Prevacid SoluTab

Yes

Use of lansoprazole in pregnant women has not been adequately evaluated.

Lansoprazole has not been studied in nursing women.

Capsules: 15 and 30 mg. Oral suspension: in 15 and 30 mg unit dose cartons of 30. Lansoprazole also is available in 15 and 30 mg tablets that disintegrate when placed under the tongue (Prevacid SoluTab). Lansoprazole is available for intravenous injection in vials containing 30 mg of powdered lansoprazole (30 mg/5 ml when mixed with sterile water).

Store at room temperature between 15 C and 30 C (59 F and 86 F). Keep away from moisture.

In the U.S.

• First - Lansoprazole
• Prevacid
• Prevacid SoluTab

Available Dosage Forms:

• Tablet Disintegrating, Delayed Release
• Capsule, Delayed Release
• Packet
• Powder for Suspension

Therapeutic Class: Gastric Acid Secretion Inhibitor

Pharmacologic Class: Proton Pump Inhibitor

It is important that your doctor check the progress of you or your child at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood, urine, and other laboratory tests may be needed to check for unwanted effects. If your or your child's condition does not improve, or if it becomes worse, discuss this with your doctor.

Check with your doctor right away if you have a fever, joint pain, skin rash, swelling of the body, feet, or ankles, or unusual weight gain after receiving this medicine. These could be symptoms of acute interstitial nephritis.

Taking this medicine for a long time may make it harder for your body to absorb vitamin B12. Tell your doctor if you have concerns about vitamin B12 deficiency.

Check with your doctor right away if you have watery stool that does not go away, stomach pain, and fever while taking this medicine.

Lansoprazole may increase your risk of having fractures of the hip, wrist, and spine. This is more likely if you have osteoporosis, if you are 50 years of age and older, if you receive high doses of this medicine, or use it for one year or more.

Cutaneous or systemic lupus erythematosus may occur or get worse in patients receiving a PPI. Call your doctor right away if you have joint pain or a skin rash on your cheeks or arms that gets worse when exposed to the sun.

This medicine may cause hypomagnesemia (low magnesium in the blood). This is more likely to occur if you are taking this medicine for more than one year, or if you are taking this medicine together with digoxin (Lanoxin®) or certain diuretics or "water pills". Check with your doctor right away if you have convulsions (seizures), fast, racing, or uneven heartbeat, muscle spasms (tetany), tremors, or unusual tiredness or weakness.

Do not stop taking this medicine without first checking with your doctor, or unless told to do so by your doctor.

Before you have any medical tests, tell the medical doctor in charge that you or your child are taking this medicine. The results of some tests may be affected by this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription (eg, atazanavir, Reyataz®) or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Along with its needed effects, a medicine 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:

• Diarrhea
• skin rash or itching

• Abdominal or stomach pain
• increased or decreased appetite
• joint pain
• nausea
• vomiting

• Anxiety
• cold or flu-like symptoms
• constipation
• increased cough
• mental depression
• muscle pain
• rectal bleeding
• unusual bleeding or bruising

• Abdominal or stomach tenderness
• back or leg pains
• bleeding gums
• blistering, peeling, or loosening of the skin
• bloating
• bloody, black, or tarry stools
• change in mental status
• chest pain
• chills
• clay colored stools
• cough or hoarseness
• dark or bloody urine
• difficulty with swallowing
• drowsiness
• fast heartbeat
• fever
• general body swelling
• high fever
• hives
• indigestion
• loss of appetite
• lower back or side pain
• mood or mental changes
• muscle spasms (tetany) or twitching seizures
• nosebleeds
• painful or difficult urination
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pale skin
• pinpoint red spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red skin lesions, often with a purple center
• red, irritated eyes
• seizures
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• swelling of the feet or lower legs
• swollen or painful glands
• tightness in the chest
• trembling
• unusual tiredness or weakness
• yellow eyes or skin

Some side effects 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:

• Dizziness
• headache

• Bleeding, blistering, burning, coldness, or discoloration of the skin
• mild nausea

• Acid or sour stomach
• bad, unusual or unpleasant (after) taste
• belching
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• change in taste
• feeling faint, dizzy, or lightheaded
• feeling of heat or warmth
• flushing or redness of the skin, especially on the face and neck
• mild diarrhea
• mild headache
• mild vomiting
• stomach discomfort or upset
• sweating

• Decrease in passing urine (dribbling)
• decrease in the frequency of urination
• decrease in urine volume
• difficulty with speaking

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

Use Prevacid SoluTab as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Keep taking this medicine as you have been told by your doctor or other health care provider, even if you feel well.
• Take 30 minutes before a meal.
• Do not take sucralfate within 30 minutes of Prevacid SoluTab.
• Place on your tongue and let it melt. Water is not needed. Do not swallow it whole. Do not chew, break, or crush it.
• You may also melt the tablet in an oral syringe with water. Place the tablet in an oral syringe. For 15 mg tablets, draw up 4 mL of water. For 30 mg tablets, draw up 10 mL of water. Shake gently until the tablet melts. Take within 15 minutes of mixing. After taking, refill the syringe with 2 mL of water for 15 mg tablet or 5 mL of water for 30 mg tablet. Shake gently and swallow.
• Those who have feeding tubes may use this medicine. Use as you have been told. Flush the feeding tube after Prevacid SoluTab (lansoprazole orally disintegrating tablets) is given.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

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.

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

• 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.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine is refilled. If you have any questions about Prevacid SoluTab, please talk with the doctor, 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 Prevacid SoluTab. 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 Prevacid SoluTab.

Review Date: October 4, 2017