Paracetamol 500mg capsules

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Toimeaine:

Paracetamol

Saadav alates:

Bristol Laboratories 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: 5060013941504 5060013941511 5060013943911

Infovoldik

SAME SIZE ARTWORK
435 x 130 mm
Front
29mm
435 mm
130 mm
IXXXXXX
Package leaflet: Information for the user
PARACETAMOL 500MG CAPSULES
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 after three days.
What is in this leaflet
1.
What Paracetamol Capsules are and what they are used for
2.
What you need to know before you take Paracetamol Capsules
3.
How to take Paracetamol Capsules
4.
Possible side effects
5.
How to Store Paracetamol Capsules
6.
Contents of the pack and other information
1. What Paracetamol Capsules are and what they are used for
Paracetamol capsules 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.
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 Capsules
Do not take this medicine if you:
•
are allergic to paracetamol or any other ingredients of this medicine
(listed in section 6)
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine if you:
•
are suffering from liver problems including liver problems due to
excessive alcohol consumption
•
if you suffer from mild arthritis
•
have a severe infection as this may increase the risk of metabolic
acidosis. Signs of metabolic acidosis include
-
deep, rapid, difficult breathing
-
feeling sick(nausea), being sick (vomiting)

Toote omadused

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
PARACETAMOL 500mg CAPSULES
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500mg of paracetamol.
Excipients with known effect: Also contains Methyl parahydroxybenzoate
(E218) and Propyl parahydroxybenzoate (E216).
For the full list of excipients, see section6.1.
3
PHARMACEUTICAL FORM
HARD GELATIN CAPSULES
Red cap, white body, hard gelatin capsule, containing a white free
flowing
powder. _ _
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For relief of mild to moderate pain including headaches, migraine,
aches and
pains, symptomatic relief of rheumatic aches and pains and of
influenza,
muscular and back pain, neuralgia, toothache, sore throat and period
pain and
to relieve the symptoms of feverishness and colds and flu.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
Unless otherwise directed by a doctor
ADULTS, THE ELDERLY AND CHILDREN AGED 16 YEARS AND OVER:
2 capsules up to 4 times a day, as required.
Do not take more frequently than every 4 hours and not more than 8
capsules
in any 24 hour period.
CHILDREN AGED 12 TO 15 YEARS:
One capsule every 4 – 6 hours when necessary to a maximum of 4 doses
in 24
hours
Do not take more than 4 capsules in any 24 hour period
CHILDREN UNDER 12:
Not recommended for children under 12 years of age.
Method of administration:
For oral administration
Intake of paracetamol with food and drink does not affect the efficacy
of the
medicinal product.
_ _
4.3.
CONTRAINDICATIONS
Hypersensitivity to paracetamol or to any of the excipients listed in
section 6.1
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Prolonged or frequent use is discouraged. Patients should be advised
not to take other
Paracetamol containing products concurrently. Taking multiple daily
doses in one
administration can severely damage the liver; in such case
unconsciousness does not
occur. However, medical assistance should be sought immediately.
Prolonged use
except under medical supervision may be harmful. In adolescents
treated