מדינה: האיחוד האירופי
שפה: אנגלית
מקור: EMA (European Medicines Agency)
tasimelteon
Vanda Pharmaceuticals Netherlands B.V.
N05CH
tasimelteon
Psycholeptics
Sleep Disorders, Circadian Rhythm
Hetlioz is indicated for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) in totally blind adults.,
Revision: 9
Authorised
2015-07-03
21 B. PACKAGE LEAFLET 22 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT HETLIOZ 20 MG HARD CAPSULES tasimelteon READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What HETLIOZ is and what it is used for 2. What you need to know before you take HETLIOZ 3. How to take HETLIOZ 4. Possible side effects 5. How to store HETLIOZ 6. Contents of the pack and other information 1. WHAT HETLIOZ IS AND WHAT IT IS USED FOR HETLIOZ contains the active substance tasimelteon. This type of medicine is called a “melatonin agonist” that acts as a regulator of daily body rhythms. It is used to treat Non-24-Hour Sleep-Wake Disorder (Non-24) in adults who are totally blind. HOW HETLIOZ WORKS In sighted people, the change in light levels between day and night helps to synchronise internal body rhythms, including feeling sleepy at night and being active during the day. The body controls these rhythms through many pathways including increases and decreases in the production of the hormone melatonin. Patients with Non-24 who are totally blind cannot see light, so their body rhythms shift out of alignment with the 24-hour world, resulting in periods of feeling sleepy during the day and the inability to sleep at night. The active substance in HETLIOZ, tasimelteon, is able to act as a time-keeper for the body rhythms and resets them each day. It aligns body rhythms with the usual 24-hour day and night cycle and so improve sleep patterns. Because of individual differences in each person’s body rhythms, it could take weeks or up t קרא את המסמך השלם
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT HETLIOZ 20 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 20 mg tasimelteon. Excipients with known effect Each hard capsule contains 183.25 mg of lactose (as anhydrous) and 0.03 mg of Orange Yellow S (E110). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule Dark blue opaque, hard capsule (dimensions 19.4 mm x 6.9 mm) marked with ‘VANDA 20 mg’ in white ink. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS HETLIOZ is indicated for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) in totally blind adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Dose and timing _ The recommended dose is 20 mg (1 capsule) tasimelteon per day taken one hour before bedtime, at the same time every night. HETLIOZ is intended for chronic use. _Elderly _ No dose adjustment is recommended for individuals older than 65 years of age (see section 5.2). _Renal impairment _ No dose adjustment is recommended for patients with renal impairment (see section 5.2). _Hepatic impairment _ 3 No dose adjustment is necessary for patients with mild or moderate hepatic impairment (see section 5.2). Tasimelteon has not been studied in patients with severe hepatic impairment (Child-Pugh Class C); therefore caution is recommended when prescribing tasimelteon to patients with severe hepatic impairment. _ _ _Paediatric population _ The safety and efficacy of tasimelteon in children and adolescents aged 0 to 18 years have not been established. No data are available. Method of administration Oral use. Hard capsules should be swallowed whole. Avoid breaking as the powder has an unpleasant taste. Tasimelteon should be taken without food; if patients eat a high-fat meal, it is recommended to wait at least 2 hours before taking tasimelteon (see section 5.2). 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNIN קרא את המסמך השלם