Natrixam 1,5 mg/5 mg

Trade Name:

Natrixam

Composition:

Indapamide 1,5 mg

Amlodipine 5 mg

Inactive ingredients:

Lactose monohydrate

Properties:

Amlodipine is a calcium influx inhibitor, a dihydropyridine derivative (slow calcium channel blocker, or calcium ion antagonist), which inhibits the transmembrane influx of calcium ions into cardiomyocytes and smooth muscle cells of the vascular wall. The mechanism of the antihypertensive action of amlodipine is due to a direct relaxing effect on vascular smooth muscle.

Indapamide is a sulfonamide derivative with an indole ring, belonging to the pharmacological group of thiazide-like diuretics. Acts by reducing sodium reabsorption in the cortical segment of the nephron loop. Indapamide increases urinary sodium and chloride excretion and, to a lesser extent, potassium and magnesium excretion, thereby increasing diuresis and exerting an antihypertensive effect.

Indications:

Treatment of hypertension in patients requiring treatment with indapamide and amlodipine at doses available in fixed combinations.

Dosage and administration:

For oral use. 1 tablet once a day, preferably in the morning before meals. The tablet is swallowed whole, without chewing, with water. The maximum daily dose is 1 tablet (1.5 mg / 10 mg). The use of a fixed combination is not intended to initiate therapy. If it is necessary to change the dose, individual titration of each of the components of the combination should be carried out. 

Special groups of patients. 

Patients with impaired renal function.

In case of severe renal impairment (creatinine clearance <30 ml / min), treatment with the drug is contraindicated. For patients with impaired renal function of mild to moderate severity, adjustment of the recommended dose is not required. Elderly patients. In elderly patients, Arifam should be used taking into account renal function. 

Patients with impaired liver function. In severe violations of liver function, treatment with the drug is contraindicated. For patients with mild to moderate hepatic impairment, recommendations regarding the dosage of amlodipine have not been established, so the dose should be selected with caution and treatment should be started at a low dose.

Side effects:

The most commonly reported adverse reactions reported with indapamide and amlodipine alone were hypokalemia, drowsiness, dizziness, headache, blurred vision, diplopia, palpitations, flushing, dyspnea, abdominal pain, nausea, dyspepsia, change in defecation rhythm, diarrhea , constipation, maculopapular rash, ankle edema, muscle cramps, edema, fatigue and asthenia.

Contraindications:

Hypersensitivity to active substances, other sulfonamides, dihydropyridine derivatives or any excipients; severe renal failure (creatinine clearance <30 ml/min); hepatic encephalopathy or severe liver dysfunction; hypokalemia; period of breastfeeding; severe hypotension; shock (including cardiogenic); obstruction of the exit from the left ventricle (for example, severe aortic stenosis). Heart failure with unstable hemodynamics after acute myocardial infarction.

Warnings and precautions:

You should tell your doctor if you have experienced or are experiencing any of the following conditions:

– recent heart attack

– if you suffer from heart failure, irregular heart rate, coronary artery disease (heart disease caused by insufficient blood flow in the blood vessels of the heart),

– if you suffer from impaired renal function,

– if you have a severe increase in blood pressure (hypertensive crisis),

– you belong to a group of elderly patients and you need to increase the dose,

– if you are taking other medicines,

– if you are malnourished,

– if you suffer from impaired liver function,

– if you suffer from diabetes,

– if you suffer from gout,

– if you need to undergo an analysis to check the function of the parathyroid gland,

– if you experience photosensitivity reactions.

Your doctor may order a blood test to look for low sodium and potassium levels or high calcium levels.

If you think one of the conditions may apply to you, if you have questions or concerns about taking this drug, call

your doctor or pharmacist.

Storage:

Store at a temperature not exceeding 30°C.

Package:

The carton box holds 4 strips of 7 tablets and inner leaflet