PACKAGE LEAFLET: INFORMATION FOR THE USERS ZOMIG® 2.5mg TABLETS / ZOLMITRIPTAN 2.5mg TABLETS (zolmitriptan)

This medicine is available under the above names but will be referred to as Zomig throughout the following 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. You should 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:

1.    What Zomig is and what it is used for

2.    Before you take Zomig

3.    How to take Zomig

4.    Possible side effects

5.    How to store Zomig

6.    Further information

1. WHAT ZOMIG IS AND WHAT IT IS USED FOI

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 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 works only when a migraine attack has started. It will not stop you from getting an attack.

2. BEFORE YOU TAKE ZOMIG

Do not take Zomig if:

•    You are allergic (hypersensitive) to zolmitriptan or any of the 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 take Zomig if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Zomig.

Take special care with Zomig

Before you take Zomig, 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.

Zomig is not recommended for people aged under 18 years or over 65.

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 taking Zomig 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 migraines

•    If you take a triptan other than Zomig (such as sumatriptan or naratriptan) leave 24 hours before taking Zomig.

•    After taking 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 taking Zomig.

•    After taking Zomig leave 6 hours before taking ergotamine or ergot-type medicines.

Medicines for depression

•    Mono-Amine Oxidase Inhibitors, also known as MAOIs (such as moclobermide).

•    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. Johns wort (hypericum perforatum) at the same time as this medicine. If you already take a St. Johns wort preparation, stop taking it and mention this to your doctor at your next visit.

Taking Zomig with food and drink

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

Pregnancy and breast-feeding

•    It is not known if taking Zomig during pregnancy is harmful. Before taking Zomig, tell your doctor if you are pregnant or trying to become pregnant.

•    Before taking Zomig tell your doctor if you are breast-feeding.

Driving and using machines

•    During a migraine attack your reaction may be slower than usual. Bear in mind when you drive or use any tools or machines.

•    Zomig is unlikely to affect driving or using tools or machines. However, it may make you feel sleepy. Wait to see how Zomig affects you before you try these activities.

Important information about some of the ingredients of Zomig

Zomig contains lactose which is a type of sugar. If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine.

3. HOW TO TAKE ZOMIG

Always take Zomig exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

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

•    The usual dose is one tablet (2.5mg).

•    Swallow your tablet with a drink of water.

•    You can take another tablet if the migraine is still present after two hours or if it returns within 24 hours.

If the tablets 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 does in one day unless prescribed to by your doctor.

•    The maximum daily dose is 10mg.

If you take more Zomig than you should

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

4. POSSIBLE SIDE EFFECTS!

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

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

Rare (affects less tan 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:

Common (affects less than 1 in 10 people):

These side effects 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 hearth beat.

•    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.

•    Increase in the amount of water you pass (urine) or in how often 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 you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

•    Keep out of the sight and reach of children.

•    Keep your medicine in the container it came in.

•    Do not use Zomig after the expiry date refers to the last day of that month.

•    Do not store above 30°C.

•    Medicines should not be disposed of via wastewater of household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

•    If the tablets become discoloured or show signs of any deterioration, you should seek the advice of your pharmacist.

6. Further Information

What Zomig contains

The active ingredient is zolmitriptan. Zomig contain 2.5mg of zolmitriptan.

The other ingredients are: hydroxypropyl methylcellulose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400 and 8000, sodium starch glycollate, titanium dioxide and yellow iron oxide.

What Zomig looks like and contents of the pack

•    Zomig are yellow, round and marked with the letter ‘Z' on one side.

•    Zomig come in blister packs containing 6 tablets.

PL No: 15814/0166

Manufacturer

AstraZeneca UK Limited, Silk Road Business Park, Macclesfield, Cheshire, SK10 2NA. Procured within the EU and Repackaged by the Product Licence holder: OPD Laboratories Ltd, Unit 6 Colonial Way, Watford, Herts, WD24 4PR.

Zomig is a Trade Mark of the AstraZeneca group of companies.

Leaflet revision and Issue date: 11/04/2013

To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.