ZOLMITRIPTAN FLAS QUALIGEN 5 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

Zolmitriptan Flas Qualigen 5mg Oral Disintegrating Tablets

Zolmitriptan

Read the entire package leaflet carefully before starting to take the medication.

• Keep this package leaflet, 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 others, 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 serious or if you notice any adverse effect not mentioned in this package leaflet, inform your doctor or pharmacist.

Contents of the Package Leaflet

1. What is Zolmitriptan Flas Qualigen and what is it used for
2. Before taking Zolmitriptan Flas Qualigen
3. How to take Zolmitriptan Flas Qualigen
4. Possible adverse effects
5. Storage of Zolmitriptan Flas Qualigen
6. Additional information

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

Zolmitriptan Flas Qualigen belongs to a group of medications called triptans.

Zolmitriptan Flas Qualigen is used to treat migraine headaches

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

2. Before taking Zolmitriptan Flas Qualigen

Do not take Zolmitriptan Flas Qualigen

• if you are allergic (hypersensitive) to the active ingredient zolmitriptan or to any of the other components of this medication (see Section 6: Additional information)
• if you have high blood pressure.
• if you have ever had heart problems, including heart attack, angina (chest pain caused by exercise or exertion), 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 (such as ergotamine or ergot-type medications like dihydroergotamine and methysergide) or other medications for migraine from the same group as zolmitriptan. For more information, see the following section: "Use of other medications".

If you are not sure if any of these apply to you, consult your doctor or pharmacist.

Be careful with Zolmitriptan Flas Qualigen

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

• if you are at risk of suffering from ischemic heart disease (poor blood flow in the heart arteries). The risk is greater if you smoke, have high blood pressure, high cholesterol levels, diabetes, or if a family member has ischemic heart disease.
• if you have been diagnosed with Wolff-Parkinson-White syndrome (a type of abnormal heartbeat).
• if you have ever had liver problems.
• if you experience headaches different from your usual migraine headaches.
• if you are taking any medication for depression.

If you go to the hospital, you should inform your doctor or healthcare staff that you are taking Zolmitriptan Flas Qualigen.

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

As with other migraine treatments, excessive use of Zolmitriptan Flas Qualigen can cause daily headaches or worsening of your migraine headaches. Consult your doctor if you think this is the case. It may be necessary to stop using Zolmitriptan 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 that you buy without a prescription.

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

Medications for migraine

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

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

Medications for depression

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

Other medications

• Cimetidine (for indigestion or stomach ulcers).
• Antibiotics from the quinolone group (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 Zolmitriptan Flas Qualigen.

Taking Zolmitriptan Flas Qualigen with food and drinks

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

It is not known if taking Zolmitriptan Flas Qualigen during pregnancy is harmful. Inform your doctor if you are pregnant or trying to become pregnant.

Avoid breastfeeding for 24 hours after taking zolmitriptan.

Driving and using machines

This medication, like migraine, can cause drowsiness. If you experience these effects, avoid driving or using machines, as it can be dangerous.

During a migraine attack, your reactions may be slower than usual. Keep this in mind when driving or using tools or machines.

Important information about some of the components of Zolmitriptan Flas Qualigen

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

3. How to take Zolmitriptan Flas Qualigen

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

You can take Zolmitriptan Flas Qualigen as soon as the migraine headache starts or the migraine attack occurs. You can also take it once the attack has started.

The usual dose is one tablet (5 mg).

• Separate the top 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 swallow it with your saliva. You do not need to drink water to swallow the tablet.
• You can take another tablet after 2 hours if the migraine still persists or if it 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 take more than the prescribed dose.

Do not take 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 Zolmitriptan Flas Qualigen than you should

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

As with other migraine treatments, excessive use of Zolmitriptan Flas Qualigen can cause daily headaches or worsening of your migraine headaches. Consult your doctor if you think this is the case. It may be necessary to stop taking Zolmitriptan Flas Qualigen to correct the problem.

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

4. Possible adverse effects

Like all medications, Zolmitriptan Flas Qualigen can cause adverse effects, although not everyone will experience them.

Some of the adverse effects mentioned below may be symptoms of the migraine attack itself.

Common adverse effects (may affect 1 to 10 in every 100 patients)

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

Uncommon adverse effects (may affect 1 to 10 in every 1,000 patients)

• Very fast heartbeat.
• Slightly higher blood pressure.
• Increased amount of urine produced or increased frequency of urination.

Rare adverse effects (may affect 1 to 10 in every 10,000 patients)

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

Very rare adverse effects (may affect less than 1 in every 10,000 patients)

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

If you consider that any of the adverse effects you are experiencing is serious or if you notice any adverse effect not mentioned in this package leaflet, inform your doctor or pharmacist.

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

5. Storage of Zolmitriptan Flas Qualigen

Keep out of the reach and sight of children.

Do not use Zolmitriptan 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 above 30°C. Keep in the original packaging.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medications in the SIGRE collection point at the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Additional information

Composition of Zolmitriptan Flas Qualigen

The active ingredient is zolmitriptan. Each oral disintegrating tablet contains 5 mg of active ingredient.

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

Appearance of Zolmitriptan Flas Qualigen and packaging contents

Zolmitriptan Flas Qualigen oral disintegrating tablets are white, flat-faced, and round.

Zolmitriptan Flas Qualigen is available in aluminum blister packs containing 2, 6, or 12 (6x2) oral disintegrating tablets.

Not all pack sizes may be marketed.

Other presentations

Zolmitriptan Flas Qualigen 2.5 mg oral disintegrating tablets: packs of 2, 6, or 12 (6x2) tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona 69

08970 Sant Joan Despí

Barcelona – Spain

Manufacturer

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona 69

08970 Sant Joan Despí

Barcelona – Spain

This package leaflet was approved in September 2021

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/