Paracetamol Tablets Effervescent 500mg

Kraj: Malta

Język: angielski

Źródło: Medicines Authority

Składnik aktywny:

PARACETAMOL

Dostępny od:

Cipla (EU) Limited Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW, United Kingdom

Kod ATC:

N02BE01

INN (International Nazwa):

PARACETAMOL 500 mg

Forma farmaceutyczna:

EFFERVESCENT TABLET

Skład:

PARACETAMOL 500 mg

Typ recepty:

OTC

Dziedzina terapeutyczna:

ANALGESICS

Status autoryzacji:

Withdrawn

Data autoryzacji:

2016-01-25

Ulotka dla pacjenta

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
PARACETAMOL 500 MG EFFERVESCENT TABLETS
paracetamol
READ ALL OF THIS LEAFLET CAREFULLY 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, 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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4

You must contact a doctor if you do not feel better or if you feel
worse after 3 days.
WHAT IS THIS LEAFLET:
1.
What Paracetamol effervescent tablets is and what it is used for
2.
What you need to know before you take Paracetamol effervescent tablets
3.
How to take Paracetamol effervescent tablets
4.
Possible side effects
5.
How to store Paracetamol effervescent tablets
6.
Contents of the pack and other information
1.
WHAT PARACETAMOL EFFERVESCENT TABLETS IS AND WHAT IT IS USED FOR
This medicine contain paracetamol, which belongs to a group of
medicines called analgesics and
antipyretics that relieve mild to moderate pain and/or fever.
It can be used to relieve headache, migraine, neuralgia, toothache,
period pain, rheumatic aches and
pains, sore throat and the symptoms of colds and flu.
You must talk to a doctor if you do not feel better or if you do not
improve after 3 days
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARACETAMOL EFFERVESCENT TABLETS
DO NOT TAKE PARACETAMOL EFFERVESCENT TABLETS

If you are allergic (hypersensitive) to paracetamol, or any of the
ingredients of this medicine
(listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before taking Paracetamol
effervescent tablets:

If you are suffering from kidney problems
Page 2 of 6

If you are suffering from liver problems including liver problems due
to excessive alcohol
consumption.
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Charakterystyka produktu

Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Paracetamol 500 mg effervescent tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each effervescent tablet contains 500 mg of paracetamol.
Excipient with known effects:
Each effervescent tablet contains 439.46mg of sodium
Each effervescent tablet contains 20 mg of aspartame.
For the full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Effervescent tablet.
White to off-white, circular, flat-faced, bevelled edge tablets
debossed with a ring on one side and
plain on the other. Diameter 25.20 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic treatment of mild to moderate pain and/or fever in adults
and adolescents aged 12
years and above.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Paediatric population _
_ _
Dose depends on body weight and age. A single dose ranges from 10 to
15 mg/kg bodyweight. The
maximum total daily dose is 60 mg/kg body weight for total daily dose.

Children below 12 years of age: this product is not recommended in
children aged
less than 12 years.

Adolescents of 12 to 15 years and weighing 41 to 50 kg: one tablet at
a time, every
4-6 hours as needed, the maximum being 4 tablets per day (paracetamol
2000 mg per 24
hours).
Page 2 of 9

Adolescents of 16 to 18 years and weighing more than 50 kg: as adults.
_ _
_Adults _
_ _
For adults and adolescents (aged 16 years and older) weighing more
than 50 kg the usual single
dose is 1-2 tablets at a time, to be repeated every 6 hours as needed,
the maximum being 8 tablets
per day (paracetamol 4000 mg per 24 hours).
For
adults
and
adolescents
(aged
16
years
and
older)
and
weighing
less
than
50
_ _
kg
_ _
the
recommended single dose is 1 tablet. The daily effective dose of
paracetamol should not exceed 60
mg/kg/day (upto maximum 2g/day).
_Renal impairment _
In patients with renal insufficiency, the dose should be reduced:
_ _
Glomerular filtration rate
Dose
10-50 ml/min
500 mg every 6 hours
< 10 ml/min
500 mg every 8 hours
_Hepat