Panadol ActiFast 500mg Soluble Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Paracetamol

Available from:

Haleon Ireland Limited

ATC code:

N02BE; N02BE01

INN (International Name):

Paracetamol

Dosage:

500 milligram(s)

Pharmaceutical form:

Soluble tablet

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Anilides; paracetamol

Authorization status:

Marketed

Authorization date:

2007-06-29

Patient Information leaflet

1
PATIENT INFORMATION LEAFLET
PANADOL
ACTIFAST
500mg Soluble Tablets
Paracetamol
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
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 Soluble Tablets are and what they are used for
2.
Before you take Panadol ActiFast Soluble Tablets
3.
How to take Panadol ActiFast Soluble Tablets
4.
Possible side effects
5.
How to store Panadol ActiFast Soluble Tablets
6.
Further information
1.
WHAT PANADOL ACTIFAST SOLUBLE TABLETS ARE AND WHAT THEY ARE USED FOR
Panadol ActiFast 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 feverishness, aches and
pains of colds and flu. Panadol ActiFast Soluble tablets also provide
relief from the pain associated
with osteoarthritis as diagnosed by a doctor. Panadol ActiFast Soluble
tablets contain paracetamol
which is an analgesic (a pain reliever which reduces aches and
shivers) and an antipyretic (it reduces
body temperature when you have a fever).
2.
BEFORE YOU TAKE PANADOL ACTIFAST SOLUBLE TABLETS
_ _
DO NOT TAKE PANADOL ACTIFAST SOLUBLE TABLETS:
• If you are allergic to paracetamol or any of the other ingredients
(listed in Section 6).
• If you are taking any
OTHER MEDICINES CONTAINING PARACETAMOL
.
• If you are under
10 YEARS OF AGE
.
TAKE SPECIAL CARE & TELL YOUR PHARMACIST OR DOCTOR BEFORE TAKING
PANADOL ACTIFAST SOLUBLE
TABLETS
• If you have liver or kidney problems.
• If you have heart or blood pressu

Summary of Product characteristics

Health Products Regulatory Authority
20 June 2023
CRN00DD7H
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Panadol ActiFast 500mg Soluble Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 mg of Paracetamol
Excipients with known effect: each tablet contains 427mg sodium and
50mg sorbitol.
For the full list of excipients see Section 6.1.
3 PHARMACEUTICAL FORM
Soluble Tablet.
Round white tablets with bevelled edges.
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
Hepatic Impairment
In patients with hepa