Zomig Rapimelt 5 mg Orodispersible 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 Zomig Rapimelt is and what it is used for
2. What you need to know before you take Zomig Rapimelt
3. How to take Zomig Rapimelt
4. Possible side effects
5. How to store Zomig Rapimelt
6. Contents of the pack and other information

Do not take Zomig Rapimelt:

• 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 ’Other medicines and Zomig Rapimelt’ for further information.

Do not take Zomig Rapimelt if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Zomig Rapimelt.

Warnings and precautions

Talk to your doctor of pharmacist before taking Zomig Rapimelt:

• 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 ‘Other medicines and Zomig Rapimelt’ for further information).

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

Zomig Rapimelt is not recommended for people aged over 65.

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

Children and adolescents

Zomig Rapimelt is not recommended in children and adolescents under 18 years.

Other medicines and Zomig Rapimelt

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 Rapimelt (such as sumatriptan or naratriptan) leave 24 hours before taking Zomig Rapimelt.
• After taking Zomig Rapimelt 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 Rapimelt.
• After taking Zomig Rapimelt 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. Serotonin syndrome is a rare, life-threatening condition that has been reported in some patients who took Zomig in combination with so called serotoninergic medicines (e.g. certain medicines for the treatment of depression). Signs of serotonin syndrome may be for example agitation, restlessness, fever, excessive sweating, tremor, uncoordinated movement of limbs or eyes, uncontrollable jerking of muscles, twitching and muscle rigidity. Your doctor may advise you on this.

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 it and mention this to your doctor at your next visit.

Zomig Rapimelt with food and drink

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

Pregnancy breast-feeding and fertility

It is not known if taking Zomig Rapimelt 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 taking 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 Rapimelt is unlikely to affect driving or using tools or machines. However, it may make you feel sleepy. Wait to see how Zomig Rapimelt affects you before you try these activities.

Zomig Rapimelt contains Aspartame (E951)

Zomig Rapimelt 5 mg orodispersible tablets contains 10 mg aspartame per tablet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’

If you take more Zomig Rapimelt than you should

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

If you forget to take Zomig Rapimelt

Do not take a double dose to make up for a forgotten dose.

If you notice any of the following serious side effects, stop taking Zomig Rapimelt and contact a doctor straight away:

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:

Common (may affect up to 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 heart 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 (may affect up to 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 you need to pass water.

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 Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

What Zomig Rapimelt 5 mg orodispersible tablet contains

The active ingredient is zolmitriptan. Each tablet contains 5 mg of zolmitriptan.

The other ingredients are: aspartame (E951), citric acid anhydrous, silica colloidal anhydrous, crospovidone, magnesium stearate, mannitol (E421), microcrystalline cellulose, orange flavour (SN027512) and sodium hydrogen carbonate.

What Zomig Rapimelt 5 mg orodispersible tablets look like and contents of the pack

• Zomig Rapimelt 5 mg orodispersible tablets are white, flat-faced, round and marked with ‘Z 5’ on one side.
• Zomig Rapimelt 5 mg orodispersible tablets come in peelable aluminium laminate blister packs containing 6 tablets.

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

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation for Zomig Rapimelt 5 mg orodispersible tablets is held by

Zomig Rapimelt 5 mg orodispersible tablets are manufactured by

or