Paracetamol 500mg capsules

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Paracetamol

Commercializzato da:

Aspar Pharmaceuticals Ltd

Codice ATC:

N02BE01

INN (Nome Internazionale):

Paracetamol

Dosaggio:

500mg

Forma farmaceutica:

Oral capsule

Via di somministrazione:

Oral

Classe:

No Controlled Drug Status

Tipo di ricetta:

Valid as a prescribable product

Dettagli prodotto:

BNF: 04070100; GTIN: 5024071260045

Foglio illustrativo

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1. W
HAT
P
ARACETAMOL IS AND WHAT IT IS USED FOR
These capsules contain paracetamol and are used to relieve mild to
moderate pain
including headache, migraine and tension headache, toothache, back
ache, rheumatic
and muscle pains, period pains and sore throat. Paracetamol is also an
anti-pyretic used to
reduce fever, aches and pains of colds and flu. You must talk to a
doctor if you do not feel
better or if you feel worse after 3 days.
2. W
HAT YOU NEED TO KNOW BEFORE YOU TAKE
P
ARACETAMOL
500
MG
C
APSULES
DO NOT TAKE PARACETAMOL 500MG CAPSULES
•
if you are allergic 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 if you:
•
Suffer from liver or kidney problems
•
Suffer from alcohol dependency
•
Suffer from non-serious arthritis and need to take painkillers every
day
OTHER MEDICINES AND PARACETAMOL
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other
medicines:
•
Blood thinning medicines such as warfarin
•
Metoclopramide and Domperidone (for sickness and digestive disorders)
•
Colestyramine (to help control cholesterol levels)
•
Any other paracetamol containing products
PREGNANCY, BREAST-FEEDING AND FERTILITY
IF YOU ARE PREGNANT OR BREAST-FEEDING, THINK YOU MAY BE PREGNANT OR
ARE PLANNING TO HAVE
A BABY, ASK YOUR DOCTOR OF PHARMACIST FOR ADVICE BEFORE TAKING THIS
MEDICINE. If necessary,
Paracetamol 500mg tablets can be used during pregnancy. You should use
the lowest
possible dose that reduces your pain and/or your fever and use it for
the shortest time
possible. Contact your doctor/midwife if the pain and/or fever are not
reduced or if you need
to take the medicine more often.
3. H
OW TO TAKE
P
ARACETAMOL
500
MG
C
APSULES
Always take this medicine exactly as described in this leaflet or as
your doctor or
pharmacist has told you. Check with your doctor or pharmacist if you
are not sure.
DOSAGE IN ADULTS, THE ELDERLY AND CHILDREN 16 Y

Scheda tecnica

1.
NAME OF THE MEDICINAL PRODUCT
Paracetamol Capsules 500mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Excipients with known effect – each capsule contains: - Paracetamol
Ph.Eur. 500mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard gelatin capsules with a white body and red cap containing a white
powder.
4.1
THERAPEUTIC INDICATIONS
Paracetamol Capsules is a mild analgesic and antipyretic, and is
recommended for the
treatment of most painful and febrile conditions, for example,
headache 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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults and the elderly:
1-2 capsules up to 4 times a day.
Children 12-15 years: One capsule given three or four times daily as
required.
These doses should not be repeated more frequently than every 4-6
hours nor should more than 4
doses should be given in any 24 hour period.
Not recommended for children under 12 years of age. Children should
not be given
Paracetamol 500mg Capsules for more than 3 days without consulting a
doctor.
Method of administration
Oral administration only.
4.3
CONTRAINDICATIONS
Hypersensitivity to paracetamol or any of the other constituents.
4.
CLINICAL PARTICULARS
4.4
SPECIAL WARNINGS AND SPECIAL 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 take more medicine than the label tells you to. If you do not
get better, talk to your doctor..
Patients should be advised to consult their doctor if their headaches
become persistent.
Patients should be advised not to take other paracetamol-containing
products concurrently.
Patients should be advised to consult a doctor if they suffer from
non-serious arthritis and need to
take painkillers every day.
If symptoms persist consult your doctor.