Tramadol Aurobindo 50mg capsules, hard

Země: Malta

Jazyk: angličtina

Zdroj: Medicines Authority

Aktivní složka:

TRAMADOL HYDROCHLORIDE

Dostupné s:

Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta

ATC kód:

N02AX02

INN (Mezinárodní Name):

TRAMADOL HYDROCHLORIDE 50 mg

Léková forma:

HARD CAPSULE

Složení:

TRAMADOL HYDROCHLORIDE 50 mg

Druh předpisu:

POM

Terapeutické oblasti:

ANALGESICS

Stav Autorizace:

Authorised

Datum autorizace:

2012-12-17

Informace pro uživatele

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PACKAGE LEAFLET: INFORMATION FOR THE USER
TRAMADOL AUROBINDO 50 MG CAPSULES, HARD
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 Tramadol Aurobindo is and what it is used for
2.
What you need to know before you take Tramadol Aurobindo
3.
How to take Tramadol Aurobindo
4.
Possible side effects
5. How to store Tramadol Aurobindo
6.
Contents of the pack and other information
1.
WHAT TRAMADOL AUROBINDO IS AND WHAT IT IS USED FOR
Tramadol hydrochloride - the active substance in Tramadol Aurobindo -
is a painkiller
belonging to the class of opioids that acts on the central nervous
system. It relieves pain by
acting on specific nerve cells of the spinal cord and brain.
Tramadol Aurobindo is used for the treatment of moderate to severe
pain.
You must talk to a doctor if you do not feel better or if you feel
worse after number of days.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRAMADOL AUROBINDO
DO NOT TAKE TRAMADOL AUROBINDO
-
if you are allergic to active substance or any of the other
ingredients of this medicine
(listed in section 6).
-
if you are under the influence of alcohol or sedative drugs including
sleeping pills, other
pain-killers or tranquiliser medicines
-
if
you
are
taking,
or
have
taken
in
the
last
two
weeks,
certain
medicines
called
“monoamine
oxidase
inhibitors”
or
MAOIs
(used
to
treat
e.g.
depression,
and
the
antibiotic linezolid). The combination could result in a serious,
potentially life threatening
interaction
-
if you have epilepsy that is n

Charakteristika produktu

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Tramadol Aurobindo 50 mg capsules, hard
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 50 mg tramadol hydrochloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, hard
Green/ Yellow, size ‘4’ hard gelatin capsules filled with white to
off-white powder and
imprinted with ‘T’ on green cap and ‘02’ on yellow body with
black ink.
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.
Unless otherwise prescribed, Tramadol should be administered as
follows:
ADULTS AND CHILDREN AGED 12 YEARS AND OVER
Oral administration
ACUTE PAIN:
An initial dose is 50-100 mg depending on the intensity of pain. This
can be
followed by doses of 50 or 100 mg 4-6 hours later, and duration of
therapy should be
matched to clinical need need (see section 5.1). A total daily dose of
400 mg should not be
exceeded except in special clinical circumstances.
PAIN ASSOCIATED WITH CHRONIC CONDITIONS:
Use an initial dose of 50 mg and then titrate dose
according to pain severity. The initial dose may be followed if
necessary by 50-100 mg every
4-6 hours. The recommended doses are intended as a guideline. Patients
should always
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receive the lowest dose that provides effective pain control. A total
daily dose of 400 mg
should not be exceeded except in special clinical circumstances. The
need for continued
treatment should be assessed at regular intervals as withdrawal
symptoms and dependence
have been reported (see section 4.4).
The
capsules
are
to
be
taken
whole,
not
divided
or
chewed,
with
sufficient
liquid,
independent of meals.
Tramadol
should
under
no
circumstances
be
administered
for
longer
than
absolutely
necessary. If long-term