Zolmitriptan 2.5 mg Orodispersible Tablets

• 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.

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

• 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 have severe kidney problems
• 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 on ‘Other medicines and Zolmitriptan Orodispersible Tablets’ for further information.

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

Talk to your doctor before taking Zolmitriptan Orodispersible Tablets. Let your doctor know 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 medicines for treatment of depression (see section below for ‘Other medicines and Zolmitriptan Orodispersable Tablets’ for further information).

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

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

As with other migraine treatments, taking too much Zolmitriptan Orodispersible Tablets 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 Zolmitriptan Orodispersible Tablets to correct the problem.

Tell your doctor or pharmacist if you are taking, have recently taken any or might take any other medicines. This include 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 Zolmitriptan Orodispersible Tablets, leave 24 hours before taking Zolmitriptan Orodispersible Tablets.
• After taking Zolmitriptan Orodispersible Tablets, leave 24 hours before taking triptans other than Zolmitriptan Orodispersible Tablets.
• If you take medicines containing ergotamine or ergot-type medicines (such as dihydroergotamine or methysergide), leave 24 hours before taking Zolmitriptan Orodispersible Tablets.
• After taking Zolmitriptan Orodispersible Tablets, 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.

Serotonin syndrome is a rare, life-threatening condition that has been reported in some patients who took Zolmitriptan Orodispersible Tablets 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, tremor, restlessness, fever, excessive sweating, twitching, muscle rigidity uncoordinated movement of limbs or eyes and uncontrollable jerking of muscles. Your doctor may advise you on this.

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 Orodispersible Tablets may be more likely to happen..

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

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 Orodispersible Tablets during pregnancy is harmful. Before taking Zolmitriptan Orodispersible Tablets, tell your doctor if you are pregnant or trying to become pregnant.
• Do not breast-feedwithin 24 hours taking zolmitriptan.

• During a migraine attack your reactions may be slower than usual. Bear this in mind when drive or use any tools or machines.
• Zolmitriptan Orodispersible Tablets is unlikely to affect driving or using tools or machines. However, it is best to wait to see how Zolmitriptan Orodispersible Tablets affects you before you try these activities.

Zolmitriptan 2.5 mg Orodispersible Tablets contains 2 mg aspartame (E951) in each orodispersible tablets.

Zolmitriptan 5 mg Orodispersible Tablets contains 4 mg aspartame (E951) in each orodispersible tablets. 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.

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

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

Rare (may affect up to 1 in 1,000 people)

• Allergic/hypersensitivity reactions including lumpy rash (hives), swelling of the face, lips, mouth, tongue or throat, difficulty swallowing or breathing difficulties.

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. You may notice chest pain or shortness of breath.
• Spasm of the blood vessels of the gut, which can cause damage to your gut. You may notice stomach pain or bloody diarrhoea.

Common (may affect up to 1 in 10 people):

• 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 (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.

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. By reporting side effects you can help provide more information on the safety of this medicine.

2.5mg

The active substance is zolmitriptan. Zolmitriptan 2.5 mg Orodispersible Tablets contain 2.5 mg of zolmitriptan.

The other ingredients are Mannitol (E421), Cellulose microcrystalline, Crospovidone Type A, Aspartame (E951), Silica colloidal anhydrous, Talc, Magnesium Stearate, Peppermint Flavour.

5mg

The active substance is zolmitriptan. Zolmitriptan Orodispersible 5 mg Tablets contain 5 mg of zolmitriptan.

The other ingredients are Mannitol (E421), Cellulose microcrystalline, Crospovidone Type A, Aspartame (E951), Silica colloidal anhydrous, Talc, Magnesium Stearate, Peppermint Flavour.

Zolmitriptan 2.5 mg Orodispersible Tablets are supplied as:

White to off-white, round tablets debossed ‘F7’ on one side and plain on other side (diameter approximately: 6,5 mm).

Zolmitriptan 5 mg Orodispersible Tablets are supplied as:

White to off-white, round tablets debossed ‘F11’ on one side and plain on other side (diameter approximately: 8 mm).

Zolmitriptan 2.5 mg Orodispersible Tablets are available in Aluminium/Aluminium peelable blisters in cartons containing 2, 3, 4, 5, 6, 12, 18 tablets.

Zolmitriptan 5 mg Orodispersible Tablets are available in Aluminium/Aluminium peelable blisters in cartons containing 2, 3, 4, 5, 6, 12, 18 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Manufacturer