Lansoprozole medication guide lit.indd

MEDICATION GUIDE
Who should not take lansoprazole delayed-release capsules?
Lansoprazole delayed-release capsules
• Do not take lansoprazole delayed-release capsules if you are allergic to lansoprazole or any of the other ingredients in lansoprazole delayed-release capsules. See the end of this Medication Guide for a complete list of ingredients in lansoprazole delayed-release Read this Medication Guide before you start taking lansoprazole delayed-release capsules and each time you get a refi ll. There may be new information. This information does not What should I tell my doctor before taking lansoprazole delayed-release capsules?
take the place of talking to your doctor about your medical condition or your treatment. Before you take lansoprazole delayed-release capsules, tell your doctor if you:
What is the most important information that I should know about lansoprazole delayed-
• have been told that you have low magnesium levels in your blood.
release capsules?
Lansoprazole delayed-release capsules may help your acid-related symptoms, but you • have any other medical conditions could still have serious stomach problems. Talk with your doctor. • are pregnant or plan to become pregnant. It is not known if lansoprazole delayed- Lansoprazole delayed-release capsules can cause serious side effects, including:
release capsules will harm your unborn baby.
• Diarrhea. Lansoprazole delayed-release capsules may increase your risk of getting • are breastfeeding or plan to breastfeed. It is not known if lansoprazole delayed-release
severe diarrhea. This diarrhea may be caused by an infection (Clostridium diffi cile) in capsules passes into your breast milk. You and your doctor should decide if you will take lansoprazole delayed-release capsules or breastfeed. You should not do both. Talk Call your doctor right away if you have watery stool, stomach pain, and fever that does to your doctor about the best way to feed your baby if you take lansoprazole delayed- • Bone fractures. People who take multiple daily doses of proton pump inhibitor Tell your doctor about all the medicines you take, including prescription and non-
medicines for a long period of time (a year or longer) may have an increased risk prescription medicines, vitamins, and herbal supplements. Lansoprazole delayed-release of fractures of the hip, wrist or spine. You should take lansoprazole delayed-release capsules may affect how other medicines work, and other medicines may affect how capsules exactly as prescribed, at the lowest dose possible for your treatment and for lansoprazole delayed-release capsules works. the shortest time needed. Talk to your doctor about your risk of bone fracture if you Especially tell your doctor if you take:
take lansoprazole delayed-release capsules. Lansoprazole delayed-release capsules can have other serious side effects. See “What • digoxin (Lanoxin)
are the possible side effects of Lansoprazole delayed-release capsules?”
What are lansoprazole delayed-release capsules?
Lansoprazole delayed-release capsule is a prescription medicine cal ed a proton pump • warfarin (Coumadin, Jantoven) inhibitor (PPI). Lansoprazole delayed-release capsules reduce the amount of acid in Lansoprazole delayed-release capsules are used in adults: • theophylline (Theo-24, Elixophyllin, Theochron, Theolair) • for 4 weeks for the healing and symptom relief of duodenal ulcers. The duodenal area • an antibiotic that contains ampicillin or clarithromycin is the area where food passes when it leaves the stomach. • with certain antibiotics to treat an infection called H. pylori. Sometimes H. pylori Ask your doctor or pharmacist for a list of these medicines if you are not sure.
bacteria can cause duodenal ulcers. The infection needs to be treated to prevent ulcers Know the medicines that you take. Keep a list of them to show your doctor and pharmacist • for continued healing of duodenal ulcers. How should I take lansoprazole delayed-release capsules?
• for up to 8 weeks to heal stomach ulcers. • Take lansoprazole delayed-release capsules exactly as prescribed by your doctor. • for up to 8 weeks to heal stomach ulcers in some people taking pain medicines called • Do not change your dose or stop taking lansoprazole delayed-release capsules without non-steroidal anti-infl ammatory drugs (NSAIDs). • for reducing the risk of stomach ulcers in some people taking NSAIDs. • You should take lansoprazole delayed-release capsules before eating. • for up to 8 weeks for the relief of heartburn and other symptoms of gastroesophageal • Lansoprazole delayed-release capsules:
o You should swallow lansoprazole delayed-release capsules whole.
GERD happens when acid in your stomach backs up into the tube (esophagus) that o Do not crush or chew lansoprazole delayed-release capsules.
connects your mouth to your stomach. This may cause a burning feeling in your chest o 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 • for 8 weeks to heal the acid-related damage to the lining of the esophagus (called end of this Medication Guide for instructions on how to take lansoprazole delayed- erosive esophagitis) and to relieve symptoms. If needed, your doctor may prescribe release capsules with certain foods and juices.
another 8 weeks of lansoprazole delayed-release capsules.
o See the “Instructions for Use” at the end of this Medication Guide for instructions on how to mix and give lansoprazole delayed-release capsules through a nasogastric • for continued healing of erosive esophagitis. • for the long-term treatment of conditions where your stomach makes too much acid. • If you miss a dose, take it as soon as you remember. If it is almost time for your next This includes a condition called Zollinger-Ellison syndrome. dose, skip the missed dose. Just take the next dose at your regular time. Do not take 2 Lansoprazole delayed-release capsules are used in children and adolescents (ages 1 to • If you take too much lansoprazole delayed-release capsules, call your doctor right • for up to 12 weeks to treat GERD and erosive esophagitis in children 1 to 11 years What are the possible side effects of lansoprazole delayed-release capsules?
• for up to 8 weeks to treat GERD and erosive esophagitis in adolescents 12 to17 years Lansoprazole delayed-release capsules can cause serious side effects, including:
• See “What is the most important information that I should know about lansoprazole
Lansoprazole delayed-release capsules are not effective for symptoms of GERD in children delayed-release capsules?”
• Low magnesium levels in your body. This problem can be serious. Low magnesium
A/s: 260 x 270 mm Lansoprozole Medication Guide literature kala 07-11-12 can happen in some people who take a proton pump inhibitor medicine for at least 3 Manufactured by: months. If low magnesium levels happen, it is usually after a year of treatment. You Natco Pharma Limited,
may or may not have symptoms of low magnesium. Tell your doctor right away if you develop any of these symptoms: Breckenridge Pharmaceutical, Inc.,
• jerking movements or shaking (tremors) Instructions for Use
• muscle weakness • spasms of the hands and feet Lansoprazole (lan-soe’-pra-zole) delayed-release capsules
• Swallow lansoprazole delayed-release capsules whole. Do not crush or chew them.
Your doctor may check the level of magnesium in your body before you start taking • You should take lansoprazole delayed-release capsules before eating lansoprazole delayed-release capsules, or during treatment; if you will be taking • Lansoprazole delayed-release capsules with certain food:
lansoprazole delayed-release capsules for a long period of time. You can only use applesauce, ENSURE pudding, cottage cheese, yogurt or strained
The most common side effects of lansoprazole delayed-release capsules in adults and 1. Open the capsule.
2. Sprinkle the granules on 1 tablespoon of either applesauce, ENSURE pudding, cottage • Lansoprazole delayed-release capsules with certain juices:
You can only use apple juice, orange juice or tomato juice.
2. Sprinkle the granules into 60 mL (about ¼ cup) of either apple juice, orange juice or • Serious allergic reactions. Tell your doctor if you get any of the following symptoms
with lansoprazole delayed-release capsules. 5. To make sure that the entire dose is taken, rinse the glass with 1/2 cup or more of juice to get out any leftover granules. Swallow the juice right away.
Lansoprazole delayed-release capsules through a nasogastric tube (NG tube) 16
Your doctor may stop lansoprazole delayed-release capsules if these symptoms happen.
French or larger, as prescribed by your doctor:
You can only use apple juice.
Tell your doctor if you have any side effect that bothers you or that does not go away.
1. Open the capsule and empty the granules into a syringe. These are not all the possible side effects of lansoprazole delayed-release capsules. For 2. Do not break or crush the granules. more information, ask your doctor or pharmacist. Call your doctor for medical advice 3. Mix with 40 mL of apple juice. Do not use other liquids.
about side effects. You may report side effects to the FDA at 1-800-FDA-1088. 4. Attach the syringe to the NG tube and give the medicine in the syringe through the How should I store lansoprazole delayed-release capsule?
• Store lansoprazole delayed-release capsules at room temperature between 68°F to 5. After giving the granules, fl ush the NG tube with more apple juice to clear the tube. Lansoprazole delayed-release capsules should not be used in foods or liquids not listed Keep lansoprazole delayed-release capsules and all medicines out of the reach of above.
children.
How should I store lansoprazole delayed-release capsule?
General information about lansoprazole delayed-release capsules
• Store lansoprazole delayed-release capsules at room temperature between 68°F to Medicines are sometimes prescribed for conditions other than those listed in a Medication Guide. Do not use lansoprazole delayed-release capsules for conditions for which it was Keep lansoprazole delayed-release capsules and all medicines out of the reach of
not prescribed. Do not give lansoprazole delayed-release capsules to other people, even children.
if they have the same symptoms you have. It may harm them.
This Instruction for Use has been approved by the U.S. Food and Drug Administration.
This Medication Guide summarizes the most important information about lansoprazole delayed-release capsules. If you would like more information, talk with your doctor. You Manufactured by: can ask your doctor or pharmacist for information about lansoprazole delayed-release NatcoPharma Limited,
capsules that is written for healthcare professionals. For more information, call 1-800-367-3395 or go to www.bpirx.com.
What are ingredients in lansoprazole delayed-release capsules?
Breckenridge Pharmaceutical, Inc.,
Active ingredient: lansoprazole.
Inactive ingredients in lansoprazole delayed-release capsules:
Acetone, hypromellose, isopropyl alcohol, light magnesium carbonate, methacrylic Oct/2012 acid copolymer, polyethylene glycol, polysorbate 80, sugar spheres, talc and titanium All trademark names are the property of their respective owners. dioxide.
This Medication Guide has been approved by the U.S. Food and Drug Administration.

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