Rayvow 100 mg film-coated tablets

Package leaflet: Information for the user

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 medicinal product is subject to additional monitoring, which will allow quicker identification of new safety information. You can help by reporting any side effects you may experience. Section 4 at the end of this leaflet includes information on how to report side effects.

Read the entire leaflet carefully before starting to take this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

1. What RAYVOW is and what it is used for
2. What you need to know before taking 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 reduce or eliminate pain and other symptoms associated with migraine. Pain relief may be felt as early as 0.5 hours after taking RAYVOW.

2. What you need to know before starting to 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 perform activities requiring 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 are unable to refrain from such activities, 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 adverse effects such as serotonin syndrome (a rare reaction that may cause mental changes, such as seeing things that are not there (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, medications for psychiatric disorders, or alcohol.
• you have ever been addicted to prescription medicines, alcohol, or other drugs.

If you repeatedly use any medication for migraine treatment over several days or weeks, this may eventually lead to daily headaches. Inform your doctor if this occurs, as you may need to discontinue treatment for a period of time.

Children and adolescents

RAYVOW must not be given to patients under 18 years of age, as there is insufficient information on its effects in this age group.

Other medicines and RAYVOW

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

In particular, inform 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 conditions)

Taking RAYVOW with alcohol

Caution is advised if you drink alcohol while taking RAYVOW.

Pregnancy, breastfeeding and fertility

If you are pregnant, think you might be pregnant, or plan to become pregnant, consult your doctor before using this medicine. It is unknown whether RAYVOW will harm the fetus. RAYVOW is not recommended during pregnancy.

If you are breastfeeding, consult your doctor before using this medicine. It is unknown whether lasmiditan passes into breast milk. Breastfeeding is recommended to be avoided for 24 hours after treatment to minimize the amount of lasmiditan passed on to the baby.

It is unknown whether RAYVOW affects fertility.

Driving and use of machines

RAYVOW affects your ability to drive and use machines. Do not engage in activities requiring your full attention, such as driving or operating machinery, for at least 8 hours after each dose of lasmiditan, even if you feel well enough to do so. If you are unable to avoid such activities, you should not take RAYVOW.

RAYVOW contains sodium

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

3. How to take RAYVOW

Follow exactly the administration instructions for this medicine given 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 which dose of lasmiditan is appropriate for you.
• If your pain does not stop after the first tablet, do not take a second tablet for the same attack, as it is unlikely to be effective.
• If, after taking a first tablet of 50 mg or 100 mg, your migraine completely resolves but then returns, you may take a second tablet of the same dose no sooner than 2 hours after the first dose.
• You must not take more than 200 mg within 24 hours.
• If your 100 mg dose does not relieve 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, 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.

Route of administration

RAYVOW is for oral use. You should swallow your tablet with some water during the headache 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 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 about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Immediately inform your doctor if you experience any of the following serious adverse effects after taking this medicine:

• allergic reactions including rashes and swelling of the eyelids, face or lips (uncommon)
• signs and symptoms of serotonin syndrome, a rare reaction that may cause mental changes such as seeing things that do not exist (hallucinations), agitation or coma; rapid heartbeat; changes in blood pressure; elevated body temperature; muscle rigidity; difficulty walking; gastrointestinal symptoms such as nausea, vomiting or diarrhoea.

Other adverse 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
• Itching or tingling of the skin
• Feeling nauseous
• Numbness
• General feeling of discomfort
• Sensation of spinning and loss of balance
• Muscle weakness
• Difficulty controlling movement, e.g. lack of coordination
• Abnormal sensation
• Vomiting
• Poor quality of sleep
• Feeling your heartbeat 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
• Sensation of heat or cold
• Muscle cramp
• Slowness
• Discomfort in arms or legs
• Difficulty concentrating
• Changes in thinking, such as memory loss or confused thinking
• Feeling that the head is not working properly
• Speech problems, e.g. stammering
• Feeling confused
• Chest discomfort
• Extremely happy or excited mood
• 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 about 5 to 10 beats per minute) and a small increase in blood pressure.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse 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 stated on the blister and the carton following “EXP”. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of any unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of RAYVOW

• The active substance 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 coating mixture of 50 mg and 200 mg tablets: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, black iron oxide (E172).

• For the purple coating mixture of 100 mg tablets: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, black iron oxide (E172), red iron oxide (E172).

Nature and contents of the container

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

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

RAYVOW is available in single-dose, pre-perforated blisters made of polychlorotrifluoroethylene/polyvinyl chloride (PCTFE/PVC) and polyvinyl chloride (PVC), sealed with an aluminum foil lid. Packs contain 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,

The Netherlands

Manufacturer

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 Authorization Holder:

Date of the most recent review of this leaflet:

Other sources of information

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 Health Products (AEMPS) (http://www.aemps.gob.es/).