Nchi: Israeli
Lugha: Kiingereza
Chanzo: Ministry of Health
FENTANYL AS CITRATE
MEGAPHARM LTD
N01AH01
BUCCAL FILM
FENTANYL AS CITRATE 600 MCG
OROMUCOSAL
Required
MEDA PHARMA GmbH & CO.KG, GERMANY
FENTANYL
Breakyl is indicated for the treatment of breakthrough pain (BTP) in adults with cancer who are already receiving maintenance opioid therapy for chronic cancer pain.BTP is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain.
2015-08-19
Megapharm Ltd. BREAK PIL 012016 P.3 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is to be supplied by physician’s prescription only BREAKYL 200, 400, 600, 800, 1200 MCG_ _ BUCCAL FILM COMPOSITION: ACTIVE INGREDIENT: Fentanyl (as citrate) 200, 400, 600, 800, 1200 mcg. For the full ingredients list see: “Additional information”. _ _ READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains essential information about this medicine. If you have any further questions, refer to the physician or the pharmacist. This medicine has been prescribed to treat your illness. Do not pass it on to others. It may harm them, even if it seems to you that their illness is similar. The medicine is not intended for use in children and adolescents below the age of 18 years. WHAT IS THIS MEDICINE INTENDED FOR? BREAKYL is indicated for the treatment of breakthrough pain (BTP) in adults with cancer who are already receiving maintenance opioid therapy for chronic cancer pain. BTP is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain. You may use BREAKYL only if you are taking other opioids such as morphine, oxycodone or transdermal fentanyl as maintenance opioid therapy for chronic cancer pain for at least 1 week. THERAPEUTIC GROUP: BREAKYL belongs to the group of opioid drugs. BEFORE USING THIS MEDICINE SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE BEFORE THE TREATMENT WITH BREAKYL, TELL YOUR PHYSICIAN IF: • The other opioids taken by you for chronic cancer pain have not yet been stabilised in your body (less than one week)_ _ • You suffer from respiratory problems • You suffer from a head injury and the physician has diagnosed an increased intracranial pressure • You have an abnormally slow heart rate or other heart problems • You have low blood pressure, especially due to a low volume of fluid in the blood circulation DO NOT USE THIS MEDICINE IF: • You are sensitive (allerg Soma hati kamili
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT BREAKYL 200 microgram BREAKYL 400 microgram BREAKYL 600 microgram BREAKYL 800 microgram BREAKYL 1200 microgram BREAKYL Start 200, 400, 600, 800 microgram 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Breakyl 200 microgram buccal film One buccal film contains: 200 micrograms fentanyl (as fentanyl citrate), Breakyl 400 microgram buccal film One buccal film contains: 400 micrograms fentanyl (as fentanyl citrate), Breakyl 600 microgram buccal film One buccal film contains: 600 micrograms fentanyl (as fentanyl citrate), Breakyl 800 microgram buccal film One buccal film contains: 800 micrograms fentanyl (as fentanyl citrate), Breakyl 1200 microgram buccal film One buccal film contains: 1200 micrograms fentanyl (as fentanyl citrate). Excipients with known effect: Breakyl, strength (microgram) Excipient 200 400 600 800 1200 propylene glycol (mg) 0.17 0.35 0.52 0.70 1.04 Sodium benzoate (mg) 0.11 0.23 0.34 0.46 0.69 methyl parahydroxybenzoate (E218) (mg) 0.12 0.24 0.36 0.48 0.71 propyl parahydroxybenzoate (E216) (mg) 0.03 0.06 0.09 0.12 0.18 For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Buccal film Breakyl is a soluble rectangular, flat, flexible buccal film with a pink side and a white side designed to deliver fentanyl directly into the blood circulation. The pink side contains the active substance fentanyl. The white side minimises fentanyl release into the saliva to avoid swallowing of the active substance. The following stencil shows the sizes of the available Breakyl strengths: Microgram microgram microgram microgram microgram 0,78 cm 2 1,56 cm 2 2,34 cm 2 3,11 cm 2 4,67 cm 2 (Dimensions probably incorrect if viewed electronically.) 2 Each buccal film is individually sealed in a child resistant sachet. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Breakyl is indicated for the treatment of breakthrough pain (BTP) in adults with cancer who are already receiving maintenance opioid therapy for chronic cancer pain. BTP is Soma hati kamili