Paracetamol Tablets 500 mg from the makers of Disprin

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Paracetamol

Available from:

Reckitt Benckiser Ireland Ltd

ATC code:

N02BE; N02BE01

INN (International Name):

Paracetamol

Dosage:

500 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Anilides; paracetamol

Authorization status:

Marketed

Authorization date:

2001-10-19

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
PARACETAMOL TABLETS 500MG
FROM THE MAKERS OF DISPRIN
PARACETAMOL
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.

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. Do not pass it on to
others. It may harm them, even if their
symptoms are the same as yours.

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 Paracetamol Tablets 500mg from the makers of Disprin are and
what they are used for
2. Before you take Paracetamol Tablets 500mg from the makers of
Disprin
3. How to take Paracetamol Tablets 500mg from the makers of Disprin
4. Possible side effects
5. How to store Paracetamol Tablets 500mg from the makers of Disprin
6. Further Information
1. WHAT PARACETAMOL TABLETS 500MG FROM THE MAKERS OF DISPRIN ARE AND
WHAT THEY ARE USED FOR
Paracetamol Tablets 500mg contain the active ingredient paracetamol.
Paracetamol belongs to a group of
medicines known as non-narcotic analgesics, which are used to relieve
pain and to lower temperature.
Paracetamol Tablets 500mg are indicated for the relief of headaches,
musculoskeletal disorders, period pain,
toothache, colds and flu and the pain of osteoarthritis.
2. BEFORE YOU TAKE PARACETAMOL TABLETS 500MG FROM THE MAKERS OF
DISPRIN
Do not take Paracetamol Tablets 500mg if you:

have had an allergic reaction to paracetamol or any of the ingredients
listed in section 6. An allergic reaction
can include a rash, itching or shortness of breath.

have a liver disorder.
Not suitable for children under 6 years of age.
TAKE SPECIAL CARE WITH PARACETAMOL TABLETS 500MG IF YOU HAVE:
•
kidney problems
•
liver problems, including alcoholic liver disease.
•
a poor diet
•
a high fever, signs of a secondary infection or if symptoms persist.
You may be more at risk of the side effects

Summary of Product characteristics

Health Products Regulatory Authority
01 July 2022
CRN00CX8S
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paracetamol Tablets 500 mg from the makers of Disprin
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Paracetamol 500 mg.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet
White tablets marked with code 293 and partial breaklines on one side
and product logo on the reverse.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
A mild analgesic and antipyretic. The tablets are recommended for use
in the short-term management of the symptoms of
headache, musculoskeletal disorders, menstrual pains, toothache and
for relieving the fever, aches and pains of common colds
and flu.
Also recommended for the symptomatic relief of mild to moderate pain
associated with osteoarthritis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults, the elderly and children aged 16 years and over: 1 to 2
tablets every 4-6 hours as required. Do not take more than 8
tablets in 24 hours.
PAEDIATRIC POPULATION
Children under 6 years: Not recommended
Aged 6 to 9 years: ½ tablet every 4-6 hours when necessary to a
maximum of 4 doses in 24 hours
Aged 10 to 11 years: 1 tablet every 4-6 hours when
necessary to a maximum of 4 doses in 24 hours
Aged 12 to 15 years 1 to 1 ½ a tablet every 4-6 hours when necessary
to a
maximum of 4 doses in 24 hours
Do not give this medicine to your child for more than 3 days without
speaking to your doctor or pharmacist.
Route of administration
Oral.
Paracetamol should be used at the lowest effective dose for the
shortest possible time. The maximum daily dose must not be
exceeded.
In all patients over 16 years of age, the maximum daily dose of
paracetamol should not exceed 60 mg/kg/day (up to a
maximum of 2 g per day) in the following situations, unless directed
by a physician: (see section 4.4)
Health Products Regulatory Authority
01 July 2022
CRN00CX8S
Page 2 of 7
·
Weight less than 50kg
·
Dehydration
·
Malnutrition
·
Chronic alcoholism