Zolmitriptan 5 Mg Film-Coated Tablets
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ZOLMITRIPTAN 2.5 mg FILM-COATED TAB LETS ZOLMITRIPTAN 5 mg FILM-COATED 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 get 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 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
WHAT ZOLMITRIPTAN IS AND WHAT IT IS 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
Do NOT take Zolmitriptan
• If you are allergic (hypersensitive) to zolmitriptan; sunset yellow (E110), allura red AC (E129) 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 sufferfrom 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
• Moclobamide, fluvoxamine, selegiline or 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).
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.
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 sugar lactose. 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 5 mg tablets also contain colourants called "Sunset Yellow" (E110) and "Allura Red AC" (E129) which may cause allergic reactions.
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0 HOWTO 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.
Very rare (affecting fewer than one person in 10,000):
• Heart attack or chest pain
• Intestinal and spleen infarction which may cause stomach pain or bloody diarrhoea.
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.
Tablets should be swallowed whole with water. You should not take more than 2 doses within any 24 hour period.The maximum daily dose of your medicine is 10 mg.
If you have liver problems, or are taking certain other medicines your doctor may decide that you need a lower dose.
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 at the approximate frequencies shown:
Common (affecting fewer than one person in 10 but more than one person in 100):
• 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.
Uncommon (affecting fewer than one person in 100 but more than one person in 1,000):
• Fast heart beat
• Increase in blood pressure
• Need to urinate more frequently or increase in amount of urine you pass.
Not known (cannot be estimated from the available data):
• 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.
HOWTO STORE ZOLMITRIPTAN
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.
What Zolmitriptan contains:
• The active ingredient is zolmitriptan.
Zolmitriptan 2.5 mg tablet:
• Each tablet contains 2.5 mg of zolmitriptan
• The other ingredients in the tablet core are lactose monohydrate, microcrystalline cellulose, sodium starch glycolate (Type A), magnesium stearate
• The other ingredients in the tablet coating are polyvinyl alcohol titanium dioxide (El71), macrogol 3350, talc, iron oxide yellow (E172).
Zolmitriptan 5 mg tablet:
• Each tablet contains 5 mg of zolmitriptan
• The other ingredients in the tablet core are lactose monohydrate, microcrystalline cellulose, sodium starch glycolate (Type A), magnesium stearate
• The other ingredients in the tablet coating are titanium dioxide (El71), hypromellose, macrogol 400, polysorbate 80, allura red AC (E129), sunset yellow (E110).
What Zolmitriptan looks like and contents of the pack:
• Zolmitriptan 2.5 mg film-coated tablets are yellow, round, biconvex tablets engraved "Z2.5" on one side and plain on the other side
• Zolmitriptan 5 mg film-coated tablets are pink, round, biconvex tablets engraved "93" on one side and "8146" on the other side.
The tablets are packed in blister packs of 2, 3, 6, 12, 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 on: October 2011
Rare (affecting fewer than one person in 1,000 but more than one PL 00289/1125 person in 10,000): PL 00289/1155
• 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 symptons.
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