ZOLMITRIPTAN FLAS TEVA-RATIO 5 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

Zolmitriptan Flas Teva-ratio 5 mg Oral LyophilisatesEFG

zolmitriptan

Read all of this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

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

Zolmitriptan Flas Teva-ratio is used to treat migraine headaches in adults over 18 years of age.

• The symptoms of migraine can be caused by the dilation (widening) of blood vessels in the head. It is thought that zolmitriptan flas reduces the dilation of these blood vessels. This helps to relieve the headache and other symptoms of a migraine attack, such as feeling sick (nausea and vomiting) and sensitivity to light and sound.
• Zolmitriptan flas only works when a migraine attack has already started. It will not prevent you from getting a migraine attack.

2. What you need to know before you take Zolmitriptan Flas Teva-ratio

Do not take zolmitriptan flas teva-ratio

• if you are allergic to the active substance zolmitriptan or 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 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 ischemic attack or TIA).
• if you have severe kidney problems.
• if you are taking other medicines for migraine (such as ergotamine or ergot-type medicines like dihydroergotamine and methysergide) or other migraine medicines from the triptan group. For more information, see section “Using Zolmitriptan Flas Teva-ratio with other medicines”.

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

Warnings and precautions

Talk to your doctor before you start taking zolmitriptan flas.

• if you are at risk of having a heart condition called ischemic 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 had 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 other than your usual migraine headache.
• if you are taking any medicine for depression (see section “Using Zolmitriptan Flas Teva-ratio with other medicines”).

If you go to the hospital, tell the medical staff that you are taking Zolmitriptan Flas Teva-ratio.

Zolmitriptan Flas Teva-ratio is not recommended for people under 18 or over 65 years of age.

As with other migraine treatments, overuse of Zolmitriptan Flas Teva-ratio can cause you to get daily headaches or make your migraine headaches worse. Talk to your doctor if you think this is happening to you. You may need to stop using Zolmitriptan Flas Teva-ratio to correct the problem.

Using Zolmitriptan Flas Teva-ratio with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take 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

• If you take 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 take 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 called SSRIs (selective serotonin reuptake inhibitors).
• medicines called SNRIs (serotonin and norepinephrine reuptake inhibitors) such as venlafaxine, duloxetine.

Serotonin syndrome is a rare but potentially life-threatening disorder that has been reported in some patients who took zolmitriptan in combination with so-called serotonergic medicines (e.g. certain medicines for the treatment of depression). The symptoms of serotonin syndrome can be, for example, agitation, tremors, restlessness, fever, excessive sweating, spasms, muscle stiffness, uncoordinated movements of the limbs or eyes, and involuntary muscle contractions. Your doctor can give you more information.

Other medicines

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

If you are using herbal preparations that contain St. John's Wort (Hypericum perforatum), it may be more likely that you will experience side effects from Zolmitriptan Flas Teva-ratio.

Taking Zolmitriptan Flas Teva-ratio with food and drinks

You can 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 or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

• It is not known if taking zolmitriptan flas during pregnancy is harmful. Before taking zolmitriptan flas, tell your doctor if you are pregnant or trying to become pregnant.
• Avoid breastfeeding for 24 hours after taking zolmitriptan flas.

Driving and using machines

• During a migraine attack, your reactions may be slower than usual. Take this into account when driving or using tools or machines.
• It is unlikely that zolmitriptan will affect your ability to drive or use tools or machines. However, it is best to wait and see how zolmitriptan flas affects you before trying to do these activities.

Zolmitriptan Flas Teva-ratio contains aspartame (E 951)

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

Zolmitriptan Flas Teva-ratio contains benzyl alcohol

This medicine contains 0.000048 mg of benzyl alcohol in each oral lyophilisate.

Benzyl alcohol may cause allergic reactions. Talk to your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol can build up in your body and cause side effects (metabolic acidosis).

Talk to your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol can build up in your body and cause side effects (metabolic acidosis).

3. How to take Zolmitriptan Flas Teva-ratio

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

You can take Zolmitriptan Flas Teva-ratio as soon as a migraine headache starts. You can also take it once a migraine attack has started.

The recommended dose is one oral lyophilisate (5 mg).

• Separate the top aluminum foil and carefully remove the oral lyophilisate. Do not push the oral lyophilisate through the aluminum foil.
• Place the oral lyophilisate on your tongue, where it will dissolve and swallow it with your saliva. You do not need to drink water to swallow the oral lyophilisate.
• You can take another oral lyophilisate after 2 hours if the migraine still persists or if it comes back within 24 hours.

If the oral lyophilisates do not provide sufficient relief for your migraine, tell your doctor. Your doctor may increase the dose to 10 mg or change your treatment. Do not use more than the dose that has been prescribed for you.

Do not use more than two doses in a 24-hour period. The maximum daily dose is 10 mg.

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

If you have taken more zolmitriptan flas than your doctor has prescribed, talk to your doctor or go to the nearest hospital or call the Toxicology Information Service, telephone 91 562 04 20. Take the medicine zolmitriptan flas and its package leaflet with you.

.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some of the symptoms mentioned 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 side effects:

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

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

Very rare side effects (may affect up to 1 in 10,000 people):

• Angina (chest pain, often caused by exercise), heart attack, or spasm of the heart's blood vessels. You may notice chest pain or shortness of breath.
• Spasm of the blood vessels of the intestine that can damage your intestine. You may notice stomach pain or bloody diarrhea.

Other side effects that may occur:

Common side effects (may affect up to 1 in 10 people)

• Abnormal sensations, such as tingling in the fingers and toes or sensitive skin to touch.
• Feeling sleepy, dizzy, or warm.
• Headache.
• Irregular heartbeat.
• Nausea, vomiting.
• 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.
• Difficulty swallowing.

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 number of times you need to urinate.

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 via the Spanish Pharmacovigilance System for Human Use Medicines: 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 Teva-ratio

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

Do not use Zolmitriptan Flas Teva-ratio after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of the month shown.

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

Medicines should not be disposed of via wastewater or household waste. Return the containers and medicines to the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Zolmitriptan Flas Teva-ratio

The active substance is zolmitriptan. Each oral lyophilisate contains 5 mg of active substance.

The other ingredients are: mannitol (E-421), crospovidone, calcium silicate, aspartame (E-951), orange flavor, strawberry flavor (which contains benzyl alcohol), citric acid monohydrate, and magnesium stearate.

Appearance of Zolmitriptan Flas Teva-ratio and contents of the pack

Zolmitriptan Flas Teva-ratio oral lyophilisates are white, flat-faced, and round.

Zolmitriptan Flas Teva-ratio is available in aluminum blister packs containing 2, 6, or 12 (6x2) oral lyophilisates.

Not all pack sizes may be marketed.

Other presentations

Zolmitriptan Flas Teva-ratio 2.5 mg oral lyophilisates: packs of 2, 6, or 12 (6x2) oral lyophilisates.

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 last revision 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 updated information about this medicine by scanning the QR code included in the packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/74381/P_74381.html.