AMILORETIC Tablet Ref.[51293] Active ingredients: Amiloride Hydrochlorothiazide

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2021  Publisher: PHARMACARE LIMITED, Healthcare Park, Woodlands drive, Woodmead 2191

Product name and form

AMILORETIC 5 mg/50 mg tablets.

AMILORETIC H.S. TABLETS 2,5 mg/25 mg.

Pharmaceutical Form

Tablets.

AMILORETIC is a round, flat, pale peach, bevelled edged tablet, bisected on one side and engraved with a mortar and pestle on the other side.

AMILORETIC H.S.TABLETS is around, flat, pale peach, bisected tablet with bevelled edges imprinted with a mortar and pestle.

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Qualitative and quantitative composition

Each tablet of AMILORETIC contains 5 mg amiloride hydrochloride and 50 mg hydrochlorothiazide.

Contains sugar: Lactose monohydrate 96,00 mg

Each tablet of AMILORETIC H.S.TABLETS contains 2,5 mg amiloride hydrochlorideand 25 mg hydrochlorothiazide.

Contains sugar: Lactose monohydrate 48,00 mg

For full list of excipients, see section 6.1.

Active Ingredient Description
Amiloride

Amiloride has mild diuretic and anti-hypertensive activity. It acts primarily in the distal tubule and does not require aldosterone for its action. Amiloride is a mild natriuretic which does not initiate a concomitant decrease in potassium levels.

Hydrochlorothiazide

Hydrochlorothiazide is a diuretic with antihypertensive properties. It acts by inhibiting the renal tubular re-absorption of sodium and chloride ions, which are excreted with an accompanying volume of water. Potassium excretion is also promoted.

List of Excipients

Amiloretic: Lactose monohydrate, magnesium stearate, maize starch, microcrystalline cellulose, sodium starch glycollate, Sunset Yellow FCF Lake (C.I. No. 15895), purified talc.

Amiloretic H.S.: Lactose monohydrate, magnesium stearate, maize starch, microcrystalline cellulose, sodium starch glycollate, dye Lennon Lake Yellow (C.I No. 15985), purified talc.

Pack sizes and marketing

AMILORETIC: 30 or 100 tablets are packed in clear polyvinylchloride blister strips with an aluminium backing. The blister strips are packed into an outer cardboard carton together with a leaflet.

1.000 tablets are packed in a white polypropylene container with a white linear low density polyethylene cap together with a white foam insert and a leaflet.

The tablets are also packed in a metallised lay flat bag sealed with a zip-lock for lay-flat.

AMILORETIC H.S.TABLETS: 30 or 100 tablets are packed in clear polyvinylchloride blister strips with an aluminium backing. The blister strips are packed into an outer cardboard carton together with a leaflet.

1.000 tablets are packed in a white polypropylene container with a white linear low density polyethylene cap together with a white foam insert and a leaflet.

The tablets are also packed in a metallised lay flat bag sealed with a zip-lock for lay-flat.

Not all packs and pack size are necessarily marketed.

Marketing authorization holder

PHARMACARE LIMITED, Healthcare Park, Woodlands drive, Woodmead 2191

Marketing authorization dates and numbers

AMILORETIC: L/18.1/396
AMILORETIC H.S.TABLETS: U/18.1/40

AMILORETIC: 23 September 1979
AMILORETIC H.S. TABLETS: 06 August 1987

Drugs

Drug Countries
AMILORETIC South Africa

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