Zomig 5mg Nasal Spray

Migraine Doctor Service

Zomig 5mg Nasal Spray contains zolmitriptan and is used to treat migraine headaches.

Zomig nasal spray contains zolmitriptan and belongs to a group of medicines called triptans. It is not a painkiller but you can use this medicine if painkillers or non-steroidal anti-inflammatory drugs (NSAIDs) have not worked. contain zolmitriptan and belong to a group of medicines called triptans.

Migraine symptoms may be caused by swollen blood vessels in the head. Zomig Nasal Spray is thought to reduce the widening of these blood vessels. This helps to take away the headache and other symptoms of a migraine attack, such as feeling or being sick (nausea or vomiting) and being sensitive to light and sound.

• Zomig Nasal Spray is a serotonin indicated for the acute treatment of migraine with or without aura in adults and paediatric patients 12 years and older.
• Zomig Nasal Spray works only when a migraine attack has started. It will not stop you from getting an attack.
• Zomig Nasal Spray indicated only after a clear diagnosis of migraine has been established
• Zomig Nasal Spray Is Not Recommended For People Aged Over 65

Effectiveness In Adults

• Nearly 36% of adult patients using Zomig Nasal Spray 5 mg were pain free at 2 hours.

• Nearly 70% of migraine attacks in adults treated with Zomig Nasal Spray 5 mg DID NOT require additional medications within 24 hours.

Effectiveness In Adolescents

• Nearly 80% of adolescent patients using Zomig Nasal Spray 5 mg DID NOT need to use a second dose or additional medications within 24 hours.
• No serious adverse events or adverse events leading to discontinuation were reported2

You can order Zomig for migraine from our UK registered online pharmacy and doctor service. To see if you are suitable for this treatment, complete the online assessment and checkout. Our UK registered doctors will review the order and after approval pass the prescription to the Pharmacy team. We will then dispense and dispatch your order to your chosen address.

Why Nasal Spray

• Oral medications—like pills and tablets—are absorbed into your blood by your digestive system. But in some people, the digestive system slows down during a migraine. This may affect how a drug is absorbed.
• Zolmitriptan (the medicine in ZOMIG) was used to make a nasal spray to get medication into the blood sooner than the tablet version of zolmitriptan.

In a clinical study with 12 healthy adult volunteers, when zolmitriptan was given to people as a nasal spray, it got into the blood in as early as 5 minutes after using the 2.5-mg dose compared to 15 minutes with the tablet form of the same medicine.

Migraine

A migraine is usually a moderate or severe headache felt as a throbbing pain on 1 side of the head. Many people also have symptoms such as feeling sick, being sick and increased sensitivity to light or sound. 

Migraine is a common health condition, affecting around 1 in every 5 women and around 1 in every 15 men. They usually begin in early adulthood. There are several types of migraine, including:

• Migraine with "aura" – where there are specific warning signs just before the migraine begins, such as seeing flashing lights.
• Migraine without aura – the most common type, where the migraine happens without the specific warning signs.
• Migraine aura without headache, also known as silent migraine – where an aura or other migraine symptoms are experienced, but a headache does not develop.

Some people have migraines frequently, up to several times a week. Other people only have a migraine occasionally. It's possible for years to pass between migraine attacks.

A good self care guide and information for migraine is available on the NHS website.

NHS - Migraine

What is Zomig Nasal Spray indicated for?

Zomig Nasal Spray is a serotonin (5-HT)1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults and paediatric patients 12 years and older.

Limitations of Use:

Use Zomig Nasal Spray only after a clear diagnosis of migraine has been established. If a patient has no response to Zomig Nasal Spray treatment for the first migraine attack, reconsider the diagnosis of migraine before Zomig Nasal Spray is administered to treat any subsequent attacks.

Zomig Nasal Spray is not indicated for the prevention of migraine attacks. Safety and effectiveness of Zomig Nasal Spray have not been established for cluster headaches. Zomig Nasal Spray is not recommended in patients with moderate to severe chronic liver failure.

Zomig Nasal Spray is contraindicated in patients with:

• Ischemic coronary artery disease (angina pectoris, history of myocardial infarction, or documented silent ischemia), other significant underlying cardiovascular disease, or coronary artery vasospasm including Prinzmetal’s angina
• Wolff-Parkinson-White Syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders
• History of stroke, transient ischemic attack (TIA) or history of hemiplegic or basilar migraine because these patients are at higher risk of stroke
• Peripheral vascular disease (PVD)
• Ischemic bowel disease
• Uncontrolled hypertension
• Recent use (i.e., within 24 hours) of another 5-HT1 agonist, ergotamine-containing medication, or ergot type medication (such as dihydroergotamine or methysergide)
• Concurrent administration of an MAO-A inhibitor or recent discontinuation of a MAO-A inhibitor (that is within 2 weeks)
• Known hypersensitivity to ZOMIG Nasal Spray (angioedema and anaphylaxis seen).

How long does it take Zomig Nasal Spray to start working?

The majority of patients had headache relief at 2 hours.  Of patients using ZOMIG Nasal Spray 5 mg, 11.5% achieved headache response within 15 minutes.

What are the potential benefits of nasal sprays?

Nasal sprays provide a range of benefits that are uniquely important to migraine patients, such as:

• No need to swallow if they have dysphagia.
• Can be used despite migraine-associated nausea.

What are the adverse reactions associated with Zomig Nasal Spray?

The most common adverse reactions: unusual taste and dizziness.

Can lifestyle changes help?

There are steps you can take to help prevent severe headaches. This includes working out what things trigger an attack so you can avoid them. Keeping a migraine diary can help.

If you smoke, it's a good idea to quit. People who smoke seem to have a higher risk of getting cluster headaches. Eating a healthy, balanced diet and avoiding trigger foods or drinks can also help.

Like all medicines, this medicine can cause side effects, although not everybody gets them. Some of the symptoms below could be part of the migraine attack itself.

Stop using Zomig Nasal Spray and contact your doctor straight away if you notice any of the following:

Rare (may affect up to 1 in 1,000 people)

• Allergic reactions including itchy rash (urticaria) and swelling of the face, lips, mouth, tongue and throat.

Very rare (may affect up to 1 in 10,000 people)

• Angina (pain in the chest, often brought on by exercise), heart attack or spasm of the blood vessels of the heart. The signs include chest pain and shortness of breath.
• Spasm of the blood vessels of the gut, which can cause damage to your gut. The signs include stomach pain or bloody diarrhoea.
• Bleeding in the brain (cerebral bleeding) or stroke.

Other possible side effects include:

Very common (may affect more than 1 in 10 people) - This is usually mild and goes away after a short time:

• Taste disturbance.

Common (may affect up to 1 in 10 people) - These are usually mild and go away after a short time.

• Abnormal sensations such as tingling in your fingers and toes or skin that is sensitive to touch.
• Feeling sleepy, dizzy or warm.
• Headache.
• Uneven heart beat.
• Nose bleed, irritation in the nose or the nose being more sensitive than usual.
• Feeling sick (nausea) or being sick (vomiting).
• Stomach pain.
• Dry mouth.
• Muscle weakness or muscle pain.
• Feeling weak.
• Heaviness, tightness, pain or pressure in the throat, neck, arms and legs or chest.
• Problems swallowing.

Uncommon (may affect up to 1 in 100 people):

• Very fast heart beat.
• Slightly higher blood pressure.
• An increase in the amount of water you pass (urine) or in how often you need to pass water.

For a full list of side effects, please read the Patient Information Leaflet.

If you get any side effects, talk to your doctor, our Rightdose pharmacists or nurse. This includes any possible side effects not listed in this leaflet.

You can help to make medicines safer by reporting any side-effects to the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.

Before taking any medication, it is important to read the Patient Information Leaflet. You can find information leaflets for your medicines by typing them into the search bar at medicines.org.uk, or by contacting us.

Patient Information Leaflet Zomig 5mg Nasal Spray

Children and adolescents
Zomig Nasal Spray is not recommended for children and adolescents aged under 18 years.

Other medicines and Zomig Nasal Spray
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 buy without prescription.

In particular, tell your doctor if you are taking any of the following medicines:
Medicines for migraine:

• If you take a triptan other than Zomig Nasal Spray (such as sumatriptan or naratriptan) leave 24 hours before using Zomig Nasal Spray.
• After using Zomig Nasal Spray leave 24 hours before taking another triptan.
• If you take medicines containing ergotamine or ergot-type medicines (such as dihydroergotamine or methysergide), leave 24 hours before using Zomig Nasal Spray.
• After using Zomig Nasal Spray leave 6 hours before taking ergotamine or ergot-type medicines.

Medicines for depression:

• Mono-Amine Oxidase Inhibitors, also known as MAOIs (such as moclobemide).
• SSRIs (selective serotonin reuptake inhibitors) such as fluoxetine, paroxetine, fluvoxamine or sertraline.
• SNRIs (serotonin norepinephrine reuptake inhibitors) such as venlafaxine or duloxetine. Serotonin syndrome is a rare, life-threatening condition that has been reported in some patients who took Zomig in combination with so-called serotonergic medicines (e.g. certain medicines for the treatment of depression). Signs of serotonin syndrome may be for example agitation, restlessness, fever, excessive sweating, tremor, uncoordinated movement of limbs or eyes, uncontrollable jerking of muscles, twitching and muscle rigidity. Your doctor may advise you on this.

Other medicines:

• Cimetidine (for indigestion or stomach ulcers).
• A quinolone antibiotic (such as ciprofloxacin).
• You should not take the herbal remedy St. John’s wort (Hypericum perforatum) at the same time as this medicine. If you already take a St. John’s wort preparation, stop taking the St. John’s wort and mention this to your doctor at your next visit.

Zomig Nasal Spray with food and drink

You can use Zomig Nasal Spray with or without food. It does not affect the way that Zomig Nasal Spray works.

Pregnancy, breastfeeding and fertility
It is not known if using Zomig Nasal Spray during pregnancy is harmful. 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.

Driving and using machines
During a migraine attack your reactions may be slower than usual. Bear this in mind when you drive or use any tools or machines. Zomig Nasal Spray is unlikely to affect driving or using tools or machines. However, it is best to wait to see how Zomig Nasal Spray affects you before you try these activities.

How to store Zomig Nasal

• Keep your medicine in the container it came in.
• Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
• Do not store above 25°C.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Keep this medicine out of the sight and reach of children.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Zomig Nasal Spray is not recommended for people aged over 65.

Zomig Nasal Spray comes in a ready-to-use spray unit. Each unit contains 5 mg of zolmitriptan.

• Each unit is for single use and gives only one dose.
• You can use Zomig Nasal Spray as soon as a migraine headache starts. You can also use it once an attack is underway.
• You can use another spray if the migraine is still present after two hours or if it returns within 24 hours.
• If the nasal spray did not give you enough help with your migraine, tell your doctor. Your doctor may change your treatment.
• Do not use more than the dose prescribed for you.
• Do not use more than two spray doses in one day. The maximum daily dose is 10 mg.

The recommended dose is one spray (5 mg) in one nostril. It does not matter which nostril you use.

How to use Zomig Nasal

Please read these instructions before using Zomig Nasal Spray.

The Protective Cover:
• This covers the nozzle to protect it.
• Remove it before you use the nasal spray.

The Nozzle:
• You put this part into your nose.
• The medicine comes out of a tiny hole in the top.

The Finger-grip:
• You hold this part when you use the spray.

The Plunger:
• You press this part once you have put the nozzle comfortably into your nose.
• The spray contains only one dose and works only once.

• Do not press the plunger until you have put the nozzle in your nostril or you will lose the dose.

Directions:

1. Blow your nose gently before use. Remove the protective cover.
2. Hold the nasal spray gently with your fingers and thumb. Do not press the plunger yet!
3. Block one nostril by pressing a finger on the side of your nose.
4. Put the nozzle of the nasal spray into the other nostril as far as feels comfortable.
5. Tilt your head back slightly and close your mouth.
6. Breathe in gently through your nose and at the same time press the plunger firmly with your thumb. The plunger may feel stiff and you may hear it click. Keep your head slightly tilted back.
7. Remove the nozzle from your nose. Breathe gently through your mouth for 5-10 seconds. You may feel liquid inside your nose. This does not mean that the dose is being lost or that the spray has
   failed. This is normal and will soon pass.

If you use more Zomig Nasal Spray than you should
If you have used more Zomig Nasal Spray than prescribed by your doctor, tell your doctor or go to the nearest hospital straight away. Take this medicine with you.

If you forget to take Zomig
Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Do not use Zomig Nasal Spray:

• If you are allergic to zolmitriptan or any of the other ingredients of this medicine.
• 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 which happens at rest) or have experienced heart related symptoms such as shortness of breath or pressure over the chest.
• If you have had a stroke or short-lasting symptoms similar to stroke (transient ischaemic attack or TIA).
• If you are at the same time taking some other medicines for migraine (e.g. ergotamine or ergottype medicines like dihydroergotamine and methysergide) or other triptan medicines for migraine. 

Do not use Zomig Nasal Spray if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using Zomig Nasal Spray.

Warnings and precautions
Talk to your doctor of pharmacist before using Zomig Nasal Spray:

• If you are at risk of getting ischaemic heart disease (poor blood flow in the arteries of the heart). Your risk is greater if you smoke, have high blood pressure, high levels of cholesterol, diabetes or if anyone in your family has ischaemic heart disease.
• If you have been told that you have Wolff-Parkinson-White Syndrome (a type of abnormal heart beat).
• If you have ever had liver problems.
• If you have headaches which are not like your usual migraine headache.
• If you are taking any medicine for treatment of depression.
• If you go into the hospital, tell the medical staff you are using Zomig Nasal Spray.

Zomig Nasal Spray is not recommended for people aged over 65.

As with other migraine treatments, using/taking too much Zomig can cause daily headaches or can make your migraine headaches worse. Ask your doctor if you think that this is the case for you. You may need to stop taking Zomig to correct the problem.

What Zomig 5 mg Nasal Spray contains

The active ingredient is zolmitriptan. Each dose contains 5 mg zolmitriptan.

The other ingredients are: citric acid, disodium phosphate and purified water.

What Zomig 5 mg Nasal Spray looks like and contents of the pack

• Zomig 5 mg Nasal Spray is a pre-assembled device.
• Zomig 5 mg Nasal Spray comes in packs containing 1, 2 or 6 single use nasal spray units. Not all pack sizes may be marketed.
• Each nasal spray unit is ready-to-use and gives only one dose.

Zomig may also be available as film-coated tablets 2.5 mg and orodispersible tablets 2.5 mg and 5 mg.