SPIROLON Film-coated tablet Ref.[28199] Active ingredients: Spironolactone

Source: Υπουργείο Υγείας (CY) Revision Year: 2015 Publisher: Remedica Ltd, Aharnon St., Limassol Industrial Estate, 3056 Limassol, Cyprus

Product name and form

Spirolon 25 mg film-coated tablets.

Spirolon 100 mg film-coated tablets.

Pharmaceutical Form
Film-coated tablet. Spirolon 25 mg film-coated tablets: Yellow, round, film-coated tablets, scored with Remedica’s logo on one side and embossed with “SP 25” on the other side. The score line is only to facilitate breaking for ease of swallowing. Spirolon 100 mg film-coated tablets: Yellow, round, film-coated tablets, scored on one side and embossed with “SP 100” on the other side. The tablet can be divided into equal doses.

Qualitative and quantitative composition

Spirolon 25 mg film-coated tablets:

Each film-coated tablet contains 25 mg spironolactone.

Spirolon 100 mg film-coated tablets:

Each film-coated tablet contains 100 mg spironolactone.

Excipient(s) with known effect:

Spirolon 25 mg film-coated tablets: This product contains 56,8 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
Spirolon 25 mg film-coated tablets Core: Starch, pregelatinised Cellulose, microcrystalline Macrogol 6000 Polysorbate 80 Sodium starch glycolate (type A) Sodium laurilsulfate Silica, colloidal anhydrous Menthol Magnesium stearate Lactose monohydrate Maize starch Povidone Coating: Hypromellose Macrogol 400 Titanium dioxide Talc Quinoline yellow aluminium lake E104 Spirolon 100 mg film-coated tablets Core: Starch, pregelatinised Cellulose, microcrystalline Macrogol 6000 Polysorbate 80 Sodium starch glycolate (type A) Sodium laurilsulfate Silica, colloidal anhydrous Menthol Magnesium stearate Coating: Hypromellose Macrogol 400 Titanium dioxide Talc Quinoline yellow aluminium lake E104

Pack sizes and marketing

Spirolon 25 mg film-coated tablets:

PVC/Aluminium blisters. Pack sizes of 30, 50, 100, 500 and 1000 film-coated tablets.

PP containers with PE closure. Pack sizes of 50, 500 and 1000 film-coated tablets.

Spirolon 100 mg film-coated tablets:

PVC/Aluminium blisters. Pack sizes of 30, 50, 100 and 1000 film-coated tablets.

PP containers with PE closure. Pack sizes of 50, 100 and 1000 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Remedica Ltd, Aharnon St., Limassol Industrial Estate, 3056 Limassol, Cyprus

Marketing authorization dates and numbers

Spirolon 25 mg film-coated tablets: 7873
Spirolon 100 mg film-coated tablets: 8679

Spirolon 25 mg film-coated tablets:

Date of first authorization: 02 April 1981
Date of latest renewal: 25 January 2012

Spirolon 100 mg film-coated tablets:

Date of first authorization: 07 February 1983
Date of latest renewal: 27 October 2010

Drugs

Drug	Countries
SPIROLON	Cyprus, Malta, Singapore

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