Zolmitriptan 2.5mg Film-Coated Tablets
Package Leaflet: Information for the User
Zomig® 2.5mg 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.
• The name of this medicine is Zomig 2.5mg Tablets but it will be referred to as Zomig throughout the remainder of this leaflet.
What is in this leaflet
1. What Zomig is and what it is used for
2. What you need to know before you take Zomig
3. How to take Zomig
4. Possible side effects
5. How to store Zomig
6. Contents of the pack and other information
1. What Zomig is and what it is used for
Zomig 2.5mg tablets contain zolmitriptan and belongs to a group of medicines called triptans.
Zomig is used to treat migraine headache.
• Migraine symptoms may be caused by swollen blood vessels in the head. Zomig 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 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 Do not take Zomig:
• 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 for further information).
Do not take Zomig if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Zomig.
Warnings and precautions
Talk to your doctor or pharmacist before taking Zomig:
• 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’ for further information).
If you go into hospital tell the medical staff you are taking Zomig.
Zomig is not recommended for people aged over 65.
Children and adolescents
Zomig is not recommended in children and adolescents under 18 years.
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 taking Zomig to correct the problem.
Other medicines and Zomig
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 (such as sumatriptan or naratriptan) leave 24 hours before taking Zomig.
• After taking Zomig 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.
• After taking Zomig 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.
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 with food and drink
You can take Zomig with or without food. It does not affect the way that Zomig works.
Pregnancy, breast-feeding and fertility
It is not known if taking Zomig 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 is unlikely to affect driving or using tools or machines. However, it may make you feel sleepy. Wait to see how Zomig affects you before you try these activities.
Zomig contains Lactose
Zomig 2.5mg tablets contain lactose which is a type of sugar. 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 Zomig
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 (2.5mg).
• 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.
Do not use more than the dose prescribed for you.
• Do not use more than two doses in one day unless prescribed to by your doctor.
• The maximum daily dose is 10mg.
If you take more Zomig than you should
If you take more Zomig 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 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 serious side effects, stop taking Zomig 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.
Very rare (may affect up to 1 in 10,000 people)
• Sudden urgent need to pass water (urine).
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 Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard.
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 sight and reach of children.
• Do not store above 30oC.
• Do not use Zomig after the expiry date which is stated on the label and carton. The expiry date refers to the last day of that month.
• If your medicine becomes discoloured or shows any sign of deterioration, return it to your pharmacist.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help to protect the environment.
6. Contents of the pack and other information
What Zomig contains
Each tablet contains 2.5mg zolmitriptan.
Other ingredients: lactose anhydrous, microcrystalline cellulose, sodium starch glycollate (type A), magnesium stearate, macrogol, hypromellose, titanium dioxide (E171) and yellow iron oxide (E172).
What Zomig looks like and contents of the pack
Zomig are yellow, round, biconvex film-coated tablets marked with the letter Z on one side and plain on the reverse.
Zomig comes in blister packs of 3, 6 or 12 tablets.
Manufactured by
AstraZeneca UK Limited, Silk Road Business Park, Macclesfield, Cheshire, SK10 2NA, UK.
Procured from within the EU by the Product Licence Holder:
MPT Pharma Ltd., Westgate Business Park, Unit 5-7 Tintagel Way, Aldridge, Walsall WS9 8ER.
Repackaged by MPT Pharma Ltd.
PL: 33532/0413
POM
Leaflet dated 5th October 2016 Leaflet coded xxxxxxxxxxxx
Zomig® is a registered trademark of IPR Pharmaceuticals, Inc.
You can also get support and information about migraine from the Migraine Action Association (UK), Unit 6, Oakley Hay Lodge Business Park, Great Folds Road, Great Oakley, Northants nN18 9AS.
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.
• The name of this medicine is Zolmitriptan 2.5mg film-coated Tablets but it will be referred to as Zolmitriptan throughout the remainder of this leaflet.
What is in this leaflet
1. What Zolmitriptan is and what it is used for
2. What you need to know before you take Zolmitriptan
3. How to take Zolmitriptan
4. Possible side effects
5. How to store Zolmitriptan
6. Contents of the pack and other information
1. What Zolmitriptan is and what it is used for
Zolmitriptan 2.5mg tablets contain zolmitriptan and belongs to a group of medicines called triptans.
Zolmitriptan is used to treat migraine headache.
• Migraine symptoms may be caused by swollen 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 Zolmitriptan Do not take Zolmitriptan:
• 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 Zolmitriptan for further information).
Do not take Zolmitriptan if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Zolmitriptan.
Warnings and precautions
Talk to your doctor or pharmacist before taking Zolmitriptan:
• 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 Zolmitriptan’ for further information).
If you go into hospital tell the medical staff you are taking Zolmitriptan.
Zolmitriptan is not recommended for people aged over 65.
Children and adolescents
Zolmitriptan is not recommended in children and adolescents under 18 years.
As with other migraine treatments, using too much Zolmitriptan 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 to correct the problem.
Other medicines and Zolmitriptan
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 Zolmitriptan (such as sumatriptan or naratriptan) leave 24 hours before taking Zolmitriptan.
• After taking Zolmitriptan 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 Zolmitriptan.
• After taking Zolmitriptan 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.
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.
Zolmitriptan with food and drink
You can take Zolmitriptan with or without food. It does not affect the way that Zolmitriptan works.
Pregnancy, breast-feeding and fertility
It is not known if taking Zolmitriptan 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. Zolmitriptan is unlikely to affect driving or using tools or machines. However, it may make you feel sleepy. Wait to see how Zolmitriptan affects you before you try these activities.
Zolmitriptan contains Lactose
Zolmitriptan 2.5mg tablets contain lactose which is a type of sugar. 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 Zolmitriptan
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 (2.5mg).
• 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.
Do not use more than the dose prescribed for you.
• Do not use more than two doses in one day unless prescribed to by your doctor.
• The maximum daily dose is 10mg.
If you take more Zolmitriptan than you should
If you take more Zolmitriptan 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 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 serious side effects, stop taking Zolmitriptan 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.
Very rare (may affect up to 1 in 10,000 people)
• Sudden urgent need to pass water (urine).
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 Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Zolmitriptan
• Keep out of the sight and reach of children.
• Do not store above 30oC.
• Do not use Zolmitriptan after the expiry date which is stated on the label and carton. The expiry date refers to the last day of that month.
• If your medicine becomes discoloured or shows any sign of deterioration, return it to your pharmacist.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help to protect the environment.
6. Contents of the pack and other information
What Zolmitriptan contains
Each tablet contains 2.5mg zolmitriptan.
Other ingredients: lactose anhydrous, microcrystalline cellulose, sodium starch glycollate (type A), magnesium stearate, macrogol, hypromellose, titanium dioxide (E171) and yellow iron oxide (E172).
What Zolmitriptan looks like and contents of the pack
Zolmitriptan are yellow, round, biconvex film-coated tablets marked with the letter Z on one side and plain on the reverse.
Zolmitriptan comes in blister packs of 3, 6 or 12 tablets.
Manufactured by
AstraZeneca UK Limited, Silk Road Business Park, Macclesfield, Cheshire, SK10 2NA, UK.
Procured from within the EU by the Product Licence Holder:
MPT Pharma Ltd., Westgate Business Park, Unit 5-7 Tintagel Way, Aldridge, Walsall WS9 8ER.
Repackaged by MPT Pharma Ltd.
PL: 33532/0413
POM
Leaflet dated 5th October 2016 Leaflet coded xxxxxxxxxxxx
You can also get support and information about migraine from the Migraine Action Association (UK), Unit 6, Oakley Hay Lodge Business Park, Great Folds Road, Great Oakley, Northants nN18 9AS.