Details for: APO-FROVATRIPTAN
Company: APOTEX INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02426471 | APO-FROVATRIPTAN | FROVATRIPTAN (FROVATRIPTAN SUCCINATE MONOHYDRATE) | 2.5 MG | TABLET | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
APO-FROVATRIPTAN is a medication used for the treatment of migraine attacks in adults. APO-FROVATRIPTAN is a member of a class of drugs called 5-HT1 agonists.
What it does
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 pain and other symptoms of migraine headache.
When it should not be used
APO-FROVATRIPTAN should only be taken if you
have a migraine headache. APO-FROVATRIPTAN
should not be used continuously to prevent or reduce
the number of attacks. Do not use APO-FROVATRIPTAN
to treat other types of headaches
that might be caused by other conditions.
Please tell your doctor all of your symptoms. Your
doctor will decide whether you have migraines and if
APO-FROVATRIPTAN is for you.
Do not take APO-FROVATRIPTAN if you:
- have uncontrolled high blood pressure
- have heart disease or history of heart disease, irregular heart beat, angina
- have had a stroke, transient ischemic attacks (TIAs)
- have circulation (blood flow) problems, Raynaud’s syndrome
- have any allergic reaction to frovatriptan or to any other ingredients in APO-FROVATRIPTAN (see “What the non-medicinal ingredients are”)
- have a severe liver problem
- 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.
What the medicinal ingredient is
Frovatriptan Succinate Monohydrate
What the non-medicinal ingredients are
Non-medicinal ingredients are as follows: anhydrous lactose, magnesium stearate, polyvinyl alcohol, polyethylene glycol, sodium starch glycolate, talc and titanium dioxide
What dosage form it comes in
Tablets: 2.5 mg frovatriptan
Warnings and precautions
BEFORE you use APO-FROVATRIPTAN talk to your doctor if you:
- have a history of high blood pressure, chest pain, shortness of breath, strokes, or heart disease
- have any risk factors for heart disease including high blood pressure, diabetes, high cholesterol, obesity, smoking, a family history of heart disease; are postmenopausal or a male over 40 years of age
- plan to take any drugs without a prescription, and/or those you normally take for a migraine; or herbal supplements
- have any past or present medical problems
- have previous allergies to any medication
- have irregular heartbeats
- have angina
- are over 65 years of age
- have liver and/or kidney disease
- have epilepsy or seizures
- experience numbness on one side of your body when you have a headache
- experience a headache different from your usual migraine headache attack
- are pregnant, or planning to become pregnant
- are breast-feeding or plan to breast-feed
- are using inadequate contraception.
Tell your doctor if you take propranolol.
Ask your physician for instructions about taking
APO-FROVATRIPTAN if you are taking selective
serotonin reuptake inhibitors (SSRIs) such as
sertraline, escitalopram and fluoxetine or serotonin
norepinephrine reuptake inhibitors (SNRIs) such as
venlafaxine or duloxetine for depression. A life-threatening
condition called serotonin syndrome can
happen when medicines called triptans, such as APO-FROVATRIPTAN,
and medicines used to treat
depression and mood disorders called SSRIs or
SNRIs are used together. Signs and symptoms of
serotonin syndrome include the following:
restlessness, diarrhea, hallucinations, coma, loss of
coordination, nausea, fast heart beat, vomiting,
increased body temperature, changes in blood
pressure and overactive reflexes.
If you use APO-FROVATRIPTAN too often, it may
make your headaches worse. If this happens, your
doctor may tell you to stop taking APO-FROVATRIPTAN.
Interactions with this medication
Do not take APO-FROVATRIPTAN if you:
- have taken another similar drug (a serotonin receptor agonist) within the last 24 hours of treatment, e.g., sumatriptan (Imitrex®), naratriptan (Amerge®), zolmitriptan (Zomig®), almotriptan (Axert®), rizatriptan (Maxalt™) or eletriptan (Relpax®) unless your doctor tells you it is safe to do so.
- have taken ergotamine type medications such as ergotamine (Bellergal®- Spacetabs®, Cafergot®, Ergomar®, Gravergol®, Megral®), dihydro-ergotamine (Dihydroergotamine (DHE), or Migranal®), or methysergide (Sansert®) within the last 24 hours unless your doctor tells you it is safe to do so.
Proper use of this medication
How to take APO-FROVATRIPTAN:
How to remove tablets:
- Tear blister at perforation to separate.
- Peel printed backing off to expose foil.
- Push the tablet through the foil.
Usual Dose
Take one APO-FROVATRIPTAN tablet with fluid
for your migraine headache. If your headache comes
back after the initial dose, a second tablet may be
taken not sooner than 4 hours after the first dose.
If your headache is not relieved by the first tablet, do
not take the second tablet for the same attack without
first consulting your doctor. Do not take more than 2
tablets (2 x 2.5 mg) a day. If your condition worsens,
seek medical attention.
Overdose
If anyone other than you accidentally takes your tablets they should seek medical advice immediately.
Side effects and what to do about them
Like all prescription drugs, APO-FROVATRIPTAN can cause side effects. The most common side effects associated with the use of APO-FROVATRIPTAN are:
- dizziness
- fatigue (tiredness)
- headache (other than a migraine headache)
- paresthesia (feeling of tingling).
Less common side effects associated with APO-FROVATRIPTAN are:
- flushing (redness of the skin lasting a short time)
- sensation of temperature change (feeling hot or cold)
- dry mouth
- dyspepsia
- dysesthesia (impairment of touch sensation)
- skeletal pain.
In very rare cases, patients taking this class of medicines experience serious heart problems, stroke, or increased blood pressure.
If you develop pain, tightness, heaviness, or pressure in your chest, throat, neck, or jaw contact your doctor right away.
Also tell your doctor if you experience symptoms that suggest an allergic reaction such as a rash or itching, or if any of the above symptoms persist or worsen.
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and call your doctor or pharmacist |
|---|---|---|---|
| Common | |||
| Sensations of numbness, tingling, feeling hot or cold, pain | ✔ | ||
| Sensations of pain, pressure or tightness in the chest or throat | ✔ | ||
| Very rare | |||
| Serious heart problems (stroke, or increased blood pressure, pain, tightness, heaviness, or pressure in your chest, throat, neck or jaw) | ✔ | ||
| Allergic Reactions (rash or itching) | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking APO-FROVATRIPTAN, contact your doctor or pharmacist.
How to store
Keep your APO-FROVATRIPTAN tablets in their
packaging in a safe place out of reach of children.
They may be harmful to children.
Store at controlled room temperature, 25°C. Protect
from moisture. Do not use after the expiry date. If
your doctor 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.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa, Ontario
K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
For more information, please contact your doctor,
pharmacist or other healthcare professional.
This leaflet plus the full product monograph,
prepared for health professionals, can be obtained by
contacting DISpedia, Apotex's Drug Information
Service at:
1-800-667-4708
This leaflet can also be found at:
http://www.apotex.ca/products.
This leaflet was prepared by Apotex Inc., Toronto,
Ontario, M9L 1T9.
Last revised: November 07, 2017