Paracetamol 500mg capsules

국가: 영국

언어: 영어

출처: MHRA (Medicines & Healthcare Products Regulatory Agency)

유효 성분:

Paracetamol

제공처:

Zentiva Pharma UK Ltd

ATC 코드:

N02BE01

INN (International Name):

Paracetamol

복용량:

500mg

약제 형태:

Oral capsule

관리 경로:

Oral

수업:

No Controlled Drug Status

처방전 유형:

Valid as a prescribable product

제품 요약:

BNF: 04070100; GTIN: 5000283607083 0000050283200 5000283653745

환자 정보 전단

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or your
pharmacist.
• 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 is and what it is used for
4.
Possible side effects
2. What you need to know before you take paracetamol
5.
How to store paracetamol
3. How to take paracetamol
6.
Contents of the pack and other information
FRONT
BACK
[554778] [1065033083]
ZEN-01180422-9TT-UK-EX
PARACETAMOL CAPSULES
-100'S PACK-
DO NOT TAKE PARACETAMOL AND TELL YOUR DOCTOR IF:
• You are allergic to the active substance or any of the other
ingredients in your medicine (listed in section 6)
Signs of an allergic reaction include a rash and breathing problems.
There can also be swelling of the legs, arms, face, throat or
tongue
CHILDREN
Paracetamol 500mg Capsules must not be given to children under 10
years of age
Do not take paracetamol if any of the above apply to you. If you are
not sure, talk to your doctor or pharmacist before taking paracetamol.
WARNINGS AND PRECAUTIONS
TAKE SPECIAL CARE AND CHECK WITH YOUR DOCTOR BEFORE TAKING PARACETAMOL
IF:
• You have severe kidney or liver problems
•
You have a liver problem caused by alcohol
If you are not sure if any of the above apply to you, talk to your
doctor or pharmacist before taking this medicine.
OTHER MEDICINES AND PARACETAMOL
Tell your doctor or pharmacist if you are taking or have recently
taken any other medicines. This includes medicines obtained without a
prescription, including herbal medicines. This is because paracetamol
can affect the way some other medicines work. Also, some other
medicines

제품 특성 요약

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Paracetamol 500mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 500mg of paracetamol
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Hard capsule.
Size 0 capsule marked ‘S174’ with blue cap and white body
containing a white
granular powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Paracetamol
capsules
are
recommended
for
the
treatment
of
headaches,
including migraine and tension headaches; also for backache, rheumatic
and
muscle pains, ‘nerve pains’, toothache, dysmenorrhoea, sore throat
and for
relieving the fever, aches and pains of colds and flu.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Adults, Elderly and Children over 16 years
Two capsules up to 4 times a day. Do not take for more than 3 days
without consulting
your doctor.
These doses should not be repeated more frequently than every 4 hours
and not more
than 4 doses should be given in any 24 hour period.
PAEDIATRIC POPULATION
Not recommended for children under 10 years of age
.
Children aged 10 to 15 years
One capsule every four to six hours when necessary to a maximum of
four
doses in 24 hours.
Do not take for more than 3 days without consulting your doctor.
METHOD OF ADMINISTRATION
For oral administration
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
PAEDIATRIC POPULATION
Not recommended for children under the age of 10 years.
Care is advised in the administration of paracetamol to patients with
severe renal or
severe hepatic impairment. The hazard of overdose is greater in those
with non-
cirrhotic alcoholic liver disease.
Do not exceed the recommended dose
Do not take with any other paracetamol-containing products.
If symptoms persist consult your doctor.
Keep out of the reach of children.
Caution is advised if paracetamol is administered concomitantly with
flucloxacillin
due to increased risk of