Zolmitriptan 2.5 Mg Orodispersible Tablets
Out of date information, search anotherPreviously assessed against the UK PIL dated June 2012
APPROVED
By BeeharryN at 2:50 pm, May 11, 2015
0573 Taking other medicines
07.05.i5[7] Please tell your doctor or pharmacist if you are taking or have recently
Variation0o09:To correctihebrand name to'Zomig Rapimelt 2.5 mg orodispersible tablets'nydahd tfiegcneric nhrs e'Zolmit riptan2mmg orodispd me^d=itnes ts', with cc^n^mujiBnanl changes to the labels and leaflet.
No other changes approved
Zomig® Rapimelt 2.5 mg
PATIENT INFORMATION LEAFLET
Read all of this leaflet carefully before you start taking this medicine.
- 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Your medicine will be referred to as Zomig Rapimelt throughout the leaflet.
In this leaflet:
1. What Zomig Rapimelt is and what it is used for
2. Before you take Zomig Rapimelt
3. How to take Zomig Rapimelt
4. Possible side effects
5. How to store Zomig Rapimelt
6. Further information
1. WHAT ZOMIG RAPIMELT IS AND WHAT 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. BEFORE YOU TAKE ZOMIG RAPIMELT Do not take Zomig Rapimelt if:
- You are allergic (hypersensitive) to zolmitriptan or any of the other ingredients of this medicine (see Section 6: Further information).
- You have high blood pressure.
- 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.
- You have had a stroke or short-lasting symptoms similar to stroke (transient ischaemic attack or TIA).
- 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 below: 'Taking other medicines' 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.
Take special care with Zomig Rapimelt
Before you take Zomig Rapimelt, tell your doctor 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.
- 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 medicine for treatment of depression (see section below: 'Taking other medicines' 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 under 18 years or 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.
in pamculai, tell youi duciui ii you aie taking any oi the lonowing-
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 MAOls (such as moclobemide).
- SSRls (selective serotonin reuptake inhibitors) such as fluoxetine, paroxetine, fluvoxamine or sertraline.
- SNRls (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.
Taking 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 and breast-feeding
- It is not known if taking Zomig Rapimelt during pregnancy is harmful. Before taking Zomig Rapimelt, tell your doctor if you are pregnant or trying to become pregnant.
- Before taking Zomig Rapimelt tell your doctor if you are breast-feeding. 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.
Important Information about some of the Ingredients of Zomig Rapimelt
Zomig Rapimelt contain aspartame, a source of phenylalanine, which may be harmful for people with phenylketonuria.
3. HOW TO TAKE ZOMIG RAPIMELT
Always take Zomig Rapimelt exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
You can take Zomig Rapimelt as soon as a migraine headache starts. You can also take it once an attack is underway.
- The usual 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.
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 10 mg.
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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Zomig Rapimelt can cause side effects, although not everybody gets them. Some of the symptoms below could be part of the migraine attack itself
Stop taking Zomig Rapimelt and contact your doctor straight away if you notice any of the following:
Rare (affects less than 1 in 1,000 people)
- Allergic reactions including itchy rash (urticaria) and swelling of the face, lips, mouth, tongue and throat.
Very rare (affects less than 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:
Common (affects less than 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 (affects less than 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 any of them. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE ZOMIG RAPIMELT
- Keep out of the sight and reach of children.
- Do not store your tablets above 30oC.
- Keep your tablets in the container they came in.
- Do not use Zomig Rapimelt after the expiry date stated on the carton. The expiry date refers to the last day of that month.
- If your orodispersible tablets become discoloured or shown any other signs of deterioration, please contact your doctor or pharmacist before taking your medicine.
- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION What Zomig Rapimelt contain
Each orodispersible tablet contains 2.5 mg of zolmitriptan which is the active ingredient. It also contains the following inactive ingredients: aspartame, citric acid anhydrous, silica colloidal anhydrous, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, orange flavour and sodium hydrogen carbonate.
What Zomig Rapimelt looks like and contents of the pack
Zomig Rapimelt are white round orodispersible tablets marked ‘Z' on one side and plain on the reverse. Zomig Rapimelt is available in packs of 2, 6 and 12 orodispersible tablets.
Manufacturer and Product Licence Holder
Manufactured by AstraZeneca UK Ltd., Macclesfield, Cheshire SK10 2NA, United Kingdom. Procured from within the EU and Repackaged by Product Licence holder P.I.E. Pharma Ltd, 207 Kenton Road, Harrow, Middlsex HA3 0HD.
POM
PL 15361/0573
Leaflet revision and issue date (Ref) 07.05.15[7]
Zomig Rapimelt is a trademark of IPR Pharmaceuticals, Inc.
0573 Taking other medicines
Zolmitriptan 2.5 mg orodispersible tablets
070515[7] Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines. This includes herbal medicines and medicines you buy without prescription.
PATIENT INFORMATION LEAFLET
Read all of this leaflet carefully before you start taking this medicine.
- 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Your medicine will be referred to as Zolmitriptan throughout the leaflet.
In this leaflet:
1. What Zolmitriptan is and what it is used for
2. Before you take Zolmitriptan
3. How to take Zolmitriptan
4. Possible side effects
5. How to store Zolmitriptan
6. Further information
1. WHAT ZOLMITRIPTAN IS AND WHAT IS USED FOR
Zolmitriptan orodispersible 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 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. BEFORE YOU TAKE ZOLMITRIPTAN Do not take Zolmitriptan if:
- You are allergic (hypersensitive) to zolmitriptan or any of the other ingredients of this medicine (see Section 6: Further information).
- You have high blood pressure.
- 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.
- You have had a stroke or short-lasting symptoms similar to stroke (transient ischaemic attack or TIA).
- 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 below: 'Taking other medicines' 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.
Take special care with Zolmitriptan
Before you take Zolmitriptan, tell your doctor 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.
- 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 medicine for treatment of depression (see section below: 'Taking other medicines' for further information).
If you go into hospital tell the medical staff you are taking Zolmitriptan.
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 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.
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 MAOls (such as moclobemide).
- SSRls (selective serotonin reuptake inhibitors) such as fluoxetine, paroxetine, fluvoxamine or sertraline.
- SNRls (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.
Taking Zolmitriptan with food and drink
You can take Zolmitriptan with or without food. It does not affect the way that Zolmitriptan works.
Pregnancy and breast-feeding
- It is not known if taking Zolmitriptan during pregnancy is harmful. Before taking Zolmitriptan, tell your doctor if you are pregnant or trying to become pregnant.
- Before taking Zolmitriptan tell your doctor if you are breast-feeding. 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.
Important Information about some of the Ingredients of Zolmitriptan
Zolmitriptan contain aspartame, a source of phenylalanine, which may be harmful for people with phenylketonuria.
3. HOW TO TAKE ZOLMITRIPTAN
Always take Zolmitriptan exactly as your doctor has told you. You should 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 usual 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.
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 10 mg.
If you take more Zolmitriptan 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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Zolmitriptan can cause side effects, although not everybody gets them. Some of the symptoms below could be part of the migraine attack itself
Stop taking Zolmitriptan and contact your doctor straight away if you notice any of the following:
Rare (affects less than 1 in 1,000 people)
- Allergic reactions including itchy rash (urticaria) and swelling of the face, lips, mouth, tongue and throat.
Very rare (affects less than 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:
Common (affects less than 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 (affects less than 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 any of them. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE ZOLMITRIPTAN
- Keep out of the sight and reach of children.
- Do not store your tablets above 30oC.
- Keep your tablets in the container they came in.
- Do not use Zolmitriptan after the expiry date stated on the carton. The expiry date refers to the last day of that month.
- If your orodispersible tablets become discoloured or shown any other signs of deterioration, please contact your doctor or pharmacist before taking your medicine.
- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION What Zolmitriptan contain
Each orodispersible tablet contains 2.5 mg of zolmitriptan which is the active ingredient. It also contains the following inactive ingredients: aspartame, citric acid anhydrous, silica colloidal anhydrous, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, orange flavour and sodium hydrogen carbonate.
What Zolmitriptan looks like and contents of the pack
Zolmitriptan are white round orodispersible tablets marked ‘Z' on one side and plain on the reverse. Zolmitriptan is available in packs of 2, 6 and 12 orodispersible tablets.
Manufacturer and Product Licence Holder
Manufactured by AstraZeneca UK Ltd., Macclesfield, Cheshire SK10 2NA, United Kingdom. Procured from within the EU and Repackaged by Product Licence holder P.I.E. Pharma Ltd, 207 Kenton Road, Harrow, Middlsex HA3 0HD.
POM
PL 15361/0573
Leaflet revision and issue date (Ref) 07.05.15[7]