Co-Tipol 500mg/30mg Hard Capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Paracetamol; Codeine phosphate hemihydrate

Available from:

Carysfort Healthcare Limited

ATC code:

N02AJ; N02AJ06

INN (International Name):

Paracetamol; Codeine phosphate hemihydrate

Dosage:

500 mg/30 milligram(s)

Pharmaceutical form:

Capsule, hard

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:

Not marketed

Authorization date:

2013-11-29

Patient Information leaflet

INFORMATION FOR THE USER
CO-TIPOL 500MG/30MG
HARD CAPSULES
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
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.
2. BEFORE YOU TAKE CO-TIPOL
DO NOT TAKE CO-TIPOL:
• if you are hypersensitive (allergic) to paracetamol, codeine or
any of the other ingredients
of Co-Tipol,
• if you are affected with severe liver problems,
• Co- Tipol is not suitable for children under 12 years or less than
40kg 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 have breathing difficulties or lung disorders (particularly
in children aged 12-18
years)
• If you are using other medicines which contain paracet

Summary of Product characteristics

Health Products Regulatory Authority
01 December 2019
CRN0097GN
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Co-Tipol 500mg/30mg 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
Capsules, hard
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
AGE
BODY WEIGHT
SINGLE DOSE
MAXIMUM DAILY DOSE
(24 HOURS)
Over 12 years
More than 40 kg
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 (8 hard capsules in 24 hours) must not be
exceeded, and the interval between doses should be at
least six hours (if any further capsules 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 capsules should be swallowed whole with fluid. They should not be
taken in a supine position.
Co-Tipol may have a delayed onset of action if the capsules are taken
after meals.
Health Products Regulatory Authority
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