Zolmitriptan Normon 5 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Zolmitriptan Normon 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 you should not give it to others, 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.

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 zolmitriptan 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 a migraine attack.

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 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 occurring at rest), or if you have experienced heart-related symptoms such as shortness of breath or pressure in the chest.
• 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 section “Use of Zolmitriptan Normon with other medicines”.

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take 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.

Like 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 applies 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 medicines and medicines you can 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 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 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.

Medicines for depression

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

Other medicines

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

If you are using 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 are planning 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 child 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 see how Zolmitriptan Normon affects you before attempting these activities.

3. How to take Zolmitriptán Normon

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

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

• The usual dose is one tablet (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 also consider changing 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.

Method of administration

Oral use.

The Zolmitriptán Normon tablet should be placed on the tongue. Prior to administration, the mouth may be rinsed with water 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 Zolmitriptán Normon than you should

If you have taken more Zolmitriptán Normon than prescribed by your doctor, inform your doctor immediately or go to the nearest hospital. Take the medicine with you.

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

4. Possible adverse effects

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

Frequent adverse effects (affecting more than 1 in 100 people):

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

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

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

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

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

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

• Angina (chest pain, often triggered by exertion), heart attack, spasm of blood vessels in the heart. If you experience chest pain or shortness of breath after taking Zolmitriptán Normon, contact your doctor and do not take any more Zolmitriptán Normon.
• Spasm of blood vessels in 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 Zolmitriptán 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 Zolmitriptan 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 or household waste. Unused medicines and their packaging should be returned to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to 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 Normon

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

Appearance of the product and contents of the pack

Zolmitriptan Normon 5 mg orodispersible tablets are white, round, bevelled tablets, marked with “5” on one side and blank on the other. They are presented in peelable laminated aluminium blisters containing 2, 6 or 12 orodispersible tablets.

Only some pack sizes may be commercially available.

Marketing Authorisation Holder and Manufacturer

LABORATORIOS NORMON, S.A.

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

Date of the most recent review of this leaflet: November 2016

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