PARACODIN Syrup Ref.[49816] Active ingredients: Dihydrocodeine

Source: Health Products Regulatory Authority (IE)  Revision Year: 2020  Publisher: Teofarma S.R.L., Valle Salimbene (PV), Via F. LLI Cervi, 8 CAP 27010, Italy

Product name and form

Paracodin 0.20% w/w Syrup.

Pharmaceutical Form

Syrup.

Clear, colourless or faintly yellow liquid with a cherry flavour.

Qualitative and quantitative composition

Dihydrocodeine hydrogen tartrate 12.1 mg per 5 ml (0.20% w/w).

Excipients: Sucrose 2424.2 mg per 5 ml (40 % w/w) benzoic acid (E210) 12.1mg per 5ml.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Dihydrocodeine

Dihydrocodeine is a semisynthetic narcotic analgesic with a potency between morphine and codeine. It is also a centrally-acting anti-tussive. Dihydrocodeine works on the cough centre to lessen the incidence and intensity of coughing fits.

List of Excipients

Purified water
Benzoic acid (E210)
Glycerol 85%
Sucrose
Cherry flavour

Pack sizes and marketing

Brown glass (type III) bottle with polyethylene flow restrictor and polypropylene screw cap.

Each bottle contains 100g Paracodin Syrup.

Marketing authorization holder

Teofarma S.R.L., Valle Salimbene (PV), Via F. LLI Cervi, 8 CAP 27010, Italy

Marketing authorization dates and numbers

PA1235/004/002

Date of first authorisation: 04 October 1991
Date of last renewal; 04 October 2006

Drugs

Drug Countries
PARACODIN Austria, Germany, Ireland

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