CO-TIPOL Hard capsule Ref.[108797] Active ingredients: Codeine Codeine and Paracetamol Paracetamol

Source: Health Products Regulatory Authority (IE)  Revision Year: 2022  Publisher: Clonmel Healthcare Ltd, Waterford Road, Clonmel, Co. Tipperary, E91 D768, Ireland

Product name and form

Co‐Tipol 500 mg/30 mg hard capsules.

Pharmaceutical Form

Hard capsule.

Co‐Tipol are hard capsules consisting of a white and a yellowish orange section containing white powder.

Qualitative and quantitative composition

Each hard capsule contains 500 mg paracetamol and 30 mg codeine phosphate hemihydrate.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Codeine

Codeine is a centrally acting weak analgesic. Codeine exerts its effect through μ opioid receptors, although codeine has low affinity for these receptors, and its analgesic effect is due to its conversion to morphine. Codeine, particularly in combination with other analgesics such as paracetamol, has been shown to be effective in acute nociceptive pain. The anti-tussive activity of codeine is probably due to its depressant effect on the medullary cough centre in the brain.

Codeine and Paracetamol

The combination of paracetamol with codeine is a well-tolerated and effective analgesic. It consists of complementary active substances with different properties, but with common indication, the relief of pain. A special feature of the combination of paracetamol and codeine is the rapid onset of action after 10-20 minutes and the duration of action for 4-6 hours.

Paracetamol

Paracetamol is a medication used to treat pain and fever. It does appear to selectively inhibit COX activities in the brain, which may contribute to its ability to treat fever and pain.

List of Excipients

Talc

Capsule body:

Gelatin
Titanium dioxide (E171)
Iron oxide red (E172)
Iron oxide yellow (E172)

Pack sizes and marketing

White PVC/aluminium blisters strips containing 10 hard capsules.

Pack sizes: 10, 20, 100 and hospital pack sizes of 200 and 1,000.

Not all pack sizes may be marketed.

Marketing authorization holder

Clonmel Healthcare Ltd, Waterford Road, Clonmel, Co. Tipperary, E91 D768, Ireland

Marketing authorization dates and numbers

PA0126/332/001

Date of first authorisation: 29th November 2013
Date of last renewal: 28th November 2018

Drugs

Drug Countries
CO-TIPOL Ireland

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