LANSOPRAZOLE- lansoprazole tablet, orally disintegrating, delayed release
Mylan Pharmaceuticals Inc.
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Lansoprazole Delayed-Release Orally Disintegrating Tablets |
What is the most important information that I should know about lansoprazole delayed-release orally disintegrating tablets?
You should take lansoprazole delayed-release orally disintegrating tablets exactly as prescribed, at the lowest dose possible and for the shortest time needed.
Lansoprazole delayed-release orally disintegrating tablets may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor.
Lansoprazole delayed-release orally disintegrating tablets can cause serious side effects, including:
Talk to your doctor about your risk of these serious side effects.
Lansoprazole delayed-release orally disintegrating tablets can have other serious side effects. See “What are the possible side effects of lansoprazole delayed-release orally disintegrating tablets?”. |
What are lansoprazole delayed-release orally disintegrating tablets?
A prescription medicine called a proton pump inhibitor (PPI) used to reduce the amount of acid in your stomach.
In adults, lansoprazole delayed-release orally disintegrating tablets are used for:
Children: Give lansoprazole delayed-release orally disintegrating tablets exactly as prescribed by your child’s doctor. Do not increase the dose of lansoprazole delayed-release orally disintegrating tablets or give your child lansoprazole delayed-release orally disintegrating tablets longer than the amount of time your doctor tells you to. In children 1 to 11 years of age, lansoprazole delayed-release orally disintegrating tablets are used for:
In children 12 to 17 years of age, lansoprazole delayed-release orally disintegrating tablets are used for:
Lansoprazole delayed-release orally disintegrating tablets are not recommended for treating the symptoms of GERD in children less than 1 year of age and may harm them. |
Do not take lansoprazole delayed-release orally disintegrating tablets if you are:
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Before you take lansoprazole delayed-release orally disintegrating tablets, tell your doctor about all of your medical conditions, including if you:
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 lansoprazole delayed-release orally disintegrating tablets?
Lansoprazole delayed-release orally disintegrating tablets:
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What are the possible side effects of lansoprazole delayed-release orally disintegrating tablets?
Lansoprazole delayed-release orally disintegrating tablets can cause serious side effects, including:
The most common side effects of lansoprazole delayed-release orally disintegrating tablets include: diarrhea, stomach-area (abdomen) pain, nausea and constipation.
These are not all the possible side effects of lansoprazole delayed-release orally disintegrating tablets.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. |
How should I store lansoprazole delayed-release orally disintegrating tablets?
Store lansoprazole delayed-release orally disintegrating tablets at room temperature between 20° to 25°C (68° to 77°F).
Keep lansoprazole delayed-release orally disintegrating tablets and all medicines out of the reach of children. |
General information about the safe and effective use of lansoprazole delayed-release orally disintegrating tablets. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use lansoprazole delayed-release orally disintegrating tablets for conditions for which they were not prescribed. Do not give lansoprazole delayed-release orally disintegrating tablets to other people, even if they have the same symptoms that you have. They may harm them. You can ask your doctor or pharmacist for information about lansoprazole delayed-release orally disintegrating tablets that is written for health professionals. |
What are the ingredients in lansoprazole delayed-release orally disintegrating tablets?
Active ingredient: lansoprazole.
Inactive ingredients in lansoprazole delayed-release orally disintegrating tablets: artificial strawberry flavor, aspartame, citric acid monohydrate, crospovidone, hydroxypropyl cellulose, magnesium carbonate, magnesium stearate, mannitol, methacrylic acid copolymer type C, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium bicarbonate, sodium hydroxide, sodium lauryl sulfate, sodium starch glycolate (potato), sugar spheres (corn starch and sucrose), talc, triethyl citrate and yellow iron oxide.
Lansoprazole delayed-release orally disintegrating tablets contain 3.37 mg of phenylalanine in each 15 mg tablet and 6.74 mg of phenylalanine in each 30 mg tablet. |
Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A. Manufactured by: Mylan Laboratories Limited, Hyderabad — 500 096, India
For more information, call Mylan at 1-877-446-3679 (1-877-4-INFO-RX). |
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Instructions for Use
Lansoprazole Delayed-Release Orally Disintegrating Tablets
(lan soe′ pra zole)
Important:
Lansoprazole Delayed-Release Orally Disintegrating Tablets:
For patients who have trouble swallowing tablets, lansoprazole delayed-release orally disintegrating tablets can be given as follows:
Giving lansoprazole delayed-release orally disintegrating tablets with water using an oral syringe:
Giving lansoprazole delayed-release orally disintegrating tablets with water through a nasogastric tube (NG tube) size 8 French or larger:
How should I store lansoprazole delayed-release orally disintegrating tablets?
Keep lansoprazole delayed-release orally disintegrating tablets and all medicines out of the reach of children.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
The brand names listed are trademarks of their respective owners.
Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.
Manufactured by:
Mylan Laboratories Limited
Hyderabad — 500 096, India
75102578
Revised: 3/2024
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