Mabron Retard 150mg prolonged-release Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

TRAMADOL HYDROCHLORIDE

Available from:

Medochemie Limited 1-10 Constantinoupleos Street, 3011 Limassol, Cyprus

ATC code:

N02AX02

INN (International Name):

TRAMADOL HYDROCHLORIDE 150 mg

Pharmaceutical form:

PROLONGED-RELEASE TABLET

Composition:

TRAMADOL HYDROCHLORIDE 150 mg

Prescription type:

POM

Therapeutic area:

ANALGESICS

Authorization status:

Authorised

Authorization date:

2011-03-14

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
MABRON RETARD 100 MG PROLONGED-RELEASE TABLETS
MABRON RETARD 150 MG PROLONGED-RELEASE TABLETS
MABRON RETARD 200 MG PROLONGED-RELEASE TABLETS
Tramadol Hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even
if their signs of illness are the same as yours.
-
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.
WHAT IS IN THIS LEAFLET
1. What Mabron Retard is and what it is used for
2. What you need to know before you take Mabron Retard
3. How to take Mabron Retard
4. Possible side effects
5. How to store Mabron Retard
6. Contents of the pack and other information
1. WHAT MABRON RETARD
IS AND WHAT IT IS USED FOR
Tramadol – the active substance in Mabron Retard is a pain killer
belonging to the class of opiods that
acts on the central nervous system. It relieves pain by acting on
specific nerve cells of the brain and
spinal cord.
Mabron Retard is used for the treatment of moderate to severe pain.
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2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MABRON RETARD
DO NOT TAKE MABRON RETARD:
▪
If you are allergic to tramadol hydrochloride or any of the other
ingredients of this medicine (listed
in section 6)
▪
In acute poisoning with alcohol, sleeping pills, pain relievers, or
other psychotropic medicines
(medicines that affect mood and emotions).
▪
If you are also taking MAO inhibitors (certain medicines used for
treatment of depression) or have
taken them in the last 14 days before treatment with Mabron Retard
(see “Other medicines and
Mabron Retard”).
▪
If you are an epileptic and your fits are not adequately controlled by
treatment
▪
As a substitut

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Mabron Retard 100 mg prolonged-release tablets
Mabron Retard 150 mg prolonged-release tablets
Mabron Retard 200 mg prolonged-release tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One prolonged-release tablet contains 100 mg tramadol hydrochloride.
One prolonged-release tablet contains 150 mg tramadol hydrochloride.
One prolonged-release tablet contains 200 mg tramadol hydrochloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release tablet.
Mabron Retard 100 mg prolonged-release tablets are off white, round
biconvex tablets, 9.1 mm
diameter
Mabron Retard 150 mg prolonged-release tablets are off white, capsule
shaped tablets, 14.3 mm
long
Mabron Retard 200 mg prolonged-release tablets are off white, capsule
shaped tablets 17.1 mm
long
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Treatment of moderate to severe pain.
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4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose should be adjusted to the intensity of the pain and the
sensitivity of the individual patient.
The lowest effective dose for analgesia should generally be selected.
Unless otherwise prescribed, Mabron Retard prolonged-release tablets
should be given as follows:
_Adults and adolescents older than 12 years:_
The usual initial dose is 50 - 100mg tramadol hydrochloride twice
daily, morning and evening. If
pain relief is insufficient, the dose may be titrated upwards to 150
mg or 200 mg tramadol
hydrochloride twice daily.
For doses not practicable with this strength, other strengths of this
medicinal product are available.
Mabron Retard prolonged-release tablets should be swallowed
completely, without breaking or
chewing, independent of meals, with sufficient liquid.
Daily doses of 400 mg of active substance should not be exceeded,
except in special clinical
circumstances.
Under no circumstances should Mabron Retard be used for longer than
absolutely necessary. If
long-term pain treatme