Package Insert: Information for the User

Zolmitriptan Flas Combix 2.5 mg Bucodispersable Tablets EFG

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 should not be given to others, even if they 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.

1. What is Zolmitriptan Flas Combix and how is it used

2. What you need to know before starting to take Zolmitriptan Flas Combix

3. How to take Zolmitriptan Flas Combix

4. Possible adverse effects

5. Storage of Zolmitriptan Flas Combix

6. Contents of the package and additional information

Zolmitriptán Flas Combix contains zolmitriptan and belongs to a group of medications called triptans.

Zolmitriptán Flas Combix is used to treat migraine headaches.

• The symptoms of migraine may be caused by a dilation of blood vessels in the head. It is believed that zolmitriptan 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 Flas Combix acts only when a migraine attack has begun. It will not prevent you from experiencing an attack.

Do not take Zolmitriptán Flas Combix

• if you are allergic to zolmitriptán or 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 effort), angina of Prinzmetal (chest pain that occurs at rest) or have experienced symptoms 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 medications for migraine (for example ergotamine or ergot-type medications such as dihydroergotamine and methysergide) or other medications for migraine of the triptan group. For additional information, see the next section: “Taking Zolmitriptán Flas Combix with other medications”.

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 takeZolmitriptán Flas Combix:

• 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 ever had liver problems
• if you suffer from headaches other than your usual migraine headache
• if you are taking any other medication for the treatment of depression (see “Taking Zolmitriptán Flas Combix with other medications” later in this section).

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

Zolmitriptán Flas Combix is not recommended for people under 18 years or over 65.

Like other migraine treatments, excessive use of zolmitriptán 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 to correct the problem.

Taking Zolmitriptán Flas Combix with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. This includes herbal remedies and medications you purchase without a prescription.

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

Migraine medications

• If you take other triptans different from zolmitriptán, leave 24 hours before taking Zolmitriptán Flas Combix.
• After taking Zolmitriptán Flas Combix, leave 24 hours before taking other triptans different from zolmitriptán.
• If you take medications containing ergotamine or ergot-type medications (such as dihydroergotamine or methysergide), leave 24 hours before taking Zolmitriptán Flas Combix.
• After taking Zolmitriptán Flas Combix, leave 6 hours before taking ergotamine or ergot-type medications.

Depression medications

• moclobemida or fluvoxamina
• medications called SSRIs (selective serotonin reuptake inhibitors)
• medications called SNRIs (serotonin and norepinephrine reuptake inhibitors) such as venlafaxina, duloxetina.

Other medications

• cimetidina (for indigestion or stomach ulcers)
• a quinolone antibiotic (such as ciprofloxacin).

If you are using herbal preparations that contain St. John's Wort (Hypericum perforatum), it may be more likely that zolmitriptán side effects will occur.

Taking Zolmitriptán Flas Combix with food and drinks

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

Pregnancy, breastfeeding, and fertility

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

The effects of taking zolmitriptán during pregnancy are unknown. Before taking Zolmitriptán Flas Combix, inform your doctor if you are pregnant or trying to become pregnant.

Avoid breastfeeding within 24 hours after taking Zolmitriptán Flas Combix.

Driving and operating machinery

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

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

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

Zolmitriptán Flas Combix contains aspartamo.This medication may be harmful to people with phenylketonuria because it contains aspartamo, which is a source of phenylalanine.

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

• The usual dose is one tablet (2.5 mg).
• Hold the blister pack by the ends and carefully press one of the cells. Gently remove the back of the cell. Carefully extract the tablet.
• Place the tablet on your tongue, where it will dissolve and be swallowed with saliva. You do not need to drink water to swallow your tablet.
• You can take another tablet after two hours if the migraine persists or if it reappears within 24 hours.

If these tablets do not provide sufficient relief for your migraine, inform your doctor. Your doctor may increase the dose to 5 mg (two tablets of 2.5 mg) or change your treatment.

Do not take more than the prescribed dose.

• 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.

If you take more Zolmitriptán Flas Combix than you should

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 forgot to take Zolmitriptán Flas Combix

Do not take a double dose to make up for the missed doses.

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

Like all medications,Zolmitriptán Flas Combixcan produce adverse effects, although not everyone will experience them. Some of the symptoms listed below may be part of the migraine crisis itself.

Frequent Adverse 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 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.

Less Frequent Adverse 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.

Rare Adverse 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 Combix is causing an allergic reaction,stop using it and contact your doctor immediately.

Very Rare Adverse Effects (may affect up to 1 in 10,000 people):

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

If you experience adverse effects, consult your doctor or pharmacist even if they are not listed in this prospectus.

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

Do not store at a temperature above 30°C.

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.

Medicines should not be disposed of through drains or in the trash. Dispose of 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 ofZolmitriptán Flas Combix

- The active ingredient is zolmitriptan. Each buccal dispersible tablet contains 2.5 mg of zolmitriptan.

- The other components are: potassium polacrilin, anhydrous citric acid (E330), gelatin, microcrystalline cellulose (E460i), anhydrous colloidal silica, aspartame (E951), orange powder flavor, mannitol (E421), magnesium stearate (E470b), and sodium stearyl fumarate.

Appearance of the product and contents of the packaging

Round, speckled, white to cream-colored, smooth on both sides buccal dispersible tablets.

OPA/Al/PVC/Al blisters.

Blister packs containing 6 buccal dispersible tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Combix Laboratories, S.L.U.

C/ Badajoz 2, Building 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Responsible for manufacturing

Zydus France

ZAC Les Hautes Patures

Parc d'activités des Peupliers

25 Rue des Peupliers

92000 Nanterre

France

or

Centre Specialites Pharmaceutiques

Zac Du Suzot

35 Rue De La Chapelle

63450 Saint Amant Tallende

France

Last review date of this leaflet January 2013.

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