URACTONUM Tablet Ref.[28219] Active ingredients: Spironolactone

Source: Υπουργείο Υγείας (CY)  Revision Year: 2016  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Product name and form

Uractonum 25 mg tablets.

Uractonum 100 mg tablets.

Pharmaceutical Form

Tablet.

Uractonum 25 mg are white, round, flat, scored tablets, with a diameter of 8.5 mm.

Uractonum 100 mg are white, round, flat, scored tablets, with a diameter of 9.5 mm.

Qualitative and quantitative composition

Uractonum 25 mg: Each tablet contains 25 mg of spironolactone.

Uractonum 100 mg: Each tablet contains 100 mg of spironolactone.

Excipient with known effect: lactose.

Each 25 mg tablet contains 145.00 mg lactose monohydrate which is equal to 137.76 mg lactose.

Each 100 mg tablet contains 139.00 mg lactose monohydrate which is equal to 132.06 mg lactose.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Spironolactone

Spironolactone, as a competitive aldosterone antagonist, increases sodium excretion whilst reducing potassium loss at the distal renal tubule. It has a gradual and prolonged action.

List of Excipients

Tablets (25 mg and 100 mg) also contain:

Lactose
Maize starch
Croscarmellose sodium
Povidone
Sodium lauryl sulphate
Magnesium stearate
Peppermint flavour

Pack sizes and marketing

Uractonum 25mg tablets:

Blisters of polyvinylchloride and aluminium, of ten tablets. Packs of 20, 50 and 100 are available.

Polypropylene securitainers with polyethylene caps containing 100, 250, 500 or 1000 tablets.

Uractonum 100mg tablets:

Blisters of polyvinylchloride and aluminium, of ten tablets. Packs of 20, 50 and 100 tablets and polypropylene securitainers with polyethylene caps of 100 tablets are available.

Not all pack sizes may be marketed.

Marketing authorization holder

MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Marketing authorization dates and numbers

Uractonum 25 mg: 6832
Uractonum 100 mg: 8523

Uractonum 25 mg: 20.10.1978 / 17.02.2010
Uractonum 100 mg: 22.10.1982 / 03.03.2010

Drugs

Drug Countries
URACTONUM Cyprus, Hong Kong, Malta, Singapore

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