Paramax sachets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Paracetamol; Metoclopramide hydrochloride

Available from:

Sanofi

ATC code:

N02BE51

INN (International Name):

Paracetamol; Metoclopramide hydrochloride

Dosage:

500mg ; 5mg

Pharmaceutical form:

Effervescent powder

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04070401; GTIN: 5026474000051

Patient Information leaflet

of the face, tongue, eyes, neck and affect speech,
expression and/or lead to unnatural positioning of
the head and shoulders
•
Decreased
level
of
consciousness,
confusion,
hallucination
•
Rigid
or
stiff
muscles,
trembling
or
shaking
or
difficulty moving
•
You bruise more easily than usual. This could be
because of a blood disorder (thrombocytopenia)
•
You
get
infections
more
often
and
easier
than
normal.
This
could
be
because
you
have
a
low
number of white blood cells (agranulocytosis)
•
Depression
TELL YOUR DOCTOR AS SOON AS POSSIBLE IF YOU HAVE ANY
OF THE FOLLOWING SIDE EFFECTS:
•
Diarrhoea
•
Dizziness, lightheadedness and fainting. This could
be because of low blood pressure
TELL YOUR DOCTOR OR PHARMACIST IF ANY OF THE FOLLOWING
SIDE EFFECTS GET SERIOUS OR LASTS LONGER THAN A FEW
DAYS:
•
Abnormal production of breast milk in men and
women
•
Breast enlargement in men
•
Loss of menstrual periods
•
Feeling nervous (anxious), restless or confused
•
Feeling drowsy
•
Lack or loss of strength (weakness)
•
Skin rash
REPORTING OF SIDE EFFECTS
If
you
get
any
side
effects,
talk
to
your
doctor
or
pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects
directly
via
the
Yellow
card
Scheme
at:
www.mhra.gov.uk/yellowcard. By reporting side effects,
you can help provide more information on the safety of
this medicine.
5. HOW TO STORE PARAMAX
Keep this medicine out of the sight and reach of children.
Do not use Paramax after the expiry date which is stated
on the sachet and carton after EXP. The expiry date refers
to the last day of that month.
Store below 25
°
C. Keep the sachets in the outer carton.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will
help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
WHAT PARAMAX CONTAINS
•
The
active
substances
are
metoclopramide
hydrochloride
and
paracetamol.
Each
sachet
con

Summary of Product characteristics

OBJECT 1
PARAMAX 500MG/5MG EFFERVESCENT POWDER
Summary of Product Characteristics Updated 10-Nov-2016 | Zentiva
1. Name of the medicinal product
Paramax 500 mg/5 mg Effervescent Powder
2. Qualitative and quantitative composition
Each sachet contains 500 mg paracetamol with 5 mg metoclopramide
hydrochloride (calculated with
reference to anhydrous substance).
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Effervescent powder
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 sachets)_
Initial dose at first warning of
attack
Maximum 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
Paramax sachets are emptied into about
1
/
4
of a glass of water and stirred before taking.
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 seizu