Leaflet: information for the user

Zolmitriptán Normon 5 mg orally disintegrating tablets EFG

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

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

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

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

3. How to take Zolmitriptán Normon

4. Possible side effects

5. Storage of Zolmitriptán Normon

6. Contents of the pack and additional information

Zolmitriptán Normon contains zolmitriptán and belongs to a group of medications called triptans.

Zolmitriptán Normon is used to treat migraine headache.

• The symptoms of migraine may be caused by a dilation of blood vessels in the head. It is believed that Zolmitriptán Normon reduces the dilation of these blood vessels. This helps the disappearance of headache pain and other symptoms of a migraine attack, such as nausea or vomiting (nausea or vomiting) and sensitivity to light and sound.

• Zolmitriptán Normon acts only when a migraine attack has begun. It will not prevent you from experiencing an attack.

Do not take Zolmitriptán Normon:

-if you are allergic (hypersensitive) to zolmitriptan or to any of the other components of this medicine (listed in section 6).

-if you have high blood pressure.

-if you have had any heart problems, including a heart attack, angina (chest pain caused by exercise or effort), angina of Prinzmetal (chest pain that occurs at rest) or if you 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 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 (for example, ergotamine or ergot-type medicines such as dihydroergotamine and methysergide) at the same time as Zolmitriptán Normon. For more information, see the section “Use of Zolmitriptán Normon 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 or pharmacist before starting to take Zolmitriptán Normon:

-if you are at risk of suffering from ischemic heart disease (insufficient 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.

-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 other types of headaches in addition to your usual migraine headache.

-if you are taking any other medicine for the treatment of depression (see “Use of Zolmitriptán Normon with other medicines”).

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

Zolmitriptán Normon is not recommended for people under 18 years or over 65 years of age.

Like other treatments for migraine, excessive use of Zolmitriptán Normon 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 Normon to correct the problem.

Use of Zolmitriptán Normon 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 that you buy without a prescription.

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

Migraine medicines

• If you take other triptans different from Zolmitriptán Normon, wait 24 hours before taking Zolmitriptán Normon.
• After taking Zolmitriptán Normon, wait 24 hours before taking other triptans different from Zolmitriptán Normon.
• If you take medicines that contain ergotamine or ergot-type medicines (such as dihydroergotamine or methysergide), wait 24 hours before taking Zolmitriptán Normon.
• After taking Zolmitriptán Normon, 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 noradrenaline reuptake inhibitors) such as venlafaxine and duloxetine.

Other medicines

• Cimetidine (for indigestion or stomach ulcers).
• A quinolone antibiotic (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 side effects with the use of Zolmitriptán Normon.

Taking Zolmitriptán Normon with food and drink

You can take Zolmitriptán Normon with or without food. This does not affect how Zolmitriptán Normon works.

Pregnancy and breastfeeding

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

• The safety of taking Zolmitriptán Normon during pregnancy is unknown.
• Consult your doctor before taking Zolmitriptán Normon during breastfeeding. To reduce the risk of exposing your baby to the medicine, avoid breastfeeding for 24 hours after taking Zolmitriptán Normon.

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 machinery.

It is unlikely that Zolmitriptán Normon will affect driving or the use of tools or machinery. However, it is best to wait and see how Zolmitriptán Normon affects you before attempting to do these activities.

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 Zolmitriptán Normon as soon as a migraine headache begins. You can also take it once a headache has started.

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

If these tablets do not provide sufficient relief for your migraine, inform your doctor. Your doctor may also change your treatment.

Do not take more than the dose prescribed.

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

Administration Form

Oral route.

The Zolmitriptán Normon tablet should be placed on the tongue. The mouth should be rinsed with water if available beforehand. It is not necessary to take the tablet with liquids, as it dissolves on the tongue and is swallowed with saliva. The blister should be opened by removing the foil; the tablets should not be pressed through the foil.

If You Take More Zolmitriptán Normon Than You Should

If you have taken more Zolmitriptán Normon than your doctor prescribed, inform your doctor immediately or go to the nearest hospital. Bring the Zolmitriptán Normon medication with you.

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

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

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

Frequent side effects (affecting more than 1 person in 100):

• Abnormal 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 (affecting less than 1 person in 100):

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

Rare side effects (affecting less than 1 person in 1,000):

• Allergic reactions/hypersensitivity, such as raised hives and swelling of the face, lips, mouth, tongue, and throat.If you think Zolmitriptán Normon is causing an allergic reaction,stop using it and contact your doctor immediately.

Very rare side effects (affecting less than 1 person in 10,000):

• Angina (chest pain, often caused by exercise), heart attack, coronary artery spasm.If you experience chest pain or shortness of breath after taking Zolmitriptán Normon,contact your doctor and do not take any more Zolmitriptán Normon.
• Coronary artery 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 Normon.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, 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 the Pharmacovigilance of Medicines for Human Use: 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 usethis medicationafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

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

Composition of Zolmitriptán Normon

• The active ingredient is zolmitriptán. Zolmitriptán Normon 5 mg buccal tablets contain 5 mg of zolmitriptán.
• The other components are: Microcrystalline cellulose, crospovidone (type B), citric acid, mannitol (E-421), sucralose micronized, orange flavor (contains tapioca dextrin, modified food starch (maize), natural flavorings, maltodextrin (maize), artificial flavorings, butylhydroxyanisole), macrogol 8000, anhydrous colloidal silica, magnesium stearate.

Appearance of the product and content of the packaging

Zolmitriptán Normon 5 mg buccal tablets are white, round, bisected, buccal tablets with a colorless finish, engraved with “5” on one face and nothing on the other. They are presented in laminated aluminum blisters that are removable and contain 2, 6, and 12 buccal tablets.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the last review of this leaflet: November 2016

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