals, clarithromycin, and erythromycin: May increase amlodipine concentrations. CYP3A4 inducers: May decrease amlodipine concentrations.

Side effects of Amlodipine + Indapamide : Common adverse effects Somnolence; Dizziness; Headache Palpitations Flushing Abdominal pain; Nausea Ankle swelling; Oedema Fatigue Hypokalaemia Maculopapular rashes Uncommon adverse effects Leukocytopenia; Thrombocytopenia; Agranulocytosis; Aplastic anaemia; Haemolytic anaemia Allergic reactions Hyperglycaemia; Hypercalcaemia; Hyponatraemia with hypovolaemia Insomnia; Mood changes; Anxiety; Depression; Confusion Tremor Dysgeusia Syncope Hypoesthaesia Paresthesia Vertigo Hypertonia Peripheral neuropathy Visual disturbances Tinnitus Myocardial infarction Arrhythmia Torsade de pointes Hypotension; Vasculitis Dyspnoea; Rhinitis; Cough Vomiting; Dyspepsia; Altered bowel habits Dry mouth Pancreatitis Gastritis Gingival hyperplasia Hepatitis; Jaundice; Elevated hepatic enzymes; Abnormal hepatic function Purpura; Alopecia; Skin discolouration; Hyperhidrosis; Pruritus; Rash; Exanthema; Angioedema; Urticaria; Toxic epidermal necrolysis; Steven Johnson syndrome; Erythema multiforme; Exfoliative dermatitis; Quincke oedema; Photosensitivity Arthralgia; Myalgia; Muscle cramps; Back pain Micturition disorder; Nocturia; Increased urinary frequency; Renal failure Impotence; Gynaecomastia Chest pain; Asthenia; Pain; Malaise Increased or decreased weight QT prolongation

Natrixam "1.5mg, 10mg" Tablets / Modified Release manufactured by Les Laboratoires Servier Industrie. Its generic name is Amlodipine + Indapamide. Natrixam is availble in United Arab Emirates. Farmaco UAE drug index information on Natrixam Tablets / Modified Release is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.