Paracetamol Rx 500 mg film-coated tablets

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

PARACETAMOL

可用日期:

Accord Healthcare Ireland Ltd.

ATC代码:

N02BE; N02BE01

INN（国际名称）:

PARACETAMOL

剂量:

500 milligram(s)

药物剂型:

Film-coated tablet

处方类型:

Product subject to prescription which may be renewed (B)

治疗领域:

Anilides; paracetamol

授权状态:

Not marketed

授权日期:

2011-06-29

资料单张

FRONT PANEL
PARACETAMOL
RX 500 MG
FILM-COATED TABLETS
PARACETAMOL
100 – Film-coated Tablets
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
CONTAINS PARACETAMOL. DO NOT TAKE ANY OTHER PARACETAMOL-CONTAINING
PRODUCTS.
DO NOT EXCEED THE STATED DOSE.
Immediate medical advice should be sought in the event of overdosage,
even if you feel well.
Please read enclosed leaflet carefully.
Each film-coated tablet contains 500 mg paracetamol.
For oral use.
Read the package leaflet before use.
Store in the original package in order to protect from light.
POM
MA Holder: Accord Healthcare Irl Ltd, Cork, T45 K857, Ireland
PA 2315/009/001
BRAILLE:
paracetamol
rx
500 mg
Remove Actavis Logo and
replace with Accord logo
INNER Panel Text
PACKAGE LEAFLET: INFORMATION FOR THE USER
PARACETAMOL RX 500 MG FILM-COATED 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.

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 you doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
1.
WHAT IS IN THIS LEAFLET:
2.
1 WHAT PARACETAMOL RX IS AND WHAT IT IS USED FOR
3.
2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARACETAMOL RX
4.
3 HOW TO TAKE PARACETAMOL RX
5.
4 POSSIBLE SIDE EFFECTS
6.
5 HOW TO STORE PARACETAMOL RX
7.
6 CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT PARACETAMOL RX IS AND WHAT IT IS USED FOR
Paracetamol Rx contains paracetamol which belongs to a group of
medicines called analgesics
(painkillers). Paracetamol Rx is used to relieve mild to moderate pain
and reduce fever.
Paracetamol Rx can be used for the relief of headache, toothache,
period pains, muscle pain and fever
in connection with common cold.
PARACETAMOL
RX "CONTAINS PARACETA

产品特点

Health Products Regulatory Authority
26 August 2019
CRN0094H3
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paracetamol Rx 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
Film-coated tablet.
Capsule-shaped, white film-coated tablet, 17.0 mm x 7.2 mm, with
break-line on one side and engraved with “PINEX 500” on
the unscored side and “A” and “L” on the break-line 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 Rx 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 nighttimes,
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 (abo