Co-Tipol 500mg/30mg Suppositories

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Codeine phosphate hemihydrate; Paracetamol

Available from:

Carysfort Healthcare Limited

ATC code:

N02AJ; N02AJ06

INN (International Name):

Codeine phosphate hemihydrate; Paracetamol

Dosage:

500 mg/30 milligram(s)

Pharmaceutical form:

Suppository

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

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

Authorization status:

Marketed

Authorization date:

2013-11-29

Patient Information 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. Do not pass it on to
others. It may harm them,
even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side
effects not listed in this
leaflet, please tell your doctor or pharmacist
• 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 with any other paracetamol containing product
• 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.
IN THIS LEAFLET:
1. What Co-Tipol is and what it is used for.
2. Before you take Co-Tipol.
3. How to take Co-Tipol.
4. Possible side effects.
5. How to store Co-Tipol.
6. Further 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.
2. BEFORE YOU TAKE CO-TIPOL
DO NOT TAKE CO-TIPOL:
• if you are hypersensitive (allergic) to paracetamol, codeine, soya
or any of the other
ingredients of Co-Tipol,
• Co-Tipol contains soya lecithin. If you are allergic to soya or
peanut, do not use this
medicinal product
• have severe liver problems,
• are in the late stages of pregnancy
• are at risk for premature delivery
• are breastfeeding
• are having an asthmatic attack
• have pneumonia
•are using monoamine oxidase (MAO) inhibitors (medicines for the
treatment of
depression)
•ar

Summary of Product characteristics

Health Products Regulatory Authority
01 December 2019
CRN0097GN
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Co-Tipol 500mg/30mg Suppositories
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each suppository contains 500mg paracetamol and 30mg codeine phosphate
hemihydrate.
Excipient: contains 12.5 mg of soya lecithin per suppository.
For a full list of excipients, see 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
Single dosage and daily dosage: Adults and children above 12 years of
age: One to two suppositories up to 4 times a day.
Usually the dose is repeated at 6 to 8 hour intervals.
Referring to the proportion of codeine in the fixed combination, the
maximum daily dosage is 240 mg codeine phosphate
hemihydrates (equivalent to 8 suppositories). Referring to the
proportion of paracetamol in the fixed combination, the total
daily dose of 60 mg per kilogram bodyweight (BW) should not be
exceeded, because the dose of paracetamol is based on
bodyweight and age (in general 10 to 15 mg per kilogram bodyweight as
single dose)
The dosage intervals are based on the symptoms and the maximum dose
per day. It should not be shorter than 6 hours.
​
Bodyweight Age
Single dose​
Maximum daily dose (24 hours)​
Children (above 12 years of
age) and adults above 43kg
1-2 suppositories (equivalent to 500-1000mg
paracetamol and 30-60mg codeine
phosphate hemihydrate)​
5-8 suppositories (equivalent to
2500-4000mg paracetamol and 150-240mg
codeine phosphate hemihydrate)​
Method and duration of administration
The duration of use shall be determined by the treating doctor.
Co-Tipol should be used at the lowest effective dos