Zomig 5 mg nasal spray solution

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Zomig 5mg nasal spray solution

zolmitriptan

Read the entire leaflet carefully before you start using 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 must not give it to other people, 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 effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Zomig Nasal is and what it is used for
2. What you need to know before using Zomig Nasal
3. How to use Zomig Nasal
4. Possible adverse effects
5. How to store 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 known as 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. Zomig Nasal is believed to reduce the dilation of these blood vessels. This helps relieve headache pain and other common symptoms of an attack, such as:
  • feeling unwell (nausea or vomiting) and sensitivity to light and sound during a migraine attack.
  • tearing and redness of the eye (conjunctival injection) and nasal congestion or discharge on the same side as the pain during a cluster headache attack.

Zomig Nasal works only once a headache attack has started. It will not prevent you from having an attack.

2. What you need to know before using 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 a heart attack, angina (chest pain caused by exercise or exertion), Prinzmetal's angina (chest pain occurring at rest), or 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 medications from the triptan group. For further information, see section “Use of Zomig Nasal with other medicines”.

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

Warnings and precautions

Consult your doctor before starting to use Zomig Nasal 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
• you have been diagnosed with Wolff-Parkinson-White syndrome (a type of abnormal heart rhythm)
• you have ever had liver problems
• you experience headaches different from your usual migraine or cluster headache
• you are taking any other medication for depression (see section “Use of Zomig Nasal with other medicines”).

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

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

Like other migraine treatments, excessive use of Zomig Nasal 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 Zomig Nasal to resolve the problem.

Use of Zomig Nasal 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 purchase without a prescription.

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

Migraine or cluster headache medicines:

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

Medicines for depression:

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

Serotonin syndrome is a rare but potentially life-threatening condition that has been reported in some patients who took Zomig in combination with so-called serotonergic medicines (e.g., certain medicines for treating depression). Symptoms of serotonin syndrome may include agitation, tremors, restlessness, fever, excessive sweating, spasms, muscle rigidity, uncoordinated movements of limbs or eyes, and involuntary muscle contractions. Your doctor can provide further information.

Other medicines:

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

If you are taking herbal preparations containing St. John’s wort (Hypericum perforatum), adverse effects from Zomig Nasal may be more likely.

Use of Zomig Nasal with food and drink

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

• It is unknown whether using Zomig Nasal during pregnancy is harmful. Before using Zomig Nasal, inform your doctor if you are pregnant or trying to become pregnant.
• Avoid breastfeeding within 24 hours after using Zomig Nasal.

Driving and use of machines

• During a headache attack, your reactions may be slower than usual. Take this into account when driving or operating tools or machinery.

It is unlikely that Zomig Nasal will affect driving or operating tools or machinery. However, it is advisable to wait and observe how Zomig Nasal affects you before attempting these activities.

3. How to use Zomig Nasal

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

Always follow exactly the instructions for use provided by your doctor. If in doubt, consult your doctor or pharmacist again. Your doctor will determine the dose you should use, which will depend on your condition.

Migraine headache

Adults and adolescents (from 12 years of age)

The recommended dose is one spray (5 mg) into one nostril. It does not matter which nostril you use, and you may use Zomig at the onset of migraine headache or once the headache has already started. You may use another dose if the migraine persists after two hours or recurs within 24 hours. However, do not use more than two spray doses in one day. The maximum daily dose is 10 mg.

Cluster headache

Adults

The recommended dose is 5 mg or 10 mg in one nostril. You may have nasal congestion on the same side as the headache. If this occurs, use the nostril that is not blocked, on the opposite side to the headache. You should use Zomig as soon as a cluster headache attack begins. The maximum daily dose is 10 mg. Therefore, do not use more than two doses of 5 mg of Zomig Nasal within a 24-hour period.

If the nasal spray does not provide sufficient relief for your headache, inform 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 the spray has been inserted into the nasal cavity, otherwise 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, inform your doctor immediately, go to the nearest hospital, or call the Toxicology Information Service at telephone number: 91 562 04 20. Take the Zomig Nasal medicine and its package leaflet with you.

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.

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

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

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

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

• Angina (chest pain, often triggered by exercise), heart attack, or spasm of the blood vessels in the heart. You may experience chest pain or shortness of breath.
• Spasm of blood vessels in the intestine which may damage your intestine. You may experience stomach pain or bloody diarrhoea.

Other adverse effects that may occur:

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

• Altered taste.

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

• Abnormal sensations such as tingling in fingers and toes or skin sensitivity to touch.
• Drowsiness, dizziness or feeling of warmth.
• Headache.
• Irregular heartbeat.
• Nosebleed. Nasal irritation. Nasal congestion and/or runny nose (rhinitis).
• 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 (may affect up to 1 in 100 people):

• Very fast heartbeat.
• Slight increase in blood pressure.
• Increase in the amount of urine produced or in the number of times you need to pass urine.

Reporting of adverse effects

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

5. Storage of Zomig Nasal

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 25 °C.

Medicines should not be disposed of via wastewater 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 dispose of unused medicines and containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Zomig Nasal

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

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

Appearance of the product and contents of the pack

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

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

Each nasal spray unit is ready for use and delivers only one dose.

Only certain pack sizes may be marketed.

Zomig may also be available as 2.5 mg film-coated tablets, and as 2.5 mg and 5 mg orodispersible tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the last review of this leaflet: December 2020

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