Apo-Frovatriptan: Uses, Side Effects and Dosage

What is APO-FROVATRIPTAN used for?

APO-FROVATRIPTAN 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-FROVATRIPTAN should not be used to prevent or reduce the number of headaches you experience. Only use APO-FROVATRIPTAN to treat an actual migraine headache attack.

How does APO-FROVATRIPTAN work?

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

What are the ingredients in APO-FROVATRIPTAN?

Medicinal ingredient: Frovatriptan (as frovatriptan succinate monohydrate)

Non-medicinal ingredients: Anhydrous lactose, magnesium stearate, polyethylene glycol, polyvinyl alcohol, sodium starch glycolate, talc and titanium dioxide

APO-FROVATRIPTAN comes in the following dosage forms:

Tablets: 2.5 mg frovatriptan (as frovatriptan succinate monohydrate)

Do not use APO-FROVATRIPTAN if:

• you are allergic to frovatriptan, or to any other ingredients in APO-FROVATRIPTAN.

• you have other specific types of migraines. If you are not sure if you have had these types of migraines, ask your healthcare professional:

  • hemiplegic migraines (migraines where you have weakness on one side of

    • your body).
  • ophthalmoplegic migraines (migraines where you have pain around the eyes).
  • basilar migraines (migraines that start in the lower part of the brain).
• you have uncontrolled or severe high blood pressure.
• you have or have a history of chest pain (angina), or have had a heart attack.
• you have any type of heart disease, or an irregular heartbeat.
• you have had a stroke or mini-stroke (transient ischemic attack).
• you have a history, symptoms, or signs of peripheral vascular disease. This is when you have poor blood flow to your limbs and organs other than the heart and brain. This may include ischemic bowel disease (when you have an injury to your bowel because of poor blood circulation), or Raynaud’s Syndrome.

• in the last 24 hours, you have taken another ‘triptan’ medication to treat migraine

  headaches, or a medication containing ergotamine.

• you have a severe liver problem.

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

• have controlled high blood pressure.
• have any risk factors for heart disease. These include high blood pressure, diabetes, high cholesterol, obesity, smoking, a family history of heart disease, are a female going through menopause or a male over 40 years of age.
• have any allergies or are allergic to any medications.
• have or have a history of epilepsy or seizures.

• are pregnant, think you are pregnant, or are planning to become pregnant.

• are breast-feeding or plan to breast-feed.
• are using inadequate contraception.

Other warnings you should know about:

Serotonin Toxicity (also known as Serotonin Syndrome): APO-FROVATRIPTAN 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-FROVATRIPTAN with certain antidepressants or other migraine medications.

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.

Driving and Using Machines: APO-FROVATRIPTAN may cause dizziness. Do not drive a car, use machinery, or do any task where you need to be alert until you know how APO-FROVATRIPTAN affects you.

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-FROVATRIPTAN:

• Propranolol, a medication used to treat high blood pressure
• Oral contraceptives (birth control pills)
• Medications used to treat depression, known as serotonergic drugs. These include drugs called selective serotonin inhibitors (SSRIs), and serotonin noradrenaline reuptake inhibitors (SNRIs)

How to take APO-FROVATRIPTAN:

How to remove tablets:

1. 1. Tear blister at perforation to separate.

1. 2. Peel printed backing off to expose foil.

1. 3. Push the tablet through the foil.

• Take APO-FROVATRIPTAN exactly as your healthcare professional tells you.
• Take APO-FROVATRIPTAN by mouth with liquids.
• If you are taking APO-FROVATRIPTAN for the first time, your healthcare professional may require you to take your first dose in the doctor’s office, or in a medical setting.

Usual dose:

Take one APO-FROVATRIPTAN tablet for your migraine.

If your headache is not relieved by the first tablet, do not take a second tablet for the same migraine without first talking to your healthcare professional. If your headache comes back after you take the first tablet and your healthcare professional agrees, a second tablet may be taken not sooner than 4 hours after the first dose.

Do NOT take more than 2 tablets a day. If your condition worsens, seek medical attention.

Overdose:

What are possible side effects from using APO-FROVATRIPTAN?

These are not all the possible side effects you may have when taking APO-FROVATRIPTAN. If you experience any side effects not listed here, tell your healthcare professional.

The most common side effects of APO-FROVATRIPTAN are:

• dizziness
• tiredness, lack of energy
• headache (other than migraine headache)
• tingling sensations
• flushing (redness of the skin lasting a short time)
• sensation of temperature change (feeling hot or cold)
• dry mouth
• indigestion or upset stomach
• bone or joint pain

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, tell your healthcare professional.

Reporting Side Effects

Storage:

Store at controlled room temperature, 25°C. Protect from moisture. Do not use after the expiry date. If your healthcare professionals decides to stop your treatment do not keep any left over tablets. You should take all expired or unused medicines to your pharmacy for safe disposal. Medicine should not be flushed down a toilet as it is not environmentally friendly.

Keep out of reach and sight of children.

If you want more information about APO-FROVATRIPTAN:

• 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: October 3, 2023