Paracetamol Pharmaclan 500 mg film-coated tablets

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

Paracetamol

Disponible desde:

Pharmaclan s.r.o.

Código ATC:

N02BE01

Designación común internacional (DCI):

Paracetamol

formulario farmacéutico:

Film-coated tablet

Área terapéutica:

paracetamol

Fecha de autorización:

2022-03-04

Información para el usuario

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PACKAGE LEAFLET: INFORMATION FOR THE USER
PARACETAMOL PHARMACLAN 500 MG FILM-COATED TABLETS
paracetamol
[For OTC]
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 or nurse has
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 or
nurse. 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 5 days in case of pain
and 3 days in case of fever.
[For Rx]
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.

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 only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist or
nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Paracetamol Pharmaclan is and what it is used for
2.
What you need to know before you take Paracetamol Pharmaclan
3.
How to take Paracetamol Pharmaclan
4.
Possible side effects
5.
How to store Paracetamol Pharmaclan
6.
Contents of the pack and other information
1.
WHAT PARACETAMOL PHARMACLAN IS AND WHAT IT IS USED FOR
Paracetamol Pharmaclan contains active substance paracetamol which
belongs to a group of
medicines called analgesics (painkillers).
Paracetamol Pharmaclan are used to relieve pain and help reduce fever.
The tablets can treat over
a short time mild to moderate pain and/or fever.
Paracetamol Pharmaclan may be used in adults and adolescents but is
no

Ficha técnica

Health Products Regulatory Authority
04 March 2022
CRN009SLJ
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paracetamol Pharmaclan 500 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 500 mg paracetamol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White to off-white coloured, caplet shaped film-coated tablets with
flat-edges debossed with "PARA500" on one side and
score line on the other side. Approximately, the tablet dimensions are
17.5 mm X 7.3 mm.
The tablet can be divided into two equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Short-term symptomatic treatment of mild to moderate pain and/or
fever.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Paracetamol is dosed depending on bodyweight and age, usually with 10
to 15 mg/kg bodyweight as a single dose, up to a
maximum of 60 mg/kg bodyweight as a total daily dose.
Adults and adolescents 15 years and above (> 55 kg bodyweight)
1 to 2 tablets (500-1000 mg) at a time, up to 6 tablets (3000 mg) per
24 hours.
The simultaneous intake of two tablets should be recommended only if
there is insufficient relieve with one tablet, or there is
higher requirement due to more intense pain.
Paediatric population (children from 6 years of age (> 22 kg
bodyweight) and adolescents up to 15 years (< 55 kg bodyweight))
AGE GROUP
RECOMMENDED DOSE
NUMBER OF TABLETS
FREQUENCY
6-9 years
(22-30 kg bodyweight)
250 mg
Half tablet
Every 4-6 hours when necessary to a
maximum of 4-6 doses (1000-1500 mg) in
24 hours
9-12 years
(30-40 kg bodyweight)
500 mg
One tablet
Every 4-6 hours when necessary to a
maximum of 4 doses (1500-2000 mg) in 24
hours
12-15 years (40-55 kg bodyweight)
500 mg
One tablet
Every 4-6 hours when necessary to a
maximum of 4-6 doses (2000-3000 mg) in
24 hours
The lower dosing frequency is intended for children in the lower limit
of the relevant weight and / or age group.
Direction for use:

Paracetamol tablet is not sui