Zomig Flas 5 mg orodispersible tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Zomig Flas 5mg orodispersible tablets

zolmitriptan

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 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 adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Zomig Flas is and what it is used for
2. What you need to know before taking Zomig Flas
3. How to take Zomig Flas
4. Possible adverse effects
5. How to store 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 known as triptans.

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

• Migraine symptoms may be caused by the dilation of blood vessels in the head. Zomig Flas 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 (feeling unwell) and sensitivity to light and sound.

Zomig Flas 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 Zomig Flas

Do not take Zomig Flas:

• if you are allergic 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 have experienced heart-related symptoms such as shortness of breath or chest pressure
• 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 currently 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 Flas with other medicines”.

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

Warnings and precautions

Consult your doctor before taking Zomig Flas 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 headaches
• you are taking any other medication for depression (see section “Use of Zomig Flas with other medicines”).

If you go to a hospital, inform medical staff that you are taking Zomig Flas.

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

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

Use of Zomig Flas 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 Zomig Flas, wait 24 hours before taking Zomig Flas.
• After taking Zomig Flas, wait 24 hours before taking other triptans different from Zomig Flas.
• If you are taking 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.

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 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)
• an antibiotic from the quinolone group (such as ciprofloxacin)

If you are using herbal remedies containing St. John’s wort (Hypericum perforatum), you may be more likely to experience adverse effects from Zomig Flas.

Taking Zomig Flas with food and drink

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

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

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 Zomig Flas will affect driving or the use of tools or machinery. However, it is advisable to wait and see how Zomig Flas affects you before attempting these activities.

Zomig Flas contains aspartame and sodium:

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

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

This medicine contains less than 23 mg of sodium (1 mmol) per orally disintegrating tablet; therefore, it is essentially “sodium-free”.

Zomig Flas contains benzyl alcohol:

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

Benzyl alcohol may cause allergic reactions.

Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

3. How to take Zomig Flas

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

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

• The recommended dose is one tablet.
• Peel back the blister pack as shown on the aluminum foil. Do not push the tablet through the aluminum foil.
• Place the tablet on your tongue, where it will dissolve and be swallowed with saliva. You do not need to drink water to swallow the tablet.
• You may take another tablet after two hours if the migraine still persists or if it returns within 24 hours.

If the tablets have not provided sufficient relief for your migraine, inform your doctor. Your doctor may change your treatment.

Do not use more than the prescribed dose.

• Do not use more than two doses in one day. The maximum daily dose is 10 mg.

If you take more Zomig Flas than you should

If you have taken more Zomig Flas than prescribed by your doctor, inform your doctor immediately, go to the nearest hospital, or call the Toxicology Information Service at: 91 562 04 20. Take the Zomig Flas 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 Flas 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, itchy rash (hives) and 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 of the heart. You may experience chest pain or shortness of breath.
• Spasm of the blood vessels in the intestine, which may damage your intestine. You may experience stomach pain or bloody diarrhoea.

Other adverse effects that may occur:

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

• Abnormal sensations such as tingling in the fingers or toes or skin sensitivity 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 (may affect up to 1 in 100 people):

• Very fast heartbeat.
• Slightly increased blood pressure.
• Increase in the amount of urine produced or in the number of times you need to urinate.

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 Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Zomig Flas Storage

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 refers to the last day of the month indicated.

Do not store above 25 °C.

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

6. Contents of the pack and other information

Composition of Zomig Flas

The active substance is zolmitriptan. Zomig Flas orodispersible tablets contain 5 mg of zolmitriptan.

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

Appearance of the product and contents of the pack

• Zomig Flas 5 mg orodispersible tablets are white, flat-faced, round tablets marked with “Z 5” on one side.
• Zomig Flas is packaged in a peelable laminated aluminium blister containing 2, 6 or 12 (2 x 6) tablets, with or without a pocket case.

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

Only certain pack sizes may be marketed.

Zomig may also be available as orodispersible tablets of 2.5 mg, nasal spray 5 mg/dose, and film-coated tablets of 2.5 mg.

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 medicinal product is authorised in the Member States of the European Economic Area under the following names:

Date of the most recent review of this leaflet: June 2024

Detailed information about this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/