Paracetamol Tablets Effervescent 1000mg

Nchi: Malta

Lugha: Kiingereza

Chanzo: Medicines Authority

Viambatanisho vya kazi:

PARACETAMOL

Inapatikana kutoka:

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

ATC kanuni:

N02BE01

INN (Jina la Kimataifa):

PARACETAMOL 1000 mg

Dawa fomu:

EFFERVESCENT TABLET

Tungo:

PARACETAMOL 1000 mg

Dawa ya aina:

OTC

Eneo la matibabu:

ANALGESICS

Idhini hali ya:

Withdrawn

Idhini ya tarehe:

2016-01-25

Taarifa za kipeperushi

Page 1 of 6
PACKAGE LEAFLET: INFROMATION FOR THE USER
PARACETAMOL 1000 MG EFFERVESCENT 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 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 3 days
WHAT IS IN THIS LEAFLET:
1.
What Paracetamol effervescent tablets are and what they are 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 ARE AND WHAT THEY ARE USED FOR
This medicine contain paracetamol, which belongs to a group of
medicines called analgesics and
antipyretics that relieve mild to moderate pain and 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 feel
worse 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
effervescents tablets:

If you are suffering from kidney problems

If you are suffering from liver problems including liver problems due
to excessive alcohol
consumption.
Page 2 of 6


Tabia za bidhaa

Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Paracetamol 1000 mg effervescent tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each effervescent tablet contains 1000mg of paracetamol.
Excipient with known effects:
Each effervescent tablet contains 533.51mg of sodium
Each effervescent tablet contains 10mg of aspartame.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Effervescent tablet
White to off white coloured circular flat-faced, bevelled tablets
plain on both sides. Diameter:
25.20mm
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Short term symptomatic treatment of mild to moderate pain and/or fever
in adults and adolescents
aged 16 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.

Children and adolescents below 16 years of age: this product is not
recommended in patients
aged less than 16 years.

Adolescents of 16 to 18 years and weighing more than 50 kg: as adults.
_ _
_ _
_ _
Page 2 of 9
_Adults _
For adults and adolescents weighing more than 50 kg (aged 16 years and
older) the usual single
dose is 1 tablet at a time, to be repeated every 6 hours as needed,
the maximum being 4 tablets per
day (paracetamol 4000 mg per 24 hours).
Paracetamol
1000mg
tablets
are
not
suitable
for
patients
weighing
less
than
50
kg.
More
appropriate forms (i.e. 500 mg tablets) are available on the market
for use.
_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
Paracetamol 1000 mg tablets are not suitable for patients with renal
insufficiency when reduced
dose is required. More appropriate forms (i.e. 500 mg tablets) are
available in the market for use.
_Hepatic impairment _
In patients with impaired hepatic function or Gilbert�