ABSTRAL fentanyl (as citrate) 400 microgram sublingual tablet blister pack

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Principio attivo:

fentanyl citrate, Quantity: 0.6248 mg (Equivalent: fentanyl, Qty 400 microgram)

Commercializzato da:

A Menarini Australia Pty Ltd

INN (Nome Internazionale):

Fentanyl citrate

Forma farmaceutica:

Tablet

Composizione:

Excipient Ingredients: mannitol; colloidal anhydrous silica; croscarmellose sodium; magnesium stearate; microcrystalline cellulose

Via di somministrazione:

Sublingual

Confezione:

10 tablets, 30 tablets

Tipo di ricetta:

(S8) Controlled Drug

Indicazioni terapeutiche:

ABSTRAL is indicated for the management of breakthrough pain in adults with cancer who are already receiving maintenance opioid therapy for chronic pain. Breakthrough pain is a transient exacerbation of otherwise controlled chronic background pain.

Dettagli prodotto:

Visual Identification: Arc diamond shaped, white, flat-faced, bevel-edged tablet; Container Type: Blister Pack; Container Material: Other composite material; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Stato dell'autorizzazione:

Licence status A

Data dell'autorizzazione:

2013-08-22

Foglio illustrativo

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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
WARNING: Important safety information is provided in a boxed warning
in the full CMI. Read before using this medicine.
1.
WHY AM I TAKING ABSTRAL?
ABSTRAL contains the active ingredient fentanyl (as citrate). ABSTRAL
is a strong pain medicine used to treat breakthrough cancer
pain in adults who are already receiving an effective maintenance dose
of opioid therapy for their underlying cancer pain. For more
information, see Section 1. Why am I taking ABSTRAL? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE ABSTRAL?
Do not take if you have ever had an allergic reaction to fentanyl or
any of the ingredients listed at the end of the CMI. Talk to your
doctor if you have any other medical conditions, take any other
medicines, or are pregnant or plan to become pregnant or are
breastfeeding. For more information, see Section 2. What should I know
before I take ABSTRAL? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with ABSTRAL and affect how it works. A
list of these medicines is in Section 3. What if I am taking
other medicines? in the full CMI.
4.
HOW DO I TAKE ABSTRAL?
•
ABSTRAL sublingual tablet is placed under your tongue until dissolved.
Do not suck, chew or swallow the tablet
•
Do not eat or drink anything until the tablet is completely dissolved.
If needed, you can moisten your mouth by rinsing it with
water before placing the tablet under your tongue.
More instructions can be found in Section 4. How do I take ABSTRAL? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE TAKING ABSTRAL?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are taking
ABSTRAL
•
Carefully follow your doctor's instructions on how much ABSTRAL to
take for each breakthrough pain
episode, especially when you first start taking ABSTRAL or change the
dose
•
Talk to

Scheda tecnica

AUSTRALIAN PRODUCT INFORMATION –
ABSTRAL
® FENTANYL (AS CITRATE)
ABSTRAL_AU_PI_vA10.0
Page 1 of 22
WARNINGS
LIMITATIONS OF USE
Because of the risks associated with the use of opioids, ABSTRAL
(fentanyl citrate sublingual tablets) 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
ABSTRAL 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 ABSTRAL. 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 ABSTRAL.
1.
NAME OF THE MEDICINE
Fentanyl (as citrate)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sublingual tablet contains 100, 200, 300, 400, 600, or 800
micrograms of fentanyl (as
citrate).
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
ABSTRAL fent