ZOMIG

PACKAGE LEAFLET: INFORMATION FOR THE USER

Zomig 2.5 mg and 5 mg film-coated tablets

Zolmitriptan
Please read this leaflet carefully before taking this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
• If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Zomig is and what it is used for
2. Before you take Zomig
3. How to take Zomig
4. Possible side effects
5. How to store Zomig
6. Further information

1. WHAT ZOMIG IS AND WHAT IT IS USED FOR

Zomig contains zolmitriptan and belongs to a group of medicines called triptans.
Zomig is used for the treatment of migraine headache.

• Migraine symptoms may be caused by the dilation of blood vessels in the head. Zomig is believed to reduce this dilation of blood vessels, thereby helping to relieve headache 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 does not prevent the onset of an attack.

2. BEFORE TAKING ZOMIG

Do not take ZOMIG

• if you are allergic (hypersensitive) to zolmitriptan or to any of the excipients of this medicine (see section 6: Further information)
• if you have high blood pressure
• if you have had heart problems, including heart attacks, angina (chest pain caused by physical exertion or stress), Prinzmetal's angina (chest pain occurring at rest), or if you have experienced cardiac symptoms such as shortness of breath or chest tightness
• if you have had a stroke or brief 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 triptans for migraine. See the section below: "Taking ZOMIG with other medicines" for further information. If in doubt, consult your doctor or pharmacist.

Take special care with ZOMIG
Before taking ZOMIG, inform your doctor if:

• you are at risk of ischemic heart disease (reduced blood flow in the coronary arteries). The risk is higher if you smoke, have high blood pressure, elevated cholesterol levels, diabetes, or if someone in your family has ischemic heart disease
• you have been diagnosed with Wolff-Parkinson-White syndrome (a type of heart rhythm abnormality)
• you have had liver problems
• you experience headaches different from your usual migraine headaches
• you are taking a medicine for depression (see 'Taking ZOMIG with other medicines' later in this section)

If you are admitted to hospital, inform the medical staff that you are taking ZOMIG.
ZOMIG is not recommended for people under 18 years of age or over 65.
As with other migraine treatments, overuse of ZOMIG may cause daily headaches or may worsen migraine headaches. Consult your doctor if you think this applies to you. You may need to stop using ZOMIG to resolve the problem.
Taking ZOMIG with other medicines
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including herbal medicines and those without a prescription.
In particular, inform your doctor if you are taking any of the following medicines:
Migraine medicines

• If you take triptans other than ZOMIG, wait 24 hours before taking ZOMIG.
• After taking ZOMIG, wait 24 hours before taking other triptans different from ZOMIG.
• If you take 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 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 taking ZOMIG in combination with serotonergic medicines (e.g. certain medicines for depression). Symptoms of serotonin syndrome may include, for example, agitation, tremors, restlessness, fever, excessive sweating, convulsions, muscle rigidity, uncoordinated limb or eye movements, and uncontrollable muscle spasms. Your doctor can advise you about this.

Other medicines

• cimetidine (for digestive problems or gastric ulcer)
• a quinolone antibiotic (e.g. ciprofloxacin)

If you are taking herbal preparations containing St. John's wort (Hypericum perforatum), there is an increased risk of experiencing side effects from ZOMIG.
Taking ZOMIG with food and drink
You may take ZOMIG with or without food. Food does not affect the action of ZOMIG.
Pregnancy and breastfeeding

• It is not known whether taking ZOMIG during pregnancy is harmful. Before taking ZOMIG, inform your doctor if you are pregnant or trying to become pregnant.
• Do not breastfeed for 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 observe how ZOMIG affects you before engaging in such activities.

Important information about some excipients in ZOMIG
ZOMIG tablets contain lactose, a type of sugar. If your doctor has told you that you cannot tolerate or digest certain sugars (have an intolerance to certain sugars), consult your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially 'sodium-free'.

3. HOW TO TAKE ZOMIG

Always take ZOMIG exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
You may take ZOMIG as soon as the migraine headache starts. You may also take it once the attack has already begun.

• The usual dose is one tablet (2.5 mg or 5 mg).
• Swallow the tablet with a glass of water.
• You may take another tablet if the migraine is still present after two hours or if it returns within 24 hours. If these tablets have not provided sufficient relief, inform your doctor. Your doctor may increase the dose to 5 mg or change the treatment.

Do not take a higher dose than the one prescribed for you.

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

If you take more ZOMIG than you should
If you have taken more ZOMIG than prescribed, contact your doctor immediately or go to the nearest hospital. Take the ZOMIG pack with you.

4. POSSIBLE ADVERSE EFFECTS

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

Common adverse effects (affect more than 1 in 100 people):

• Abnormal sensations such as tingling in the fingers and toes or skin sensitive to touch.
• Drowsiness, dizziness, or a feeling of warmth.
• Headache.
• Irregular heartbeat.
• Nausea, vomiting.
• Stomach discomfort.
• Dry mouth.
• Muscle weakness or muscle pain.
• Weakness.
• Heaviness, tightness, pain, or pressure sensation in the throat, neck, arms, legs, or chest.
• Difficulty swallowing.

Uncommon adverse effects (affect less than 1 in 100 people):

• Very fast heartbeat.
• Slight increase in blood pressure.
• Increased amount of urine or increased need to urinate.

Rare adverse effects (affect less than 1 in 1,000 people):

• Allergic/hypersensitivity reactions, including raised skin rash (urticaria) and swelling of the face, lips, mouth, tongue, and throat. If you think Zomig is causing an allergic reaction, stop taking it and contact your doctor immediately.

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

• Angina (chest pain, often triggered by physical exertion), heart attacks, or spasms of the blood vessels in the heart. If you experience chest pain or shortness of breath after taking Zomig, contact your doctor and do not take any further Zomig.
• Spasms of the intestinal blood vessels, which may damage the intestine. You may experience stomach pain or bloody diarrhea. If this occurs, contact your doctor and do not take any further Zomig.

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report adverse effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE ZOMIG

• Keep out of the reach and sight of children.
• Do not use Zomig after the expiry date stated on the package. The expiry date refers to the last day of the month.
• Do not store above 30°C.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. OTHER INFORMATION

What Zomig contains
The active substance is zolmitriptan. Zomig film-coated tablets contain 2.5 mg or 5 mg of
zolmitriptan.
The excipients are: anhydrous lactose, microcrystalline cellulose, sodium starch glycolate (type A),
magnesium stearate, macrogol, hypromellose, titanium dioxide (E171), yellow iron oxide (E172, only in 2.5 mg tablets), red iron oxide (E172, only in 5 mg tablets).
Description of the appearance of Zomig 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 5 mg film-coated tablets are pink, round and marked with the letter “Z” on one side.
• Zomig 2.5 mg and 5 mg film-coated tablets are available in blisters containing 3, 6, 12 or 18 tablets.

Not all pack sizes may be marketed.
Zomig may also be available as a nasal spray containing 2.5 mg/dose and 5 mg/dose, and as orodispersible tablets containing 2.5 mg.
Marketing Authorization Holder
GRÜNENTHAL ITALIA S.r.l.
Via Carlo Bo, 11
20143 Milano
Manufacturer
FARMACEUTICI FORMENTI S.p.A.
Via Di Vittorio 2 - 21040 Origgio (VA)
Alternatively:
AstraZeneca UK Limited
Silk Road Business Park
Macclesfield
Cheshire SK10 2NA
United Kingdom
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