Medinol Under 6 Oral Suspension

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

PARACETAMOL

Available from:

Cupal Limited 103 - 105 Bath Road Slough, SL1 3UK, United Kingdom

ATC code:

N02BE01

INN (International Name):

PARACETAMOL 120 mg/5ml

Pharmaceutical form:

ORAL SUSPENSION

Composition:

PARACETAMOL 120 mg/5ml

Prescription type:

OTC

Therapeutic area:

ANALGESICS

Authorization status:

Withdrawn

Authorization date:

2008-06-23

Summary of Product characteristics

 
Page 1 of 4 
SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 
Medinol Under 6 Paracetamol Oral Suspension BP 120mg/5ml 
2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Paracetamol 120mg/5ml 
3 
PHARMACEUTICAL FORM 
Oral Suspension 
4 
CLINICAL PARTICULARS 

4.1 
THERAPEUTIC INDICATIONS 
For the relief of pain and to relieve or reduce fever. 
4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 
ROUTE OF ADMINISTRATION: oral 
To be taken four times daily 
Do not repeat dose more frequently than every four hours 
INFANTS UNDER 3 MONTHS: on doctors advice only (10mg/kg).   
A 2.5ml dose is suitable for babies who develop a fever following vaccination 
at 2 months.  In all other cases use only under medical
supervision. 
INFANTS 3 MONTHS TO 1 YEAR: half to one 5ml spoonful (60-120mg) 
CHILDREN 1-UNDER 6 YEARS: one or two 5ml spoonfuls (120-240mg) 
CHILDREN OVER 6 YEARS: two or four 5ml spoonfuls (240-480mg) 
Do not give more than four doses in 24 hours. 
Not to be given to infants under 3 months except on medical advice. 
4.3 
CONTRA-INDICATIONS 
Hypersensitivity to paracetamol and/or other constituents.
 Impaired kidney 
and liver function. 
4.4 
SPECIAL WARNINGS AND PRECAUTIONS FOR USE 
1.  If pain or fever persists for more than 3
days consult a doctor. 
2.  Prolonged use without medical supervision may be harmful. 
3.  Do not give with other product
containing paracetamol concurrently. 

Page 2 of 4 
4.  If  your baby was born prematurely and is less than 3 months old consult 
your doctor before use. 
5.  In cases of accidental overdose seek medical attention
immediately. 
6.  Care  is  advised  in  the  administration  of  paracetamol  to  patients  with 
severe  renal  or  severe  hepatic  impairment.    The  hazards  of  overdose  are 
greater in those with (non-cirrhotic) alcoholic liver