PARACODIN Tablet Ref.[49814] 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 Tablets.

Pharmaceutical Form

Tablet.

Round, off white biplane tablets, with a score line on one side and a star with three rays on the other side.

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Qualitative and quantitative composition

Each tablet contains 10 mg Dihydrocodeine Hydrogen Tartrate.

Excipients with known effect: Each tablet also includes Lactose monohydrate.

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

Lactose monohydrate
Microcrystalline cellulose (E460)
Sodium starch glycolate
Magnesium stearate (E572)

Pack sizes and marketing

Aluminium/PVC foil blister strips containing 20 tablets.

Marketing authorization holder

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

Marketing authorization dates and numbers

PA1235/004/003

Date of first authorisation: 01 April 1978
Date of last renewal: 01 April 2008

Drugs

Drug Countries
PARACODIN Austria, Germany, Ireland

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