Paracetamol 500 mg Effervescent Tablets

Страна: Ірландія

мова: англійська

Джерело: HPRA (Health Products Regulatory Authority)

Активний інгредієнт:

Paracetamol

Доступна з:

Accord Healthcare Limited

Код атс:

N02BE; N02BE01

ІПН (Міжнародна Ім'я):

Paracetamol

Дозування:

500 milligram(s)

Фармацевтична форма:

Effervescent tablet

Тип рецепту:

Product subject to prescription which may be renewed (B)

Терапевтична области:

Anilides; paracetamol

Статус Авторизація:

Marketed

Дата Авторизація:

2010-03-05

інформаційний буклет

PACKAGE LEAFLET: INFORMATION FOR THE USER
PARACETAMOL 500 MG EFFERVESCENT 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, 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, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Paracetamol Effervescent Tablets is and what it is used for
2. What you need to know before you take Paracetamol Effervescent
Tablets
3. How to take Paracetamol Effervescent Tablets
4. Possible side effects
5. How to store Paracetamol Effervescent Tablets
6. Contents of the pack and other information
1. WHAT PARACETAMOL EFFERVESCENT TABLETS IS AND WHAT IT IS USED FOR
Paracetamol Effervescent Tablets contain Paracetamol, which is a mild
pain killer and reduces the
body temperature in fever. The tablets are recommended for use in
treatment of mild to moderate pain
and/or fever.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARACETAMOL EFFERVESCENT
TABLETS
DO NOT TAKE PARACETAMOL EFFERVESCENT TABLETS

If you are allergic to Paracetamol, or any of the ingredients of this
medicine (listed in section 6)..
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Paracetamol
Effervescent Tablets if you:

Are suffering from liver problems including liver problems due to
excessive alcohol consumption.

Gilbert’s syndrome (mild jaundice)

Are suffering from kidney problems

Are suffering from dehydration and chronic malnutrition

Are on long-term treatment with higher doses of Paracetamol.

Are asthmatics sensitive to Aspirin.

Are on other Paracetamol containing drugs

Have fever even after Paracetamol t

Характеристики продукта

Health Products Regulatory Authority
03 December 2018
CRN008LD1
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paracetamol 500 mg Effervescent Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each effervescent tablet contains 500 mg of Paracetamol.
Excipients with known effect:
Sodium content approximately 418.5 mg/tablet. Also contains sorbitol
(E420) 100 mg
/tablet.
For the full list of excipients see section 6.1
3 PHARMACEUTICAL FORM
Effervescent Tablet
White to off white round, flat, beveled edged plain on both side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of mild to moderate pain and/or fever.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
This presentation is reserved for use only in adults and in
adolescents aged 12 years
and above.
Doses depend on body weight and age; a single dose ranges from 10 to
15 mg/kg
body weight (= b.w.) to a maximum of 60 mg/kg b.w. for total daily
dose.
Pediatric Patients:

Children below 12 years of age: Paracetamol effervescent Tablet is not
recommended in children aged less than 12 years.

Adolescents of 12 to 15 years and weighing 41 to 50 kg the posology is
one
tablet
per
dose,
repeated
if
necessary
4-6
hours
later,
without
exceeding 4 tablets daily.
Health Products Regulatory Authority
03 December 2018
CRN008LD1
Page 2 of 12

Adolescents of 16 to 18 years and weighing more than 50 kg: as adults.
Adults:
The usual adults dose is one to two tablets of 500mg, repeated if
necessary 4 hours
later, without exceeding 3g of Paracetamol a day (i.e. 6 tablets).
Maximum daily dose:

The maximum daily dose of Paracetamol must not exceed 3g.

Maximum single dose is 1g (2 effervescent tablets)
Frequency of administration:
The specific dose interval depends on the symptoms and the maximum
daily dose.
Systematic administration enables to avoid pain or fever oscillation.
Depending on
the
reoccurrence
of
symptoms
(fever
and/or
pain),
repeated
administration
is
allowed. It should, however, preferably never fall below