Co-Tipol 500 mg/30 mg hard capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Paracetamol; Codeine phosphate hemihydrate

Available from:

Clonmel Healthcare Ltd

ATC code:

N02AJ; N02AJ06

INN (International Name):

Paracetamol; Codeine phosphate hemihydrate

Dosage:

500 mg/30 milligram(s)

Pharmaceutical form:

Capsule, hard

Therapeutic area:

Opioids in combination with non-opioid analgesics; codeine and paracetamol

Authorization status:

Not marketed

Authorization date:

2013-11-29

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
CO-TIPOL 500MG / 30MG HARD CAPSULES
PARACETAMOL/ CODEINE PHOSPHATE HEMIHYDRATE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IM-
PORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Co-Tipol is and what it is used for
2.
What you need to know before you take Co-Tipol
3.
How to take Co-Tipol
4.
Possible side effects
5.
How to store Co-Tipol
6.
Contents of the pack and other information
1. WHAT CO-TIPOL IS AND WHAT IT IS USED FOR
Co-Tipol is a pain killer (analgesic) used for the treatment of
moderate to severe pain. It is a mixture of
two drugs, paracetamol and codeine phosphate hemihydrate. They are
part of a group of medicines
known as analgesics (pain killers).
Co-Tipol can be used in children over 12 years of age for the
short-term relief of moderate pain that is
not relieved by other painkillers such as paracetamol or ibuprofen
alone.
This product contains codeine. Codeine belongs to a group of medicines
called opioid analgesics which
act to relieve pain. It can be used on its own or in combination with
other pain killers such as paraceta-
mol.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CO-TIPOL
-
This product contains paracetamol and codeine phosphate hemihydrate.
Do not take Co-Tipol with
any other product that contains paracetamol or codeine phosphate.
-
Contains paracetamol
-
Do not take any other paracetamol-containing products
-
Do not exceed the stated dose
-
Immediate medical advice should be sought in the event of overdosage,
because of the risk of irre-
versible liver damage.
DO NOT TAKE

Summary of Product characteristics

Health Products Regulatory Authority
19 September 2022
CRN00CX41
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Co‐Tipol 500 mg/30 mg hard capsules
2 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.
3 PHARMACEUTICAL FORM
Hard capsule
Co‐Tipol are hard capsules consisting of a white and a yellowish
orange section containing white powder
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Adults: Moderate to severe pain.
Children 12‐18 years: Co‐Tipol is only suitable for use in
children older than 12 years for treatment of acute moderate pain that
cannot be relieved by other analgesics such as paracetamol and
ibuprofen (alone).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
AGE
SINGLE DOSE
MAXIMUM DAILY DOSE
(24 HOURS)
Adults (18 years and over)
1 ‐ 2 hard capsules
(equivalent to 500 ‐ 1,000 mg of paracetamol
and
30 ‐ 60 mg of codeine phosphate hemihydrate)
Up to 8 hard capsules
(equivalent to up to 4,000 mg of paracetamol
and up to 240 mg of codeine phosphate
hemihydrate)
The maximum daily dose must not be exceeded, and the interval between
doses should be at least six hours (if any further
capsules are needed).
This product should not be used with other paracetamol or
codeine‐containing medicines.
Co‐Tipol should be used at the lowest effective dose for the
shortest possible time. This dose may be taken, up to 4 times a
day at intervals of not less than 6 hours. Maximum daily dose of
codeine should not exceed 240mg.
The maximum daily dose of paracetamol should not exceed 60mg/kg/day
(up to a maximum of 2g per day) in the following
situations, unless directed by a physician:

Weight less than 50kg

Chronic alcoholism

Dehydration

Chronic malnutrition
Renal and hepatic impairment
The dose should be reduced or the interval between doses should be
increased in the presence of impaired liver and/or kidney
function and in subje