Leaflet: information for the user

Zolmitriptan Flas Pharmagenus 5 mg orally disintegrating tablets EFG

Read this leaflet carefully before you start taking the medicine.

-Keep this leaflet, as 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 pass it on to others even if they have similar symptoms, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Zolmitriptan Flas Pharmagenus is and what it is used for

2. What you need to know before you start taking Zolmitriptan Flas Pharmagenus

3. How to take Zolmitriptan Flas Pharmagenus

4. Possible side effects

5. Storage of Zolmitriptan Flas Pharmagenus

6. Contents of the pack and additional information

Zolmitriptán Flas Pharmagenus contains zolmitriptán and belongs to a group of medications called triptans.

Zolmitriptán Flas Pharmagenus is used to treat migraine headaches 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 zolmitriptán 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 sound.
• Zolmitriptán acts only when a migraine attack has begun. It will not prevent you from experiencing an attack.

Do not take Zolmitriptán Flas Pharmagenus

• if you are allergic to zolmitriptán or any of the other ingredients in this medication (listed in section 6)
• if you have high blood pressure
• if you have ever had 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 have had transient ischemic attack (TIA) symptoms.
• if you have severe kidney problems.
• if you are taking other migraine medications (such as ergotamine or ergot-type medications like dihydroergotamine and methysergide) or other triptan medications at the same time. For additional information, see the section “Use of Zolmitriptán Flas Pharmagenus with other medications”.

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

Warnings and precautions

Consult your doctor before starting to take Zolmitriptán Flas Pharmagenus if:

• you are at risk of developing ischemic heart disease (reduced 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 ever had liver problems
• you experience headaches other than your usual migraine headaches.
• you are taking any other medication for depression (see the section “Use of Zolmitriptán Flas Pharmagenus with other medications”).

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

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

Like other migraine treatments, excessive use of Zolmitriptán Flas Pharmagenus 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 Zolmitriptán Flas Pharmagenus to correct the problem.

Use of Zolmitriptán Flas Pharmagenus with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take another 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 are taking other triptans different from Zolmitriptán Flas Pharmagenus, wait 24 hours before taking Zolmitriptán Flas Pharmagenus.
• After taking Zolmitriptán Flas Pharmagenus, wait 24 hours before taking other triptans different from Zolmitriptán Flas Pharmagenus.
• If you are taking medications that contain ergotamine or ergot-type medications (such as dihydroergotamine or methysergide), wait 24 hours before taking Zolmitriptán Flas Pharmagenus.
• After taking Zolmitriptán Flas Pharmagenus, wait 6 hours before taking ergotamine or ergot-type medications.

Depression medications

• moclobemida or fluvoxamina.
• 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 Zolmitriptán Flas Pharmagenus in combination with certain serotonin-related medications (such as buprenorphine or certain medications for 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

• cimetidina (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), it may be more likely that you will experience adverse effects from Zolmitriptán Flas Pharmagenus.

Taking Zolmitriptán Flas Pharmagenus with food and drinks

You can take Zolmitriptán Flas Pharmagenus with or without food. This does not affect how Zolmitriptán Flas Pharmagenus 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 Zolmitriptán Flas Pharmagenus during pregnancy is unknown. Before taking Zolmitriptán Flas Pharmagenus, inform your doctor if you are pregnant or trying to become pregnant.

Avoid breastfeeding within 24 hours of taking Zolmitriptán Flas Pharmagenus.

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 Zolmitriptán Flas Pharmagenus will affect driving or operating machinery. However, it is best to wait and see how Zolmitriptán Flas Pharmagenus affects you before attempting these activities.

Zolmitriptán Flas Pharmagenus contains alcohol benzyl, ethanol (alcohol), aspartame, and sodium

This medication contains less than 0.02 µg of alcohol (ethanol) in each tablet. The amount of alcohol in this medication is much less than 1 ml of beer.

The small amount of alcohol in this medication does not produce any noticeable effects.

This medication contains 0.06 µmg of alcohol benzyl in each tablet. Alcohol benzyl may cause allergic reactions. Consult your doctor or pharmacist if you are pregnant or breastfeeding, or if you have liver or kidney disease. This is because large amounts of alcohol benzyl may accumulate in your body and cause adverse effects (metabolic acidosis).

This medication contains 1.80 mg of aspartame in each tablet.

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

This medication contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially “sodium-free”.

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

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

The usual dose is a tablet.

• Separate the aluminum foil and carefully remove the tablet. 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 still persists or if it reappears within 24 hours.

If the tablets did 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 Zolmitriptán Flas Pharmagenus than you should

If you have taken more zolmitriptán than your doctor prescribed, consult your doctor or pharmacist immediately, go to the nearest hospital, or call the Toxicological Information Service, phone 91 562 04 20. Bring the Zolmitriptán Flas Pharmagenus medication and its packaging with you.

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

Stop taking Zolmitriptán Flas Pharmagenus 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 coronary artery spasm. You may observe chest pain or shortness of breath.
• Intestinal artery spasm that may damage your intestine. You may observe abdominal 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.
• Abdominal 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 number of times you need to urinate.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish System for 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 30°C. Store in the original packaging.

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

Composition of Zolmitriptán Flas Pharmagenus

The active ingredient is zolmitriptan. Each buccal dispersible tablet contains 5 mg of zolmitriptan.

The other components (excipients) are: mannitol (E-421), crospovidone, calcium silicate, aspartate (E-951), orange aroma, strawberry aroma (contains benzyl alcohol, ethanol (alcohol) and sodium), citric acid monohydrate (E-330) and magnesium stearate (E-470). See section 2 Zolmitriptán Flas Pharmagenus contains benzyl alcohol, ethanol (alcohol), aspartame and sodium.

Appearance of the product and content of the container

• Zolmitriptán Flas Pharmagenus 5 mg buccal dispersible tablets are white, flat-faced and round.
• Zolmitriptán Flas Pharmagenus is available in aluminum blister packs containing 2, 6, or 12 (6x2) buccal dispersible tablets.

Only some container sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Aristo Pharma Iberia, S.L.

C/Solana, 26

28850 Torrejón de Ardoz, Madrid

Spain

Responsible for manufacturing

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona 69

08970 Sant Joan Despí

Barcelona – Spain

Date of the last review of this leaflet : January 2024

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