Medinol Over 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 250 mg/5ml

Pharmaceutical form:

ORAL SUSPENSION

Composition:

PARACETAMOL 250 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Withdrawn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. 
TRADE NAME OF MEDICINAL PRODUCT 

Medinol Over 6 Paracetamol Oral Suspension 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Paracetamol 250mg/5ml 

3. 
PHARMACEUTICAL FORM 

Oral suspension 

4. 
CLINICAL PARTICULARS 

4.1 
Therapeutic Indications 

For the relief of mild to moderate pain including headache,
migraine, 
neuralgia, toothache and sore throat.  Symptomatic relief
of rheumatic aches 
and pains.  Symptomatic relief of influenza, feverishness and
colds. 

4.2 
Posology and Method of Administration 

Oral 
To be taken four times daily.  Do not repeat doses
more frequently than every 
four hours. 
Adults, the elderly and children over 12 years of age: two to
four 5ml 
spoonfuls 

Children 6 to 12 years: one to two 5ml spoonfuls 

Not to be given to children under 6 years of age 

Do not take more than 4 doses in 24 hours 

4.3 
Contraindications 

Should be used with caution in patients having impaired kidney or
liver 
function. 

Hypersensitivity to paracetamol and/or other constituents. 

4.4 
Special Warnings 

Care is advised in the administration of paracetamol to patients
with severe 
renal or severe hepatic impairment and in those with
non-cirrhotic alcoholic 
liver disease.  The hazards of overdose are greater in
those with alcoholic liver 
disease. 

If pain or fever persists for more than 3 days, consult your
doctor. 

Prolonged use without medical supervision may be harmful. 

Do not exceed the stated dose. 

Keep out of the reach of children. 

Page 2 of 4 

The labels will say: Do not give with
any other paracetamol-containing 
products. 
Immediate medical advice should be sought in the event of an
overdose, even 
if the child seems well.  

The leaflet will say: Immediate medical advice should be sought in
the eve