Pays: Royaume-Uni
Langue: anglais
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Indapamide
Servier Laboratories Ltd
C03BA11
Indapamide
1.5mg
Modified-release tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02020100; GTIN: 5017476071002
OBJECT 1 Natrilix SR 1.5 mg Tablets Summary of Product Characteristics Updated 18-Nov-2021 | Servier Laboratories Limited • 1. Name of the medicinal product • 2. Qualitative and quantitative composition • 3. Pharmaceutical form • 4. Clinical particulars • 4.1 Therapeutic indications • 4.2 Posology and method of administration • 4.3 Contraindications • 4.4 Special warnings and precautions for use • 4.5 Interaction with other medicinal products and other forms of interaction • 4.6 Fertility, pregnancy and lactation • 4.7 Effects on ability to drive and use machines • 4.8 Undesirable effects • 4.9 Overdose • 5. Pharmacological properties • 5.1 Pharmacodynamic properties • 5.2 Pharmacokinetic properties • 5.3 Preclinical safety data • 6. Pharmaceutical particulars • 6.1 List of excipients • 6.2 Incompatibilities • 6.3 Shelf life • 6.4 Special precautions for storage • 6.5 Nature and contents of container • 6.6 Special precautions for disposal and other handling • 7. Marketing authorisation holder • 8. Marketing authorisation number(s) • 9. Date of first authorisation/renewal of the authorisation • 10. Date of revision of the text 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 clea Lire le document complet