Package Insert: Information for the User

Zolmitriptán Flas Qualigen 5mg Bucodispersable Tablets

Zolmitriptán

Read this package insert carefully before starting to take the medication.

• Keep this package insert, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you, and you should not give it to other people, even if they have the same symptoms, as it may harm them.
• If you consider that any of the adverse effects you are experiencing is severe or if you notice any adverse effect not mentioned in this package insert, inform your doctor or pharmacist.

Zolmitriptán Flas Qualigen belongs to a group of medicines called triptans.

Zolmitriptán Flas Qualigen is used to treat migraine headache

• The symptoms of a migraine may be caused by a dilation (widening) of blood vessels in the head. Zolmitriptán Flas Qualigen reduces the dilation of these blood vessels. This helps the disappearance of headache pain and other symptoms of a migraine attack, such as nausea, presence of vomiting and sensitivity to light and noise.
• Zolmitriptán Flas Qualigen will not prevent a migraine attack from occurring, it is only effective when a migraine attack has started.

Do not take Zolmitriptán Flas Qualigen

• if you are allergic (hypersensitive) to the active ingredient zolmitriptán or to any of the other components of this medication (see Section 6: Additional Information)
• if you have high blood pressure.
• if you have had any heart problems, including heart attack, angina (chest pain caused by exercise or effort), Prinzmetal's angina (chest pain that occurs at rest) or have experienced symptoms that may be related to the heart such as shortness of breath or pressure on the chest.
• if you have had a stroke (cerebrovascular accident) or symptoms of short duration similar to a stroke (transient ischemic attack or TIA).
• if you have severe kidney problems.
• if you are already taking other medications for migraine (for example ergotamine or ergot-type medications such as dihydroergotamine and methysergide) or other medications for migraine in the same group as zolmitriptán. For additional information, see the next section: “Use of other medications”.

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

Be especially careful with Zolmitriptán Flas Qualigen

Before starting treatment with Zolmitriptán Flas Qualigen, inform your doctor:

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

If you go to a hospital, you must inform your doctor or healthcare staff that you are taking Zolmitriptán Flas Qualigen.

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

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

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications. This includes herbal remedies and medications you purchase without a prescription.

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

Migraine medications

• Other triptans, different from zolmitriptán: wait 24 hours before taking Zolmitriptán Flas Qualigen
• Ergotamine or ergot-type medications (such as dihydroergotamine or methysergide):

• Wait 24 hours before taking Zolmitriptán Flas Qualigen after taking ergotamine or ergot-type medications.
• Wait 6 hours before taking ergotamine or ergot-type medications after taking Zolmitriptán Flas Qualigen

Depression medications

• Moclobemida or fluvoxamina.
• Medications called SSRIs (selective serotonin reuptake inhibitors) such as paroxetine or citalopram.
• Medications called SNRIs (serotonin and norepinephrine reuptake inhibitors) such as venlafaxine, duloxetine.

Other medications

• Cimetidina (for indigestion or stomach ulcers).
• Antibiotics in the quinolone group (such as ciprofloxacin).

If you are using herbal preparations that contain St. John's Wort (Hypericum perforatum), you may increase the likelihood of adverse effects of Zolmitriptán Flas Qualigen.

Taking Zolmitriptán Flas Qualigen with food and drinks

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

The safety of taking Zolmitriptán Flas Qualigen during pregnancy is unknown. Inform your doctor if you are pregnant or trying to become pregnant.

Avoid breastfeeding within 24 hours after taking zolmitriptán.

Driving and operating machinery

This medication, like migraine, can cause drowsiness. If you experience these effects, avoid driving or operating machinery as it may be hazardous.

During a migraine crisis, your reactions may be slower than usual. Take this into account when driving or using tools or machinery.

Important information about some of the components of Zolmitriptán Flas Qualigen

This medication contains 1.80 mg of aspartame in each tablet. Aspartame contains a source of phenylalanine that may be harmful in the case of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

Follow exactly the administration instructions for Zolmitriptán Flas Qualigen as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

You can take Zolmitriptán Flas Qualigen as soon as a migraine headache or migraine crisis begins. You can also take it once a crisis has started.

The usual dose is one tablet (5 mg).

• Separate the aluminum foil and carefully remove the tablet. Do not push the tablet through the aluminum foil.
• Place the tablet on the tongue, where it will dissolve, and swallow it with saliva. You do not need to drink water to swallow the tablet.
• You can take another tablet after two hours if the migraine persists or recurs within 24 hours.

If the tablets do not provide sufficient relief for your migraine, inform your doctor. Your doctor may increase the dose to 10 mg or change your treatment. Do not use more than the dose prescribed.

Do not use more than two doses in a day. If you have been prescribed the 5 mg tablet, the maximum daily dose is 10 mg.

If you take more Zolmitriptán Flas Qualigen than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

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

If you have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medicines, Zolmitriptán Flas Qualigen can cause side effects, although not everyone will experience them.

Some of the side effects listed below may be symptoms of the migraine itself.

Frequent side effects (may affect between 1 and 10 in every 100 patients)

• Abnormal tactile 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.

Less frequent side effects (may affect between 1 and 10 in every 1,000 patients)

• Very rapid heartbeat.
• Slightly higher blood pressure.
• Increased urine production or the number of times you need to urinate.

Rare side effects (may affect between 1 and 10 in every 10,000 patients)

• Allergic reactions (hypersensitivity), including raised bumps (hives) and swelling of the face, lips, mouth, tongue, and throat. If you think Zolmitriptán Flas Qualigen is causing an allergic reaction,stop taking it and contact your doctor immediately.

Very rare side effects (may affect fewer than 1 in every 10,000 patients)

• Angina (chest pain, often caused by exercise), heart attack, or spasm of the heart's blood vessels. If you experience chest pain or difficulty breathing after taking Zolmitriptán Flas Qualigen,stop taking it and contact your doctor.
• Spasm of the blood vessels of the intestine that may damage your intestine. You may have stomach pain or bloody diarrhea. If this occurs,contact your doctor and do not take any more Zolmitriptán Flas Qualigen

If you consider any of the side effects you experience to be severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

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 out of reach and sight of children.

Do not use Zolmitriptán Flas Qualigen after the expiration date that appears on the packaging. 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.

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

Composition of Zolmitriptán Flas Qualigen

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

The other components are: mannitol (E-421), crospovidone, calcium silicate, aspartate (E-951), orange aroma (contains natural aroma and flavoring components, corn maltodextrin and gum arabic), strawberry aroma (contains natural aroma and flavoring components, corn maltodextrin, triethyl citrate (E-1505) and propylene glycol (E-1520)), citric acid monohydrate (E-330) and magnesium stearate (E-470).

Appearance of Zolmitriptán Flas Qualigen and packaging contents

Zolmitriptán Flas Qualigen buccal dispersible tablets are white, flat-faced, and round.

Zolmitriptán Flas Qualigen is available in aluminum blister packs containing 2, 6, or 12 (6x2) buccal dispersible tablets.

Only some package sizes may be marketed.

Other presentations

Zolmitriptán Flas Qualigen 2.5mg buccal dispersible tablets: blister packs of 2, 6, or 12 (6 x2) tablets.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona 69

08970 Sant Joan Despí

Barcelona – Spain

Responsible manufacturer

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona 69

08970 Sant Joan Despí

Barcelona – Spain

This leaflet was approved in September 2021

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