Details for: FROVA
Company: ENDO PHARMACEUTICALS INC.
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02257084 | FROVA | FROVATRIPTAN (FROVATRIPTAN SUCCINATE) | 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
FROVA is a medication used for the treatment of migraine attacks in adults. FROVA 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. FROVA narrows the vessels and relieves the pain and other symptoms of migraine headache.
When it should not be used
FROVA should only be taken if you have a migraine
headache. FROVA should not be used continuously to
prevent or reduce the number of attacks. Do not use FROVA
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 FROVA is for
you.
Do not take FROVA 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 FROVA (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
What the non-medicinal ingredients are
colloidal silicon dioxide, hydroxypropylmethylcellulose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 3000, sodium starch glycollate, titanium dioxide, and triacetin.
What dosage form it comes in
Tablets: 2.5 mg frovatriptan
Warnings and precautions
BEFORE you use FROVA 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.
Ask your physician for instructions about taking FROVA 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 FROVA, 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 FROVA too often, it may make your headaches worse. If this happens, your doctor may tell you to stop taking FROVA.
Interactions with this medication
Do not take FROVA 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
Usual Dose
Take one FROVA 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, FROVA can cause side effects. The most common side effects associated with the use of FROVA are:
- dizziness
- fatigue (tiredness)
- headache (other than a migraine headache)
- paresthesia (feeling of tingling).
Less common side effects associated with FROVA 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 with your doctor or pharmacist only if severe | Talk with your doctor or pharmacist 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 FROVA, contact your doctor or pharmacist.
How to store
Keep your FROVA 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 (77°F),
excursions permitted to 15°-30°C (59°-86°F). 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 three 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 ON 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
This document plus the full product monograph, prepared for
health professionals can be found at:
http://www.frova.ca
or by contacting the Marketer of FROVA, Teva Canada
Innovation at:
1-866-530-6065
This leaflet was prepared by Endo Pharmaceuticals Inc.
Manufactured by Endo Pharmaceuticals Inc., PA 19317.
Distributed by Teva Canada Limited, ON M1B 2K9.
Marketed by Teva Canada Innovation, QC H2Z 1S8.
Last revised: December 17, 2012.