Uses

This product is used to treat stomach/intestinal ulcers caused by the bacteria H. pylori and to prevent the ulcers from returning. Treating an ulcer reduces the risk of serious damage to the lining of the stomach/intestines (such as bleeding, tearing, blockage).

Lansoprazole is known as a proton pump inhibitor (PPI). It works by blocking acid production in the stomach. Decreasing excess stomach acid can help the ulcer heal. Amoxicillin and clarithromycin are antibiotics used to treat a wide variety of bacterial infections (including H. pylori). Treating the infection helps reduce the risk of the ulcer returning. Amoxicillin is a penicillin-type antibiotic and clarithromycin is a macrolide-type antibiotic. They work by stopping the growth of bacteria.

The antibiotics in this product treat only bacterial infections. Antibiotics do not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.

Lansoprazole is not recommended for use in children younger than 1 year due to an increased risk of serious side effects. Ask the doctor or pharmacist for details.

How To Use

Take this medication by mouth exactly as directed by your doctor, usually 1 dose (4 pills) twice daily before a meal. Swallow the lansoprazole capsules whole. Do not crush or chew.

Each packet contains both the morning and evening doses of this medication (a 1-day supply). Consult your doctor or pharmacist for instructions on the proper use of this product. The dosage and length of treatment is based on your medical condition and response to treatment.

For the best effect, take this product at evenly spaced times. To help you remember, take this product at the same times every day. Continue to take this medication until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may result in a return of the infection.

Tell your doctor if your condition lasts or gets worse.

Side Effects

Diarrhea, headache, nausea, vomiting, and abnormal taste may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• muscle weakness
• dark urine
• yellowing eyes/skin
• easy bruising/bleeding
• mental/mood changes (such as agitation, confusion)
• signs of lupus (such as rash on nose and cheeks, new or worsening joint pain)

Get medical help right away if you have any very serious side effects, including:

• severe dizziness
• fainting
• fast/irregular heartbeat

This medication may rarely cause a severe intestinal condition due to a bacteria called C. difficile. This condition may occur during treatment or weeks to months after treatment has stopped. Tell your doctor right away if you develop:

• diarrhea that doesn't stop
• abdominal or stomach pain/cramping
• blood/mucus in your stool

If you have these symptoms, do not use anti-diarrhea or opioid products because they may make symptoms worse.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new yeast infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• fever
• swollen lymph nodes
• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing
• signs of kidney problems (such as change in the amount of urine)

Amoxicillin can commonly cause a mild rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe allergic reaction. Get medical help right away if you develop any rash.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking this product, tell your doctor or pharmacist if you are allergic to lansoprazole, amoxicillin, or clarithromycin; or to penicillins (such as ampicillin), cephalosporins (such as cephalexin), or macrolide antibiotics (such as erythromycin); or to dexlansoprazole; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• liver disease (including liver problems with past clarithromycin use)
• kidney disease
• heart disease (coronary artery disease, heart attack)
• a certain type of muscle disease (myasthenia gravis)
• a certain type of viral infection (infectious mononucleosis)
• lupus

Some symptoms may actually be signs of a more serious condition. Get medical help right away if you have:

• heartburn with lightheadedness/sweating/dizziness
• chest/jaw/arm/shoulder pain (especially with shortness of breath, unusual sweating)
• unexplained weight loss

Clarithromycin may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using this product, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions:

• certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG)
• family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death)

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using this product safely.

This medication may cause live bacterial vaccines (such as typhoid vaccine) to not work well. Tell your health care professional that you are using this medication before having any immunizations/vaccinations.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above), and C. difficile infection (see Side Effects section).

During pregnancy, this product should be used only when clearly needed. Discuss the risks and benefits with your doctor.

Amoxicillin and clarithromycin pass into breast milk. It is unknown if lansoprazole passes into breast milk. Consult your doctor before breast-feeding.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

A product that may interact with this drug is:

• methotrexate

Many drugs besides clarithromycin may affect the heart rhythm (QT prolongation), including amiodarone, disopyramide, dofetilide, pacritinib, pimozide, procainamide, quinidine, sotalol, among others.

Other medications can affect the removal of clarithromycin from your body, which may affect how clarithromycin works. Examples include rifamycins (such as rifabutin), efavirenz, nevirapine, saquinavir, among others.

Clarithromycin can slow down the removal of other medications from your body, which may affect how they work. Examples of affected drugs include colchicine, digoxin, some drugs used to treat erectile dysfunction-ED/pulmonary hypertension (such as sildenafil, tadalafil), ergot alkaloids (such as ergotamine, dihydroergotamine), flibanserin, some statin drugs (such as lovastatin, simvastatin), tamsulosin, tolvaptan, ticagrelor, among others.

Some products need stomach acid so that the body can absorb them properly. Lansoprazole decreases stomach acid, so it may change how well these other products work. Some affected products include atazanavir, erlotinib, levoketoconazole, nelfinavir, pazopanib, rilpivirine, sparsentan, certain azole antifungals (itraconazole, ketoconazole, posaconazole), among others. Before using lansoprazole, consult your doctor or pharmacist about the other medications you take and for advice on how to reduce or avoid these types of interactions.

Lansoprazole is very similar to dexlansoprazole. Do not use medications containing dexlansoprazole while using lansoprazole.

This medication may interfere with certain lab tests (such as urine glucose test), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center. Symptoms of overdose may include: change in the amount of urine.

Notes

Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for another infection unless your doctor tells you to.

Lab and/or medical tests may be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

Missed Dose

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.