Apo-Zolmitriptan: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

The name of your medicine is APO-ZOLMITRIPTAN or APO-ZOLMITRIPTAN RAPID which can only be obtained by prescription from your doctor. The decision to use APO-ZOLMITRIPTAN/APO- ZOLMITRIPTAN RAPID is one that you and your doctor should make jointly, taking into account your individual preferences and medical circumstances. If you have risk factors for heart disease (such as high blood pressure, high cholesterol, obesity, diabetes, smoking, strong family history of heart disease, or you are a post-menopausal female, or a male over 40), tell your doctor. Your doctor should evaluate you for heart disease in order to determine if APO- ZOLMITRIPTAN/APO-ZOLMITRIPTAN RAPID is appropriate for you.

What the medication is used for:

APO-ZOLMITRIPTAN and APO-ZOLMITRIPTAN

RAPID belong to a group of anti-migraine drugs called 5-HT₁ agonists. APO-ZOLMITRIPTAN/APO-

ZOLMITRIPTAN RAPID is used to relieve your migraine headache and other associated symptoms of a migraine attack.

APO-ZOLMITRIPTAN/APO-ZOLMITRIPTAN RAPID

should not be used continuously to prevent or reduce the number of attacks you experience. Use APO-ZOLMITRIPTAN/APO-ZOLMITRIPTAN RAPID

only to treat an actual migraine headache attack. What it does:

Migraine headache is believed to be caused by a widening of the blood vessels in the head APO- ZOLMITRIPTAN/APO-ZOLMITRIPTAN RAPID narrows the vessels and relieves the pain and other symptoms of migraine headache.

When it should not be used:

APO-ZOLMITRIPTAN/APO-ZOLMITRIPTAN RAPID

should not be used if:

• you are allergic to zolmitriptan or any of the other ingredients in APO-ZOLMITRIPTAN/APO- ZOLMITRIPTAN RAPID (see “WHAT THE NONMEDICINAL INGREDIENTS ARE”)
• you have a history, or any symptoms or signs of a heart condition.
• you suffer from chest pain, occurring either on exertion or at rest (the latter condition is known as Prinzmetal’s Angina.
• you have severe or uncontrolled hypertension.
• you are taking or have recently taken (within 24 hours) an ergotamine containing or ergot-like drug, or another triptan used to treat migraines.
• you have another type of headache that is different from a migraine attack
• you are taking or have recently taken (within 2 weeks) a monoamine oxidase inhibitor (MAOI)

What the medicinal ingredient is:

APO-ZOLMITRIPTAN and APO-ZOLMITRIPTAN

RAPID tablets contain 2.5 mg of zolmitriptan as the active ingredient.

What the important nonmedicinal ingredients are:

APO-ZOLMITRIPTAN contains: Hydroxypropyl methylcellulose, Hydroxypropyl cellulose, Lactose Monohydrate, Microcrystalline cellulose, Magnesium stearate, Polyethylene glycol 8000, Sodium starch glycolate, Titanium dioxide, Yellow iron oxide.

APO-ZOLMITRIPTAN RAPID contains:

Aspartame, Colloidal Silicon Dioxide, Crospovidone, orange natural flavor, Magnesium stearate, Mannitol, Microcrystalline Cellulose.

What dosage forms it comes in:

APO-ZOLMITRIPTAN is supplied in conventional tablets of 2.5 mg in blister packs containing 3 or 6 tablets.

APO-ZOLMITRIPTAN RAPID is supplied in orally disintegrating tablets of 2.5 mg in blister packs containing 2 or 6 tablets.

WARNINGS AND PRECAUTIONS

BEFORE you use APO-ZOLMITRIPTAN/APO-

ZOLMITRIPTAN RAPID talk to your doctor or pharmacist if the answer to any of the following questions is YES, or if you do not know the answer:

• Are you pregnant, think you might be pregnant, or trying to become pregnant? Are you using inadequate contraception? Are you breastfeeding?

• Do you or have you ever experienced any pain or tightness in the chest, (which may or may not spread to your neck, jaw, or upper arm), shortness of breath, or irregular heartbeats (including a fast heart beat called Wolff-Parkinson-White syndrome)? Do you have angina? Have you ever had heart or blood
• vessel disease? Do you have a history of cerebral bleeding? Have you had a heart attack or stroke?
• Do you have risk factors for heart disease, such as: high blood pressure, high cholesterol, smoking, obesity, diabetes, or strong family history of heart disease?
• Do you have a condition called phenylketonuria (a specific blood disorder)?
• Do you have rare hereditary problems of galactose intolerance?
• Are you post-menopausal or a male over 40?
• Do you have high blood pressure?
• Have you ever had to stop taking this or any other medication because of an allergy or other problems?
• Are you taking any other migraine 5-HT₁ agonist medications such as sumatriptan succinate, naratriptan hydrochloride, rizatriptan benzoate, almotriptan malate or migraine medications containing ergotamine, dihydroergotamine, or methysergide?
• Are you taking any medications for depression such as selective serotonin reuptake inhibitors (SSRI’s), for example, fluoxetine hydrochloride, sertraline hydrochloride, fluvoxamine maleate, paroxetine hydrochloride, etc., or serotonin norepinephrine reuptake inhibitors (SNRIs), for example, venlafaxine hydrochloride, or monoamine oxidase inhibitors (MAOIs), for example, phenelzine sulfate, tranylcypromine sulfate or moclobemide?
• Have you ever experienced numbness on one side of your body when you have a headache?
• Have you ever had epilepsy or seizures?
• Have you ever had liver disease?
• Are you over 65 years of age?
• Is this headache different from your usual migraine attacks?

• Are you taking cimetidine (for treatment of indigestion or stomach ulcers) or a member of the quinolone family of antibiotics (for example ciprofloxacin)?

  As with other migraine treatments, using too much APO-ZOLMITRIPTAN / APO-

ZOLMITRIPTAN RAPID can cause daily headaches or can make your migraine headaches worse. Ask your doctor if you think that this is the case for you. You may need to stop using APO-ZOLMITRIPTAN / APO-

ZOLMITRIPTAN RAPID to correct the problem.

APO-ZOLMITRIPTAN tablets contain lactose which is a type of sugar. If you have been told by your doctor that you cannot tolerate or digest milk or some sugars, talk to your doctor before taking this medicine.

Use of APO-ZOLMITRIPTAN/APO-ZOLMITRIPTAN

RAPID during pregnancy:

Do not use APO-ZOLMITRIPTAN or APO- ZOLMITRIPTAN RAPID if you are pregnant, think you might be pregnant, are trying to become pregnant or are using inadequate contraception, unless you have discussed this with your doctor.

Tell your doctor or pharmacist about any other drugs, vitamins, minerals, natural supplements or alternative medicines you take, including:

• other 5-HT₁ agonist migraine drugs (sumatriptan succinate, naratriptan hydrochloride, rizatriptan benzoate, almotriptan malate) or migraine drugs that contain ergotamine, dihydroergotamine, methysergide
• drugs for depression such as selective serotonin reuptake inhibitors (SSRI’s), for example, fluoxetine hydrochloride, sertraline hydrochloride, fluvoxamine maleate, paroxetine hydrochloride, etc., or serotonin norepinephrine reuptake inhibitors (SNRIs), for example, venlafaxine hydrochloride, or monoamine oxidase inhibitors (MAOIs), for example, phenelzine sulfate, tranylcypromine sulfate or moclobemide
• drugs used to treat upset stomach or stomach ulcers (cimetidine)
• antibiotics from the quinolone family (for example ciprofloxacin)
• Herbal remedies containing St John’s wort

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those that can be bought without a prescription

PROPER USE OF THIS MEDICATION

Usual Dose:

Adults

The usual dosage is 2.5 mg, or lower if recommended by your doctor. A lower dose can be obtained by manually breaking a conventional tablet in half. The APO-ZOLMITRIPTAN RAPID 2.5mg orally

disintegrating tablets cannot be broken in half. The dose should be taken as soon as your migraine appears, but it may be taken at any time during your migraine headache. Swallow your dose with water.

APO-ZOLMITRIPTAN RAPID orally disintegrating tablets should be pushed through the foil to open. The APO-ZOLMITRIPTAN RAPID tablet should be placed on the tongue, where it will dissolve with the saliva. Water is not needed for the disintegrating tablet.

A second dose may be taken if your headache returns, but not sooner than 2 hours following the first tablet. For any attack where you have no response to the first dose, do not take a second dose without first consulting your doctor.

Do not administer more than 10 mg in any 24 hour period.

Overdose:

Although the vast majority of zolmitriptan tablets and zolmitriptan orally disintegrating tablets users have not experienced any significant problems, you should be aware that the following side effects may occur.

Commonly reported side effects of zolmitriptan tablets and zolmitriptan orally disintegrating tablets is:

• feeling sick
• vomiting
• dizziness
• tiredness
• weakness

APO-ZOLMITRIPTAN/APO-ZOLMITRIPTAN RAPID

may cause drowsiness. Do not drive or operate machinery until you are sure that you are not drowsy.

Other common side effects include:

• muscle aches and pains
• difficulty swallowing
• dry mouth
• headache
• stomach pain

Uncommon side effects include:

• increase in the production of urine or in the frequency of urination

Tell your doctor of these symptoms at your next visit.

Migraineurs may be at risk of certain cerebrovascular events such as cerebral bleeding and stroke. In very rare cases, as with other drugs of this type, such diseases have been reported in association with the use of zolmitriptan.

In very rare cases, as with other drugs of this type (5HT₁ agonists), the following side effects have been reported:

• spasm of the blood vessels of the heart
• spasm of the blood vessels of the Gastro-Intestinal tract and spleen with possible infarctions

See the following table for what to do about serious side effects.

Serious side effects and what to do about them

For any unexpected effects while taking APO- ZOLMITRIPTAN and APO-ZOLMITRIPTAN RAPID, contact your doctor or pharmacist.

HOW TO STORE IT

APO-ZOLMITRIPTAN RAPID tablets should be stored at controlled room temperature 15°C to 30°C Protect from moisture.

APO-ZOLMITRIPTAN tablets should be stored at controlled room temperature 15°C to 25°C. Protect from moisture.

Keep all medicine in a safe place out of the reach of children.

If your doctor decides to stop your treatment, return your medicine to the pharmacist for disposal. Do not take your medication after the expiry date on the package and blister foil. Return the tablets to your pharmacist for disposal.

REPORTING SIDE EFFECTS

MORE INFORMATION

If you want more information about APO-ZOLMITRIPTAN or APO-ZOLMITRIPTAN RAPID

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp); the manufacturer’s website http://www.apotex.ca/products, or by calling 1-800-667-4708.

Last revised: April 2, 2020