Paracetamol Tablets 500mg/ Mandanol Paracetamol 500/ Paracetamol 500mg Caplets

Χώρα: Μάλτα

Γλώσσα: Αγγλικά

Πηγή: Medicines Authority

Δραστική ουσία:

PARACETAMOL

Διαθέσιμο από:

M & A Pharmachem Limited Allenby Laboratories, Wigan Road Westhoughton, Bolton, BL 5 2AL, United Kingdom

Φαρμακολογική κατηγορία (ATC):

N02BE01

INN (Διεθνής Όνομα):

PARACETAMOL 500 mg

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

PARACETAMOL 500 mg

Τρόπος διάθεσης:

OTC

Θεραπευτική περιοχή:

ANALGESICS

Καθεστώς αδειοδότησης:

Withdrawn

Ημερομηνία της άδειας:

2007-06-04

Φύλλο οδηγιών χρήσης

Αρχείο Π.Χ.Π.

 
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SUMMARY OF PRODUCT CHARACTERISTICS 

1.  
NAME OF THE MEDICINAL PRODUCT  

Paracetamol Tablets BP 500mg, and  

Mandanol Paracetamol 500.  

Paracetamol 500mg Caplets.  

2.  
QUALITATIVE AND QUANTITATIVE COMPOSITION  

Each tablet contains: Paracetamol BP 500mg.  

3.  
PHARMACEUTICAL FORM  

Compressed tablet.  

4.  
CLINICAL PARTICULARS  

4.1  
Therapeutic indications: 

Paracetamol is a mild analgesic and antipyretic. It is indicated in
the treatment of most painful and 
febrile conditions, for example, headache, toothache, colds,
influenza, rheumatic pain, 
dysmenorrhoea, sore throat, migraine, muscular aches and pains and
neuralgia.  

4.2  
Posology and method of administration  

This preparation is intended for oral administration.  
_Adults and children over 12 years: _ 
One or two tablets to be taken three or four times daily as required.

_Children 6 to 12 years _ 
Half to one tablet to be taken three or four times daily as required.

_Elderly patients: _ 
As the adult dose - but see warnings.  
_Dosage warnings: _ 
Four hours must elapse between each dose and not more than 4 doses
should be taken in 24 hours.  

4.3  
Contraindications  

Hypersensitivity to paracetamol and/or other constituents.  

4.4  
Special warnings and precautions for use  

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 alcoholic liver disease.  
Do not exceed the recommended dose.  
Do not take with any other paracetamol-containing products  
If symptoms persist, consult your doctor.  
Keep out of the sight and reach of children.  
Immediate medical advice should be sought in the event of an
overdose, even  

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if you feel well, because of the risk of delayed, serious liver
damage.  

4.5 
Interactions with other medicinal products and other forms of
interact