Consumer medicine information

Sumatriptan AN tablets

Sumatriptan AN tablets

Sumatriptan succinate tablets


Consumer Medicine Information

What is in this leaflet

Please read this leaflet carefully before you start taking SUMATRIPTAN AN Tablets.

This leaflet answers some common questions about SUMATRIPTAN AN 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 AN tablets against the risks that 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 AN is used for

SUMATRIPTAN AN Tablets contain the active ingredient sumatriptan succinate.

This medicine belongs to a group of drugs called serotonin agonists.

SUMATRIPTAN AN Tablets are used to relieve a migraine attack. They should not be used to prevent migraine attacks from occurring.

SUMATRIPTAN AN 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 AN works by making those vessels normal again and ease the symptoms of migraine.

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

SUMATRIPTAN AN tablets are not addictive

Before You Take SUMATRIPTAN AN

Do not take if:

You must not take SUMATRIPTAN AN 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 a 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 (e.g. Cafergot)
    – Dihydroergotamine (e.g dihydergot)
    – Methysergide (eg Deseril)
    – Naratriptan (e.g Naramig)
    – Zolmitriptan (eg Zomig)
  • You have taken any of these medicines in the last two weeks
    – Monoamine oxidase inhibitors (MAOI’s), 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 breast feeding, 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 have been told that you are prone to this problem
    – Stroke

How to take SUMATRIPTAN AN

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 AN Tablets increased to 100 mg. Your doctor will tell you which dose is right for you. If the first SUMATRIPTAN AN.

Tablet helps your migraine, but the migraine comes back later, you may take another SUMATRIPTAN AN Tablet.. Do not take more than 300 mg of SUMATRIPTAN AN Tablets in any 24 hours. Six pink (50 mg strength) or three white (100 mg strength) tablets contain 300 mg.

Do not take more SUMATRIPTAN AN 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 ergotamidine or methysergide. If you are not sure what to do ask your doctor or pharmacist.

If your migraine is not relieved by SUMATRIPTAN AN Tablets, you may use SUMATRIPTAN AN Tablets on another occasion to treat another migraine attack.

Provided there are no side effects, you can use SUMATRIPTAN AN 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 AN tablets should be swallowed whole 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 AN tablet

  1. When the migraine headache begins
  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 SUMATRIPTAN AN tablet before the above symptoms occur.

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 the nearest hospital, if you think you or anyone else may have taken too much SUMATRIPTAN AN. Do this 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 AN

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 AN may cause drowsiness in some people.

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

If you use SUMATRIPTAN AN Tablets too often, it may make your headache worse. If this happens, your doctor may tell you to stop taking SUMATRIPTAN AN Tablets.

  • Salt restriction – too much salt can make your heart failure worse. Try to avoid using salt in cooking and at the table.

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

Like other medicines, SUMATRIPTAN AN 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 AN tablets:

  • 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.

Tell your doctor immediately, or seek urgent medical attention, and do not take any more SUMATRIPTAN AN 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 discolouration 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 AN 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 taking SUMATRIPTAN AN

Storage

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 your tablets in the blister pack until it is time to take them. If you take the tablets out of the blister pack they may not keep well.

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

Do not leave your tablets in the car or on window sills. Heat and dampness can destroy some medicines.

Disposal

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

Product description

What it looks like

SUMATRIPTAN AN comes in 50 mg and 100 mg strengths.

SUMATRIPTAN AN 50 mg (AUST R 187213)
Pink coloured, capsule shaped biconvex film coated tablets, plain on both sides. Available in blister packs of 2 & 4 tablets.

SUMATRIPTAN AN 100 mg (AUST R 187212)
White to off-white coloured capsule shaped, biconvex film coated tablets, plain on both sides. Available in blister packs of 2 tablets.

Ingredients

Active Ingredient:

  • SUMATRIPTAN AN 50 mg
    Contain sumatriptan succinate equivalent to 50 mg sumatriptan per tablet.
  • SUMATRIPTAN AN 100 mg
    Contain sumatriptan succinate equivalent to 100 mg sumatriptan per tablet.

Other Ingredients:

  • Lactose
  • Microcrystalline cellulose
  • Croscarmellose sodium
  • Hypromellose
  • Magnesium stearate

SUMATRIPTAN AN 50 mg also contains OPADRY complete film coating system 03K54036 PINK

SUMATRIPTAN AN 100 mg also contains OPADRY complete film coating system 03A58900 WHITE.

SUMATRIPTAN AN tablets do not contain gluten or sugar.

Please read this leaflet carefully before you start taking SUMATRIPTAN AN. You may wish to keep it to read again.

Name and Address of the Sponsor

Amneal Pharma Australia Pty Ltd
12 River Street
South Yarra
VIC 3141
Australia

Date of Preparation

October 2014.

Doc ID: 100.AN.M.1.0

Published by MIMS February 2017