Zolmitriptan Flas Teva-Ratio 5 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Zolmitriptán Flas Teva-ratio 5 mg orodispersible tablets EFG

zolmitriptan

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Zolmitriptán Flas Teva-ratio is and what it is used for
2. What you need to know before taking Zolmitriptán Flas Teva-ratio
3. How to take Zolmitriptán Flas Teva-ratio
4. Possible adverse effects
5. How to store Zolmitriptán Flas Teva-ratio
6. Contents of the pack and other information

1. What Zolmitriptán Flas Teva-ratio is and what it is used for

Zolmitriptán Flas Teva-ratio belongs to a group of medicines called triptans.

Zolmitriptán Flas Teva-ratio is used to treat migraine headache in adults aged 18 years and over.

• Migraine symptoms may be caused by dilation (widening) of the blood vessels in the head. Zolmitriptán flas is believed to reduce this dilation of blood vessels, helping to relieve headache pain and other symptoms of a migraine attack, such as nausea and vomiting, and sensitivity to light and sound.
• Zolmitriptán flas works only once a migraine attack has started. It will not prevent you from having a migraine attack.

2. What you need to know before taking Zolmitriptán Flas Teva-ratio

Do not take zolmitriptan flas teva-ratio

• if you are allergic to the active substance zolmitriptán or to any of the other ingredients of this medicine (listed in section 6)
• if you have high blood pressure.
• if you have ever had heart problems, including a heart attack, angina (chest pain brought on 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 pressure in the chest.
• 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 simultaneously taking other migraine medications (for example ergotamine or ergot-type medications such as dihydroergotamine and methysergide) or other migraine medicines from the triptan group. For further information, see section "Taking zolmitriptan flas teva-ratio with other medicines".

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

Warnings and precautions

Consult your doctor before starting to take zolmitriptan flas.

• if you are at risk of having ischaemic heart disease (reduced 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 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 the treatment of depression (see section “Use of Zolmitriptán Flas Teva-ratio with other medicines”).

If you go to a hospital, inform the medical staff that you are taking Zolmitriptán Flas Teva-ratio.

Zolmitriptán Flas Teva-ratio 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 Teva-ratio 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 using Zolmitriptán Flas Teva-ratio to correct the problem.

Use of Zolmitriptan Flas Teva-ratio with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes herbal medicines and non-prescription medicines.

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

Migraine medicines

• If you are taking other triptans different from zolmitriptan flas, wait 24 hours before taking zolmitriptan flas
• After taking zolmitriptan flas, wait 24 hours before taking other triptans different from zolmitriptan flas
• If you are taking medicines containing ergotamine or ergot-type medicines (such as dihydroergotamine or methysergide), wait 24 hours before taking zolmitriptan flas
• After taking zolmitriptan flas, wait 6 hours before taking ergotamine or ergot-type medicines

Medicines for depression

• moclobemide or fluvoxamine
• medicines known as SSRIs (selective serotonin reuptake inhibitors)
• medicines known as SNRIs (serotonin and norepinephrine reuptake inhibitors) such as venlafaxine, duloxetine

Serotonin syndrome is a rare but potentially life-threatening condition that has been reported in some patients who took zolmitriptan in combination with so-called serotonergic medicines (for example, certain medicines used to treat depression). Symptoms of serotonin syndrome may include agitation, tremors, restlessness, fever, excessive sweating, spasms, muscle rigidity, uncoordinated movements of limbs or eyes, and involuntary muscle contractions. Your doctor can provide further information.

Other medicines

• cimetidine (for indigestion or stomach ulcers)
• an antibiotic from the quinolone group (such as ciprofloxacin)

If you are using herbal preparations containing St. John's wort (Hypericum perforatum), adverse effects of Zolmitriptan Flas Teva-ratio may be more likely to occur.

Taking Zolmitriptan Flas Teva-ratio with food and drink

You may take Zolmitriptan Flas Teva-ratio with or without food. This does not affect how Zolmitriptan Flas Teva-ratio works.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

• It is unknown whether taking zolmitriptan flas during pregnancy is harmful. Before taking zolmitriptan flas, inform your doctor if you are pregnant or trying to become pregnant.
• Avoid breastfeeding within 24 hours after taking zolmitriptan flas.

Driving and use of machines

• During a migraine attack, your reactions may be slower than usual. Take this into account when driving or operating tools or machinery.
• Zolmitriptan is unlikely to affect driving or the use of tools or machines. However, it is advisable to wait and observe how zolmitriptan flas affects you before attempting these activities.

Zolmitriptan Flas Teva-ratio contains aspartame (E 951)

This medicine contains 1.80 mg of aspartame in each orally disintegrating 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 properly eliminate it.

Zolmitriptan Flas Teva-ratio contains benzyl alcohol

This medicine contains 0.000048 mg of benzyl alcohol in each tablet.

Benzyl alcohol may cause allergic reactions. Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

3. How to take Zolmitriptán Flas Teva-ratio

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

You may take Zolmitriptán Flas Teva-ratio as soon as a migraine headache starts. You may also take it once an attack has begun.

The recommended dose is one tablet (5 mg).

• Carefully peel back the upper aluminum layer and 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. 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 have not provided 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. The maximum daily dose is 10 mg.

If you take more Zolmitriptán Flas Teva-ratio than you should

If you have taken more zolmitriptán flas than your doctor has prescribed, contact your doctor immediately, go to the nearest hospital, or call the Poison Information Service at telephone number 91 562 04 20. Take the zolmitriptán flas medicine and its package leaflet with you.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

Stop taking zolmitriptan flas and contact your doctor immediately if you experience any of the following adverse effects:

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

• Allergic/hypersensitivity reactions, including raised rash (hives) and swelling of the face, lips, mouth, tongue, or throat; difficulty swallowing or breathing difficulties.

Very rare adverse effects (may affect 1 in 10,000 people):

• Angina (chest pain, often triggered by exercise), heart attack, or spasm of blood vessels in the heart. You may experience chest pain or shortness of breath.
• Spasm of blood vessels in the intestine that may damage your intestine. You may experience stomach pain or bloody diarrhea.

Other adverse effects that may occur:

Frequent adverse effects (may affect up to 1 in 10 people)

• Abnormal 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 weak.
• Heaviness, tightness, pain, or pressure in the throat, neck, arms, legs, or chest.
• Difficulty swallowing.

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

• Very fast heartbeat.
• Slightly increased blood pressure.
• Increase in the amount of urine produced or in the number of times you need to urinate.

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 Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Zolmitriptán Flas Teva-ratio

Keep this medicine out of the sight and reach of children.

Do not use Zolmitriptán Flas Teva-ratio after the expiry date stated on the packaging after “CAD” or “EXP”. 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 empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Zolmitriptán Flas Teva-ratio

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, strawberry flavour (containing benzyl alcohol), citric acid monohydrate and magnesium stearate.

Appearance of Zolmitriptán Flas Teva-ratio and pack contents

The orodispersible tablets of Zolmitriptán Flas Teva-ratio are white, flat-faced, and round.

Zolmitriptán Flas Teva-ratio is available in aluminum blister packs containing 2, 6, or 12 (6x2) orodispersible tablets.

Only certain pack sizes may be marketed.

Other presentations

Zolmitriptán Flas Teva-ratio 2.5 mg orodispersible tablets: packs of 2, 6 or 12 (6x2) tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.S
C/Anabel Segura, 11. Edificio Albatros B, 1ª Planta.
28108 Alcobendas (Madrid)

Manufacturer

Neuraxpharm Pharmaceuticals, S.L.
Avda. de Barcelona, 69
08970 Sant Joan Despí
Barcelona – Spain

Date of the most recent review of this leaflet: June 2025

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/74381/P_74381.html