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PREVACID
(prev-a-sid)
(lansoprazole) Delayed-Release Capsules and

PREVACID SoluTab
(prev-a-sid sol-u-tab)
(lansoprazole) Delayed-Release Orally Disintegrating Tablets

Read this Patient Information that comes with PREVACID 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 with your doctor about your medical condition or your treatment.

What is PREVACID?

PREVACID is a prescription medicine called a proton pump inhibitor (PPI). PREVACID reduces the amount of acid in your stomach.

PREVACID is used in adults:

• for 4 weeks to heal ulcers in the first part of the small bowel (duodenal ulcers).
• along with certain antibiotics to treat a stomach infection called Helicobacter pylori.
• for continued healing of duodenal ulcers.
• for up to 8 weeks to heal stomach ulcers.
• for up to 8 weeks to heal stomach ulcers in some people taking pain medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
• for reducing the risk of stomach ulcers in some people taking NSAIDs.
• for up to 8 weeks for the relief of heartburn and other symptoms of gastroesophageal reflux disease (GERD).
  GERD happens when acid from your stomach enters 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. In some cases, acid can damage the lining of your esophagus. This damage is called erosive esophagitis.
• for 8 weeks to heal the acid-related damage to the lining of the esophagus (called erosive esophagitis) and to relieve symptoms, such as heartburn pain. If needed, your doctor may prescribe an additional 8 weeks of PREVACID.
• for continued healing of erosive esophagitis.
• for the long-term treatment of conditions where your stomach makes too much acid. This includes a condition called Zollinger-Ellison syndrome.

PREVACID is used in children and adolescents (ages 1 to 17):

• for up to 12 weeks to treat GERD and erosive esophagitis in children 1 to 11 years old.
• for up to 8 weeks to treat GERD and erosive esophagitis in adolescents 12 to 17 years old.

PREVACID is not effective for symptoms of GERD in children under the age of 1 year.

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

Who should not take PREVACID?

• Do not take PREVACID if you are allergic to PREVACID or any of its ingredients. See the end of this leaflet for a complete list of ingredients in PREVACID.

What should I tell my doctor before taking PREVACID?

Before you take PREVACID, tell your doctor if you:

• have been told that you have low magnesium levels in your blood.
• have liver problems
• have phenylketonuria. PREVACID SoluTab contains aspartame.
• have any other medical conditions
• are pregnant or plan to become pregnant. It is not known if PREVACID will harm your unborn baby. Talk to your
• doctor if you are pregnant or plan to become pregnant.
• are breast-feeding or planning to breast-feed. You and your doctor should decide if you will take PREVACID or breast-feed. You should not do both without first talking with your doctor.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

PREVACID may affect how other medicines work, and other medicines may affect how PREVACID works.

Especially tell your doctor if you take:

• ampicillin sodium (Unasyn) or ampicillin trihydrate (Principen)
• atazanavir (Reyataz)
• digoxin (Lanoxin)
• a product that contains iron
• ketoconazole (Nizoral)
• warfarin (Coumadin, Jantoven)
• tacrolimus (Prograf)
• theophylline (Theo-24, Elixophyllin, Theochron, Theolair)
• methotrexate

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

How should I take PREVACID?

• Take PREVACID exactly as prescribed by your doctor.
• Do not change your dose or stop taking PREVACID without talking to your doctor first.
• You should take PREVACID before eating.
• PREVACID Delayed-Release Capsules:
  • You should swallow PREVACID Delayed-Release Capsules whole.
  • Do not crush or chew PREVACID Delayed-Release Capsules.
  • If you have trouble swallowing a whole capsule, you can open the capsule and take the contents with certain foods or juices. See “Patient Instructions for Use” at the end of this leaflet for instructions on how to take PREVACID capsules with certain foods and juices.
  • See “Patient Instructions for Use” at the end of this leaflet for instructions on how to mix and give PREVACID capsules through a nasogastric tube.
• PREVACID SoluTab:
  • is a tablet that melts in your mouth with or without water.
  • Do not break, cut or chew the tablets.
  • See “Patient Instructions for Use” at the end of this leaflet for instructions on how to mix and give PREVACID SoluTab tablets through a syringe and nasogastric tube.
• If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose. Just take the next dose at your regular time. Do not take 2 doses at the same time. If you are not sure about dosing, call your doctor. If you take too much PREVACID, call your doctor right away.

What are the possible side effects of PREVACID?

The most common side effects of PREVACID in adults and children include:

• diarrhea
• stomach pain
• nausea
• constipation
• headache
• dizziness

Other side effects

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

Your doctor may stop PREVACID if these symptoms happen.

• Bone Fractures. 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.
• 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 heartbeat
• 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 PREVACID, or during treatment; if you will be taking PREVACID for a long period of time.

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 PREVACID. 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 PREVACID?

• Store PREVACID at room temperature between 59°F to 86°F (15°C to 30°C).

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

General information about PREVACID

Medicines are sometimes prescribed for conditions other than those listed in a Patient Information Leaflet. Do not use PREVACID for conditions for which it was not prescribed. Do not give PREVACID to other people, even if they have the same symptoms you have. It may harm them.

This Patient Information Leaflet provides a summary of the most important information about PREVACID. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information that is written for healthcare professionals.

For more information go to www.PREVACID.com or call 1-877-825-3327.

What are the ingredients in PREVACID?

Active ingredient: lansoprazole.

Inactive ingredients in PREVACID Delayed-Release Capsules:

Sugar sphere, sucrose, methacrylic acid copolymer, low substituted hydroxypropyl cellulose, starch, magnesium carbonate, talc, polyethylene glycol, titanium dioxide, polysorbate 80, hydroxypropyl cellulose, colloidal silicon dioxide, D&C Red No. 28, FD&C Blue No. 1, and FD&C Red No. 40.

In addition PREVACID 15 mg Capsule only: FD&C Green No. 3.

Inactive ingredients in PREVACID SoluTab Delayed-Release Orally Disintegrating Tablets:

Mannitol, methacrylic acid, hydroxypropyl cellulose, lactose monohydrate-microcrystalline cellulose sphere, triethyl citrate, crospovidone, polyacrylate, magnesium carbonate, aspartame, glyceryl monostearate, hypromellose, magnesium stearate, citric acid, titanium dioxide, talc, artificial strawberry flavor, polyethylene glycol, polysorbate 80 and ferric oxide.

PREVACID SoluTab contains phenylalanine 2.5 mg per 15 mg Tablet and 5.1 mg per 30 mg Tablet.

Patient Instructions for Use

PREVACID
(prev-a -sid) (lansoprazole) Delayed-Release Capsules and

PREVACID SoluTab
(prev-a -sid sol-u-tab) (lansoprazole) Delayed-Release Orally Disintegrating Tablets

PREVACID Delayed-Release Capsules

• Swallow PREVACID Delayed-Release Capsules whole. Do not crush or chew them.
• You should take PREVACID before eating.
• PREVACID Delayed-Release Capsule with certain food:

You can only use applesauce, ENSURE pudding, cottage cheese, yogurt or strained pears.

1. Open the capsule.
2. Sprinkle the granules on 1 tablespoon of either applesauce, ENSURE pudding, cottage cheese, yogurt or strained pears.
3. Swallow right away.

PREVACID Delayed-Release Capsule with certain juices:

You can only use apple juice, orange juice or tomato juice.

1. Open the capsule.
2. Sprinkle the granules into 60 mL ( about ¼ cup) of either apple juice, orange juice or tomato juice.
3. Stir.
4. Swallow right away.
5. To make sure that the entire dose is taken, rinse the glass with ½ cup or more of juice to get out any leftover granules. Swallow the juice right away.

PREVACID Delayed-Release Capsules through a nasogastric tube (NG tube) 16 French or larger, as prescribed by your doctor:

You can only use apple juice.

1. Open the capsule and empty the granules into a syringe.
2. Do not break or crush the granules.
3. Mix with 40 mL of apple juice. Do not use other liquids.
4. Attach the syringe to the NG tube and give the medicine in the syringe through the NG tube into the stomach.
5. After giving the granules, flush the NG tube with more apple juice to clear the tube.

PREVACID should not be used in foods or liquids not listed above.

• PREVACID SoluTab Delayed-Release Orally Disintegrating Tablets

1. Do not chew, crush, cut or break tablets.
2. Put the tablet on the tongue and let it dissolve, with or without water.
3. Swallow after the tablet dissolves.
4. The tablet usually dissolves in less than 1 minute.

• PREVACID SoluTab Delayed-Release Orally Disintegrating Tablets with an oral syringe:

1. Put a 15 mg tablet in an oral syringe and add 4 mL of water, or put a 30 mg tablet in an oral syringe and add 10 mL of water.
2. Shake the syringe gently to dissolve the tablet quickly.
3. After the tablet has dissolved, give the mixture within 15 minutes.
4. To make sure that the entire dose is taken, refill the syringe with about 2 mL (5 mL for the 30 mg tablet) of water, shake gently, and give the water in the syringe.

• PREVACID SoluTab Delayed-Release Orally Disintegrating Tablets through a nasogastric tube (NG tube) 8 French or larger, as prescribed by your doctor:

1. Put a 15 mg tablet in a syringe and add 4 mL of water, or put a 30 mg tablet in a syringe and add 10 mL of water.
2. Shake the syringe gently to dissolve the tablet quickly.
3. After the tablet has dissolved, give the mixture in the syringe through the NG tube into the stomach within 15 minutes.
4. Refill the syringe with about 5 mL of water, shake gently, and flush the NG tube.

How should I store PREVACID?

• Store PREVACID at room temperature between 59°F to 86°F (15°C to 30°C).

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

Last reviewed on RxList: 5/18/2012
This monograph has been modified to include the generic and brand name in many instances.