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PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Medinol Under 6 Paracetamol Oral Suspension 120mg/5ml.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml suspension contains 120mg Paracetamol.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Oral Suspension.
A grey/white viscous thixotropic liquid oral suspension with a strawberry odour and taste.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As an analgesic for the treatment of mild to moderate pain and as an anti-pyretic.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ROUTE OF ADMINISTRATION
Oral.
DOSAGE
_Infants 2-3 months:_
Give a dose to babies who are feverish after vaccination at 2 months. For other feverish conditions, use only if your
doctor tells you to.
_Children 3 months to 1 year:_
Half to one 5ml spoonful.
_Children 1-5 years:_
One to two 5ml spoonfuls.
_Children over 5 years:_
Three or four 5ml spoonfuls.
Do not take more than four doses in 24 hours. Not to be given to infants under 2 months except on medical advice.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 07/09/2007_
_CRN 2040047_
_page number: 1_
4.3 CONTRAINDICATIONS
Hypersensitivity to paracetamol and/or other constituents. Impaired kidney or liver function.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
1.
If pain or fever persists for more than 24 hours consult a doctor.
2.
Prolonged use without medical supervision may be harmful.
3.
Patients with rare hereditary problems of fructose intolerance should not take this medicine.
4.
Do not take with other product containing paracetamol concurrently.
5.
In cases of accidental overdose seek medical attention immediately due to the risk of delayed serious liver
damage.
6.
Keep out of the reach of chil
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