FENTORA fentanyl (as citrate) 200 microgram orally disintegrating tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
19-08-2021
Summary of Product characteristics
(SPC)
19-08-2021
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
fentanyl citrate, Quantity: 314 microgram (Equivalent: fentanyl, Qty 200 microgram)
Available from:
Teva Pharma Australia Pty Ltd
INN (International Name):
Fentanyl citrate
Pharmaceutical form:
Tablet, orally disintegrating
Composition:
Excipient Ingredients: magnesium stearate; sodium bicarbonate; mannitol; citric acid; sodium starch glycollate type A; sodium carbonate
Administration route:
Buccal
Units in package:
28, 4
Prescription type:
(S8) Controlled Drug
Therapeutic indications:
Fentora is indicated for the treatment of breakthrough pain (BTP) in adults with cancer who are already receiving maintenance opioid therapy for chronic cancer pain.
Product summary:
Visual Identification: White to off-white, flat-faced, round, bevelled tablet, debossed with "C" on one side and with "2" on the other side; Container Type: Blister Pack; Container Material: Other composite material; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Authorization status:
Licence status A
Authorization date:
2015-03-06
Patient Information leaflet
FENTORA
®
_ORALLY DISINTEGRATING TABLETS_
_Fentanyl (as citrate)_
CONSUMER MEDICINE INFORMATION (CMI)
WARNING
LIMITATIONS OF USE
Fentora 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
Fentora poses risks of abuse, misuse and addiction which can lead to
overdose and death.
Your doctor may you regularly during treatment.
LIFE THREATENING RESPIRATORY DEPRESSION
Fentora 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 Fentora 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 FENTORA
Using Fentora 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 mini-
mise 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 Fentora.
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Fentora. It does not
contain all of 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 your taking Fentora
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING FENTORA, TALK TO YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may want to read it again.
WHAT FENTORA IS USED
FOR
Fentora contains a medicine called
fentanyl citrate. It is a pain-
Read the complete document
Summary of Product characteristics
Based on CCSI 439/19/05/21
Version 5.0
1
AUSTRALIAN PRODUCT INFORMATION – FENTORA (FENTANYL
CITRATE) ORALLY DISINTEGRATING TABLETS
WARNINGS
_LIMITATIONS OF USE _
Because of the risks associated with the use of opioids, FENTORA
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 _
FENTORA 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 FENTORA.
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 FENTORA.
Based on CCSI 439/19/05/21
Version 5.0
2
1
NAME OF THE MEDICINE
Fentanyl citrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
FENTORA (fentanyl citrate) is a synthetic opioid analgesic related to
pethidine and with similar
properties to morphine. Fentanyl citrate is a white, crystalline
pow
Read the complete document
