Tramadol Capsule 50mg

Страна: Мальта

Язык: английский

Источник: Medicines Authority

Активный ингредиент:

TRAMADOL HYDROCHLORIDE

Доступна с:

Chelonia Healthcare Limited 11 Boumpoulinas, 3rd Floor, Nicosia, P.C. 1060, Cyprus

код АТС:

N02AX02

ИНН (Международная Имя):

TRAMADOL HYDROCHLORIDE 50 mg

Фармацевтическая форма:

CAPSULE

состав:

TRAMADOL HYDROCHLORIDE 50 mg

Тип рецепта:

POM

Терапевтические области:

ANALGESICS

Статус Авторизация:

Authorised

Дата Авторизация:

2016-03-21

тонкая брошюра

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE
PATIENT
TRAMADOL 50 MG CAPSULES
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. Do not pass it on to
others. It may harm them, even if their symptoms 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 TRAMADOL IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRAMADOL
3.
HOW TO TAKE TRAMADOL
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE TRAMADOL
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT TRAMADOL IS AND WHAT IT IS USED FOR
Tramadol 50 mg Capsules contain the active substance tramadol
hydrochloride, which belongs to a group of medicines
called opioid analgesics.
These act on specific nerve cells of the spinal cord and brain.
Tramadol is used to relieve moderate to severe pain.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRAMADOL
DO NOT TAKE TRAMADOL AND TELL YOUR DOCTOR IF YOU:
•
are allergic to tramadol hydrochloride, or any of the other
ingredients of these capsules (listed in section 6)
•
have recently taken alcohol,
medicines to help you sleep, other pain killers or medicines that
affect your mood and
behaviour
•
have taken medicines known as monoamine oxidase inhibitors (MAOIs) to
treat depression within the last 14 days
(see “Other medicines and Tramadol”)
•
suffer from epilepsy and your fits are not well controlled by
treatment
•
are undergoing treatment to withdraw from the use of narcotics
WARNINGS AND PRECAUTIONS
Talk to your doctor before taking Tramadol if you:
•
think that you are addicted to other pain relievers (opioids)
•
suffer from consciousness disorders (if you feel that you are going to
faint)
�

Характеристики продукта

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1
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12
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Tramadol 50 mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 50 mg tramadol hydrochloride. For a
full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsule, hard
An opaque hard gelatine capsule, with a yellow body and a yellow cap.
The size of the
capsule is about 14.4 mm.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of moderate to severe pain.
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.
The total daily dose of 400 mg active substance should not be
exceeded,
except in
special clinical circumstances.
Unless otherwise prescribed, tramadol should be administered as
follows:
_Adults and Children aged 12 years and over_
Acute Pain: An initial dose of 100 mg is usually necessary. This can
be followed by doses
of 50 or 100 mg not more frequently at 4-6 hourly intervals, and
duration of therapy
should be matched to clinical need.
Pain Associated with Chronic Conditions: Use an initial dose of 50 mg
and then titrate
dose according to pain severity. The need for continued treatment
should be assessed at
regular
intervals
as
withdrawal
symptoms
and
dependence
have
been
reported (See
section 4.4).
_Children_
Tramadol capsules are not suitable for children below the age of 12
years.
_Elderly patients_
A dose adjustment is not usually necessary in patients up to 75 years
without
clinically
manifest hepatic or renal insufficiency. In elderly patients over 75
years
elimination
may be prolonged. Therefore, if necessary the dosage interval is to be
extended according
to the patient's requirements.
Page
2
of
12
_Patients with renal and/or hepatic impairment_
In
patients
with
renal
and/or
hepatic
insufficiency
the
elimination
of
tramadol
is
delayed.
In
these
patients
prolongation
of
the
dosage
intervals
should
be
care