PATIENT INFORMATION: The following wording is contained in a separate leaflet provided for patients.

PATIENT INFORMATION ABOUT
FROVA® (frovatriptan succinate) Tablets

Read this information before you start taking FROVA (FRO-va). Also, read the information each time you renew your prescription, in case anything has changed. This leaflet does not contain all of the information about FROVA. For further information or advice ask your doctor or pharmacist. You and your doctor should discuss FROVA before you start taking the medicine and at regular checkups.

What is FROVA?

FROVA is a prescription medicine used to treat migraine attacks in adults. It is in the class of drugs called selective serotonin receptor agonists.

FROVA should only be taken for a migraine headache. Do not use FROVA to treat headaches that might be caused by other conditions. Tell your doctor about your symptoms. Your doctor will decide if you have migraine headaches and if FROVA is for you.

There is more information about migraine at the end of this leaflet.

Who should not take FROVA?

Do not take FROVA if you:

have uncontrolled high blood pressure
have heart disease or a history of heart disease
have hemiplegic or basilar migraine (if you are not sure about this, ask your doctor)
have had a stroke
have circulation (blood flow) problems
have taken a similar drug (a serotonin receptor agonist) in the last 24 hours. These include sumatriptan (IMITREX®), naratriptan (AMERGE™), zolmitriptan (ZOMIG™), rizatriptan (MAXALT™), eletriptan hydrobromide (RELPAX®),or almotriptan (AXERT™)
have taken ergotamine type medicines in the last 24 hours. These include BELLERGAL®, CAFERGOT®, ERGOMAR®, WIGRAINE®, DHE 45®, or SANSERT®
have any allergic reaction to the tablet

What you should tell your doctor before and during treatment with FROVA?

To help your doctor decide if FROVA is right for you, tell your doctor if you:

are pregnant, or planning to become pregnant
are breast-feeding or plan to breast-feed
have any history of chest pain, shortness of breath, or palpitations
have any risk factors for heart disease, including
- high blood pressure
- diabetes
- high cholesterol
- overweight
- smoking
- a family history of heart disease
- past menopause
- male over 40 years old
are taking any other medicines, including prescription and non-prescription medicines, and herbal supplements
have any past or present medical problems
have previous allergies to any medicine

Tell your doctor if you take

propranolol
selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs), two types of drugs for depression or other disorders. Common SSRIs are CELEXA® (citalopram HBr), LEXAPRO® (escitalopram oxalate), PAXIL® (paroxetine), PROZAC®/SARAFEM® (fluoxetine), SYMBYAX® (olanzapine/fluoxetine), ZOLOFT® (sertraline), and fluvoxamine. Common SNRIs are CYMBALTA® (duloxetine) and EFFEXOR® (venlafaxine).

These medicines may affect how FROVA works, or FROVA may affect how these medicines work.

How should you take FROVA?

Take one FROVA tablet anytime after the start of your migraine headache. If your headache comes back after your first dose, you may take a second tablet after two (2) hours. Do not take more than three (3) FROVA tablets in a 24-hour period.

If you take too much medicine, contact your doctor, hospital emergency department, or poison control center right away.

What are the common side effects of FROVA?

The most common side effects associated with use of FROVA are:

dizziness
fatigue (tiredness)
headache (other than a migraine headache)
paresthesia (feeling of tingling)
dry mouth
flushing (hot flashes)
feeling hot or cold
chest pain
dyspepsia (indigestion)
skeletal pain (pain in joints or bones)

Tell your doctor about any symptoms that you develop while taking FROVA. If you feel dizziness or fatigue, take extra care or avoid driving and operating machinery.

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 contact your doctor right away if you develop a rash or itching after taking FROVA. You may be allergic to this medicine.

What is a migraine and how does it differ from other headaches?

Migraine is an intense, throbbing headache that often affects one side of the head. It often includes nausea, vomiting, and sensitivity to light and sound. The pain and symptoms from a migraine headache may be worse than the pain and symptoms of a common headache. Migraine headaches usually last for hours or longer.

Some people have problems with vision (an aura) before they get a migraine headache. These include flashing lights, wavy lines, and dark spots.

Only your doctor can determine that your headache is a migraine headache, so it is important that you discuss all of your symptoms with your doctor.

LEXAPRO® / CELEXA® are registered trademarks of Forest Pharmaceuticals, Inc.

PAXIL® is a registered trademark of GlaxoSmithKline.

PROZAC® / SARAFEM® / SYMBYAX® / CYMBALTA® are registered trademarks of Eli Lilly and Company

ZOLOFT® is a registered trademark of Pfizer Pharmaceuticals.

EFFEXOR® is a registered trademark of Wyeth Pharmaceuticals.

FROVA is a registered trademark of Vernalis Development Limited.

Medication Guide — Frova