PALEXIA SR tapentadol (as hydrochloride)150 mg sustained release tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

tapentadol hydrochloride, Quantity: 174.72 mg (Equivalent: tapentadol, Qty 150 mg)

Available from:

Seqirus Pty Ltd

INN (International Name):

tapentadol hydrochloride

Pharmaceutical form:

Tablet, modified release

Composition:

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

Administration route:

Oral

Units in package:

60 tablet, 7 tablets, 14 tablets, 20 tablet, 100 tablet, 56 tablets, 28 tablets, 30 tablet, 50 tablet, 10 tablet, 90 tablet, 40 tablet

Prescription type:

(S8) Controlled Drug

Therapeutic indications:

PALEXIA 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. PALEXIA SR is not indicated for use in chronic non-cancer pain other than in exceptional circumstances. PALEXIA SR is not indicated as an as-needed (PRN) analgesia.

Product summary:

Visual Identification: Pale pink, film-coated, oblong-shaped tablets, engraved with Grunenthal logo on one side and 'H3' on the other side; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2011-01-19

Patient Information leaflet

1
PALEXIA
® SR
SUSTAINED RELEASE TABLETS
Tapentadol (as hydrochloride) _(TA-PEN-TA-DOL)_
CONSUMER MEDICINE INFORMATION (CMI)
WARNING
LIMITATIONS OF USE
PALEXIA
®
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
PALEXIA
®
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
PALEXIA
®
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 PALEXIA
®
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 PALEXIA
® SR
Using PALEXIA
®
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 PALEXIA
®
SR.
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
PALEXIA
®
SR.
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 having
PALEXIA
®
SR against the
benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS
ABOUT THIS MEDICINE, ASK YOUR
DOCTOR, NURSE OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to
read it again.
WHAT PAL

Summary of Product characteristics

PALEXIA
®
SR Product Information
AUST R 165332, 165346, 165347, 165356, 165357, 229737
Page 1
AUSTRALIAN PRODUCT INFORMATION – PALEXIA
® SR
(TAPENTADOL (AS HYDROCHLORIDE)) SUSTAINED RELEASE TABLETS
WARNINGS
LIMITATIONS OF USE
Because of the risks associated with the use of opioids, PALEXIA
®
SR
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
PALEXIA
®
SR
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 PALEXIA
®
SR. 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 PALEXIA
®
SR.
PALEXIA
®
SR Product Information
AUST R 165332, 165346, 165347, 165356, 165357, 229737
Page 2
1
NAME OF THE MEDICINE
Tapentadol (as hydrochloride)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ea