Rayvow 50 mg comprimidos recubiertos con pelicula

Label: 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 expedite the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this label carefully before starting to take this medicine, as it contains important information for you.

• Keep this label, as you may need to refer to it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

RAYVOW contains the active ingredient 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 may be felt even 30 minutes after taking RAYVOW.

Do not take RAYVOW

• if you are allergic to midodrine or any of the other ingredients of this medication (listed in section 6).

Warnings and precautions

Do not perform 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, as it may affect your ability to drive or operate machinery safely. If you cannot do so, do not take RAYVOW.

Consult your doctor or pharmacist before starting to take RAYVOW if:

• you are taking medications that increase serotonin levels (see “Other medications and RAYVOW”). These medications increase the risk of adverse effects such as serotonin syndrome (a rare reaction that can cause mental changes, such as seeing things that are not there (hallucinations), agitation, or coma; rapid heartbeats; changes in blood pressure; high body temperature; muscle rigidity; difficulty walking; nausea, vomiting, or diarrhea).
• you are taking other medications or substances that cause drowsiness, such as sleep aids, psychiatric medications, or alcohol.
• you have ever been addicted to prescription medications, alcohol, or other drugs.

If you use a medication for migraine treatment repeatedly for several days or weeks, this may cause you to experience daily headaches in the long term. Inform your doctor if you experience this, as it may be necessary to interrupt treatment for a time.

Children and adolescents

RAYVOW should not be administered to patients under 18 years of age because there is not enough information about how it acts in this age group.

Other medications and RAYVOW

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

In particular, inform your doctor or pharmacist before taking RAYVOW if you are taking:

• medications that reduce heart rate, such as propranolol
• medications that increase serotonin levels (including SSRIs, SNRIs, tricyclic antidepressants, monoamine oxidase inhibitors [MAOIs], or triptans)
• digoxin (used to treat heart conditions)

RAYVOW and 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 intend to become pregnant, consult your doctor before using this medication. It is unknown whether RAYVOW will cause harm to the fetus. RAYVOW is not recommended during pregnancy.

If you are breastfeeding, consult your doctor before using this medication. It is unknown whether midodrine passes into breast milk. It is recommended to avoid breastfeeding for 24 hours after treatment to minimize the amount of midodrine that is transmitted to your baby.

It is unknown whether RAYVOW affects fertility.

Driving and operating machinery

RAYVOW affects your ability to drive and operate machinery. Do not participate in activities that require your full attention, such as driving or operating machinery, for at least 8 hours after taking each dose of midodrine, even if you feel well enough to do so. If you cannot do so, do not take RAYVOW.

RAYVOW contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

• The recommended initial dose is 100 mg of lasmiditan. Your doctor will decide what dose of lasmiditan is appropriate 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 resolves completely and then reappears, you may take a second tablet of the same dose not before 2 hours after the first dose.
• You should not take more than 200 mg in 24 hours.
• If your 100 mg dose does not alleviate your migraine or causes adverse effects, speak with your doctor, who may recommend a higher dose (200 mg) or lower dose (50 mg).

Use in children and adolescents and patients with liver insufficiency

RAYVOW is not recommended for children and adolescents (under 18 years of age), or for patients with severe liver problems.

Administration route

RAYVOW is for oral use. You should swallow your tablet with a little water during the pain phase of your migraine attack. You may 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 adverse effects described in section 4.

If you forgot to take RAYVOW

RAYVOW is indicated for the acute treatment of migraines and should only be taken when necessary.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may cause side effects, although not everyone will experience them.

Inform your doctor immediatelyif you experience any of the followingserious side effectsafter taking this medication:

• Allergic reactions, including rashes and inflammation of the eyelids, face, or lips (rare)
• Signs and symptoms of serotonin syndrome, a rare reaction that can cause changes in mental status, such as seeing things that are not there (hallucinations), agitation, or coma; rapid heartbeats; changes in blood pressure; elevated body temperature; muscle rigidity; difficulty walking; gastrointestinal symptoms such as nausea, vomiting, or diarrhea.

Other side effectsmay 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
• Itching or tingling in the skin
• Feeling nauseous
• Numbness
• General feeling of discomfort
• Feeling like you are spinning and loss of balance
• Muscle weakness
• Difficulty controlling movement, e.g. lack of coordination
• Abnormal sensation
• Vomiting
• Poor quality sleep
• Feeling like your heart is beating in your chest, e.g. palpitations
• Visual problems, e.g. blurred vision

Rare(may affect up to 1 in 100 people):

• Feeling restless or inability to sit or remain still
• Agitation or tremors
• Feeling anxious
• Feeling hot or cold
• Muscle cramps
• Slowing down
• Discomfort in arms or legs
• Difficulty concentrating
• Changes in thought, such as memory loss or confused thinking
• Feeling like your head is not working correctly
• Speech problems, e.g. stuttering
• Feeling confused
• Discomfort in the chest
• Extremely happy or excited mood
• Seeing or hearing things that are not there
• Lack of air or difficulty breathing

In the hours following administration, midazolam has been associated with a decrease in heart rate (a mean of around 5 to 10 beats per minute) and a small increase in blood pressure.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in Appendix V. By reporting side effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister pack and the box after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains. Ask your pharmacist how to dispose of the packaging and the medication that you no longer need. In this way, you will help protect the environment.

Composition of RAYVOW

• The active principle is 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 other components are: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, pregelatinized starch

• For the grey mixture of 50 mg and 200 mg: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, iron oxide black (E172)
• For the purple mixture of 100 mg: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, iron oxide black (E172), iron oxide red (E172)

Appearance of the product and contents of the pack

RAYVOW is available in 3 doses: 50 mg, 100 mg and 200 mg

• The 50 mg film-coated tablets are oval-shaped, light grey in colour, with "4312" on one side and "L-50" on the other.
• The 100 mg film-coated tablets are oval-shaped, light purple in colour, with "4491" on one side and "L-100" on the other.
• The 200 mg film-coated tablets are oval-shaped, grey in colour, with "4736" on one side and "L-200" on the other.

RAYVOW is available in blister packs of 2 x 1, 4 x 1, 6 x 1, 12 x 1 and 16 x 1 film-coated tablets, made of polychlorotrifluoroethylene/polyvinyl chloride (PCTFE/PVC) and polyvinyl chloride (PVC) with an aluminium foil backing. Only some pack sizes may be marketed.

Marketing authorisation holder

Eli Lilly Nederland B.V.,

Papendorpseweg 83,

3528 BJ Utrecht,

Netherlands

Responsible for manufacturing

Lilly S.A.,

Avda. de la Industria, 30,

28108 Alcobendas,

Madrid,

Spain

For further information about this medicinal product, please contact the local representative of the marketing authorisation holder:

Last date of revision of this leaflet:

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu,and on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) ( http://www.aemps.gob.es/).