MYGRAN

Sumatriptan (as succinate) 50 mg Tablets

What is in this leaflet

This leaflet answers some common questions about MYGRAN.

It does not contain all of the available information. It does not take the place of talking to your pharmacist or doctor.

All medicines have benefits and risks. Your pharmacist or doctor has weighed the risks of you taking MYGRAN against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, talk to your pharmacist or doctor.

Keep this leaflet with your medicine. You may need to read it again.

What MYGRAN is used for

MYGRAN contains the active ingredient sumatriptan succinate. This medicine belongs to a group of drugs called serotonin agonists.

MYGRAN is used to treat migraine headache, with or without what is known as 'aura' (eg seeing dots or flickering lights, weakness or numbness of limbs). It also relieves other symptoms of a migraine attack like nausea, vomiting or sensitivity to light and sound. MYGRAN is only suitable when your migraine has been diagnosed by your doctor and has a stable, well-established pattern of symptoms.

MYGRAN should not be used to prevent migraine attacks from occurring. MYGRAN may not prevent the development of a headache if used during a migraine aura before other symptoms occur.

It is thought that migraine headache is due to widening of certain blood vessels in the head. MYGRAN works by making those vessels normal again and ease the symptoms of migraine.

MYGRAN does not work in other types of headache that are not a migraine.

MYGRAN is not recommended for use in children and adolescents under 18 years of age.

MYGRAN tablets are not addictive.

Before you take MYGRAN

When you must not take it

Do not take MYGRAN if you are allergic to medicines containing sumatriptan succinate or sulfur (eg sulfonamides), or 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 or other parts of the body
• lumpy skin rash ('hives'), hayfever or fainting.

Do not take MYGRAN if you have or have had the following medical conditions:

• previous heart attack
• angina, including Prinzmetal's angina
• shortness of breath, pain or tightness in the chest, jaw or upper arm (signs of ischaemic heart disease)
• other heart diseases (eg arrhythmias)
• stroke or mini-stroke
• vascular disease (pain in the back of the legs) or are prone to cold, tingling or numb hands and feet
• uncontrolled high blood pressure
• liver or kidney disease
• history of seizures or fits.

Do not take MYGRAN if you have taken any of these medicines in the last 24 hours:

• ergotamine (eg Cafergot)
• methysergide (eg Deseril)
• dihydroergotamine (eg Dihydergot)
• naratriptan (eg Naramig)
• zolmitriptan (eg Zomig; not available in NZ).

Do not take MYGRAN if you are taking monoamine oxidase inhibitor (MAOI), a type of medicine used for depression, or have taken a MAOI in the last two weeks.

Do not take MYGRAN if you are pregnant or try to become pregnant, breastfeeding or plan to breastfeed, without first discussing with your doctor or pharmacist.

Your doctor or pharmacist will discuss the risks and benefits of taking MYGRAN during pregnancy and breastfeeding.

Do not take MYGRAN if the expiry date (Exp.) printed on the pack has passed.

It may not work as well if you do.

Do not take MYGRAN if the packaging shows signs of tampering or the tablets do not look quite right.

Before you start to take it

Tell your pharmacist or doctor if you are allergic to

• foods, dyes, preservatives
• lactose, or you are lactose intolerant (MYGRAN tablets contain lactose)
• any other medicines, especially those contain sulfur (eg sulphonamide).

Tell your pharmacist or doctor if you have or have had the following medical conditions:

• previous heart attack
• angina, any other chest pain or tightness
• shortness of breath, pain or tightness in the chest, jaw or upper arm
• irregular heartbeats
• other heart diseases; family history of heart problems
• stroke or mini-stroke
• brain tumours, or any other condition affecting the brain
• blood vessel disease
• epilepsy or fits
• liver or kidney problems
• diabetes
• high blood pressure
• high blood cholesterol levels.

Tell your pharmacist or doctor if:

• you are under 18 or over 65 years of age
• for females, you are pregnant, breastfeeding or have reached menopause
• for males, you are over 40 years of age
• your migraine symptoms start for the first time after age 50
• you have not had your headache diagnosed as migraine by a doctor
• your migraine last longer than 24 hours
• you think that this headache is different and worse than your usual migraine
• you have difficulty moving one side of your body when you have the migraine headache
• you have 4 or more migraine attacks per month
• you smoke.

If you have not told your pharmacist or doctor about any of the above, tell him/her before you start taking MYGRAN.

Taking other medicines

Tell your pharmacist or doctor if you are taking or have taken any other medicines in the last two weeks, including those you buy without a prescription from a pharmacy, supermarket or health food shop.

Some medicines may be affected by MYGRAN or may affect how well it works. These include:

• ergotamine or ergot-type medicines
• monoamine oxidase inhibitors
• triptans
• selective serotonin reuptake inhibitors (SSRI)
• herbal preparations containing St John's wort (Hypericum perforatum)
• tricyclic antidepressants.

Your pharmacist or doctor can tell you what to do when taking MYGRAN with other medicines. If you are not sure whether you are taking any of these medicines, check with your pharmacist or doctor.

Your pharmacist and doctor have more information on medicines to be careful with or avoid while taking MYGRAN.

How to take MYGRAN

Follow all directions given to you by your pharmacist or doctor carefully.

How much to take

The recommended dose is one MYGRAN tablet.

If the first MYGRAN tablet helps your migraine, but the symptoms return later, you may take another tablet. Wait at least 2 hours before taking this second tablet.

Do not take more than two MYGRAN tablets (total 100 mg of sumatriptan) in any 24-hour period or to treat the same attack.

If the first tablet has not provided any relief of your symptoms, do not take more MYGRAN tablets, or any other form of medications containing sumatriptan.

You may take your other usual headache relief medication, provided it does not contain ergot-type medicines such as ergotamine, dihydroergotamine or methysergide. You must not take ergot-type medicines within 6 hours of taking MYGRAN. If you are not sure what to do, ask your doctor or pharmacist.

If your migraine is not relieved by MYGRAN, you may use it on another occasion to treat another migraine attack. Provided there are no side effects, you can use MYGRAN tablets to treat at least three separate migraine attacks before you and your pharmacist or doctor decide whether this medicine is ineffective for you.

How to take MYGRAN

Swallow the tablet with a glass of water, without regard to meals. Do not crush or chew the tablet, as it has a bitter taste.

When to take MYGRAN

It is best to take your MYGRAN tablet at the first sign of a migraine attack when:

• migraine headache begins
• other symptoms of the migraine begin, such as nausea (feeling sick), vomiting or your eyes becoming sensitive to light.

If you take your tablet later during the migraine attack, it will still work for you.

Do not take your MYGRAN tablet before the above symptoms occur.

If you take too much MYGRAN (overdose)

Immediately telephone your doctor, or the National Poisons Information Centre (0800 POISON or 0800 764 766), or go to Accident and Emergency department at your nearest hospital, if you think that you or anyone else may have taken too many MYGRAN tablets.

Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

While you are taking MYGRAN

Things you must do

Before starting any new medicine, tell your doctor or pharmacist that you are taking MYGRAN.

Tell all the doctors, dentists and pharmacists who are treating you that you are taking MYGRAN.

If you become pregnant or trying to become pregnant while taking MYGRAN, tell your doctor or pharmacist.

Things you must not do

Do not use MYGRAN to treat any other conditions unless your doctor tells you to.

Do not give MYGRAN to anyone else, even if they have the same condition as you.

Do not use MYGRAN for any other headache that is not a migraine. MYGRAN only treats migraine headaches.

Do not take MYGRAN to try and prevent a migraine attack.

Things to be careful of

Be careful driving or operating machinery until you know how MYGRAN affects you.

Drowsiness may occur as a result of migraine or its treatment with sumatriptan. Caution is recommended when skilled tasks are to be performed eg driving or operating machine. Make sure you know how you react to MYGRAN before driving a car or operating machinery.

Side effects

Tell your pharmacist or doctor as soon as possible if you do not feel well while you are taking MYGRAN.

Like other medicines, MYGRAN can cause some side effects. If they occur, they are most likely to be minor and temporary. However, some may be serious and need medical attention.

Do not be alarmed by this list of possible side effects.

You may not experience any of them.

Ask your pharmacist or doctor to answer any questions you may have.

Tell your pharmacist or doctor if you notice any of the following and they worry you:

• pain, tingling, warmth or flushing in any part of the body
• feel fainting, dizzy, tired or sleepy
• nausea (feeling sick) or vomiting
• visual disturbances (blurred vision, flickering)
• shaking or tremors.

Tell your doctor immediately or go to Accident and Emergency at the nearest hospital if you notice any of the following after taking MYGRAN:

• feel heaviness, pressure or tightness in any part of the body including the chest or throat
• irregular heartbeats - too fast or too slow
• a fit or convulsion
• wheezing, swelling of the lips or mouth, difficulty in breathing, hayfever, lumpy rash ('hives') or fainting, which can be symptoms of allergic reactions.

These side effects are likely to be serious. Stop taking MYGRAN tablets and seek medical attention straight away.

This is not a complete list of all possible side effects. Other side effects not listed above may also occur in some patients. Tell your doctor or pharmacist if you notice anything that is making you feel unwell.

After taking MYGRAN

Storage

Keep MYGRAN 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.

Keep your tablets in the blister packs in a cool, dry place where the temperature stays below 25°C.

Do not store MYGRAN or any other medicines in the bathroom or near a sink. Do not leave the tablets in the car or on window sills.

Heat, light and dampness can destroy some medicines.

Disposal

If your pharmacist or doctor tells you to stop taking MYGRAN, or your tablets have passed their expiry date, ask your pharmacist what to do with any tablets that are left over.

Product description

What it looks like

MYGRAN is a white to off-white, round, biconvex tablet, embossed with 'SA' over '50' on one side and '>' on the other side. Each pack contains 2 tablets.

Ingredients

The active ingredient in MYGRAN is sumatriptan (as succinate). Each MYGRAN tablet contains 50 mg of sumatriptan.

The tablets also contain

• microcrystalline cellulose
• croscarmellose sodium
• magnesium stearate
• anhydrous lactose.

The tablets do not contain gluten, sucrose, tartrazine or any azo dyes.