Paramax

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Metoclopramide hydrochloride monohydrate 5.3mg equivalent to 5 mg metoclopramide hydrochloride anhydrous;  ; Paracetamol 500mg (as 520mg paracetamol DC);  

Available from:

GlaxoSmithKline NZ Limited

INN (International Name):

Metoclopramide hydrochloride monohydrate 5.3 mg (= 5 mg metoclopramide hydrochloride anhydrous)

Pharmaceutical form:

Tablet

Composition:

Active: Metoclopramide hydrochloride monohydrate 5.3mg equivalent to 5 mg metoclopramide hydrochloride anhydrous   Paracetamol 500mg (as 520mg paracetamol DC)   Excipient: Colloidal silicon dioxide Gelatin as 520mg paracetamol DC Magnesium stearate Microcrystalline cellulose

Units in package:

Blister pack, 60 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Anonima Materie Sintetiche & Affini SpA (AMSA)

Product summary:

Package - Contents - Shelf Life: Blister pack, - 60 tablets - 36 months from date of manufacture stored at or below 25°C protect from light

Authorization date:

1983-08-23

Summary of Product characteristics

DATA SHEET

PARAMAX 
_PARACETAMOL/METOCLOPRAMIDE HYDROCHLORIDE _
PRESENTATION 
Round, biconvex, white tablets, 12.5mm in diameter with
"PARAMAX" debossed on one side 
and break-bar on the
other. Each tablet contains 500mg Paracetamol and 5.3mg  with 
Metoclopramide Hydrochloride (equivalent to 5mg Metoclopramide
hydrochloride 
anhydrous). 
CLINICAL PARTICULARS 
_THERAPEUTIC INDICATIONS _
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. 
_POSOLOGY AND METHOD OF ADMINISTRATION _
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. 
_CONTRAINDICATIONS _
Paramax is contraindicated in patients with
known  hypersensitivity to metoclopramide, 
paracetamol and any ingredients of PARAMAX. 
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. 
•  Phaeochromocytoma due to the possibility of a hypertensive
crisis, probably due to 
catecholamines from the tumour 
•  Patients in whom increased
gastro