Zomig Rapimelt 2.5mg

Package leaflet: Information for the user

Zomig Rapimelt 2.5 mg orodispersible tablets

zolmitriptan

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

1.        What Zomig Rapimelt is and what it is used for

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

Zomig Rapimelt is used to treat migraine headache.

·      Migraine symptoms may be caused by swollen blood vessels in the head. Zomig Rapimelt 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 Rapimelt 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 Zomig Rapimelt

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 poor blood circulation, usually affecting the legs and arms (peripheral vascular disease).

·      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.

·      If you have severe kidney problems.

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 or pharmacist before you take Zomig Rapimelt:

·      If you have headaches which are not like your usual migraine headache.

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

·      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 are a man over 40 or a woman who has reached the menopause, if you smoke, have high blood pressure, high levels of cholesterol or diabetes or if anyone in your family has ischaemic heart disease.

·      If you have ever had liver problems, your dose of Zomig Rapimelt may need to be adjusted.

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.

If you are treated with both Zomig and certain types of antidepressants, then your doctor will need to carefully monitor you.

If you use any type of painkiller whilst taking Zomig Rapimelt, then your headache could get worse. If this happens, speak to your doctor as soon as possible.

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

Zomig Rapimelt is not recommended for people aged over 65.

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 Rapimelt 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).

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 advise 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 2.5 mg contains 5 mg aspartame in each orodispersible 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.

Zomig Rapimelt contains sodium:

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

Zomig Rapimelt contains benzyl alcohol:

Zomig Rapimelt contains 0.0000032 mg of benzyl alcohol in each orodispersible tablet.

Benzyl alcohol may cause allergic reactions.

Ask your doctor or pharmacist for advice if you are pregnant or breast-feeding. This is because large amounts of benzyl alcohol can build up in your body and may cause side effects (called “metabolic acidosis”).

Ask your doctor or pharmacist for advice if you have a liver or kidney disease. This is because large amounts of benzyl alcohol can build up in your body and may cause side effects (called “metabolic acidosis”).

3.        How to take Zomig Rapimelt

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

·      The recommended dose is one tablet (2.5 mg).

·      Peel the blister pack open as shown on the foil. Do not push the tablet through the foil.

·      Place the tablet on your tongue, where it will dissolve and be swallowed with the saliva. You do not have to take a drink of water in order to swallow your tablet.

·      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.

If you take more Zomig Rapimelt than you should

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

If you forget to take Zomig Rapimelt

Do not use more than the dose prescribed for you.

·      Do not take a double dose to make up for a forgotten dose or use more than four doses of one tablet (four doses of 2.5 mg) in a day unless prescribed by your doctor.

·      The maximum daily dose is 10 mg.

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.

If you notice any of the following 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.

Other 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.

·      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.

Do not be concerned by this list of possible side effects. You may not get them.

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:

HPRA Pharmacovigilance

Website: www.hpra.ie

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

5.      How to store Zomig Rapimelt

·      Keep this medicine out of the sight and reach of children.

·      Do not store above 25°C.

·      Keep your medicine in the container it came in.

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

·      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 Zomig Rapimelt contains

The active ingredient is zolmitriptan. Each tablet contains 2.5 mg of zolmitriptan.

The other ingredients are: aspartame (E951) (see section 2), citric acid anhydrous, silica colloidal anhydrous, crospovidone, magnesium stearate, mannitol (E421), microcrystalline cellulose, orange flavour (contains benzyl alcohol) and sodium hydrogen carbonate.

What Zomig Rapimelt 2.5 mg orodispersible tablets look like and contents of the pack

·      Zomig Rapimelt 2.5 mg orodispersible tablets are white, flat-faced, round and marked with the letter ‘Z’ on one side.

·      Zomig Rapimelt 2.5 mg orodispersible tablets come in peelable aluminium laminate blister packs containing 2 or 6 tablets.

·      Not all pack sizes may be marketed.

Zomig may also be available as film-coated tablets 2.5 mg.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation for Zomig Rapimelt 2.5 mg orodispersible tablets is held by Grünenthal Pharma Ltd., 4045 Kingswood Road, Citywest Business Park, Citywest, Co. Dublin,

Ireland

Zomig Rapimelt 2.5 mg orodispersible tablets are manufactured by Farmaceutici Formenti S.p.A. Via Di Vittorio 2, 21040 Origgio (VA) Italy or Grünenthal GmbH, Zieglerstraße 6, 52078 Aachen, Germany.

This leaflet was last revised in June 2024.