Panadol Actifast Lemon 500 mg Soluble Tablets

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

Paracetamol

Saadav alates:

Haleon Ireland Limited

ATC kood:

N02BE01

INN (Rahvusvaheline Nimetus):

Paracetamol

Ravimvorm:

Soluble tablet

Terapeutiline ala:

paracetamol

Loa andmise kuupäev:

2022-10-21

Infovoldik

100
1226
Pharmacode Standard
Barcode Type
Barcode Number:
Magnification:
BARCODE INFO
BWR:
0
Micrometre
70%
50%
1.
20%
BLACK
Dungarvan
Ireland
PANADOL ACTIFAST
OTC.LT.009
Offset - Lithography
N/A
62000000206200
PK 201259356
Leaflet
OTC.LT.SPEC.009
1226
N/A
TR2945280/A
0000018504
AIP_CHAMPS_2022_HALEON_Version 1
27 - Jul - 2023
V1
STUDIO LOCATION:
NON PRODUCTION
D2A
AWP NO:
Artwork Information Panel
CHAMPS NO:
MANUFACTURING SITE:
SITE COMPONENT NO:
SITE CHANGE CONTROL NO:
APPROVING MARKET:
PRODUCT MARKET TRADE NAME:
MATERIAL SPEC NO:
PRINT PROCESS:
TECHNICAL DRAWING NO:
BARCODE NO:
BAR WIDTH REDUCTION:
PHARMA CODE NO:
TOTAL NUMBER OF COLOURS INCLUDING VARNISH & FOILS:
TOTAL SPECIAL FINISHES:
X
No
MICRO TEXT:
7.0pt
7.0pt
7.9pt
85%
BODY TEXT SIZE:
N/A
FORMULATION CODE
SMALLEST TEXT SIZE:
LEADING:
HORIZONTAL SCALE:
PRODUCTION
COMPONENT TYPE:
0
1
EUROPE
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
This medicine is available without prescription.
However, you still need to take Panadol ActiFast Lemon
Soluble Tablets carefully to get the best results from
it.
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more information
or advice.
•
You must contact a doctor if your symptoms
worsen or do not improve.
•
If any of the side effects get serious, or if you
notice any side effect not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Panadol ActiFast Lemon Soluble Tablets are and
what they are used for
2. Before you take Panadol ActiFast Lemon Soluble Tablets
3. How to take Panadol ActiFast Lemon Soluble Tablets
4. Possible side effects
5. How to store Panadol ActiFast Lemon Soluble Tablets
6. Contents of the pack and other information
1.
WHAT PANADOL ACTIFAST LEMON SOLUBLE
TABLETS ARE AND WHAT THEY ARE USED
FOR
Panadol ActiFast Lemon Soluble Tablets provide fast
and effective relief of headaches, toothache, backache,
rheumatic and muscle pains and period pain. It also
relieves sore throat and the fev

Toote omadused

Health Products Regulatory Authority
10 January 2024
CRN00F1W1
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Panadol Actifast Lemon 500 mg Soluble Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 mg of paracetamol.
Excipients with known effect: each tablet contains 427 mg sodium and
50 mg sorbitol. For a full list of excipients, see Section
6.1
3 PHARMACEUTICAL FORM
Soluble Tablet
Round white, flat tablets with bevelled edges, plain on both sides
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As a mild analgesic and antipyretic. The tablets are recommended for
use in the short-term management of the symptoms of
headache, toothache, menstrual pain, musculoskeletal disorders and for
symptoms of common colds and 'flu including sore
throat, headache, muscle ache and fever. Panadol may also be used in
the symptomatic relief of mild to moderate pain
associated with osteoarthritis, as diagnosed by a doctor.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration only.
ADULTS (INCLUDING THE ELDERLY) AND CHILDREN AGED 16 YEARS AND OVER:
One or two tablets dissolved in water up to 4 times daily as required.
CHILDREN AGED 10-15 YEARS:
One tablet dissolved in water up to 4 times daily as required.
Children should not be given paracetamol for more than 3 days without
consulting a doctor.
Not recommended for children under the age of 10 years. Minimum dosing
interval: 4 hours.
Not more than 4 doses should be taken in any 24 hour period. Do not
exceed the stated dose.
Should not be used with other paracetamol containing products.
The lowest dose necessary to achieve efficacy should be used.
Renal Impairment
It is recommended, when giving paracetamol to patients with renal
impairment, to reduce the dose and to increase the
minimum interval between each administration to at least 6 hours
unless directed otherwise by a physician. See Table below.
Adults:
_Glomerular filtration rate_
_Dose_
10-50 ml/min
500mg every 6 hours
< 10 ml/min
500mg every 8 hours
Hepa