FULL CMI

MAXALT^® MIGRAINE RELIEF

Active ingredient: rizatriptan benzoate

Consumer Medicine Information (CMI)

This leaflet provides important information about using MAXALT MIGRAINE RELIEF. 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 MAXALT MIGRAINE RELIEF.

Where to find information in this leaflet:

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

1. Why am I using MAXALT MIGRAINE RELIEF?

MAXALT MIGRAINE RELIEF contains the active ingredient rizatriptan benzoate. MAXALT MIGRAINE RELIEF belongs to a class of drugs called serotonin agonists.

MAXALT MIGRAINE RELIEF is used for the acute relief of migraine 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 MAXALT MIGRAINE RELIEF unless your condition has been diagnosed by a doctor.

MAXALT MIGRAINE RELIEF does not work in other types of headaches which are not migraine.

Migraine is an intense, throbbing, typically one-sided headache. It often includes nausea, vomiting, sensitivity to light, and sensitivity to sound. Some people may have visual symptoms before the headache, called an aura. An aura can include flashing lights or wavy lines.

Migraine attacks last anything from two hours to two days and they can return frequently. The severity and. frequency of migraine attacks may vary.

Migraine occurs in about one out of every 10 people. It is three times more common in women than men.

Six out of ten migraine sufferers have their first attack before the age of 20.

There is no single cause of migraine. It tends to run in families. Certain things, singly or in combination, can trigger migraine attacks in some people. Some of these triggers are:

• certain foods or drinks, for example, cheese and other dairy products, chocolate, citrus fruit, caffeine, alcohol (especially red wine)
• stress, anger, worry
• changes in routine, for example, under or over sleeping, missing a meal, change in diet
• bright light or loud noises
• hormonal changes in women, for example, during menstrual periods

If you understand what triggers your attacks, you may be able to prevent migraine attacks or reduce their frequency. Keeping a headache diary will help you identify and monitor all of the possible migraine triggers you encounter. Once the triggers are identified, you and your doctor or pharmacist can modify your treatment and lifestyle appropriately.

During a migraine attack, blood vessels in the brain dilate, or widen, resulting in a throbbing pain. MAXALT MIGRAINE RELIEF decreases this widening, returning the blood vessels to their normal size, and therefore helps to relieve the pain. MAXALT MIGRAINE RELIEF also blocks the release of certain chemicals from nerve endings that cause more pain and other symptoms of migraine.

Ask your doctor or pharmacist if you have any questions about MAXALT MIGRAINE RELIEF.

2. What should I know before I use MAXALT MIGRAINE RELIEF?

Warnings

Do not use MAXALT MIGRAINE RELIEF if:

• you are allergic to rizatriptan benzoate, 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:
  - high blood pressure that is not being treated
  - some heart diseases, including angina, or a previous heart attack
  - a stroke or transient ischaemic attack (TIA)
  - blood vessel problems, including ischaemic bowel disease
• you are currently taking monoamine oxidase inhibitors (MAOIs) for depression, or have taken them within the last 2 weeks. MAOIs include moclobemide, phenelzine, tranylcypromine and pargyline.
• you are currently taking any of these medicines:
  - ergotamine
  - dihydroergotamine
  - methysergide
  - sumatriptan
  - eletriptan
  - naratriptan
  - zolmitriptan
• the packaging is torn or shows signs of tampering
• the expiry date on the pack has passed. If you take this medicine after the expiry has passed, it may not work.

If you are not sure whether you should start taking MAXALT MIGRAINE RELIEF, talk to your doctor or pharmacist.

Check with your doctor or pharmacist if:

• you have any risk factors for heart or blood vessel disease, including:
  - high blood pressure
  - diabetes
  - smoking
  - a high cholesterol level
  - a family history of heart or blood vessel disease
  - obesity
  - are a male and over 40 years of age
  - are female and have undergone menopause
• your headache is more severe than your ‘usual’ migraine, or it behaves differently
• you have a condition called phenylketonuria
• The 5 mg wafer contains 1.05 mg phenylalanine (a component of aspartame)
• you have, or have had any other medical conditions
• you have allergies to any other medicines or any other substances, such as foods, preservatives or dyes
• take any medicines for any other condition

If you have not told your doctor or pharmacist about any of the above, tell them before you take any MAXALT MIGRAINE RELIEF.

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.

Like most medicines, MAXALT MIGRAINE RELIEF is not recommended for use during pregnancy. If there is a need to consider MAXALT MIGRAINE RELIEF during pregnancy, your doctor or pharmacist will discuss with you the risks and benefits of taking them during pregnancy.

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

It is not known whether MAXALT MIGRAINE RELIEF passes into breast milk. Your doctor or pharmacist will discuss with you the risks and benefits of taking them while breast-feeding

Use in Children and Adolescents (under 18 years)

Do not give MAXALT MIRGRAINE RELIEF to children under 18 years of age.

The safety and effectiveness of MAXALT MIGRAINE RELIEF in children under 18 years have not been established.

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.

Some medicines should not be taken with MAXALT MIGRAINE RELIEF. These include:

• monoamine oxidase inhibitors (MAOIs) used to treat depression, including moclobemide, tranylcypromine, phenelzine, pargyline
• other medicine used to treat migraine

Some medicines, herbal products, or dietary supplements, and MAXALT MIGRAINE RELIEF may interfere with each other. These include:

• propranolol, a medicine used to treat high blood pressure
• ergotamine, dihydroergotamine, other medicines used to treat migraine
• methysergide, a medicine used to prevent migraine
• St. John's wort (Hypericum perforatum), a herbal product sold as a dietary supplement, or products containing St. John's wort

These medicines, herbal products, or dietary supplements may be affected by MAXALT MIGRAINE RELIEF, or may affect how well it works. You may need different amounts of your medicine, you may need to take different medicines or you may need to be careful of the timing of some of these medicines.

Ask your doctor or pharmacist for instructions about taking MAXALT MIGRAINE RELIEF if you are also taking selective serotonin reuptake inhibitors (SSRIs) such as sertraline, escitalopram oxalate, and fluoxetine or serotonin norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine, and duloxetine for depression.

Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking MAXALT MIGRAINE RELIEF.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect MAXALT MIGRAINE RELIEF.

4. How do I use MAXALT MIGRAINE RELIEF?

How much to take

• Take MAXALT MIGRAINE RELIEF only if your condition has been diagnosed by your doctor.
• The usual adult dose (18 years and over) to relieve a migraine is 10 mg, or two 5 mg wafers.
• If the first dose does help your migraine but it comes back within 24 hours, talk to your doctor or pharmacist
• You should not take a dose of 10 mg (two 5 mg wafers) while you are taking propranolol.
• Follow the instructions provided with the medicine.
• Do not exceed the recommended dosage.

When to take it

MAXALT MIGRAINE RELIEF 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.

Do not take MAXALT MIGRAINE RELIEF before the above symptoms occur.

How to take it

Remove the blister containing each individual wafer from the outer sachet when it is time to take it.

The blister pack should then be peeled open with dry hands and the wafer placed on your tongue, where it will dissolve and be swallowed with your saliva. No water is needed for taking the wafer.

It does not matter if you take MAXALT MIGRAINE RELIEF before or after food.

If you use too much MAXALT MIGRAINE RELIEF

If you think that you have used too much MAXALT MIGRAINE RELIEF, 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.

If you take too many wafers, you may feel sleepy, dizzy, faint or have a slow heart beat.

5. What should I know while using MAXALT MIGRAINE RELIEF?

Things you should do

• If your headache is more severe than your 'usual' migraine or it behaves differently, tell your doctor or pharmacist.
• If you are about to be started on any new medicine, tell your doctor and pharmacist that you take MAXALT MIGRAINE RELIEF for migraines.
• If you become pregnant while taking MAXALT MIGRAINE RELIEF, tell your doctor immediately.
• Remind any doctor, dentist or pharmacist you visit that you are using MAXALT MIGRAINE RELIEF

Things you should not do

• Do not give MAXALT MIGRAINE RELIEF to anyone else, even if they have the same condition as you

Medication overuse headaches

Overuse of migraine medications, such as rizatriptan, 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 MAXALT MIGRAINE RELIEF affects you.

Migraine or treatment with MAXALT MIGRAINE RELIEF may cause sleepiness or dizziness in some people. Make sure you know how you react to MAXALT MIGRAINE RELIEF before you drive a car, operate machinery, or do anything else that could be dangerous if you are sleepy or dizzy.

Drinking alcohol

Tell your doctor or pharmacist if you drink alcohol.

If you drink alcohol, sleepiness or dizziness may be worse.

Looking after your medicine

• Keep your blister containing each individual wafer in the aluminium sachet until it is time to take it.
• Each wafer is packed in a blister within an outer aluminium sachet. If you take the wafer out of the blister and PVC/PVDC/Al sachet, it may not keep well.
• Keep MAXALT MIGRAINE RELIEF 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.

Heat and dampness can destroy some medicines. 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.

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 MAXALT MIGRAINE RELIEF contains

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

What MAXALT MIGRAINE RELIEF looks like

MAXALT MIGRAINE RELIEF – a white to off-white round wafer with a flat or slightly irregular surface. (Aust R 407853).

A pack contains 2 wafers

Who distributes MAXALT MIGRAINE RELIEF

Organon Pharma Pty Ltd
Building A, 26 Talavera Road
Macquarie Park NSW 2113

This leaflet was prepared in April 2023.

This CMI leaflet was current at the time of printing. To check if it has been updated, please visit our website, www.organon.com/Australia, or ask your pharmacist.

Published by MIMS June 2024

1 Name of Medicine

Rizatriptan benzoate.

2 Qualitative and Quantitative Composition

Rizatriptan benzoate is a white to off-white, crystalline solid. Rizatriptan benzoate is soluble in water at about 42 mg per mL (expressed as free base) at 25°C.
Each lyophilised wafer contains 7.265 mg of rizatriptan benzoate (corresponding to 5 mg of rizatriptan).

List of excipients with known effect.

3 Pharmaceutical Form

5 mg wafer.

4 Clinical Particulars

4.1 Therapeutic Indications

For the acute relief of migraine in patients who have a stable, well-established pattern of symptoms.

4.2 Dose and Method of Administration

Maxalt Migraine Reliefs are rapidly dissolving wafers. Administration with liquid is not necessary.
The wafer is packaged in a blister within an outer aluminium sachet (pouch). Patients should be instructed not to remove the blister from the outer sachet until just prior to dosing. The blister pack should then be peeled open with dry hands and the wafer placed on the tongue, where it will dissolve and be swallowed with the saliva.
The recommended adult dose (18 years and over) is 10 mg, or two 5 mg wafers. Clinical experience has shown that this dose provides the optimal clinical benefit.
Onset of relief (i.e. reduction of headache pain to mild or none) can occur within 30 minutes after dosing.
If the headache returns after relief of the initial attack, further doses may be taken. Doses should be separated by at least 2 hours and no more than 30 mg of rizatriptan should be taken in any 24 hour period.

Patients receiving propranolol.

4.3 Contraindications

Maxalt Migraine Relief is contraindicated in patients with:
hypersensitivity to rizatriptan or any of the ingredients;
concurrent administration of monoamine oxidase (MAO) inhibitors or use within 2 weeks of discontinuation of MAO inhibitor therapy (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
Based on the mechanism of action of this class of compounds, Maxalt Migraine Relief is also contraindicated in patients with:
uncontrolled hypertension;
established coronary artery disease, including ischemic heart disease (angina pectoris, history of myocardial infarction, or documented silent ischemia), signs and symptoms of ischemic heart disease, or Prinzmetal angina;
history of stroke or transient ischemic attack (TIA);
peripheral vascular disease, including (but not limited to) ischemic bowel disease.

4.4 Special Warnings and Precautions for Use

Maxalt Migraine Relief should only be administered to patients in whom a clear diagnosis of migraine has been established. Maxalt Migraine Relief should not be administered to patients with basilar or hemiplegic migraine.
Maxalt Migraine Relief should not be used to treat "atypical" headaches, i.e. those that might be associated with potentially serious medical conditions (e.g. stroke, ruptured aneurysm) in which cerebrovascular vasoconstriction could be harmful.
There have been rare reports of serious coronary events with this class of drugs including rizatriptan (see Section 4.8 Adverse Effects (Undesirable Effects)). Prior to prescribing this drug, cardiovascular assessment should be considered in patients at risk for coronary artery disease (CAD) [e.g. patients with hypertension, diabetics, smokers, and those with strong family history for CAD]. Those in whom CAD is established should not be given Maxalt Migraine Relief (see Section 4.3 Contraindications).
Other 5-HT_1B/1D agonists (e.g. sumatriptan) should not be used concomitantly with Maxalt Migraine Relief.
Administration of ergotamine-type medications (e.g. ergotamine, dihydroergotamine or methysergide) and Maxalt Migraine Relief within 6 hours of each other is not recommended. Although additive vasospastic effects were not observed in a clinical pharmacology study in which 16 healthy males received oral rizatriptan and parenteral ergotamine, such additive effects are theoretically possible.
Cases of life-threatening serotonin syndrome have been reported during combined use of selective serotonin reuptake inhibitors (SSRIs)/serotonin norepinephrine reuptake inhibitors (SNRIs) and triptans. If concomitant treatment with Maxalt Migraine Relief and an SSRI (e.g. sertraline, escitalopram oxalate, and fluoxetine) or SNRI (e.g. venlafaxine, duloxetine) is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases. Serotonin syndrome symptoms may include mental status changes (e.g. agitation, hallucinations, coma), autonomic instability (e.g. tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g. hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea) (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
Overuse of acute migraine drugs may lead to exacerbation of headache (medication overuse headache). Medication overuse headache may present as migraine-like daily headaches or as a marked increase in frequency of migraine attacks. Detoxification of patients, including withdrawal of the overused drugs, and treatment of withdrawal symptoms (which often includes a transient worsening of headache) may be necessary.

Use by gender or in individuals of various ethnic origins.

Phenylketonurics.

Use in hepatic impairment.

Use in renal impairment.

Use in the elderly.

Paediatric use.

Children (under 12 years of age).

Adolescents (12-17 years of age).

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Pharmacokinetic interactions.

Cytochrome P450 isoforms.

Monoamine oxidase inhibitors.

Beta-blockers.

Selective serotonin reuptake inhibitors/ serotonin norepinephrine reuptake inhibitors and serotonin syndrome.

Paroxetine.

Oral contraceptives.

Experience in migraine patients.

St John's wort (Hypericum perforatum).

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

Migraine or treatment with rizatriptan may cause somnolence in some patients. Dizziness has also been reported in some patients receiving rizatriptan. Patients should, therefore, evaluate their ability to perform complex tasks during migraine attacks and after administration of Maxalt Migraine Relief.

4.8 Adverse Effects (Undesirable Effects)

Adverse experiences were assessed in controlled clinical trials in which over 3,600 patients received single or multiple doses of rizatriptan as the tablet and wafer formulation. More than 1,500 patients were treated in long-term extension studies for up to one year.
In clinical trials, rizatriptan was generally well-tolerated. Adverse experiences were typically mild in intensity and transient. The most common drug-related adverse experiences were dizziness, somnolence, and asthenia/fatigue. Table 1 lists drug-related adverse experiences in acute Phase III trials in outpatients with migraine.

Body as a whole.

Cardiovascular.

Digestive.

Musculoskeletal.

Nervous system.

Respiratory.

Skin.

Special senses.

Urogenital.

Post-marketing experience.

Hypersensitivity.

Musculoskeletal.

Special senses.

Nervous system.

Vascular disorders.

Cardiac disorders.

Gastrointestinal disorders.

Investigations.

Reporting suspected adverse effects.

For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).
No overdoses of rizatriptan were reported during clinical trials.
Rizatriptan 40 mg (administered as either a single dose or as two doses with a 2-hour interdose interval) was generally well tolerated in over 300 patients; dizziness and somnolence were the most common drug-related adverse effects.
In a clinical pharmacology study in which 12 subjects received rizatriptan, at total cumulative doses of 80 mg (given within four hours), two subjects experienced syncope and/or bradycardia. One subject, a female aged 29 years, developed vomiting, bradycardia, and dizziness beginning three hours after receiving a total of 80 mg rizatriptan (administered over two hours). A third-degree AV block, responsive to atropine, was observed an hour after the onset of the other symptoms. The second subject, a 25 year old male, experienced transient dizziness, syncope, incontinence, and a 5 second systolic pause (on ECG monitor) immediately after a painful venipuncture. The venipuncture occurred two hours after the subject had received a total of 80 mg rizatriptan (administered over four hours).
In addition, based on the pharmacology of rizatriptan, hypertension or other more serious cardiovascular symptoms could occur after overdosage. Gastrointestinal decontamination (e.g. gastric lavage followed by activated charcoal) should be considered in patients suspected of an overdose with Maxalt Migraine Relief. Clinical and electrocardiographic monitoring should be continued for at least 12 hours, even if clinical symptoms are not observed.
The effects of haemo or peritoneal dialysis on serum concentrations of rizatriptan are unknown.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Pharmacodynamics.

Clinical trials.

Rizatriptan tablets.

Rizatriptan wafers.

5.2 Pharmacokinetic Properties

Absorption.

Distribution.

Metabolism.

Excretion.

Characteristics in patients.

Gender.

Elderly.

Hepatic impairment.

Renal impairment.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Each lyophilised wafer contains the following inactive ingredients: gelatin, mannitol, glycine, aspartame, and Peppermint NAEFCO P0551 957685 (ARTG ID: 2890).

6.2 Incompatibilities

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

6.3 Shelf Life

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

6.4 Special Precautions for Storage

Store at room temperature below 30°C. For the wafer, the patient should be instructed not to remove the blister from the outer aluminium sachet until the patient is ready to consume the wafer inside.

6.5 Nature and Contents of Container

5 mg wafer.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Rizatriptan benzoate is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate.
Its empirical formula is C₁₅H₁₉N₅.C₇H₆O₂.
The molecular weight of the benzoate salt is 391.47; the molecular weight of the free base is 269.4.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Pharmacist Only Medicines (S3) - 5 mg wafer 2 pack.