PARACODIN Oral drops, solution Ref.[49815] 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 10 mg/g Oral Drops, Solution

Pharmaceutical Form

Oral drops, solution.

Clear, brown solution.

Qualitative and quantitative composition

Each drop contains 0.5 mg of dihydrocodeine hydrorhodanide.

1 g of Paracodin drops (=20 drops) contains 10 mg of dihydrocodeine hydrorhodanide.

Excipients: benzoic acid (E201) 2mg per 20-drop dose.

For 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 per cent)
Saccharin sodium
Sodium chloride
Caramel (E150)
Thyme flavour
Eucalyptus flavour

Pack sizes and marketing

Amber glass bottle (type III) with polyethylene dropper and polypropylene screw cap containing 15 gof solution.

Marketing authorization holder

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

Marketing authorization dates and numbers

PA1235/004/001

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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