This is a product that contains three separate medications: lansoprazole, clarithromycin, and amoxicillin. Lansoprazole belongs to the group of medications called proton pump inhibitors (PPIs). Clarithromycin and amoxicillin belong to the group of medications called antibiotics. Together these medications are used to treat H. pylori (bacteria that cause inflammation in the stomach) for people with a duodenal ulcer (an ulcer at the beginning of the small intestine).

These medications are also used to reduce the risk of another duodenal ulcer for people who have recently had a duodenal ulcer and who have tested positive for H. pylori. Lansoprazole helps to lower the acidity of the stomach, which helps the antibiotics (clarithromycin and amoxicillin) kill the bacteria and heal the ulcer.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

The usual adult dose of this combination of medications is 30 mg of lansoprazole, 500 mg of clarithromycin and 1 g of amoxicillin (2 × 500 mg capsules), twice a day before meals for 7, 10, or 14 days.

Lansoprazole capsules should be swallowed whole with water – do not crush, break, or chew them.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor and to finish all this medication. Not doing so may decrease the effectiveness of this medication and may increase the chances of bacteria developing resistance to amoxicillin and clarithromycin.

If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Each triple therapy AA-Lansoprazole-Amoxicillin-Clarithromycin daily administration blister pack contains:

Lansoprazole 30 mg
Each opaque, hard gelatin, delayed-release capsule, with a black opaque body and pink opaque cap, imprinted with "APO L30" on the capsule in white ink, contains 30 mg of lansoprazole. Nonmedicinal ingredients: ammonium hydroxide, D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, hydroxypropyl methylcellulose, magnesium hydroxide, methacrylic acid copolymer dispersion, methylcellulose, poloxamer (micro), polyethylene glycol, propylene glycol, shellac, simethicone, talc, titanium dioxide, and triethylcitrate.

Clarithromycin 500 mg
Each light yellow, capsule-shaped, biconvex, film-coated tablet, engraved "CLA500" on one side, "APO" on the other side, contains 500 mg of clarithromycin. Nonmedicinal ingredients: colloidal silicon dioxide, crospovidone, D&C Yellow No. 10, hydroxyethyl cellulose, magnesium stearate, polyethylene glycol, stearic acid and titanium dioxide.

Amoxicillin 500 mg
Each hard gelatin capsule with gold opaque body, scarlet opaque cap and a loosely slugged powder fill, printed with "APO 500" contains 500 mg of amoxicillin trihydrate. Nonmedicinal ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C Red No. 28, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Blue No. 2, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, iron oxide black, propylene glycol, shellac, stearic acid, talc, and titanium dioxide.

Do not take this medication if you:

• are allergic to lansoprazole, clarithromycin, amoxicillin, or any ingredients of these medications
• are allergic to other penicillins (e.g., cloxacillin, penicillin), cephalosporins, or other macrolide antibiotics (e.g., erythromycin, azithromycin)
• have had jaundice (yellowing of the skin or eyes) or liver problems associated with taking clarithromycin
• have severely reduced liver function in combination with decreased kidney function
• are taking astemizole, terfenadine, cisapride, domperidone, pimozide, ergotamine, dihydroergotamine, colchicine, rilpivirine, ticagrelor, midazolam, saquinavir, ritonavir, lomitapide, or "statin" cholesterol medications
• have or may have mononucleosis
• have untreated hypokalemia (low levels of potassium in the blood)
• have untreated hypomagnesemia (low levels of magnesium in the blood)
• have a history of irregular heartbeat (prolonged QT-interval, torsades de pointes, ventricular arrhythmia)

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• burping
• constipation
• diarrhea
• difficulty sleeping
• dizziness
• dry mouth
• gas
• "hairy" black tongue
• headache
• heartburn or indigestion
• muscle pain
• nausea
• rash
• taste changes
• vomiting
• weakness

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• anxiety or behavioural changes
• confusion
• new or worsening joint pain
• rash on the cheeks or arms that gets worse in the sun
• severe abdominal pain or cramps
• signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
• signs of kidney problems (e.g., increased urination at night, decreased urine production, blood in the urine, change of urine colour)
• signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
• symptoms of a bladder infection (pain or burning when urinating)
• symptoms of low magnesium levels in the blood (e.g., tremor, pounding heartbeat, fatigue, weakness, muscle spasms, numbness in the hands and feet, seizures)
• symptoms of an upper airway infection such as cough, nasal congestion, sinus pain, runny nose, or sore throat

Stop taking the medication and seek immediate medical attention if any of the following occur:

• abnormal heart rhythms (such as fast or slow heart rate, palpitations),
• severe diarrhea with or without blood or mucus
• signs of an allergic reaction (e.g., hives; difficulty breathing; swelling of the face, mouth, tongue, or throat)
• symptoms of meningitis not caused by infection (e.g., headache [severe], throbbing, or with stiff neck or back)
• signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin taking a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should take this medication.

Abnormal heart rhythm: Clarithromycin may cause a heart rhythm problem called QT prolongation. If you have a history of QT prolongation, a medical condition associated with QT prolongation, or are taking certain medications (e.g., amiodarone, sotalol), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Allergic reactions: Some people who are allergic to penicillin or cephalosporins also experience allergic reactions to amoxicillin. Some people who are allergic to erythromycin or azithromycin also experience allergic reactions to clarithromycin. Before you take lansoprazole - clarithromycin - amoxicillin, inform your doctor about any previous adverse reactions you have had to medications, especially penicillin or erythromycin antibiotics. Contact your doctor at once if you experience signs of an allergic reaction, such as skin rash, itching, difficulty breathing, or swelling of the face and throat.

Diarrhea: Diarrhea is a common side effect of antibiotics such as amoxicillin and clarithromycin. Diarrhea usually stops when the antibiotic is finished. However, a serious condition called pseudomembranous colitis can occur. If you develop severe watery and bloody diarrhea (with or without stomach cramps and fever) any time during treatment or up to 1 or 2 months after stopping this medication, contact your doctor.

Kidney function: A safe and effective dose of lansoprazole - clarithromycin - amoxicillin for people with reduced kidney function has not been determined. If you have kidney disease or decreased kidney function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver function: Liver disease or reduced liver function may cause clarithromycin or lansoprazole to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.

Clarithromycin may also cause a decrease in liver function. If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Methotrexate: When taken together, proton pump inhibitors such as lansoprazole may cause methotrexate to build up in the body, causing severe side effects, including possible death. Methotrexate is used to treat certain types of cancer, arthritis, and gastrointestinal disease. If you are taking methotrexate for any reason, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Myasthenia gravis: Myasthenia gravis is a condition that causes specific muscle weakness. Clarithromycin may cause symptoms of myasthenia gravis to occur or become worse. If you have myasthenia gravis, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Stomach cancer: Lansoprazole can improve some of the symptoms of stomach cancer and make it harder for a doctor to diagnose it.

Subacute cutaneous lupus erythematosus (SCLE): Rarely, this medication has been associated with SCLE, an autoimmune disease. If you develop any skin lesions, especially in sun-exposed skin areas, and if accompanied by muscle aches or pains, contact your doctor immediately.

Pregnancy: This medication should not be used during pregnancy, especially during the first 3 months, unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: Amoxicillin and clarithromycin pass into breast milk. It is not known if lansoprazole passes into breast milk. If you are breast-feeding and taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this combination of medications have not been established for children.

Seniors: Due to the possibility of reduced kidney and liver function, seniors should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

For a full list of interactions, use the Drug Interaction Checker available on the Drugs.com website.

If you are taking other medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.