Paracetamol 500mg tablets

Ülke: Birleşik Krallık

Dil: İngilizce

Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktif bileşen:

Paracetamol

Mevcut itibaren:

Medley Pharma Ltd

ATC kodu:

N02BE01

INN (International Adı):

Paracetamol

Doz:

500mg

Farmasötik formu:

Oral tablet

Uygulama yolu:

Oral

Sınıf:

No Controlled Drug Status

Reçete türü:

Valid as a prescribable product

Ürün özeti:

BNF: 04070100; GTIN: 5060545240496

Bilgilendirme broşürü

07-322/06
PARACETAMOL 500MG TABLETS BP
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 or
nurse have 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 or
nurse. 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.
WHAT IS IN THIS LEAFLET:
1.
What
Paracetamol
is and what
it
is used for
2.
What
you need to know before you take Paracetamol
3.
How to take Paracetamol
4 .
P os s i b l e s i d e e f f ec t s
5.
How to store Paracetamol
6.
Contents of
the pack and other information
1.
WHAT PARACETAMOL IS AND WHAT IT IS USED FOR
The name of your medicine is Paracetamol 500mg Tablets (called
Paracetamol throughout this
leaflet). It belongs to a group of medicines called painkillers
(analgesics).
IT IS USED FOR:
Mild to moderate pain including headache, neuralgia, toothache and
pain caused by
rheumatism
Relief of symptoms from colds and flu
Lowering high temperature (fever).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARACETAMOL
DO NOT TAKE PARACETAMOL IF:
You are allergic (hypersensitive) to Paracetamol or any of the other
ingredients in
your medicine (listed in Section 6)
You are taking anything else with paracetamol in it.
If you are not sure, talk to your doctor or pharmacist before taking
Paracetamol.
WARNINGS AND PRECAUTIONS:
Talk to your doctor or pharmacist or nurse before taking Paracetamol
if:
You have severe kidney or liver problems
You have liver disease due to a dependence on alcohol
OTHER MEDICINES AND PARACETAMOL
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other
medicines. This includes medicines obtained without a prescription,
including herbal medic

Ürün özellikleri

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Paracetamol Tablets B.P. 500mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Paracetamol 500mg
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablet
White capsule shaped tablet debossed “PARA 500” with a break line
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Analgesic and antipyretic, mild to moderate pain including headache,
tooth-ache,
rheumatic pains, period pains, colds and influenza symptoms
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS, THE ELDERLY AND CHILDREN 15 YEARS AND OVER:
One or two tablets to be taken every four to six hours when necessary
to a maximum
of four doses in 24 hours.
Maximum dose of 8 tablets in 24 hours
PAEDIATRIC POPULATION
CHILDREN FROM 10 TO 15 YEARS OF AGE
The recommended dose is 1 tablet up to four times a day as required
CHILDREN UNDER 10 YEARS OF AGE
Not recommended for children under 10 years of age
.
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
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 alcohol disease.
Do not take more medicine than the label tells you to. If you do not
get better,
talk to your doctor.
Contains Paracetamol.
Do not take anything else containing paracetamol while taking this
medicine
Talk to your 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.
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 absorption of paracetamol is reduced by
cholestyramine. Theref