Paracetamol 500mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Paracetamol

Available from:

Medreich Plc

ATC code:

N02BE01

INN (International Name):

Paracetamol

Dosage:

500mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04070100; GTIN: 05060292740324 05060292740331 05060292740348

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
PARACETAMOL 500 MG TABLETS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Always take this medicine exactly as described in this
leaflet or as your doctor, pharmacist, or nurse has told
you.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor,
pharmacist or nurse.
•
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. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Paracetamol 500 mg Tablets are and what
they are used for
2. Before you take Paracetamol 500 mg Tablets
3. How to take Paracetamol 500 mg Tablets
4. Possible side effects
5. How to store Paracetamol 500 mg Tablets
6. Further information
1. WHAT PARACETAMOL 500 MG TABLETS ARE AND
WHAT THEY ARE USED FOR
Paracetamol 500mg Tablets are used for the relief of
headache,
tension
headache,
migraine,
backache,
rheumatic and muscle pain, toothache and period
pain.
They also relieve sore throat and the fever, aches and
pains of colds and flu and are recommended for the
relief of pain due to mild arthritis.
The
active
ingredient
is
paracetamol
which
is
a
painkiller and also reduces your temperature when you
have a fever.
2.
WHAT
YOU
NEED
TO
KNOW
BEFORE
YOU
TAKE
PARACETAMOL 500 MG TABLETS
DO NOT TAKE PARACETAMOL 500 MG TABLETS:
•
If you are allergic (hypersensitive) to paracetamol
or to any of the other ingredients listed in section 6
•
If you are taking other paracetamol containing
products
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before taking
Paracetamol 500mg Tablets if:
•
You have liver or kidney disease, including non-cirrhotic
alcoholic liver disease
•
You are on a sodium controlled diet
The other ingredients are: magnesium s

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Paracetamol 500mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Paracetamol 500.0 mg
This medicinal product contains 0.007 mmol of sodium per dose. To be
taken into consideration by patients on a controlled sodium diet.
For excipients, see 6.1.
3
PHARMACEUTICAL FORM
Tablets
White capsule shaped tablets marked with ‘PARA 500’ on one side
and M+
on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Paracetamol 500mg Tablets is a mild analgesic and antipyretic, and is
recommended for the treatment of most painful and febrile conditions,
for
example headaches, including migraine and tension headaches,
toothache,
backache, rheumatic and muscle pains, dysmenorrhoea, sore throat and
for
relieving the fever, aches and pains of colds and flu. Also
recommended for
the symptomatic relief of pain due to non-serious arthritis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults
Two tablets every 4 hours to a maximum of 8 tablets in 24 hours.
Children
Optimised Paracetamol Dosing for Paediatric Patients:
AGE
500MG TABLET DOSE
HOW OFTEN
10-15 years
One
Every 4-6 hours when necessary to a
maximum of 4 doses in 24 hours
NOT RECOMMENDED FOR CHILDREN UNDER 10 YEARS OF AGE
The dose should not be repeated more frequently than every 4 hours and
not
more than 4 doses should be taken in any 24 hour period.
Children should not be given Paracetamol 500mg Tablets for more than 3
days
without consulting a doctor.
Oral administration only.
4.3
CONTRAINDICATIONS
Hypersensitivity to paracetamol or any of the other constituents.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Care is advised in the administration of paracetamol to patients with
renal or
hepatic impairment. The hazard of overdose is greater in those with
non-
cirrhotic alcoholic liver disease.
Do not exceed the stated dose.
Patients should be advised to consult their doctor if their headaches
become
persistent.
Patients should be advised not to take other paracetamol-contai