Lansoprazole Delayed-Release CapsulesGeneric Name:
Lansoprazole (lan-SOE-pra-zole and na-PROX-en)Brand Name:
Lansoprazole Delayed-Release Capsules contains a nonsteroidal anti-inflammatory drug (NSAID). It may cause an increased risk of serious and sometimes fatal heart and blood vessel problems (eg, heart attack, stroke). The risk may be greater if you already have heart problems or if you take Lansoprazole Delayed-Release Capsules for a long time. Do not use Lansoprazole Delayed-Release Capsules right before or after bypass heart surgery.
Lansoprazole Delayed-Release Capsules may cause an increased risk of serious and sometimes fatal stomach ulcers and bleeding. Elderly patients may be at greater risk. This may occur without warning signs.
Lansoprazole Delayed-Release Capsules are used for:
Treating rheumatoid arthritis, osteoarthritis, or ankylosing spondylitis in certain patients with a history of gastric ulcer. It may also be used for other conditions as determined by your doctor.
Lansoprazole Delayed-Release Capsules are a combination package that contains an NSAID and a proton pump inhibitor (PPI). Exactly how the NSAID works is not known. It may block certain substances in the body that are linked to inflammation. NSAIDs treat symptoms of pain and inflammation. The PPI works by decreasing the amount of acid produced in the stomach. This decreases the risk of developing an ulcer from using an NSAID.
Do NOT use Lansoprazole Delayed-Release Capsules if:
- you are allergic to any ingredient in Lansoprazole Delayed-Release Capsules
- you have had a severe allergic reaction (eg, severe rash, hives, trouble breathing, growths in the nose, dizziness) to aspirin or an NSAID (eg, ibuprofen, celecoxib)
- you have recently had or will be having bypass heart surgery
- you have moderate to severe kidney problems
- you are in the last 3 months of pregnancy
- you are taking an HIV protease inhibitor (eg, atazanavir)
Contact your doctor or health care provider right away if any of these apply to you.
Before using Lansoprazole Delayed-Release Capsules:
Some medical conditions may interact with Lansoprazole Delayed-Release Capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a history of kidney or liver disease, diabetes, or stomach or bowel problems (eg, bleeding, perforation, ulcers, cancer)
- if you have a history of swelling or fluid buildup, asthma, growths in the nose (nasal polyps), or mouth inflammation
- if you have high blood pressure, blood disorders, bleeding or clotting problems, heart problems (eg, heart failure), or blood vessel disease, or if you are at risk for any of these diseases
- if you have poor health, dehydration or low fluid volume, or low blood sodium levels, you smoke or drink alcohol, or you have a history of alcohol abuse
Some MEDICINES MAY INTERACT with Lansoprazole Delayed-Release Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Anticoagulants (eg, warfarin), aspirin, clopidogrel, corticosteroids (eg, prednisone), heparin, or selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine) because the risk of stomach bleeding may be increased
- Clarithromycin, probenecid, or voriconazole because they may increase the risk of Lansoprazole Delayed-Release Capsules's side effects
- Cyclosporine, digoxin, hydantoins (eg, phenytoin), lithium, methotrexate, quinolones (eg, ciprofloxacin), sulfonamides (eg, sulfamethoxazole), or sulfonylureas (eg, glipizide) because the risk of their side effects may be increased by Lansoprazole Delayed-Release Capsules
- Ampicillin, angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), azole antifungals (eg, ketaconazole) beta-blockers (eg, propranolol), clopidogrel, diuretics (eg, furosemide, hydrochlorothiazide), HIV protease inhibitors (eg, atazanavir), iron, or theophylline because their effectiveness may be decreased by Lansoprazole Delayed-Release Capsules
This may not be a complete list of all interactions that may occur. Ask your health care provider if Lansoprazole Delayed-Release Capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Lansoprazole Delayed-Release Capsules:
Use Lansoprazole Delayed-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Lansoprazole Delayed-Release Capsules comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Lansoprazole Delayed-Release Capsules refilled.
- Take Lansoprazole Delayed-Release Capsules by mouth before eating, unless your doctor tells you otherwise. Naproxen may be taken with food if it upsets your stomach. Taking it with food may not lower the risk of stomach or bowel problems (eg, bleeding, ulcers). Talk with your doctor or pharmacist if you have persistent stomach upset.
- Take Lansoprazole Delayed-Release Capsules with a full glass of water (8 oz/240 mL).
- Swallow the lansoprazole capsule whole. Do not break, crush, or chew before swallowing.
- If you are taking sucralfate, take Lansoprazole Delayed-Release Capsules at least 30 minutes before taking sucralfate.
- If you also take an imidazole antifungal (eg ketoconazole), take it at least 2 hours before taking Lansoprazole Delayed-Release Capsules.
- If you also take antacids or cholestyramine, ask your doctor or pharmacist how to take them with Lansoprazole Delayed-Release Capsules.
- Continue to take Lansoprazole Delayed-Release Capsules even if you feel well. Do not miss any doses.
- If you miss a dose of Lansoprazole Delayed-Release Capsules, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Lansoprazole Delayed-Release Capsules.
Important safety information:
- Lansoprazole Delayed-Release Capsules may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Lansoprazole Delayed-Release Capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Serious stomach ulcers or bleeding can occur with the use of an NSAID. Taking it in high doses or for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking Lansoprazole Delayed-Release Capsules with food will NOT reduce the risk of these effects. Contact your doctor or emergency room at once if you develop severe stomach or back pain; black, tarry stools; vomit that looks like blood or coffee grounds; or unusual weight gain or swelling.
- Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
- Lansoprazole Delayed-Release Capsules has naproxen in it. Before you start any new medicine, check the label to see if it has naproxen or any other NSAID (eg, ibuprofen) in it too. If it does or if you are not sure, check with your doctor or pharmacist.
- Do not take aspirin while you are using Lansoprazole Delayed-Release Capsules unless your doctor tells you to.
- Lansoprazole Delayed-Release Capsules may interfere with certain lab tests. Be sure your doctor and lab personnel know that you take Lansoprazole Delayed-Release Capsules.
- Lab tests, including kidney or liver function, complete blood cell counts, and blood pressure, may be performed while you use Lansoprazole Delayed-Release Capsules. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Lansoprazole Delayed-Release Capsules should be used with caution in Asian patients; the risk of side effects may be increased in these patients.
- Use Lansoprazole Delayed-Release Capsules with caution in the ELDERLY; they may be more sensitive to its effects, especially stomach bleeding and kidney problems.
- Lansoprazole Delayed-Release Capsules should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Lansoprazole Delayed-Release Capsules may harm the fetus. Do not use it during the last 3 months of pregnancy. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Lansoprazole Delayed-Release Capsules while you are pregnant. Lansoprazole Delayed-Release Capsules should not be used during labor. Lansoprazole Delayed-Release Capsules are found in breast milk. Do not breast-feed while taking Lansoprazole Delayed-Release Capsules.
Possible side effects of Lansoprazole Delayed-Release Capsules:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Constipation; diarrhea; dizziness; drowsiness; gas; headache; heartburn; nausea; stomach upset.Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; trouble breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or black, tarry stools; change in the amount of urine produced; chest pain; confusion; dark urine; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; mental or mood changes; numbness of an arm or leg; one-sided weakness; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe headache or dizziness; severe or persistent stomach pain or nausea; severe vomiting; shortness of breath; sudden or unexplained weight gain; swelling of hands, legs, or feet; unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; vision, hearing, or speech changes; vomit that looks like coffee grounds; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include decreased urination; loss of consciousness; seizures; severe dizziness or drowsiness; severe nausea or stomach pain; slow or troubled breathing; unusual bleeding or bruising; vomit that looks like coffee grounds.Proper storage of Lansoprazole Delayed-Release Capsules:
Store Lansoprazole Delayed-Release Capsules at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store in the original packaging until just before use. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Lansoprazole Delayed-Release Capsules out of the reach of children and away from pets.
- If you have any questions about Lansoprazole Delayed-Release Capsules, please talk with your doctor, pharmacist, or other health care provider.
- Lansoprazole Delayed-Release Capsules are to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
This information is summary only. It does not contain all information about Lansoprazole Delayed-Release Capsules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.