RAYVOW 50 mg FILM-COATED TABLETS

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 and other information

1. What is RAYVOW and what is it used for
2. What you need to know before you take RAYVOW
3. How to take RAYVOW
4. Possible side effects
5. Storage of RAYVOW
6. Contents of the pack and further 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 whether 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 whether 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 whether 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 sleepy
• Feeling tired
• Pins and needles or tingling in the skin
• Feeling sick
• 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 restless or unable to sit or stand still
• Agitation or tremors
• Feeling anxious
• Feeling hot or cold
• Muscle cramp
• Slowing down
• Pain 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 pain
• 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 further 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 gray 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 gray, 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, gray, with “4736” on one side and “L-200” on the other.

RAYVOW is available in single-dose precut 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 authorization 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 authorization holder:

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/).