Paracetamol 500mg tablets

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Paracetamol

Commercializzato da:

Bell,Sons & Co (Druggists) Ltd

Codice ATC:

N02BE01

INN (Nome Internazionale):

Paracetamol

Dosaggio:

500mg

Forma farmaceutica:

Oral tablet

Via di somministrazione:

Oral

Classe:

No Controlled Drug Status

Tipo di ricetta:

Valid as a prescribable product

Dettagli prodotto:

BNF: 04070100; GTIN: 5017848251872

Foglio illustrativo

PL 16028/0053 – LABEL/LEAFLET/GENERIC TEXT – GALPHARM LIVERY.
LABEL
PARACETAMOL 500MG TABLETS
Effective Pain Relief
16 Tablets
Please read the attached leaflet carefully before use.
Keep out of the reach and sight of children.
For dosage instructions please see attached leaflet.
_ _
_Batch No: _
_Exp. Date: _
Each tablet contains 500mg Paracetamol.
Also contains E223.
Galpharm Healthcare Ltd.,
South Yorkshire, EX33 2DL
PL 16028/0053
GSL
Barcode
LEAFLET
PATIENT INFORMATION
PATIENT INF ORMATION
READ THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION
FOR YOU.
• Ask your pharmacist if you need more information or advice.
• You must contact a doctor if your symptoms worsen or do not
improve after 3 days.
1. WHAT THIS MEDICINE IS FOR
Paracetamol relieves pain and brings down high temperatures (reduces
fever).
Paracetamol 500mg Tablets are used for relief of:
• mild to moderate pain including headache, migraine, nerve pain
(neuralgia), toothache,
sore throat and period pains.
• symptoms of rheumatic and muscular aches and pains, sciatica, back
pain (lumbago), joint
swelling and stiffness.
• symptoms of colds and flu.
2. BEFORE YOU TAKE THE MEDICINE
DO NOT TAKE PARACETAMOL 500MG TABLETS:
• if you are allergic to paracetamol, sodium metabisulphite or any
of the other ingredients listed in
section 6.
DO NOT TAKE ANYTHING ELSE CONTAINING PARACETAMOL WHILE TAKING THIS
MEDICINE.
TALK TO YOUR PHARMACIST OR DOCTOR BEFORE TAKING IF:
• you suffer from severe liver or kidney disease, including
alcoholic liver disease
IF YOU ARE TAKING OTHER MEDICINES:
Talk to your pharmacist or doctor before taking the tablets if you are
taking any of the following:
• medicines for nausea or sickness, such as metoclopramide or
domperidone.
• colestyramine for high cholesterol or high blood fats
• warfarin (or other medicines used to thin the blood and reduce the
risk of clotting). The risk of
bleeding may be increased if you take
paracetamol daily over a long period of time. However you can
take occasional dos

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Paracetamol 500mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500.00 mg of Paracetamol BP
3
PHARMACEUTICAL FORM
Tablet
White, capsule-shaped tablets, plain on one side and with a breakline
on the
other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Paracetamol is indicated for the relief of headaches, migraine,
neuralgia,
rheumatic aches and pains.
For the relief of colds and influenza.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS, THE ELDERLY AND CHILDREN 16 YEARS AND OVER: Take one or two
tablets
up to 4 times a day.
CHILDREN 10 TO 15 YEARS OF AGE: Take one tablet up to 4 times a day.
NOT RECOMMENDED FOR CHILDREN UNDER 10 YEARS OF AGE
The dose should not be repeated more frequently than every 4 hours and
not
more than 4 doses should be taken in any 24 hour period.
Route of administration: Oral
4.3
CONTRAINDICATIONS
Hypersensitivity to paracetamol and/or other constituents.
_4.4 _
_SPECIAL WARNINGS AND PRECAUTIONS FOR USE _
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
noncirrhotic alcoholic liver disease.
Do not exceed the recommended dose.
If symptoms persist consult your doctor.
Keep out of the reach and sight of children.
Immediate medical advice should be sought in the event of an overdose
even if you
feel well, because of the risk of delayed serious liver damage.
Do not take with any other paracetamol-containing products.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Cholestyramine: The speed of absorption of paracetamol is reduced by
cholestyramine. Therefore, the cholestyramine should not be taken
within one
hour if maximal analgesia is required.
Metoclopramide and Domperidone: The absorption of paracetamol is
increased by metoclopramide and domperidone. However, concurrent use
need
not be avoided.
Warfarin: The anticoagulant effect of warfarin and oth