Zomig 5mg Nasal Spray
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Patient Information Leaflet
This product is known as the above name but will be referred to as Zomig Nasal throughout this leaflet.
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
4. Possible side effects
5. How to store Zomig Nasal
6. Further information
1. What Zomig Nasal is and what it is used for
2. Before you use Zomig Nasal
3. How to use Zomig Nasal
1. 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 migraine headache.
• Migraine symptoms may be caused by swollen blood vessels in the head. Zomig Nasal 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 works only when a migraine attack has started. It will not stop you from getting an attack.
2. BEFORE YOU USE ZOMIG NASAL Do not use Zomig Nasal if:
• You are allergic (hypersensitive) to zolmitriptan or any of the other ingredients of this medicine (see Section 6: Further information).
• You have high blood pressure.
• 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.
• You have had a stroke or short-lasting symptoms similar to stroke (transient ischaemic attack or TIA).
• You are at the same time taking some other medicines for migraine (e.g. ergotamine or ergot-type medicines like dihydroergotamine and methysergide) or other triptan medicines for migraine. See section below: 'Taking other medicines' for further information.
Do not use Zomig Nasal if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using Zomig Nasal.
Take special care with Zomig Nasal
Before you use Zomig Nasal, tell your doctor 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.
• You have been told that you have Wolff-Parkinson-White Syndrome (a type of abnormal heart beat).
• You have ever had liver problems.
• You have headaches which are not like your usual migraine headache.
• You are taking any medicine for treatment of depression (see section below: 'Taking other medicines' for further information).
If you go into hospital tell the medical staff you are taking Zomig Nasal.
Zomig Nasal is not recommended for people aged under 18 years or over 65.
As with other migraine treatments, using too much Zomig Nasal 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 using Zomig Nasal to correct the problem.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken 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 (such as sumatriptan or naratriptan) leave 24 hours before using Zomig Nasal.
• After using Zomig Nasal 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.
• After using Zomig Nasal leave 6 hours before taking ergotamine or ergot-type medicines.
Medicines for depression:
• Mono-Amine Oxidase Inhibitors, also known as MAOls (such as moclobemide).
• SSRls (selective serotonin reuptake inhibitors) such as fluoxetine, paroxetine, fluvoxamine or sertraline.
• SNRIs (serotonin norepinephrine reuptake inhibitors) such as venlafaxine or duloxetine.
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.
Using Zomig Nasal with food and drink
You can take Zomig Nasal with or without food. It does not affect the way that Zomig Nasal works.
Pregnancy and breast-feeding
• It is not known if using Zomig Nasal during pregnancy is harmful. Before using Zomig Nasal, tell your doctor if you are pregnant or trying to become pregnant.
• Before using Zomig Nasal, tell your doctor if you are breast-feeding.
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 is unlikely to affect driving or using tools or machines. However, it is best to wait to see how Zomig Nasal affects you before you try these activities.
3. HOW TO USE ZOMIG NASAL
Zomig Nasal 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.
Always use Zomig Nasal exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
You can use Zomig Nasal as soon as a migraine headache starts. You can also use it once an attack is underway.
• The usual dose is one spray (5 mg) in one nostril. It does not matter which nostril you use.
• 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.
How to use Zomig Nasal
A
Please read these instructions before using Zomig Nasal.
A. The Protective Cover:
• This covers the nozzle to protect it.
• Remove it before you use the nasal spray.
B. The Nozzle:
• You put this part into your nose.
• The medicine comes out of a tiny hole in the top.
C. The Finger-grip:
• You hold this part when you use the spray.
D. 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.
1 • Blow your nose gently before use.
• Remove the protective cover.
2 • Hold the nasal spray gently with your fingers and thumb as shown in picture 2.
• Do not press the plunger yet!
3 • Block one nostril by pressing a finger on the side of your nose as shown in picture 3.
• Put the nozzle of the nasal spray into the other nostril as far as feels comfortable.
• Tilt your head back slightly and close your mouth as shown in picture 3.
• 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. 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 than you should
If you have taken more Zomig Nasal than prescribed by your doctor, tell your doctor or go to the nearest hospital straight away. Take the Zomig Nasal medicine with you.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Zomig Nasal 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 and contact your doctor straight away if you notice any of the following:
Rare (affects less than 1 in 1,000 people)
• Allergic reactions including itchy rash (urticaria) and swelling of the face, lips, mouth, tongue and throat.
Very rare (affects less than 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:
Very common (affects more than 1 in 10 people):
This is usually mild and goes away after a short time. • Taste disturbance.
Common (affects less than 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 (affects less than 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.
Do not be concerned by this list of possible side effects. You may not get any of them. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE ZOMIG NASAL
• Do not store your nasal spray(s) above 25°C.
• If your doctor tells you to stop taking this medicine, take any nasal spray you have left back to the pharmacy.
• Do not use Zomig Nasal after the expiry date on the container. This date refers to the last day of the month. Take any nasal spray(s) that are out of date back to the pharmacy.
• Keep out of the sight and reach of children.
• Medicines should not be disposed of via waste water or house hold waste. Ask your Pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
• If the nasal spray becomes discoloured, shows any other signs of deterioration or is damaged, you should consult your pharmacist who will advise you what to do.
6. FURTHER INFORMATION What Zomig Nasal contains
• The active ingredient is zolmitriptan in an aqueous solution. Each pre-filled nasal spray device delivers a total dose of 5mg of Zolmitriptan.
• Your Zomig Nasal also contains the following inactive ingredients: citric acid, disodium phosphate and purified water.
What Zomig Nasal 5 mg Nasal spray looks like and contents of the pack
• Zomig 5mg Nasal Spray is a pre-assembled device.
• Zomig 5mg Nasal Spray comes in pack sizes of 6 nasal sprays.
• Each nasal spray device is ready-to-use and gives only one dose.
• Zomig 5mg Nasal Spray is a blue coloured plastic device with a protective grey, plastic cap, containing a clear, yellow coloured liquid.
Marketing Authorisation Holder and Manufacturer
POM PL No: 06464/2834
This product is manufactured by AstraZeneca UK Limited, Macclesfield, Cheshire, UK and is procured from within the EU and repackaged by the Product Licence holder:
Waymade Plc Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 03.03.2014
Zomig is a registered trademark of AstraZeneca UK Limited
You can also get support and information about migraine from Migraine Action Association (UK), Unit 6, Oakley Hay Lodge Business Park, Great Folds Road, Great Oakley, Northants NN18 9AS