Co-Tipol 500 mg/30 mg suppositories

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

Paracetamol; Codeine phosphate hemihydrate

Disponible desde:

Clonmel Healthcare Ltd

Código ATC:

N02AJ; N02AJ06

Designación común internacional (DCI):

Paracetamol; Codeine phosphate hemihydrate

Dosis:

500 mg/30 milligram(s)

formulario farmacéutico:

Suppository

Área terapéutica:

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

Estado de Autorización:

Not marketed

Fecha de autorización:

2013-11-29

Información para el usuario

PACKAGE LEAFLET: INFORMATION FOR THE USER
CO-TIPOL 500MG / 30MG SUPPOSITORIES
PARACETAMOL / CODEINE PHOSPHATE HEMIHYDRATE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
-
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 use Co-Tipol
3.
How to use 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
Your suppositories are called Co-Tipol. They are 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 is used for the treatment of moderate to severe pain.
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
paracetamol.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE 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
irreversible liver damage.
DO NOT USE CO-TIPOL:
-
if you are allergic to paracet

Ficha técnica

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 suppositories
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each suppository contains 500mg paracetamol and 30mg codeine phosphate
hemihydrate.
Excipient with known effect: contains 12.5 mg of soya lecithin per
suppository.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Suppository
White to ivory coloured, torpedo shaped suppository
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
BODYWEIGHT
SINGLE DOSE
MAXIMUM DAILY DOSE(24HOURS)
Adults and children above
12 years of age
More than 43 kg
1 – 2 suppositories
(equivalent to 500 – 1000 mg
paracetamol and 30—60 mg codeine
phosphate hemihydrate)
5 ‐ 8 suppositories
(equivalent to 2500 – 4000 mg
paracetamol and 150 ‐ 240 mg
codeine phosphate hemihydrate)
The maximum daily dose (8 suppositories in 24 hours) must not be
exceeded, and the interval between doses should be at
least six hours (if any further suppositories 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 period of time. This dose may be used, up to 4 times a
day at intervals of not less than 6 hours. Maximum daily dose of
codeine should not exceed 240mg.
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 subjects suffering from Gilbert's syndrome
(Meulengracht's disease). Patients with severe renal impairment
(creatinine clearance < 10 ml/min) must not exceed a dose int