ZOMIG 5 mg NASAL SPRAY SOLUTION

Introduction

Package Leaflet: Information for the User

Zomig 5mg Nasal Spray Solution

zolmitriptan

Read all of this leaflet carefully before you start using 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 signs of illness 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 Zomig Nasal is and what it is used for
2. What you need to know before you use Zomig Nasal
3. How to use Zomig Nasal
4. Possible side effects
5. Storing Zomig Nasal
6. Contents of the pack and other information

1. What Zomig Nasal is and what it is used for

Zomig Nasal contains zolmitriptan and belongs to a group of medicines called triptans.

Zomig Nasal is used to treat migraine headache in adults and adolescents aged 12 years and older and cluster headache in adults.

• The symptoms of headache may be caused by the dilation of blood vessels in the head. It is believed that Zomig Nasal decreases the dilation of these blood vessels. This helps to relieve the headache and other frequent symptoms of the attack, such as:
• • feeling sick (nausea or vomiting) and sensitivity to light and sound during a migraine attack.
  • tearfulness and redness of the eye (conjunctival injection) and blockage or runny nose on the same side as the headache during a cluster headache attack.

Zomig Nasal only works when a headache attack has already begun. It will not prevent you from having an attack.

2. What you need to know before you use Zomig Nasal

Do not use Zomig Nasal:

• 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 heart attack, angina (chest pain caused by exercise or effort), 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 short-term symptoms similar to a stroke (transient ischaemic attack or TIA)
• if you have severe kidney problems
• if you are taking other medicines for migraine (e.g. ergotamine or ergot-type medicines such as dihydroergotamine and methysergide) or other migraine medicines from the triptan group at the same time. For more information, see section “Using Zomig Nasal with other medicines”.

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

Warnings and precautions

Talk to your doctor before you start using Zomig Nasal 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
• you have been told you have Wolff-Parkinson-White Syndrome (a type of irregular heartbeat)
• you have ever had liver problems
• you have headaches that are not migraine headaches or cluster headaches
• you are taking any other medicine for treating depression (see section “Using Zomig Nasal with other medicines”)

If you go to hospital, tell the medical staff that you are using Zomig Nasal.

Zomig Nasal is not recommended for children under 12 years or adults over 65.

Like other migraine treatments, overuse of Zomig Nasal can lead to daily headaches or worsening of your migraine headaches. Talk to your doctor if you think this may be happening to you. You may need to stop using Zomig Nasal to correct the problem.

Using Zomig Nasal with other medicines

Tell your doctor or pharmacist if you are using, have recently used or might use 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:

Medicines for migraine or cluster headache:

• If you take other triptans different from Zomig Nasal, wait 24 hours before using Zomig Nasal.

• After using Zomig Nasal, wait 24 hours before taking other triptans different from Zomig Nasal.
• If you take medicines containing ergotamine or ergot-type medicines (such as dihydroergotamine or methysergide), wait 24 hours before using Zomig Nasal.
• After using Zomig Nasal, wait 6 hours before taking ergotamine or ergot-type medicines.

Medicines for depression:

• moclobemide or fluvoxamine
• medicines called SSRIs (selective serotonin reuptake inhibitors)
• medicines called SNRIs (serotonin and norepinephrine reuptake inhibitors) such as venlafaxine, duloxetine

Serotonin syndrome is a rare but potentially life-threatening disorder that has been reported in some patients who have taken Zomig with certain other medicines that affect serotonin levels (e.g. certain medicines for depression). Symptoms of serotonin syndrome may include restlessness, confusion, confusion, rapid heartbeat, changes in blood pressure, fever, excessive sweating, shivering or shaking, muscle stiffness, loss of coordination or twitching. Your doctor can give you more information.

Other medicines:

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

If you are using herbal preparations containing St. John's Wort (Hypericum perforatum), you may be more likely to experience side effects of Zomig Nasal.

Using Zomig Nasal with food and drink

You can use Zomig Nasal with or without food. This does not affect how Zomig Nasal 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 for advice before using this medicine.

• The use of Zomig Nasal during pregnancy is not known to be harmful. Before using Zomig Nasal, tell your doctor if you are pregnant or trying to become pregnant.
• Avoid breastfeeding for 24 hours after using Zomig Nasal.

Driving and using machines

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

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

3. How to use Zomig Nasal

Zomig Nasal comes in a ready-to-use spray device. Each device contains 5 mg of zolmitriptan. Each device is for single use and provides only one dose.

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are not sure, ask your doctor or pharmacist again. Your doctor will decide the dose you should use, depending on your illness.

Migraine headache

Adults and adolescents (aged 12 years and older)

The recommended dose is one spray (5 mg) into one nostril. It does not matter which nostril you use and you can use Zomig at the start of the migraine headache or once the headache has already begun. You can use another dose if the migraine still persists after 2 hours or if it recurs within 24 hours. However, do not use more than two spray doses in a 24-hour period. The maximum daily dose is 10 mg.

Cluster headache

Adults

The recommended dose is 5 mg or 10 mg into one nostril. You may have a blocked nostril on the same side as the headache. If this happens, use the unblocked nostril on the opposite side of the headache. You should use Zomig as soon as the cluster headache attack starts. The maximum daily dose is 10 mg. Therefore, do not use more than 2 doses of 5 mg Zomig Nasal in a 24-hour period.

If the nasal spray does not give you enough relief from your headache, tell your doctor. Your doctor may increase the dose or change your treatment.

How to use Zomig Nasal

Please read these instructions before using Zomig Nasal.

Do not press the plunger until you have inserted the spray device into your nostril or the dose will be wasted.

If you use more Zomig Nasal than you should

If you have used more Zomig Nasal than your doctor has prescribed, tell your doctor immediately, go to the nearest hospital or call the Poison Information Service on 91 562 04 20. Take the medicine Zomig Nasal and this leaflet with you.

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.

Stop taking Zomig Nasal and contact your doctor immediately if you experience any of the following side effects:

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

• Allergic reactions/hypersensitivity, including lumpy rash (hives), swelling of the face, lips, mouth, tongue or throat; difficulty swallowing or breathing difficulties.

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 blood vessels of the heart. You may feel chest pain or shortness of breath.
• Spasm of the blood vessels of the intestine that can damage your intestine. You may feel stomach pain or bloody diarrhea.

Other side effects that may occur:

Very common side effects (may affect more than 1 in 10 people):

• Altered taste.

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

• Abnormal sensations such as tingling in the fingers of the hands and feet or sensitive skin.
• Feeling sleepy, dizzy or warm.
• Headache.
• Irregular heartbeat.
• Nosebleed. Irritation in the nose. Blockage and/or runny nose (rhinitis).
• Feeling sick. 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.
• Difficulty swallowing.

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.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Zomig Nasal

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 is the last day of the month shown.

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

What Zomig Nasal contains

The active substance is zolmitriptan. Zomig Nasal contains 5 mg of zolmitriptan per dose.

The other ingredients are: citric acid, disodium phosphate and purified water.

Appearance and packaging

Zomig 5 mg nasal spray solution is a pre-assembled device.

Zomig Nasal is available in pack sizes of 1, 2, 6 or 18 single-use nasal spray devices.

Each spray device is ready to use and provides only one dose.

Not all pack sizes may be marketed.

Zomig may also be available in the form of film-coated tablets of 2.5 mg, and orodispersible tablets of 2.5 mg and 5 mg.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Grünenthal Pharma, S.A.

Doctor Zamenhof, 36 – 28027 Madrid, Spain

Manufacturer:

Grünenthal GmbH

Zieglerstrasse 6– D- 52078 Aachen, Germany

or

Farmaceutici Formenti S.p.A.

Via Di Vittorio 2 - 21040 Origgio (VA), Italy

This medicine is authorised in the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet:December 2020

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.gob.es/