Paracetamol 500mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Paracetamol

Available from:

Waymade Healthcare Plc

ATC code:

N02BE01

INN (International Name):

Paracetamol

Dosage:

500mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04070100

Patient Information leaflet

CHANGE CONTROL : Version changes due to change in:
Size/Layout Regulatory Non-Regulatory
Changes in detail:
• New regulatory text
PACKAGE LEAFLET: INFORMATION FOR THE USER
PARACETAMOL 500MG CAPSULES
Paracetamol
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
This medicine is available without prescription. Always take this
medicine exactly
as described in this leaflet or as your doctor or pharmacist or nurse
has told you.
−
Keep this leaflet. You may need to read it again.
−
Ask your pharmacist if you need more information or advice.
−
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.
−
You must talk to a doctor if you do not feel better or if you feel
worse after
3 days.
WHAT IS IN THIS LEAFLET
1. What Paracetamol 500mg Capsules are and what they are used for
2. What you need to know before you take Paracetamol 500mg Capsules
3. How to take Paracetamol 500mg Capsules
4. Possible side effects
5. How to store Paracetamol 500mg Capsules
6. Contents of the pack and other information
1. WHAT PARACETAMOL 500MG CAPSULES ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Paracetamol 500mg Capsules. These
capsules
contain paracetamol (a painkiller).
Paracetamol 500mg Capsules are used to relieve mild
to moderate pain including, toothache, period pains,
pains associated with the joints and muscles and to
reduce fever and other symptoms found in colds and flu.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
PARACETAMOL 500MG CAPSULES
DO NOT TAKE PARACETAMOL 500MG CAPSULES IF YOU:
•
are allergic (hypersensitive) to paracetamol, or any of
the other ingredients of this medicine (listed in
section 6)
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR OR PHARMACIST BEFORE TAKING PARACETAMOL 500MG
CAPSULES IF YOU:
•
suffer from kidney disease
•
suffer from liver disease, particularly if caused by alcohol
•
suffer from alcoholism
•
su

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Paracetamol Capsules
Paracetamol 500 mg Capsules.
Spar Paracetamol 500 mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
INGREDIENT
QTY
UNIT
DOSE
Paracetamol
500
mg
capsule
3
PHARMACEUTICAL FORM
Capsule
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of mild to moderate pain including headache,
migraine,
neuralgia, toothache, sore throat, period pains, symptomatic relief of
sprains,
strains, rheumatic pain, sciatica, lumbago, fibrositis, muscular aches
and pains,
joint swelling and stiffness, influenza, feverishness and feverish
colds.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: Oral.
For all indication:
Adults, the elderly and children over 16 years of age:
2 capsules every 4 – 6 hours when necessary to a maximum of 4 doses
in 24
hours. Maximum daily dose is 4g in divided doses.
Children from 12 to 15 years:
1 capsule every 4-6 hours when necessary to a maximum of 4 doses in 24
hours.
Not recommended for children under 12 years of age.
The dose should not be repeated more frequently than every 4 hours.
Dosage
should not be continued for longer than 3 days without consulting a
doctor.
4.3
CONTRAINDICATIONS
Hypersensitivity to paracetamol and/or other constituents.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
–
If symptoms persist consult your doctor
–
Do not take more medicine than the label tells you to.
–
Keep this medicine out of the sight and reach of children.
–
Do not take anything else containing paracetamol while taking this
medicine.
–
TALK TO A DOCTOR AT ONCE IF YOU TAKE TOO MUCH OF THIS MEDICINE EVEN IF
YOU FEEL
WELL. THIS IS BECAUSE TOO MUCH PARACETAMOL CAN CAUSE DELAYED, SERIOUS
LIVER
DAMAGE.
–
Care is advised in the administration of paracetamol to patients with
severe renal
or severe hepatic impairment. The hazards of overdose are greater in
those with
(non-cirrhotic) alcoholic liver disease.
–
Care is advised in the administration of paracetamol to patients who
are al