SUMMARY CMI

APO-ZOLMITRIPTAN 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 APO-ZOLMITRIPTAN?

APO-ZOLMITRIPTAN contains the active ingredient zolmitriptan.

APO-ZOLMITRIPTAN is used to relieve migraine.

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

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

Do not use if APO-ZOLMITRIPTAN if you are pregnant or breastfeeding unless your doctor says so. Do not give APO-ZOLMITRIPTAN to children.

Tell your doctor if you have any allergies or other medical conditions.

For more information, see Section 2. What should I know before I use APO-ZOLMITRIPTAN? in the full CMI.

3. What if I am taking other medicines?

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

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-ZOLMITRIPTAN?

• One tablet (2.5 mg) as soon as you feel the migraine headache start.
• If your migraine is still present after two hours, or if it returns within 24 hours, you can take another tablet.
• APO-ZOLMITRIPTAN can be taken with or without food.
• Do not take more than 10 mg (four 2.5 mg tablets) in twenty-four hours.
• More instructions can be found in Section 4. How do I use APO-ZOLMITRIPTAN? in the full CMI.

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

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

6. Are there any side effects?

There are a number of side effects associated with this medicine. It is important to be aware of them so that you can identify any symptoms if they occur (see the full CMI for more details). The serious side effects are: signs of allergy; fast or irregular heart beats; a feeling of tightness in the chest; numbness or loss of strength of the arms or legs, headache, dizziness, confusion, visual disturbance, difficulty swallowing, slurred speech or loss of speech; bloody diarrhoea or prolonged stomach pain. The common side effects are increased feeling or sensitivity in the skin; feeling warm, feelings of heaviness in the throat, neck arm or legs; unusual tiredness or weakness; aching muscles; headache; dizziness; flushing; sleepiness; stomach pain; vomiting or nausea dry mouth.

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-ZOLMITRIPTAN Tablets

Active ingredient: Zolmitriptan

Consumer Medicine Information (CMI)

This leaflet provides important information about using APO-ZOLMITRIPTAN tablets. It does not contain all 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 risks of you taking APO-ZOLMITRIPTAN against the benefits this medicine is expected to have for you.

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-ZOLMITRIPTAN.

Keep this leaflet with your medicine. You may need to read it again.

Where to find information in this leaflet:

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

1. Why am I using APO-ZOLMITRIPTAN?

APO-ZOLMITRIPTAN belongs to a group of medicines called serotonin agonists. These medicines are used to relieve migraine.

Migraine is thought to be caused by the widening of certain blood vessels in the brain. APO-ZOLMITRIPTAN makes the blood vessels narrower to ease the migraine.

Some people have a warning stage called 'aura' before the migraine headache starts. Aura can include numbness in the face or down one arm, changes in mood, or problems with eyesight such as seeing blank spots or flashing lights.

APO-ZOLMITRIPTAN can be used in migraine with or without aura. It should not be used to treat types of migraine called 'hemiplegic' or 'basilar' migraine.

APO-ZOLMITRIPTAN does not work in headaches that are not migraine.

Your doctor will have explained why you are being treated with APO-ZOLMITRIPTAN and told you what dose to take.

Follow all directions given to you by your doctor carefully. They may differ from the information contained in this leaflet.

Your doctor may prescribe this medicine for another use. Ask your doctor if you want more information.

APO-ZOLMITRIPTAN is not addictive.

Use in Children

There is no experience of its use in children under 12 years of age.

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

Warnings

Do not use APO-ZOLMITRIPTAN if:

• you are pregnant or breastfeeding unless your doctor says so. The safety of taking this medicine when you are pregnant is unknown.

Do not give APO-ZOLMITRIPTAN to children. One study in children aged 12 to 17 years indicated no benefit with APO-ZOLMITRIPTAN treatment.

Do not use APO-ZOLMITRIPTAN if the packaging is torn or shows signs of tampering.

Do not give this medicine to anyone else.

If you are not sure whether you should be taking APO-ZOLMITRIPTAN, talk to your doctor.

Do not use APO-ZOLMITRIPTAN if the packaging is torn or shows signs of tampering. Do not use APO-ZOLMITRIPTAN beyond the expiry date printed on the pack.

Check with your doctor or pharmacist if you:

• have allergies to any other medicines, foods, preservatives or dyes, or any ingredients listed at the end of this leaflet. If you have an allergic reaction, you may get a skin rash, hayfever, difficulty breathing or feel faint.
• have or have had any of the following medical conditions:
  - high blood pressure
  - a feeling of tightness, pressure of heaviness in the chest
  - a heart attack, other heart problems or a family history of heart problems
  - a stroke or dizzy spells caused by lack of blood flow to the brain
  - blood vessel problems that cause poor circulation in the arms or legs
  - kidney or liver disease
  - high cholesterol levels in the blood
  - diabetes

It may not be safe for you to take APO-ZOLMITRIPTAN if you have any of these conditions. Your doctor may decide to do tests to check if your heart is healthy before prescribing APO-ZOLMITRIPTAN tablets.

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?

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 may be affected by APO-ZOLMITRIPTAN 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 will advise you.

In particular, you should tell your doctor if you are taking or have recently taken medicines like:

• other medicines for migraine, such as sumatriptan, naratriptan, ergotamine, dihydroergotamine or methysergide
• medicines for depression
• cimetidine for the treatment of indigestion or stomach ulcers
• antibiotics known as quinolones (eg noroxin).
• St John's Wort (Hypericum perforatum).

If you have not told your doctor about any of these things, tell them before you take any APO-ZOLMITRIPTAN.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking APO-ZOLMITRIPTAN.

4. How do I use APO-ZOLMITRIPTAN?

Follow all directions given to you by your doctor or pharmacist. They may differ from the information contained in this leaflet.

If you do not understand the instructions on the box ask your doctor or pharmacist for help.

How much to take

The usual dose is one tablet (2.5 mg) as soon as you feel the migraine headache start.

If your migraine is still present after two hours, or if it returns within 24 hours, you can take another tablet.

Your doctor may prescribe another dose of APO-ZOLMITRIPTAN depending on your condition and how you respond to this medicine.

Do not take more than 10 mg (four 2.5 mg tablets) in twenty-four hours.

When to take / use APO-ZOLMITRIPTAN

You can take APO-ZOLMITRIPTAN when you feel the headache start or after it has already begun.

APO-ZOLMITRIPTAN tablets should only be taken to treat the migraine headache after it has started. They should not be used to prevent the migraine attacks from occurring.

How to take APO-ZOLMITRIPTAN?

• Swallow the tablet whole with a full glass of water.
• APO-ZOLMITRIPTAN can be taken with or without food.
• If you accidentally take a larger dose than recommended, tell your doctor immediately.
• If you do not understand the instructions provided with this medicine, ask your doctor or pharmacist for help.

If you use too much APO-ZOLMITRIPTAN

If you think that you have used too much APO-ZOLMITRIPTAN, 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. You may need urgent medical attention.

You may need urgent medical attention.

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

Things you should do

Tell any other doctors, dentists and pharmacists who are treating you that you are taking APO-ZOLMITRIPTAN.

If you are about to start any new medicine, tell your doctor or pharmacist that you are taking APO-ZOLMITRIPTAN.

Things you should not do

• Do not take APO-ZOLMITRIPTAN 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

Driving or using machines

Be careful driving or operating machinery until you know how APO-ZOLMITRIPTAN affects you.

APO-ZOLMITRIPTAN can make some people feel dizzy or sleepy. Make sure you know how you react to APO-ZOLMITRIPTAN before you do anything that could be dangerous if you are dizzy or sleepy.

Looking after your medicine

• Keep APO-ZOLMITRIPTAN tablets in the original pack until it is time to take them.
• Keep APO-ZOLMITRIPTAN tablets in a cool dry place where the temperature is below 25°C.

Do not store APO-ZOLMITRIPTAN, or any other medicine, in the bathroom or near a sink.

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

Keep your medicines where children cannot reach them. A locked cupboard at least one-and-a-half metres (1.5 m) above the ground is a good place to store medicines.

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.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Less serious side effects

Serious side effects

These are serious side effects. If you have them, you may have had a serious reaction to APO-ZOLMITRIPTAN. You may need urgent medical attention or hospitalisation.

Serious side effects are rare.

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 available with a doctor's prescription.

What APO-ZOLMITRIPTAN contains

This medicine does not contain sucrose, gluten, tartrazine or any other azo dyes.

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

What APO-ZOLMITRIPTAN looks like

APO-ZOLMITRIPTAN 2.5 mg are light pink, round, film-coated tablets, debossed with ‘2.5’ on one side and plain on the other.

APO-ZOLMITRIPTAN 2.5 mg tablets are presented in blister packs containing 2 tablets.

AUST R 200878

Who distributes APO-ZOLMITRIPTAN

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 May 2025

1 Name of Medicine

Zolmitriptan.

2 Qualitative and Quantitative Composition

Each tablet contains 2.5 mg zolmitriptan, as the active ingredient.

Excipients with known effect.

3 Pharmaceutical Form

2.5 mg film coated tablet.

4 Clinical Particulars

4.1 Therapeutic Indications

Zolmitriptan is indicated for the acute treatment of migraine with or without aura.

4.2 Dose and Method of Administration

APO-Zolmitriptan tablets are intended for oral administration.
The tablet should be swallowed whole with water.

Dosage.

Patient sub-groups.

Paediatric use.

Use in the elderly.

Use in adults with hepatic impairment.

Use in adults with renal impairment.

Instructions for use/handling.

4.3 Contraindications

Zolmitriptan is contraindicated in the following cases:
Hypersensitivity to any component of the product.
A history of myocardial infarction.
Ischaemic heart disease; Prinzmetal angina/coronary vasospasm; peripheral vascular disease; symptoms or signs consistent with ischaemic heart disease.
Moderate or severe hypertension and mild uncontrolled hypertension.
Ergotamine or ergotamine derivatives should not be used concomitantly with zolmitriptan.
Other 5HT_1D receptor agonists should not be used concomitantly with zolmitriptan.
Creatinine clearance of less than 15 mL/min.
On theoretical grounds (see Section 5 Pharmacological Properties), zolmitriptan should not be administered to patients with a history of cerebrovascular accident (CVA) or transient ischaemic attack (TIA).

4.4 Special Warnings and Precautions for Use

Cerebrovascular events have been reported in patients treated with 5HT₁ agonists, some resulting in fatalities. In a number of cases, it appears that the cerebrovascular events were primary, the agonist having been administered in the incorrect belief that the symptoms were a consequence of the migraine. Zolmitriptan should only be used when a clear diagnosis of migraine has been established. Care should be taken to exclude other potentially serious neurological conditions. There are no data on the use of zolmitriptan in hemiplegic or basilar migraine.
Migraneurs may be at risk of certain cerebrovascular events. Cerebral haemorrhage, subarachnoid haemorrhage, stroke, and other cerebrovascular events have been reported in patients treated with 5HT₁ agonists.
There have been rare reports of anaphylaxis/anaphylactoid reactions in patients receiving zolmitriptan.
Zolmitriptan should not be given to patients with symptomatic Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathways.
This class of compounds (5HT_1B/1D agonists) has been associated with coronary vasospasm, angina pectoris and myocardial infarction. In very rare cases this has occurred with zolmitriptan. In patients with risk factors for ischaemic heart disease, cardiovascular evaluation prior to commencement of treatment with this class of compounds, including zolmitriptan, is recommended (see Section 4.3 Contraindications). These evaluations, however, may not identify every patient who has cardiac disease, and in very rare cases, serious cardiac events have occurred in patients without underlying cardiovascular disease.
As with other 5HT_1D agonists, atypical sensations over the precordium (see Section 4.8 Adverse Effects (Undesirable Effects)) have been reported after the administration of zolmitriptan. Where such symptoms are thought to indicate ischaemic heart disease, no further doses of zolmitriptan should be given and appropriate evaluation carried out.
Serotonin syndrome has been reported with combined use of triptans, and selective serotonin reuptake inhibitors (SSRIs) and serotonin noradrenaline reuptake inhibitors (SNRIs). Serotonin syndrome is a potentially life-threatening condition, and it may include signs and symptoms such as: mental status changes (e.g. agitation, hallucinations, coma), autonomic instability (e.g. tachycardia, labile blood-pressure, hyperthermia), neuromuscular aberrations (e.g. hyperreflexia, in-coordination, weakness), and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea).
In accordance with the Hunter Criteria, diagnosis is likely when (in presence of a serotonergic agent) one of the following is observed:
Spontaneous clonus;
Inducible or ocular clonus with agitation or diaphoresis;
Tremor and hyperreflexia;
Hypertonia and body temperature > 38°C and inducible or ocular clonus.
Careful observation of the patient is advised when zolmitriptan is administered with an SSRI or SNRI, particularly during treatment initiation and dosage increases (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
Withdrawal of the serotonergic medicines usually brings about an improvement. Treatment depends on the type and severity of the symptoms.
Overuse of acute migraine medications may lead to exacerbations 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 medications, and treatment of withdrawal symptoms (which often includes a transient worsening of headache) may be necessary.
Transient increases in systemic blood pressure (which may be more pronounced in the elderly) have been reported in patients with and without a history of hypertension; very rarely these increases in blood pressure have been associated with significant clinical events.

Use in adults with hepatic impairment.

Use in adults with renal impairment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

There is no evidence that concomitant use of migraine prophylactic medications has any effect on the efficacy or unwanted effects of zolmitriptan (for example beta-blockers, oral dihydroergotamine, pizotifen).
The pharmacokinetics and tolerability of zolmitriptan were unaffected by acute symptomatic treatments such as paracetamol, metoclopramide and ergotamine. Concomitant administration of other 5HT_1D agonists within 24 hours of zolmitriptan treatment should be avoided.
Data from healthy subjects suggest there are no pharmacokinetic or clinically significant interactions between zolmitriptan and ergotamine. However, the increased risk of coronary vasospasm is a theoretical possibility, and concomitant administration is contraindicated. It is advised to wait at least 24 hours following the use of ergotamine containing preparations before administering zolmitriptan. Conversely it is advised to wait at least six hours following use of zolmitriptan before administering an ergotamine containing product.
The major metabolite of zolmitriptan, the indole acetic acid (2161W92), is derived from the active metabolite, N-desmethyl zolmitriptan (183C91), by the action of monoamine oxidase A. This is evidenced by the effects of co-administration of the selective MAO-A inhibitor, moclobemide, which resulted in a 3-fold increase in the exposure to N-desmethylzolmitriptan but had minimal effects (increase of 26% in AUC) on zolmitriptan levels. (The metabolite N-desmethylzolmitriptan is also a 5HT_1D agonist with higher receptor affinity than the parent drug and therefore contributes to the overall effect after zolmitriptan administration). Hence, in patients taking a MAO-A inhibitor (selective or non-selective), a maximum intake of 5 mg zolmitriptan in 24 hours is recommended.
Following the administration of cimetidine, a general P450 inhibitor, the half-life of zolmitriptan was increased by 44% and the AUC increased by 48%. In addition, the half-life and AUC of the active, N-desmethylated, metabolite (N-desmethylzolmitriptan) were doubled. A maximum dose of 5 mg zolmitriptan in 24 hours is recommended in patients taking cimetidine. Based on the overall interaction profile, an interaction with inhibitors of the cytochrome P450 isoenzyme CYP1A2 cannot be excluded. Therefore, the same dosage reduction is recommended with compounds of this type, such as fluvoxamine and the quinolone antibiotics (e.g. ciprofloxacin). Following the administration of rifampicin, no clinically relevant differences in the pharmacokinetics of zolmitriptan or its active metabolite were observed.
Cases of life-threatening syndrome have been reported during combined use of triptans and SSRIs (e.g. fluoxetine, fluvoxamine, paroxetine, sertraline) and SNRIs (e.g. venlafaxine) (see Section 4.4 Special Warnings and Precautions for Use).
As with other 5HT_1B/1D agonists, there is a potential pharmacodynamic interaction with the herbal remedy, St. John's wort (Hypericum perforatum), which may result in an increase in undesirable effects.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

Even though there was no significant impairment of psychomotor test performances in healthy volunteers following doses of up to 20 mg, somnolence was reported in pharmacological and clinical trials. Caution is recommended in patients performing skilled tasks (e.g. driving or operating machinery) as drowsiness and other symptoms may occur during a migraine attack and following treatment.

4.8 Adverse Effects (Undesirable Effects)

Zolmitriptan is well tolerated. Adverse reactions are typically mild/moderate, transient, not serious and resolve spontaneously without additional treatment. The adverse event profile has been demonstrated to be similar for the administration of either 2.5 mg or 5 mg of zolmitriptan.
Possible adverse reactions tend to occur within four hours of dosing and are no more frequent following repeated dosing; certain symptoms may be considered to be part of the migraine attack itself.

Clinical trial data.

Zolmitriptan tablet (2.5 mg and 5 mg) controlled clinical studies.

Atypical sensation.

General.

Cardiovascular.

Digestive.

Haemic.

Metabolic.

Musculoskeletal.

Neurological.

Respiratory.

Skin.

Special senses.

Urogenital.

Post-marketing data.

Reporting suspected adverse effects.

4.9 Overdose

Volunteers receiving single oral doses of 50 mg commonly experienced sedation.
The elimination half-life of zolmitriptan tablets is 2.5 to 3 hours, (see Section 5.2 Pharmacokinetic Properties) and therefore monitoring of patients after overdose with zolmitriptan tablets should continue for at least 15 hours or while symptoms or signs persist.
There is no specific antidote to zolmitriptan. In cases of severe intoxication, intensive care procedures are recommended, including establishing and maintaining a patent airway, ensuring adequate oxygenation and ventilation, and monitoring and support of the cardiovascular system.
It is unknown what effect haemodialysis or peritoneal dialysis has on the serum concentrations of zolmitriptan.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

Treatment of acute migraine, with or without aura, with zolmitriptan tablets.

5.2 Pharmacokinetic Properties

Absorption.

Distribution.

Metabolism.

Excretion.

Special patient populations.

Hepatic impairment.

Renal impairment.

Pharmacokinetic interaction with other medications.

Elderly.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Microcrystalline cellulose, lactose, sodium starch glycollate type A, magnesium stearate and Opadry complete film coating system 02G84574 (PI 108588): hypromellose, titanium dioxide, macrogol 400, macrogol 8000, iron oxide red.

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 25°C. Store in original container.

6.5 Nature and Contents of Container

Blister pack (aluminum foil/aluminum foil) of 2 or 6 tablets (AUST R 200878).
APO and APOTEX are registered trademarks of Apotex Inc.
Not all pack sizes may be available.

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

Zolmitriptan is a white to almost white powder slightly soluble in water (1.3 mg/mL at 250°C) but shows greater solubility in 0.1 M hydrochloric acid. Zolmitriptan has a pKa of 9.6. Zolmitriptan is a chiral molecule, which is synthesized as the S enantiomer.

Chemical name.

Chemical structure.

Molecular formula.

Molecular weight.

CAS number.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes