Zolmitriptan Flas Combix 2.5 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Zolmitriptan Flas Combix 2.5 mg orodispersible tablets EFG

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

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

Contents of the leaflet:

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

1. What Zolmitriptán Flas Combix is and what it is used for

Zolmitriptán Flas Combix contains the active substance zolmitriptan and belongs to a group of medicines known as triptans.

Zolmitriptán Flas Combix is used to treat migraine headache pain.

• The symptoms of migraine may be caused by the dilation of blood vessels in the head. Zolmitriptan is believed to reduce this dilation of blood vessels, helping to relieve headache pain and other symptoms of a migraine attack, such as nausea or vomiting, and sensitivity to light and sound.

• Zolmitriptán Flas Combix works only once a migraine attack has started. It will not prevent you from having a migraine attack.

2. What you need to know before taking Zolmitriptán Flas Combix

Do not take Zolmitriptán Flas Combix

• if you are allergic to zolmitriptan or any of the other components of this medicine (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 occurring at rest), or have experienced heart-related symptoms such as shortness of breath or chest tightness.
• if you have had a stroke (cerebrovascular accident) or transient stroke-like symptoms (transient ischemic attack or TIA).
• if you have severe kidney problems.
• if you are simultaneously taking other migraine medications (e.g. ergotamine or ergot-type medications such as dihydroergotamine and methysergide) or other migraine medicines from the triptan group. For further information, see the following section: "Taking Zolmitriptán Flas Combix with other medicines".

If you are unsure whether any of the above applies to you, consult your doctor or pharmacist.

Warnings and precautions

Consult your doctor or pharmacist before taking Zolmitriptán Flas Combix:

• if you are at risk of ischemic heart disease (reduced 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.
• if you have been diagnosed with Wolff-Parkinson-White syndrome (a type of abnormal heart rhythm).
• if you have ever had liver problems.
• if you experience headaches different from your usual migraine headaches.
• if you are taking any other medication for depression (see "Taking Zolmitriptán Flas Combix with other medicines" 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 individuals under 18 years of age or over 65 years of age.

Like other migraine treatments, excessive use of zolmitriptan may lead to daily headaches or worsening of your migraine headaches. Consult your doctor if you think this applies to you. It may be necessary to stop using zolmitriptan to resolve the problem.

Taking Zolmitriptán Flas Combix with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines. This includes herbal medicines and medicines you buy without a prescription.

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

Migraine medicines

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

Medicines for depression

• moclobemide or fluvoxamine
• medicines known as SSRIs (selective serotonin reuptake inhibitors)
• medicines known as SNRIs (serotonin-norepinephrine reuptake inhibitors) such as venlafaxine, duloxetine.

Other medicines

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

If you are taking herbal remedies containing St. John's wort (Hypericum perforatum), you may be more likely to experience adverse effects from zolmitriptan.

Taking Zolmitriptán Flas Combix with food and drink

You may 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, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

It is unknown whether taking zolmitriptan during pregnancy is harmful. 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 using machines

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

It is unlikely that zolmitriptan will affect your ability to drive or operate tools or machinery. However, it is advisable to wait and see how zolmitriptan affects you before attempting these activities.

This medicine, as well as migraine itself, may cause drowsiness. If you experience these effects, avoid driving or using machines, as it could be dangerous.

Zolmitriptán Flas Combix contains aspartame. This medicine may be harmful to people with phenylketonuria because aspartame is a source of phenylalanine.

3. How to take Zolmitriptán Flas Combix

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

You may take Zolmitriptán Flas Combix as soon as a migraine headache starts. You may also take it once an attack has begun.

• The usual dose is one tablet (2.5 mg).
• Hold the blister pack at the edges and carefully press one of the blisters. Gently remove the back of the blister. Carefully take out 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 the tablet.
• You may take another tablet after two hours if the migraine still persists or if it returns within 24 hours.

If these tablets have not provided 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 one 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Zolmitriptán Flas Combix

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

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

4. Possible adverse effects

Like all medicines, Zolmitriptan Flas Combix may produce adverse effects, although not everyone experiences them. Some of the symptoms listed below may be part of the migraine attack itself.

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

• Abnormal sensations such as tingling in the fingers and toes or skin sensitivity to touch
• Drowsiness, dizziness, or feeling warm
• Headache
• Irregular heartbeat
• Nausea, vomiting
• Stomach pain
• Dry mouth
• Muscle weakness or muscle pain
• Feeling of weakness
• Heaviness, tightness, pain, or pressure in the throat, neck, arms, legs, or chest.

Uncommon adverse effects (may affect up to 1 in 100 people):

• Very fast heartbeat
• Slightly increased blood pressure
• Increase in the amount of urine produced or in the number of times you need to urinate.

Rare adverse effects (may affect up to 1 in 1,000 people):

• Allergic reactions/hypersensitivity, including raised rash (hives) and swelling of the face, lips, mouth, tongue, and throat. If you think Zolmitriptan Flas Combix is causing you 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 triggered by exercise), heart attack, or spasm of the blood vessels of the heart. If you experience chest pain or shortness of breath after taking Zolmitriptan Flas Combix, contact your doctor and do not take any more Zolmitriptan Flas Combix.
• Spasm of the blood vessels of the intestine, which may damage your intestine. You may experience stomach pain or bloody diarrhoea. If this occurs, contact your doctor and do not take any more Zolmitriptan Flas Combix.

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

5. Storage of Zolmitriptan Flas Combix

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

Do not store above 30°C.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point located at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Zolmitriptan Flas Combix

• The active substance is zolmitriptan. Each orodispersible 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 flavour powder, mannitol (E421), magnesium stearate (E470b), and sodium stearyl fumarate.

Appearance of the product and contents of the pack

Orodispersible tablets, round, mottled, white to cream in colour, smooth on both sides.

OPA/Al/PVC/Al blisters.

Packs containing 6 orodispersible tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

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

Date of the most recent revision of this leaflet: January 2013.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.es/