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Document: leaflet MAH BRAND_PLPI 18799-0686 change

• leaflet MAH BRAND_PL 17901-0095
• leaflet MAH BRAND_PLPI 18799-0686

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Package leaflet: Information for the user ZOMIG® 5ma NASAL SPRAY (zolmitriptan)

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

•    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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any of the side effects, talk to your doctor or pharmacist.

This includes any possible side effects not listed in this leaflet. See section 4

The name of your medicine is ZOMIG 5mg NASAL SPRAY but will be referred to as Zomig or Zomig Nasal Spray throughout this leaflet.

What is in this leaflet:

1.    What Zomig is and what it is used for

2.    What you need to know before you use Zomig

3.    How to use Zomig

4.    Possible side effects

5.    How to store Zomig

6.    Contents of the pack and other information

1. 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 headache.

•    Migraine symptoms may be caused by swollen blood vessels in the head. Zomig is thought to reduce the widening of these blood vessels. This helps 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 works only when a migraine attack has started. It will not stop you from getting an attack.

2. 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 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 ergot-type medicines like dihydroergotamine and methysergide) or other triptan medicines for migraine. See section: ‘Other medicines and Zomig ’for further information.

Do not use Zomig if any of the above apply to you. If you are not sure,

talk to your doctor or pharmacist before using Zomig.

Warnings and precautions

Talk to your doctor of pharmacist before using Zomig :

•    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 (see section below: ‘Other medicines and Zomig’ for further information).

If you go into hospital tell the medical staff you are using Zomig.

Zomig is not recommended for people aged over 65.

Children and adolescents

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

As with other migraine treatments, using 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 using Zomig to correct the problem.

Other medicines and Zomig

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 (such as sumatriptan or naratriptan) leave 24 hours before using Zomig.

•    After using Zomig 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.

•    After using Zomig 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.

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 with food and drink

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

Pregnancy, breast-feeding and fertility

It is not known if using Zomig Nasal Spray during pregnancy is harmful.

If you are pregnant or breast-feeding, 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 is unlikely to affect driving or using tools or machines. However, it is best to wait to see how Zomig affects you before you try these activities.

3. How to use Zomig

Zomig comes in a ready-to-use spray unit. Each unit contains 5mg of zolmitriptan. Each unit is for single use and gives only one dose.

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

You can use Zomig as soon as a migraine headache starts. You can also use it once an attack is underway.

•    The recommended dose is one spray (5mg) 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 10mg.

How to use Zomig

Please read these instructions before using Zomig.

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

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 than you should

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

4. Possible side effects

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.

Do not be concerned by this list of possible side effects. You may not get any of them.

Reporting 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

Do not store above 25°C.

Keep your nasal spray(s) in the container it came in.

If your doctor tells you to stop taking this medicine, take any nasal spray you have left back to the pharmacy.

Do not use a nasal spray after the expiry date on the container.

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 wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information

What Zomig contains

Zomig Spray delivers 5mg (milligrams) unit dose of the active ingredient zolmitriptan in each spray. Your nasal spray also contains the following inactive ingredients: citric acid, disodium phosphate and purified water.

What Zomig looks like and contents of the pack

Zomig is a pre-assembled device and comes in pack of 2 nasal sprays. Each nasal spray device is ready-to-use and gives only one dose.

Manufactured by: AstraZeneca UK Ltd, Macclesfield, Cheshire, UK.

Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 ONU, UK.

POM

ZOMIG® 5mg NASAL SPRAY, PL No: 18799/0686    -

Leaflet date: 02.11.2015

ZOMIG is a registered trademark of the AstraZeneca Group of Companies.