ABSTRAL 800 MCG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

FENTANYL AS CITRATE

Available from:

NEOPHARM LTD, ISRAEL

ATC code:

N01AH01

Pharmaceutical form:

TABLETS SUBLINGUAL

Composition:

FENTANYL AS CITRATE 800 MCG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

KYOWA KIRIN LTD, UK

Therapeutic area:

FENTANYL

Therapeutic indications:

Management of breakthrough pain in adult patients using opioid therapy for chronic cancer pain. Breakthrough pain is a transient exacerbation of otherwise controlled chronic background pain.

Authorization date:

2017-09-30

Patient Information leaflet

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) - 1986
This medicine is to be supplied upon a doctor's prescription only
ABSTRAL
 100 MCG
ABSTRAL
 400 MCG
ABSTRAL
 200 MCG
ABSTRAL
 600 MCG
ABSTRAL
 300 MCG
ABSTRAL
 800 MCG
SUBLINGUAL TABLETS
COMPOSITION:
Each tablet contains:
The active ingredient and its quantity:
ABSTRAL 100 MCG: Fentanyl (as citrate) 100 mcg
ABSTRAL 200 MCG: Fentanyl (as citrate) 200 mcg
ABSTRAL 300 MCG: Fentanyl (as citrate) 300 mcg
ABSTRAL 400 MCG: Fentanyl (as citrate) 400 mcg
ABSTRAL 600 MCG: Fentanyl (as citrate) 600 mcg
ABSTRAL 800 MCG: Fentanyl (as citrate) 800 mcg
INACTIVE
INGREDIENTS
AND
ALLERGENS:
see
section
6
of
this
leaflet:
"ADDITIONAL
INFORMATION".
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet
contains concise information about the medicine. If you have any
further questions, ask
your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them
even if it seems to you that their illness is similar to yours. This
medicine is intended for
adults above 18 years of age.
●
Taking this medicine with benzodiazepines or other medications which
suppress the
central nervous system (including narcotics) or alcohol may result in
profound sedation,
breathing difficulties (respiratory depression), coma and death.
●
Opiates could cause addiction, especially in prolonged use, and may
potentially lead
to abuse and overdose. A response to overdose could result in slow
breathing and
even cause death. Make sure you know the name of the medicine, the
dose you are
taking, administration frequency, duration of treatment, side effects
and potential risks.
Additional information related to the risk of dependence and addiction
can be found at
the following link:
https://www.health.gov.il/UnitsOffice/HD/MTI/Drugs/risk/DocLib/opioids_en.pdf
1.
WHAT IS THE MEDICINE INTENDED FOR?
_ _
Abstral is intended for the treatment of breakthrough pain in
oncologic patients who

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
.
NAME OF THE MEDICINAL PRODUCT
ABSTRAL
 100 MCG
- sublingual tablets
ABSTRAL
 200 MCG
- sublingual tablets
ABSTRAL
 300 MCG
- sublingual tablets
ABSTRAL
 400 MCG
- sublingual tablets
ABSTRAL
 600 MCG
- sublingual tablets
ABSTRAL
 800 MCG
- sublingual tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sublingual tablet contains:
100 micrograms fentanyl (as citrate)
200 micrograms fentanyl (as citrate)
300 micrograms fentanyl (as citrate)
400 micrograms fentanyl (as citrate)
600 micrograms fentanyl (as citrate)
800 micrograms fentanyl (as citrate)
For the full list of excipients, see section 6.1.
3
.
PHARMACEUTICAL FORM
Sublingual tablet
100 microgram sublingual tablet is a white round tablet
200 microgram sublingual tablet is a white oval-shaped tablet
300 microgram sublingual tablet is a white triangle-shaped tablet
400 microgram sublingual tablet is a white diamond-shaped tablet
600 microgram sublingual tablet is a white “D”-shaped tablet
800 microgram sublingual tablet is a white capsule-shaped tablet
WARNING:
LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; RISK
FROM CYTOCHROME P450 3A4 INTERACTION; RISKS FROM CONCOMITANT USE
WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; RISK OF MEDICATION
ERRORS; ADDICTION, ABUSE, AND MISUSE; AND NEONATAL OPIOID WITHDRAWAL
SYNDROME
LIFE-THREATENING RESPIRATORY DEPRESSION
SERIOUS, LIFE-THREATENING AND/OR FATAL RESPIRATORY DEPRESSION HAS
OCCURRED IN PATIENTS TREATED WITH
ABSTRAL, INCLUDING FOLLOWING USE IN OPIOID NON-TOLERANT PATIENTS AND
IMPROPER DOSING. MONITOR
FOR RESPIRATORY DEPRESSION, ESPECIALLY DURING INITIATION OF ABSTRAL OR
FOLLOWING A DOSE INCREASE.
THE SUBSTITUTION OF ABSTRAL FOR ANY OTHER FENTANYL PRODUCT MAY RESULT
IN FATAL OVERDOSE _[SEE _
_SPECIAL WARNINGS AND PRECAUTIONS FOR USE (4.4)]. _
DUE TO THE RISK OF RESPIRATORY DEPRESSION, ABSTRAL IS CONTRAINDICATED
IN THE MANAGEMENT OF
ACUTE OR POSTOPERATIVE PAIN INCLUDING HEADACHE/MIGRAINE AND IN OPIOID
NON-TOLERANT PATIENTS.
ACCIDENTAL IN