MEDINOL OVER 6

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PARACETAMOL

Available from:

Cupal Limited

Dosage:

250 MG/5ml

Pharmaceutical form:

Oral Suspension

Authorization date:

1996-01-08

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Medinol Over 6 250mg/5ml oral suspension.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml contains Paracetamol 250mg.
For excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral suspension.
A yellowish/off-white to light orange/brown translucent oral suspension with a taste and smell characteristic of
strawberries.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the relief of mild to moderate pain including headache, toothache and sore throat.
Symptomatic relief of influenza, feverishness and colds.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Oral.
DOSAGE
Adults and children over 12 years
Two to four 5ml spoonfuls, up to 4 times daily.
Children 6 – 12 years
One or two 5ml spoonfuls, up to 4 times daily.
Do not repeat doses more frequently than every 4 hours.
Not to be given to children under 6 years.
Do not take more than 4 doses in 24 hours.
Shake the bottle before use.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 21/02/2012_
_CRN 2110176_
_page number: 1_
4.3 CONTRAINDICATIONS
Hypersensitivity to paracetamol or any of the other constituents.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Should be used with caution in impaired kidney or liver function.
Patients with rare hereditary problems of fructose intolerance should not take this medicine.
If pain or fever persists for more than 3 days consult a doctor.
Prolonged use without medical supervision may be harmful.
Do not exceed the stated dose.
In case of accidental overdose seek medical attention immediately.
Keep out of the reach of children.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION
Alcohol, barbiturates, anti-convulsants and