Relpax

Yes

Safe use of eletriptan in pregnancy has not been established.

Safe use of eletriptan in nursing mothers has not been established.

RELPAX is indicated for the acute treatment of migraine with or without aura in adults.

Limitations Of Use

• Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with RELPAX, reconsider the diagnosis of migraine before RELPAX is administered to treat any subsequent attacks.
• RELPAX is not intended for the prevention of migraine attacks.
• Safety and effectiveness of RELPAX have not been established for cluster headache.

Dosage Forms And Strengths

Orange, round, convex shaped, film-coated, with "PFIZER" and "REP20" debossed.

Orange, round, convex shaped, film-coated, with "PFIZER" and "REP40" debossed.

Storage And Handling

RELPAX Tablets containing 20 mg or 40 mg eletriptan (base) as the hydrobromide salt. RELPAX Tablets are orange, round, convex shaped, film-coated tablets with appropriate debossing.

They are supplied in the following strengths and package configurations:

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Distributed by: Pfizer, Roering, Division of Pfizer Inc, NY, NY 10017. Revised: Nov 2013

Grapefruit and grapefruit juice may interact with Relpax and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

You should not use this medication if you are allergic to eletriptan, or if you have:

• coronary heart disease, angina (chest pain), blood circulation problems, lack of blood supply to the heart;

• a history of heart disease, heart attack, or stroke, including "mini-stroke";

• severe or uncontrolled high blood pressure;

• severe liver disease;

• ischemic bowel disease; or

• a headache that seems different from your usual migraine headaches.

To make sure you can safely take eletriptan, tell your doctor if you have any of these other conditions:

• liver disease;

• kidney disease;

• high blood pressure, a heart rhythm disorder; or

• risk factors for coronary artery disease (such as diabetes, menopause, smoking, being overweight, having high blood pressure or high cholesterol, having a family history of coronary artery disease, being older than 40 and a man, or being a woman who has had a hysterectomy).

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Eletriptan can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not give this medicine to anyone under 18 years old.

• If you have an allergy to eletriptan or any other part of Relpax (eletriptan).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have any of these health problems: High blood pressure or some types of migraine headaches like hemiplegic or basilar migraine.
• If you have ever had any of these health problems: Chest pain or pressure; diseased arteries going to the legs or arms; heart attack; heart disease; poor blood flow in the heart, brain, bowel, or kidney; stroke; or a heartbeat that is not normal like Wolff-Parkinson-White syndrome.
• If you have liver disease.
• If you have taken almotriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, or zolmitriptan in the last 24 hours.
• If you have taken ergotamine, methysergide, dihydroergotamine, or any drug like them in the last 24 hours.
• If you have taken clarithromycin, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, or troleandomycin in the last 72 hours.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Relpax with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Relpax, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Relpax (eletriptan). It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Relpax.

Review Date: October 4, 2017

Relpax is indicated for the acute treatment of migraine with or without aura in adults.

Limitations of Use:

• Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with Relpax, reconsider the diagnosis of migraine before Relpax is administered to treat any subsequent attacks.
• Relpax is not intended for the prevention of migraine attacks.
• Safety and effectiveness of Relpax have not been established for cluster headache.

The elimination half-life of eletriptan is about 4 hours [see Clinical Pharmacology (12.3)], therefore monitoring of patients after overdose with eletriptan should continue for at least 20 hours or longer while symptoms or signs persist.

There is no specific antidote to eletriptan.

It is unknown what effect hemodialysis or peritoneal dialysis has on the serum concentration of eletriptan.

Relpax® (REL - packs)

(eletriptan hydrobromide)

Tablets

Please read this information before you start taking Relpax and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.

What is the most important information I should know about Relpax?

Relpax can cause serious side effects, including:

Heart attack and other heart problems. Heart problems may lead to death.

Stop taking Relpax and get emergency medical help right away if you have any of the following symptoms of a heart attack:

• discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
• chest pain or chest discomfort that feels like an uncomfortable heavy pressure, squeezing, fullness, or pain
• pain or discomfort in your arms, back, neck, jaw, or stomach
• shortness of breath with or without chest discomfort
• breaking out in a cold sweat
• nausea or vomiting
• feeling lightheaded

Relpax is not for people with risk factors for heart disease unless a heart exam is done and shows no problem. You have a higher risk for heart disease if you:

• have high blood pressure
• have high cholesterol levels
• smoke
• are overweight
• have diabetes
• have a family history of heart disease
• are a female who has gone through menopause
• are a male over age 40

Serotonin syndrome. Serotonin syndrome is a serious and life-threatening problem that can happen in people taking Relpax, especially if Relpax is taken with anti-depressant medicines called selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs).

Ask your doctor or pharmacist for a list of these medicines if you are not sure.

Call your doctor right away if you have any of the following symptoms of serotonin syndrome:

• mental changes such as seeing things that are not there (hallucinations), agitation, or coma
• fast heartbeat
• changes in blood pressure
• high body temperature
• tight muscles
• trouble walking
• nausea, vomiting, or diarrhea

What is Relpax?

Relpax is a prescription medicine used to treat acute migraine headaches with or without aura in adults.

Relpax is for people who have been diagnosed with migraine headaches.

Relpax is not used to prevent or decrease the number of migraine headaches you have.

It is not known if Relpax is safe and effective to treat cluster headaches.

It is not known if Relpax is safe and effective in children.

Who should not take Relpax?

Do not take Relpax if you:

• have heart problems or a history of heart problems
• have or have had a stroke or problems with your blood circulation
• have hemiplegic or basilar migraines. If you are not sure if you have these types of migraines, ask your doctor
• have narrowing of the blood vessels in your legs, arms, stomach, or kidney (peripheral vascular disease)
• have ischemic bowel disease
• have uncontrolled high blood pressure
• have taken any of the following medicines in the last 24 hours:
  • other "triptans" or triptan combination products such as:
    • almotriptan (Axert®)
    • sumatriptan and naproxen sodium, (Treximet®)
    • frovatriptan (Frova®)
    • zolmitriptan (Zomig®)
    • naratriptan (Amerge®)
    • rizatriptan (Maxalt®)
    • sumatriptan (Imitrex®)
  • ergotamines such as:
    • Bellergal-S®
    • Ergomar®
    • Cafergot®
    • Wigraine®
  • dihydroergotamines such as:
    • D.H.E. 45® or Migranal® or methysergide (Sansert®)
• have taken the following medicines within the last 72 hours:  
  • ketoconazole (Nizoral®)
  • clarithromycin (Biaxin®)
  • itraconazole (Sporanox®)
  • ritonavir (Norvir®)
  • nefazodone (Serzone®)
  • nelfinavir (Viracept®)
  • troleandomycin (TAO®)
• are allergic to eletriptan or any of the ingredients in Relpax. See the end of this leaflet for a complete list of ingredients in Relpax.

What should I tell my doctor before taking Relpax?

Before you take Relpax, tell your doctor if you:

• have heart problems or family history of heart problems or stroke
• have high blood pressure
• have high cholesterol
• have diabetes
• smoke
• are overweight
• are a female who has gone through menopause
• have kidney problems
• have liver problems
• are pregnant or plan to become pregnant. It is not known if Relpax will harm your unborn baby.
• are breastfeeding or plan to breastfeed. Relpax passes into your breast milk and may harm your baby. Talk to your doctor about the best way to feed your baby if you take Relpax.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Your doctor will decide if you can take Relpax with your other medicines. Relpax and other medicines may affect each other causing side effects.

Especially tell your doctor if you take anti-depressant medicines called:

• selective serotonin reuptake inhibitors (SSRIs)
• serotonin and norepinephrine reuptake inhibitors (SNRIs)

Ask your doctor or pharmacist for a list of these medicines if you are not sure.

Know the medicines you take. Keep a list of them to show your doctor or pharmacist when you get a new medicine.

How should I take Relpax?

• Take Relpax exactly as your doctor tells you to take it.
• Your doctor will tell you how much Relpax to take and when to take it.
• Your doctor may change your dose if needed. Do not change your dose without first talking to your doctor.
• Take 1 Relpax tablet as soon as you feel a migraine coming on.
• If you do not get any relief after your first Relpax tablet, do not take a second tablet without first talking with your doctor.
• If your headache comes back or you only get some relief from your headache, you can take a second tablet 2 hours after the first tablet.
• Do not take more than a total of 80 mg of Relpax tablets in a 24-hour period.
• If you take too much Relpax, call your doctor or go to the nearest hospital emergency room right away.
• You should write down when you have headaches and when you take Relpax so you can talk to your doctor about how well Relpax is working for you.

What should I avoid while taking Relpax?

Relpax can cause dizziness, weakness, or drowsiness. If you have these symptoms, do not drive a car, use machinery, or do anything where you need to be alert.

What are the possible side effects of Relpax?

Relpax may cause serious side effects. See "What is the most important information I should know about Relpax?"

These serious side effects include:

• changes in color or sensation in your fingers and toes (Raynaud's syndrome)
• stomach and intestinal problems (gastrointestinal and colonic ischemic events). Symptoms of gastrointestinal and colonic ischemic events include:
  • sudden or severe stomach pain
  • stomach pain after meals
  • weight loss
  • nausea or vomiting
  • constipation or diarrhea
  • bloody diarrhea
  • fever
• problems with blood circulation to your legs and feet (peripheral vascular ischemia). Symptoms of peripheral vascular ischemia include:
  • cramping and pain in your legs or hips
  • feeling of heaviness or tightness in your leg muscles
  • burning or aching pain in your feet or toes while resting
  • numbness, tingling, or weakness in your legs
  • cold feeling or color changes in 1 or both legs or feet
• medication overuse headaches. Some people who take too many Relpax may have worse headaches (medication overuse headache). If your headaches get worse, your doctor may decide to stop your treatment with Relpax.

The most common side effects of Relpax include:

• dizziness
• nausea
• weakness
• tiredness
• drowsiness

Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Relpax. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

How should I store Relpax?

• Store Relpax at room temperature between 68°F to 77°F (20°C to 25°C).

General information about the safe and effective use of Relpax

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. It may harm them.

This Patient Information 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.

For more information, call 1-866-4Relpax (1-866-473-5729) or go to www.Relpax.com.

What are the ingredients in Relpax?

Active ingredient: eletriptan hydrobromide

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

All brands are trademarks of their owners.

This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com.

LAB 0077-12.0

November 2013

Applies to eletriptan: oral tablet

Along with its needed effects, eletriptan (the active ingredient contained in Relpax) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking eletriptan:

• Chest pain or tightness
• difficulty with swallowing
• tightness in the throat

• Chest discomfort
• dizziness
• headache
• nausea
• nosebleeds
• numbness or tingling in the face, arms or legs
• pain or discomfort in the arms, jaw, back or neck
• sweating
• vision problems
• vomiting

• Abdominal or stomach pain
• agitation
• bloody diarrhea
• confusion
• cough
• diarrhea
• difficulty in speaking
• fainting
• fast, slow, pounding, or irregular heartbeat or pulse
• fever
• inability to move arms, legs, or facial muscles
• overactive reflexes
• pain in the arms legs, or lower back, especially pain in calves or heels upon exertion
• pale, bluish-colored, or cold hands or feet
• paleness or cold feeling in fingertips and toes
• poor coordination
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• restlessness
• seizures
• severe or sudden headache
• shivering
• skin rash, hives, or itching
• slurred speech
• sudden loss of coordination
• sweating
• talking or acting with excitement you cannot control
• tingling or pain in the fingers or toes when exposed to cold
• trembling or shaking
• twitching
• unusual tiredness or weakness
• weak or absent pulses in the legs
• weakness in the arm or leg on one side of the body, sudden and severe

Some side effects of eletriptan may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Lack or loss of strength
• sleepiness or unusual drowsiness

• Acid or sour stomach
• belching
• burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
• dry mouth
• heartburn
• indigestion
• stomach soreness or discomfort
• stomach upset

Applies to eletriptan: oral tablet

General

The most commonly reported adverse events have included asthenia, nausea, dizziness, and somnolence.[Ref]

Cardiovascular

Transient, dose-related increases in blood pressure (BP) have been observed, particularly in the elderly and among patients with renal impairment, and predominantly increases to diastolic BP. One patients with hepatic cirrhosis experienced a BP of 220/96 mmHg 5 hours after a receiving an 80 mg dose.[Ref]

Common (1% to 10%): Chest tightness/pain/pressure, palpitation
Uncommon (0.1% to 1%): Hypertension, peripheral vascular disorder, tachycardia
Rare (0.01% to 0.1%): Angina pectoris, arrhythmia, atrial fibrillation, AV block, bradycardia, hypotension, syncope, thrombophlebitis, vasospasm, shock
Very rare (less than 0.01%): Acute myocardial infarction, ventricular tachycardia, ventricular fibrillation, coronary artery vasospasm, transient myocardial ischemia
Frequency not reported: Edema[Ref]

Gastrointestinal

Common (1% to 10%): Abdominal pain/discomfort/stomach pain/cramps/pressure, dry mouth, dyspepsia, nausea
Uncommon (0.1% to 1%): Dysphagia, throat tightness/difficulty swallowing, anorexia, constipation, diarrhea, eructation, esophagitis, flatulence, gastritis, gastrointestinal disorder, glossitis, increased salivation
Rare (0.01% to 0.1%): Enlarged abdomen, halitosis, gingivitis, hematemesis, stomatitis, tongue disorder, tongue edema, tooth disorder
Postmarketing reports: Ischemic colitis, vomiting[Ref]

Nervous system

Common (1% to 10%): Paresthesia, dizziness, somnolence, headache, hypertonia, hyperesthesia, myasthenia
Uncommon (0.1% to 1%): Ataxia, incoordination, speech disorder, stupor, tremor, taste perversion
Rare (0.01% to 0.1%): Abnormal gait, aphasia, dystonia, hemiplegia, hyperalgesia, hypokinesia, neuropathy, paralysis, twitching, parosmia
Frequency not reported: Serotonin syndrome
Postmarketing reports: Seizure, cerebrovascular accident[Ref]

Hypersensitivity

Postmarketing reports: Allergic reactions including angioedema[Ref]

Endocrine

Rare (0.01% to 0.1%): Goiter, thyroid adenoma, thyroiditis, breast pain[Ref]

Hematologic

Rare (0.01% to 0.1%): Anemia, leukopenia, purpura, lymphadenopathy[Ref]

Metabolic

Uncommon (0.1% to 1%): Thirst
Rare (0.01% to 0.1%): Increased appetite, weight gain, weight loss[Ref]

Musculoskeletal

Common (1% to 10%): Back pain[Ref]

Respiratory

Common (1% to 10%): Pharyngitis, throat tightness
Uncommon (0.1% to 1%): Asthma, dyspnea, respiratory disorder, respiratory tract infection, rhinitis, voice alteration, yawn
Rare (0.01% to 0.1%): Bronchitis, choking sensation, increased cough, epistaxis, hyperventilation, laryngitis, sinusitis, increased sputum[Ref]

Dermatologic

Common (1% to 10%): Sweating
Uncommon (0.1% to 1%): Face edema, pruritus, rash, skin disorder
Rare (0.01% to 0.1%): Alopecia, dry skin, eczema, exfoliative dermatitis, maculopapular rash, psoriasis, skin discoloration, skin hypertrophy, urticaria[Ref]

Ocular

Uncommon (0.1% to 1%): Abnormal vision, conjunctivitis, eye pain, lacrimation disorder, photophobia
Rare (0.01% to 0.1%): Oculogyric crisis, dry eyes, eye hemorrhage, ptosis, diplopia, abnormality of accommodation[Ref]

Other

Common (1% to 10%): Asthenia, flushing/feeling of warmth, chills, malaise, vertigo
Uncommon (0.1% to 1%): Ear pain, tinnitus
Rare (0.01% to 0.1%): Fever, hypothermia, otitis media[Ref]

Genitourinary

Uncommon (0.1% to 1%): Impotence, polyuria, urinary frequency, urinary tract disorder
Rare (0.01% to 0.1%): Menstrual disorder, menorrhagia, vaginitis[Ref]

Psychiatric

Uncommon (0.1% to 1%): Abnormal dreams, agitation, anxiety, apathy, depersonalization, depression, emotional lability euphoria, insomnia, nervousness
Rare (0.01% to 0.1%): Amnesia, catatonic reaction, hallucinations, manic reaction, hysteria, neurosis, psychotic depression, sleep disorder[Ref]

Some side effects of Relpax may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.