Zolmitriptan 2.5mg Orodispersible Tablets
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Zolmitriptan 2.5mg and 5mg 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:
T| What Zolmitriptan tablets are and what they are used for
What you need to know before you take Zolmitriptan tablets How to take Zolmitriptan tablets 5 Possible side effects 1| How to store Zolmitriptan tablets Contents of the pack and other information
J What Zolmitriptan tablets are and what they are used for
Zolmitriptan 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 the widening of 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.
What you need to know before you take
Zolmitriptan tablets
Do not take Zolmitriptan tablets if you
• are allergic to zolmitriptan or any of the other ingredients of this medicine (listed in section 6)
• have high blood pressure
• 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
• have had a stroke or short-lasting symptoms similar to stroke (transient ischaemic attack or TIA)
• have severe kidney problems
• 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: 'Other medicines and Zolmitriptan tablets' for further information.
If you are not sure if any of these apply to you, talk to your doctor or pharmacist.
Warnings and precautions
Talk to your doctor or pharmacist before taking Zolmitripan tablets 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
• have been told that you have Wolff-Parkinson-White Syndrome (a type of abnormal heart beat)
• have ever had liver problems
• have headaches which are not like your usual migraine headache
• are taking any other medicine for treatment of depression (see 'Other medicines and Zolmitriptan tablets' later in this section).
When Zolmitriptan is taken at the same time as
medicines of the type SSRI or SNRI, which are used for the treatment of depression, there is a risk of development of so called serotonin syndrome. The symptoms can be severe and include shivering, overreactive reflexes, nausea, fever, sweating, delirium, mental confusion and coma. In case you are taking this combination your doctor should monitor you carefully, especially in the beginning of treatment, when doses are increased or if another serotonergic medication is added. If you experience any of these symptoms contact a doctor as soon as possible
If you go into hospital tell the medical staff you are taking Zolmitriptan.
Children and elderly patients
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 using Zolmitriptan to correct the problem.
Other medicines and Zolmitriptan tablets Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular, tell your doctor if you are taking any of the following medicines:
Medicines for migraine
• other triptans than zolmitriptan
• 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 (see also section 'Warnings and precautions' above)
• moclobemide or fluvoxamine
• medicines called SSRIs (selective serotonin reuptake inhibitors)
• medicines called SNRIs (serotonin norepinephrine reuptake inhibitors) such as venlafaxine, duloxetine
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 may be more likely to happen.
Zolmitriptan tablets 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
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 during pregnancy is harmful.
Do not breast-feed within 24 hours of taking Zolmitriptan.
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 is best to wait to see how Zolmitriptan affects you before you try these activities.
Zolmitriptan tablets contain aspartame
Zolmitriptan orodispersible tablets contain aspartame, a source of phenylalanine. May be harmful for people with phenylketonuria.
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Figure 2
Figure 5
3| How to take Zolmitriptan tablets
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 Zolmitriptan as soon as a migraine headache starts. You can also take it once an attack is underway.
The recommended dose is one tablet (either 2.5mg or 5mg).
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 raise the dose to 5mg or change your treatment.
Do not use more than the dose prescribed for you.
Do not use more than two doses in one day. If you have been prescribed the 2.5mg tablet, the maximum daily dose is 5mg. If you have been prescribed the 5mg tablet, the maximum daily dose is 10mg.
Instruction for use
1. Do not push the tablet out of the pocket (Figure 1).
Figure 1
2. Separate one blister cell from the strip (Figure 2).
3. Carefully peel off the lidding foil starting at the corner as indicated by the arrow (Figure 3 and 4).
\
Figure 3
Figure 4
4. Take the tablet out of the pocket with dry hands and place it on the tongue (Figure 5). It will rapidly disintegrate and can be swallowed without water.
If you take more Zolmitriptan tablets 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.
When too many orodispersible tablets are taken the symptoms may possibly include sedation.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
^ 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.
Common side effects (affects 1 to 10 users in 100):
• 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
Uncommon side effects (affects 1 to 10 users in 1,000):
• 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
Rare side effects (affects 1 to 10 users in 10,000):
• Allergic/hypersensitivity reactions including lumpy rash (hives) and swelling of the face, lips, mouth, tongue and throat. If you think that Zolmitriptan
is causing an allergic reaction, stop using it and contact your doctor straight away.
Very rare side effects (affects less than 1 user in 10,000):
• Angina (pain in the chest, often brought on by exercise), heart attack or spasm of the blood vessels of the heart. If you notice chest pain or shortness of breath after taking Zolmitriptan, contact your doctor and do not take any more Zolmitriptan.
• Spasm of the blood vessels of the gut, which can cause damage to your gut. You may notice stomach pain or bloody diarrhoea. If this happens, contact your doctor and do not take any more Zolmitriptan.
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 internet at HYPERLINK “http:// www.mhra.gov.uk/"www.mhra.gov.uk/yellowcard. Alternatively you can call Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from your local pharmacy. By reporting side effects you can help provide more information on the safety of this medicine.
How to store Zolmitriptan tablets
Keep out of the sight and reach of children.
Do not use Zolmitriptan after the expiry date which is stated on the blister and the carton after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
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.
Contents of the pack and other information
What Zolmitriptan tablets contain
• The active substance is zolmitriptan. Zolmitriptan orodispersible tablets contain either 2.5mg or 5mg of zolmitriptan.
• The other ingredients are mannitol (E421), calcium silicate, microcrystalline cellulose, aspartame (E951), sodium starch glycolate type A, crospovidone type B, colloidal anhydrous silica, magnesium stearate and orange cream flavour (containing e.g. maltodextrin (maize), acacia (E414), ascorbic acid (E300), butylhydroxyanisole (E320)).
What Zolmitriptan tablets look like and contents of the pack
Zolmitriptan 2.5mg orodispersible tablets are white and round flat tablets with the diameter 7.5mm. Zolmitriptan 5mg orodispersible tablets are white and round flat tablets with the diameter 9.5mm.
Zolmitriptan orodispersible tablets 2.5mg and 5mg come in peelable aluminium laminate blister packs containing 6 or 12 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavikurvegur 76-78,
220 HafnarfjorSur Iceland
Manufacturer
Actavis Ltd
BLB016, Bulebel Industrial Estate
Zejtun ZTN 3000
Malta
This leaflet was last revised in - June 2013
If you would like a leaflet with larger text, please contact 01271 311257.
Actavis, Barnstaple, EX32 8NS, UK
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