PARACETAMOL

Страна: Ірландія

мова: англійська

Джерело: HPRA (Health Products Regulatory Authority)

Активний інгредієнт:

PARACETAMOL

Доступна з:

Actavis Group PTC ehf

Код атс:

N02BE01

ІПН (Міжнародна Ім'я):

PARACETAMOL

Дозування:

500 Milligram

Фармацевтична форма:

Film Coated Tablet

Тип рецепту:

Product not subject to medical prescription

Терапевтична области:

paracetamol

Статус Авторизація:

Marketed

Дата Авторизація:

2011-06-29

інформаційний буклет

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PARACETAMOL 500 MG FILM-COATED
TABLETS
Paracetamol
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 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 effect, talk to your doctor or
pharmacist. 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 IS AND WHAT IT IS USED
FOR
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
PARACETAMOL
3
HOW TO TAKE PARACETAMOL
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE PARACETAMOL
6
CONTENTS OF THE PACK AND OTHER
INFORMATION
1
WHAT PARACETAMOL IS AND WHAT IT IS USED
FOR
Paracetamol contains paracetamol which belongs to
a group of medicines called analgesics (painkillers).
Paracetamol is used to relieve mild to moderate pain and
reduce fever.
Paracetamol can be used for the relief of headache,
toothache, period pains, muscle pain and fever in
connection with common cold.
PARACETAMOL “CONTAINS PARACETAMOL”
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
PARACETAMOL
DO NOT TAKE PARACETAMOL
•
if you are allergic to paracetamol or any of the other
ingredients of this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Paracetamol should not be used in combination with
alcohol, as it may severely damage your liver. The effect
of alcohol will not be enhanced by the addition of
paracetamol.
Talk to your doctor before taking Paracetamol:
•
if you have kidney or liver disease (including Gilbert’s
syndrome or hepatitis);
•
if you regularly consume large amount of alcohol. You
may need lower doses and to limit the use for a short
period of time, otherwise your li

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paracetamol 500 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 500 mg paracetamol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule-shaped, white film-coated tablet, with break-line on one side.
The tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Symptomatic treatment of mild to moderate pain and/or fever.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Paracetamol 500 mg film-coated tablets are not intended for children
weighing less than 26 kg.
_POSOLOGY_
_Adults and adolescents (weighing more than 50 kg)_
The usual dose is 500 mg to 1,000 mg every 4 to 6 hours as needed, to
a maximum of 3 g daily. Maximum single dose
is 1,000 mg.
Maximal daily dose should not be exceeded due to risk of serious
hepatic damage (see sections 4.4 and 4.9).
_Paediatric population (weighing 20–50 kg)_
The recommended total daily dose of paracetamol is approximately 60
mg/kg divided in 4 or 6 separate doses, or
approximately 15 mg/kg every 6 hours or 10 mg/kg every 4 hours.
Maximal daily dose should not be exceeded due to
risk of serious hepatic damage (see sections 4.4 and 4.9).
Paediatric dosage should be based on body weight and suitable dosage
form used. Information on the age of children
within each weight group given below is for guidance only.
Regular administration minimizes pain and fever oscillation. In
children administration should be regular, including
night times, preferably at 6 hours intervals, otherwise at intervals
of minimum 4 hours.
_Children and adolescents weighing 43_
-
_50 kg (about 12_
-
_15 years)_
The usual dose is 500 mg every 4 hours as needed, to a maximum of 2.5
g daily.
_Children weighing 34_
-
_43 kg (about 11_
-
_12 years)_
The usual dose is 500 mg every 6 hours as needed, to a maximum of 2 g
daily.
_Children weighing 26_
-
_34 kg (about 8_
-
_11 years)_
The usual dose is 250 mg every 4 hours or 500 mg every 6 hou