Zolmitriptan 5mg Film-coated Tablets

Read all of this leaflet carefully before you start taking 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 side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Zolmitriptan tablets are and what they are used for

2.    What you need to know before you take

3.    How to take

4.    Possible side effects

5.    How to store

6.    Contents of the pack and other information

1. What zolmitriptan tablets are and what they are used for

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

Zolmitriptan is used to treat migraine headache.

Migraine symptoms may be caused by the widening of blood vessels in the head. Zolmitriptan 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. Zolmitriptan 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 take

Do not take Zolmitriptan tablets if you:

-    are allergic to zolmitriptan or any of the other ingredients of this medicine (listed in section 6).

-    have high blood pressure

-    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

-    have had a stroke or short-lasting symptoms similar to stroke (transient ischaemic attack or TIA)

-    have severe kidney problems

-    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: ‘Other medicines and Zolmitriptan tablets’ for further information.

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Zolmitriptan tablets 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

-    have been told that you have Wolff-Parkinson-White Syndrome (a type of abnormal heart beat)

-    have ever had liver problems

-    have headaches which are not like your usual migraine headache

-    are taking any other medicine for treatment of depression (see ‘Other medicine and Zolmitriptan tablets’ later in this section).

When Zolmitriptan is taken at the same time as medicines of the type SSRI or SNRI, which are used for the treatment of depression, there is a risk of development of so called serotonin syndrome. The symptoms can be severe and include shivering, over-reactive reflexes, nausea, fever, sweating, delirium, mental confusion and coma. In case you are taking this combination your doctor should monitor you carefully, especially in the beginning of treatment, when doses are increased or if another serotonergic medication is added. If you experience any of these symptoms contact a doctor as soon as possible.

If you go into hospital tell the medical staff you are taking Zolmitriptan.

Children and elderly patients

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

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

Other medicines and Zolmitriptan tablets

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular, tell your doctor if you are taking any of the following medicines:

Medicines for migraine

-    other triptans than zolmitriptan

-    if you take medicines containing ergotamine or ergot-type medicines (such as dihydroergotamine or methysergide), leave 24 hours before taking Zolmitriptan.

-    after taking Zolmitriptan leave 6 hours before taking ergotamine or ergot-type medicines.

Medicines for depression (see also section ‘Warnings and precautions’ above)

-    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 Zolmitriptan may be more likely to happen.

Zolmitriptan tablets with food and drink

You can take Zolmitriptan with or without food. It does not affect they way that Zolmitriptan works. Pregnancy and breast-feeding

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 taking this medicine.

It is not known if taking Zolmitriptan during pregnancy is harmful.

Do not breast-feed within 24 hours of taking Zolmitriptan.

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.

Zolmitriptan is unlikely to affect driving or using tools or machines. However, it is best to wait to see how Zolmitriptan affects you before you try these activities.

Zolmitriptan tablets contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take

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

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

The recommended dose is 2.5 mg zolmitriptan or one 5 mg tablet (5 mg zolmitriptan). For the lower 2.5 mg zolmitriptan dose, formulation with a more suitable content of active substance is available.

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

If the tablet 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 doses in one day. If you have been prescribed 2.5 mg zolmitriptan, the maximum daily dose is one 5 mg tablet (5 mg zolmitriptan) . If you have been prescribed 5 mg tablet (5 mg zolmitriptan), the maximum daily dose is two 5 mg tablets (10 mg zolmitriptan).

Swallow your tablet with a drink of water.

If you take more Zolmitriptan tablets than you should

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

When too many tablets are taken the symptoms may possible include sedation.

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

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.

Common side effects (affects 1-10 users 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

Uncommon side effects (affects 1-10 users in 1,000):

•    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 (affects 1-10 users in 10,000):

•    Allergic/hypersensitivity reactions including lumpy rash (hives) and swelling of the face, lips, mouth, tongue and throat. If you think that Zolmitriptan is causing an allergic reaction, stop using it and contact your doctor straight away.

Very rare side effects (affects less than 1 user 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 Zolmitriptan, contact your doctor and do not take any more Zolmitriptan.

•    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 Zolmitriptan.

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.

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. Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at www.mhra.gov.uk/yellowcard. Alternatively you can call Freephone 0808 100 3352 (available from 10am to 2pm Mondays to Fridays) or fill in a paper form available from your local pharmacy.

5. How to store

Keep out of the sight and reach of children.

Do not use Zolmitriptan after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

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.

6. Contents of the pack and other information What Zolmitriptan tablets contains

-    The active substance is zolmitriptan. Zolmitriptan film-coated tablets contain 5mg of zolmitriptan.

-    The other ingredients are: tablet core: lactose (anhydrous), microcrystalline cellulose, sodium starch glycolate (Type A), magnesium stearate; tablet coating: hypromellose (E464), titanium dioxide (E171), polydextrose, talc, maltodextrin, medium chain triglycerides, iron oxide yellow (E172) and iron oxide red (E172).

What Zolmitriptan tablets looks like and contents of the pack

Zolmitriptan 5mg film-coated tablets are light pink, round, biconvex tablets with ‘ZL 5’ debossed on one side.

Zolmitriptan 5mg come in blister packs containing 3, 6, 12 or 18 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Actavis Group PTC ehf Reykjavlkurvegur 76-78 220 HafnarfjorQur Iceland

Manufacturer

Actavis Ltd.

BLB016 Bulebel Industrial Estate

Zejtun ZTN3000

Malta

This leaflet was last revised in - June 2013

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