2.5 mg/dose and 5 mg/dose nasal spray solution
zolmitriptan
What Zomig Nasal is and what it is used for
Zomig Nasal contains zolmitriptan and belongs to a group of medicines called triptans.
Zomig Nasal is used to treat the headache during a migraine attack in adults aged 18 and over.
- Headache symptoms can be caused by a dilation of blood vessels in the head. Zomig Nasal is thought to reduce the dilation of these blood vessels. This contributes to the disappearance of the headache and other migraine symptoms such as nausea, vomiting, and sensitivity to light and sound.
- Zomig Nasal only helps when a migraine attack has started. It cannot prevent an attack.
Zomig Nasal is not intended for the treatment of other types of headaches, such as tension headaches.
What you need to know before using Zomig Nasal
Do not use Zomig Nasal
Zomig Nasal should only be used by those who know that you have a migraine diagnosed by a doctor.
You probably have a migraine if you have recurring headaches such as:
- Has a pulsating character and is one-sided
- Has moderate to the strong intensity and lasts for 4-72 hours
- Worsens with normal physical activity (eg walking or climbing stairs)
- Affects your ability to concentrate and impairs your daily activities
Migraine can be accompanied by other symptoms such as:
- Nausea, sensitivity to light and sound
- Aura symptoms, for example, visual field loss, zigzag patterns or flashes in the visual field, and less often numbness or speech difficulties.
Consult a doctor or pharmacist if you are unsure or need more information.
Do not use Zomig Nasal:
- 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 Nasal if:
- you belong to the risk group for ischemic heart disease (poor blood flow in the coronary arteries of the heart). The risk is higher if you smoke, have high blood pressure, or high cholesterol levels, have diabetes or if someone in your family has ischemic heart disease.
- you have been told that you have Wolff-Parkinson-White syndrome (a type of heart rhythm disorder).
- you have or have had liver problems.
- you have a headache that is not like a regular migraine headache or the headache caused by Horton’s headache
- 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 Nasal.
Zomig Nasal is not recommended for children and adolescents under 18 years of age or for adults over 65 years of age.
Like other migraine medications, overconsumption of Zomig Nasal 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 Nasal to correct the problem.
Other medicines and Zomig Nasal
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.
Do not use other medicines containing triptans (including other medicines containing sumatriptan, zolmitriptan, rizatriptan, naratriptan, eletriptan, and almotriptan) or other medicines containing ergotamine or ergotamine derivatives (including methysergide) together with Zomig Nasal.
Consult your doctor before using Zomig Nasal, if you are simultaneously treated with any of the following medicines of the MAO inhibitor type:
- Selegiline (for Parkinson’s disease )
Consult your doctor before using Zomig Nasal, if you are simultaneously treated with any of the following anti-depressant medicines:
- 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.
Consult your doctor before using Zomig Nasal, if you are simultaneously treated with any of the following medicines:
- Cimetidine (for indigestion or stomach ulcers )
- Quinolone – antibiotics (such as ciprofloxacin )
- Propranolol (used for example against high blood pressure )
If you use herbal medicines that contain St. John’s wort ( Hypericum perforatum), the risk of side effects may increase.
Zomig Nasal with food and drink
You can take Zomig Nasal with or without food. It does not affect how Zomig Nasal 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 Nasal during pregnancy is harmful. Before using Zomig Nasal, tell your doctor if you are pregnant or trying to become pregnant.
- You should not breastfeed within 24 hours after taking Zomig Nasal.
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 Nasal is unlikely to affect your ability to drive or use tools or machines. However, you should wait and see how Zomig Nasal 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 insert. Therefore, read all the information in this leaflet. Discuss with a doctor or pharmacist if you are unsure.
How to use Zomig Nasal
Zomig Nasal is supplied in ready-to-use single-dose containers. Each unit contains either 2.5 mg or 5 mg zolmitriptan. Each unit should be used once and contains only one dose.
Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
You can use Zomig Nasal as soon as you feel a migraine headache coming on, but you can also use Zomig Nasal during an ongoing attack.
- The usual dose for adults (18-65 years) is 1 spray (either 2.5 mg or 5 mg) in one nostril. It does not matter which nostril is used.
- You can take another dose if the migraine symptoms persist after 2 hours or if the symptoms return within 24 hours, but you may only take a maximum of 2 doses in 24 hours.
- If you take Zomig Nasal 2.5 mg/dose, the maximum daily dose is 5 mg. If you take Zomig Nasal 5 mg/dose, the maximum daily dose is 10 mg.
You must contact a doctor if symptoms worsen or do not improve within 3 days.
How to use Zomig Nasal
Read the instructions before using Zomig Nasal
| C. | The finger grip: This is where you should hold when using the nasal spray. |
| D. | The piston: Press this part after inserting the mouthpiece into the nose, and it feels comfortable. The nasal spray contains only 1 dose and only works once |
Do not press the plunger until you have inserted the mouthpiece into the nostril, otherwise, a dose will be lost.
If you have used too much Zomig Nasal
If you have ingested too much Zomig Nasal 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 Nasal 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 Nasal 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 spasms (pain in the chest, often brought on by exertion), heart attack, or spasms in the blood vessels of the heart. You may have chest pains or become short 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:
Very common side effects (may affect more than 1 in 10 users):
- Taste disturbance
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
- Nosebleed. Irritation in the nose. Nasal congestion and/or runny nose ( rhinitis ).
- Nausea, vomiting
- Stomach pain
- Dry mouth
- Muscle weakness or muscle pain
- Impotence
- Heaviness, tightness, pain, or pressure in the throat, neck, arms, and 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 Nasal
- 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 Nasal contains either 2.5 mg or 5 mg zolmitriptan in each dose.
- Other ingredients are citric acid, disodium phosphate, and purified water.
Appearance and package sizes of the medicine
- Zomig Nasal 2.5 mg/dose and 5 mg/dose nasal spray in a pre-assembled pump with nasal spray nozzle.
- Zomig Nasal 2.5 mg/dose is available in pack sizes of 1, 2, or 6 single-use nasal spray pumps.
- Zomig Nasal 5 mg/dose is available in pack sizes of 1, 2, 6, or 18 single-use nasal spray pumps.
- Each nasal spray pump is ready to use and contains only 1 dose.
Not all pack sizes may be marketed.
Zomig is also available as film-coated tablets 2.5 mg and 5 mg and as orodispersible tablets 2.5 mg and 5 mg.
Grünenthal GmbH, Zieglerstrasse 6, 52078 Aachen, Germany.