Prospect: information for the patient

Zolmitriptán Teva2.5mg buccal dispersible tabletsefg

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

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you should not give it to other people 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 prospect. See section 4.

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

2.What you need to know before starting to take Zolmitriptán Teva

3.How to take Zolmitriptán Teva

4.Possible adverse effects

1. Conservation of Zolmitriptán Teva

6.Contents of the package and additional information

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

Zolmitriptán Teva is used to treat migraine headache in adults aged 18 years and older.

• Migraine symptoms may be caused by a dilation of blood vessels in the head. It is believed that Zolmitriptán Teva reduces the dilation of these blood vessels. This helps the disappearance of headache pain and other symptoms of a migraine attack, such as discomfort (nausea or vomiting and sensitivity to light and sound.
• Zolmitriptán Teva acts only when a migraine attack has begun. It will not prevent you from experiencing an attack.

Do not take Zolmitriptán Teva

• if you are allergic to zolmitriptan, peanuts, or soy or any of the other ingredients of this medicine (listed in section 6).
• if you have high blood pressure.
• if you have ever had any 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 heart-related symptoms such as shortness of breath or pressure on the chest.
• if you have had a stroke (cerebrovascular accident) or have had transient ischemic attack (TIA) symptoms.
• if you have severe kidney problems.
• if you are taking other migraine medicines (such as ergotamine or ergot-type medicines like dihydroergotamine and methysergide) at the same time. For additional information, see the section “Taking Zolmitriptán Teva 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 Zolmitriptán Teva if:

• you are at risk of developing ischemic heart disease (reduced blood flow to the heart). 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 told you have Wolff-Parkinson-White syndrome (a type of abnormal heart rhythm)
• you have ever had liver problems
• you have headaches other than your usual migraine headache
• you are taking any other medicine for depression (see the section “Taking Zolmitriptán Teva with other medicines”).

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

Zolmitriptán 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 happens, consult your doctor.

Zolmitriptán Teva is not recommended for people under 18 years old or over 65 years old.

Like other migraine treatments, taking too much Zolmitriptán Teva 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 taking Zolmitriptán Teva to correct the problem.

Taking Zolmitriptán Teva with other medicines

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

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

Migraine medicines

• Take other triptans different from Zolmitriptán Teva, wait 24 hours before taking Zolmitriptán Teva.
• After taking Zolmitriptán Teva, wait 24 hours before taking other triptans different from Zolmitriptán Teva.
• Take medicines that contain ergotamine or ergot-type medicines (such as dihydroergotamine or methysergide), wait 24 hours before taking Zolmitriptán Teva.

After taking Zolmitriptán Teva, wait 6 hours before taking ergotamine or ergot-type medicines.

Depression medicines

• 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 fatal condition that has been reported in some patients taking zolmitriptan in combination with certain serotonin-related medicines (such as some depression medicines). Symptoms of serotonin syndrome may include agitation, tremors, restlessness, fever, excessive sweating, spasms, muscle rigidity, uncoordinated movements of the limbs or eyes, and involuntary muscle contractions. Your doctor may provide additional information.

Other medicines

• 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), it may be more likely that you will experience adverse effects from Zolmitriptán Teva.

Zolmitriptán Teva with food and drinks

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

Pregnancy and breastfeeding

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

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

Driving and operating machinery

• During a migraine attack, your reactions may be slower than usual. Be aware of this when driving or using tools or machines.

• It is unlikely that Zolmitriptán Teva will affect driving or operating tools or machines. However, it is best to wait and see how Zolmitriptán Teva affects you before attempting these activities.

Zolmitriptán 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 medicine.

Zolmitriptán Teva contains aspartame (E951)

This medicine contains 2 mg of aspartame in each buccal dispersible tablet.

Aspartame contains a source of phenylalanine that may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

Zolmitriptán Teva contains soy lecithin

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

Zolmitriptán Teva contains sodium

This medicine contains less than 23 mg (1 mmol) of sodium per buccal dispersible tablet; that is, it is essentially “sodium-free”.

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

You can take this medication as soon as a migraine headache begins. You can also take it once a headache has started.

• The recommended dose is one tablet (either 2.5 mg or 5 mg)
• You can take another tablet after two hours if the migraine persists or recurs within 24 hours.

If the tablets did 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 dose prescribed.

• Do not use more than two doses in a day. If you have been prescribed the 2.5 mg tablets, the maximum daily dose is 5 mg. If you have been prescribed the 5 mg tablets, the maximum daily dose is 10 mg.

No liquids are needed to take the tablet. The tablet will dissolve directly in the mouth. Place the tablet on the tongue and, once it has dissolved, you can swallow it with saliva.

Follow these steps to remove the tablet from the blister:

1. Separate an individual cell from the blister from the rest of the strip by carefully cutting around its perforations.

2. Peel off the back.

3. Carefully remove the tablet (do not push it out).

4. Place the tablet on the 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 Zolmitriptán Teva than you should

If you have taken more Zolmitriptán Teva than prescribed by your doctor, 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 taken.

Bring the Zolmitriptán Teva medication and its packaging with you.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them. Some of the symptoms listed below may be part of the migraine itself.

Stop taking Zolmitriptán 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 hives, facial swelling, lip, mouth, tongue, or throat swelling; 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 observe chest pain or shortness of breath.
• Intestinal artery spasm that may damage your intestine. You may observe abdominal pain or bloody diarrhea.

Other possible side effects that may occur:

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

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

Infrequent side effects (may affect up to 1 in 100 people):

• Very rapid heartbeat.

• Slightly higher blood pressure.
• Increased urine production or the need to urinate more frequently.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: http://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 use this medication after the expiration date that appears 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 observe visible signs of deterioration.

Medications should not be disposed of through drains or in the trash.Deposit the packaging and medications you no longer need at the SIGRE collection point of the pharmacy.In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Zolmitriptan Teva

• The active ingredient is zolmitriptan.

Tablets of 2.5mg

• Each buccal dispersible tablet contains 2.5mg of zolmitriptan.

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

Appearance of Zolmitriptan Teva and packaging contents

Zolmitriptan Teva 2.5mg are white or almost white, round, flat, beveled edge tablets, with "93" engraved on one face and "8147" on the other.

Zolmitriptan Tevais presented in aluminum blisters with 2, 3, 6, 12 or 18 buccal dispersible tablets. Some packaging sizes may only be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Teva Pharma S.L.U.

C/ Anabel Segura, nº 11 Edificio Albatros B, 1st floor

28108 Alcobendas

Spain

Responsible 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 medicine is authorized in the member states of the European Economic Area with 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

Last review date of thisleaflet: April 2023

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