Co-Tipol Max 1000mg/60mg 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:

1000 mg/60 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 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. 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 Max 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 Max is and what it is used for.
2. Before you take Co-Tipol Max.
3. How to take Co-Tipol Max.
4. Possible side effects.
5. How to store Co-Tipol Max.
6. Further information.
1.
WHAT CO-TIPOL MAX IS AND WHAT IT IS USED FOR
Co-Tipol Max is a pain killer (analgesic) used for the treatment of
moderate to severe pain.
Co-Tipol Max is a mixture of two drugs, paracetamol and codeine
phosphate hemihydrate
2. BEFORE YOU TAKE CO-TIPOL MAX
DO NOT TAKE CO-TIPOL MAX:
• if you are hypersensitive (allergic) to paracetamol, codeine, soya
or any of the other
ingredients of Co-Tipol Max,
• Co-Tipol Max contains soya lecithin. If you are allergic to soya
or peanut, do not use this
medicinal product
• if you have severe liver disease or liver failure
• for children under 12 years or less than 43kg body weight
• if you are well advanced in pregnancy,
• if you are at risk for premature delivery
• if you are breastfeeding
• if you are having an asthmatic attack
• if you have pneumonia
• if you are

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 Max 1000mg/60mg Suppositories
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each suppository contains 1000 mg of paracetamol and 60 mg of codeine
phosphate hemihydrate.
Excipient: contains 25 mg of soya lecithin per suppository.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Suppository
Co-Tipol Max are white to ivory coloured, torpedo shaped
suppositories.
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
​
AGE
​
BODY WEIGHT
SINGLE DOSE
​
MAXIMUM DAILY DOSE
(24 HOURS)
Over 12 years​
​
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).
Co-Tipol should be used at the lowest effective dose for the shortest
possible time.
Note
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).
_Severe renal insufficiency_
Patients with severe renal failure (creatinine clearance below 10
ml/min) should not be given the drug at intervals shorter than
8 hours.
Method of administration
The suppositories should be put deeply into the rectum after bowel
movement. They may be warmed in the hand or dipped
shortly into hot water to improve sliding properties.
Du