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Round, biconvex, white tablets, 12.5mm in diameter with "PARAMAX" debossed on one side and breakbar on the other. Each tablet contains 500mg Paracetamol and 5.3mg with Metoclopramide Hydrochloride (equivalent to 5mg Metoclopramide hydrochloride anhydrous).
PARAMAX is indicated for the symptomatic treatment of migraine.
It is also indicated for the treatment of pain accompanied by gastric stasis or nausea and vomiting.
For oral administration only.
PARAMAX should be taken at the first warning of an attack. If symptoms persist, further doses may be taken at 4 hourly intervals. Total dosage in any 24 hour period should not exceed the quantity stated.
| Usual recommended dosage | Initial Dose at First Warning of Attack |
Maximum Dosage in any 24 Hour Period |
|---|---|---|
Adults (including elderly patients) |
2 |
6 |
| Young Adults (15-20 Years) - 60kg and over - 30-59kg |
2 1 |
5 3 |
| Adolescents (12-14 Years) - 30kg and over |
1 |
3 |
Children: A presentation of PARAMAX suitable for the treatment of children under
12 years of age is not available.
Note: Total daily dosage of metoclopramide should not exceed 0.5mg/kg bodyweight.
There are no absolute contraindications.
Following operations such as pyloroplasty or gut anastomosis therapy should be withheld for three or four days as vigorous muscular contractions may not help healing.
If vomiting persists the patient should be reassessed to exclude the possibility of an underlying disorder, e.g. cerebral irritation.
Care should be exercised in patients being treated with other centrally active medicines e.g. in epilepsy. Since extrapyramidal symptoms may occur with both PARAMAX and phenothiazines, care should be exercised in the event of both medicines being prescribed concurrently.
Metoclopramide may induce an acute hypersensitive response in patients with phaeochromocytoma.
The action of metoclopramide on the gastrointestinal tract is antagonized by anticholinergics.
The absorption of any concurrently administered oral medication may be modified by the effect of PARAMAX on gastric motility.
Adequate human data on use during pregnancy are not available. However, animal studies have not identified any risk to pregnancy or embryo-foetal development.
Adequate human data on use during lactation and adequate animal reproduction studies are not available.
None known.
Various extrapyramidal reactions to metoclopramide, usually of the dystonic type, have been reported. The incidence of these reactions may be increased if the metoclopramide dosage exceeds 0.5 mg/kg body weight per day. Reactions include: spasm of the facial muscles; trismus; rhythmic protrusion of the tongue; a bulbar type of speech spasm of extraocular muscles; including oculogyric crises; unnatural positioning of the head and shoulders and opisthotonos. There may be a generalized increase in muscle tone. The majority of reactions occur within 36 hours of starting treatment and the effects usually disappear within 24 hours of withdrawal of medicine. Should treatment of a reaction be required, a benzodiazepine, and anticholinergic or and antiparkinson agent may be used.
Rarely, drowsiness, restlessness, acute depression and diarrhea have been reported in patients receiving metoclopramide therapy. Anxiety or agitation may occur, especially after rapid injection.
Elevated serum prolactin levels and galactorrhoea may occur during metoclopramide therapy.
See Undesirable effects for treatment of extrapyramidal reactions.
As with other paracetamol-containing products, an overdose of can be toxic to the liver. Overdosage should be treated by gastric lavage with appropriate supportive measures. Intravenous N-acetylcysteine or oral methionine if administered within 10 hours of paracetamol overdosage appears to exert a protective effect on the liver.
Paracetamol relieves pain. More rapid absorption is promoted by the action of metoclopramide which also relieves gastric stasis and overcomes nausea and vomiting.
An acute attack of migraine is frequently characterised by impaired absorption of analgesics even when abdominal symptoms are absent. The beneficial effect of delayed gastric emptying, nausea and vomiting contrasts with the gastric stasis which may occur following administration of phenothiazine or antihistamine antiemetics.
Protect tablets from light.
36 months when stored below 25°C.
Prescription Medicine in packs of >10 tablets
Restricted Medicine in packs of ≤10 tablets.
Blister packs of 10 tablets (Restricted Medicine)
Blister packs of 60 tablets (Prescription Medicine)
GlaxoSmithKline (NZ) Ltd
Trading as GlaxoSmithKline Consumer Healthcare)
8th Floor, AMP Centre, cnr Customs & Alberts Sts
Auckland, New Zealand
Telephone: (09) 367 2970
2 June 1999
Updated: 16 January 2008