Patient Medication Information: uses, side effects, how to take - AA-Lansoprazole-Amoxicillin-Clarithromycin
What is AA-LANSOPRAZOLE-AMOXICILLIN-CLARITHROMYCIN used for?
AA-LANSOPRAZOLE-AMOXICILLIN-CLARITHROMYCIN is used in adults to treat infection caused by bacteria called H. pylori and reduce the risk of ulcer recurrence in the small intestine.
How does AA-LANSOPRAZOLE-AMOXICILLIN-CLARITHROMYCIN work?
AA-LANSOPRAZOLE-AMOXICILLIN-CLARITHROMYCIN contains 3 different medicines; lansoprazole delayed-release capsules, clarithromycin tablets, and amoxicillin capsules. Lansoprazole delayed-release capsules reduce stomach acid. This helps the 2 antibiotics, clarithromycin tablets and amoxicillin capsules, to kill bacteria. Reducing the bacteria helps heal the ulcer.
What are the ingredients in AA-LANSOPRAZOLE-AMOXICILLIN-CLARITHROMYCIN?
Medicinal ingredients: lansoprazole, clarithromycin and amoxicillin trihydrate
Non-medicinal ingredients:
Serious Warnings and Precautions
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Lansoprazole delayed-release capsules 30 mg contain: ammonium hydroxide, D&C red #28, FD&C blue #1, FD&C red #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 tablets contain: colloidal silicon dioxide, crospovidone, D&C yellow #10, hydroxyethyl cellulose, magnesium stearate, polyethylene glycol, stearic acid and titanium dioxide.
Amoxicillin 500 mg capsules contain: colloidal silicon dioxide, croscarmellose sodium, D&C red#28, D&C yellow #10, FD&C blue #1, FD&C blue #2, FD&C red #40, FD&C yellow #6, gelatin, iron oxide black, propylene glycol, shellac, stearic acid, talc and titanium dioxide.
AA-LANSOPRAZOLE-AMOXICILLIN-CLARITHROMYCIN comes in the following dosage forms:
Each daily blister pack of AA-LANSOPRAZOLE-AMOXICILLIN-CLARITHROMYCIN contains:
- Lansoprazole delayed-release capsules: 2 x 30 mg capsules
- Clarithromycin tablets: 2 x 500 mg tablets
- Amoxicillin capsules: 4 x 500 mg capsules
Each box contains 7 daily blister packs.
Do not use AA-LANSOPRAZOLE-AMOXICILLIN-CLARITHROMYCIN if:
Do not take AA-LANSOPRAZOLE-AMOXICILLIN-CLARITHROMYCIN if you have an allergy to:
- lansoprazole, clarithromycin or amoxicillin.
- other beta-lactam (e.g. penicillin or cephalosporin), macrolide (erythromycin), or other similar antibiotics.
- any of the non-medicinal ingredients in lansoprazole delayed-release capsules, clarithromycin tablets or amoxicillin capsules (see What are the ingredients in AA-LANSOPRAZOLE-AMOXICILLIN-CLARITHROMYCIN?).
Do not take lansoprazole delayed-release capsules if you:
- are taking rilpivirine, used to treat HIV.
Do not take clarithromycin tablets if you:
- have ever developed liver problems after taking clarithromycin.
- have kidney problems.
- have liver problems.
- have a history of heart disturbance or irregular heartbeat (arrhythmias, QT prolongation, torsades de pointes).
- have low levels of potassium in the blood (hypokalaemia).
- have low levels of magnesium in the blood (hypomagnesaemia).
- have, or may have, a viral infection called mononucleosis (also known as “Mono”).
- are taking any of the medicines listed in the Serious Drug Interactions box below.
Do not take amoxicillin capsules if you:
- have, or may have, a viral infection called mononucleosis (also known as “Mono”).
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take AA-LANSOPRAZOLE-AMOXICILLIN-CLARITHROMYCIN. Talk about any health conditions or problems you may have, including if you:
- have a history of mild diarrhea or colitis influenced by the use of antibiotics.
- have kidney problems.
- have stomach cancer.
- have liver problems.
are taking any of the following medications:
- atorvastatin, pravastatin, used to lower high cholesterol
- midazolam, used to relieve anxiety before surgery or certain procedures
- digoxin, used to treat heart problems
- other medications (see The following may interact with AA-LANSOPRAZOLE-AMOXICILLIN-CLARITHROMYCIN)
are pregnant, become pregnant or trying to get pregnant, taking clarithromycin during pregnancy may increase the risk of miscarriage.
- are breast-feeding or planning to breastfeed. Talk to your healthcare professional about how to feed your baby while you are taking AA-LANSOPRAZOLE-AMOXICILLIN-CLARITHROMYCIN.
are taking blood thinners, have been told you are at high risk of bleeding or are taking clarithromycin together with the oral blood thinners dabigatran, rivaroxaban or apixaban. Tell your healthcare professional if you have signs of heavy bleeding or unusual bruising, including:
- prolonged bleeding from cuts.
- bleeding from nose or gums.
- heavy menstruation.
- red or brown urine.
- red or black stools.
- have blood problems such as leukopenia (low white blood cell count), neutropenia (low blood cell count).
- are due to have a specific blood test (Chromogranin A).
Other warnings you should know about:
Lansoprazole delayed-release capsules may help your acid-related symptoms. However you could still have serious stomach problems. Talk to your healthcare professional if your problems continue.
Take lansoprazole delayed-release capsules exactly as your healthcare professional tells you. You will use the lowest dose and shortest time suitable for your condition. Talk to your healthcare professional if you have any concerns about your treatment.
Depending on your condition, your healthcare professional may tell you to use lansoprazole delayed-release capsules for a longer period.
Using proton pump inhibitors like lansoprazole delayed-release capsules for a long time (every day for a year or longer) may increase risks of broken bones of the hip, wrist or spine. Talk to your healthcare professional about this risk.
Long term use of proton pump inhibitors may also interfere with the absorption of Vitamin B12 from the diet. This may cause a shortage of Vitamin B12 in your body. Talk to your healthcare professional.
Antibacterial drugs like clarithromycin tablets or amoxicillin capsules treat only bacterial infections. They do not treat viral infections such as the common cold. Although you may feel better early in treatment, clarithromycin tablets and amoxicillin capsules should be used exactly as directed. Misuse or overuse of clarithromycin tablets or amoxicillin capsules could lead to the growth of bacteria that will not be killed by clarithromycin tablets or amoxicillin capsules (resistance). This means that clarithromycin or amoxicillin may not work for you in the future. Do not share your medicine.
While taking clarithromycin tablets, talk to your healthcare professional immediately if you develop:
symptoms or worsening of the muscle disease, myasthenia gravis, such as:
- muscle weakness that gets worse with activity.
- muscle weakness that gets better with rest.
- difficulty chewing, swallowing or breathing.
- drooping eyelid, blurred or double vision.
symptoms of liver inflammation (hepatitis) such as:
- abdominal pain, nausea, vomiting.
- yellowing of skin and eyes.
- dark-coloured urine.
AA-LANSOPRAZOLE-AMOXICILLIN-CLARITHROMYCIN can cause abnormal blood test results. Your healthcare professional will decide when to do blood tests and will interpret the results.
Driving and using machinery: Clarithromycin tablets may cause dizziness, vertigo, confusion or disorientation. Give yourself time after taking AA-LANSOPRAZOLE-AMOXICILLIN-CLARITHROMYCIN to see how you feel before driving or using machinery.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with AA-LANSOPRAZOLE-AMOXICILLIN-CLARITHROMYCIN:
Serious Drug Interactions
* Not marketed in Canada. When used together, these medicines can interact with AA-LANSOPRAZOLE-AMOXICILLIN-CLARITHROMYCIN. It can cause an irregular heartbeat or even death.
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The following may also interact with AA-LANSOPRAZOLE-AMOXICILLIN-CLARITHROMYCIN:
- Medicines used to treat bacterial and fungal infections (such as ampicillin esters, tetracyclines, rifabutin, rifampin, rifapentine*, fluconazole, itraconazole, and ketoconazole)
- Medicines used to treat cancer (such as methotrexate, and vinblastine)
- Medicines used to help prevent blood clots (such as acenocoumarol, apixaban, cilostazol, dabigatran, rivaroxaban, and warfarin)
- Medicines used to treat diabetes (such as insulin, nateglinide, pioglitazone, repaglinide, and rosiglitazone)
- Medicines used to treat, prevent or control seizures (such as carbamazepine, phenobarbital, phenytoin, and valproic acid)
- Medicines used to treat psychosis (such as aripiprazole, quetiapine, and risperidone)
- Herbal products such as St. John’s Wort (Hypericum perforatum)
- Medicines used to treat high blood pressure (such as amlodipine, diltiazem, and verapamil)
- Medicines used to treat high cholesterol (such as atorvastatin, pravastatin, and rosuvastatin)
- Medicines used to treat HIV/AIDS (such as atazanavir, efavirenz, etravirine, indinavir, nelfinavir, nevirapine, ritonavir, saquinavir, and zidovudine)
- Medicines used to block hormones (such as bromocriptine)
- Medicines used to prevent organ rejection after a transplant (such as cyclosporine, and tacrolimus)
- Medications to treat blood problems (such as iron salts)
- Medications to treat digestive problems (such as lansoprazole, omeprazole, and sucralfate)
- Medications to treat erectile dysfunction (such as sildenafil, tadalafil, and vardenafil)
- Medications to treat gout (such as probenecid)
- Medications to treat heart problems and stroke (such as clopidogrel, digoxin, disopyramide, and quinidine)
- Medications to treat lung diseases (such as theophylline)
- Medications to treat an overactive bladder (such as tolterodine)
- Medicines used to treat pain (such as alfentanil)
- Medicines used for contraception (“birth control”)
- Sedatives (such as alprazolam, hexobarbital, and triazolam)
- Steroid anti-inflammatory medicines (such as methylprednisolone)
* Not marketed in Canada.
How to take AA-LANSOPRAZOLE-AMOXICILLIN-CLARITHROMYCIN:
- AA-LANSOPRAZOLE-AMOXICILLIN-CLARITHROMYCIN consists of lansoprazole delayed-release capsules, clarithromycin tablets, and amoxicillin capsules.
- AA-LANSOPRAZOLE-AMOXICILLIN-CLARITHROMYCIN should be taken prior to breakfast and another meal.
- You should not chew, break, cut or crush the lansoprazole delayed-release capsules. Capsules should be swallowed whole with sufficient water.
Usual dose:
The recommended dose of AA-LANSOPRAZOLE-AMOXICILLIN-CLARITHROMYCIN is:
- Lansoprazole delayed-release capsules: 30 mg every 12 hours
- Clarithromycin tablets: 500 mg every 12 hours
- Amoxicillin capsules: 1000 mg (2 x 500 mg) every 12 hours
Duration of treatment may be 7, 10 or 14 days, as directed by your healthcare professional.
Overdose:
Symptoms of clarithromycin tablets overdose include:
- abdominal pain
- vomiting
- nausea
- diarrhea
| If you think you, or a person you are caring for, have taken too much AA-LANSOPRAZOLE- |
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| AMOXICILLIN-CLARITHROMYCIN, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
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Missed Dose:
If you miss a dose, take it as soon as you remember unless it is almost time for the next dose. In that case, skip the missed dose and take the next one as directed. Do not take double or extra doses.
What are possible side effects from using AA-LANSOPRAZOLE-AMOXICILLIN-
CLARITHROMYCIN?
These are not all the possible side effects you may have when taking AA-LANSOPRAZOLE-AMOXICILLIN-CLARITHROMYCIN. If you experience any side effects not listed here, tell your healthcare professional.
The following side effects may occur when all three components of AA-LANSOPRAZOLE-AMOXICILLIN-CLARITHROMYCIN are taken at the same time: abnormal taste, diarrhea, and headache.
Tell your healthcare professional right away if you have any of these symptoms:
- New or worsening joint pain
- Rash on your cheeks or arms that gets worse in the sun
Lansoprazole delayed-release capsules
The following side effects may occur: muscle pain, belching, constipation, diarrhea, dizziness, dry mouth, gas, headache, indigestion, insomnia, nausea, rash, vomiting, weakness.
Tell your healthcare professional if the following symptoms appear: bladder infection (pain, burning sensation upon urination) and upper respiratory tract infections (e.g., bronchitis, sinusitis, runny nose, sore throat).
Clarithromycin tablets
The following side effects may occur: abdominal pain, abnormal taste, diarrhea, ear disorder, flatulence, indigestion, headache, nausea, rash, vomiting.
Amoxicillin capsules
The following side effects may occur: diarrhea, nausea, skin rashes and vomiting.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help |
|---|---|---|
| Only if severe | In all cases | |
| COMMON | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| Allergic reactions: itching, skin rash, skin eruption or other effect on the skin or eyes, light-headedness/dizziness, fever, swelling, sore throat | √ | ||
| UNCOMMON | |||
| Gastrointestinal problems: nausea, vomiting, diarrhea, bloody stool, stool with mucous, severe abdominal cramps | √ | ||
| Serious allergic reactions / Anaphylaxis: swollen nose, eyes, throat, difficulty breathing, and serious skin reactions such as blistering, peeling skin, rash | √ | ||
| Kidney problems: excretion of crystals in the urine, cloudy urine, pain when urinating | √ | ||
| Liver problems: yellowing of the skin and eyes (jaundice), abdominal pain, nausea, vomiting, unusual tiredness | √ | ||
| Oral problems: black “hairy” tongue and stomatitis (mouth inflammation), tooth discoloration in children (brown, yellow or gray staining) | √ | ||
| Central Nervous System problems: dizziness, anxiety, insomnia, confusion, behavioural changes | √ | ||
| Blood problems (leukopenia (low white blood cell count), neutropenia (low blood cell count)): infections, fatigue, fever, aches, pains, flu-like symptoms | √ | ||
| Irregular heartbeat | √ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| Clostridium difficile colitis (bowel inflammation): severe watery or bloody diarrhea, fever, abdominal pain or tenderness | √ | ||
| RARE | |||
Severe Cutaneous Adverse Reactions (SCAR) (severe skin reactions that may also affect other organs):
| √ | ||
| NOT KNOWN | |||
| Cardiovascular Kounis syndrome: chest pain which can be a sign of a potentially serious allergic reaction | √ | ||
| Drug-induced enterocolitis syndrome: repetitive vomiting (1 to 4 hours after taking amoxicillin containing drug products), stomach pain, abnormal drowsiness, diarrhea and low blood pressure. These can be a sign of a serious allergic reaction | √ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| Hypomagnesaemia (low levels of magnesium in the blood): tremors, heart palpitations, fatigue or weakness, muscle spasms or pain, tingling or numbness in your hands and feet, seizures or delirium | √ | ||
| Linear IgA disease: rash with blisters arranged in a circle with central crusting or like a string of pearls | √ | ||
| Aseptic meningitis (inflammation of the protective lining of the brain): confusion, fever, nausea, fatigue, sudden headache or stiffness of your neck, sensitivity to light, vomiting | √ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
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Storage:
Store between 15°C to 25°C in the original package. Protect from light and moisture. Do not use beyond the expiration date.
Keep out of reach and sight of children.
If you want more information about AA-LANSOPRAZOLE-AMOXICILLIN-CLARITHROMYCIN:
- Talk to your healthcare professional.
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (https://www.aapharma.ca/en/product-listing), or by calling 1-877-998-9097.
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