Paracetamol 500 mg tablets

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

Paracetamol

Disponível em:

Bluefish Pharmaceuticals AB

Código ATC:

N02BE01

DCI (Denominação Comum Internacional):

Paracetamol

Forma farmacêutica:

Tablet

Área terapêutica:

paracetamol

Status de autorização:

Not marketed

Data de autorização:

2022-09-02

Folheto informativo - Bula

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PARACETAMOL 500 MG TABLETS
paracetamol
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 this 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, or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
You must talk to a doctor if you do not feel better or if you feel
worse after 3 days of fever and 5
days of pain or if other symptoms appear.
WHAT IS IN THIS LEAFLET
1.
What Paracetamol is and what it is used for
2.
What you need to know before you take Paracetamol
3.
How to take Paracetamol
4.
Possible side effects
5.
How to store Paracetamol
6.
Contents of the pack and other information
1.
WHAT PARACETAMOL IS AND WHAT IT IS USED FOR
Paracetamol contains the active substance paracetamol which is a
painkiller and also reduces your
temperature when you have a fever. It is recommended for the
short-term treatment of mild to moderate
pain such as headache, toothache, muscle and joint pain and menstrual
pain.
It also relieves fever associated with common colds and flu.
You must talk to a doctor if you do not feel better or if you feel
worse after 3 days of fever and 5 days
of pain or if other symptoms appear.
Paracetamol is indicated in adults and adolescents aged 12 or older.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARACETAMOL
DO NOT TAKE PARACETAMOL IF:
-
you are allergic to paracetamol or any of the other ingredients of
this medicine (listed in section 6);
WARNINGS AND PRECAUTIONS
Never take more Paracetamol than what is stated in the dosing
instructions. Higher doses than
recommended will not lead to better pain relief, instead it increases
the risk of very severe liver damage.
The symptoms of liver damage usually appear after a few days. It is
t

Características técnicas

Health Products Regulatory Authority
05 October 2022
CRN00D68N
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paracetamol 500 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 mg paracetamol.
Excipient(s) with known effect: each tablet contains 30 mg wheat
starch.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Round, flat tablets, with a facet and a score line on the one side,
with a 13 mm diameter and 4 mm thickness. Colour – white to
almost white.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Paracetamol is recommended for the short-term treatment of the mild to
moderate pain such as headache, toothache,
musculoskeletal disorders and menstrual pain and for fever associated
with cold and flu.
Paracetamol is indicated in adults and adolescents aged 12 or older.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The lowest effective dose should be used for the shortest time
possible. The maximum daily dose must not be exceeded (3000
mg).
Dose depends on age and body weight, generally 10 to 15 mg/kg body
weight as a single dose, up to a maximum of 60 mg/kg
body weight as the total daily dose.
For dosing according to the body weight and age see the table.
AGE
BODY WEIGHT
SINGLE DOSE
MAXIMUM DAILY DOSE
DOSING INTERVAL
12 – 15 years
40-55 kg
500 mg
2-3 g (maximum of 4-6 tablets per 24 hours)
at least
4 – 6 hours
> 15 years
40-55 kg
500 mg
2-3 g (maximum of 4-6 tablets per 24 hours)
at least
4 – 6 hours
​
> 55 kg
500 – 1,000 mg
3 g (maximum of 6 tablets per 24 hours)
​
Paracetamol is not recommended for children under 12 years of age.
Other formulations containing paracetamol are available.
The paediatric dosage shall be based on the body weight with a maximum
daily dose of 60 mg/kg body weight, not exceeding
3000 mg for total daily dose.
If the pain persists for more than 5 days or the fever lasts for more
than 3 days, or gets worse or other symptoms appear, a
doctor shou