Paracetamol 120mg/5ml Oral Suspension

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

PARACETAMOL

Available from:

Rosemont Pharmaceuticals Limited Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds LS11 9XE, United Kingdom

ATC code:

N02BE01

INN (International Name):

PARACETAMOL 120 mg/5ml

Pharmaceutical form:

ORAL SUSPENSION

Composition:

PARACETAMOL 120 mg/5ml

Prescription type:

OTC

Therapeutic area:

ANALGESICS

Authorization status:

Withdrawn

Authorization date:

2006-08-28

Patient Information leaflet

PARACETAMOL 120MG/5ML ORAL SUSPENSION
MODULE 1.3.1
LEAFLET
VERSION: APRIL 2018
PAGE 1
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 have 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.
WHAT IS IN THIS LEAFLET
1. What Paracetamol Oral Suspension is and what it is used for
2. What you need to know before you take Paracetamol Oral Suspension
3. How to take Paracetamol Oral Suspension
4. Possible side effects
5. How to store Paracetamol Oral Suspension
6. Contents of the pack and other information
Paracetamol belongs to a group of medicines called pain-killers or
analgesics.

It is used for mild to moderate pain including headache, migraine,
nerve pain,
toothache, sore throat, period pains and general aches and pains.

It is also used to relieve the symptoms of cold and flu.

It is also used to help reduce a fever (high temperature).
DO NOT TAKE PARACETAMOL:

If you are allergic to paracetamol or any of the other ingredients of
this medicine
(listed in section 6). An allergic reaction can include a rash,
itching or shortness of
breath

If you have a liver disorder.
Speak to your doctor or pharmacist if any of these apply to you.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Paracetamol if you
have:

kidney problems

liver problems, including those due to drinking too much alcohol.
1. WHAT PARACETAMOL ORAL SUSPENSION IS AND WHAT IT IS USED FOR
PARACETAMOL 120MG/5ML ORAL SUSPENSION
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARACETAMOL ORAL SUSPENSION
PARACETA

Summary of Product characteristics

PARACETAMOL 120MG/5ML ORAL SUSPENSION
PAGE 1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Paracetamol 120mg/5ml Oral Suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Paracetamol 120mg/5ml
Excipients with known effect:
Methyl hydroxybenzoate (E218)
Propyl hydroxybenzoate (E216)
Sucrose 3g/5ml
Sorbitol (E420)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral Suspension
Off-white cream suspension
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
For the treatment of mild to moderate pain, including headache,
migraine,
neuralgia, toothache, sore throat, period pains, aches and pains.
For the reduction of fever and to be used as an adjunctive treatment
to relieve
symptoms of cold and flu.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
FOR THE RELIEF OF FEVER AFTER VACCINATIONS AT 2, 3 AND 4 MONTHS
One 2.5 mL spoonful (small end). This dose may be given up to 4 times
a day starting
at the time of vaccination. Do not give more than 4 doses in any 24
hour period. Leave
at least 4 hours between doses. If your baby still needs this medicine
two days after
receiving the vaccine talk to your doctor or pharmacist.
AGE: 2 – 3 MONTHS
DOSE
PAIN AND OTHER CAUSES OF FEVER - if your
One 2.5 mL spoonful (small end).
PARACETAMOL 120MG/5ML ORAL SUSPENSION
PAGE 2
baby weighs over 4 kg and was born after
37 weeks
If necessary, after 4-6 hours, give a
second 2.5 mL dose

Do not give to babies less than 2 months of age

Leave at least 4 hours between doses

Do not give more than 2 doses. This is to ensure that fever that may
be due to a
serious infection is quickly diagnosed. If your child is still
feverish after two
doses, talk to your doctor or pharmacist.
CHILD’S AGE
HOW MUCH
HOW OFTEN (IN 24
HOURS)
3 – 6 months
One 2.5 mL spoonful (small end)
4 times
6 – 24 months
One 5 mL spoonful (large end)
4 times
2 – 4 years
One 5.0 mL spoonful (large end) and
one 2.5 mL spoonful (small end)
4 times
4 – 8 years
Two 5 mL spoonfuls (large end)
4 times
8 – 10 yea