SUMMARY CMI

APO-SUMATRIPTAN

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 APO-SUMATRIPTAN?

APO-SUMATRIPTAN contains the active ingredient sumatriptan succinate. APO-SUMATRIPTAN is used to relieve a migraine attack. This medicine may be used for migraine headaches with or without what is known as 'aura'.

Sumatriptan belongs to a group of drugs called serotonin agonists. It is thought that a migraine headache is due to widening of certain blood vessels in the head. Sumatriptan works by making the affected vessels normal again, to ease the symptoms of migraine.

For more information, see Section 1. Why am I using APO-SUMATRIPTAN? in the full CMI.

2. What should I know before I use APO-SUMATRIPTAN?

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

Talk to your doctor 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 APO-SUMATRIPTAN? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with APO-SUMATRIPTAN 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 APO-SUMATRIPTAN?

• Follow all directions given to you by your doctor or pharmacist carefully.
• If you do not understand the instructions on the box, ask your doctor or pharmacist for help.
• Swallow the tablets whole with a glass of water. Do not crush or chew this medicine as it has a bitter taste.

More instructions can be found in Section 4. How do I use APO-SUMATRIPTAN? in the full CMI.

5. What should I know while using APO-SUMATRIPTAN?

For more information, see Section 5. What should I know while using APO-SUMATRIPTAN? in the full CMI.

6. Are there any side effects?

The common side effects include pain, tingling, burning, prickling, cold or flushing in any part of the body, loss of touch sensitivity, feeling of sleepiness, dizziness weakness or tiredness, nausea (feeling sick) or vomiting, a change in blood pressure, feeling of faintness, problems with your eyesight or jittery eye movements or shaking or tremors, uncontrolled movements. Tell your doctor or go to emergency if you experience more serious side effects of pain in the lower tummy and bloody diarrhoea (signs of ischemic colitis), breathing problems or feeling faint due to a drop in blood pressure. If any of the following happen, stop taking your medicine and contact your doctor immediately or go to Accident and Emergency at your nearest hospital: The very serious side effects include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue, throat or other parts of the body; rash, itching or hives on the skin; fainting; hayfever-like symptoms (signs of an allergic reaction), neck pain or stiffness, feeling of heaviness, pressure or tightness in any part of the body including the head, chest or throat, chest pain or angina; or symptoms of a heart attack such as chest pain, shortness of breath nausea, vomiting, palpitations, sweating, anxiety, fast, slow, thumping or irregular heartbeats, seizures (fits), problems with speech, and/or lack of muscle movement on one side of your body (signs of a stroke), persistent purple or white discolouration and/or pain in the fingers, toes, ears, nose or jaw, sometimes 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.

FULL CMI

APO-SUMATRIPTAN

Active ingredient: sumatriptan succinate

Consumer Medicine Information (CMI)

This leaflet provides important information about using APO-SUMATRIPTAN. 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 APO-SUMATRIPTAN.

Where to find information in this leaflet:

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

1. Why am I using APO-SUMATRIPTAN?

APO-SUMATRIPTAN contains the active ingredient sumatriptan succinate.

APO-SUMATRIPTAN is used to relieve a migraine attack. This medicine may be used for migraine headaches with or without what is known as 'aura'.

APO-SUMATRIPTAN belongs to a group of drugs called serotonin agonists. It is thought that a migraine headache is due to widening of certain blood vessels in the head. Sumatriptan works by making the affected vessels normal again, to ease the symptoms of migraine.

This medicine does not work in other types of headache which are not a migraine. It should not be used to prevent migraine attacks from occurring.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

Your doctor may have prescribed this medicine for another reason.

This medicine is available only with a doctor's prescription.

This medicine is not addictive.

The effectiveness of this medicine has not been established in adolescents between 12 and 17; and the safety and effectiveness of this medicine in children under the age of 12 years has not been established.

Sumatriptan is not recommended for use in people aged over 65 years.

2. What should I know before I use APO-SUMATRIPTAN?

Warnings

Do not use APO-SUMATRIPTAN 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.
• Do not take this medicine if you have or have had any of the following medical conditions:
  - 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 you 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 which is not controlled by medication
  - stroke or "mini-stroke"
  - severe liver disease
  - types of migraine called hemiplegic, basilar or ophthalmoplegic migraine
• Do not take this medicine if you are taking or have taken any of these medicines in the last 24 hours:
  - ergotamine (e.g. Cafergot)
  - dihydroergotamine (e.g. Dihydergot)
  - methysergide (e.g. Deseril)
• Do not take this medicine if you are taking or have taken Monoamine Oxidase Inhibitors (MAOIs) in the last two weeks, such as:
  - phenelzine, tranylcypromine and moclobemide, used to treat depression
  - selegiline, used to treat Parkinson's disease
  - linezolid, used to treat certain infections
  - methylene blue, used to diagnose certain medical conditions.
• Do not take this medicine if you are taking or have taken SSRIs (Selective Serotonin Reuptake Inhibitors) or SNRIs (Serotonin-Noradrenaline Reuptake Inhibitors) used to treat depression in the last two weeks.
• Do not use this medicine after the expiry date printed on the pack or the packaging is torn or shows signs of tampering.
• If it has expired or is damaged, return it to your pharmacist for disposal.

Check with your doctor if you:

• have allergies to any other medicines, foods, preservatives or dyes.
• are allergic to any medicines that contain sulphur, such as sulphonamide antibiotics.
• are lactose-intolerant or unable to consume lactose, as these tablets contain lactose.
• have discussed the risks and benefits involved.
• have or have had any of the following medical conditions:
  - liver or kidney problems
  - heart problems or you have conditions which may make you prone to heart problems such as:
  -- 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
  -- smoking
  - epilepsy, seizures, or fits, or been told that you are prone to this problem
  - stroke or 'mini-stroke'

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 if you are pregnant or intend to become pregnant.

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

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, or you have taken any medicine in the last 2 weeks, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with APO-SUMATRIPTAN and affect how it works

• MAO inhibitors, such as phenelzine, tranylcypromine, moclobemide, selegiline, linezolid, and methylene blue. Do not take this medicine with MAOIs or for two weeks after stopping taking a MAOI.
• other triptans (similar to sumatriptan) such as naratriptan and zolmitriptan. Do not take sumatriptan for 24 hours before or after taking another triptan.
• other medicines for treating migraine such as ergotamine, dihydroergotamine or methysergide. Do not take sumatriptan for 6 hours before or 24 hours after taking ergotamine-type medicines.
• medicines for treating depression such as SSRIs and SNRIs (e.g. fluoxetine, paroxetine, fluvoxamine, sertraline, citalopram, venlafaxine, nefazodone, mirtazapine)
• St John's wort, a herbal medicine.

These medicines may be affected by this medicine or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

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

Other medicines not listed above may also interact with sumatriptan.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect APO-SUMATRIPTAN.

4. How do I use APO-SUMATRIPTAN?

How much to take

• Follow the instructions provided and use APO-SUMATRIPTAN until your doctor tells you to stop.
• They may differ to the information contained in this leaflet.
• If you do not understand the instructions on the box, ask your doctor or pharmacist for help.

When to take APO-SUMATRIPTAN

• Your doctor or pharmacist will tell you how much of this medicine you should take. This will depend on your condition and whether you are taking any other medicines. If you have liver problems you may be prescribed a lower dose.
• The recommended starting dose for adults aged 18 to 65 is 50 mg, however your dose may be increased to 100 mg if needed.
• If the first tablet helps your migraine, but the migraine comes back again later, you may take another tablet.
• If the first dose has not provided any relief from your symptoms, do not take any more sumatriptan for this attack. Your doctor should review your treatment to check if this medicine is still appropriate for you.
• Do not take more than 300 mg of this medicine in any 24 hours.
• Six pink (50 mg strength) or three white (100 mg strength) tablets contain 300 mg of sumatriptan.
• You may take your usual headache relief medication provided it does not contain ergotamine, methysergide, naratriptan or zolmitriptan. If you are not sure what to do, ask your doctor or pharmacist.
• If your migraine is not relieved by this medicine, you may use sumatriptan tablets on another occasion to treat another migraine attack. Provided there are no side effects, you can use sumatriptan tablets to treat at least three separate migraine attacks before you and your doctor decide this medicine is ineffective for you.

How to take APO-SUMATRIPTAN

• Swallow the tablets whole with a glass of water. Do not crush or chew this medicine as it has a bitter taste. insert relevant step-by-step instructions / considerations for device use
• It is best to take this medicine:
  - 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 this medicine later during the migraine attack, it will still work for you. Do not take this medicine before the above symptoms occur.
• It does not matter if you take it with or without food

Do not change the dosage without first checking with your doctor.

If you forget to use APO-SUMATRIPTAN

APO-SUMATRIPTAN is not to be used on a regular basis. Use it only when you have migraine symptoms, and if the tablets do not relieve your migraine then do not take any more for that migraine.

If you use too much APO-SUMATRIPTAN

If you think that you have used too much APO-SUMATRIPTAN, 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 APO-SUMATRIPTAN?

Things you should do

Tell any other doctors, dentists and pharmacists who are treating you that you take this medicine.

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking this medicine.

Tell your doctor if, for any reason, you have not taken this medicine exactly as directed.

Otherwise your doctor may think that it is not working and change your treatment unnecessarily.

If you become pregnant while taking this medicine, tell your doctor immediately.

Tell your doctor if you are going to have surgery or are going into hospital.

Call your doctor straight away if you:

• notice any of the following:
  - pain in the lower tummy and bloody diarrhoea (signs of ischemic colitis)
  - breathing problems
  - feeling faint due to a drop in blood pressure
• The above list includes serious side effects that may need medical attention.
• If any of the following happen, stop taking your medicine and contact your doctor immediately or go to Accident and Emergency at your nearest hospital:
  - shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue, throat or other parts of the body; rash, itching or hives on the skin; fainting; hayfever-like symptoms (signs of an allergic reaction)
  - neck pain or stiffness, feeling of heaviness, pressure or tightness in any part of the body including the head, chest or throat
  - chest pain or angina; or symptoms of a heart attack such as chest pain, shortness of breath nausea, vomiting, palpitations, sweating, anxiety
  - fast, slow, thumping or irregular heartbeats
  - seizures (fits)
  - problems with speech, and/or lack of muscle movement on one side of your body (signs of a stroke)
  - persistent purple or white discolouration and/or pain in the fingers, toes, ears, nose or jaw, sometimes in response to cold
• The above list includes very serious side effects. Stop taking sumatriptan tablets and seek medical attention straight away. Most of these side effects are rare.
• Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
• Other side effects not listed above may occur in some patients.

Remind any doctor, dentist or pharmacist you visit that you are using APO-SUMATRIPTN.

Things you should not do

• Do not stop using this medicine suddenly
• Do not give this medicine to anyone else, even if they have the same condition as you.
• Do not take your medicine to treat any other complaint unless your doctor tells you to.
• Do not change the dosage without first checking with your doctor.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how APO-SUMATRIPTAN affects you.

APO-SUMATRIPTAN may cause drowsiness in some people. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.

Looking after your medicine

• Keep your medicine in the pack until it is time to take it.
• If you take your medicine out of the pack it may not keep well.
• Keep your medicine in a cool dry place where the temperature stays below 30°C.

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 about side effects.

Less serious side effects

Serious side effects

Very 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.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What APO-SUMATRIPTAN contains

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

What APO-SUMATRIPTAN looks like

50 mg tablets: pink coloured, capsule shaped, biconvex film coated tablets, debossed with '50' on one side and plain on the other side.

APO-SUMATRIPTAN is available in blister packs containing 2 or 4 tablets. AUST R 160188.

Who distributes APO-SUMATRIPTAN

Arrotex Pharmaceuticals Pty Ltd,
15 – 17 Chapel st,
Cremorne VIC 3121

www.arrotex.com.au

This leaflet was prepared in March 2025.

Published by MIMS April 2025

1 Name of Medicine

Sumatriptan succinate.

2 Qualitative and Quantitative Composition

For APO-Sumatriptan brand:
Each tablet contains 50 mg sumatriptan (as succinate), as the active ingredient.
In addition, each tablet contains the following inactive ingredients: lactose, microcrystalline cellulose, crospovidone, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate and Opadry 03B84755 Pink as coating material. The coating material contains hypromellose, titanium dioxide, macrogol 400, iron oxide red and iron oxide black.
APO-Sumatriptan tablets are intended for oral administration.

Excipients with known effect.

3 Pharmaceutical Form

For APO-Sumatriptan brand:
Pink coloured, capsule shaped, biconvex film coated tablets, debossed with "50" on one side and plain on the other side.

4 Clinical Particulars

4.1 Therapeutic Indications

Sumatriptan tablets are indicated for the acute relief of migraine attacks with or without aura.
There is no information available on the use of sumatriptan tablets in the treatment of basilar or hemiplegic migraine.

4.2 Dose and Method of Administration

Sumatriptan is indicated for the acute intermittent relief of both migraine and cluster headache. It should not be used prophylactically.
Ergotamine or ergotamine derivatives and sumatriptan should not be administered concurrently (see Section 4.3 Contraindications).

Migraine.

4.3 Contraindications

Sumatriptan should not be used in patients who have:
hypersensitivity to any component of the preparation (see Section 2 Qualitative and Quantitative Composition; Section 3 Pharmaceutical Form);
a history of myocardial infarction;
peripheral vascular disease or symptoms or signs consistent with ischaemic heart disease;
Prinzmetal's angina/ coronary vasospasm;
uncontrolled hypertension;
cerebrovascular accident or transient ischaemic attack;
severe hepatic impairment.
Sumatriptan should not be used within 24 hours of treatment with an ergotamine containing or ergot type medication such as dihydroergotamine or methysergide.
Sumatriptan should not be given to patients receiving monoamine oxidase inhibitors (MAOIs) or within two weeks of discontinuation of MAOI therapy.
Sumatriptan should not be administered to patients with hemiplegic, basilar or ophthalmoplegic migraine.

4.4 Special Warnings and Precautions for Use

General.

Cardiovascular.

Cerebrovascular.

Other vasospastic events.

Use in the elderly.

Use in adolescents (12-17 years).

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Pharmacodynamics.

Pharmacokinetics.

Ophthalmic.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

No studies on the effects on the ability to drive and use machines have been performed. Drowsiness may occur as a result of migraine or its treatment with sumatriptan. This may influence the ability to drive and to operate machinery.

4.8 Adverse Effects (Undesirable Effects)

The most common side effects associated with treatment with sumatriptan are:
Pain, sensations of tingling, heat or cold, heaviness, pressure or tightness. These are usually transient and may be intense and can affect any part of the body including the chest and throat.
Flushing, dizziness and feelings of weakness. These are mostly mild to moderate in intensity and transient.
Fatigue, drowsiness, sensory disturbance including paraesthesia and hypoaesthesia have been reported.
Nausea and vomiting occurred in some patients but the relationship to sumatriptan is not clear.
Transient increases in blood pressure arising soon after treatment have been recorded.
Dyspnoea.
Serious coronary events have been reported (see Section 4.4 Special Warnings and Precautions for Use). Other cardiovascular adverse reactions include hypotension, bradycardia, tachycardia and palpitations. Very rarely (less than 1 in 10,000) Raynaud's phenomenon, angina and ischaemic colitis have been reported.
There have been rare (less than 1 in 1,000) reports of seizures following migraine attacks treated with sumatriptan. Although some have occurred in patients with either a history of seizures or concurrent conditions predisposing to seizures, there are also reports in patients where no such predisposing factors are apparent.
Patients treated with sumatriptan very rarely (less than 1 in 10,000) exhibit visual disorders like flickering and diplopia. Additionally cases of nystagmus, scotoma and reduced vision have been observed. Very rarely loss of vision has occurred, which is usually transient. However, visual disorders may also occur during a migraine attack itself.
Hypersensitivity reactions ranging from cutaneous hypersensitivity (e.g. rash, urticaria, pruritus or erythema) to, in rare (less than 1 in 10,000) cases, anaphylaxis have been recorded (see Section 4.4 Special Warnings and Precautions for Use).
Minor disturbances of liver function tests have occasionally been observed. There is no evidence that clinically significant abnormalities occurred more frequently than with placebo.
In the clinical trial programme, decreased lymphocyte count post-treatment was observed in a number of patients receiving oral sumatriptan. This effect was not dose related and was also observed in patients receiving placebo. The significance of these findings is uncertain.
In the clinical trial programme, a similar profile of clinical adverse events was reported in the adolescent and adult populations taking sumatriptan tablets.

Post-marketing data.

Cardiovascular.

Cerebrovascular.

Neurology.

Non-site specific.

Skin.

General disorders.

Reporting suspected adverse effects.

4.9 Overdose

Symptoms.

Treatment.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

Clinical studies conducted in the adult population.

5.2 Pharmacokinetic Properties

In a pilot study no significant differences were found in the pharmacokinetic parameters between elderly and young healthy volunteers.
The pharmacokinetics of oral sumatriptan do not appear to be significantly affected by migraine attacks.

Absorption.

Distribution.

Metabolism.

Excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

See Section 2 Qualitative and Quantitative Composition.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 30°C.

6.5 Nature and Contents of Container

50 mg tablets.

6.6 Special Precautions for Disposal

In Australia, any used medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Sumatriptan takes the form of a white to pale yellow powder. Sumatriptan succinate takes the form of a white to off-white powder.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes