Riik: Malaisia
keel: inglise
Allikas: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
AMLODIPINE BESILATE; INDAPAMIDE
SERVIER MALAYSIA SDN BHD
AMLODIPINE BESILATE; INDAPAMIDE
30tablet Tablets; 10tablet Tablets
LES LABORATOIRES SERVIER INDUSTRIE
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ ___________________________________________________________________________________________ 1 NATRIXAM_ _MODIFIED-RELEASE TABLETS_ _ _Indapamide /amlodipine (1.5 mg/5 mg & 1.5 mg/10 mg) _ WHAT IS IN THIS LEAFLET 1. What Natrixam is used for 2. How Natrixam works 3. Before you use Natrixam 4. How to use Natrixam 5. While you are using it 6. Side effects 7. Storage and Disposal of Natrixam 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT NATRIXAM IS USED FOR Natrixam is prescribed as substitution treatment of high blood pressure (hypertension) in patients already taking i ndapamide and amlodipine from separate tablets in the same strength. HOW NATRIXAM WORKS Natrixam is a combination of two active ingredients, indapamide and amlodipine. Indapamide is a diuretic . Diuretics increase the amount of urine produced by the kidneys. However, indapamide is different from other diuretics, as it only causes a slight increase in the amount of urine produced. Amlodipine is a calcium antagonist (which belongs to a class of medicines called dihydropyridines) and it works by relaxing blood vessels, so that blood passes through them more easily. Each of the active ingredients reduces blood pressure. BEFORE YOU USE NATRIXAM - _When you must not use it_ DO NOT TAKE NATRIXAM - if you are allergic to indapamide or any other sulfonamide (class of medicinal product for the treatment of hypertension), or to amlodipine or any other calcium antagonist (class of medicinal product for the treatment of hypertension) or to any of the other ingredients of this medicine (listed in section Product Description). This may be itching, reddening of the skin or difficulty in breathing, - if you have severe low blood pressure (hypotension), - if you have narrowing of the aortic heart valve (aortic stenosis) or cardiogenic shock (a condition where your heart is unable to supply enough blood to the body), - if you suffer from heart failure after a heart att Lugege kogu dokumenti
_ _ _Final PI_Natrixam_02.12.2022 _ _ _ _ _ 1 _ _ 1. NAME OF THE MEDICINAL PRODUCT Natrixam 1.5 mg / 5 mg modified-release tablets Natrixam 1.5 mg / 10 mg modified-release tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains 1.5 mg indapamide and 6.935 mg amlodipine besilate equivalent to 5 mg amlodipine. One tablet contains 1.5 mg indapamide and 13.87 mg amlodipine besilate equivalent to 10 mg amlodipine. Excipient with known effect: 104.5 mg lactose monohydrate For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Modified-release tablet. 1.5 mg / 5 mg : White, round, film-coated, bilayered, modified-release tablet of 9 mm diameter engraved with on one face. 1.5 mg / 10 mg : Pink, round, film-coated, bilayered, modified-release tablet of 9 mm diameter engraved with on one face. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Natrixam 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology 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. Special populations _Paediatric population _ The safety and efficacy of Natrixam in children and adolescents have not been established. No data are available. _Patients with renal impairment (see sections 4.3 and 4.4): _ 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 (see section 4.4 and 5.2): _ Older people can be treated with Natrixam according to renal function. _ _ _Final PI_Natrixam_02.12.2022 _ _ _ _ _ 2 _ _ _Patients with hepatic impairment (see sections 4.3 and 4.4): _ In severe Lugege kogu dokumenti