ZOLMITRIPTAN TEVA 5 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the Patient

Zolmitriptan Teva5mg Oral Lyophilisatesefg

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

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

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

1. What is Zolmitriptan Teva and what is it used for

This medication contains zolmitriptan and belongs to a group of medications called triptans.

Zolmitriptan Teva is used to treat migraine headaches in adults aged 18 and over.

• Migraine symptoms may be caused by the dilation of blood vessels in the head. It is believed that Zolmitriptan Teva reduces the dilation of these blood vessels. This helps to alleviate headache pain and other symptoms of a migraine attack, such as nausea or vomiting and sensitivity to light and sound.
• Zolmitriptan Teva only works once a migraine attack has started. It will not prevent you from having a migraine attack.

2. What you need to know before taking Zolmitriptan Teva

Do not take Zolmitriptan Teva

• if you are allergic to zolmitriptan, peanuts, or soy, or to any of the other ingredients of this medication (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 exertion), Prinzmetal's angina (chest pain that occurs at rest), or have experienced heart-related symptoms such as shortness of breath or pressure on the chest.
• if you have had a stroke (cerebrovascular accident) or symptoms similar to a stroke (transient ischemic attack or TIA).
• if you have severe kidney problems.
• if you are taking other medications for migraine (such as ergotamine or ergot-type medications like dihydroergotamine and methysergide) or other migraine medications from the triptan group. For more information, see the section "Using Zolmitriptan Teva with other medications".

If you are unsure whether any of these apply to you, consult your doctor or pharmacist.

Warnings and precautions

Consult your doctor before starting to take Zolmitriptan Teva if:

• you are at risk of suffering from ischemic heart disease (poor 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 ischemic heart disease.
• you have been diagnosed with Wolff-Parkinson-White syndrome (a type of abnormal heartbeat).
• you have ever had liver problems.
• you suffer from headaches different from your usual migraine headaches.
• you are taking any other medication for the treatment of depression (see the section "Using Zolmitriptan Teva with other medications").

If you go to the hospital, inform the medical staff that you are taking Zolmitriptan Teva.

Zolmitriptan Teva may cause an increase in blood pressure. If your blood pressure rises too high, you may experience symptoms such as headache, dizziness, or ringing in the ears. If this occurs, consult your doctor.

Zolmitriptan Teva is not recommended for people under 18 or over 65.

As with other migraine treatments, excessive use of Zolmitriptan Teva may cause daily headaches or worsen your migraine headaches. Consult your doctor if you think this is the case. You may need to stop using Zolmitriptan Teva to correct the problem.

Using Zolmitriptan Teva with other medications

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

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

Migraine medications

• If you take other triptans different from Zolmitriptan Teva, wait 24 hours before taking Zolmitriptan Teva.
• After taking Zolmitriptan Teva, wait 24 hours before taking other triptans different from Zolmitriptan Teva.
• If you take medications that contain ergotamine or ergot-type medications (such as dihydroergotamine or methysergide), wait 24 hours before taking Zolmitriptan Teva.

After taking Zolmitriptan Teva, wait 6 hours before taking ergotamine or ergot-type medications.

Depression medications

• moclobemide or fluvoxamine
• medications known as SSRIs (selective serotonin reuptake inhibitors)
• medications known as 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 serotonergic medications (e.g., certain medications for the treatment of depression). Symptoms of serotonin syndrome may include agitation, tremors, restlessness, fever, excessive sweating, spasms, muscle stiffness, uncoordinated movements of the limbs or eyes, and involuntary muscle contractions. Your doctor can provide you with more information.

Other medications

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

If you are using herbal remedies that contain St. John's Wort (Hypericum perforatum), you may be more likely to experience side effects from Zolmitriptan Teva.

Zolmitriptan Teva with food and drinks

Zolmitriptan Teva can be taken with or without food. This does not affect how Zolmitriptan Teva works.

Pregnancy and breastfeeding

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

• The use of Zolmitriptan Teva during pregnancy is not known to be harmful. Before taking Zolmitriptan Teva, inform your doctor if you are pregnant or trying to become pregnant.
• Avoid breastfeeding for 24 hours after taking Zolmitriptan Teva.

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 Teva will affect driving or the use of tools or machines. However, it is best to wait and see how Zolmitriptan Teva affects you before attempting these activities.

Zolmitriptan Tevacontains lactose, sucrose, and glucose (component of maltodextrin).

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Zolmitriptan Teva contains aspartame (E951)

This medication contains 4 mg of aspartame in each oral lyophilisate.

Aspartame is a source of phenylalanine, which may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it properly.

Zolmitriptan Teva contains soy lecithin

Do not use this medication if you are allergic to peanuts or soy.

Zolmitriptan Teva contains sodium

This medication contains less than 23 mg (1 mmol) of sodium per oral lyophilisate; it is essentially "sodium-free".

3. How to take Zolmitriptan Teva

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

You can take Zolmitriptan Teva 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 (either 2.5 mg or 5 mg).
• You can take another oral lyophilisate after 2 hours if the migraine still persists or if it recurs within 24 hours.

If the oral lyophilisates do not provide sufficient relief for your migraine, inform your doctor. Your doctor may increase the dose to 5 mg or change your treatment.

Do not use more than the prescribed dose.

• Do not use more than two doses in a 24-hour period. If you have been prescribed 2.5 mg oral lyophilisates, the maximum daily dose is 5 mg. If you have been prescribed 5 mg oral lyophilisates, the maximum daily dose is 10 mg.

You do not need to take the oral lyophilisate with liquids. The oral lyophilisate will dissolve directly in the mouth. Place the oral lyophilisate on your tongue and, once it has dissolved, you can swallow it with saliva.

Follow these steps to remove the oral lyophilisate from the blister pack:

1. Separate a single cell from the rest of the strip by carefully cutting along the perforations around it.
2. Peel off the backing.
3. Remove the oral lyophilisate carefully (do not push it out).
4. Place the oral lyophilisate on your tongue, let it dissolve directly in the mouth, and swallow it with saliva.

If you have liver problems or are taking certain medications, your doctor may decide that you need a lower dose.

If you take more Zolmitriptan Teva than you should

If you have taken more Zolmitriptan Teva than your doctor prescribed, inform your doctor immediately, go to the nearest hospital, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

Bring the medication Zolmitriptan Teva and its package leaflet with you.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them. Some of the symptoms mentioned below may be part of the migraine attack itself.

Stop taking Zolmitriptan Teva 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, hives, and 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 coronary artery spasm. You may experience chest pain or shortness of breath.

Spasm of the intestinal blood vessels that can damage your intestine. You may experience stomach pain or bloody diarrhea.

Other possible side effects that may occur:

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

• Abnormal sensations such as tingling in the fingers or toes or sensitive skin.
• Feeling of drowsiness, dizziness, or warmth.
• Headache.
• Irregular heartbeat.
• Nausea. Vomiting.
• Stomach pain.
• Dry mouth.
• Muscle weakness and muscle pain.
• Feeling of weakness.
• 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 urine production or increased frequency of urination.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Zolmitriptan Teva

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

Do not use this medication after the expiration date stated on the packaging. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Do not use this medication if you notice visible signs of deterioration.

Medications should not be disposed of via wastewater or household waste. Place the packaging and any unused medication in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Contents of the pack and further information

Composition of Zolmitriptan Teva

• The active ingredient is zolmitriptan.

5 mg oral lyophilisates

• Each oral lyophilisate contains 5 mg of zolmitriptan.

• The other ingredients of the oral lyophilisate are lactose monohydrate, colloidal anhydrous silica, cornstarch, mannitol (E421), sodium croscarmellose, citric acid, sodium bicarbonate, aspartame (E951), magnesium stearate, orange flavor (sucrose, maltodextrin (contains glucose), natural flavors, soy lecithin, colloidal anhydrous silica).

Appearance of Zolmitriptan Teva and contents of the pack

Zolmitriptan Teva 5 mg are white or almost white, round, flat, oral lyophilisates with a beveled edge, with "93" engraved on one side and "8148" on the other.

Zolmitriptan Teva is available in aluminum blister packs containing 2, 3, 6, 12, or 18 oral lyophilisates. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharma S.L.U.

C/ Anabel Segura, nº 11 Edificio Albatros B, 1ª planta

28108 Alcobendas, Madrid.

Spain

Manufacturer

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen

Hungary

or

Pharmachemie B.V.

Swensweg 5, 2031 GA Haarlem

Netherlands

or

Teva Operations Poland Sp. z o.o.

ul. Mogilska 80, 31-546 Kraków

Poland

or

Merckle GmbH,

Ludwig-Merckle-Straße 3, 89143 Blaubeuren,

Germany

This medication is authorized in the Member States of the European Economic Area under the following names:

Belgium: Zolmitriptan Teva Instant 2.5 mg orodispergeerbare tabletten

Germany: Zolmitriptan-ratiopharm 2.5 mg Schmelztabletten

Zolmitriptan-ratiopharm 5 mg Schmelztabletten

Netherlands: Zolmitriptan disp 2.5 mg PCH, orodispergeerbare tabletten

Spain: Zolmitriptán Teva 2.5 mg comprimidos bucodispersables EFG

Zolmitriptán Teva 5 mg comprimidos bucodispersables EFG

Sweden: Zolmitriptan Teva 2.5 mg, munsönderfallande tabletter

Zolmitriptan Teva 5 mg, munsönderfallande tabletter

Date of the last revision of this package leaflet: April 2023

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