ZOLMITRIPTAN NORMON 5 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

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

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

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

Zolmitriptan Normon 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 Normon 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 Normon 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 Normon

Do not take Zolmitriptan Normon:

• if you are allergic (hypersensitive) 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 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 (such as ergotamine or ergot-type medicines like dihydroergotamine and methysergide) or other migraine medicines from the triptan group. For more information, see the section "Using Zolmitriptan Normon 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 Normon:

• if you are at risk of having ischemic heart disease (poor blood flow in the heart arteries). The risk is greater 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 you have Wolff-Parkinson-White syndrome (a type of abnormal heartbeat).
• if you have ever had liver problems.
• if you have headaches different from your usual migraine headaches.
• if you are taking any other medicine for the treatment of depression (see "Using Zolmitriptan Normon with other medicines").

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

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

As with other migraine treatments, excessive use of Zolmitriptan Normon can cause you to have daily headaches or worsen your migraine headaches. Consult your doctor if you think this is the case. You may need to stop using Zolmitriptan Normon to correct the problem.

Using Zolmitriptan Normon with other medicines

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

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

Migraine medicines

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

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), you may be more likely to experience side effects with the use of Zolmitriptan Normon.

Taking Zolmitriptan Normon with food and drinks

You can take Zolmitriptan Normon with or without food. It does not affect how Zolmitriptan Normon works.

Pregnancy and breastfeeding

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 Normon during pregnancy is harmful.
• Consult your doctor before taking Zolmitriptan Normon during breastfeeding. To reduce the risk of exposing your child to the medicine, avoid breastfeeding for 24 hours after taking Zolmitriptan Normon.

Driving and using machines

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

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

3. How to take Zolmitriptan Normon

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

• The usual dose is one tablet (5 mg).
• 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 also change your treatment.

Do not take more than the dose that has been prescribed for you.

• 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.

Method of administration

Oral use.

The Zolmitriptan Normon tablet should be placed on the tongue. Before doing so, the mouth should be rinsed with water if available. 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 peeling off the foil; the tablets should not be pressed through the foil.

If you take more Zolmitriptan Normon than you should

If you have taken more Zolmitriptan Normon than your doctor has prescribed, contact your doctor or go to the nearest hospital immediately. Take the medicine Zolmitriptan Normon with you.

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

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

4. Possible side effects

Like all medicines, this medicine 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 (affecting more than 1 in 100 people):

• Abnormal sensations, such as tingling in the fingers of the hands and feet or sensitive skin to the touch.
• Feeling of drowsiness, dizziness, or heat.
• Headache.
• Irregular heartbeat.
• Nausea, vomiting.
• Stomach pain.
• Dry mouth.
• Muscle weakness or muscle pain.
• Feeling of weakness.
• Heaviness, tension, pain, or pressure in the throat, neck, arms, and legs or chest.
• Difficulty swallowing.

Uncommon side effects (affecting less than 1 in 100 people):

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

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

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

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

• Angina (chest pain, often caused by exercise), heart attack, spasm of the heart's blood vessels. If you experience chest pain or shortness of breath after taking Zolmitriptan Normon, contact your doctor and do not take any more Zolmitriptan Normon.
• 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 Normon.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Health Products Agency's website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Zolmitriptan Normon

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

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 that month.

Do not store above 30°C.

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 Normon

• The active substance is zolmitriptan. Zolmitriptan Normon 5 mg oral disintegrating tablets contain 5 mg of zolmitriptan.
• The other ingredients are: Microcrystalline cellulose, crospovidone (type B), citric acid, mannitol (E-421), sucralose micronized, orange flavor (contains tapioca dextrin, modified cornstarch, natural flavorings, corn maltodextrin, artificial flavorings, butylhydroxyanisole), macrogol 8000, colloidal anhydrous silica, magnesium stearate.

Appearance of the product and pack contents

Zolmitriptan Normon 5 mg oral disintegrating tablets are white, round, and bisected tablets, engraved with "5" on one side and nothing on the other. They are presented in peelable aluminum blisters containing 2, 6, and 12 oral disintegrating tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

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

Date of last revision of this leaflet: November 2016

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