Trabest 37.5mg325mg Tablets

البلد: ماليزيا

اللغة: الإنجليزية

المصدر: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

العنصر النشط:

Paracetamol; TRAMADOL HYDROCHLORIDE

متاح من:

Generic Health Sdn. Bhd.

INN (الاسم الدولي):

Paracetamol; TRAMADOL HYDROCHLORIDE

الوحدات في الحزمة:

10tablet Tablets; 30 Tablets

المصنعة من قبل:

LUPIN LIMITED

نشرة المعلومات

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
TRABEST 37.5MG/325MG FILM COATED TABLETS
Tramadol/Paracetamol (37.5mg/325mg)
1
WHAT IS IN THE LEAFLET
1.
What Trabest Tablet is used for
2.
How Trabest Tablet works
3.
Before you take Trabest Tablet
4.
How to take Trabest Tablet
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Trabest
Tablet
8.
Product Description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of revision
WHAT TRABEST TABLET IS USED FOR
This
medicine
is
intended
for
the
management
of
moderate
to
severe
pain when your doctor recommends
that a combination of tramadol and
paracetamol is needed.
This medicine should only be taken by
adults and adolescents over 16 years of
age.
HOW TRABEST TABLET WORKS
Trabest
is
a
combination
of
two
analgesics, Tramadol and Paracetamol,
which act together to relieve your pain.
BEFORE YOU TAKE TRABEST TABLET
-
_When you must not take it _
•
If you are allergic or have had an
allergic reaction (such as skin rash,
swelling of the face, wheezing or
difficulty
breathing)
to
paracetamol, tramadol or any of
the
other
ingredients
of
this
medicine (listed in section 6).
•
In
cases
of
acute
alcohol
poisoning.
•
If you are taking sleeping pills,
pain
relievers
or
medicines
that
affect mood and emotions.
•
If you are also taking medicines
called
monoamine
oxidase
inhibitors (MAOIs) or have taken
MAOIs in the last 14 days, before
starting
treatment
with
Trabest.
MAOIs are used in the treatment of
depression or Parkinson's disease.
•
If you have a severe liver disorder.
•
If you have epilepsy that is not
adequately
controlled
by
your
current medicine.
-
_Before you start to take it _
Follow all instructions given to you
by your doctor carefully, even if they
differ
from
the
information
contained in this leaflet.
-
_Taking other medicines _
Tell your doctor or pharmacist if you
are taking, have recently taken or
might
take
any
other
medicines,
including
medicines
obtained
without a prescription. Your doctor
will tell you which medicines

خصائص المنتج

XXXX
XXXXXX
Each film coated tablet contains:
Tramadol Hydrochloride …...37.5 mg
Paracetamol .…………….…..325 mg
PHARMACEUTICAL DOSAGE FORM AND DESCRIPTION
Film Coated Tablet
Pale yellow, capsule shaped, film-coated tablet, debossed with "TP"
on one side and plain on the other side.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Tramadol and Paracetamol tablets are indicated for the management of
moderate to severe pain.
POSOLOGY AND METHOD OF ADMINISTRATIONS
Posology:
Tramadol and Paracetamol should under no circumstances be administered
for longer than is strictly necessary. If repeated use or long term
treatment with Tramadol and Paracetamol is
required as a result of the nature and severity of the illness, then
careful, regular monitoring should take place (with breaks in the
treatment, where possible), to assess whether continuation
of the treatment is necessary.
_Adults and Children Over 16 Years _
The maximum single dose of Tramadol and Paracetamol is 1 to 2 tablets
every 4 to 6 hours as needed for pain relief up to a maximum of 8
tablets per day.
Tramadol and Paracetamol can be administered without regard to food.
_Pediatric (Children Below 16 Years): _
The effective and safe use of Tramadol and Paracetamol has not been
established in children below the age of 16 years. Treatment is
therefore not recommended in this population.
_Elderly (Geriatric) patients: _
The usual dosages may be used, although it should be noted that in
volunteers aged over 75 years, the elimination half life of tramadol
was increased by 17% following oral administration.
In patients over 75 years old, it is recommended that the minimum
interval between doses should be not less than 6 hours, due to the
presence of tramadol.
Method of administration:
Oral use.
Tablets must be swallowed whole, with a sufficient quantity of liquid.
They must not be broken or chewed.
CONTRA-INDICATIONS
Hypersensitivity to tramadol, paracetamol or to any of the excipients
of the medicinal product.
Acute intoxication with alcohol, hypnotic dru