TERRY WHITE CHEMISTS TRAMADOL tramadol hydrochloride 50mg capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

tramadol hydrochloride

Available from:

Apotex Pty Ltd

INN (International Name):

Tramadol hydrochloride

Authorization status:

Registered

Patient Information leaflet

TERRY WHITE CHEMISTS
TRAMADOL
_Contains the active ingredient tramadol hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about tramadol. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet with your medicine.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is Terry
White Chemists Tramadol. It
contains the active ingredient
tramadol hydrochloride.
It is used to treat:
•
moderate to severe pain
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you. Your
doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
Tramadol is not normally addictive,
although some cases have been
reported.
_USE IN CHILDREN_
This medicine should not be used in
children. The safety and
effectiveness of this medicine in
children have not been established.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE THIS MEDICINE IF:
•
You have or have had any of the
following:
-
epilepsy which is not well
controlled
-
known sensitivity to opioids
(such as morphine or codeine).
•
You are taking a class of
medicine known as 'monoamine
oxidase inhibitors' (MAOIs)
(often taken for depression), or
you have taken such a

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
TERRY WHITE CHEMISTS TRAMADOL
(TRAMADOL
HYDROCHLORIDE) CAPSULES
1
NAME OF THE MEDICINE
Tramadol Hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The capsules_ _contain 50 mg tramadol hydrochloride as the active
ingredient.
EXCIPIENTS WITH KNOWN EFFECT
Methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216), gelatin
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Hard gelatin capsules having green cap and yellow body filled with a
homogeneous white to
off-white powder.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Relief of moderate to severe pain.
4.2
DOSE AND METHOD OF ADMINISTRATION
The dose of tramadol should be titrated according to the severity of
the pain and the clinical
response of the individual patient. Tramadol is approved for use in
adults and adolescents over
the age of 12 years.
The recommended dosage of Terry White Chemists Tramadol capsules is as
follows:
For the treatment of moderate pain, 50 mg to 100 mg of tramadol
administered orally, two or
three times daily may be sufficient. An initial dose of 50 mg of
tramadol may be sufficient for
moderate pain.
For moderate to severe pain, oral doses of 50 mg to 100 mg of
tramadol, as needed for pain
relief, every four to six hours may be administered. A 100 mg initial
dose of tramadol is usually
more effective for more severe pain.
The maximum daily dose should not exceed 400 mg per day.
2
DOSAGE
PAEDIATRIC USE
Use of tramadol is not recommended as safety and efficacy in children
have not been
established.
USE IN THE ELDERLY
In subjects over the age of 75 years, serum concentrations are
slightly elevated and the
elimination half life is slightly prolonged. Subjects in this age
group are also expected to vary
more widely in their ability to tolerate adverse drug effects. Daily
doses in excess of 300 mg
are not recommended in patients over 75 years.
RENAL IMPAIRMENT
In patients with renal insufficiency the elimination of tramadol is
delayed. In these patients
prol