PARACETAMOL

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

PARACETAMOL

Disponível em:

Accord Healthcare Limited

Código ATC:

N02BE01

DCI (Denominação Comum Internacional):

PARACETAMOL

Dosagem:

500 Milligram

Forma farmacêutica:

Tablets

Tipo de prescrição:

Product not subject to medical prescription

Área terapêutica:

paracetamol

Status de autorização:

Marketed

Data de autorização:

2015-07-10

Folheto informativo - Bula

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PARACETAMOL 500 MG TABLETS
paracetamol
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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BBBA1617
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 has 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 after 3 days.
WHAT IS IN THIS LEAFLET:
1 WHAT PARACETAMOL TABLETS ARE AND WHAT THEY ARE 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 ARE AND WHAT THEY ARE USED
FOR
Paracetamol Tablets contain the active substance paracetamol which
belongs to a group of medicines called analgesics (painkillers).
Paracetamol Tablets are 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 are
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 Gilbert’s
syndrome or
acute hepatitis).
• if you have a deficiency of a certain enzy

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paracetamol 500mg 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.
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.
-
Depending on the onset of symptoms (fever and pain) repeated
administration is allowed.
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