Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - rayvow

Document Subject

Generated Narrative: MedicinalProductDefinition mp8bb757daadba0c9862c13659a934b71b

identifier: http://ema.europa.eu/identifier/EU/1/21/1587/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: RAYVOW 50 mg film-coated tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-8bb757daadba0c9862c13659a934b71b

identifier: http://ema.europa.eu/identifier/EU/1/21/1587/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - rayvow

Attesters

What is in this leaflet

1. What RAYVOW is and what it is used for
2. What you need to know before you take RAYVOW
3. How to take RAYVOW
4. Possible side effects
5. How to store RAYVOW
6. Contents of the pack and other information

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 get rid of the pain and other symptoms associated with a migraine headache. Pain relief may be felt from as early as 30 minutes after taking 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 ability 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).
• 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 .

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.
• 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 headache 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.

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; trouble 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 tingling of the skin
• Feeling sick
• Numbness
• Feeling of general discomfort
• Feeling of spinning and loss of balance
• Muscle 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
• 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.

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.

What RAYVOW contains

• The active substance is lasmiditan. * RAYVOW 50 mg film coated tablets Each film coated tablet contains 50 mg lasmiditan (as succinate).

RAYVOW 100 mg film coated tablets Each film coated tablet contains 100 mg lasmiditan (as succinate). * RAYVOW 200 mg film coated tablets Each film coated tablet contains 200 mg lasmiditan (as succinate).

• The other ingredients are: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, sodium laurilsulfate, pregelatinized starch * For 50 mg and 200 mg colour mixture grey: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, iron oxide black (E172) * For 100 mg colour mixture purple: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, 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 polychlorotrifluoroethylene/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:

Belgi /Belgique/Belgien Eli Lilly Benelux S.A./N.V. T l/Tel: + 32-(0)2 548 84 Lietuva Eli Lilly Lietuva Tel. +370 (5) 2649
" " . . -
. + 359 2 491 41 Luxembourg/Luxemburg Eli Lilly Benelux S.A./N.V. T l/Tel: + 32-(0)2 548 84 esk republika ELI LILLY R, s.r.o. Tel: + 420 234 664 Magyarorsz g Lilly Hung ria Kft. Tel: + 36 1 328 5Danmark Eli Lilly Danmark A/S
Tlf: +45 45 26 60 Malta Charles de Giorgio Ltd. Tel: + 356 25600 Deutschland Lilly Deutschland GmbH
Tel. + 49-(0) 6172 273 2Nederland Eli Lilly Nederland B.V.
Tel: + 31-(0) 30 60 25 Eesti Eli Lilly Nederland B.V. Tel: +372 6 817 Norge Eli Lilly Norge A.S. Tlf: + 47 22 88 18

• . . . .
  : +30 210 629 4 sterreich Eli Lilly Ges.m.b.H. Tel: + 43-(0) 1 711 Espa a Lilly S.A.
  Tel: + 34-91 663 50 Polska
  Eli Lilly Polska Sp. z o.o. Tel: +48 22 440 33 France Lilly France T l: +33-(0) 1 55 49 34 Portugal Lilly Portugal Produtos Farmac uticos, Lda Tel: + 351-21-4126Hrvatska Eli Lilly Hrvatska d.o.o. Tel: +385 1 2350 Rom nia Eli Lilly Rom nia S.R.L. Tel: + 40 21 4023Ireland Eli Lilly and Company (Ireland) Limited Tel: + 353-(0) 1 661 4Slovenija Eli Lilly farmacevtska dru ba, d.o.o. Tel: +386 (0)1 580 00 sland Icepharma hf. S mi: + 354 540 8Slovensk republika Eli Lilly Slovakia s.r.o. Tel: + 421 220 663 Italia Eli Lilly Italia S.p.A. Tel: + 39- 055 42Suomi/Finland Oy Eli Lilly Finland Ab Puh/Tel: + 358-(0) 9 85 45
  Phadisco Ltd
  : +357 22 715Sverige Eli Lilly Sweden AB Tel: + 46-(0) 8 7378Latvija Eli Lilly (Suisse) S.A P rst vniec ba Latvij
  Tel: +371 67364United Kingdom (Northern Ireland) Eli Lilly and Company (Ireland) Limited Tel: + 353-(0) 1 661 4This leaflet was last revised in

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: