Paramax tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Metoclopramide hydrochloride; Paracetamol

Available from:

CST Pharma Ltd

ATC code:

N02BE51

INN (International Name):

Metoclopramide hydrochloride; Paracetamol

Dosage:

5mg ; 500mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04070401; GTIN: 5055946802626

Patient Information leaflet

PARAMAX
® 500MG/5MG TABLETS
(paracetamol, metoclopramide hydrochloride)
PATIENT INFORMATION LEAFLET
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
- Keep this leaflet. You may need to read it again
- If you have any further questions, ask your doctor or pharmacist
- This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same
as
yours
- If you get any side effects talk to your doctor or pharmacist. This
includes
any possible side effects not listed in this leaflet
WHAT IS IN THIS LEAFLET:
1. What Paramax is and what it is used for
2. What you need to know before you take Paramax
3. How to take Paramax
4. Possible side effects
5. How to store Paramax
6. Contents of the pack and other information
This medicine is available using above name but will be referred to as
Paramax throughout the leaflet.
1. WHAT PARAMAX IS AND WHAT IT IS USED FOR
The name of your medicine is Paramax 500mg/5mg Tablets (called
Paramax in this leaflet).
WHAT PARAMAX CONTAINS
Paramax contains two different medicines. These are called:
- METOCLOPRAMIDE HYDROCHLORIDE: this belongs to a group of medicines
called antiemetics. It works on muscles in the upper part of the
digestive
system causing your stomach to empty. It also works on a part of your
brain that prevents you from feeling sick (nausea) or being sick
(vomiting)
- PARACETAMOL: this belongs to a group of medicines called painkillers
(analgesics). It works by stopping substances that naturally occur in
your
body called prostaglandins from being made. Prostaglandins cause pain.
If they are blocked, pain is relieved
WHAT PARAMAX IS USED FOR
Paramax is used to treat the signs of migraine, such as headache,
feeling
sick (nausea) or being sick (vomiting) in adults 18 years and over.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARAMAX
DO NOT TAKE THIS MEDICINE AND TELL YOUR DOCTOR IF:
- You are allergic to the active substances or any of the o

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Paramax 500mg/5mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
tablet
contains
500mg
paracetamol
with
5mg
metoclopramide
hydrochloride (calculated with reference to anhydrous substance).
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablets
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Adult population
Paramax is indicated for the symptomatic treatment of migraine
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Paramax should be taken at the first warning of an attack. If symptoms
persist,
further doses may be taken at four-hourly intervals. Total dosage in
any 24-
hour period should not exceed the quantity stated.
The dosage recommendations given below should be strictly adhered to
if side-
effects of the dystonic type are to be avoided.
USUAL RECOMMENDED DOSAGE (NUMBER OF TABLETS)
Initial dose at first
Maximum
warning of attack
dosage
in
any
24-hour period
Adults (including elderly patients)
2
6
Treatment should not exceed 3 months due to the presence of
metoclopramide
(see also sections 4.4 and 4.8).
Paediatric population including adolescents
Use in children less than 1 year of age is contra-indicated due to
increased risk
of extrapyramidal disorders (see section 4.4).
Use in children and adolescents between the ages of 1 and 18 years is
not recommended.
METHOD OF ADMINISTRATION
For oral administration only.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substances or to any of the excipients
listed in
section 6.1.
Gastrointestinal haemorrhage, obstruction or perforation, since
stimulation of
gastrointestinal motility constitutes a risk in these situations.
History of neuroleptic or metoclopramide-induced tardive dyskinesia.
Confirmed epilepsy, since the frequency and severity of seizures may
be
increased.
Confirmed
or
suspected
phaeochromocytoma,
because
of
the
risk
of
hypertensive crisis.
Combination with levodopa because of a mutual antagonism.
Metoclopramide should be not be used in the imm