TRAMAL SR tramadol hydrochloride 50 mg modified release tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

tramadol hydrochloride, Quantity: 50 mg

Available from:

Seqirus Pty Ltd

INN (International Name):

Tramadol hydrochloride

Pharmaceutical form:

Tablet, modified release

Composition:

Excipient Ingredients: purified talc; lactose monohydrate; hypromellose; titanium dioxide; propylene glycol; magnesium stearate; macrogol 6000; colloidal anhydrous silica; iron oxide yellow; microcrystalline cellulose

Administration route:

Oral

Units in package:

60 tablets, 20 tablets, 4 tablets (sample pack)

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Tramal SR is indicated for the management of severe pain where: ? other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and ? the pain is opioid-responsive, and ? requires daily, continuous, long term treatment. Tramal SR is not indicated for use in chronic non-cancer pain other than in exceptional circumstances. Tramal SR is not indicated as an as-needed (PRN) analgesia.

Product summary:

Visual Identification: Pale yellow coloured, round, biconvex, film-coated tablets. Engraved on one side woth "T0" and on the other with the Grunenthal logo.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2006-09-28

Patient Information leaflet

TRAMAL
®
SR CMI
TRAMAL
® SR
TRAMADOL HYDROCHLORIDE
SUSTAINED RELEASE TABLETS
CONSUMER MEDICINE INFORMATION
WARNING
LIMITATIONS OF USE
TRAMAL
®
SR 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
TRAMAL
®
SR 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
TRAMAL
®
SR 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 TRAMAL
®
SR 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 TRAMAL
® SR
USING TRAMAL
® SR 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 TRAMAL
®
SR.
WHAT IS IN THIS LEAFLET?
This leaflet answers some
common questions about
TRAMAL
®
SR. It does not
contain all the available
information. It does not replace
talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you taking
TRAMAL
®
SR against the benefits
this medicine is expected to have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET. You may need
to read it again.
WHAT TRAMAL
® SR IS
USED FOR
TRAMAL
®
SR is used t

Summary of Product characteristics

Page 1 of 31
AUSTRALIAN PRODUCT INFORMATION – TRAMAL [TRAMADOL
HYDROCHLORIDE]
WARNINGS
LIMITATIONS OF USE
Because of the risks associated with the use of opioids, Tramal
®
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
_ _
Tramal
®
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 Tramal
®
.
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 Tramal
®
.
Page 2 of 31
1
NAME OF THE MEDICINE
Tramadol hydrochloride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tramal

(tramadol hydrochloride) immediate release capsules 50 mg
Tramal

(tramadol hydrochloride) solution for injection 50 mg/mL, 100 mg/2 mL
Tramal

SR (tramadol hydrochloride) sustained release tablets 50 mg,