SUMMARY CMI

APOHEALTH ACUTE MIGRAINE RELIEF SUMATRIPTAN TABLETS

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 APOHEALTH ACUTE MIGRAINE RELIEF SUMATRIPTAN TABLETS?

APOHEALTH ACUTE MIGRAINE RELIEF SUMATRIPTAN TABLETS contain the active ingredient sumatriptan succinate. APOHEALTH ACUTE MIGRAINE RELIEF SUMATRIPTAN TABLETS are used to relieve a migraine headache in patients who have a stable, well-established pattern of symptoms. They should not be used to prevent migraine attacks from occurring.

For more information, see Section 1. Why am I using APOHEALTH ACUTE MIGRAINE RELIEF SUMATRIPTAN TABLETS? in the full CMI.

2. What should I know before I use APOHEALTH ACUTE MIGRAINE RELIEF SUMATRIPTAN TABLETS?

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 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 APOHEALTH ACUTE MIGRAINE RELIEF SUMATRIPTAN TABLETS? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with APOHEALTH ACUTE MIGRAINE RELIEF SUMATRIPTAN TABLETS 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 APOHEALTH ACUTE MIGRAINE RELIEF SUMATRIPTAN TABLETS?

• The recommended dose for adults aged 18 to 65 years is 50 mg (one tablet) as soon as the migraine headache begins.
• If the first tablet helps your migraine, but the migraine comes back later, you may take another tablet. Wait at least two hours after the first tablet was taken.
• Do not take more APOHEALTH ACUTE MIGRAINE RELIEF SUMATRIPTAN TABLETS, 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.
• The tablet should be swallowed whole with water. Do not crush or chew the tablet as it has a bitter taste.

More instructions can be found in Section 4. How do I use APOHEALTH ACUTE MIGRAINE RELIEF SUMATRIPTAN TABLETS? in the full CMI.

5. What should I know while using APOHEALTH ACUTE MIGRAINE RELIEF SUMATRIPTAN TABLETS?

For more information, see Section 5. What should I know while using APOHEALTH ACUTE MIGRAINE RELIEF SUMATRIPTAN TABLETS? 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.

FULL CMI

APOHEALTH ACUTE MIGRAINE RELIEF SUMATRIPTAN TABLETS

Active ingredient: sumatriptan succinate

Consumer Medicine Information (CMI)

This leaflet provides important information about using APOHEALTH ACUTE MIGRAINE RELIEF SUMATRIPTAN TABLETS. 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 APOHEALTH ACUTE MIGRAINE RELIEF SUMATRIPTAN TABLETS.

Where to find information in this leaflet:

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

1. Why am I using APOHEALTH ACUTE MIGRAINE RELIEF SUMATRIPTAN TABLETS?

APOHEALTH ACUTE MIGRAINE RELIEF SUMATRIPTAN TABLETS contain the active ingredient sumatriptan succinate. APOHEALTH ACUTE MIGRAINE RELIEF SUMATRIPTAN TABLETS belongs to a group of drugs called serotonin agonists.

APOHEALTH ACUTE MIGRAINE RELIEF SUMATRIPTAN TABLETS is used to relieve a migraine headache in patients who have a stable, well-established pattern of symptoms. They should not be used to prevent migraine attacks from occurring. Do not use APOHEALTH ACUTE MIGRAINE RELIEF SUMATRIPTAN TABLETS unless your condition has been diagnosed by a doctor.

It is thought that migraine headache is due to widening of certain blood vessels in the head. APOHEALTH ACUTE MIGRAINE RELIEF SUMATRIPTAN TABLETS work by making the blood vessels normal again and ease the symptoms of migraine.

APOHEALTH ACUTE MIGRAINE RELIEF SUMATRIPTAN TABLETS do not work in other types of headaches which are not migraine

2. What should I know before I use APOHEALTH ACUTE MIGRAINE RELIEF SUMATRIPTAN TABLETS?

Warnings

Do not use APOHEALTH ACUTE MIGRAINE RELIEF SUMATRIPTAN TABLETS if:

• you have not been previously diagnosed with migraine by a doctor.
• 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 (e.g., Cafegot)
  - dihydroergotamine (e.g., Dihydergot)
  - methysergide (e.g., Deseril)
  - rizatriptan (e.g., Maxalt)
  - eletriptan (e.g., Relpax)
  - naratriptan (e.g., Naramig)
  - zolmitriptan (e.g., Zomig)

Check with your doctor or pharmacist if you:

• have any other medical conditions:
  - liver or kidney problems
  - heart problems including high blood pressure even if it is under control, high blood cholesterol levels, a family history of heart problems, obesity, diabetes, you are a 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 sulphur (e.g., sulphonamide 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 patient 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 APOHEALTH ACUTE MIGRAINE RELIEF SUMATRIPTAN TABLETS 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 APOHEALTH ACUTE MIGRAINE RELIEF SUMATRIPTAN TABLETS.

4. How do I use APOHEALTH ACUTE MIGRAINE RELIEF SUMATRIPTAN TABLETS?

How much to take

• 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 than 100 mg (2 tablets) in any 24-hour period.
• Do not take more APOHEALTH ACUTE MIGRAINE RELIEF SUMATRIPTAN 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 APOHEALTH ACUTE MIGRAINE RELIEF SUMATRIPTAN TABLETS, you may use APOHEALTH ACUTE MIGRAINE RELIEF SUMATRIPTAN TABLETS on another occasion to treat another migraine attack.
• APOHEALTH ACUTE MIGRAINE RELIEF SUMATRIPTAN TABLETS 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.

When to take APOHEALTH ACUTE MIGRAINE RELIEF SUMATRIPTAN TABLETS

APOHEALTH ACUTE MIGRAINE RELIEF SUMATRIPTAN TABLETS 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 become 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 APOHEALTH ACUTE MIGRAINE RELIEF SUMATRIPTAN TABLETS before the above symptoms occur.

If you use too much APOHEALTH ACUTE MIGRAINE RELIEF SUMATRIPTAN TABLETS

If you think that you have used too much APOHEALTH ACUTE MIGRAINE RELIEF SUMATRIPTAN TABLETS, 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 APOHEALTH ACUTE MIGRAINE RELIEF SUMATRIPTAN TABLETS?

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 e.g., 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 uncoordinated 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 APOHEALTH ACUTE MIGRAINE RELIEF SUMATRIPTAN TABLETS.

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
• Can make your condition 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 APOHEALTH ACUTE MIGRAINE RELIEF SUMATRIPTAN TABLETS 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

• Keep APOHEALTH ACUTE MIGRAINE RELIEF SUMATRIPTAN TABLETS in the blister pack in a cool, dry place where it 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 windowsills.

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 side effects

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 APOHEALTH ACUTE MIGRAINE RELIEF SUMATRIPTAN TABLETS contains

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

What APOHEALTH ACUTE MIGRAINE RELIEF SUMATRIPTAN TABLETS looks like

APOHEALTH ACUTE MIGRAINE RELIEF SUMATRIPTAN TABLETS are pink coloured, capsule shaped, biconvex film coated tablets, debossed with “50” on one side and plain on the other side in blister packs of 2 tablets (Aust R 401753).

Who distributes APOHEALTH ACUTE MIGRAINE RELIEF SUMATRIPTAN TABLETS

Arrotex Pharmaceuticals Pty Ltd
15 – 17 Chapel Street
Cremorne VIC 3121
www.arrotex.com.au

This leaflet was prepared in April 2024.

Published by MIMS June 2024

1 Name of Medicine

Sumatriptan succinate.

2 Qualitative and Quantitative Composition

Each tablet contains 50 mg sumatriptan (as succinate), as the active ingredient.

Excipients with known effect.

3 Pharmaceutical Form

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

APOHealth Acute Migraine Relief Sumatriptan tablets are indicated for the acute relief of migraine in patients who have a stable, well-established pattern of symptoms.

4.2 Dose and Method of Administration

APOHealth Acute Migraine Relief Sumatriptan tablets are indicated for the acute intermittent relief of migraine. They should not be used prophylactically.

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 6.1 List of Excipients);
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.

Drowsiness.

Use in hepatic or renal impairment.

Hypersensitivity to sulphonamides.

Overuse.

Co-administration with 5-HT₁ agonists.

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 and excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Each tablet contains the following inactive ingredients: lactose, microcrystalline cellulose, crospovidone, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, Opadry 03B84755 pink as coating material. The coating material contains hypromellose, titanium dioxide, macrogol 400, iron oxide red and iron oxide black.

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)

Schedule 3 (Pharmacist Only Medicine).

Summary Table of Changes