RAYVOW 100 mg FILM-COATED TABLETS
How to use RAYVOW 100 mg FILM-COATED TABLETS
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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.
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Introduction
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, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of section 4 will tell you 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.
Contents of the pack
- What is RAYVOW and what is it used for
- What you need to know before you take RAYVOW
- How to take RAYVOW
- Possible side effects
- Storage of RAYVOW
- Contents of the pack and other information
1. What is RAYVOW and what is it 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 eliminate the pain and other symptoms associated with migraine. Pain relief can be felt even 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 engage in activities that require your full attention, such as driving or operating machinery, within 8 hours after taking each dose of RAYVOW, even if you feel well enough to do so, because it may affect your ability to drive or operate machinery safely. If you cannot do so, you should not take RAYVOW.
Consult your doctor or pharmacist before starting to take RAYVOW if:
- you are taking medicines that increase serotonin levels (see “Other medicines and RAYVOW”). These medicines increase the risk of side effects such as serotonin syndrome (a rare reaction that can cause mental changes, such as seeing things that do not exist (hallucinations), agitation or coma; rapid heartbeat; changes in blood pressure; high body temperature; muscle stiffness; difficulty walking; nausea, vomiting or diarrhea).
- you are taking other medicines or substances that cause drowsiness, such as sleeping pills, medicines for psychiatric disorders or alcohol.
- you have ever been addicted to prescription medicines, alcohol or other drugs.
If you repeatedly use any medicine for the treatment of migraine for several days or weeks, this may cause you to have daily headaches in the long term. Tell your doctor if you experience this, as it may be necessary to interrupt treatment for a while.
Children and adolescents
RAYVOW should not be given to patients under 18 years of age because there is not enough information on how it works in this age group.
Other medicines and RAYVOW
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, tell your doctor or pharmacist before taking RAYVOW if you are taking:
- medicines that reduce heart rate, such as propranolol
- medicines that increase serotonin levels (including SSRIs, SNRIs, tricyclic antidepressants, monoamine oxidase inhibitors (MAOIs) or triptans)
- digoxin (used to treat heart disorders)
Taking RAYVOW with alcohol
Caution should be exercised if you drink alcohol while taking RAYVOW.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. It is not known if RAYVOW will harm your unborn baby. RAYVOW is not recommended during pregnancy.
If you are breastfeeding, ask your doctor for advice before taking this medicine. It is not known if lasmiditan passes into breast milk. Breastfeeding should be avoided for 24 hours after treatment to minimize the amount of lasmiditan that is passed to your baby.
It is not known if RAYVOW affects fertility.
Driving and using machines
RAYVOW affects your ability to drive and use machines. Do not engage in activities that require your full attention, such as driving or operating machinery, for at least 8 hours after taking each dose of lasmiditan, even if you feel well enough to do so. If you cannot do so, you should not take RAYVOW.
RAYVOW contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.
3. How to take RAYVOW
Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.
- The recommended initial dose is 100 mg of lasmiditan. Your doctor will decide which dose of lasmiditan is suitable for you.
- If you do not stop feeling pain after the first tablet, do not take a second tablet for the same attack as it is unlikely to be effective.
- If after a first tablet of 50 mg or 100 mg your migraine is completely resolved and then recurs, you can take a second tablet of the same dose no earlier than 2 hours after the first dose.
- Do not take more than 200 mg in 24 hours.
- If your dose of 100 mg does not relieve your migraine or causes side effects, talk to your doctor, who may recommend a higher dose (200 mg) or a lower dose (50 mg).
Use in children and adolescents and patients with hepatic impairment
RAYVOW is not recommended in children and adolescents (under 18 years of age) or in patients with severe liver problems.
Method of administration
RAYVOW is for oral use. You should swallow your tablet with a little water during the headache phase of your migraine attack. You can take the tablet with or without food.
If you take more RAYVOW than you should
If you take more RAYVOW than you should, contact your doctor immediately. You may develop some of the side effects described in section 4.
If you forget to take RAYVOW
RAYVOW is indicated for the acute treatment of migraines and should only be taken when needed.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediatelyif you experience any of the following serious side effects after taking this medicine:
- allergic reactions including rash and swelling of the eyelids, face or lips (uncommon)
- signs and symptoms of serotonin syndrome, a rare reaction that can cause mental changes, such as seeing things that do not exist (hallucinations), agitation or coma; rapid heartbeat; changes in blood pressure; high body temperature; muscle stiffness; difficulty walking; gastrointestinal symptoms such as nausea, vomiting or diarrhea.
Other side effects may include:
Very common(may affect more than 1 in 10 people):
- Dizziness
Common(may affect up to 1 in 10 people):
- Feeling of sleepiness
- Feeling of tiredness
- Pins and needles or tingling in the skin
- Feeling of nausea
- Numbness
- General feeling of being unwell
- Feeling of spinning or loss of balance
- Muscle weakness
- Difficulty controlling movement, e.g. lack of coordination
- Abnormal sensation
- Vomiting
- Poor quality sleep
- Feeling your heart beating in your chest, e.g. palpitations
- Vision problems, e.g. blurred vision
Uncommon(may affect up to 1 in 100 people):
- Feeling of restlessness or inability to sit or stand still
- Agitation or tremors
- Feeling anxious
- Feeling hot or cold
- Muscle cramp
- Slowing down
- Discomfort in arms or legs
- Difficulty concentrating
- Changes in thinking, such as memory loss or confused thinking
- Feeling that your head is not working properly
- Speech problems, e.g. stuttering
- Feeling confused
- Chest discomfort
- Feeling extremely happy or excited
- Seeing or hearing things that do not exist
- Shortness of breath or difficulty breathing
In the hours following administration, lasmiditan has been associated with a decrease in heart rate (an average of around 5 to 10 beats per minute) and a small increase in blood pressure.
Reporting of side effects
If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
5. Storage of RAYVOW
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and carton after “EXP”. The expiry date refers to the last day of the month shown.
This medicine does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
6. Contents of the pack and other information
Composition of RAYVOW
- The active substanceis lasmiditan.
- RAYVOW 50 mg film-coated tablets
Each film-coated tablet contains 50 mg of lasmiditan (as succinate).
- RAYVOW 100 mg film-coated tablets
Each film-coated tablet contains 100 mg of lasmiditan (as succinate).
- RAYVOW 200 mg film-coated tablets
Each film-coated tablet contains 200 mg of lasmiditan (as succinate).
- The otheringredients are: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, pregelatinized starch
- For the grey color mixture of 50 mg and 200 mg: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, iron oxide black (E172)
- For the purple color mixture of 100 mg: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, iron oxide black (E172), iron oxide red (E172)
Appearance and packaging
RAYVOW is available in 3 doses: 50 mg, 100 mg and 200 mg
- The 50 mg film-coated tablets are oval, light grey, with “4312” on one side and “L-50” on the other.
- The 100 mg film-coated tablets are oval, light purple, with “4491” on one side and “L-100” on the other.
- The 200 mg film-coated tablets are oval, grey, with “4736” on one side and “L-200” on the other.
RAYVOW is available in precut unit dose blisters of polychlorotrifluoroethylene/polyvinyl chloride (PCTFE/PVC) and polyvinyl chloride (PVC) sealed with an aluminum foil in packs of 2 x 1, 4 x 1, 6 x 1, 12 x 1 and 16 x 1 film-coated tablets. Not all pack sizes may be marketed.
Marketing authorisation holder
Eli Lilly Nederland B.V.,
Papendorpseweg 83,
3528 BJ Utrecht,
Netherlands
Manufacturer
Lilly S.A.,
Avda. de la Industria, 30,
28108 Alcobendas,
Madrid,
Spain
You can request more information about this medicine from the local representative of the marketing authorisation holder:
Belgium/Belgique/Belgien Eli Lilly Benelux S.A./N.V. Tel: + 32-(0)2 548 84 84 | Lithuania Eli Lilly Lietuva Tel: +370 (5) 2649600 |
| Luxembourg/Luxemburg Eli Lilly Benelux S.A./N.V. Tel: + 32-(0)2 548 84 84 |
Czech Republic ELI LILLY CR, s.r.o. Tel: + 420 234 664 111 | Hungary Lilly Hungária Kft. Tel: + 36 1 328 5100 |
Denmark Eli Lilly Danmark A/S Tel: +45 45 26 60 00 | Malta Charles de Giorgio Ltd. Tel: + 356 25600 500 |
Germany Lilly Deutschland GmbH Tel: + 49-(0) 6172 273 2222 | Netherlands Eli Lilly Nederland B.V. Tel: + 31-(0) 30 60 25 800 |
Estonia Eli Lilly Nederland B.V. Tel: +372 6 817 280 | Norway Eli Lilly Norge A.S. Tel: + 47 22 88 18 00 |
Greece ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε. Tel: +30 210 629 4600 | Austria Eli Lilly Ges.m.b.H. Tel: + 43-(0) 1 711 780 |
Spain Organon Salud, S.L. Tel: +34 91 591 12 79 | Poland Eli Lilly Polska Sp. z o.o. Tel: +48 22 440 33 00 |
France Organon France Tel: +33-(0) 1 57 77 32 00 | Portugal Lilly Portugal Produtos Farmacêuticos, Lda Tel: + 351-21-4126600 |
Croatia Eli Lilly Hrvatska d.o.o. Tel: +385 1 2350 999 | Romania Eli Lilly România S.R.L. Tel: + 40 21 4023000 |
Ireland Eli Lilly and Company (Ireland) Limited Tel: + 353-(0) 1 661 4377 | Slovenia Eli Lilly farmacevtska družba, d.o.o. Tel: +386 (0)1 580 00 10 |
Iceland Icepharma hf. Tel: + 354 540 8000 | Slovakia Eli Lilly Slovakia s.r.o. Tel: + 421 220 663 111 |
Italy Eli Lilly Italia S.p.A. Tel: + 39- 055 42571 | Finland Oy Eli Lilly Finland Ab Tel: + 358-(0) 9 85 45 250 |
Cyprus Phadisco Ltd Tel: +357 22 715000 | Sweden Eli Lilly Sweden AB Tel: + 46-(0) 8 7378800 |
Latvia Eli Lilly (Suisse) S.A Parstavnieciba Latvija Tel: +371 67364000 | United Kingdom (Northern Ireland) Eli Lilly and Company (Ireland) Limited Tel: + 353-(0) 1 661 4377 |
Date of last revision of this leaflet:
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu, and on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).
- Country of registration
- Average pharmacy price15.61 EUR
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to RAYVOW 100 mg FILM-COATED TABLETSDosage form: TABLET, 50 mgActive substance: lasmiditanManufacturer: Eli Lilly Nederland B.V.Prescription requiredDosage form: TABLET, 12.5 mgActive substance: almotriptanManufacturer: Almirall S.A.Prescription requiredDosage form: TABLET, 12.5 mgActive substance: almotriptanManufacturer: Laboratorios Cinfa S.A.Prescription required
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