RESTATIN Coated tablet Ref.[51080] Active ingredients: Nystatin

Source: Υπουργείο Υγείας (CY)  Revision Year: 2019  Publisher: Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

Product name and form

Restatin 500 000 IU coated tablets.

Pharmaceutical Form

Coated tablet.

Chocolate brown, round, coated tablets.

Qualitative and quantitative composition

Each coated tablet contains nystatin 500 000 IU.

Excipient(s) with known effect: This product contains 109,1 mg lactose and 121,05 mg sucrose.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Nystatin

Nystatin is an antifungal antibiotic active against a wide range of yeasts and yeast-like fungi, including Candida albicans.
List of Excipients

Core:

Povidone
Cellulose, microcrystalline
Lactose monohydrate
Maize starch
Sodium starch glycolate (Type A)
Magnesium stearate
Talc
Silica, colloidal anhydrous

Coating:

Hypromellose
Macrogol 400
Titanium dioxide
Talc
Gelatin
Macrogol 6000
Povidone
Sucrose
Calcium carbonate
Brown HT E155
Quinoline Yellow E104

Pack sizes and marketing

PVC/Aluminium blisters. Pack sizes of 20, 30 and 100 coated tablets.

PP containers with PE closure. Pack sizes of 100 and 1000 coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

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

Marketing authorization dates and numbers

13308

Date of first authorization: 18 March 1991
Date of latest renewal: 24 August 2011

Drugs

Drug Countries
RESTATIN Cyprus, Nigeria
 
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