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Sumatriptan-GA

Sumatriptan succinate


Consumer Medicine Information

What is in this leaflet

Please read this leaflet carefully before you start taking Sumatriptan-GA tablets.

This leaflet answers some common questions about Sumatriptan-GA tablets. It does not contain all of 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 expected benefits of you taking Sumatriptan-GA tablets against the risks this medicine could 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 need to read it again.

What Sumatriptan-GA is used for

Sumatriptan-GA tablets contain the active ingredient sumatriptan succinate. This medicine belongs to a group of drugs called serotonin agonists.

Sumatriptan-GA tablets are used to relieve a migraine attack. They should not be used to prevent migraine attacks from occurring. Sumatriptan-GA tablets 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. Sumatriptan-GA tablets work by making those vessels normal again and ease the symptoms of migraine.

Your Sumatriptan-GA tablets do not work in other types of headache which are not a migraine.

Sumatriptan-GA tablets are not addictive.

Before you take Sumatriptan-GA

When you must not take it

Do not take Sumatriptan-GA tablets if:

  • you have ever had an allergic reaction to sumatriptan succinate (See "Side-Effects") or any of the ingredients listed toward the end of this leaflet. (See "Ingredients").
  • 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)
  • you have taken Monoamine oxidase inhibitors (MAOIs), a type of medicine used for depression, in the last two weeks
  • the expiry date printed on the pack has passed
  • the packaging is torn or shows signs of tampering

Before you start to take it

You must tell your doctor if you are allergic to:

  • foods
  • dyes
  • preservatives or any other medicines, including any that contain sulphur (eg sulphonamide antibiotics)
  • lactose

You must tell your doctor if you are breastfeeding, pregnant or trying to become pregnant

You must tell your doctor if you have or have had medical conditions like:

  • 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
  • you smoke
  • epilepsy, seizures, or fits or been told that you are prone to this problem
  • stroke

Taking other medicines

You must tell your doctor if you 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.

How to take Sumatriptan-GA

Take your medicine as your doctor has told you. The label on the pack will tell you how many tablets to take and how often you should take them. If you do not understand what you should do, ask your doctor or pharmacist.

How much to take

The recommended starting dose for adults is 50 mg, however you may need to have your dose of Sumatriptan-GA tablets increased to 100 mg. Your doctor will tell you which dose is right for you.

If the first Sumatriptan-GA tablet helps your migraine, but the migraine comes back later, you may take another Sumatriptan-GA tablet. Do not take more than 300 mg of Sumatriptan-GA tablets in any twenty-four hours. Six pink (50 mg strength) or three white (100 mg strength) tablets contain 300 mg.

Do not take more Sumatriptan-GA Tablets, 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 you are not sure what to do, ask your doctor or pharmacist.

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

How to take it

Your Sumatriptan-GA tablet should be swallowed with a drink of water. Do not crush or chew the tablet as it has a bitter taste.

When to take it

It is best to take your Sumatriptan-GA tablet -

(i) when the migraine headache begins; or

(ii) when 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 Sumatriptan-GA tablet before the above symptoms occur.

How long to take it

Continue taking Sumatriptan-GA for as long as your doctor tells you.

If you take too much (overdose)

Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) for advice, if you think you or anyone else may have taken too many Sumatriptan-GA tablets, even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

If you are not sure what to do, contact your doctor or pharmacist.

While you are taking Sumatriptan-GA

Things you must do

Tell your doctor if, for any reason, you have not taken your medicine exactly as directed. Otherwise, your doctor may think that it is not working and change your treatment unnecessarily.

Things you must not do

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

Things to be careful of

As with many other medicines, Sumatriptan-GA tablets may cause drowsiness in some people.

Be careful driving or operating machinery until you know how Sumatriptan-GA tablets affect you.

If you use Sumatriptan-GA tablets too often, it may make your headache worse. If this happens, your doctor may tell you to stop taking Sumatriptan-GA tablets.

Side Effects

Check with your doctor as soon as possible if you think you are experiencing any side effects or allergic reactions due to taking Sumatriptan-GA tablets, even if the problem is not listed below.

Like other medicines, Sumatriptan-GA tablets 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.

Tell your doctor if you experience any of the following after taking Sumatriptan-GA tablets:

  • pain, tingling, heat or flushing in any part of the body
  • feeling of sleepiness, dizziness or tiredness
  • nausea (feeling sick) or vomiting
  • 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

Tell your doctor immediately, or seek urgent medical attention, and do not take any more Sumatriptan-GA tablets if you:

  • feel heaviness, pressure or tightness in any part of the body including the chest or throat
  • feel irregular heart beats
  • 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

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

This is not a complete list of all possible side effects. Others may occur in some people and there may be some side effects not yet known.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

After using Sumatriptan-GA

Storage

Keep this medicine where children cannot reach it, such as in a locked cupboard.

Keep Sumatriptan-GA tablets in the blister pack in a cool, dry place. Store below 30°C.

Do not leave them in a car, on a window sill or in a bathroom.

Keep Sumatriptan-GA tablets in their pack until it is time to take them.

Disposal

Return any unused or expired medicine to your pharmacist.

Product Description

What it looks like

Sumatriptan-GA tablets are available in two different strengths.

  • Sumatriptan-GA tablets 50mg are pink colored, capsule shaped, biconvex film coated tablets, debossed with “50” on one side and plain on the other side.
  • Sumatriptan-GA tablets 100mg are white colored, capsule shaped, biconvex film coated tablets, debossed with “100” on one side and plain on the other side.

Sumatriptan-GA tablets 50 mg & 100mg are available in blister packs containing 4 tablets & 2 tablets respectively.

Ingredients

Sumatriptan-GA tablets contain:
Sumatriptan succinate (active ingredient),
Lactose,
Croscarmellose sodium, cellulose-microcrystalline,
Crospovidone,
Colloidal silicon dioxide, Magnesium stearate ,
Opadry White/ Pink (depending on the colour, contains Hypromellose, macrogol 400 , Titanium dioxide, Iron oxide red CI77491, Iron oxide black CI77499)

Supplier

www.ascentpharma.com.au
Ascent Pharma Pty Ltd
151-153 Clarendon St
South Melbourne, Vic 3205
For further information call 1800 554 414

Registration numbers:

Sumatriptan-GA 50mg:

AUST R 160187

Sumatriptan-GA 100mg:

AUST R 160195

Date of preparation: January 2011.

Published by MIMS/myDr July 2011

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