PATIENT INFORMATION

ACIPHEX (a-se-feks)
(rabeprazole sodium)
Delayed-Release Tablets

Read the Patient Information that comes with ACIPHEX before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your healthcare provider about your medical condition or treatment.

What is ACIPHEX?

ACIPHEX is a medicine called a proton pump inhibitor. ACIPHEX reduces the amount of acid in your stomach.

ACIPHEX is used in adults:

• for up to 8 weeks to heal acid-related damage to the lining of the esophagus (called erosive esophagitis or EE) and to relieve symptoms, such as heartburn pain. If needed, your doctor may prescribe an additional 8 weeks of ACIPHEX.
• to maintain the healing of the esophagus and relief of symptoms related to EE. ACIPHEX has not been studied for treatment lasting longer than 12 months (1 year).
• for 4 weeks for the treatment of daytime and nighttime heartburn and other symptoms that happen with Gastroesophageal Reflux Disease (GERD). If needed your doctor may prescribe an additional 4 weeks of ACIPHEX.
  GERD happens when acid in your stomach backs up into the tube (esophagus) that connects your mouth to your stomach. This may cause a burning feeling in your chest or throat, sour taste, or burping.
• for up to 4 weeks for the healing and relief of duodenal ulcers. The duodenal area is the area where food passes when it leaves the stomach.
• with certain antibiotic medicines for the treatment of an infection caused by bacteria called H. pylori. Sometimes H. pylori bacteria can cause duodenal ulcers. The infection needs to be treated to prevent the ulcers from coming back.
• for the long-term treatment of conditions where your stomach makes too much acid. This includes a rare condition called Zollinger-Ellison syndrome.

ACIPHEX is used in adolescents 12 years of age and above:

• for up to 8 weeks for the treatment of GERD.

It is not known if ACIPHEX is safe and effective in children under the age of 12.

ACIPHEX may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor.

Who should not take ACIPHEX?

Do not take ACIPHEX if you:

• are allergic to any of the ingredients in ACIPHEX. See the end of this leaflet for a complete list of ingredients in ACIPHEX.
• are allergic to any other Proton Pump Inhibitor (PPI) medicine.

What should I tell my doctor before taking ACIPHEX?

Before you take ACIPHEX tell your doctor about all of your medical conditions, including if you:

• have been told that you have low magnesium levels in your blood.
• have any liver problems.
• have any allergies.
• are pregnant or planning to become pregnant. It is not known if ACIPHEX can harm your unborn baby.
• are breastfeeding. It is not known if ACIPHEX passes into your breast milk or if it can harm your baby. You should choose to breastfeed or take ACIPHEX, but not both. Talk to your doctor about other ways to feed your baby while taking ACIPHEX.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. ACIPHEX and certain medicines can affect each other. This can cause serious side effects. Know the medicines that you take. Keep a list of them with you and show it to your doctor when you get a new medicine. Be sure to tell your doctor if you are taking:

• atazanavir (Reyataz)
• cyclosporine (Sandimmune, Neoral)
• digoxin (Lanoxin)
• ketoconazole (Nizoral)
• warfarin (Coumadin)
• theophylline (THEO-24 Thelair)
• diazepam (Valium)
• phenytoin (Dilantin)
• antibiotics

Ask your doctor or pharmacist if you are not sure if your medicine is listed above.

How should I take ACIPHEX?

• Take ACIPHEX exactly as prescribed. Your doctor will prescribe the dose that is right for you and your medical condition. Do not change your dose or stop taking ACIPHEX unless you talk to your doctor. Take ACIPHEX for as long as it is prescribed even if you feel better.
• ACIPHEX is usually taken once a day. Your doctor will tell you the time of day to take ACIPHEX, based on your medical condition.
• ACIPHEX can be taken with or without food. Your healthcare provider will tell you whether to take this medicine with or without food based on your medical condition.
• Swallow each ACIPHEX tablet whole with water. Do not chew, crush, or split ACIPHEX tablets because this will damage the tablet and the medicine will not work. Tell your doctor if you cannot swallow tablets whole. You may need a different medicine.
• If you miss a dose of ACIPHEX, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your normal schedule. Do not take 2 doses at the same time.
• If you take too much ACIPHEX, call your doctor or Poison Control Center right away, or go to the emergency department.
• Your doctor may prescribe antibiotic medicines with ACIPHEX to help treat a stomach infection and heal stomach-area (duodenal) ulcers that are caused by bacteria called H. pylori. Make sure you read the patient information that comes with an antibiotic before you start taking it.

What are the possible side effects of ACIPHEX?

ACIPHEX, like other proton pump inhibitors, may cause serious allergic reactions. See the end of this leaflet for a complete list of ingredients in ACIPHEX.

• Serious allergic reactions. Tell your doctor if you have any of the following symptoms with ACIPHEX.
• rash
• face swelling
• throat tightness
• difficulty breathing

Your doctor may stop ACIPHEX if these symptoms happen

• Low magnesium levels in your body. This problem can be serious. Low magnesium can happen in some people who take a proton pump inhibitor medicine for at least 3 months. If low magnesium levels happen, it is usually after a year of treatment. You may or may not have symptoms of low magnesium.
  Tell your doctor right away if you have any of these symptoms:
  • seizures
  • dizziness
  • abnormal or fast heart beat
  • jitteriness
  • jerking movements or shaking (tremors)
  • muscle weakness
  • spasms of the hands and feet
  • cramps or muscle aches
  • spasm of the voice box

Your doctor may check the level of magnesium in your body before you start taking ACIPHEX, during treatment, or if you will be taking ACIPHEX for a long period of time.

The most common side effects with ACIPHEX may include:

• headache
• pain
• sore throat
• gas
• infection
• constipation

People who are taking multiple daily doses of Proton Pump Inhibitor medicines for a long period of time may have an increased risk of fractures of the hip, wrist, or spine.

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

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

How should I store ACIPHEX?

• Store ACIPHEX in a dry place at room temperature, 59°F to 86°F (15°C to 30°C).

Keep ACIPHEX and all medicines out of the reach of children.

General Information about ACIPHEX

Medicines are sometimes prescribed for conditions other than those described in patient information leaflets. Do not use ACIPHEX for any condition for which it was not prescribed by your doctor. Do not give ACIPHEX to other people, even if they have the same symptoms as you. It may harm them.

This leaflet summarizes the most important information about ACIPHEX. If you would like more information, talk to your doctor. You can also ask your doctor or pharmacist for information about ACIPHEX that is written for healthcare professionals. For full product information, visit the website at http://www.aciphex.com/ or call the toll-free numbers 1-888-4-ACIPHEX or 1-800 JANSSEN.

What are the ingredients in ACIPHEX?

Active Ingredient: rabeprazole sodium

Inactive ingredients of the 20 mg tablet are carnauba wax, crospovidone, diacetylated monoglycerides, ethylcellulose, hydroxypropyl cellulose, hypromellose phthalate, magnesium stearate, mannitol, propylene glycol, sodium hydroxide, sodium stearyl fumarate, talc, and titanium dioxide. Iron oxide yellow is the coloring agent for the tablet coating. Iron oxide red is the ink pigment.

The following are registered trademarks of their respective manufacturers:
Reyataz (Bristol-Myers Squibb Company), Sandimmune and Neoral (Novartis Pharmaceuticals Corporation), Lanoxin (GlaxoSmithKline), Nizoral (Janssen Pharmaceutica Products, LP), and Coumadin (Bristol-Myers Squibb Company).

For prescription only

Revised May 2011

ACIPHEX is a registered trademark of Eisai Co., Ltd., Tokyo, Japan.

Manufactured and Marketed by Eisai Inc., Woodcliff Lake, NJ 07677
Marketed by PRICARA, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., Raritan, NJ 08869