Zolmitriptan 5mg Orodispersible Tablets
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ZOLMITRIPTAN 2.5 mg AND 5 mg ORODISPERSIBLE
TABLETS
PACKAGE LEAFLET: INFORMATION FORTHE USER
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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Zolmitriptan OrodispersibleTablets are and what they are used for
2. Before you take Zolmitriptan OrodispersibleTablets
3. How to take Zolmitriptan OrodispersibleTablets
4. Possible side effects
5. Howto store Zolmitriptan OrodispersibleTablets
6. Further information
A WHAT ZOLMITRIPTAN ORODISPERSIBLETABLETS ARE AND W WHATTHEYARE USED FOR
Zolmitriptan belongs to a group of medicines called "selective serotonin (5HT1) agonists" and works in your brain to relieve the symptoms of migraine.
Zolmitriptan is used for the treatment of migraine.You should not take Zolmitriptan to prevent migraines occuring.
Q BEFORE YOU TAKE ZOLMITRIPTAN ORODISPERSIBLETABLETS
Do not take Zolmitriptan
• If you are allergic (hypersensitive) to zolmitriptan or to any of the other ingredients of this medicine (see section 6. Further information)
• If you suffer from high blood pressure which is difficult to treat or have poorly controlled blood pressure. Speak to your doctor if unsure
• If you have had a heart attack, have heart disease, suffer from angina (chest pain) or have other circulatory problems
• If you are taking certain other medicines used for treatment or prevention of migraine such as ergotamine, dihydroergotamine, methysergide, sumatriptan or naratriptan
• If you have severe kidney failure
• If you have previously had a stroke or a transient ischaemic attack (a mini-stroke which gets completely better within a day or two).
• 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
Tell your doctor before you start to take this medicine if you:
• Have an irregular heart beat
• Suffer from a condition called Wolff-Parkinson-White Syndrome which is characterised by an abnormal heart rhythm
• Smoke, suffer from high cholesterol, have diabetes, have high blood pressure, have a history of heart disease in your family or have any other condition which puts you at higher risk of developing heart disease. Your doctor may decide to conduct some additional tests
to make sure that it is safe for you to take Zolmitriptan, especially if you are male and over 40 or are female and have gone through the menopause
• Are taking a herbal remedy called St. John's wort
• If you are taking any medicine for the treatment of depression such as fluoxetine, sertraline or venlafaxine.Taking Zolmitriptan together with any of these medicines may cause a life-threatening condition called Serotonin syndrome which is characterised by agitation, hallucinations, a fast heart beat, lack of coordination, vomiting, feeling sick or diarrhoea.
If you experience chest pain or chest tightness you should stop taking this medicine and contact your doctor straight away.
Zolmitriptan can lead to an increase in blood pressure. If your blood pressure rises too high you may experience symptoms such as headache, dizziness or ringing in the ears. If this applies to you, you should contact your doctor.
Overuse of some common painkillers can make headaches worse. If you take common painkillers (e.g. paracetamol) regularly and suffer from frequent or daily headaches you should discuss this with your doctor.
It is not recommended to take Zolmitriptan during the aura phase (period that precedes the head pain) to prevent migraine headaches from developing. You should take your medicine during the headache phase of the migraine.
Taking other medicines
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.
The effects of Zolmitriptan may be altered or undesirable effects may occur if you are taking other medicines. In particular, talk to your doctor if you are taking any of the following:
• Ergotamine (also used for treatment of migraine) or ergo-type medicines, such as dihydroergotamine or methysergide.You should not take Zolmitriptan within 24 hours of using ergotamine.You should not take ergotamine within 6 hours of taking Zolmitriptan
• Other triptans, such as sumatriptan or naratriptan.You should not take Zolmitriptan within 24 hours of using another triptan.You should not take another triptan within 24 hours of using Zolmitriptan
• Moclobamide, fluvoxamine, selegiline, fluoxetine, paroxetine or sertraline (for treatment of depression)
• SNRIs (serotonin norepinephrine reuptake inhibitors) such as venlaflaxine or duloxetine (for treatment of depression)
• Cimetidine (for treatment of indigestion or stomach ulcers)
• Certain antibiotics used for treatment of infection (e.g. ciprofloxacin, levofloxacin, norfloxacin or ofloxacin)
• St. John's wort (herbal remedy containing Hypericum perforatum).
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 Pregnancy:
You should not take Zolmitriptan if you are pregnant unless your doctor considers it to be absolutely necessary.The effect of Zolmitriptan on your baby is not known.
Breast-feeding:
The active substance in your medicine may pass into your breastmilk.To minimise the risk of exposing your baby to your medicine you should not breast-feed for 24 hours after taking Zolmitriptan.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
During a migraine you may experience drowsiness. If affected do not drive, operate heavy machinery or participate in any other dangerous activity that requires your full attention.
Important information about some of the ingredients of Zolmitriptan
Your medicine contains the sugars lactose and sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Zolmitriptan also contains soya lecithin. If you are allergic to soya, do not use this medicinal product.
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This medicine also contains aspartame, a source of phenylalanine.This may be harmful for people with phenylketonuria.
0 HOWTO TAKE ZOLMITRIPTAN ORODISPERSIBLETABLETS
Always take Zolmitriptan exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The usual dose of Zolmitriptan is 2.5 mg which should be taken as soon as possible after your migraine starts. If taken later it will still work.
If a dose of 2.5 mg is not strong enough to treat your symptoms, your doctor may advise you to take a higher dose of 5 mg next time you have a migraine. You are more likely to suffer side effects with the higher dose (5 mg).
If your symptoms go away but then come back within 24 hours a second dose can be taken. However, you should wait until at least two hours after your first dose.
You do not have to take your tablet with liquid.The tablet will dissolve directly in your mouth. Put the tablet on your tongue and once it is dissolved swallow it with saliva. You should not take more than 2 doses within any 24 hour period.The maximum daily dose of your medicine is 10 mg.
Please follow these steps to remove the tablet from the blister strip:
1. Separate one individual blister cell from the rest of the strip by gently tearing along the perforations around it
2. Peel off the backing
3. Carefully take the tablet out (do not push it out)
4. Put the tablet on your tongue, allow it to dissolve directly in your mouth and swallow it with saliva.
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If you have liver problems, or are taking certain other medicines your doctor may decide that you need a lower dose.
Uncommon side effects:
• Fast heart beat
• Increase in blood pressure
• Need to urinate more frequently or increase in amount of urine you pass.
Rare side effects:
• Allergic reactions including nettle rash, swelling of the face, lips, mouth, tongue or throat or difficulty in breathing. Stop taking Zolmitriptan and contact your doctor straight away if you notice any of these symptoms.
Very rare side effects:
• Heart attack or chest pain
• Intestinal and spleen infarction which may cause stomach pain or bloody diarrhoea
• Need to urinate more urgently.
Not known side effects:
• Irregular heart beat
• Ventricular tachycardia (rapid heart beat).
Some of the symptoms described above may be caused by your migraine itself and may not be due to your medicine.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
0 HOWTO STORE ZOLMITRIPTAN ORODISPERSIBLETABLETS
Keep out of the reach and sight of children.
Do not use Zolmitriptan after the expiry date that is stated on the outer packaging.The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
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.
Zolmitriptan is not recommended in patients under 18 or over 65 years old.
If you take more Zolmitriptan than you should
If you (or someone else) swallow a lot of the tablets all together or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Q POSSIBLE SIDE EFFECTS
Like all medicines, Zolmitriptan can cause side effects, although not everybody gets them.
The following side effects have been reported.They are listed according to frequency as follows:
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Very common: |
affects more than 1 user in 10 |
|
Common: |
affects 1 to 10 users in 100 |
|
Uncommon: |
affects 1 to 10 users in 1,000 |
|
Rare: |
affects 1 to 10 users in 10,000 |
|
Very rare: |
affects less than 1 user in 10,000 |
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Not known: |
Frequency cannot be estimated from the available data |
Common side effects:
• Abnormal sensations such as tingling or prickling sensation on the skin, warm sensation, increased sensitivity to touch or sound
• Dizziness or headache
• Sleepiness
• Palpitations (awareness of your heartbeat)
• Pain in the abdomen, nausea (feeling sick), vomiting or dry mouth
• Muscle weakness and muscular pain
• Weakness
• Heaviness, tightness, pain or pressure in the throat, neck, arms and legs or chest.
0 FURTHER INFORMATION
What Zolmitriptan OrodispersibleTablets contain
• The active substance is zolmitriptan.
2.5 mg tablets
• Each orodispersible tablet contains 2.5 mg of zolmitriptan.
5 mg tablets
• Each orodispersible tablet contains 5 mg of zolmitriptan
• The other ingredients in the tablet are lactose monohydrate, silica colloidal anhydrous, maize starch, mannitol (E421), croscarmellose sodium, citric acid anhydrous, sodium hydrogen carbonate, aspartame (E951), magnesium stearate, orange flavour (sucrose, maltodextrin, natural flavours, soya lecithin, silica colloidal anhydrous).
What Zolmitriptan OrodispersibleTablets look like and contents of the pack
Zolmitriptan 2.5 mg OrodispersibleTablets are white to off-white, round flat-face bevel edged orodispersible tablets, engraved with '93' on one side and '8147' on the other side.
Zolmitriptan 5 mg OrodispersibleTablets are white to off-white, round flat-face bevel edged orodispersible tablets, engraved with '93' on one side and '8148' on the other side.
Zolmitriptan OrodispersibleTablets are supplied in aluminium blisters containing 2, 3, 6, 12 or 18 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
TEVA UK Limited, Eastbourne, BN22 9AG, United Kingdom. Manufacturer
TEVA Operations Poland Sp. z o.o. ul., Mogilska 80, 31-546 Krakow, Poland.
This leaflet was last revised in October 2011.
PL 00289/1344-1345
94522-C |
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5 mm minimum