ZOMIG 2.5 mg FILM-COATED TABLETS

2. What you need to know before you take Zomig

Do not take Zomig:

• 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 a heart attack, angina (chest pain caused by exercise or effort), Prinzmetal's angina (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 ischaemic attack or TIA)
• if you have severe kidney problems
• if you are taking other medicines for migraine (such as ergotamine or ergot-type medicines like dihydroergotamine and methysergide) or other migraine medicines from the triptan group. For more information, see section "Using Zomig with other medicines".

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist.

Warnings and precautions

Talk to your doctor before taking Zomig if:

• you are at risk of having a heart attack (ischaemic heart disease). The risk is greater if you smoke, have high blood pressure, high cholesterol levels, diabetes, or if a close relative has had 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 other than your usual migraine headache
• you are taking any other medicine for depression (see section "Using Zomig with other medicines").

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

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

As with other migraine treatments, taking too much Zomig may cause you to have daily headaches or make your migraine headaches worse. Talk to your doctor if you think this is happening to you. You may need to stop taking Zomig to correct the problem.

Using Zomig 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 that are not Zomig, wait 24 hours before taking Zomig.
• After taking Zomig, wait 24 hours before taking other triptans that are not Zomig.
• If you take medicines that contain 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 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 disorder that has been reported in some patients who have taken Zomig in combination with certain serotoninergic medicines (such as certain medicines for depression). Symptoms of serotonin syndrome can include agitation, tremors, restlessness, fever, excessive sweating, spasms, muscle stiffness, uncoordinated movements of the limbs or eyes, and involuntary muscle contractions. Your doctor can give you more information.

Other medicines

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

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

Taking Zomig with food and drink

You can 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 are planning to have a baby, ask your doctor for advice before taking this medicine.

• It is not known if taking Zomig during pregnancy is harmful. If you are pregnant or planning to become pregnant, talk to your doctor before taking this medicine.
• Avoid breastfeeding for 24 hours after taking Zomig.

Driving and using machines

• During a migraine attack, your reactions may be slower than usual. Take this into account when driving or using tools or machines.
• It is unlikely that Zomig will affect your ability to drive or use tools or machines. However, it is best to wait and see how Zomig affects you before trying to do these activities.

Zomig contains lactose and sodium:

Zomig film-coated tablets contain lactose. If your doctor has told you that you have an intolerance to some sugars, talk to your doctor before taking this medicine.

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

3. How to take Zomig

Always take this medicine exactly as your doctor has told you. If you are not sure, talk to your doctor or pharmacist.

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

• The recommended dose is one tablet (2.5 mg).
• Swallow the tablet with water.
• You can take another tablet after 2 hours if the migraine is still present, or if it comes back within 24 hours.

If these 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 24-hour period. 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 you have been prescribed, talk to your doctor or go to the nearest hospital casualty department immediately. Take the medicine pack 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 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, swelling of the face, lips, mouth, tongue, and throat; difficulty swallowing or breathing difficulties.

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

• Angina (chest pain, often caused by exercise), heart attack, or spasm of the heart's blood vessels. You may experience chest pain or shortness of breath.
• Spasm of the blood vessels of the intestine that can damage your intestine. You may experience stomach pain or bloody diarrhea.

Other side effects that may occur:

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

• Abnormal sensations such as tingling in the fingers and toes or sensitive skin.
• Feeling sleepy, dizzy, or warm.
• Headache.
• Irregular heartbeat.
• Nausea. Vomiting.
• Stomach pain.
• Dry mouth.
• Muscle weakness or muscle pain.
• Feeling weak.
• Heaviness, tension, 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 experience 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 Surveillance System 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

• 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. The expiry date is the last day of the month stated.
• 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 protect the environment.

6. Contents of the pack and further information

What is in Zomig

• The active substance is zolmitriptan.

Each film-coated tablet contains 2.5 mg of zolmitriptan.

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

Appearance and packaging

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.

Not all pack sizes may be marketed.

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

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

Date of last revision of this leaflet:April 2022

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