Zomig 2.5 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Zomig 2.5 mg film-coated 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 must not be given to other people, even if they have the same symptoms, as it may 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.

Leaflet contents

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

1. What Zomig is and what it is used for

Zomig contains zolmitriptan and belongs to a group of medicines known as triptans.

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

• Migraine symptoms may be caused by the widening of blood vessels in the head. Zomig is believed to reduce this widening of the blood vessels, helping to relieve headache pain and other symptoms of a migraine attack, such as nausea or vomiting, and sensitivity to light and sound.

• Zomig 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 using Zomig

Do not take Zomig:

• 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 physical exertion or stress), Prinzmetal's angina (chest pain occurring at rest), or have experienced heart-related symptoms such as shortness of breath or chest tightness
• if you have had a stroke (cerebrovascular accident) or transient stroke-like symptoms (transient ischaemic attack or TIA)
• if you have severe kidney problems
• if you are simultaneously taking other migraine medicines (e.g. ergotamine or ergot-type medicines such as dihydroergotamine and methysergide) or other migraine medicines from the triptan group. For further information, see section “Use of Zomig with other medicines”.

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

Warnings and precautions

Talk to your doctor before starting Zomig if:

• you are at risk of ischaemic 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 ischaemic 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 medicine for depression (see section “Use of Zomig with other medicines”).

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

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

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

Use of Zomig with other medicines

Tell 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 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, wait 24 hours before taking Zomig.
• After taking Zomig, wait 24 hours before taking other triptans different from Zomig.
• If you are taking medicines containing ergotamine or ergot-type medicines (such as dihydroergotamine or methysergide), wait 24 hours before taking Zomig.
• After taking Zomig, 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 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)
• an antibiotic from the quinolone group (such as ciprofloxacin)

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

Taking Zomig with food and drink

You may take Zomig with or without food. This does not affect how Zomig 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 taking Zomig during pregnancy is harmful. If you are pregnant or planning to become pregnant, consult your doctor before using this medicine.
• Avoid breastfeeding within 24 hours after taking Zomig.

Driving and using machines

• During a migraine attack, your reactions may be slower than usual. Keep this in mind when driving or operating tools or machinery.
• It is unlikely that Zomig will affect your ability to drive or operate tools or machinery. However, it is advisable to wait and see how Zomig affects you before attempting these activities.

Zomig contains lactose and sodium:

Zomig tablets contain lactose. If your doctor has told you that you have an intolerance to certain sugars, consult him before taking this medicine.

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

3. How to take Zomig

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

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

• The recommended dose is one tablet (2.5 mg).
• Swallow the tablet with water.
• You may take another tablet after two hours if the migraine persists, or if it returns within 24 hours.

If these tablets have not provided sufficient relief for your migraine, inform your doctor. Your doctor might increase your dose to 5 mg or change your treatment.

Do not take more than the prescribed dose.

• Do not take more than two doses in one day. If you have been prescribed 2.5 mg, the maximum daily dose is 5 mg. If you have been prescribed 5 mg, the maximum daily dose is 10 mg.

If you take more Zomig than you should

If you have taken more Zomig than your doctor has prescribed, contact your doctor immediately, go to the nearest hospital, or call the Toxicology Information Service at 91 562 04 20. Take the Zomig medicine and its package leaflet with you.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. Some of the symptoms listed below may be part of the migraine attack itself.

Stop taking Zomig 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) and swelling of the face, lips, mouth, tongue, and throat; difficulty swallowing or breathing difficulties.

Very rare adverse effects (may affect less than 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 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.
• 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 type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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. Storage of Zomig

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the container. 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. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused containers and medicines. This helps protect the environment.

6. Contents of the pack and other information

Composition of Zomig

• The active substance is zolmitriptan.

Each film-coated tablet contains 2.5 mg of zolmitriptan.

• The other components (excipients) are: anhydrous lactose, microcrystalline cellulose, sodium carboxymethylstarch (Type A) (derived from potato starch), magnesium stearate, polyethylene glycol, hypromellose, titanium dioxide (E171), yellow iron oxide (E172).

Appearance of the product and contents of the pack

Zomig 2.5 mg film-coated tablets are yellow, round and marked with the letter "Z" on one side.

Zomig 2.5 mg film-coated tablets are available in blister packs containing 3, 6, 12 or 18 tablets.

Only certain pack sizes may be marketed.

Zomig may also be available as a nasal spray containing 5 mg/dose and as orodispersible tablets containing 2.5 mg and 5 mg.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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

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

Date of the most recent review of this summary: April 2022

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