Product Information for the User

Zomig Flas 5 mg buccal tablets

zolmitriptán

Read this entire product information carefully before starting to take this medication, as it contains important information for you.

• Keep this product information, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this product information. See section 4.

1.What is Zomig Flas and how is it used

2.What you need to know before starting to take Zomig Flas

3.How to take Zomig Flas

4.Possible adverse effects

5.Storage of Zomig Flas

6.Contents of the package and additional information

Zomig Flas contains zolmitriptan and belongs to a group of medications called triptans.

Zomig Flas is used to treat migraine headache in adults aged 18 years and older.

• The symptoms of migraine may be caused by a dilation of blood vessels in the head. It is believed that Zomig Flas reduces the dilation of these blood vessels. This helps the disappearance of headache pain and other symptoms of a migraine attack, such as a feeling of discomfort (nausea or vomiting) and sensitivity to light and noise.

Zomig Flas only acts when a migraine attack has begun. It will not prevent you from experiencing an attack.

Do not take Zomig Flas:

• if you are allergic to zolmitriptan or any of the other ingredients of this medication (listed in section6)
• if you have high blood pressure
• if you have had any heart problems, including a heart attack, angina (chest pain caused by exercise or effort), Prinzmetal's angina (chest pain that occurs at rest) or have experienced heart-related symptoms such as shortness of breath or pressure on the chest
• if you have had a stroke (cerebrovascular accident) or symptoms of a short duration similar to a stroke (transient ischemic attack or TIA)
• if you have severe kidney problems
• if you are taking other medications for migraine (such as ergotamine or ergot-type medications like dihydroergotamine and methysergide) or other triptan medications. For additional information, see the section “Use of Zomig Flas with other medications”.

If you are unsure whether any of this applies to you, consult your doctor or pharmacist.

Warnings and precautions

Consult your doctor before starting to take Zomig Flas if:

• you are at risk of developing ischemic heart disease (insufficient blood flow to the heart). The risk is higher if you smoke, have high blood pressure, high cholesterol levels, diabetes, or if a family member has ischemic heart disease
• you have been told that you have Wolff-Parkinson-White syndrome (a type of abnormal heart rhythm)
• you have had any liver problems
• you have headaches other than your usual migraine headache
• you are taking any other medication for the treatment of depression (see the section “Use of Zomig Flas with other medications”).

If you are admitted to a hospital, inform the medical staff that you are taking Zomig Flas.

Zomig Flas is not recommended for people under 18years or over 65.

Like other migraine treatments, excessive use of Zomig Flas may cause daily headaches or worsening of your migraine headaches. Consult your doctor if you think this is the case. You may need to stop using Zomig Flas to correct the problem.

Use of Zomig Flas with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This includes herbal remedies and medications that you purchase without a prescription.

Especially, inform your doctor if you are taking any of the following medications:

Migraine medications

• If you take other triptans different from Zomig Flas, wait 24hours before taking Zomig Flas.
• After taking Zomig Flas, wait 24hours before taking other triptans different from Zomig Flas.
• If you take medications containing ergotamine or ergot-type medications (such as dihydroergotamine or methysergide), wait 24hours before taking Zomig Flas.
• After taking Zomig Flas, wait 6hours before taking ergotamine or ergot-type medications.

Depression medications

• moclobemide or fluvoxamine
• medications called SSRIs (selective serotonin reuptake inhibitors)
• medications called SNRIs (serotonin and norepinephrine reuptake inhibitors) such as venlafaxine, duloxetine

Serotonin syndrome is a rare but potentially fatal condition that has been reported in some patients taking Zomig in combination with certain serotonin-related medications (such as certain medications for the treatment of depression). Symptoms of serotonin syndrome may include agitation, tremors, restlessness, fever, excessive sweating, spasms, muscle rigidity, uncoordinated movements of the limbs or eyes, and involuntary muscle contractions. Your doctor may provide additional information.

Other medications

• cimetidine (for indigestion or stomach ulcers)
• a quinolone antibiotic (such as ciprofloxacin)

If you are using herbal remedies that contain St. John's Wort (Hypericum perforatum), you may be more likely to experience adverse effects from Zomig Flas.

Taking Zomig Flas with food and drinks

You can take Zomig Flas with or without food. This does not affect how Zomig Flas works.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor before using this medication.

• The safety of taking Zomig Flas during pregnancy is unknown. Before taking Zomig Flas, inform your doctor if you are pregnant or trying to become pregnant.
• Avoid breastfeeding within 24hours after taking Zomig Flas.

Driving and operating machinery

• During a migraine crisis, your reactions may be slower than usual. Be aware of this when driving or operating tools or machinery.
• It is unlikely that Zomig Flas will affect driving or operating tools or machinery. However, it is best to wait and see how Zomig Flas affects you before attempting to do these activities.

Zomig Flas contains aspartame and sodium:

Zomig Flas 5 mg contains 10 mg of aspartame in each buccal dispersible tablet.

Aspartame contains a source of phenylalanine that may be harmful in people with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

This medication contains less than 23 mg of sodium (1mmol) per buccal dispersible tablet; it is essentially “sodium-free”.

Zomig Flas contains benzyl alcohol:

Zomig Flas 5mg contains 0.0000064 mg of benzyl alcohol in each buccal dispersible tablet.

Benzyl alcohol may cause allergic reactions.

Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

You can take Zomig Tablets as soon as a migraine headache begins. You can also take it once a headache has started.

• The recommended dose is one tablet.
• Remove the blister pack to open it as shown on the aluminum foil. Do not push the tablet through the aluminum foil.
• Place the tablet on your tongue, where it will dissolve and be swallowed with saliva. You do not need to drink water to swallow your tablet.
• You can take another tablet after two hours if the migraine persists or if it reappears within 24 hours.

If the tablets do not provide enough help for your migraine, inform your doctor. Your doctor may change your treatment.

Do not use more than the dose prescribed.

• Do not use more than two doses in a day. The maximum daily dose is 10 mg.

If you take more Zomig Tablets than you should

If you have taken more Zomig Tablets than your doctor prescribed, inform your doctor immediately, go to the nearest hospital, or call the Toxicology Information Service, phone: 91 562 04 20. Bring the Zomig Tablets and your package insert with you.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. Some of the symptoms listed below may be part of the migraine itself.

Stop taking Zomig Flas and contact your doctor immediately if you experience any of the following side effects:

Rare side effects (may affect up to 1 in 1,000 people):

• Allergic reactions/hypersensitivity, including hives and swelling of the face, lips, mouth, tongue, or throat; difficulty swallowing or breathing difficulties.

Very rare side effects (may affect 1 person in 10,000):

• Angina (chest pain, often caused by exercise), heart attack, or spasm of the heart's blood vessels. You may observe chest pain or shortness of breath.
• Spasm of the blood vessels of the intestine that may damage your intestine. You may observe stomach pain or bloody diarrhea.

Other side effects that may occur:

Frequent side effects (may affect up to 1 in 10 people):

• Abnormal sensations such as tingling in the fingers of the hands and feet or sensitive skin.
• Sensation of drowsiness, dizziness, or heat.
• Headache.
• Irregular heartbeat.
• Nausea. Vomiting.
• Stomach pain.
• Dry mouth.
• Muscle weakness or muscle pain.
• Sensation of weakness.
• Weight, tension, pain, or pressure in the throat, neck, arms, and legs or chest.
• Difficulty swallowing.

Infrequent side effects (may affect up to 1 in 100 people):

• Very rapid heartbeat.
• Slightly higher blood pressure.
• Increased urine production or the need to urinate more frequently.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25 °C.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Zomig Flas

The active ingredient is zolmitriptan. Zomig Flas buccal tablets contain 5mg of zolmitriptan.

The other components (excipients) are: aspartame (E951), anhydrous citric acid, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol (E421), microcrystalline cellulose, orange flavor (contains benzyl alcohol) and baking soda.

Appearance of the product and contents of the package

• Zomig Flas 5mg buccal tablets are white, flat-faced, round, and marked with “Z 5” on one face.
• Zomig Flas is packaged in a laminated aluminum blister pack that contains 2, 6, or 12 (2 x 6) tablets with or without a pocket pouch.

The pocket pouch is a hard plastic container in which you can store the tablets for your convenience. You should keep the outer carton and this leaflet when using the pocket pouch, as you may need to refer to them again.

Only some package sizes may be marketed.

Zomig may also be available in the form of 2.5 mg buccal tablets, 5mg nasal spray per dose, and 2.5mg film-coated tablets.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Grünenthal Pharma, S.A.

Doctor Zamenhof, 36 – 28027 Madrid, Spain

Responsible manufacturer:

Farmaceutici Formenti S.p.A.

Via Di Vittorio 2

21040 Origgio (VA)

Italy

or

Grünenthal GmbH

Zieglerstrasse 6 – D- 52078 Aachen, Germany

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: June 2024

Further information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/