Anagraine

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

Paracetamol; Metoclopramide hydrochloride anhydrous

Preparatomtale

ANAGRAINE –Marketed Product Information                 

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PRODUCT INFORMATION 

ANAGRAINE 

COMPOSITION 

Each ANAGRAINE tablet contains 5 mg metoclopramide and 500 mg
paracetamol. 

ACTIONS 

Metoclopramide stimulates gastrointestinal tract motility and
accelerates gastric 
emptying and intestinal transit and has been shown to increase the
speed of 
absorption of paracetamol.  Metoclopramide also possesses dopamine
antagonist 
activity.  It is useful in the symptomatic relief of nausea and
vomiting. 

Paracetamol is an analgesic useful in the relief of pain associated
with migraine. 

INDICATIONS 

For the symptomatic relief of headache, nausea and vomiting
associated with 
migraine. 

CONTRAINDICATIONS 

Hypersensitivity to paracetamol or metoclopramide,
phaeochromocytoma and in 
cases wherever stimulation of the gastrointestinal tract may be
dangerous, eg. in the 
presence of gastrointestinal haemorrhage, mechanical obstruction or
perforation.  

Insufficient safety data exists to support the use of ANAGRAINE 
(metoclopramide/paracetamol combination) in pregnancy or during
lactation (see 
PRECAUTIONS). 

Children under 12 years of age (see PRECAUTIONS). 

PRECAUTIONS 

METOCLOPRAMIDE 

Dystonic reactions occur in approximately 1% of patients given
metoclopramide.  
These occur more frequently in children and young adults and may
occur after a 
single dose.

Tardive dyskinesia may occur in some patients following long term
therapy or may 
appear after drug therapy has been discontinued.  The risk appears
to be greater in 
elderly patients on high dose therapy, especially females.  The
symptoms are 
persistent and in some patients appear to be irreversible.  The
syndrome is 
characterized by rhythmical involuntary movement of the tongue, face,
mouth or jaw 
(eg. protrusion of tongue, puff