TRAMADOLOR 50 CAPSULE

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

TRAMADOL HYDROCHLORIDE

Boleh didapati daripada:

IMEKS PHARMA SDN. BHD.

INN (Nama Antarabangsa):

TRAMADOL HYDROCHLORIDE

Unit dalam pakej:

50Capsule Capsules; 100Capsule Capsules; 10Capsule Capsules; 30Capsule Capsules

Dikeluarkan oleh:

Salutas pharma GmbH

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
TRAMADOLOR
® 50 CAPSULES
Tramadol HCl (50 mg)
_ _
1
WHAT IS IN THE LEAFLET
1.
What
TRAMADOLOR
®
is used for
2.
How
TRAMADOLOR
®
works
3.
Before you use
TRAMADOLOR
®
4.
How to use
TRAMADOLOR
®
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
TRAMADOLOR
®
8.
Product Description
9.
Manufacturer and Product Registration
Holder
10.
Date of Revision
WHAT TRAMADOLOR
®
IS USED FOR
TRAMADOLOR
®
contains the active ingredient
Tramadol hydrochloride. It is used to treat
moderate to severe pain.
HOW TRAMADOLOR
®
WORKS
TRAMADOLOR
®
is classified as a pain reliever
medicine. It works by blocking a chemical
messenger
from
reaching
the
brain
to
interpret
pain.
The
chemical
messenger
called prostaglandin is secreted by injured or
damaged cell.
BEFORE YOU USE TRAMADOLOR
®
_ _
_- _
_When you must not use it_
Do not take
TRAMADOLOR
®
if you:
•
Have
allergic
reaction
to
the
active
ingredient Tramadol hydrochloride or to any
other ingredients in this product.
• Recently take large amount of alcohol.
• Taking any other pain killers.
• Taking any medicines that may affect your
alertness or mood including medicines for
psychiatry problems.
•
Taking
monoamine
oxidase
(MAO)
inhibitors
or
within
two
weeks
of
their
withdrawal
• In acute poisoning with alcohol, hypnotics,
centrally analgesics, opioids, or psychotropic
medicinal products
• Are less than 12 years old
• Have slow or shallow breathing, or other
breathing problems.
• Are pregnant
• Are breastfeeding.
_If you are not sure whether you should start _
_taking this medicine, consult your doctor._
-
_Before you start to use it _
Tell your doctor if you:
• Have thyroid hormone deficiency.
• Have adrenal insufficiency (adrenal gland
not producing enough of its hormone)
• Have history of head injury or increase
pressure inside the skull.
• Have history with seizure.
• Have respiratory problem.
• Have opioids dependency.
• Have abdominal problems.
• Have liver and kidney pro

Ciri produk

Directions for Use
Please Read Carefully!
Tramadolor
®
50
Capsules
Tramadolor 50 Capsule
(Active Ingredient: Tramadol HCI 50mg)
DESCRIPTION
Snap-fit, green cap and yellow body, hard gelatine capsule
(size 3), containing a white odourless
powder.
CLINICAL PARTICULARS
Indications
Management of moderate to severe pain.
Mode of Administration
Oral
Recommended Dosage
Unless otherwise prescribed, the following dosage guidelines
apply:
Tramadol should not in any circumstances be used longer than
therapeutically absolutely necessary.
If the nature and severity of the disease makes more prolonged
analgesic treatment with tramadol necessary, a regular, careful
and frequent check should be carried out (possibly by the use of
treatment-free intervals) to determine whether and to what
extent a medical requirement still exists.
Tramadol should be adjusted to the severity of pain and the
patient’s
individual
sensitivity.
For
moderately
severe
pain,
tramadol should be given at the following dosage:
Adults and adolescents (12 years and older)
Tramadolor
®
50 is not approved for use in patients below 12
years old.
1-2
capsules
Tramadolor
®
50,
equivalent
to
50-100mg
tramadol
hydrochloride.
Single
oral
dose
of
tramadol
hydrochloride ranging from 50 – 200mg have provided relief of
postoperative pain in patients who have undergo various types
of surgery.
If a dose of 1 capsule of Tramadolor
®
50 is not followed by
adequate pain relief within 30-60 minutes, a single second dose
of 1 capsule of
Tramadolor
®
50 may be given.
In severe pain, if clinical experience suggests that a higher
analgesic dose is likely to be required, the initial dose may be 2
capsules
Tramadolor
®
50.
Not suitable for children weighing less than 25kg and cannot
usually dosed individually for children under 14 years. An oral
solution and an injectable solution are available for this purpose.
The duration of action of tramadol hydrochloride is an average
of
4-8
hours,
depending
on
the
severity
of
pain,
when
therapeutic doses are given.
Daily doses of up