InfoCons Consumer Protection informs you – RAYVOW – Package Leaflet

Before anything else

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.

ℹ️ 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 attack s with or without aura in adults .

RAYVOW helps to reduce or get rid of the pain and other symptoms associated with a migraine heada che. Pain relief may be felt from as early as 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 take part in activities requiring your full attention, such as driving or operating machinery, within 8 hours of taking each dose of RAYVOW , even if you feel well enough to do so, because it can affect your ab ility to drive or operate machinery safely . If you cannot do this, you should not take RAYVOW.

Talk to your doctor or pharmacist before taking RAYVOW if you:

• are taking medicines that increase the level of serotonin (see ‘Other medicines and RAYVOW’ ).

These medicines increase the risk of side effects such as serotonin syndrome (a rare reaction which may cause mental changes, such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; trouble walking; nausea, vomiting, or diarrhoea).

31 – are taking other medicines or substances that cause sleepiness such as sleeping pills, medicines for psychiatric conditions, or alcohol

• have ever been addicted to prescription medicines, alcohol, or other drugs.

If you repeatedly use any medicines for the treatment of migraine over several days or weeks, this can cause long -term daily headaches. Tell your doctor if you experience this as you might need to stop treatment for a while.

Children and adolescents

RAYVOW should not be given to patients under the age of 18 years because there is not enough information about 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 lower heart rate, such as propranolol
• medicines that increase the level of serotonin (including SSRIs, SNRIs, tricyclic antidepressants, monoamine oxidase inhibitors [MAOIs] , or triptans )
• digoxin ( used to treat heart disorders ) RAYVOW with alcohol Care should be taken if you drink alcohol while taking RAYVOW.

Pregnancy, breast -feeding 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 breast -feeding, ask your doctor for advice before taking this medicine. It is not known if lasmiditan passes into your breastmilk. It is recommended to avoid breast -feeding for 24 hours after treatment in order to minimise the amount of lasmiditan that is passed onto your baby.

It is not known whether RAYVOW affects your fertility.

Driving and using machines

RAYVOW affects your ability to drive and use machines. Do not take part in activities requiring 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 this, you should not take RAYVOW.

RAYVOW contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say it is essentially “sodium -free”.

💊 3. How to take RAYVOW

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

• The recommended starting dose is 100 mg lasmiditan . Your doctor will decide which dose of lasmiditan is appropriate for you.
• If you do not become pain free after the first tablet, do not take a second tablet for the same attack as it is unlikely to be effective .

32 – If after a first tablet of 50 mg or 100 mg your migraine is completely resolved and then comes back, you may take a second tablet of the same strength no sooner than 2 hours after the first dose.

• You should not take more than 200 mg within 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 (200 mg) or lower (50 mg) dose.

Use in children and adolescents and patients with liver 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 a drink of water during the hea dache phase of your migraine attack. You can take the tablet either with or without food.

If you take more RAYVOW than you should

If you take more RAYVOW than you should, immediately contact your doctor. You may get some of the side effects described in section 4.

If you forget to take RAYVOW

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

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 immediately if you experience any of the following serious side effects after taking this medicine:

• allergic reactions including rashes and swelling of eyelids, face, or lips (frequency uncommon)
• 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; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; troubl e walking; gastrointestinal signs 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
• Prickling or t ingling of the skin
• Feeling sick
• Numbness
• Feeling of general discomfort
• Feeling of spinning and loss of balance
• Muscl e weakness
• Difficulty controlling movement e.g. lack of coordination
• Feeling abnormal
• Vomiting
• Poor quality sleep
• Feeling the heart pumping in the chest, e.g. palpitations 33 – Vision problems, e.g. blurred vision

Uncommon (may affect up to 1 in 100 people)

• Sensation of restlessness or an inability to sit or stand still
• Shaking or tremor
• Feeling anxious
• Feeling hot or cold
• Muscle cramp
• Feeling sluggish
• Arm or leg discomfort
• Difficulty in concentrating
• Thinking changes such as memory loss or foggy thinking
• Feeling of mind not working properly
• Speech 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 lowering of heart rate (on average about 5 to 10 beats per minute) , and a small increase in blood pressure , in the hours after dosing.

Reporting of side effects

If you get 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. 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 throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

📦 6. Contents of the pack 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).

34 – The other ingredients are: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, sodium laur ilsulfate, pregelatinized starch o For 50 mg and 200 mg colour mixture grey: polyvinyl alcohol, titanium dioxide (E171) , macrogol 3350, t alc, iron oxide black (E172) o For 100 mg colour mixture purple: polyvinyl alcohol, titanium dioxide (E171) , macrogol 3350, t alc, iron oxide black (E172) , iron oxide red (E172)

What RAYVOW looks like and contents of the pack

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

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

RAYVOW is available in p olychlorotrifluoroethylene /polyvinyl chloride (PCTFE/PVC ) and polyvinyl chloride (PVC ) perforated unit dose blisters sealed with an aluminium foil lid in packs of 2 x 1, 4 x 1, 6 x 1, 12 x 1 and 16 x 1 film-coated tablets. Not all the 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 any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Eli Lilly Benelux S.A./N.V.

Tél/Tel: + 32-(0)2 548 84 84 Lietuva Eli Lilly Lietuva Tel. +370 (5) 2649600 България ТП “Ели Лили Недерланд” Б.В. – България тел. + 359 2 491 41 40 Luxembourg/Luxemburg Eli Lilly Benelux S.A./N.V.

Tél/Tel: + 32 -(0)2 548 84 84 Česká republika ELI LILLY Č R, s.r.o.

Tel: + 420 234 664 111 Magyarország Lilly Hungária Kft.

Tel: + 36 1 328 5100 Danmark Eli Lilly Danmark A/S Tlf: +45 45 26 60 00 Malta Charles de Giorgio Ltd.

Tel: + 356 25600 500 Deutschland Lilly Deutschland GmbH Tel. + 49 -(0) 6172 273 2222 Nederland Eli Lilly Nederland B.V.

Tel: + 31 -(0) 30 60 25 800 Eesti Eli Lilly Nederland B.V.

Tel: +372 6 817 280 Norge Eli Lilly Norge A.S.

Tlf: + 47 22 88 18 00 35 Ελλάδα ΦΑΡΜΑΣΕΡΒ -ΛΙΛΛΥ Α.Ε.Β.Ε.

Τηλ: +30 210 629 4600 Österreich Eli Lilly Ges.m.b.H.

Tel: + 43 -(0) 1 711 780 España Organon Salud, S.L.

Tel: +34 91 591 12 79 Polska Eli Lilly Polska Sp. z o.o.

Tel: +48 22 440 33 00 France Organon France Tél: +33 -(0) 1 57 77 32 00 Portugal Lilly Portugal Produtos Farmacêuticos, Lda Tel: + 351 -21-4126600 Hrvatska Eli Lilly Hrvatska d.o.o.

Tel: +385 1 2350 999 România Eli Lilly România S.R.L.

Tel: + 40 21 4023000 Ireland Eli Lilly and Company (Ireland) Limited Tel: + 353-(0) 1 661 4377 Slovenija Eli Lilly farmacevtska družba, d.o.o.

Tel: +386 (0)1 580 00 10 Ísland Icepharma hf.

Sími: + 354 540 8000 Slovenská republika Eli Lilly Slovakia s.r.o.

Tel: + 421 220 663 111 Italia Eli Lilly Italia S.p.A.

Tel: + 39- 055 42571 Suomi/Finland Oy Eli Lilly Finland Ab Puh/Tel: + 358 -(0) 9 85 45 250 Κύπρος Phadisco Ltd Τηλ: +357 22 715000 Sverige Eli Lilly Sweden AB Tel: + 46 -(0) 8 7378800 Latvija Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā Tel: +371 67364000 United Kingdom (Northern Ireland) Eli Lilly and Company (Ireland) Limited Tel: + 353 -(0) 1 661 4377

This leaflet was last revised in

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information RAYVOW (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/21/1587).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.