ZOMIG FLAS 2.5 mg ORALLY DISINTEGRATING TABLETS

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 exertion), Prinzmetal's angina (chest pain at rest), or have had symptoms related to the heart such as shortness of breath or pressure on 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 other medicines for migraine (e.g. ergotamine or ergot-type medicines such as dihydroergotamine and methysergide) or other triptan medicines for migraine. For more information, see section "Using 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 (e.g. you smoke, have high blood pressure, high cholesterol, diabetes, or a family history of heart disease)
• you have been told you have Wolff-Parkinson-White Syndrome (a type of abnormal heartbeat)
• you have ever had liver problems
• you have headaches that are not like your usual migraine headaches
• you are taking any other medicines for depression (see section "Using 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 years old.

Like other migraine treatments, taking too much Zomig Flas may lead to daily headaches or make your migraine headaches worse. If you think this is happening to you, talk to your doctor. You may need to stop taking Zomig Flas to correct the problem.

Using 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:

Migraine medicines

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

Depression medicines

• 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 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 muscle coordination or twitching muscles. Your doctor can give you more information.

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 experience side effects when taking Zomig Flas.

Taking Zomig Flas with food and drink

You can take Zomig Flas with or without food. This does not affect how Zomig Flas 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 taking this medicine.

• The use of Zomig Flas during pregnancy is not known to be harmful. Before taking Zomig Flas, tell your doctor if you are pregnant or trying to become pregnant.
• Do not breastfeed 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 2.5 mg contains 5 mg of aspartame in each orodispersible tablet.

Aspartame is a source of phenylalanine, which may be harmful for people with phenylketonuria (a rare genetic disorder in which phenylalanine accumulates in the body because it cannot be eliminated properly).

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

Zomig Flas contains benzyl alcohol:

Zomig Flas 2.5 mg contains 0.0000032 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 breastfeeding. This is because large amounts of benzyl alcohol can build up in your body and 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 cause side effects (metabolic acidosis).

3. How to take Zomig Flas

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

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.
• Open the blister pack by peeling off the foil as shown on the aluminium 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 is still present or if it comes back within 24 hours.

If the tablets do not give you enough help with your migraine, talk to your doctor. Your doctor may increase the dose to 5 mg or change your treatment.

Do not take more than the dose that has been prescribed for you.

• Do not take more than two doses in a day. The maximum daily dose is 5 mg.

If you take more Zomig Flas than you should

If you have taken more Zomig Flas than your doctor has prescribed, talk to your doctor or go to the nearest hospital casualty department immediately. Take the medicine 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 due to the migraine attack itself.

Stop taking Zomig Flas 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 rash, hives, and 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 heart's blood vessels. You may feel chest pain or shortness of breath.
• Spasm of the intestines' blood vessels, which can damage your intestines. You may feel 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 the fingers and toes or skin sensitivity to touch.
• Feeling sleepy, dizzy, or 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, 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 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 Medicines Agency's website: 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. Zomig Flas orodispersible tablets contain 2.5 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 bicarbonate.

Appearance and packaging

• Zomig Flas 2.5 mg orodispersible tablets are white, flat-faced, round, and marked with the letter "Z" on one side.
• Zomig Flas is packaged in a peelable blister pack of aluminium laminate that contains 2, 6, or 12 (2 x 6) tablets, with or without a pocket-sized case.

The pocket-sized case 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-sized case, as you may need to read them again.

Not all pack sizes may be marketed.

Zomig may also be available as 5 mg orodispersible tablets, 5 mg/dose 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/