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Document: Zolmitriptan Teva orodispersible tablet ENG PL change

• Zolmitriptan Teva orodispersible tablet PL
• Zolmitriptan Teva orodispersible tablet ENG PL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Zolmitriptan Teva 2.5 mg orodispersible tablets

Zolmitriptan Teva 5 mg orodispersible 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.

What is in this leaflet:

1. What Zolmitriptan Teva is and what it is used for

2. What you need to know before you take Zolmitriptan Teva

3. How to take Zolmitriptan Teva

4. Possible side effects

6. Contents of the pack and other information

Zolmitriptan belongs to a group of medicines called “selective serotonin (5HT1) agonists” and works in your brain to relieve the symptoms of migraine.

Zolmitriptan Teva is used for the treatment of migraine. You should not take Zolmitriptan Teva to prevent migraines occuring.

Do not take Zolmitriptan Teva

• If you are allergic to zolmitriptan, peanut or soya or to any of the other ingredients of this medicine (listed in section 6).

• 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 takeZolmitriptan Teva if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Zolmitriptan Teva.

Warnings and precautions

Talk to your doctor or pharmacist before taking Zolmitriptan Tevaif 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 Teva, 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

• Are taking any medicine for the treatment of depression such as fluoxetine, sertraline or venlafaxine. Taking Zolmitriptan Teva 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 Teva 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 Teva 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.

Other medicines and Zolmitriptan Teva

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

The effects of Zolmitriptan Teva 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 Teva within 24 hours of using ergotamine. You should not take ergotamine within 6 hours of taking Zolmitriptan Teva

• Other triptans, such as sumatriptan or naratriptan. You should not take Zolmitriptan Teva within 24 hours of using another triptan. You should not take another triptan within 24 hours of using Zolmitriptan Teva.

• 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).

Zolmitriptan Teva with food and drink

You can take Zolmitriptan Teva with or without food. It does not affect the way that Zolmitriptan Teva works.

Pregnancy, breast-feeding and fertility

Pregnancy:

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.

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 Teva.

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.

Zolmitriptan Teva containslactose, sucrose, soya lecithin and aspartame.

Zolmitriptan Teva 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 Teva also contains soya lecithin. If you are allergic to peanut, soya, do not use this medicinal product.

Zolmitriptan Teva also contains aspartame, a source of phenylalanine. This may be harmful for people with phenylketonuria.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose 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

If you have liver problems, or are taking certain other medicines your doctor may decide that you need a lower dose.

Zolmitriptan Teva is not recommended in patients under 18 or over 65 years old.

If you take more Zolmitriptan Teva 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 medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you notice any of the following side effects, stop taking Zolmitriptan Teva and contact your doctor straight away:

Rare: may affect up to 1 in 1,000 people

• Allergic reactions including nettle rash, swelling of the face, lips, mouth, tongue or throat or difficulty in breathing.

Very rare: may affect up to 1 in 10,000 people

• Heart attack or chest pain.

• Intestinal and spleen infarction which may cause stomach pain or bloody diarrhoea.

Other possible side effects:

Common: may affect up to 1 in 10 people

• 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, dry mouth, dysphagia (difficulties in swallowing).

• Muscle weakness and muscular pain

• Weakness

• Heaviness, tightness, pain or pressure in the throat, neck, arms and legs or chest.

Uncommon: may affect up to 1 in 100 people

• Increase in blood pressure

• Need to urinate more frequently or increase in amount of urine you pass.

Very rare: may affect up to 1 in 10,000 people

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.

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 national reporting system listed in Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Zolmitriptan Teva

Keep this medicine out of the sight and reach of children.

Do not use this medicineafter the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Do not use this medicine if you notice visible signs of deterioration.

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.

6. Contents of the pack and other information

What Zolmitriptan Teva contains

2.5 mg tablets

5 mg tablets

What Zolmitriptan Teva looks like and contents of the pack

Zolmitriptan Teva 2.5 mg orodispersible tablets 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 Teva 5 mg orodispersible tablets 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 Teva is supplied in aluminium blisters containing 2, 3, 6, 12 or 18 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

[To be completed nationally]

Manufacturer

[To be completed nationally]

<This medicinal product is authorised in the Member States of the EEA under the following names:>

This leaflet was last revised in 8^thJuly 2014