Paracetamol 500mg tablets

Šalis: Didžioji Britanija

kalba: anglų

Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)

Veiklioji medžiaga:

Paracetamol

Prieinama:

Alliance Healthcare (Distribution) Ltd

ATC kodas:

N02BE01

INN (Tarptautinis Pavadinimas):

Paracetamol

Dozė:

500mg

Vaisto forma:

Oral tablet

Vartojimo būdas:

Oral

Klasė:

No Controlled Drug Status

Recepto tipas:

Valid as a prescribable product

Produkto santrauka:

BNF: 04070100

Pakuotės lapelis

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

Prekės savybės

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 and the elderly: Take one or two tablets
Children:
6-8 years: Take half a tablet
8-10 years: Take half to three quarters tablet
10-12 years: Take one tablet
12-15 years: Take one to one & half tablet
Not recommended for children under 6 years of age.
The does should only be taken every 4-6 hours when necessary to a
maximum of 4 doses in 24
hours.
Route of administration: Oral
4.3
CONTRAINDICATIONS
Hypersensitivity to paracetamol and/or other constituents.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Special warnings and precautions for use
Not recommended for children under 10 years of age.
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.
Do not take more medicine than the label tells you to. If you do not
get better,
talk to your doctor.
Keep out of the sight and reach of children.
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.
Do not take anything else containing paracetamol while taking this
medicine.
Patients should be advised that paracetamol may cause severe skin
reactions. If a skin
reaction such as skin reddening, blisters, or rash occurs, they should
stop use and seek
medical assistance right away.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Cholestyramine: The speed of abs