Rayvow

Patient Information Leaflet

RAYVOW 50 mg film-coated tablets, 100 mg film-coated tablets, 200 mg film-coated tablets

lasmiditan
This medicinal product is under additional monitoring. This will allow for rapid identification of
new safety information. You can help by reporting any side effects you experience while taking
this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before taking this medicine, as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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 headache during acute migraine attacks, with or without aura, in adults.
RAYVOW helps to reduce or eliminate pain and other symptoms associated with migraine headache. Pain relief may be felt as early as 30 minutes after taking RAYVOW.

2. What you should know before taking RAYVOW

Do not take RAYVOW

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

Warnings and precautions
Do not engage in activities requiring 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 are unable
to follow this recommendation, you must not take RAYVOW.
Talk to your doctor or pharmacist before taking 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 may cause mental changes, such as seeing things that are not there (hallucinations), agitation or coma; rapid heartbeat; changes in

blood pressure; elevated body temperature; muscle stiffness; difficulty walking;
nausea, vomiting or diarrhoea)

• you are taking other medicines or substances that cause drowsiness, such as sleeping pills, medicines for psychiatric conditions, or alcohol
• you have ever been dependent on prescription medicines, alcohol, or other drugs.

If you repeatedly use any medicine for migraine treatment over several days or
weeks, this may lead to long-term daily headaches. Inform your doctor if this
occurs, as treatment may need to be stopped for a period.
Children and adolescents
RAYVOW must not be given to patients under 18 years of age because 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 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)

RAYVOW and alcohol
Caution is advised if you drink alcohol while taking RAYVOW.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor
before taking this medicine. It is not known whether RAYVOW has harmful effects on the unborn child.
RAYVOW is not recommended during pregnancy.
If you are breastfeeding, consult your doctor before taking this medicine. It is not known whether
lasmiditan passes into breast milk. Breastfeeding is recommended to be avoided for 24 hours
after treatment to minimize the amount of lasmiditan passed to the infant.
It is not known whether RAYVOW affects fertility.
Driving and using machines
RAYVOW affects the ability to drive vehicles and use machinery. Do not engage in activities
requiring 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 follow
this recommendation, you must not take RAYVOW.
RAYVOW contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
‘sodium-free’.

3. How to take RAYVOW

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.

• The recommended starting dose of lasmiditan is 100 mg. Your doctor will decide which lasmiditan dose is appropriate for you.
• If you do not obtain relief from pain after the first tablet, do not take a second tablet for the same attack, as it is unlikely to be effective.
• If after taking the first tablet of 50 mg or 100 mg the migraine completely resolves and 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 a dose of 100 mg does not relieve your migraine or causes undesirable effects, consult your doctor, who may recommend a higher dose (200 mg) or a 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. Swallow the tablet with a glass of water during the headache phase of a 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 experience some of the adverse effects described in section 4.
If you forget to take RAYVOW
RAYVOW is indicated for the acute treatment of migraine and should only be taken when needed.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately if you experience any of the following serious side effects after taking
this medicine:

• allergic reactions including skin rashes and swelling of the eyelids, face or lips (uncommon frequency)
• signs and symptoms of serotonin syndrome, a rare reaction which 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; stiff muscles; difficulty walking; gastrointestinal symptoms such as nausea, vomiting or diarrhoea.

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
• Itching or tingling of the skin
• Feeling unwell
• Numbness
• Feeling of general malaise
• Feeling dizzy and loss of balance
• Muscle weakness
• Difficulty controlling movement, e.g. lack of coordination
• Feeling of abnormality
• Vomiting
• Poor quality sleep
• Awareness of your heartbeat, e.g. palpitations
• Vision problems, e.g. blurred vision

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

• Feeling restless or unable to sit still or stay still
• Agitation or tremor
• Feeling of anxiety
• Feeling of heat or cold
• Muscle cramp
• Feeling of apathy
• Discomfort in arms and legs
• Difficulty concentrating
• Changes in thinking such as memory loss or blurred thinking
• Feeling that the mind is not working properly
• Language problems, e.g. slurred speech
• Feeling confused
• Chest discomfort
• Extremely happy or excited mood
• Seeing or hearing things that are not there
• Shortness of breath or difficulty breathing

Lasmiditan has been associated with a decrease in heart rate (on average from 5 to 10 beats per
minute) and a small increase in blood pressure, in the hours following administration.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What RAYVOW contains

• The active substance is lasmiditan.
  o RAYVOW 50 mg film-coated tablets: Each film-coated tablet contains 50 mg lasmiditan (as succinate).
  o RAYVOW 100 mg film-coated tablets: Each film-coated tablet contains 100 mg lasmiditan (as succinate).
  o RAYVOW 200 mg film-coated tablets: Each film-coated tablet contains 200 mg lasmiditan (as succinate).

• The other components are: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, pregelatinized starch.
  o For the grey colour mixture of 50 mg and 200 mg: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, black iron oxide (E172).
  o For the purple colour mixture of 100 mg: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, black iron oxide (E172), red iron oxide (E172).

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

RAYVOW is available in blisters made of polychlorotrifluoroethylene/polyvinyl chloride (PCTFE/PVC) and polyvinyl chloride (PVC), single-dose divisible blisters sealed with an aluminium foil, in pack sizes 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,
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 Authorisation Holder in your country:

België/Belgique/Belgien Lietuva
Eli Lilly Benelux S.A./N.V. Eli Lilly Lietuva
Tél/Tel: + 32-(0)2 548 84 84 Tel. +370 (5) 2649600

България Luxembourg/Luxemburg
ТП "Ели Лили Недерланд" Б.В. - България Eli Lilly Benelux S.A./N.V.
тел. + 359 2 491 41 40 Tél/Tel: + 32-(0)2 548 84 84

Česká republika Magyarország
ELI LILLY ČR, s.r.o. Lilly Hungária Kft.
Tel: + 420 234 664 111 Tel: + 36 1 328 5100

Danmark Malta
Eli Lilly Danmark A/S Charles de Giorgio Ltd.
Tlf: +45 45 26 60 00 Tel: + 356 25600 500

Deutschland Nederland
Lilly Deutschland GmbH Eli Lilly Nederland B.V.
Tel. + 49-(0) 6172 273 2222 Tel: + 31-(0) 30 60 25 800

Eesti Norge
Eli Lilly Nederland B.V. Eli Lilly Norge A.S.
Tel: +372 6 817 280 Tlf: + 47 22 88 18 00

Ελλάδα Österreich
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε. Eli Lilly Ges.m.b.H.
Τηλ: +30 210 629 4600 Tel: + 43-(0) 1 711 780

España Polska
Organon Salud, S.L. Eli Lilly Polska Sp. z o.o.
Tel: +34 91 591 12 79 Tel: +48 22 440 33 00

France Portugal
Organon France Lilly Portugal Produtos Farmacêuticos, Lda
Tél: +33-(0) 1 57 77 32 00 Tel: + 351-21-4126600

Hrvatska România
Eli Lilly Hrvatska d.o.o. Eli Lilly România S.R.L.
Tel: +385 1 2350 999 Tel: + 40 21 4023000

Ireland Slovenija
Eli Lilly and Company (Ireland) Limited Eli Lilly farmacevtska družba, d.o.o.
Tel: + 353-(0) 1 661 4377 Tel: +386 (0)1 580 00 10

Ísland Slovenská republika
Icepharma hf. Eli Lilly Slovakia s.r.o.
Sími: + 354 540 8000 Tel: + 421 220 663 111

Italia Suomi/Finland
Eli Lilly Italia S.p.A. Oy Eli Lilly Finland Ab
Tel: + 39- 055 42571 Puh/Tel: + 358-(0) 9 85 45 250

Κύπρος Sverige
Phadisco Ltd Eli Lilly Sweden AB
Τηλ: +357 22 715000 Tel: + 46-(0) 8 7378800

Latvija United Kingdom (Northern Ireland)
Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā Eli Lilly and Company (Ireland) Limited
Tel: + 371 67364000 Tel: + 353-(0) 1 661 4377

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/