Co-Tipol Max 1000 mg/60 mg suppositories

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:

1000 mg/60 milligram(s)

Pharmaceutical form:

Suppository

Therapeutic area:

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

Authorization status:

Marketed

Authorization date:

2013-11-29

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
CO-TIPOL MAX 1000MG/60MG 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 Max is and what it is used for
2.
What you need to know before you use Co-Tipol Max
3.
How to use Co-Tipol Max
4.
Possible side effects
5.
How to store Co-Tipol Max
6.
Contents of the pack and other information
1. WHAT CO-TIPOL MAX IS AND WHAT IT IS USED FOR
Your suppositories are called Co-Tipol Max. 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 Max is used for the treatment of moderate to severe pain.
Co-Tipol Max 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 MAX
-
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-T

Summary of Product characteristics

Health Products Regulatory Authority
19 September 2022
CRN00CX41
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Co‐Tipol Max 1000 mg/60 mg suppositories
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each suppository contains 1000 mg of paracetamol and 60 mg of codeine
phosphate hemihydrate.
Excipient with known effect: contains 25 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
BODY WEIGHT
SINGLE DOSE
MAXIMUM DAILY DOSE
(24 HOURS)
Adults and
children above 12 years of age
More than 43 kg
1 suppository
(equivalent to 1,000 mg of
paracetamol and
60 mg of codeine phosphate
hemihydrate)
Up to 4 suppositories
(equivalent to up to 4,000 mg of
paracetamol and up to 240 mg of
codeine phosphate hemihydrate)
The maximum daily dose (4 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 Max 1000mg/60mg should be used at the lowest effective dose
for the shortest period of 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.
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 n