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PACKAGE LEAFLET: INFORMATION FOR THE USER

Zomig 2.5 mg and 5 mg film-coated tablets

Zolmitriptan

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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

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

6. Further information

Zomig contains zolmitriptan and belongs to a group of medicines called triptans.

Zomig is used to treat migraine headache.

Do not take Zomig 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 have severe kidney problems

- 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.

If you are not sure if any of these apply to you, talk to your doctor or pharmacist.

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 ischeamic 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 other medicine for treatment of depression (see ‘Taking other medicines’ later in this section).

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 using 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 migraine

• If you take triptans other than Zomig, leave 24 hours before taking Zomig.

• After taking Zomig leave 24 hours before taking triptans other than Zomig.

• 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

• moclobemide or fluvoxamine

• medicines called SSRIs (selective serotonin reuptake inhibitors)

• medicines called SNRIs (serotonin norepinephrine reuptake inhibitors) such as venlafaxine, duloxetine

Other medicines

• cimetidine (for indigestion or stomach ulcers)

• a quinolone antibiotic (such as ciprofloxacin)

If you are using herbal remedies containing St John’s Wort (Hypericum perforatum), side effects of Zomig may be more likely to happen.

Using 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.

• Do not breast-feed within 24 hours of taking Zomig.

Driving and using machines

• During a migraine attack your reactions may be slower than usual. Bear this in mind when you drive or operate 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.

Important information about some of the ingredients of Zomig

Zomig tablets contain 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.

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 (either 2.5 mg or 5 mg).

• 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 these tablets did not give you enough help with your migraine, tell your doctor. Your doctor may raise the dose to 5 mg or change your treatment.

Do not take more than the dose prescribed for you.

If you have taken more Zomig than prescribed by your doctor, tell your 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.

Common side effects (that affect more than 1 person in 100):

• 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

• Feeling sick. Vomiting

• Stomach pain

• Dry mouth

• Muscle weakness or muscle pain

• Feeling weak

• Heaviness, tightness, pain or pressure in throat, neck, arms and legs or chest

• Difficulty in swallowing

Uncommon side effects (that affect less than 1 person in 100):

• Very fast heart beat

• Slightly higher blood pressure

• Increase in the amount of water you pass (urine) or in how often you need to pass water

Rare side effects (that affect less less than 1 person in 1,000):

Very rare side effects (that affect less than 1 person in 10,000):

• Angina (pain in the chest, often brought on by exercise), heart attack or spasm of the blood vessels of the heart. If you notice chest pain or shortness of breath after taking Zomig, contact your doctor and do not take any more Zomig.

• Spasm of the blood vessels of the gut, which can cause damage to your gut. You may notice stomach pain or bloody diarrhoea. If this happens, contact your doctor and do not take any more Zomig.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE ZOMIG

• Keep out of the reach and sight of children.

• Do not use Zomig after the expiry date stated on the carton. 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 or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

What Zomig contains

The active ingredient is zolmitriptan. Zomig film-coated tablets contain either 2.5 mg or 5 mg of zolmitriptan.

The other ingredients are: anhydrous lactose, microcrystalline cellulose, sodium starch glycollate (Type A), magnesium stearate, macrogol, hypromellose, titanium dioxide (E171), yellow iron oxide (E172, only in 2.5 mg tablets), red iron oxide (E172, only in 5 mg tablets).

What Zomig looks like and contents of the pack

• Zomig 2.5 mg film-coated tablets are yellow, round and marked with the letter ‘Z’ on one side.

• Zomig 5 mg film-coated tablets are pink, round and marked with the letter ‘Z’ on one side.

• Zomig film-coated tablets 2.5 mg and 5 mg come in blister packs containing 3, 6 (with or without wallet), 12 or 18 tablets.

A wallet is a hard plastic cover which you can store your tablets in for convenience. You must keep the outer carton and this leaflet when using the wallet, as you may need to refer to them again.

Not all pack sizes may be marketed.

Zomig may also be available as nasal spray 2.5 mg/dose and 5 mg/dose and orodispersible tablets 2.5 mg and 5 mg.

Marketing Authorisation Holder and Manufacturer

To be completed nationally.

This leaflet was last approved in

2015-06-04