Valsts: Eiropas Savienība
Valoda: angļu
Klimata pārmaiņas: EMA (European Medicines Agency)
lasmiditan succinate
Eli Lilly Nederland B.V.
N02CC08
lasmiditan
Analgesics
Migraine Disorders
RAYVOW is indicated for the acute treatment of the headache phase of migraine attacks, with or without aura in adults.
Authorised
2022-08-17
29 B. PACKAGE LEAFLET 30 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT RAYVOW 50 MG FILM-COATED TABLETS RAYVOW 100 MG FILM-COATED TABLETS RAYVOW 200 MG FILM-COATED TABLETS lasmiditan This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. 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 RAYVOW is and what it is used for 2. What you need to know before you take RAYVOW 3. How to take RAYVOW 4. Possible side effects 5. How to store RAYVOW 6. Contents of the pack and other information 1. WHAT RAYVOW IS AND WHAT IT IS USED FOR RAYVOW contains the active substance lasmiditan, which is used to treat the headache phase of migraine attacks with or without aura in adults. RAYVOW helps to reduce or get rid of the pain and other symptoms associated with a migraine headache. Pain relief may be felt from as early as 30 minutes after taking RAYVOW. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RAYVOW DO NOT TAKE RAYVOW - if you are allergic to lasmiditan or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Do not take part in activities requiring your full attention, such as driving or operating machinery, within 8 hours of taking each dose of RAYVOW, even if you feel well enough to do so, because it can affect your ability to drive or operate machinery safely. If you cannot do this, you should not take R Izlasiet visu dokumentu
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT RAYVOW 50 mg film-coated tablets RAYVOW 100 mg film-coated tablets RAYVOW 200 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION RAYVOW 50 mg film-coated tablets Each film-coated tablet contains 50 mg lasmiditan (as succinate). RAYVOW 100 mg film-coated tablets Each film-coated tablet contains 100 mg lasmiditan (as succinate). RAYVOW 200 mg film-coated tablets Each film-coated tablet contains 200 mg lasmiditan (as succinate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). RAYVOW 50 mg film-coated tablets Light grey, oval tablet of 8.9 x 4.9 mm, debossed with “4312” on one side and “L-50” on the other. RAYVOW 100 mg film-coated tablets Light purple, oval tablet of 11.2 x 6.15 mm, debossed with “4491” on one side and “L-100” on the other. RAYVOW 200 mg film-coated tablets Grey, oval tablet of 14.1 x 7.75 mm, debossed with “4736” on one side and “L-200” on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS RAYVOW is indicated for the acute treatment of the headache phase of migraine attacks, with or without aura in adults. 3 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology In general, recommended initial dose in adults is 100 mg lasmiditan for acute treatment of migraine attacks. If necessary, the dose can be increased to 200 mg for greater efficacy or can be decreased to 50 mg for greater tolerability. If the migraine headache recurs within 24 hours of an initial response after taking 50 mg or 100 mg lasmiditan, a second dose of the same strength may be taken. The second dose should not be taken within 2 hours of the initial dose. No more than 200 mg should be taken in 24 hours. Izlasiet visu dokumentu