ZOMIG FLAS 5 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

Zomig Flas 5mg Orodispersible Tablets

zolmitriptan

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

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

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

Zomig Flas is used to treat migraine headaches in adults aged 18 and over.

• Migraine symptoms may be caused by the swelling of blood vessels in the head. It is thought that Zomig Flas works by shrinking the swollen blood vessels. This helps to stop the headache and other symptoms of a migraine attack, such as feeling sick (nausea or vomiting) and being sensitive to light and sound.

Zomig Flas only works when a migraine attack has started. It will not stop you from getting a migraine attack.

2. What you need to know before you take Zomig Flas

Do not take Zomig Flas:

• 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 attacks, angina (chest pain caused by exercise or strain), Prinzmetal's angina (chest pain at rest), or have had symptoms of heart disease such as shortness of breath or pressure over the chest
• if you have had a stroke (cerebrovascular accident) or symptoms similar to a stroke (transient ischaemic attack or TIA)
• if you have severe kidney problems
• if you are taking or have taken in the last 24 hours other medicines for migraine (such as ergotamine or ergot-type medicines like dihydroergotamine and methysergide) or other triptan medicines. For further information, see section “Taking Zomig Flas 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 taking Zomig Flas if:

• you are at risk of heart disease (poor blood flow in the arteries of the heart). The risk is greater if you smoke, have high blood pressure, high levels of cholesterol, diabetes, or if a close relative has heart disease
• you have been told you have Wolff-Parkinson-White Syndrome (a type of abnormal heartbeat)
• you have ever had liver problems
• you get headaches that are not like your usual migraine headaches
• you are taking any other medicines for depression (see section “Taking Zomig Flas with other medicines”)

If you go to hospital, tell the medical staff that you are taking Zomig Flas.

Zomig Flas is not recommended for people under 18 or over 65.

As with other migraine treatments, taking too much Zomig Flas may lead to daily headaches or make your migraine headaches worse. Talk to your doctor if you think this might be happening to you. You may need to stop taking Zomig Flas to get rid of the problem.

Taking Zomig Flas with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take 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 for migraine

• If you take other triptans, wait 24 hours after taking Zomig Flas before taking another triptan.
• After taking Zomig Flas, wait 24 hours before taking another triptan.
• If you take medicines containing ergotamine or ergot-type medicines (such as dihydroergotamine or methysergide), wait 24 hours after taking Zomig Flas before taking these medicines.
• After taking Zomig Flas, 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 condition that can occur when Zomig is taken with other medicines that increase the amount of serotonin in the body. Symptoms of serotonin syndrome may include: restlessness, hallucinations, loss of coordination, fast heart beat, increased heart blood pressure, increased body temperature, overactive reflexes, nausea, vomiting, and diarrhea. Your doctor will tell you more about this.

Other medicines

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

If you are taking herbal remedies containing St John's Wort (Hypericum perforatum), you may be more likely to get side effects from Zomig Flas.

Taking Zomig Flas with food and drink

You can take Zomig Flas with or without food. This will not affect how Zomig Flas works.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

• The use of Zomig Flas during pregnancy is not recommended. If you are pregnant, think you may be pregnant or are planning to have a baby, tell your doctor before taking Zomig Flas.
• Do not breast-feed for 24 hours after taking Zomig Flas.

Driving and using machines

• During a migraine attack, your reactions may be slower than usual. Bear this in mind when driving or using tools or machines.
• It is unlikely that Zomig Flas will affect your ability to drive or use machines. However, it is best to wait and see how Zomig Flas affects you before attempting to do so.

Zomig Flas contains aspartame and sodium:

Zomig Flas 5 mg contains 10 mg of aspartame in each orodispersible tablet.

Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (a rare, inherited disorder).

This medicine contains less than 23 mg of sodium (1mmol) per orodispersible tablet, which is essentially “sodium-free”.

Zomig Flas contains benzyl alcohol:

Zomig Flas 5 mg contains 0.0000064 mg of benzyl alcohol in each orodispersible tablet.

Benzyl alcohol may cause allergic reactions.

Talk to your doctor or pharmacist if you are pregnant or breast-feeding. This is because large amounts of benzyl alcohol can build up in your body and may cause side effects (metabolic acidosis).

Talk to your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol can build up in your body and may cause side effects (metabolic acidosis).

3. How to take Zomig Flas

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

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

• The recommended dose is one tablet.
• Peel back the blister packaging to open it as shown on the foil. Do not push the tablet through the foil.
• Place the tablet on your tongue, where it will dissolve and be swallowed with your saliva. You do not need to drink water to swallow your tablet.
• You can take another tablet after 2 hours, if the migraine has not resolved or has returned within 24 hours.

If the tablets do not give you enough help with your migraine, tell your doctor. Your doctor may change your treatment.

Do not take more than the recommended dose.

• Do not take more than two doses in a 24-hour period. The maximum daily dose is 10 mg.

If you take more Zomig Flas than you should

If you have taken more Zomig Flas than you should, talk to a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Zomig Flas can cause side effects, although not everybody gets them. Some of the symptoms listed below may be due to the migraine attack itself.

Stop taking Zomig Flas and contact a 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 rash, hives, and swelling of the face, lips, tongue or throat; difficulty swallowing or breathing.

Very rare side effects (may affect up to 1 in 10,000 people):

• Angina (chest pain, often brought on by exercise), heart attack, or spasm of the heart's blood vessels. You may notice chest pain or shortness of breath.
• Spasm of the intestines' blood vessels, which can damage your intestines. You may notice stomach pain or bloody diarrhea.

Other side effects that may occur:

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

• Unusual sensations such as tingling in your fingers and toes or skin sensitivity.
• Feeling sleepy, dizzy, or warm.
• Headache.
• Irregular heart rhythm.
• Nausea. Vomiting.
• Stomach pain.
• Dry mouth.
• Muscle weakness or muscle pain.
• Feeling weak.
• Heaviness, tightness, pain, or pressure in the throat, neck, arms, or legs, or chest.
• Difficulty swallowing.

Uncommon side effects (may affect up to 1 in 100 people):

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

Reporting of side effects

If you get 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 Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Zomig Flas

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 25°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 to protect the environment.

6. Contents of the pack and other information

What Zomig Flas contains

The active substance is zolmitriptan. Each Zomig Flas orodispersible tablet contains 5 mg of zolmitriptan.

The other ingredients are: aspartame (E951), anhydrous citric acid, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol (E421), microcrystalline cellulose, orange flavor (contains benzyl alcohol), and sodium bicarbonate.

Appearance and packaging

• Zomig Flas 5 mg orodispersible tablets are white, flat-faced, round, and marked with “Z 5” on one side.
• Zomig Flas is packaged in a peelable blister pack of aluminum laminate that contains 2, 6, or 12 (2 x 6) tablets, with or without a pocket pack.

The pocket pack is a hard plastic container in which you can store your tablets for convenience. You should keep the outer carton and this leaflet when you are using the pocket pack, as you may need to read them again.

Not all pack sizes may be marketed.

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

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Grünenthal Pharma, S.A.

Doctor Zamenhof, 36 – 28027 Madrid, Spain

Manufacturer:

Farmaceutici Formenti S.p.A.

Via Di Vittorio 2

21040 Origgio (VA)

Italy

or

Grünenthal GmbH

Zieglerstrasse 6 – D- 52078 Aachen, Germany

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

Date of last revision of this leaflet: June 2024

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