Prospecto: Information for the User

Zomig 2.5mg Film-Coated Tablets

zolmitriptán

Read this prospectus carefully before starting to take the medication, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, 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 not listed in this prospectus. See section4.

1.What is Zomig and for what it is used

2.What you need to know before starting to use Zomig

3.How to take Zomig

4.Possible adverse effects

5.Storage of Zomig

6.Contents of the package and additional information

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

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

• The symptoms of migraine may be caused by a dilation of blood vessels in the head. It is believed that Zomig reduces the dilation of these blood vessels. This helps the disappearance of headache pain and other symptoms of a migraine attack, such as a feeling of discomfort (nausea or vomiting) and sensitivity to light and sound.

• Zomig acts only when a migraine attack has begun. It will not prevent you from experiencing a migraine attack.

Do not take Zomig:

• if you are allergic to zolmitriptan or any of the other ingredients in this medication (listed in section6)
• if you have high blood pressure
• if you have had any heart problems, including a heart attack, angina (chest pain caused by exercise or effort), angina of Prinzmetal (chest pain that occurs at rest) or have experienced 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 of short duration similar to a stroke (transient ischemic attack or TIA)
• if you have severe kidney problems
• if you are taking other medications for migraine (for example ergotamine or ergot-type medications such as dihydroergotamine and methysergide) or other medications for migraine in the triptan group. For additional information, see the section “Use of Zomig with other medications”.

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

Warnings and precautions

Consult your doctor before starting to take Zomig if:

• you are at risk of developing ischemic heart disease (insufficient blood flow to 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 told that you have Wolff-Parkinson-White syndrome (a type of abnormal heart rhythm)
• you have had any liver problems
• you have headaches other than your usual migraine headache
• you are taking any other medication for depression (see the section “Use of Zomig with other medications”).

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

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

Like other migraine treatments, excessive use of Zomig may cause daily headaches or worsening of your migraine headaches. Consult your doctor if you think this is the case. You may need to stop using Zomig to correct the problem.

Use of Zomig with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This includes herbal remedies and medications you purchase without a prescription.

Especially, inform your doctor if you are taking any of the following medications:

Migraine medications

• If you take other triptans different from Zomig, wait 24hours before taking Zomig.
• After taking Zomig, wait 24hours before taking other triptans different from Zomig.
• If you take medications that contain ergotamine or ergot-type medications (such as dihydroergotamine or methysergide), wait 24hours before taking Zomig.
• After taking Zomig, wait 6hours before taking ergotamine or ergot-type medications.

Depression medications

• moclobemide or fluvoxamine
• medications called SSRIs (selective serotonin reuptake inhibitors)
• medications called SNRIs (serotonin and norepinephrine reuptake inhibitors) such as venlafaxine, duloxetine

The serotonin syndrome is a rare but potentially fatal condition that has been reported in some patients who took Zomig in combination with certain serotonin-related medications (such as some medications for depression). Symptoms of the serotonin syndrome may include agitation, tremors, restlessness, fever, excessive sweating, spasms, muscle rigidity, uncoordinated movements of the limbs or eyes, and involuntary muscle contractions. Your doctor may provide additional information.

Other medications

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

If you are using herbal remedies that contain St. John's Wort (Hypericum perforatum), you may be more likely to experience adverse effects from Zomig.

Taking Zomig with food and drinks

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor before using this medication.

• The safety of taking Zomig during pregnancy is unknown. If you are pregnant or intend to become pregnant, consult your doctor before using this medication.
• Avoid breastfeeding within 24 hours of taking Zomig.

Driving and operating machinery

• During a migraine crisis, your reactions may be slower than usual. Be aware of this when driving or operating tools or machinery.
• It is unlikely that Zomig will affect driving or operating tools or machinery. However, it is best 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 a certain sugar intolerance, consult with them before taking this medication.

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

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

You can take Zomig as soon as a migraine headache begins. You can also take it once a headache has started.

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

If these tablets did not provide enough help for your migraine, inform your doctor. Your doctor may increase the dose to 5 mg or change your treatment.

Do not take more than the dose prescribed.

• Do not take more than two doses in a 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 dose is 10 mg.

If you take more Zomig than you should

If you have taken more Zomig than your doctor prescribed, inform your doctor immediately, go to the nearest hospital, or call the Toxicological Information Service, phone 91 562 04 20. Bring the Zomig medication and its packaging with you.

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

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

Very rare side effects (may affect fewer than 1 in 10,000 people):

• Angina (chest pain, often caused by exercise), heart attack, or coronary artery spasm. You may observe chest pain or shortness of breath.
• Intestinal artery spasm that may damage your intestine. You may observe abdominal pain or bloody diarrhea.

Other side effects that may occur:

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

• Abnormal sensations such as tingling in the fingers of the hands and feet or sensitive skin.
• Sensation of drowsiness, dizziness, or heat.
• Headache.
• Irregular heartbeat.
• Nausea. Vomiting.
• Abdominal pain.
• Dry mouth.
• Muscle weakness or muscle pain.
• Sensation of weakness.
• Weight, tension, pain, or pressure in the throat, neck, arms, and legs or chest.
• Difficulty swallowing.

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

• Very rapid heartbeat.
• Slightly higher blood pressure.
• Increased urine production or the need to urinate more frequently.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.
• Do not store at a temperature above 25 °C.
• Medicines should not be thrown into the drains or trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Zomig

• The active ingredient is zolmitriptan.

Each film-coated tablet contains 2.5 mg of zolmitriptan.

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

Appearance of the product and contents of the packaging

Zomig 2.5 mg film-coated tablets are yellow, round, and marked with the letter “Z” on one of their faces.

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

Only some pack sizes may be marketed.

Zomig may also be available in the form of a nasal spray of 5 mg/dose and in orally disintegrating tablets of 2.5 mg and 5 mg.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Grünenthal Pharma, S.A.

Doctor Zamenhof, 36 – 28027 Madrid, Spain

Responsible manufacturer:

Farmaceutici Formenti S.p.A.

Via Di Vittorio 2

21040 Origgio (VA)

Italy

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this prospectus: April 2022

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/