2.5 mg and 5 mg film-coated tablets
zolmitriptan
What Zomig is and what it is used for
Zomig contains zolmitriptan and belongs to a group of medicines called triptans.
Zomig is used to treat migraine headaches in adults aged 18 and over.
- Migraine symptoms can be caused by a dilation of blood vessels in the head. Zomig is thought to reduce the dilation of these blood vessels. This helps to relieve the headache and other symptoms of a migraine attack, such as nausea, vomiting, and sensitivity to light and sound.
- Zomig only helps when a migraine attack has started. It cannot prevent an attack.
What you need to know before you use Zomig
Do not use 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 or have had heart problems, such as a heart attack, angina (chest pain caused by exercise or exertion), Prinzmetal’s angina (chest pain at rest), or heart-related symptoms such as shortness of breath or chest tightness
- if you have had a stroke or short-term stroke-like symptoms ( TIA, transient ischemic attack, i.e. a temporary circulatory disturbance in the brain)
- if you have severe kidney problems
- if you simultaneously take certain other anti-migraine medicines (for example medicines with ergotamine or substances similar to ergotamine, such as dihydroergotamine and methysergide) or other triptan anti-migraine medicines. Read the section “Use of other medicines” for further information.
If you are not sure if any of the above applies to you, ask your doctor or pharmacist for advice.
Warnings and precautions
Talk to your doctor before using Zomig:
- if you are at risk of developing ischemic heart disease (poor blood flow in the coronary arteries of the heart). The risk is higher if you smoke, have high blood pressure, high cholesterol levels, or diabetes or if someone in your family has ischemic heart disease
- if you have been told that you have Wolff-Parkinson-White syndrome (a type of heart rhythm disorder)
- if you have or have had liver problems
- if you have a headache that is not similar to a regular migraine headache
- if you are taking any other medicine for depression (see “Using other medicines” later in this section)
If you are admitted to the hospital, tell the healthcare staff that you are taking Zomig.
Zomig is not recommended for people under 18 or over 65.
Like other migraine medications, overconsumption of Zomig can cause daily headaches or worsening migraine headaches. Consult a doctor if you think it has affected you. It may be necessary to stop treatment with Zomig to correct the problem.
Other medicines and Zomig
Tell your doctor or pharmacist if you are using, have recently used, or might be using other medicines. This includes herbal medicines and over-the-counter medicines.
In particular, tell your doctor if you are using any of the following medicines:
Migraine medication
- If you use triptans other than Zomig, at least 24 hours should pass before using Zomig.
- After using Zomig, at least 24 hours should pass before using triptans other than Zomig.
- If you have used medicines containing ergotamine or substances similar to ergotamine (such as dihydroergotamine or methysergide), at least 24 hours should pass before using Zomig.
- After using Zomig, at least 6 hours should pass before using any medicine containing ergotamine or substances similar to ergotamine.
Medicines for depression
- Moclobemide or fluvoxamine
- SSRIs (selective serotonin reuptake inhibitors)
- SNRI preparations ( serotonin-norepinephrine reuptake inhibitors), for example, venlafaxine, duloxetine
Serotonin syndrome is a rare, life-threatening condition that has been reported in some patients who have taken Zomig at the same time as so-called serotonergic medicines (eg some medicines for the treatment of depression). Symptoms of serotonin syndrome can e.g. be restlessness, tremors, restlessness, fever, heavy sweating, twitching, muscle stiffness, uncoordinated arm, leg, or eye movements, and uncontrollable muscle twitching. Your doctor can advise you on this.
Other medicines
- Cimetidine (for indigestion or stomach ulcers )
- Quinolone antibiotics (such as ciprofloxacin )
If you use herbal medicines containing St. John’s wort ( Hypericum perforatum ), the risk of side effects may increase.
Zomig with food and drink
You can take Zomig with or without food. It 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 or pharmacist for advice before using this medicine.
- It is not known whether using Zomig during pregnancy is harmful. Before using Zomig, tell the doctor if you are pregnant or trying to become pregnant.
- You should not breastfeed within 24 hours of taking Zomig.
Driving ability and use of machinery
- During a migraine attack, you may have a longer reaction time than usual. Keep this in mind when driving or using tools or machinery.
- Zomig is unlikely to affect your ability to drive or use tools or machines. However, you should wait and see how Zomig affects you before trying any of these activities.
You are responsible for assessing whether you can drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect this ability is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found under other headings in the package leaflet. Therefore, read all the information in this leaflet. Discuss with a doctor or pharmacist if you are unsure.
Zomig contains lactose
Zomig tablets contain lactose, which is a type of sugar. If you have an intolerance to certain sugars, you should consult your doctor before taking this medication.
Zomig contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is almost ‘sodium-free’.
How to use Zomig
Always use this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
You can use Zomig as soon as you feel a migraine headache coming on, but you can also use Zomig during an ongoing attack.
- The usual dose is 1 tablet (either 2.5 mg or 5 mg).
- Swallow the tablet with water.
- You can use 1 more dose if the migraine symptoms persist after 2 hours or if the symptoms return within 24 hours.
Talk to your doctor if the tablets do not have a sufficient effect against migraines. The doctor can then increase the dose to 5 mg or change the treatment.
The prescribed dose must not be exceeded.
- Take a maximum of 2 doses per 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 use too much Zomig
If you have ingested too much Zomig or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice. Take the Zomig pack with you.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Some of the symptoms described below may be part of the migraine attack itself.
Stop using 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 users):
- Allergic/hypersensitivity reactions, including urticaria ( hives ) and swelling of the face, lips, mouth, tongue, and throat, difficulty swallowing, or difficulty breathing.
Very rare side effects (may affect up to 1 in 10,000 users):
- Vascular spasm (pain in the chest, often brought on by exertion), heart attack, or spasms in the blood vessels of the heart. You may feel chest pains or shortness of breath.
- Spasms in the intestinal blood vessels can cause damage to the intestine. You may experience stomach pains or bloody diarrhea.
Other side effects that may occur:
Common side effects (may affect up to 1 in 10 users):
- Abnormal sensory sensations, such as tingling in fingers and toes or increased skin sensitivity to touch
- Fatigue, dizziness, or feeling hot
- Headache
- Irregular heartbeat
- Nausea, vomiting
- Stomach pain
- Dry mouth
- Muscle weakness or muscle pain
- Impotence
- Heaviness, tightness, pain, or pressure in the throat, neck, arms, legs, or chest.
- Difficulty swallowing
Uncommon side effects (may affect up to 1 in 100 users):
- Very high heart rate
- Slight increase in blood pressure
- The increased amount of urine or more frequent urges to urinate.
How to store Zomig
- Keep this medicine out of the sight and reach of children.
- Use before the expiry date stated on the carton. The expiration date is the last day of the specified month.
- Store at a maximum of 25 °C.
- Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
The active substance is zolmitriptan. Zomig film-coated tablets contain either 2.5 mg or 5 mg of zolmitriptan.
Other ingredients are anhydrous lactose, microcrystalline cellulose, sodium starch glycolate (Type A), magnesium stearate, macrogol, hypromellose, titanium dioxide (E171), yellow iron oxide (E172, only in tablets 2.5 mg), red iron oxide (E172, only in tablets 5 mg ).
Appearance and package sizes of the medicine
- Zomig film-coated tablet 2.5 mg is yellow, round, and debossed with the letter “Z” on one side.
- Zomig film-coated tablet 5 mg is pink, round, and debossed with the letter “Z” on one side.
- Zomig film-coated tablets 2.5 mg and 5 mg in blister packs containing: 3, 6, 12, or 18 tablets.
Not all pack sizes may be marketed.
Zomig is also available as a nasal spray 2.5 mg/dose and 5 mg/dose and as an orodispersible tablet 2.5 mg and 5 mg.
Marketing Authorization Holder: Grünenthal GmbH, Zieglerstrasse 6, 52078 Aachen, Germany.
Manufacturer: Farmaceutici Formenti SpA, Via Di Vittorio 2, 21040 Origgio (VA), Italy.