Apo-Sumatriptan (Apotex, 5 mg, 20 mg): Uses, Side Effects and Dosage

What is APO-SUMATRIPTAN Nasal Spray used for?

APO-SUMATRIPTAN nasal spray is used in adults to relieve migraine headaches. These migraine headaches may or may not be accompanied by an aura. This is when you may see black spots, flashes of light or shimmering spots or stars. APO-SUMATRIPTAN nasal spray should not be used to prevent or reduce the number of headaches you experience. Use APO-SUMATRIPTAN nasal spray only to treat an actual migraine headache attack.

How does APO-SUMATRIPTAN Nasal Spray work?

Migraine headache is believed to be caused by a widening of the blood vessels in the head. APO-SUMATRIPTAN narrows these vessels and relieves the symptoms of migraine headache.

What are the ingredients in APO-SUMATRIPTAN Nasal Spray?

Medicinal ingredients: sumatriptan hemisulphate.

Non-medicinal ingredients: anhydrous dibasic sodium phosphate, monobasic potassium phosphate, purified water, sodium hydroxide and sulphuric acid.

APO-SUMATRIPTAN Nasal Spray comes in the following dosage forms:

Spray; 5 mg, 20 mg.

Do not use APO-SUMATRIPTAN Nasal Spray if:

• you are allergic to sumatriptan or to any of the ingredients in APO-SUMATRIPTAN nasal spray. (See “What are the ingredients in APO-SUMATRIPTAN nasal spray?”).
• you have a heart problem such as heart failure or chest pains (angina), or have already had a heart attack.
• you have had a stroke or a mini-stroke (also called a transient ischaemic attack or TIA).
• you have a history, symptoms or signs of peripheral vascular disease. This is a reduced blood flow to the limbs and organs other than the heart and brain, such as ischemic bowel disease and Raynaud’s syndrome.
• you have uncontrolled or severe high blood pressure.
• you are taking or have taken within the past 2 weeks, a monoamine oxidase inhibitor (MAO), medication (such as phenelzine sulfate, tranylcypromine sulfate, moclobemide or selegiline).
• you are taking or have taken within the past 24 hours, medication containing ergotamine, dihydroergotamine, methysergide, or another triptan used to treat migraine headaches. If you are not sure if you have been prescribed these types of medications, ask your healthcare professional.
• you have severe liver problems.

• you have certain other types of migraine headaches including:

  • hemiplegic migraines. These are migraine headaches where you have weakness on one side of your body, or
  • basilar migraines. These are migraine headaches that start in the lower part of the brain, or
  • ophthalmoplegic migraines. These are migraine headaches where you have pain around the eyes.

If you are not sure if you have these types of migraines, ask your healthcare professional.

APO-SUMATRIPTAN nasal spray should not be used for the treatment of other types of headaches that are different from migraine attacks.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take APO-SUMATRIPTAN Nasal Spray. Talk about any health conditions or problems you may have, including if you:

• are pregnant, think you might be pregnant, or are trying to become pregnant.

• are breastfeeding. The active ingredient in APO-SUMATRIPTAN nasal spray, sumatriptan, will pass into your breast milk. Avoid breastfeeding for 24 hours after taking APO-SUMATRIPTAN nasal spray.
• have risk factors for heart disease. This includes high blood pressure, high cholesterol, obesity, diabetes, smoking, strong family history of heart disease, or you are postmenopausal or a male over 40.
• have ever had to stop taking this or any other medication because of an allergy or other problems, or you are allergic to drugs containing sulphonamides
• are under 18 years of age
• are over 65 years of age
• had or have any liver or kidney problems.
• had or have epilepsy or seizures.
• experience a headache that is different from your usual migraine attacks.

Other warnings you should know about:

Taking APO-SUMATRIPTAN Nasal Spray can cause serious side effects, including:

• Serious heart problems
• Long term eye problems
• Raynaud’s Syndrome

See the Serious side effects and what to do about them table, below for more information on these and other serious side effects.

Serotonin toxicity (also known as Serotonin syndrome): APO-SUMATRIPTAN nasal spray can cause serotonin toxicity, a rare but potentially life-threatening condition. It can cause serious changes in how your brain, muscles and digestive system work. You may develop serotonin toxicity if you take APO-SUMATRIPTAN nasal spray with certain medication to treat depression.

Serotonin toxicity symptoms include:

• fever, sweating, shivering, diarrhea, nausea, vomiting;
• muscle shakes, jerks, twitches or stiffness, overactive reflexes, loss of coordination;
• fast heartbeat, changes in blood pressure;
• confusion, agitation, restlessness, hallucinations, mood changes, unconsciousness, and coma.

Continuous use of APO-SUMATRIPTAN Nasal Spray: APO-SUMATRIPTAN nasal spray should not be used continuously to prevent or reduce the number of attacks you experience. Use APO-SUMATRIPTAN nasal spray only to treat an actual migraine headache attack. If you use APO-SUMATRIPTAN nasal spray too often, it may make your migraine headaches worse. If this happens, your healthcare professional may tell you to stop using APO-SUMATRIPTAN nasal spray.

Driving and Operating Machines: APO-SUMATRIPTAN nasal spray can cause dizziness which may affect your ability to drive or use machines. Wait to see how you respond to APO-SUMATRIPTAN nasal spray before you drive or use machines.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with APO-SUMATRIPTAN Nasal Spray:

• Medicines used to treat depression such as MAO Inhibitors, selective serotonin reuptake inhibitors (SSRIs), and serotonin noradrenaline reuptake inhibitors (SNRIs).
• Other medicines used to treat migraine headaches such as triptans, 5-HT₁ agonists, ergotamine, dihydroergotamine, and methysergide.

How to use APO-SUMATRIPTAN Nasal Spray:

• Before using the APO-SUMATRIPTAN nasal spray device, read the instructions below for information on how to use it.
• APO-SUMATRIPTAN nasal spray comes ready to use. DO NOT test the spray before using.
• Take APO-SUMATRIPTAN nasal spray as one spray into one nostril.
• APO-SUMATRIPTAN nasal spray can be taken at any time during your migraine headache.
• It may take up to 15 minutes for APO-SUMATRIPTAN nasal spray to start working.
• If after taking APO-SUMATRIPTAN nasal spray you need more pain relief, you can take another pain medication. This medication should not contain ergotamine. If you are not sure which medications you can use talk to your healthcare professional.

Remember, this medicine has been prescribed only for you. Do not give it to anybody else, as they may experience undesirable effects, which may be serious.

Instructions for use of your APO-SUMATRIPTAN nasal spray:

This explains how to use the APO-SUMATRIPTAN nasal spray device. Read it several times to make sure you understand it before you begin the first step. If you have any questions, ask your healthcare professional.

The Nasal Spray Pack

• Your APO-SUMATRIPTAN nasal spray is packed in a box containing two separate nasal spray devices. Each device contains one dose of APO-SUMATRIPTAN.
• Keep your APO-SUMATRIPTAN nasal spray in the box to help protect it from light and damage.
• Keep this information leaflet in a safe place. This leaflet tells you how to use your nasal spray device and provides other useful information about your medicine.

The APO-SUMATRIPTAN nasal spray device consists of the following parts (See Figure 1):

Nozzle: This is the part that you put into your nostril. The spray comes out of a tiny hole in the top.

Finger-Grip: This is the part that you hold when you use the device.

Plunger: When you press the plunger the entire dose sprays into your nostril. The Plunger only works once so do not press it until you have inserted the nozzle into your nostril or you will waste the dose.

Figure 1

How to use APO-SUMATRIPTAN Nasal Spray:

Do not remove the nasal spray device from the carton until you are ready to use it.

1. 1. Blow your nose if it feels blocked.
2. 2. Hold the nasal spray device gently with your fingers and thumb as shown in Figure 2. Do not press the plunger yet.
3. 3. Block one nostril by pressing a finger firmly on the side of your nose, and breathe out gently through your mouth.

Figure 2

1. 4. Put the nozzle of the nasal spray device into your other nostril, as far as it feels comfortable.

Figure 3

Nozzle

Finger-Grip

Plunger

1. 5. Hold your head in an upright position, looking straight ahead and close your mouth. Do not tilt your head and do not lie down.
2. 6. Start to breathe in gently through your nose and at the same time press the plunger firmly with your thumb. This will spray the entire dose into your nostril.

Note: The plunger may feel a bit stiff and you may hear it click.

1. 7. Keep your head upright, looking straight ahead and breathe in gently through your nose and out through your mouth for 10 to 20 seconds. Do not breathe deeply. This helps the medicine stay in your nose so that it can be absorbed into your body. You can remove the device and your finger from the other side of your nose while you do this.
2. 8. Your nose may feel wet inside and you may notice a slight taste after using the spray. This is normal and will soon pass.

9 Your nasal spray device is now empty. It should be disposed of safely and hygienically.

Usual dose:

• The usual adult dose is 5mg.
• Based on your response and tolerability, your healthcare professional may increase your dose to 20 mg. The maximum dose is 20 mg.
• If the first dose of APO-SUMATRIPTAN nasal spray does not help, DO NOT take another dose for the same attack.
• If your symptoms come back, and it has been two or more hours since your first dose, you may take a second dose.
• DO NOT take more than 40 mg in any 24-hour period.

Overdose:

If you think you, or a person you are caring for, have taken too much APO-SUMATRIPTAN nasal spray, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.

What are possible side effects from using APO-SUMATRIPTAN nasal spray?

These are not all the possible side effects you may feel when taking APO-SUMATRIPTAN nasal spray. If you experience any side effects not listed here, contact your healthcare professional.

The most commonly reported side effects of APO-SUMATRIPTAN nasal spray are:

• flushing (redness of the face lasting for a short time)
• feeling sick or vomiting
• dizziness
• drowsiness
• tiredness
• weakness
• unpleasant taste
• temporary increase in blood pressure
• irritation or burning sensation in the nose or throat, nose bleeds

Other side effects include:

• trouble with eyesight, such as blind spots, flashes of light, and seeing two images of a single object.
• shaking, tremors or uncontrolled movements
• loss of normal colour in the fingers and toes.

Serious side effects and what to do about them

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Reporting Side Effects

Storage:

Keep APO-SUMATRIPTAN nasal spray away from heat and light. Always keep APO-SUMATRIPTAN nasal spray in the carton provided and store between 15°C to 30°C.

Medicines should not be disposed of via waste water or household waste. Your healthcare professional will throw away any medicines that are no longer being used. These measures will help protect the environment.

Keep out of reach and sight of children.

If you want more information about APO-SUMATRIPTAN:

• 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://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (http://www.apotex.ca/products), or by calling 1-800-667-4708

Last Revised: MAR 20, 2023