Prevacid

What is the most important information I should know about Prevacid and Prevacid SoluTab?

You should take Prevacid and Prevacid SoluTab exactly as prescribed, at the lowest dose possible and for the shortest time needed.

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

Prevacid and Prevacid SoluTab can cause serious side effects, including:

• A type of kidney problem (acute interstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including Prevacid and Prevacid SoluTab, may develop a kidney problem called acute interstitial nephritis that can happen at any time during treatment with PPI medicines including Prevacid and Prevacid SoluTab. Call your doctor right away if you have a decrease in the amount that you urinate or if you have blood in your urine.
• Diarrhea caused by an infection (Clostridium difficile) in your intestines. Call your doctor right away if you have watery stools or stomach pain that does not go away. You may or may not have a fever.
• Bone fractures (hip, wrist, or spine). Bone fractures in the hip, wrist, or spine may happen in people who take multiple daily doses of PPI medicines and for a long period of time (a year or longer). Tell your doctor if you have a bone fracture, especially in the hip, wrist, or spine.
• Certain types of lupus erythematosus. Lupus erythematosus is an autoimmune disorder (the body’s immune cells attack other cells or organs in the body). Some people who take PPI medicines, including Prevacid and Prevacid SoluTab, may develop certain types of lupus erythematosus or have worsening of the lupus they already have. Call your doctor right away if you have new or worsening joint pain or a rash on your cheeks or arms that gets worse in the sun.

Talk to your doctor about your risk of these serious side effects.

Prevacid and Prevacid SoluTab can have other serious side effects. See “What are the possible side effects of Prevacid and Prevacid SoluTab?”.

Who should not take Prevacid or Prevacid SoluTab?

Do not take Prevacid or Prevacid SoluTab if you are:

• allergic to lansoprazole, any other PPI medicine, or any of the ingredients in Prevacid or Prevacid SoluTab. See the end of this Medication Guide for a complete list of ingredients in Prevacid and Prevacid SoluTab.
• taking a medicine that contains rilpivirine (Edurant, Complera, Odefsey, Juluca) used to treat HIV-1 (Human Immunodeficiency Virus).

What should I tell my healthcare provider before taking Prevacid or Prevacid SoluTab?

Before you take Prevacid or Prevacid SoluTab, tell your doctor about all of your medical conditions, including if you:

• have low magnesium levels in your blood.
• have liver problems.
• have phenylketonuria. Prevacid SoluTab contains aspartame.
• are pregnant, think you may be pregnant or plan to become pregnant. Prevacid or Prevacid SoluTab may harm your unborn baby. Talk to your doctor about the possible risks to an unborn baby if Prevacid or Prevacid SoluTab is taken during pregnancy.
• are breastfeeding or plan to breastfeed. It is not known if Prevacid or Prevacid SoluTab passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take Prevacid or Prevacid SoluTab.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor if you take methotrexate (Otrexup, Rasuvo, Trexall, Reditrex, Xatmep).

How should I take Prevacid and Prevacid SoluTab?

• Take Prevacid or Prevacid SoluTab exactly as prescribed by your doctor.
• Do not change your dose or stop taking Prevacid or Prevacid SoluTab without talking to your doctor.
• Take Prevacid or Prevacid SoluTab before meals.
  Prevacid capsules:
  • Swallow Prevacid capsules whole.
  • Do not crush or chew Prevacid capsules.
  • If you have trouble swallowing a whole capsule, you can open the capsule and take the contents with certain foods or juices. See the “Instructions for Use” at the end of this Medication Guide for instructions on how to take Prevacid capsules with certain foods or juices.
  • See the “Instructions for Use” at the end of this Medication Guide for instructions on how to mix and give Prevacid capsules through a nasogastric tube (NG tube).

  Prevacid SoluTab:

  • Prevacid SoluTab is a tablet that melts in your mouth with or without water.
  • Do not break, cut, crush or chew the tablets.
  • See the “Instructions for Use” at the end of this Medication Guide for instructions on how to mix and give Prevacid SoluTab through a syringe and NG tube.
• If you miss a dose of Prevacid or Prevacid SoluTab, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose. Take your next dose at your regular time. Do not take 2 doses at the same time.
• If you take too much Prevacid or Prevacid SoluTab, call your doctor or your poison control center at 1-800-222-1222 right away or go to the nearest hospital emergency room.

What are the possible side effects of Prevacid and Prevacid SoluTab?

Prevacid and Prevacid SoluTab can cause serious side effects, including:

• See “What is the most important information I should know about Prevacid and Prevacid SoluTab?”.
• Low vitamin B12 levels in the body can happen in people who have taken Prevacid or Prevacid SoluTab for a long time (more than 3 years). Tell your doctor if you have symptoms of low vitamin B12 levels, including shortness of breath, lightheadedness, irregular heartbeat, muscle weakness, pale skin, feeling tired, mood changes, and tingling or numbness in the arms and legs.
• Low magnesium levels in the body can happen in people who have taken Prevacid for at least 3 months. Tell your doctor if you have symptoms of low magnesium levels, including seizures, dizziness, irregular heartbeat, jitteriness, muscle aches or weakness, and spasms of hands, feet or voice.
• Stomach growths (fundic gland polyps). People who take PPI medicines for a long time have an increased risk of developing a certain type of stomach growth called fundic gland polyps, especially after taking PPI medicines for more than 1 year.

The most common side effects of Prevacid and Prevacid SoluTab include: diarrhea, stomach-area (abdomen) pain, nausea and constipation.

These are not all the possible side effects of Prevacid and Prevacid SoluTab.

Call your doctor for medical advice about side effects.

You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Prevacid and Prevacid SoluTab

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Prevacid or Prevacid SoluTab for conditions for which it was not prescribed. Do not give Prevacid or Prevacid SoluTab to other people, even if they have the same symptoms that you have. It may harm them. You can ask your doctor or pharmacist for information about Prevacid and Prevacid SoluTab that is written for health professionals.

How should I store Prevacid and Prevacid SoluTab?

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

Keep Prevacid and Prevacid SoluTab and all medicines out of the reach of children.

What are the ingredients in Prevacid and Prevacid SoluTab?

Active ingredient: lansoprazole.

Inactive ingredients:

Prevacid 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.

Prevacid 15 mg capsule only: FD&C Green No. 3.

Prevacid SoluTab: 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 2.5 mg of phenylalanine in each 15 mg tablet and 5.1 mg of phenylalanine in each 30 mg tablet.

For more information go to www.PREVACID.com or call 1-877- TAKEDA-7 (1-877- 825- 3327).

Instructions for use for Prevacid and Prevacid SoluTab

Important:

• Take Prevacid or Prevacid SoluTab before meals.
• Do not crush or chew Prevacid capsules or Prevacid SoluTab.
• Prevacid or Prevacid SoluTab should only be used with the foods and juices listed below.

Prevacid delayed-release capsules (Prevacid capsules)

Taking Prevacid capsules with certain foods:

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 applesauce, ENSURE pudding, cottage cheese, yogurt or strained pears.
3. Swallow right away.

Taking Prevacid capsules 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 apple juice, orange juice or tomato juice.
3. Stir.
4. Swallow right away.
5. To make sure that the entire dose is taken, add 1/2 cup or more of juice to the glass, stir and swallow right away.

Giving Prevacid capsules through a nasogastric tube (NG tube) size 16 French or larger:

You can only use apple juice.

1. Place 40 mL of apple juice into a clean container.
2. Open the capsule and empty the granules into the container of apple juice.
3. Use a catheter-tip syringe to draw up the apple juice and granule mixture.
4. Gently mix the catheter-tip syringe to keep the granules from settling.
5. Attach the catheter-tip syringe to the NG tube.
6. Give the mixture right away through the NG tube that goes into the stomach. Do not save the apple juice and granule mixture for later use.
7. Refill the catheter-tip syringe with 40 mL of apple juice and mix gently. Flush the NG tube with apple juice.

Prevacid SoluTab Delayed-Release Orally Disintegrating Tablets (Prevacid SoluTab)

1. Do not chew, crush, cut or break the 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.

For patients who have trouble swallowing tablets, Prevacid SoluTab can be given as follows:

Giving Prevacid SoluTab with water using an oral syringe:

1. Put a 15 mg tablet in an oral syringe and draw up 4 mL of water into the oral syringe, or put a 30 mg tablet in an oral syringe and draw up 10 mL of water into the oral syringe.
2. Gently shake the oral syringe to mix the tablet and the water.
3. After the tablet is mixed in the water, place the tip of the oral syringe in the mouth. Give the medicine within 15 minutes of mixing. Do not save the tablet and water mixture for later use.
4. Refill the oral syringe with about 2 mL of water for the 15 mg tablet or 5 mL of water for the 30 mg tablet, and shake gently. Place the tip of the oral syringe in the mouth and give the medicine that is left in the syringe.

Giving Prevacid SoluTab with water through a nasogastric tube (NG tube) size 8 French or larger:

1. Put a 15 mg tablet in a catheter-tip syringe and draw up 4 mL of water, or put a 30 mg tablet in a catheter-tip syringe and draw up 10 mL of water.
2. Gently shake the catheter-tip syringe to mix the tablet and the water.
3. Connect the catheter-tip syringe to the NG tube.
4. Give the mixture right away through the NG tube that goes into the stomach. Give the medicine within 15 minutes of mixing. Do not save the granule and water mixture for later use.
5. Refill the catheter-tip syringe with about 5 mL of water and shake gently. Flush the NG tube with the water.

How should I store Prevacid and Prevacid SoluTab?

• Store Prevacid capsules and Prevacid SoluTab at room temperature between 68°F to 77°F (20°C to 25°C).

Label

PRINCIPAL DISPLAY PANEL – 15 MG TABLET BLISTER PACK CARTON

• NDC 64764-543-11
• PREVACID® SoluTab™
  LANSOPRAZOLE
  Delayed-Release Orally Disintegrating Tablets
• 15
  mg
• Rx only
• Takeda
• Dispense the enclosed
  Medication Guide to each patient.
• 100 Tablets
  Contains: 10 Packs of 10 Tablets Each

SRC: NLM .