Zolmitriptan Flas Qualigen 2.5 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Zolmitriptán Flas Qualigen 2.5 mg orodispersible tablets EFG

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 you, as it may harm them.
• If you consider that you are experiencing any adverse reaction, or if you notice any adverse reaction not mentioned in this leaflet, inform your doctor or pharmacist.

Contents of the leaflet

1. What Zolmitriptán Flas Qualigen is and what it is used for
2. Before you take Zolmitriptán Flas Qualigen
3. How to take Zolmitriptán Flas Qualigen
4. Possible side effects
5. How to store Zolmitriptán 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: 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 occurring at rest), or have experienced symptoms that may be related to heart problems, such as shortness of breath or chest tightness.
• if you have had a stroke (cerebrovascular accident) or transient 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 the above 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 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 of age or over 65 years of age.

Like other migraine treatments, excessive use of Zolmitriptán Flas Qualigen may lead to daily headaches or worsening of your migraine headaches. Consult your doctor if you think this applies to you. It may be necessary to stop using Zolmitriptán Flas Qualigen to correct the problem.

Use of other medicines

Inform your doctor or pharmacist if you are currently using, or have recently used, any other medicines. This includes herbal remedies and medicines obtained without a prescription.

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

Migraine medications

• Other triptans different from zolmitriptan: 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.

Medications 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 using herbal preparations containing St. John's wort (Hypericum perforatum), you may have an increased risk of adverse effects from Zolmitriptán Flas Qualigen.

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 machines, as it could be dangerous.

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

Important information about some of the ingredients of Zolmitriptán Flas Qualigen

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

3. How to take Zolmitriptan Flas Qualigen

Follow exactly the instructions for using Zolmitriptan Flas Qualigen as given by your doctor. If you have any doubts, consult your doctor or pharmacist.

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

The usual dose is one tablet (2.5 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 recurs within 24 hours.

If the tablets do not provide sufficient relief for your migraine, inform your doctor. Your doctor may increase your dose to 5 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 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, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at 91 562 04 20, stating the medication and the amount ingested.

As with other migraine treatments, excessive use of Zolmitriptan 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 Zolmitriptan Flas Qualigen to resolve 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 actually be symptoms of the migraine attack itself.

Frequent 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 rapid heartbeat.
• Slightly increased 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, itchy 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 diarrhea. 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, talk to 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. Return any unused medicines and their containers to the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Additional Information

Composition of Zolmitriptan Flas Qualigen

The active substance is zolmitriptan. Each orodispersible tablet contains 2.5 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 gum arabic), 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

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