Consumer medicine information

Sumagraine Migraine Relief


Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.


1. Why am I using Sumagraine Migraine Relief?

Sumagraine Migraine Relief contains the active ingredient sumatriptan succinate. Sumagraine Migraine Relief is used to relieve a migraine attack in patients who have a stable, well-established pattern of symptoms.

For more information, see Section 1. Why am I using Sumagraine Migraine Relief? in the full CMI.

2. What should I know before I use Sumagraine Migraine Relief?

Do not use if you have ever had an allergic reaction to sumatriptan or any of the ingredients listed at the end of the CMI.

Talk to your doctor or pharmacist if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use Sumagraine Migraine Relief? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Sumagraine Migraine Relief and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Sumagraine Migraine Relief?

  • The recommended dose for adults aged 18 to 65 years is 50 mg (one tablet).
  • If the first tablet helps your migraine, but the migraine comes back later, you may take another 50 mg tablet. Wait at least two hours after the first tablet was taken.
  • Do not take more Sumagraine Migraine Relief, or any other form of sumatriptan, if the first dose has not provided any relief from your symptoms.
  • Do not take more than 100 mg (2 tablets) in any 24-hour period.

More instructions can be found in Section 4. How do I use Sumagraine Migraine Relief? in the full CMI.

5. What should I know while using Sumagraine Migraine Relief?

Things you should do
  • Remind any doctor, dentist, or pharmacist you visit that you are using Sumagraine Migraine Relief.
  • Tell your doctor or pharmacist if, your migraine lasts for longer than 24 hours.
Things you should not do
  • Do not give this medicine to anyone else, even if their symptoms seem similar to yours.
Driving or using machines
  • Be careful before you drive or use any machines or tools until you know how Sumagraine Migraine Relief affects you.
  • Drowsiness may occur as a result of migraine or its treatment with sumatriptan. This may influence the ability to drive and to operate machinery.
Drinking alcohol
  • Tell your doctor or pharmacist if you drink alcohol.
Looking after your medicine
  • Store the tablets in a place where the temperature stays below 30°C and where children cannot reach it.

For more information, see Section 5. What should I know while using Sumagraine Migraine Relief? in the full CMI.

6. Are there any side effects?

Common side effects: pain, tingling, heat or flushing in any part of the body, feeling of sleepiness, dizziness or tiredness, nausea (feeling sick) or vomiting, a change in blood pressure, feeling of faintness and shortness of breath. Serious side effects: heaviness, pressure or tightness in any part of the body including the chest or throat, irregular heartbeats, a fit or convulsion, symptoms of an allergic reaction (wheezing, swelling of the lips/mouth, difficulty in breathing, hay fever, lumpy rash (“hives”), or fainting), and persistent purple discoloration and/or pain in the fingers, toes, ears, nose, or jaw in response to cold.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

Sumagraine Migraine Relief

Active ingredient: sumatriptan succinate


Consumer Medicine Information (CMI)

This leaflet provides important information about using Sumagraine Migraine Relief. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Sumagraine Migraine Relief.

Where to find information in this leaflet:

1. Why am I using Sumagraine Migraine Relief?
2. What should I know before I use Sumagraine Migraine Relief?
3. What if I am taking other medicines?
4. How do I use Sumagraine Migraine Relief?
5. What should I know while using Sumagraine Migraine Relief?
6. Are there any side effects?
7. Product details

1. Why am I using Sumagraine Migraine Relief?

Sumagraine Migraine Relief contains the active ingredient sumatriptan succinate. Sumagraine Migraine Relief belongs to a group of drugs called serotonin agonists.

Sumagraine Migraine Relief is used to relieve a migraine attack in patients who have a stable, well-established pattern of symptoms. They should not be used to prevent migraine attacks from occurring. Sumagraine Migraine Relief may be used for migraine headaches with or without what is known as ‘aura’.

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

Sumagraine Migraine Relief tablets do not work in other types of headache which are not a migraine.

Do not take Sumagraine Migraine Relief unless your condition has been diagnosed by a doctor.

2. What should I know before I use Sumagraine Migraine Relief?

Warnings

Do not use Sumagraine Migraine Relief if:

  • you are allergic to sumatriptan succinate, or any of the ingredients listed at the end of this leaflet.
    Always check the ingredients to make sure you can use this medicine.
  • you have or have had:
    – heart disease or heart attack;
    – shortness of breath, pain or tightness in the chest,
    – jaw or upper arm;
    – peripheral vascular disease (pain in the back of the legs) or are prone to cold, tingling, or numb hands and feet;
    – Prinzmetal’s angina (an uncommon form of angina where pain is experienced at rest rather than during activity);
    – angina;
    – high blood pressure;
    – stroke;
    – severe liver disease.
  • you have taken any of these medicines in the last 24 hours:
    – ergotamine (eg. Cafergot);
    – dihydroergotamine (eg. Dihydergot);
    – methysergide (eg. Deseril);
    – naratriptan (eg. Naramig);
    – zolmitriptan (eg. Zomig);
    – rizatriptan;
    – eletriptan.
  • you have taken any of these medicines in the last two weeks:
    – monoamine oxidase inhibitors (MAOIs), a type of medicine used for depression;
    – SSRIs (selective serotonin reuptake inhibitors) or SNRIs (serotonin-noradrenaline reuptake inhibitors) used to treat depression.
  • the expiry date (EXP) printed on the pack has passed.
  • the packaging is torn or shows signs of tampering.

Check with your doctor or pharmacist if you:

  • have any other medical conditions:
    – liver or kidney problems;
    – heart problems. Risk factors including high blood pressure, even if it is under control, high blood cholesterol levels, a family history of heart problems, obesity, diabetes, you are male and over 40 years of age, you are female and have undergone menopause or you smoke;
    – epilepsy, seizures, or fits or been told that you are prone to this problem;
    – stroke.
  • take any medicines for any other condition.
  • are allergic to foods, dyes, preservatives, or any other medicines, including any that contain sulfur (eg. sulfonamide antibiotics).
  • are allergic to lactose.
  • are taking or have taken any other medicines in the last two weeks, including medicines you buy without a prescription, particularly herbal preparations containing St John’s Wort and medicines prescribed for depression.
  • are breastfeeding, pregnant or trying to become pregnant.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor or pharmacist if you are pregnant or intend to become pregnant.

Talk to your doctor or pharmacist if you are breastfeeding or intend to breastfeed.

Use in children and adolescents (under 18 years)

Do not use in children or adolescents under the age of 18 years.

Use in patients over 65 years

Not recommended for patients over the age of 65 years.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Tell your doctor or pharmacist if you are taking any other medicines, including:

  • herbal preparations containing St John’s Wort;
  • medicines prescribed for depression;
  • oral contraceptive pill.

Some medicines may be affected by Sumagraine Migraine Relief or may affect how well it works.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Sumagraine Migraine Relief.

4. How do I use Sumagraine Migraine Relief?

How much to take/use

  • The recommended dose for adults aged 18 to 65 is 50 mg (one tablet).
  • If the first tablet helps your migraine, but the migraine comes back later, you may take another 50 mg tablet. Wait at least two hours after the first tablet was taken.
  • Do not take more than 100 mg (2 tablets) in any 24-hour period.
  • Do not take more Sumagraine Migraine Relief, or any other form of sumatriptan, if the first dose has not provided any relief from your symptoms.
  • You may take your usual headache relief medication provided it does not contain ergotamine or methysergide.
  • If your migraine is not relieved by Sumagraine Migraine Relief, you may use Sumagraine Migraine Relief on another occasion to treat another migraine attack.
  • Your Sumagraine Migraine Relief tablet should be swallowed with a drink of water. Do not crush or chew the tablet as it has a bitter taste.
  • Follow the instructions provided with the medicine.
  • Do not exceed the recommended dosage.
  • If you are not sure what to do, ask your doctor or pharmacist.

When to take/use Sumagraine Migraine Relief

  • Sumagraine Migraine Relief should be used:
    – when the migraine headache begins; or
    – when other symptoms of the migraine begin, such as nausea (feeling sick), vomiting or your eyes becoming sensitive to light.
  • If you take your first tablet during the migraine attack, and not at the beginning as recommended, it may still work for you.
  • Do not take your Sumagraine Migraine Relief before the above symptoms occur.

If you use too much Sumagraine Migraine Relief

If you think that you have used too much Sumagraine Migraine Relief, you may need urgent medical attention.

You should immediately:

  • phone the Poisons Information Centre
    (by calling 13 11 26); or
  • contact your doctor; or
  • go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using Sumagraine Migraine Relief?

Things you should do

  • Tell your doctor if, for any reason, you have not taken your medicine exactly as directed.
  • Tell your doctor or pharmacist if your migraine headache lasts for longer than 24 hours.
  • Tell your doctor or pharmacist if your pattern of symptoms has changed.
  • Tell your doctor or pharmacist if you generally have four or more migraine attacks each month.
  • Tell your doctor or pharmacist if you feel this headache is different or worse than your usual migraine, eg. more frequent, more persistent, more severe, or you don’t recover between attacks.
  • Tell your doctor or pharmacist if you have these symptoms with your migraine headache:
    – weakness on one side of your body;
    – double vision;
    – clumsy and unco-ordinated movements;
    – tinnitus (ringing in the ears);
    – reduced levels of consciousness;
    – seizure-like movements;
    – recent rash with a headache.

Remind any doctor, dentist, pharmacist or other health professionals you visit that you are using Sumagraine Migraine Relief.

Things you should not do

  • Do not give this medicine to anyone else, even if their symptoms seem similar to yours.

Medication overuse headaches

Overuse of migraine medications, such as sumatriptan, have been associated with worsening of headaches (medication overuse headache or MOH) in some patients.

Overuse of medications for relief of headache and migraine can worsen your condition and lead to:

  • increase of headache frequency; and
  • your condition becoming less responsive to treatments.

If you are experiencing frequent or daily headaches, it is possible that you may be experiencing medication overuse headache. If your migraines have become more frequent, you should speak with your doctor or pharmacist.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Sumagraine Migraine Relief affects you.

Drowsiness may occur as a result of migraine or its treatment with sumatriptan. This may influence the ability to drive and to operate machinery.

Drinking alcohol

Tell your doctor or pharmacist if you drink alcohol.

Looking after your medicine

  • Store below 30°C.
  • Keep Sumagraine Migraine Relief tablets in the pack until it is time to take it.

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat, or sunlight. For example, do not store it:

  • in the bathroom or near a sink; or
  • in the car or on window sills.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions.

Less serious/common side effects

Less serious side effects What to do
  • Pain, tingling, heat or flushing in any part of the body.
  • Feeling of sleepiness, dizziness, or tiredness.
  • Nausea (feeling sick) or vomiting.
  • A change in blood pressure.
  • Feeling of faintness.
  • Problems with your eyesight.
  • Pain in the lower tummy and bloody diarrhoea (ischaemic colitis).
  • Shaking or tremors.
  • Uncontrolled movements.
  • Shortness of breath.
Speak to your doctor or pharmacist if you have any of these less serious side effects and they worry you.

Serious/rare side effects

Serious side effects What to do
  • Feel heaviness, pressure, or tightness in any part of the body including the chest or throat.
  • Feel irregular heartbeat.
  • Have a fit or convulsion.
  • Have wheezing, swelling of the lips/mouth, difficulty in breathing, hay fever, lumpy rash (“hives”) or fainting. These could be a symptom of an allergic reaction.
  • Have persistent purple discoloration and/or pain in the fingers, toes, ears, nose, or jaw in response to cold.
Stop taking Sumagraine Migraine Relief and tell your doctor immediately, or go straight to the Emergency Department at your nearest hospital, if you notice any of these serious side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

7. Product details

This medicine is available over-the-counter without a doctor’s prescription.

What Sumagraine Migraine Relief contains

Active ingredient
(main ingredient)
Sumatriptan succinate
Other ingredients
(inactive ingredients)
Lactose
Croscarmellose sodium
Microcrystalline cellulose
Crospovidone
Colloidal anhydrous silica
Magnesium stearate
OPADRY complete film coating system 03B84755 Pink
Potential allergens Contains sugars as lactose.

Do not take this medicine if you are allergic to any of these ingredients.

What Sumagraine Migraine Relief looks like

Sumagraine Migraine Relief 50 mg tablets are pink coloured, capsule-shaped, biconvex, film-coated tablets, debossed with “50” on one side and plain on the other side (AUST R 160186).

Sumagraine Migraine Relief 50 mg tablets are available in blister packs containing 2 tablets.

Who distributes Sumagraine Migraine Relief

Generic Health Pty Ltd
Suite 2, Level 2
19-23 Prospect Street
Box Hill, VIC, 3128
ii1383701  ghinfo@generichealth.com.au
ii1383702  +61 3 9809 7900
ii1383703  www.generichealth.com.au

This leaflet was prepared in May 2022.

Published by MIMS February 2024