ZOLMITRIPTAN FLAS COMBIX 2.5 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

Zolmitriptan Flas Combix 2.5 mg Oral Dispersible Tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

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

Zolmitriptan Flas Combix contains zolmitriptan and belongs to a group of medicines called triptans.

Zolmitriptan Flas Combix is used to treat migraine headaches.

• The symptoms of migraine can be caused by the dilation of blood vessels in the head. It is believed that zolmitriptan decreases the dilation of these blood vessels. This helps to alleviate the headache and other symptoms of a migraine attack, such as nausea or vomiting and sensitivity to light and sound.

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

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

Do not take Zolmitriptan Flas Combix

• if you are allergic to zolmitriptan or any of the other ingredients 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 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 transient ischaemic attack (TIA, a temporary stroke-like attack).
• if you have severe kidney problems.
• if you are taking other medicines for migraine (such as ergotamine or ergot-type medicines like dihydroergotamine and methysergide) or other triptan medicines for migraine. For more information, see the next section: "Taking Zolmitriptan Flas Combix with other medicines".

If you are not sure if any of these apply to you, consult your doctor or pharmacist.

Warnings and precautions

Consult your doctor or pharmacist before taking Zolmitriptan Flas Combix:

• if you are at risk of having a heart attack (ischaemic heart disease). The risk is greater if you smoke, have high blood pressure, high cholesterol levels, diabetes, or if a close relative has had heart disease.
• if you have been told you have Wolff-Parkinson-White syndrome (a type of abnormal heartbeat).
• if you have ever had liver problems.
• if you have headaches that are not your usual migraine headaches.
• if you are taking any other medicine for depression (see "Taking Zolmitriptan Flas Combix with other medicines" below).

If you go to hospital, tell the medical staff that you are taking Zolmitriptan Flas Combix.

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

As with other migraine treatments, overuse of zolmitriptan can lead to daily headaches or worsening of your migraine headaches. Consult your doctor if you think this is the case. You may need to stop using zolmitriptan to correct the problem.

Taking Zolmitriptan Flas Combix with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes herbal medicines and medicines you have bought without a prescription.

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

Migraine medicines

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

Other medicines

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

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

Taking Zolmitriptan Flas Combix with food and drink

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

It is not known if taking zolmitriptan during pregnancy is harmful. Before taking Zolmitriptan Flas Combix, tell your doctor if you are pregnant or trying to become pregnant.

Avoid breastfeeding for 24 hours after taking Zolmitriptan Flas Combix.

Driving and using machines

During a migraine attack, your reactions may be slower than usual. Bear this in mind when driving or using tools or machines.

It is unlikely that zolmitriptan will affect your ability to drive or use machines. However, it is best to wait and see how zolmitriptan affects you before attempting these activities.

This medicine, like migraine, can cause drowsiness. If you experience these effects, avoid driving or using machines, as it can be dangerous.

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

3. How to take Zolmitriptan Flas Combix

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

You can take Zolmitriptan Flas Combix as soon as a migraine headache starts. You can also take it once the attack has started.

• The usual dose is one tablet (2.5 mg).
• Hold the blister pack by the edges and carefully press one of the compartments. Gently peel off the backing and remove the tablet.
• Place the tablet on your tongue, where it will dissolve and be swallowed with your saliva. You do not need to drink water to swallow your tablet.
• You can take another tablet after 2 hours if the migraine still persists or if it comes back within 24 hours.

If these tablets do not provide enough help for your migraine, tell your doctor. Your doctor may increase the dose to 5 mg (two 2.5 mg tablets) 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 Zolmitriptan Flas Combix than you should

If you have taken more than the prescribed dose, contact your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Zolmitriptan Flas Combix

Do not take a double dose to make up for a forgotten dose.

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

4. Possible side effects

Like all medicines, Zolmitriptan Flas Combix can cause side effects, although not everybody gets them. Some of the symptoms mentioned below may be part of the migraine attack itself.

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

• Abnormal sensations such as tingling in the fingers and toes or sensitive skin
• Feeling sleepy, dizzy, or warm
• Headache
• Irregular heartbeat
• Nausea. Vomiting
• Stomach pain
• Dry mouth
• Muscle weakness or muscle pain
• Feeling weak
• Heaviness, tension, pain, or pressure in the throat, neck, arms, and legs, or chest.

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

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

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

• Allergic reactions/hypersensitivity, including rash and swelling of the face, lips, mouth, tongue, and throat. If you think Zolmitriptan Flas Combix is causing an allergic reaction, stop using it and contact your doctor immediately.

Very rare side effects (may affect up to 1 in 10,000 people):

• Angina (chest pain, often caused by exercise), heart attack, or spasm of the heart's blood vessels. 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 intestine's blood vessels that can damage your intestine. You may experience stomach pain or bloody diarrhea. If this happens, contact your doctor and do not take any more Zolmitriptan Flas Combix.

If you experience any side effects, talk to your doctor or pharmacist, even if they are 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 which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Zolmitriptan Flas Combix

• The active substance is zolmitriptan. Each dispersible tablet contains 2.5 mg of zolmitriptan.
• The other ingredients are: potassium polacrylate, anhydrous citric acid (E330), gelatin, microcrystalline cellulose (E460i), colloidal anhydrous silica, aspartame (E951), orange flavor powder, mannitol (E421), magnesium stearate (E470b), and sodium stearyl fumarate.

Appearance of the product and pack contents

Round, speckled, white to cream-colored, smooth oral dispersible tablets.

OPA/Al/PVC/Al blisters.

Packs containing 6 oral dispersible tablets.

Marketing authorisation holder and manufacturer

Marketing authorisation 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 last revision of this leaflet January 2013.

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