Relpax Patient, Information, Instructions - Eletriptan hydrobromide

Relpax Patient, Information, Instructions - Eletriptan hydrobromide

PATIENT INFORMATION

Please read this information before you start taking RELPAX and each time you renew your prescription. Remember, this summary does not take the place of discussions with your doctor. You and your doctor should discuss RELPAX when you start taking your medication and at regular checkups.

RELPAX is a prescription medicine used to treat migraine headaches in adults. RELPAX is not for other types of headaches.

Migraine is an intense, throbbing headache. You may have pain on one or both sides of your head. You may have nausea and vomiting, and be sensitive to light and noise. The pain and symptoms of a migraine headache can be worse than a common headache. Some women get migraines around the time of their menstrual period. Some people have visual symptoms before the headache, such as flashing lights or wavy lines, called an aura.

Treatment with RELPAX reduces swelling of blood vessels surrounding the brain. This swelling is associated with the headache pain of a migraine attack. RELPAX blocks the release of substances from nerve endings that cause more pain and other symptoms like nausea, and sensitivity to light and sound. It is thought that these actions contribute to relief of your symptoms by RELPAX.

· 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 or had a stroke or problems with your blood circulation.

· have serious liver problems.

· have taken any of the following medicines in the last 24 hours: other "triptans" like almotriptan (Axert®), frovatriptan (Frova^TM), naratriptan (AmergeÒ), rizatriptan (MaxaltÒ), sumatriptan (ImitrexÒ), zolmitriptan (Zomig^Ò); ergotamines like Bellegral-SÒ, CafergotÒ, ErgomarÒ, WigraineÒ; dihydroergotamine like D.H.E. 45Ò or MigranalÒ; or methysergide (SansertÒ). These medicines have side effects similar to RELPAX.*

· have taken the following medicines within at least 72 hours: ketoconazole (NizoralÒ), itraconazole (SporonoxÒ), nefazodone (SerzoneÒ), troleandomycin (TAOÒ), clarithromycin (BiaxinÒ), ritonavir (NorvirÒ), and nelfinavir (ViraceptÒ). These medicines may cause an increase in the amount of RELPAX in the blood.*

· are allergic to RELPAX or any of its ingredients. The active ingredient is eletriptan. The inactive ingredients are listed at the end of this leaflet. Tell your doctor about all the medicines you take or plan to take, including prescription and nonprescription medicines, supplements, and herbal remedies. Your doctor will decide if you can take RELPAX with your other medicines. Tell your doctor if you know that you have any of the following: risk factors for heart disease like high cholesterol, diabetes, smoking, obesity, menopause, or a family history of heart disease or stroke.

RELPAX comes in 20 mg and 40 mg tablets. When you have a migraine headache, take your medicine as directed by your doctor.

· Take one RELPAX tablet as soon as you feel a migraine coming on.

· If your headache improves and then comes back after 2 hours, you can take a second tablet.

· If the first tablet did not help your headache at all, do not take a second tablet without talking with your doctor.

· Do not take more than two RELPAX tablets in any 24-hour period.

RELPAX is generally well tolerated. As with any medicine, people taking RELPAX may have side effects. The side effects are usually mild and do not last long.

The most common side effects of RELPAX are:

· dizziness

· nausea

· weakness

· tiredness

· pain or pressure sensation (e.g., in the chest or throat)

In very rare cases, patients taking triptans may experience serious side effects, including heart attacks.

Call your doctor right away if you have:

· severe chest pains

· shortness of breath

This is not a complete list of side effects. Talk to your doctor if you develop any symptoms that concern you.

Call your doctor or poison control center or go to the ER.

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use RELPAX for a condition for which it was not prescribed. Do not give RELPAX to other people, even if they have the same symptoms you have.

This leaflet summarizes the most important information about RELPAX. If you would like more information about RELPAX, talk with your doctor. You can ask your doctor or pharmacist for information on RELPAX that is written for health professionals. You can also call 1-866-4RELPAX (1-866-473-5729) or visit our web site at www.RELPAX.com.

Active ingredient: eletriptan hydrobromide

Inactive ingredients: microcrystalline cellulose, lactose, croscarmellose sodium, magnesium stearate, titanium dioxide, hypromellose, triacetin, and FD&C Yellow No. 6 aluminum lake.

Store RELPAX Tablets at room temperature 15-30°C (59-86°F).

*The brands listed are the trademarks of their respective owners and are not trademarks of Pfizer Inc.

Distributed by: Roerig Division of Pfizer Inc, NY, NY 10017 , 70-5586-00-0

Issued December 2002