How does it work?

Zomig nasal spray contains the active ingredient zolmitriptan, which is a type of medicine called a serotonin (or 5HT) agonist. This type of medicine is also commonly known as a 'triptan'. It is a painkiller specifically used to relieve migraine attacks.

Although the cause of migraine attacks is not fully understood, it is thought that widening of blood vessels in the brain causes the throbbing pain of migraine headaches. Zolmitriptan relieves this pain by causing the blood vessels in the brain to narrow.

Zolmitriptan works by stimulating receptors called serotonin (or 5HT) receptors that are found in the brain. A natural substance called serotonin normally acts on these receptors, causing blood vessels in the brain to narrow. Zolmitriptan mimics this action of serotonin by directly stimulating the serotonin receptors in the brain. This narrows the blood vessels and so relieves the pain of migraine headaches.

The dose of zolmitriptan should be taken as early as possible after the migraine headache has started, though it is also effective if taken at a later stage during the migraine attack.

Zomig nasal spray is administered into one nostril to relieve a migraine attack. The medicine is absorbed into the bloodstream through the blood vessels lining the nose and starts to work within about 15 minutes. It may be particularly useful for people who feel sick or vomit during their migraine attack, as it is not taken by mouth.

What is it used for?

• Relieving migraine attacks.

Warning!

• This medicine should not be used to prevent migraines.
• This medicine should only be used by people with a clear diagnosis of migraine from their doctor.
• Follow the instructions provided with your Zomig nasal sprays. Each spray contains one dose and is for single use only.
• If your migraine symptoms persist or return after one dose, a second dose can be effective. If you need a second dose, you should NOT take it within two hours of the first dose. Do not exceed the recommended dose. The maximum recommended dose in 24 hours is two sprays (10mg), unless you have liver problems, or are taking certain other medicines (see below). Discuss this with your doctor.
• This medicine can cause feelings of warmth, heaviness, pressure, tightness or pain in certain parts of the body, including the chest or throat. Although sometimes very strong, these feelings usually only last a few minutes. If theycontinue or are particularly severe (especially chest pain), you should tell your doctor immediately, as there have beenextremely rare reports of such problems being caused by a heart attack. Do NOT take another dose; yourdoctor will decide if you should stop using this medicine.
• This medicine might make you feel sleepy and so may reduce your ability to drive or operate machinery safely. Do not drive or operate machinery until you know how this medicine affects you and you are sure it won't affect your performance.

Use with caution in

• Decreased liver function.
• High blood pressure (hypertension).
• People with risk factors for ischaemic heart disease, such as smoking, high cholesterol levels, diabetes, obesity, or a family history of heart disease.

Not to be used in

• Heart disease caused by inadequate blood flow to the heart (ischaemic heart disease), eg angina.
• People who have had a heart attack.
• A severe form of angina pectoris, not caused by exertion (Prinzmetal's angina).
• Uncontrolled high blood pressure (hypertension).
• History of stroke.
• History of small temporary strokes (transient ischaemic attacks).
• Abnormal heart beats caused by Wolff-Parkinson-White syndrome.
• Irregular heart beats (arrhythmias).
• A form of migraine associated with temporary paralysis of one side of the body (hemiplegic migraine).
• A type of migraine where there is a disturbance in brain function which initially presents with total blindness followed by dizziness, speach disturbances, ringing in the ears and double vision (basilar migraine).
• The safety and efficacy of this medicine have not been established in children and adolescents under 18 years of age, or in elderly people over 65 years of age. It is not recommended for these age groups.

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

• The safety of this medicine in pregnancy has not been established. It should only be used by pregnant women if the expected benefit to the mother is greater than any possible risk to the foetus. Seek medical advice from your doctor.
• It is not known if this medicine passes into breast milk. It should be used with caution in nursing mothers, and only if the benefits to the mother outweigh any risks to the nursing infant. Discuss this with your doctor.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.

• Taste disturbance.
• Discomfort in the nasal cavity.
• Sensation of tightness, pressure, tingling, heaviness, heat or pain in any part of the body, including the chest and throat (see warning above).
• Dry mouth.
• Nausea.
• Muscle pain and weakness.
• Abnormal sensations or disturbance of sensation, eg pins and needles.
• Dizziness.
• Sleepiness (somnolence).
• Weakness or loss of strength (asthenia).
• Increased heart rate (tachycardia).
• Awareness of your heart beat (palpitations).
• Headache.
• Hives.
• Swelling of the face, lips or tongue (angioedema).
• Increases in blood pressure.

The side effects listed above may not include all of the side effects reported by the drug's manufacturer.For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to ensure that the combination is safe.

This medicine must not taken within 24 hours of taking ergotamine or its derivatives, eg dihydroergotamine or methysergide. These medicines should not be taken within six hours of taking zolmitriptan.

This medicine should not be taken within 12 hours of taking other serotonin (5HT) agonists (triptans), such as sumatriptan, and vice versa.

The following medicines may increase the blood level of zolmitriptan, and people taking these medicines should not take more than 5mg zolmitriptan (one nasal spray) in 24 hours:

• cimetidine
• fluvoxamine
• moclobemide
• quinolone-type antibiotics such as ciprofloxacin.

There may be an increased risk of side effects if this medicine is taken by people taking any of the following medicines:

• selective serotonin reuptake inhibitor antidepressants (SSRIs), such as citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine or sertraline
• the herbal remedy St John's wort (Hypericum perforatum).

Other medicines containing the same active ingredient