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DISTACLOR Capsules (2018)

Product Name and Form

Distaclor 500mg capsules.

Cefaclor 500mg capsules.

Pharmaceutical form

Capsule, Size 0 with opaque purple cap and opaque grey body.

Qualitative and Quantitative Composition

Each capsule contains as the active ingredient, cefaclor monohydrate Ph.Eur. equivalent to 500mg of cefaclor base.

List of excipients

Magnesium Stearate
Dimeticone Starch Flowable
Erythrosine Patent Blue V Black
Iron Oxide
Titanium Dioxide
Gelatin

Pack sizes and Marketing

High density polyethylene bottles with screw caps containing 20, 50 or 100 capsules

or

UPVC/Aluminium foil blister packs containing 14 or 21 capsules or

PVC/PCTFE/Aluminium foil blister packs containing 14 or 21 capsules or

PVC/PCTFE/PE/Aluminium foil blister packs containing 14 or 21 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

Flynn Pharma Limited, Marine House Clanwilliam Place, Dublin 2, Ireland

Date of first authorisation: 21 August 1978

Date of latest renewal: 30 September 2005

Marketing authorization number:

PL 13621/0008