Remedol 120/5ml Oral Suspension

Država: Malta

Jezik: engleski

Izvor: Medicines Authority

Aktivni sastojci:

PARACETAMOL

Dostupno od:

Remedica Limited Limassol Industrial Estate, Aharnon Street, 3056 Limassol, Cyprus

ATC koda:

N02BE01

INN (International ime):

PARACETAMOL 120 mg/5ml

Farmaceutski oblik:

ORAL SUSPENSION

Sastav:

PARACETAMOL 120 mg/5ml

Tip recepta:

OTC

Područje terapije:

ANALGESICS

Status autorizacije:

Authorised

Datum autorizacije:

2007-02-15

Uputa o lijeku

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
REMEDOL 120 MG/5 ML ORAL SUSPENSION
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
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 your doctor if you do not feel better or if you
feel worse after a few days.
WHAT IS IN THIS LEAFLET
1.
What Remedol is and what it is used for
2.
What you need to know before you take Remedol
3.
How to take Remedol
4.
Possible side effects
5.
How to store Remedol
6.
Contents of the pack and other information
1.
WHAT REMEDOL IS AND WHAT IT IS USED FOR
Remedol contains the active substance paracetamol.
It is used to relieve pain and/or bring down fever (high temperature)
in many conditions
including post-immunisation fever, teething, headache, cold and flu,
toothache, earache, sore
throat and other aches and pains.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE REMEDOL
This medicine is suitable for most people but a few people should not
use it. If you are in any
doubt, talk to your doctor or pharmacist.
DO NOT TAKE REMEDOL
•
if you are allergic to paracetamol or any of the other ingredients of
this medicine (listed
in section 6).
•
if you are taking anything else with paracetamol in it.
•
if she/he is between 2-3 months old and is taking this medicine for
other causes of pain
and fever and:

weighs less than 4 kg or

was born before 37 weeks.
If any of these applies, get advice from a doctor or pharmacist
without using Remedol.
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WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Remedol
•
if your child has serious kidney

Svojstava lijeka

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Remedol 120 mg/5 ml oral suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of oral suspension contains 120 mg paracetamol.
Excipient(s) with known effect:
Each 5 ml of oral suspension contains 5 mg sodium methyl
hydroxybenzoate E219, 0,5 mg
sodium propyl hydroxybenzoate E217, 1,25 ml (1625 mg) sorbitol E420,
1.9 g sucrose (main
constituent of Syrup BP) and 0,1 mg carmoisine E122.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral suspension.
Pink, flavoured suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Remedol suspension is indicated for the treatment mild to moderate
pain (including teething
pain), and as an antipyretic. It can be used in many conditions
including headache, toothache,
earache, teething, sore throat, colds & influenza, aches and pains and
post-immunisation fever.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
FOR THE RELIEF OF FEVER AFTER VACCINATIONS AT 2, 3 AND 4 MONTHS
2.5ml. 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 baby weighs over 4 kg and was
born after 37 weeks
2,5 ml
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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.
If
necessary,
after
4-6
hours,
give
a
second 2.5 ml dose
CHILDREN AGED 3 MONTHS – 6 YEARS:
CHILD’S AGE
HOW MUCH
HOW OFTEN (IN 24 HOURS)
3-6 months
2,5 ml
4 times
6-24 months
5 ml
4 times
2-4 years
7,5 m