Remedol 250 mg suppositories

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

PARACETAMOL

Available from:

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

ATC code:

N02BE01

INN (International Name):

PARACETAMOL 250 mg

Pharmaceutical form:

SUPPOSITORY

Composition:

PARACETAMOL 250 mg

Prescription type:

OTC

Therapeutic area:

ANALGESICS

Authorization status:

Authorised

Authorization date:

2007-02-15

Patient Information leaflet

mt-pl-remedol-supp-a3
Page 1 of 5
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
REMEDOL
125 MG SUPPOSITORIES
REMEDOL 250 MG SUPPOSITORIES
paracetamol
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU
Always use 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 after using the
medicine.
WHAT IS IN THIS LEAFLET
1.
What Remedol is and what it is used for
2.
What you need to know before you use Remedol
3.
How to use 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
The paracetamol in Remedol is used to relieve mild to moderate pain
and / or bring down fever
(high temperature).
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE REMEDOL
DO NOT USE REMEDOL
•
if you are allergic to paracetamol or any of the other ingredients of
this medicine (listed
in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Remedol if your child
is suffering from:
•
impaired liver function (e.g. inflammation of the liver, chronic
alcohol abuse, Gilbert’s
syndrome).
•
already existing liver damage.
•
impaired kidney function.
In these cases Remedol suppositories should be used only after
consulting with your doctor.
mt-pl-remedol-supp-a3
Page 2 of 5
Remedol suppositories are administered to children with a body weight
of more than 4 kg.
Long-term, the unspecified use of high-dose of painkillers, headaches
can appear, which should
not be treated with increased doses of painkiller.
Generally the habit of using painkillers, especially in combination
with many painkiller
su

Summary of Product characteristics

mt-spc-remedol-supp-v05-r00-a0
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Remedol 125 mg suppositories
Remedol 250 mg suppositories
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Remedol 125 mg suppositories: Each suppository contains 125 mg
paracetamol.
Remedol 250 mg suppositories: Each suppository contains 250 mg
paracetamol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suppository.
Off-white, torpedo-shaped suppositories.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of mild to moderate pain and fever.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Remedol 125 mg suppositories
The dosage depends on the patient’s age and body weight. The single
dose is between 10 mg
and 25 mg of paracetamol per kg b.wt. Maximum daily dose: about 50 mg
of paracetamol per
kg b.wt.
The dosage schedule in mg per kg b.wt. applies to the treatment of
pain and fever. The single
dose can be given at 6-hour intervals. Infants weighing up to 7 kg
should receive 1 suppository
as a single dose and should not be given more than 3 suppositories
daily. Infants weighing 7 to
10 kg may be treated with this single dose up to four times daily.
The dosage should be reduced or the interval between doses should be
longer in patients with
impaired liver or kidney function or with Gilbert’s syndrome.
Remedol 250 mg suppositories
mt-spc-remedol-supp-v05-r00-a0
Page 2 of 7
The dosage depends on the patient’s age and body weight. The single
dose is between 10 mg
and 25 mg of paracetamol per kg b.wt. Maximum daily dose: about 50 mg
of paracetamol per
kg b.wt.
The dosage schedule in mg per kg b.wt. applies to the treatment of
pain and fever. The single
dose can be given at 6 hour intervals. Children weighing up to 15 kg
should receive 1
suppository as a single dose and should not be given more than 3
suppositories daily. Children
weighing up to 22 kg may be treated with this single dose up to four
times daily.
The dosage should be reduced or the interval betwee