APO-TRAMADOL tramadol hydrochloride 50mg capsule blister pack

Страна: Австралія

мова: англійська

Джерело: Department of Health (Therapeutic Goods Administration)

Активний інгредієнт:

tramadol hydrochloride, Quantity: 50 mg

Доступна з:

Arrotex Pharmaceuticals Pty Ltd

ІПН (Міжнародна Ім'я):

Tramadol hydrochloride

Фармацевтична форма:

Capsule

Склад:

Excipient Ingredients: Gelatin; indigo carmine aluminium lake; magnesium stearate; colloidal anhydrous silica; propyl hydroxybenzoate; methyl hydroxybenzoate; sodium lauryl sulfate; titanium dioxide; iron oxide yellow; sodium starch glycollate; microcrystalline cellulose

Адміністрація маршрут:

Oral

Одиниць в упаковці:

6, 8, 10 and 20

Тип рецепту:

(S4) Prescription Only Medicine

Терапевтичні свідчення:

For the short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain.

Огляд продуктів:

Visual Identification: hard gelatin capsules, size 3, having green cap and yellow body filled with a homogeneous white to off-white powder; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Статус Авторизація:

Licence status A

Дата Авторизація:

2010-04-09

інформаційний буклет

APO-TRAMADOL
1
APO-TRAMADOL
_Contains the active ingredient tramadol hydrochloride _
CONSUMER MEDICINE INFORMATION
WARNING
LIMITATIONS OF USE
TRAMADOL should only be used when your doctor decides that other
treatment options are not able to effectively manage
your pain or you cannot tolerate them.
HAZARDOUS AND HARMFUL USE
TRAMADOL poses risks of abuse, misuse and addiction which can lead to
overdose and death. Your doctor will monitor you
regularly during treatment.
LIFE THREATENING RESPIRATORY DEPRESSION
TRAMADOL can cause life-threatening or fatal breathing problems (slow,
shallow, unusual or no breathing) even when used
as recommended. These problems can occur at any time during use, but
the risk is higher when first starting TRAMADOL and
after a dose increase, if you are older, or have an existing problem
with your lungs. Your doctor will monitor you and change
the dose as appropriate.
USE OF OTHER MEDICINES WHILE USING TRAMADOL
USING TRAMADOL WITH OTHER MEDICINES THAT CAN MAKE YOU FEEL DROWSY SUCH
AS SLEEPING TABLETS (E.G. BENZODIAZEPINES),
OTHER PAIN RELIEVERS, ANTIHISTAMINES, ANTIDEPRESSANTS, ANTIPSYCHOTICS,
GABAPENTINOIDS (E.G. GABAPENTIN AND PREGABALIN),
CANNABIS AND ALCOHOL MAY RESULT IN SEVERE DROWSINESS, DECREASED
AWARENESS, BREATHING PROBLEMS, COMA AND DEATH.
Your doctor will minimise the dose and duration of use; and monitor
you for signs and symptoms of breathing difficulties and
sedation. You must not drink alcohol while using TRAMADOL.
_ _
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about this medicine. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it a

Характеристики продукта

1
AUSTRALIAN PRODUCT INFORMATION
APO-TRAMADOL
(TRAMADOL HYDROCHLORIDE)
CAPSULES
WARNINGS
LIMITATIONS OF USE
Because of the risks associated with the use of opioids, APO-Tramadol
should only be used in
patients for whom other treatment options, including non-opioid
analgesics, are ineffective,
not tolerated or otherwise inadequate to provide appropriate
management of pain (see section
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE).
HAZARDOUS AND HARMFUL USE
APO-Tramadol poses risks of hazardous and harmful use which can lead
to overdose and death.
Assess the patient’s risk of hazardous and harmful use before
prescribing and monitor the
patient regularly during treatment (see section 4.4. SPECIAL WARNINGS
AND
PRECAUTIONS FOR USE).
LIFE THREATENING RESPIRATORY DEPRESSION
Serious, life-threatening or fatal respiratory depression may occur
with the use of APO-
Tramadol.
Be aware of situations which increase the risk of respiratory
depression, modify dosing in
patients at risk and monitor patients closely, especially on
initiation or following a dose
increase (see section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE).
CONCOMITANT USE OF BENZODIAZEPINES AND OTHER CENTRAL NERVOUS SYSTEM
(CNS)
DEPRESSANTS, INCLUDING ALCOHOL
Concomitant use of opioids with benzodiazepines, gabapentinoids,
antihistamines, tricyclic
antidepressants, antipsychotics, cannabis or other central nervous
system (CNS) depressants,
including alcohol, may result in profound sedation, respiratory
depression, coma, and death.
Limit dosages and durations to the minimum required; and monitor
patients for signs and
symptoms of respiratory depression and sedation. Caution patients not
to drink alcohol while
taking APO-Tramadol.
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
Hydroxybenzoates and sulfites
2
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Hard gelatin ca