Natrilix SR 1.5mg tablets

Country: Միացյալ Թագավորություն

language: անգլերեն

source: MHRA (Medicines & Healthcare Products Regulatory Agency)

active_ingredient:

Indapamide

MAH:

Servier Laboratories Ltd

ATC_code:

C03BA11

INN:

Indapamide

dosage:

1.5mg

pharmaceutical_form:

Modified-release tablet

administration_route:

Oral

class:

No Controlled Drug Status

prescription_type:

Valid as a prescribable product

leaflet_short:

BNF: 02020100; GTIN: 5017476071002

SPC

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
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2. Qualitative and quantitative composition
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3. Pharmaceutical form
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4. Clinical particulars
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4.1 Therapeutic indications
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4.2 Posology and method of administration
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4.3 Contraindications
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4.4 Special warnings and precautions for use
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4.5 Interaction with other medicinal products and other forms of
interaction
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4.6 Fertility, pregnancy and lactation
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4.7 Effects on ability to drive and use machines
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4.8 Undesirable effects
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4.9 Overdose
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5. Pharmacological properties
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5.1 Pharmacodynamic properties
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5.2 Pharmacokinetic properties
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5.3 Preclinical safety data
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6. Pharmaceutical particulars
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6.1 List of excipients
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6.2 Incompatibilities
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6.3 Shelf life
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6.4 Special precautions for storage
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6.5 Nature and contents of container
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6.6 Special precautions for disposal and other handling
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7. Marketing authorisation holder
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8. Marketing authorisation number(s)
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9. Date of first authorisation/renewal of the authorisation
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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