RAYVOW 50 mg Tabletki Powlekane

Treść ulotki

1. RAYVOW 50 mg film-coated tablets, 100 mg film-coated tablets, 200 mg film-coated tablets
   1. What is RAYVOW and what is it 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. Package contents and other information

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

lasmiditan
Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicinal product. See the end of section 4 for
information on how to report adverse effects.

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 other people, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell 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 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

1. What is RAYVOW and what is it used for

RAYVOW contains the active ingredient lasmiditan which is used to treat headache in 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 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 engage in activities that require 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 may affect your ability to drive or operate machinery safely. If you cannot follow this recommendation, you should 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 can cause mental changes, such as seeing things that are not there (hallucinations), agitation or coma; rapid heartbeat; changes in

blood pressure; high body temperature; contracted muscles; 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 addicted to prescription medicines, alcohol or other drugs.

If you repeatedly use any medicine to treat migraine for several days or weeks, this can cause long-term daily headaches. Tell your doctor if this problem occurs as you may need to stop treatment for a while.

Children and adolescents
RAYVOW should not be given to patients under 18 years of age because there is insufficient information on 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 slow down the heart rate, such as propranolol
• medicines that increase serotonin levels (including SSRIs, SNRIs, tricyclic antidepressants, monoamine oxidase inhibitors [MAOIs] or triptans).

RAYVOW with alcohol
Caution should be exercised if you drink alcohol while taking RAYVOW.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor for advice before taking this medicine. It is not known whether RAYVOW will have harmful effects on the unborn child.
RAYVOW is not recommended during pregnancy.
If you are breastfeeding, ask your doctor for advice before taking this medicine. It is not known whether lasmiditan passes into breast milk. It is recommended to avoid breastfeeding for 24 hours after treatment to minimize the amount of lasmiditan passed to the baby.
It is not known whether RAYVOW affects fertility.

Driving and using machines
RAYVOW affects the ability to drive and use machines. Do not engage in activities that require 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 follow this recommendation, you should not take RAYVOW.

RAYVOW contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, that is to say essentially ‘sodium-free’.

3. How to take RAYVOW

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.

• The recommended initial dose of lasmiditan is 100 mg. Your doctor will decide which dose of lasmiditan is appropriate for you.
• If you do not get relief from the 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 50 mg or 100 mg tablet the migraine has completely resolved and then recurs, you can take a second tablet of the same dosage not less than 2 hours after the first dose.
• You must not take more than 200 mg within 24 hours.
• If a 100 mg dose does not relieve the migraine or causes undesirable effects, consult your doctor, who may advise you a higher (200 mg) or lower (50 mg) dose.

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 must swallow the tablet with a glass of water during the headache phase of the migraine attack. You can 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 undesirable 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
necessary.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Inform your doctor immediatelyif 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 that can cause mental changes, such as seeing things that are not there (hallucinations), agitation or coma; rapid heartbeat; changes in blood pressure; high body temperature; tense muscles; difficulty walking; nausea, vomiting or diarrhea.

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
• Feeling your heart beating in your chest, e.g. palpitations
• Vision problems, e.g. blurred vision

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

• Feeling restless or inability to sit still
• Agitation or tremor
• Feeling anxious
• Feeling hot or cold
• Muscle cramp
• Feeling apathetic
• Discomfort in the arms and legs
• Difficulty concentrating
• Changes in thinking such as memory loss or foggy thinking
• Feeling that the mind is not working properly
• Problems with speech, for example 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 (average of 5 to 10 beats per
minute) and a small increase in blood pressure, in the hours following administration.

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 through 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 the carton after
"Exp.". The expiry date refers to the last day of that month.
This medicine does not require special storage conditions.
Do not dispose of any medicine in waste water 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 activeingredient is lasmiditan. or 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 otheringredients are: sodium croscarmellose, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, pregelatinized starch or For the gray color mixture of 50 mg and 200 mg: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, black iron oxide (E172) or For the purple color 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 package contents
RAYVOW is available in 3 dosages: 50 mg, 100 mg and 200 mg

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

RAYVOW is available in blister packs of polychlorotrifluoroethylene/polyvinyl chloride (PCTFE/PVC) and
polyvinyl chloride (PVC), divisible for single doses, sealed with an aluminum foil in packs 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 authorization holder
Eli Lilly Nederland B.V.,
Papendorpseweg 83,
3528 BJ Utrecht,
Netherlands

Manufacturer
Lilly S.A.,
Avda. de la Industria, 30,
28108 Alcobendas,
Madrid,
Spain
For further information on this medicinal product, contact the local representative of the marketing
authorization 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
TP "Eli Lilly Nederland" B.V. - България
tel. + 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 ČR, 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

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
Lilly S.A.
Tel: + 34-91 663 50 00

Polska
Eli Lilly Polska Sp. z o.o.
Tel: +48 22 440 33 00

France
Lilly France
Tél: +33-(0) 1 55 49 34 34

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

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/