ZOLMITRIPTAN FLAS QUALIGEN 2.5 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

Zolmitriptan Flas Qualigen 2.5 mg Oral Dispersible Tablets EFG

Zolmitriptan

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack

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

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

Zolmitriptan Flas Qualigen belongs to a group of medicines 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 reduces the dilation of these blood vessels. This helps to relieve the headache and other symptoms of a migraine attack, such as feeling sick, being sick, and sensitivity to light and sound.
• Zolmitriptan Flas Qualigen will not prevent a migraine attack from happening, it will only work when an attack has started.

2. Before taking Zolmitriptan Flas Qualigen

Do not take Zolmitriptan Flas Qualigen

• if you are allergic (hypersensitive) to the active substance zolmitriptan or any of the other ingredients of this medicine (see Section 6: Further information)
• if you have high blood pressure.
• if you have ever had 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 ischaemic attack or TIA).
• if you have severe kidney problems.
• if you are already taking other medicines for migraine (such as ergotamine or ergot-type medicines like dihydroergotamine and methysergide) or other migraine medicines of the same type as zolmitriptan. For more information, see the following section: "Use of other medicines".

If you are not sure if any of the above applies to you, consult your doctor or pharmacist.

Be careful with Zolmitriptan Flas Qualigen

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

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

If you go to hospital, tell 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 you to have daily headaches or make your migraine headaches worse. Consult your doctor if you think this is the case. You may need to stop using Zolmitriptan Flas Qualigen to correct the problem.

Use of other medicines

Tell your doctor or pharmacist if you are using or have recently used any other medicines. This includes herbal medicines and medicines you have bought without a prescription.

In particular, tell your doctor if you are taking any of the following medicines:

Migraine medicines

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

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

Medicines for depression

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

Other medicines

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

If you are using herbal preparations containing St. John's Wort (Hypericum perforatum), you may be more likely to experience side effects of Zolmitriptan Flas Qualigen.

Taking Zolmitriptan Flas Qualigen with food and drink

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 medicine.

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

Avoid breastfeeding for 24 hours after taking zolmitriptan.

Driving and using machines

This medicine, 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 ingredients of Zolmitriptan Flas Qualigen

This medicine contains 0.90 mg of aspartame in each tablet. Aspartame is a source of phenylalanine, which can be harmful in people with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

3. How to take Zolmitriptan Flas Qualigen

Follow the instructions for taking Zolmitriptan Flas Qualigen exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

You can take Zolmitriptan Flas Qualigen as soon as the migraine headache starts or when the attack has begun.

The usual dose is one tablet (2.5 mg).

• Separate the top aluminium foil and carefully remove the tablet. Do not push the tablet through the aluminium 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 comes back within 24 hours.

If the tablets do not provide enough help for your migraine, tell your doctor. Your doctor may increase the dose to 5 mg or change your treatment. Do not take more than the dose prescribed for you.

Do not take more than two doses in a day. If you have been prescribed the 2.5 mg tablet, the maximum daily dose is 5 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, telephone 91 562 04 20, indicating the medicine and the amount taken.

As with other migraine treatments, excessive use of Zolmitriptan Flas Qualigen can cause you to have daily headaches or make your migraine headaches worse. Consult your doctor if you think this is the case. You may need to stop taking Zolmitriptan Flas Qualigen to correct the problem.

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

4. Possible side effects

Like all medicines, Zolmitriptan Flas Qualigen can cause side effects, although not everybody gets them.

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

Common 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.
• Feeling sleepy, dizzy, or warm.
• Headache.
• Irregular heartbeat.
• Feeling sick, being sick.
• Stomach pain.
• Dry mouth.
• Muscle weakness or muscle pain.
• Feeling weak.
• Heaviness, tension, pain, or pressure in the throat, neck, arms, and legs, or chest.

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

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

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

• Allergic reactions (hypersensitivity), including raised bumps (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 side effects (may affect less than 1 in 1,000 people)

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

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Reporting of side effects:If you experience 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 to the Spanish Medicines Agency's Pharmacovigilance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Zolmitriptan Flas Qualigen

Keep out of the reach and sight of children.

Do not use Zolmitriptan Flas Qualigen after the expiry date stated on the pack. The expiry date is the last day of the month stated.

Do not store above 30°C. Store in the original package.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Further information

Composition of Zolmitriptan Flas Qualigen

The active substance is zolmitriptan. Each dispersible tablet contains 2.5 mg of active substance.

The other ingredients are: mannitol (E-421), crospovidone, calcium silicate, aspartame (E-951), orange flavour (contains natural flavour and flavouring ingredients, maize maltodextrin, and gum arabic), strawberry flavour (contains natural flavour and flavouring ingredients, maize 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 pack contents

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

Zolmitriptan Flas Qualigen is available in aluminium blister packs containing 2, 6, or 12 (6x2) dispersible tablets.

Not all pack sizes may be marketed.

Other presentations

Zolmitriptan Flas Qualigen 5 mg dispersible tablets: packs of 2, 6, or 12 (6x2) dispersible tablets.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Neuraxpharm Spain, S.L.U.

Avenida Barcelona 69

08970 Sant Joan Despí

Barcelona – Spain

Manufacturer

Neuraxpharm Pharmaceuticals, S.L.

Avenida Barcelona 69

08970 Sant Joan Despí

Barcelona – Spain

This leaflet was approved in September 2021

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/