Package Insert: Information for the User

Zolmitriptan Teva-ratio 5 mg Orally Disintegrating Tablets EFG

Zolmitriptan

Read this package insert carefully before starting to take this medication, as it contains important information for you.

-Keep this package insert, as you may need to refer to it again.

-If you have any questions, consult your doctor or pharmacist.

-This medication has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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

Zolmitriptán Flas Teva-ratio is used to treat migraine headache.

• The symptoms of migraine may be caused by a dilation (widening) of blood vessels in the head. Zolmitriptán Flas Teva-ratio reduces the dilation of these blood vessels. This helps the disappearance of headache pain and other symptoms of a migraine attack, such as nausea, presence of vomiting and sensitivity to light and noise.
• Zolmitriptán Flas Teva-ratio will not prevent a migraine attack from appearing, it is only effective when a migraine attack has started.

Do not take Zolmitriptán Flas Teva-ratio

• if you are allergic (hypersensitive) to the active ingredient zolmitriptán or to any of the other components of this medication(listed in section 6)
• if you have high blood pressure.
• if you have had any 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 ischemic attack or TIA).
• if you have severe kidney problems.
• if you are already taking other medications for migraine (for example ergotamine or ergot-type medications such as dihydroergotamine and methysergide) or other medications for migraine in the same group as zolmitriptán.For additional information, see the next section: “Use of other medications”.

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

Warnings and precautions

Before starting treatment with Zolmitriptán Flas Teva-ratio, inform your doctor:

• if you are at risk of suffering from ischemic heart disease (insufficient blood flow to the heart arteries). The risk is higher if you smoke, have high blood pressure, high cholesterol levels, diabetes, or if a family member has ischemic heart disease.
• if you have been told that you have Wolff-Parkinson-White syndrome (a type of abnormal heart rhythm).
• if you have had any liver problems.
• if you have headaches other than 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 Teva-ratio

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

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 is the case. You may need to stop using Zolmitriptán Flas Teva-ratio to correct the problem.

Use of Zolmitriptán Flas Teva-ratio with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This includes herbal preparations and medications you purchase without a prescription.

Especially inform your doctor if you are taking any of the following medications:

Migraine medications

• Other triptans, different from zolmitriptán: wait 24 hours before taking Zolmitriptán Flas Teva-ratio
• Ergotamine or ergot-type medications (such as dihydroergotamine or methysergide):

- Wait 24 hours before taking Zolmitriptán Flas Teva-ratio after taking ergotamine or ergot-type medications.

- Wait 6 hours before taking ergotamine or ergot-type medications after taking Zolmitriptán Flas Teva-ratio

Depression medications

• Moclobemida or fluvoxamina.
• Medications called SSRIs (selective serotonin reuptake inhibitors) such as paroxetine or citalopram.
• Medications called SNRIs (serotonin and norepinephrine reuptake inhibitors) such as venlafaxine, duloxetine.

Other medications

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

If you are using herbal preparations that contain St. John's Wort (Hypericum perforatum), you may increase the likelihood of adverse effects of Zolmitriptán Flas Teva-ratio

Use of Zolmitriptán Flas Teva-ratio with food and drinks

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

Consult your doctor or pharmacist before using any medication.

The use of Zolmitriptán Flas Teva-ratio during pregnancy is unknown. Inform your doctor if you are pregnant or trying to become pregnant.

Avoid breastfeeding within 24 hours after taking zolmitriptán.

Driving and operating machinery

This medication, like migraine, can cause drowsiness. If you experience these effects, avoid driving or operating machinery as it may be hazardous.

During a migraine crisis, your reactions may be slower than usual. Take this into account when driving or using tools or machinery.

Zolmitriptán Flas Teva-ratio contains aspartame (E 951)

This medication contains 1.80 mg of aspartame in each buccal tablet. Aspartame contains a source of phenylalanine that may be harmful in the case of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

You can take Zolmitriptán Flas Teva-ratio as soon as a migraine headache or migraine crisis begins. You can also take it once a crisis has started.

The usual dose is one tablet (5 mg).

- Separate the aluminum foil and carefully remove the tablet. Do not push the tablet through the aluminum foil.

- Place the tablet on the tongue, where it will dissolve, and swallow with saliva. No water is needed to swallow the tablet.

- You can 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 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 a day. If you have been prescribed the 5 mg tablet, the maximum daily dose is 10 mg.

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

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service at 91 562 04 20, indicating the medication and the amount ingested.

Like other migraine treatments, excessive use of Zolmitriptán Flas Teva-ratio can cause daily headaches or worsening of migraine headaches. Consult your doctor if you think this is the case. You may need to stop taking Zolmitriptán Flas Teva-ratio to correct the problem.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

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

• Abnormal tactile sensations, such as tingling in the fingers of the hands and feet or sensitive skin to the touch.
• Sensation of drowsiness, dizziness, or heat.
• Headache.
• Irregular heartbeat.
• Nausea, vomiting.
• Stomach pain.
• Dry mouth.
• Muscle weakness or muscle pain.
• Sensation of weakness.
• Weight, tension, pain, or pressure in the throat, neck, arms, and legs or chest.
• Difficulty swallowing.

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

• Very rapid heartbeat.
• Slightly higher blood pressure.
• Increased urine production or the number of times you need to urinate.

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 Zolmitriptán Flas Teva-ratio is causing an allergic reaction,stop taking it and contact your doctor immediately.

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

• Angina (chest pain, often caused by exercise), heart attack, or coronary artery spasm. If you experience chest pain or difficulty breathing after taking Zolmitriptán Flas Teva-ratio,stop taking it and contact your doctor.

• Intestinal blood vessel spasm that may damage your intestine. You may experience stomach pain or bloody diarrhea. If this occurs,contact your doctor and do not take any more Zolmitriptán Flas Teva-ratio.

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not useZolmitriptán Flas Teva-ratioafter the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

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

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and medication at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medication that you no longer need. In this way, you will help protect the environment.

Composition of Zolmitriptán Flas Teva-ratio

The active ingredient is zolmitriptan. Each buccal dispersible tablet contains 5 mg of active ingredient.

The other components are: mannitol (E-421), crospovidone, calcium silicate, aspartame (E-951), orange aroma, strawberry aroma, citric acid monohydrate, and magnesium stearate.

Appearance of Zolmitriptán Flas Teva-ratio and contents of the packaging

The buccal dispersible tablets ofZolmitriptán Flas Teva-ratioare white, flat-faced, and round.

Zolmitriptán Flas Teva-ratiois available in aluminum blister packs containing 2, 6, or 12 (6x2) buccal dispersible tablets.

Only some sizes of packaging may be commercially marketed.

Other presentations

Zolmitriptán Flas Teva-ratio 2.5mg buccal dispersible tablets: packaging of 2, 6, or 12 (6 x2) tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Teva Pharma, S.L.U.S

C/Anabel Segura, 11. Edificio Albatros B, 1st Floor.

28108 Alcobendas (Madrid)

Responsible for manufacturing

Neuraxpharm Pharmaceuticals, S.L.

Avda. de Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Last review date of this leaflet: December 2021

The detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)

You can access detailed and updated information on this medicine by scanning the QR code included in the carton 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