APO-Zolmitriptan

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.

Zolmitriptan
Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about zolmitriptan. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may want to read it again.

What this medicine is used for

Zolmitriptan is used to relieve migraine headaches. It belongs to a group of medicines called serotonin agonists.

How it works

Migraine is thought to be caused by the widening of certain blood vessels in the brain. Zolmitriptan narrows the blood vessels to help ease the migraine.
Some people have a warning stage called 'aura' before the migraine headache starts. Aura can include numbness in the face or down one arm, mood changes, or problems with eyesight such as seeing blank spots or flashing lights.
Zolmitriptan can be used in migraine with or without aura. It should not be used to treat types of migraine called 'hemiplegic' or 'basilar' migraine.
Zolmitriptan does not work in headaches that are not migraine.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed this medicine for another reason.
This medicine is available only with a doctor's prescription.
This medicine is not addictive.
There is no experience of zolmitriptan use in children under 12 years of age. One study in children aged 12 to 17 years indicated no benefit with zolmitriptan treatment.

Before you take this medicine

When you must not take it

Do not take this medicine if you have an allergy to:
zolmitriptan
any of the ingredients listed at the end of this leaflet
Some of the symptoms of an allergic reaction may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue, throat or other parts of the body
rash, itching or hives on the skin
Do not use this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to take it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if you have or have had any of the following medical conditions:
high blood pressure
a feeling of tightness, pressure of heaviness in the chest
a heart attack, other heart problems or a family history of heart problems
a stroke or dizzy spells caused by lack of blood flow to the brain
blood vessel problems causing poor circulation in the arms or legs
kidney or liver disease
high cholesterol levels in the blood
diabetes
Tell your doctor if you are pregnant, plan to become pregnant or are breastfeeding.
Do not take zolmitriptan until you and your doctor have discussed the risks and benefits involved.
If you have not told your doctor about any of the above, tell them before you start taking this medicine.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.
Some medicines may interact with zolmitriptan. These include:
other medicines for migraine, (e.g. ergotamine, dihydroergotamine, methysergide, sumatriptan, naratriptan, or other medicines known as 'triptans')
medicines for depression
cimetidine, used for indigestion or stomach ulcers
quinolone antibiotics (e.g. norfloxacin)
St John's Wort (Hypericum perforatum)
These medicines may be affected by this medicine or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

How to take this medicine

Follow all directions given to you by your doctor and pharmacist carefully.
They may differ to the information contained in this leaflet.
If you do not understand the instructions on the box, ask your doctor or pharmacist for help.

How much to take

The usual dose is one tablet (2.5 mg) taken as soon as you feel the migraine headache starting.
If your migraine is still present after two hours, or if it returns within 24 hours, you can take another tablet.
Do not take more than 10 mg (four 2.5 mg tablets) in 24 hours.

How to take it

Swallow your tablets whole with a glass of water.

When to take it

You can take zolmitriptan when you feel the headache start or after it has already begun.
Zolmitriptan should not be used to prevent the migraine attacks from occurring.
It does not matter if you take it with or without food.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice or go to Accident and Emergency at your nearest hospital if you think that you or anyone else may have taken too much of this medicine. Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.

While you are taking this medicine

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking this medicine.
Tell any other doctors, dentists and pharmacists who are treating you that you take this medicine.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine.
It may affect other medicines used during surgery.
If you become pregnant or start breastfeeding whilst taking this medicine, tell your doctor immediately.
Keep all of your doctor's appointments so that your progress can be checked.
Your doctor may occasionally do tests to make sure the medicine is working and to prevent side effects.

Things you must not do

Do not give this medicine to anyone else, even if they have the same condition as you.
Do not take your medicine to treat any other complaint unless your doctor tells you to.

Things to be careful of

Be careful driving or operating machinery until you know how this medicine affects you.
Zolmitriptan can make some people feel dizzy or sleepy. Make sure you know how you react to zolmitriptan before you do anything that could be dangerous if you are dizzy or sleepy.

Side effects

Tell your doctor and pharmacist as soon as possible if you do not feel well while you are taking zolmitriptan.
This medicine helps most people with migraines but may have unwanted side effects in some people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.
Do not be alarmed by the following lists of side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following and they worry you:
increased feeling or sensitivity, especially in the skin
feeling warm
aching muscles not caused by exercise
dizziness
stomach upset, including nausea, pain or vomiting
headache
sleepiness, unusual tiredness or weakness
dry mouth
The above list includes the more common side effects of zolmitriptan.
If you experience any of the following, stop taking your medicine and contact your doctor immediately or go to Accident and Emergency at your nearest hospital:
shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue, throat or other parts of the body; rash, itching or hives on the skin (signs of an allergic reaction)
a feeling of tightness, pressure or heaviness in the chest, throat, neck, arms or legs
palpitations, irregular heartbeats, increased heart rate
numbness or loss of strength of the arms or legs, headache, dizziness, confusion, visual disturbance, difficulty or discomfort in swallowing, slurred speech or loss of speech (these can be signs of a stroke)
bloody diarrhoea or prolonged stomach pain
These are very serious side effects and you may need urgent medical attention or hospitalisation:
Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
Other side effects not listed above may occur in some patients.

Storage and disposal

Storage

Keep your medicine in the pack until it is time to take it.
If you take your medicine out of the pack it may not keep well.
Keep your medicine in a cool dry place where the temperature stays below 25°C.
Do not store your medicine, or any other medicine, in the bathroom or near a sink. Do not leave it on a window sill or in the car.
Heat and dampness can destroy some medicines.
Keep this medicine where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any leftover medicine.

Product description

What it looks like

Light pink, round, film-coated tablets, debossed with '2.5' on one side and plain on the other. Blister pack of 2 or 6 tablets. AUST R 200878.

Ingredients

Each tablet contains 2.5 mg zolmitriptan as the active ingredient.
It also contains the following:
microcrystalline cellulose
lactose
sodium starch glycollate type A
magnesium stearate
Opadry complete film coating system 02G84574 Pink
This medicine does not contain gluten, sucrose, tartrazine or any other azo dyes.

Sponsor

Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park NSW 2113
APO and APOTEX are registered trademarks of Apotex Inc.
This leaflet was prepared in August 2019.