Country: Israel
Language: English
Source: Ministry of Health
FENTANYL AS CITRATE
NEOPHARM LTD, ISRAEL
N01AH01
TABLETS SUBLINGUAL
FENTANYL AS CITRATE 600 MCG
PER OS
Required
KYOWA KIRIN LTD, UK
FENTANYL
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.
2017-09-30
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 Read the complete document
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 Read the complete document