Panadol Actifast Tablets 500mg

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Paracetamol

Available from:

GlaxoSmithKline Consumer Healthcare (Ireland) Limited

ATC code:

N02BE; N02BE01

INN (International Name):

Paracetamol

Dosage:

500 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Anilides; paracetamol

Authorization status:

Marketed

Authorization date:

2001-12-14

Patient Information leaflet

1
PATIENT INFORMATION LEAFLET
PANADOL
ACTIFAST
Tablets 500mg
Paracetamol
PLEASE READ RIGHT THROUHT THIS LEAFLET BEFORE YOU START USING THIS
MEDICINE.
This medicine is available without prescription, but you still need to
use Panadol ActiFast tablets
carefully to get the best results from them.
•
Keep this leaflet, you may need to read it again.
•
If you have any further questions, ask your pharmacist.
•
IN THIS LEAFLET:
1.
What Panadol ActiFast tablets are and what they are used for
2.
Check before you take Panadol ActiFast tablets
3.
How to take Panadol ActiFast tablets
4.
Possible side effects
5.
How to store and dispose of Panadol ActiFast tablets
6.
Further information
1.
WHAT PANADOL ACTIFAST TABLETS ARE AND WHAT THEY ARE USED FOR
PANADOL ACTIFAST TABLETS ARE USED FOR FAST PAIN 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. The active ingredient is paracetamol which
is a painkiller and also reduces
your temperature when you have a fever. The tablets have been
specially formulated so that the
paracetamol is absorbed into the bloodstream twice as fast as standard
paracetamol tablets and so gets
to the source of pain fast.
2.
CHECK BEFORE YOU TAKE PANADOL ACTIFAST TABLETS_ _
DO NOT TAKE PANADOL ACTIFAST TABLETS:
•
IF YOU HAVE EVER HAD AN ALLERGIC REACTION
to paracetamol or to any of the other ingredients
(listed in Section 6).
•
if you are taking any
OTHER MEDICINES CONTAINING PARACETAMOL.
•
• if you are
UNDER 12 YEARS.
CHECK WITH YOUR DOCTOR BEFORE USE IF YOU:
•
have
LIVER
or
KIDNEY
problems, including
ALCOHOLIC LIVER DISEASE
•
are underweight or malnourished
•
regularly drink alcohol
•
need 2 or more tablets daily for a prolonged period, especially if you
have been advised to
follow a
LOW SALT (SODIUM) DIET
. Each tablet contains
176MG OF SODIUM
.
•
have a
SEVERE INFECTION
as this may increase the risk of
METABOLIC ACIDOSIS
. Signs of
metabolic acidosis include:
-

Summary of Product characteristics

Health Products Regulatory Authority
20 April 2023
CRN00DHPP
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Panadol Actifast Tablets 500mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains paracetamol 500mg.
Excipients: Contains 176mg (7.5mmol) sodium per tablet. For a full
list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets.
White to off-white film-coated capsule shaped tablets with flat edges,
debossed with the letter 'P' on one side and '--' on the
other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
A mild analgesic and antipyretic recommended in the short-term
management of the symptoms of headaches, musculoskeletal
disorders, menstrual pains, toothache and for relieving fever, aches
and pains of common colds and flu.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration.
ADULTS (INCLUDING THE ELDERLY) AND CHILDREN AGED 16 YEARS AND OVER:
One or two tablets up to four times daily as required.
CHILDREN AGED 12-15 YEARS:
One tablet up to four times daily as required.
Children should not be given Panadol ActiFast for more than 3 days
without consulting a doctor.
Not recommended for children under 12 years of age.
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.
4.3 CONTRAINDICATIONS
Panadol Actifast is contraindicated in patients with a previous
history of hypersensitivity to paracetamol or any of the other
ingredients.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Contains paracetamol. Do not use with any other paracetamol-containing
products. The concomitant use with other products
containing paracetamol may lead to an overdose. Paracetamol overdose
may cause liver failure which can lead to liver
transplant or death.
Cases of hepatic dysfunction/failure have been reported in patients
with depleted glutathione levels, s