PALEXIA IR tapentadol (as hydrochloride) 75 mg tablet blister pack

Država: Australija

Jezik: engleski

Izvor: Department of Health (Therapeutic Goods Administration)

Aktivni sastojci:

tapentadol hydrochloride, Quantity: 87.36 mg (Equivalent: tapentadol, Qty 75 mg)

Dostupno od:

Seqirus Pty Ltd

INN (International ime):

tapentadol hydrochloride

Farmaceutski oblik:

Tablet, film coated

Sastav:

Excipient Ingredients: macrogol 3350; polyvinyl alcohol; iron oxide red; croscarmellose sodium; purified talc; lactose monohydrate; titanium dioxide; microcrystalline cellulose; povidone; magnesium stearate; iron oxide yellow

Administracija rute:

Oral

Jedinice u paketu:

14 tablets, 5 tablets, 90 tablet, 10 tablet, 30 tablet, 56 tablets, 50 tablet, 20 tablet, 60 tablet, 40 tablet, 100 tablet, 28 tablets

Tip recepta:

(S8) Controlled Drug

Terapijske indikacije:

PALEXIA IR is indicated 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.

Proizvod sažetak:

Visual Identification: Pale yellow, round, biconvex, film-coated tablets, engraved with Grunenthal logo on one side and 'H7' 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

Status autorizacije:

Registered

Datum autorizacije:

2010-11-22

Uputa o lijeku

1
PALEXIA
® IR
IMMEDIATE RELEASE TABLETS
Tapentadol (as hydrochloride) _(TA-PEN-TA-DOL)_
CONSUMER MEDICINE INFORMATION (CMI)
WARNING
LIMITATIONS OF USE
PALEXIA
®
IR 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
®
IR 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
®
IR 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
®
IR 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
® IR
Using PALEXIA
®
IR 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
®
IR.
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
PALEXIA
®
IR.
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
®
IR 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

Svojstava lijeka

PALEXIA
®
IR AUST R 165310, 165317, 165318
Page 1 of 30
AUSTRALIAN PRODUCT INFORMATION – PALEXIA
® IR
(TAPENTADOL (AS HYDROCHLORIDE)) IMMEDIATE RELEASE TABLETS
WARNINGS
LIMITATIONS OF USE
Because of the risks associated with the use of opioids, PALEXIA
®
IR
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
®
IR
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
®
IR. 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
®
IR.
PALEXIA
®
IR AUST R 165310, 165317, 165318
Page 2 of 30
1
NAME OF THE MEDICINE
Tapentadol (as hydrochloride)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
PALEXIA
®
IR tablets contain 50, 75 or 100 mg tapentadol (as hydrochloride).