Paramax 500mg/5mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Paracetamol; Metoclopramide hydrochloride

Available from:

Sanofi-Aventis Ireland Limited T/A SANOFI

ATC code:

N02BE; N02BE51

INN (International Name):

Paracetamol; Metoclopramide hydrochloride

Dosage:

500mg/5 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Anilides; paracetamol, combinations excl. psycholeptics

Authorization status:

Not marketed

Authorization date:

1995-09-11

Patient Information leaflet

768436
PACKAGE LEAFLET:
INFORMATION FOR THE USER
PARAMAX 500MG/5MG TABLETS
_Paracetamol _
_Metoclopramide_
IS THIS LEAFLET HARD TO SEE OR READ? PHONE [phone] FOR HELP
READ
ALL
OF
THIS
LEAFLET
CAREFULLY
BEFORE
YOU
START
TAKING
THIS MEDICINE
•
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. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours
•
If any of the side effects gets serious, or if you notice any side
effects
not listed in this leaflet, please tell your doctor or pharmacist
•
You must talk to a doctor if you do not feel better after 3 days or
if you start to feel worse
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 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).
Paramax contains two different medicines. These are called:
•
METOCLOPRAMIDE: this belongs to a group of medicines called
anti-emetics.
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.
Paramax is used to treat the signs of migraine, such as headache,
feeling
sick (nausea) or being sick (vomiting). Paramax should not be used for
more than 3 days.
You should talk to a doctor if you do not feel better after 3 days or
if you
start to feel worse.
Prolonged or frequent use of Paramax is not advised. 2. WHAT YOU NEED TO KNOW BEF

Summary of Product characteristics

Health Products Regulatory Authority
01 December 2019
CRN009FS3
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paramax 500mg/5mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500mg paracetamol and metoclopramide
hydrochloride equivalent to 5mg metoclopramide.
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Tablets
White, round tablets, engraved “Paramax” on one side with a
break-line on the other side.
The scoreline is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Adult population: Paramax is indicated in the management of the
symptoms of pain, nausea and vomiting associated with a
migraine attack.
4.2 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 four-hourly
intervals. Total dosage in any 24-hour period should not exceed the
quantity stated.
It should be noted that total daily dosage of metoclopramide, for
young adults (18-20 years), should not normally exceed
0.5mg/kg body weight.
Recommended Dosage:
Adults: Two tablets should be taken at the first warning of a migraine
attack. This dosage may be repeated to a maximum of 6
tablets in a 24 hour period.
The maximum daily dose should not exceed 60mg/kg/day of paracetamol
(up to a maximum of 4 tablets per day) in the
following situations, unless directed by a physician:
● Weight less than 50kg
● Chronic alcoholism
● Dehydration
● Chronic malnutrition
Elderly patients:
Experience has indicated that normal adult dosage is usually
appropriate. However in frail, immobile, elderly subjects or in
elderly patients with renal or hepatic impairment, a reduction in the
amount or frequency of dosing may be appropriate.
Young adults (18-20 years):
At the first warning of a migraine attack 1 to 2 tablets should be
taken. Do not exceed 5 tablets in a 24 hour period.
Hea