Paracetamol 500mg capsules

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Toimeaine:

Paracetamol

Saadav alates:

Focus Pharmaceuticals Ltd

ATC kood:

N02BE01

INN (Rahvusvaheline Nimetus):

Paracetamol

Annus:

500mg

Ravimvorm:

Oral capsule

Manustamisviis:

Oral

Klass:

No Controlled Drug Status

Retsepti tüüp:

Valid as a prescribable product

Toote kokkuvõte:

BNF: 04070100; GTIN: 5060064790953

Infovoldik

Please turn over
➥
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 or pharmacist 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.
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
This medicine contains
• paracetamol which is a pain reliever
(analgesic) and helps reduce your temperature
when you have a fever.
These capsules are for the relief of mild to moderate
pain including headache, migraine, toothache,
nerve pain, sore throat and period pains.
They are also for the symptomatic relief of sprains
and strains, rheumatic pains, sciatica, lumbago,
fibrositis, muscular aches and pains, joint swelling
and stiffness, flu, feverishness and feverish colds.
2. What you need to know before you take
Paracetamol 500mg Capsules
Do not take this medicine if you
• are allergic to paracetamol or any of the other
ingredients.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Paracetamol 500mg Capsules, if you
• are breastfeeding
• suffer from kidney or liver problems, including
alcoholic liver disease
• are alcohol dependent.
Pregnancy and breast-feeding
If necessary, Paracetamol 500mg Capsules can
be used during pregnancy. You should use the
lowest possible dose that reduces your pain
and/or your fever and u

Toote omadused

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