Zolmitriptan Flas Qualigen 5 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Zolmitriptan Flas Qualigen 5 mg orodispersible tablets

Zolmitriptan

Read the entire leaflet carefully before you start taking this 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; do not give it to other people, even if they have the same symptoms, as it may harm them.
• If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not mentioned in this leaflet, inform your doctor or pharmacist.

Leaflet contents

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

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

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

Zolmitriptán Flas Qualigen is used to treat migraine headache pain

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

2. Before taking Zolmitriptán Flas Qualigen

Do not take Zolmitriptán Flas Qualigen

• if you are allergic (hypersensitive) to the active substance zolmitriptan or to 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 physical exertion or stress), Prinzmetal's angina (chest pain occurring at rest), or have experienced symptoms that may be related to the heart, such as shortness of breath or chest pressure.
• if you have had a stroke (cerebrovascular accident) or brief stroke-like symptoms (transient ischaemic attack or TIA).
• if you have severe kidney problems.
• if you are already taking other migraine medications (e.g. ergotamine or ergot-type medications such as dihydroergotamine and methysergide) or other migraine medicines from the same group as zolmitriptan. For further information, see the following section: "Use of other medicines").

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

Take special care with Zolmitriptán Flas Qualigen

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

• if you are at risk of ischaemic heart disease (reduced blood flow in the heart arteries). The risk is higher if you smoke, have high blood pressure, high cholesterol levels, diabetes, or if a family member has ischaemic heart disease.
• if you have been diagnosed with Wolff-Parkinson-White syndrome (a type of abnormal heart rhythm).
• 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 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 of age or over 65 years of age.

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 may apply to you. It may be necessary to stop using Zolmitriptán Flas Qualigen to resolve the problem.

Use of other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes herbal medicines and medicines you purchase without a prescription.

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

Migraine medicines

• Other triptans different from zolmitriptan: wait 24 hours before taking Zolmitriptán Flas Qualigen

• Ergotamine or ergot-type medicines (such as dihydroergotamine or methysergide):

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

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

Medicines for depression

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

Other medicines

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

If you are taking herbal remedies containing St. John's wort (Hypericum perforatum), the likelihood of adverse effects from Zolmitriptán Flas Qualigen may increase.

Taking Zolmitriptán Flas Qualigen with food and drink

You may 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 medicine.

It is unknown whether taking Zolmitriptán Flas Qualigen during pregnancy is harmful. Inform your doctor if you are pregnant or trying to become pregnant.

Avoid breastfeeding within 24 hours after taking zolmitriptan.

Driving and using machines

This medicine, like migraine itself, may cause drowsiness. If you experience these effects, avoid driving or using machinery, as it could be dangerous.

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

Important information about some of the ingredients of Zolmitriptán Flas Qualigen

This medicine contains 1.80 mg of aspartame per tablet. Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

3. How to take Zolmitriptán Flas Qualigen

Follow exactly the administration instructions for Zolmitriptán Flas Qualigen provided by your doctor. If you have any doubts, consult your doctor or pharmacist.

You may take Zolmitriptán Flas Qualigen as soon as migraine headache or migraine attack begins. You may also take it once an attack has started.

The normal dose is one tablet (5 mg).

• Peel back the upper 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 saliva. It is not necessary to drink water to swallow the tablet.
• You may take another tablet after two hours if the migraine persists or returns 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 prescribed dose.

Do not use more than two doses in one 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, contact your doctor, pharmacist, or call the Toxicology Information Service at 91 562 04 20 immediately, indicating the medication and the amount ingested.

As with 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 applies to you. It may be necessary to stop taking Zolmitriptán Flas Qualigen to correct the problem.

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

4. Possible adverse effects

Like all medicines, Zolmitriptan Flas Qualigen may cause adverse effects, although not everyone experiences them.

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

Common adverse effects (may affect between 1 and 10 out of 100 patients)

• Abnormal skin sensations, such as tingling in the fingers or toes or skin sensitivity to touch.
• Drowsiness, dizziness, or feeling warm.
• Headache.
• Irregular heartbeat.
• Nausea, vomiting.
• Stomach pain.
• Dry mouth.
• Muscle weakness or muscle pain.
• Feeling of weakness.
• Heaviness, tightness, pain, or pressure in the throat, neck, arms, legs, or chest.

Uncommon adverse effects (may affect between 1 and 10 out of 1,000 patients)

• Very fast heartbeat.
• Slight increase in blood pressure.
• Increased amount of urine produced or increased frequency of urination.

Rare adverse effects (may affect between 1 and 10 out of 10,000 patients)

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

Very rare adverse effects (may affect fewer than 1 out of 10,000 patients)

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

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

Reporting of adverse effects: If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 packaging. The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, please ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Information for users

Composition of Zolmitriptan Flas Qualigen

The active substance is zolmitriptan. Each orodispersible tablet contains 5 mg of active substance.

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

Orodispersible tablets of Zolmitriptan Flas Qualigen are white, flat-faced, round tablets.

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

Only certain pack sizes may be marketed.

Other presentations

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

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 leaflet was approved in September 2021

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