Zolmitriptan Normon 2.5 mg orodispersible tablets EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the user

Zolmitriptan Normon 2.5 mg orodispersible tablets EFG

Read the entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Zolmitriptán Normon contains zolmitriptán and belongs to a group of medicines known as triptans.

Zolmitriptán Normon is used to treat migraine headache pain.

• Migraine symptoms may be caused by the dilation of blood vessels in the head. Zolmitriptán Normon 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 Normon works only once a migraine attack has started. It will not prevent you from having migraine attacks.

2. What you need to know before taking Zolmitriptan Normon

Do not take Zolmitriptan 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 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 if you have experienced heart-related symptoms such as shortness of breath or chest pressure.
• 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 currently 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 section “Use of Zolmitriptan Normon with other medicines”.

If you are unsure whether any of the above 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 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 “Use of Zolmitriptan Normon with other medicines”).

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

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

As with other migraine treatments, excessive use of Zolmitriptan Normon may lead to daily headaches or worsening of your migraine headaches. Consult your doctor if you think this may apply to you. It may be necessary to stop using Zolmitriptan Normon to resolve the problem.

Use of Zolmitriptan Normon with other medicines

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

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

Migraine medications

• If you are taking 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 are taking medications containing ergotamine or ergot-type medications (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 medications.

Medications for depression

• moclobemide or fluvoxamine.
• medicines known as SSRIs (selective serotonin reuptake inhibitors).
• medicines known as SNRIs (serotonin and noradrenaline 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 taking herbal preparations containing St. John’s wort (Hypericum perforatum), you may be more likely to experience adverse effects when using Zolmitriptan Normon.

Taking Zolmitriptan Normon with food and drink

You may 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

• It is unknown whether taking Zolmitriptan Normon during pregnancy is harmful. Consult your doctor before taking Zolmitriptan Normon while breastfeeding. To reduce the risk of exposing your baby to the medicine, avoid breastfeeding within 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 operating tools or machinery.

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

3. How to take Zolmitriptan Normon

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

You may take Zolmitriptan Normon 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).
• 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 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.

Method of administration

Oral use.

The Zolmitriptan Normon tablet should be placed on the tongue. The mouth may be rinsed with water beforehand, if available. It is not necessary to take the tablet with liquid, as it dissolves on the tongue and is swallowed with saliva. Open the blister pack by peeling off the foil; do not push the tablets 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 immediately or go to the nearest hospital. Take the medicine Zolmitriptan Normon with you.

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

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

4. Possible adverse effects

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

Common adverse effects (affect more than 1 in 100 people):

• Abnormal sensations, such as tingling in the fingers or 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.
• Difficulty swallowing.

Uncommon adverse effects (affect less than 1 in 100 people):

• Very fast heartbeat.
• Slightly increased blood pressure.
• Increased amount of urine produced or increased frequency of urination.

Rare adverse effects (affect less than 1 in 1,000 people):

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

Very rare adverse effects (affect less than 1 in 10,000 people):

• Angina (chest pain, often triggered by exercise), heart attack, or spasm of the blood vessels in the heart. 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 blood vessels in the intestine, which may damage your bowel. You may experience stomach pain or bloody diarrhoea. If this occurs, contact your doctor and do not take any more Zolmitriptan Normon.

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Zolmitriptán Normon

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

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

Do not store above 30°C.

Medicines should not be disposed of via wastewater drains or household waste. Unused medicines and their containers should be returned to the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the container and other information

Composition of Zolmitriptan Normon

• The active substance is zolmitriptan. Zolmitriptan Normon 2.5 mg orodispersible tablets contain 2.5 mg of zolmitriptan.
• The other components are: microcrystalline cellulose, crospovidone (type B), citric acid, mannitol, micronized sucralose, orange flavor (contains dextrin (tapioca), modified food starch (corn), natural flavors, maltodextrin (corn), artificial flavors, butylhydroxyanisole), macrogol 8000, anhydrous colloidal silica, magnesium stearate.

Appearance of the product and contents of the container

Zolmitriptan Normon 2.5 mg orodispersible tablets are white, round, bevel-edged tablets, embossed with "2.5" on one side and blank on the other.

They are presented in peelable laminated aluminum blisters containing 2, 6, 10, 12, and 18 orodispersible tablets.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

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

Date of the most recent revision of this package leaflet: November 2016

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.gob.es