Paracetamol 500mg tablets

Land: Malta

Språk: engelsk

Kilde: Medicines Authority

Aktiv ingrediens:

PARACETAMOL

Tilgjengelig fra:

Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland

ATC-kode:

N02BE01

INN (International Name):

PARACETAMOL 500 mg

Legemiddelform:

TABLET

Sammensetning:

PARACETAMOL 500 mg

Resept typen:

POM

Terapeutisk område:

ANALGESICS

Autorisasjon status:

Withdrawn

Autorisasjon dato:

2016-02-22

Informasjon til brukeren

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PARACETAMOL 500 MG TABLETS
PARACETAMOL
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 pharmacist or
nurse.
•
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 tablets is and what is it used for
2.
What you need to know before you take Paracetamol tablets
3.
How to take Paracetamol tablets
4.
Possible side effects
5.
How to store Paracetamol tablets
6.
Contents of the pack and other information
1.
WHAT PARACETAMOL TABLETS IS AND WHAT IT IS USED FOR
Paracetamol tablets contains active substance paracetamol which
belongs to a group of medicines
called analgesics (painkillers).
Paracetamol tablets is used to relieve pain and help reduce fever. The
tablets can treat mild to
moderate pain and/or fever.
Paracetamol tablets may be used in adults and adolescents but is not
suitable for use in children
below 6 years.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARACETAMOL TABLETS
DO NOT TAKE PARACETAMOL TABLETS:
-
If you are allergic to paracetamol or any of the other ingredients of
this medicine (listed in
section 6).
-
If you are below 6 years of age.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist or nurse before taking Paracetamol
tablets
-
if you are taking other paracetamol containing medicines, as it may
severely damage the liver.
-
if you have kidney or liver disease (including Glibert’s syndrome or
acute hepatitis)
-
if you have a deficiency of a certain enzyme called
glucose-6-phosphatase
-
if you have haemolytic anaemia (abnormal breakdown of red blood
cells).
-
if you

Preparatomtale

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1
NAME OF THE MEDICINAL PRODUCT
Paracetamol 500 mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Paracetamol 500.0 mg.
Excipients(s):
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
White, uncoated capsule shape tablet marked with “B score T” on
one side and plain on the other
side.
NOTE:
Length, width and thickness of the tablet is 16.50±0.20 mm,
8.20±0.20 mm and 5.10±0.30
mm respectively.
The tablet can be divided into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic treatment of mild to moderate pain and/or fever.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
For oral use only.
Adults and adolescents 15 years (> 55 kg body weight)
1 to 2 tablets (500-1000 mg) at a time, up to 6 tablets (3000 mg) per
24 hours.
Children and young people up to 15 years
6-9 years: ½ tablet at a time, up to 4-6 times per 24 hours
9-12 years: 1 tablet at a time, up to 3-4 times in 24 hours
12-15 years: 1 tablet at time, up to 4-6 times per 24 hours
Direction for use:
-
Paracetamol tablet is not suitable for children below 6 years.
-
The dosing interval should be at least 4 hours.
-
Do not use in combination with other paracetamol-containing products.
-
The indicated dose should not be exceeded due to risk of serious
damage to the liver (see
section 4.4 and 4.9).
-
The lower frequency of administration is intended for children in the
lower limit of the
relevant age group.
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-
Depending on the onset of symptoms (fever and pain) repeated
administration is allowed.
-
If pain for more than 5 days or fever for more than 3 days exists or
get worse, or if any other
symptom occur, treatment should be discontinued and a physician should
be consulted.
-
The ingestion of paracetamol with food and drink does not affect the
efficacy of the
medicinal product.
-
In case of renal insufficiency (renal failure), the dose should be
reduced:
Glomerular filtration rate
Dose
10 – 50 ml/min
500 mg every 6 hours
< 10 ml/min
500 mg every 8