Paracetamol 500 mg Film Coated Tablets

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Paracetamol

Tilgjengelig fra:

Pfizer Healthcare Ireland

ATC-kode:

N02BE; N02BE01

INN (International Name):

Paracetamol

Dosering :

500 milligram(s)

Legemiddelform:

Film-coated tablet

Resept typen:

Product not subject to medical prescription

Terapeutisk område:

Anilides; paracetamol

Autorisasjon status:

Marketed

Autorisasjon dato:

1989-03-02

Informasjon til brukeren

DTP ARTWORK
APRILIA PLANT
Black
Dieline
Technical
2/5 code
Area reserved
Product Name:
INS -
ANADIN FCT 12 EA BLST 1 EA IFC ENG / ANADIN PARA FCT 12 EA BLST 2 EA
IFC ENG
PLEASE ENSURE ARTWORK IS CHECKED WITH THIS SETTINGS: PRINT PRODUCTION
>> OUTPUT PREVIEW >> OVERPRINT PREVIEW TURNED ON AND COLOR PROFILE
SIMULATION SET TO “COATED FOGRA 39”
Draft No:
04 -
Date:
09/03/2020 -
Operator: TT
Barcode Type(s):
-
X-Hight Rule:
N
Std Spec / Label Text Number:
N/A
Dieline:
117 X 173 MM
2 of 5 code :
N/A
Standard Color:
0032
Item Code:
MK-PAA110965-2
PAR:
2019-0014398
Market:
IRELAND
The full name of this medicine as listed above has been abbreviated
throughout the leaflet for ease of reference to
‘paracetamol tablets’ or ‘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 the leaflet or as
your doctor or pharmacist 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, PHARMACIST OR NURSE.
THIS INCLUDES ANY POSSIBLE SIDE EFFECTS NOT LISTED IN THIS LEAFLET.
SEE SECTION 4. YOU MUST SEE A DOCTOR IF YOUR SYMPTOMS WORSEN OR
DO NOT IMPROVE AFTER 3 DAYS.
IN THIS LEAFLET:
1. WHAT PARACETAMOL IS AND WHAT IT IS 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. CONTENT OF THE PACK AND OTHER INFORMATION
1. WHAT PARACETAMOL IS AND WHAT IT IS USED FOR
Each Film-coated tablet contains paracetamol 500mg.
Paracetamol is an analgesic (relieves pain) and antipyretic (reduces
high temperature).
Your medicine is for the treatment of the symptoms of mild to moderate
pain such as,
HEADACHE, PERIOD PAINS, MIGRAINE, RHEUMATIC ACHES, NEURALGIA (SHARP
NERVE PAIN), TOOTHACHE, SYMPTOMS OF FLU,
FEVERISHNESS, COLDS AND SORE THROAT.
2.

Preparatomtale

Health Products Regulatory Authority
19 May 2020
CRN00966X
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paracetamol 500 mg Film Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains: Paracetamol 500 mg.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated Tablet.
White capsule shaped film coated tablets embossed on one face with
"P-500" and with a break bar on the reverse.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Paracetamol is a mild analgesic and anti-pyretic.The tablets are
recommended for use in the short-term management of
headaches including migraine and tension headaches, backache,
rheumatic, muscle pain, period pains, nerve pains, toothache
and for relieving fever, aches and pains of colds and flu.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
ADULTS:
1-2 tablets 3-4 times daily.
A maximum of 8 tablets should not be exceeded in any 24-hour period.
Paediatric Population
Alternative liquid paracetamol formulations are available which may be
more appropriate, especially for younger children.
CHILDREN UNDER 6 YEARS:
This medicine is not appropriate for children under 6 years of age.
FOR CHILDREN 6 TO 9 YEARS OF AGE:
Give ½ a tablet with a drink of water, every 4 to 6 hours as
required.
FOR CHILDREN 10 TO 11 YEARS OF AGE:
Give 1 tablet with a drink of water, every 4 to 6 hours as required.
FOR ADOLESCENTS 12 TO 15 YEARS OF AGE:
Give 1 to 1 ½ a tablet with a drink of water, every 4 to 6 hours as
required.
A maximum of 4 doses should not be exceeded in any 24 hour period.
Method of Administration: Oral
4.3 CONTRAINDICATIONS
Hypersensitivity to Paracetamol or any of the constituents.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Health Products Regulatory Authority
19 May 2020
CRN00966X
Page 2 of 5
Paracetamol should be administered with caution under the following
circumstances (see section 4.2 where relevant):

Hepatic impairment

Chronic alcoholism. The hazards of overdose are greater in those with
non