Consumer medicine information

Sumatab Tablets

Sumatriptan

BRAND INFORMATION

Brand name

Sumatab Tablets

Active ingredient

Sumatriptan

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Sumatab Tablets.

What is in this leaflet

Please read this leaflet carefully before you start taking Sumatab tablets.

This leaflet answers some common questions about Sumatab 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 Sumatab 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 Sumatab tablets used for

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

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

Your Sumatab tablets do not work in other types of headache which are not a migraine.

Sumatab tablets are not addictive.

Before you take Sumatab tablets

Do not take if:

You must not take Sumatab 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 any of these medicines in the last two weeks:
    - Monoamine oxidase inhibitors (MAOIs), a type of medicine used for depression.
  • the expiry date (EXP) printed on the pack has passed.
  • the packaging is torn or shows signs of tampering.

Tell your doctor if:

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).
  • you are allergic to lactose.
  • 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.
  • you are breastfeeding, pregnant or trying to become pregnant.
  • 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 or you smoke.
    - epilepsy, seizures, or fits or been told that you are prone to this problem
    - stroke.

How to take Sumatab tablets

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

They may differ from the information contained in this leaflet.

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 Sumatab tablets increased to 100 mg. Your doctor will tell you which dose is right for you.

If the first Sumatab tablet helps your migraine, but the migraine comes back later, you may take another Sumatab tablet.

Do not take more than 300 mg of Sumatab 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 Sumatab Tablets, or any other form of Sumatab, 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 Sumatab, you may use Sumatab tablets on another occasion to treat another migraine attack. Provided there are no side effects, you can use Sumatab 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 Sumatab 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 Sumatab tablet -

  1. when the migraine headache begins; or
  2. 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 Sumatab tablet before the above symptoms occur.

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 Sumatab 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.

If you take too much Sumatab, you may experience a worsening of your migraines, or other forms of headache may occur.

While you are taking Sumatab tablets

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 take Sumatab tablets to treat any other complaints unless your doctor tells you to.

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

Things to be careful of

Be careful driving or operating machinery until you know how Sumatab tablets affect you.

As with many other medicines, this medicine may cause drowsiness in some people.

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 Sumatab tablets, even if the problem is not listed below.

Like other medicines, Sumatab 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.

Do not be alarmed by the following lists of side effects.

You may not experience any of them.

Tell your doctor or pharmacist if you notice any of the following after taking Sumatab tablets:

  • pain, tingling, numbness, heat, cold or flushing in any part of the body
  • decreased feeling or sensitivity, especially in the skin
  • feeling of sleepiness, dizziness or tiredness
  • nausea (feeling sick) or vomiting
  • difficulty in breathing
  • 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.

Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you:

  • feel pain, 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 discolouration and/or pain in the fingers, toes, ears, nose or jaw in response to cold.

The above list includes serious side effects. You may need urgent medical attention or hospitalisation.

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.

After taking Sumatab tablets

Storage

Keep Sumatab tablets in their pack until it is time to take them.

If you take the tablets out of the pack, they may not keep well.

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.

Keep Sumatab tablets in the blister pack in a cool, dry place where it stays below 30 degrees C.

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

Heat and dampness can destroy some medicines

Disposal

Return any unused or expired medicine to your pharmacist.

Product description

What Sumatab tablets look like

Sumatab tablets come in two strengths:

  • Sumatab 100 mg tablets are white to off-white and capsule shaped with "GX ET2" on one face and plain on the other. A box contains 2 tablets.
  • Sumatab 50 mg tablets are pink and capsule shaped with "GX ES3" on one face and plain on the other. A box contains either 2 or 4 tablets.

The tablets have a film coating to protect the tablet and this gives the colour.

Ingredients

Each Sumatab tablet contains the active ingredient sumatriptan succinate.

Sumatab tablets also contain lactose, microcrystalline cellulose (460), croscarmellose sodium and magnesium stearate (572).

  • Sumatab tablets 100 mg are coated with hypromellose (464) and Opadry White OY-S-7393.
  • Sumatab tablets 50 mg are coated with Opadry YS-1-1441-G.

Sumatab tablets contain lactose.

Supplier

Your Sumatab tablets are supplied by:

Alphapharm Pty Limited
(ABN 93 002 359 739)
Chase Building 2
Wentworth Park Road
Glebe NSW 2037

Phone: (02) 9298 3999

www.alphapharm.com.au

Medical Information
Phone: 1800 028 365

www.alphapharm.com.au

Australian registration numbers:
100 mg tablets - AUST R 124439
50 mg tablets - AUST R 124432

This leaflet was prepared on
4 June 2009.

BRAND INFORMATION

Brand name

Sumatab Tablets

Active ingredient

Sumatriptan

Schedule

S4