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Details for: LANSOPRAZOLE

Company: SANIS HEALTH INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02357682LANSOPRAZOLELANSOPRAZOLE15 MGCAPSULE (DELAYED RELEASE)ORAL
02357690LANSOPRAZOLELANSOPRAZOLE30 MGCAPSULE (DELAYED RELEASE)ORAL
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Summary Reports

Summary Safety Review - Proton Pump Inhibitors - Assessing the Potential Risk of Clostridium difficile Infection
Summary Safety Review - Proton Pump Inhibitors (PPIs) - Assessing the risk of a type of skin reaction [Subacute Cutaneous Lupus Erythematosus (SCLE)]

Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

What the medication is used for

LANSOPRAZOLE is used to treat conditions where reducing stomach acid production is needed, such as:

  • Duodenal ulcer A duodenal ulcer is a sore on the lining of the duodenum, which is the beginning of the small intestine.
  • Gastric ulcer A gastric ulcer is a sore on the lining of the stomach.
  • Reflux esophagitis A reflux esophagitis is an inflammation of the swallowing tube (esophagus) resulting from regurgitation of gastric contents into the esophagus. Because stomach contents are acidic, this may result in irritation of the esophagus.
  • Healing of non-steroidal anti-inflammatory drugs (NSAID)-Associated Gastric Ulcer
  • Reduction of risk of NSAID-Associated Gastric Ulcer
  • Symptomatic gastroesophageal reflux disease (GERD) GERD is a disorder that results from stomach acid moving backward from the stomach into the esophagus.
  • Pathological hypersecretory conditions Pathological hypersecretory conditions are conditions in which the stomach produces too much acid, which comes up into the esophagus and causes heartburn.
  • Treatment of the bacterial infection caused by Helicobacter pylori (H. pylori) in combination with other medications (e.g., the antibiotics clarithromycin and amoxicillin) to treat stomach ulcers.

    • LANSOPRAZOLE is also indicated for the treatment of erosive and non-erosive GERD in children, aged 1 to 17 years.
    What it does

    LANSOPRAZOLE is a proton pump inhibitor (PPI).It helps reduce acid production in the stomach.

    When it should not be used

  • You should not take LANSOPRAZOLE if you have an allergy to:
  • lansoprazole or
  • any of the nonmedicinal ingredients in LANSOPRAZOLE (see What are the ingredients in LANSOPRAZOLE?).
  • you are taking rilpivirine
    • What the medicinal ingredient is

    LANSOPRAZOLE is a proton pump inhibitor (PPI).It helps reduce acid production in the stomach.

    What the non-medicinal ingredients are

    hydroxypropyl methylcellulose 2910 E5, magnesium hydroxide, methacrylic acid copolymer dispersion, methylcellulose 15 CPS, poloxamer 407 (micro), polyethylene glycol 8000, talc (500 mesh) and triethyl citrate.

    15 mg caps composition:
    Pink opaque cap: D&C red #28, FD&C blue #1, FD&C red #40, gelatin, titanium dioxide Green opaque body: FD&C green #3, gelatin, titanium dioxide.

    30 mg caps composition: Pink opaque cap: D&C red #28, FD&C blue #1, FD&C red #40, gelatin, titanium dioxide Black opaque body: FD&C blue #1, FD&C red #40, gelatin

    What dosage form it comes in

    15 mg and 30 mg delayed-release capsules

    Warnings and precautions

    If you are taking LANSOPRAZOLE and clarithromycin, and you are pregnant or nursing: do not use clarithromycin unless your doctor tells you. This may harm your fetus or infant.

    To help avoid side effects and ensure proper use, talk to your healthcare professional before you take LANSOPRAZOLE. Talk about any health conditions or problems you may have, including :

  • about all health problems you have now or have had in the past;
  • if you have or develop severe diarrhea. This may be a sign of a more serious condition;
  • if you have kidney problems;
  • if you have a stomach cancer;
  • if you have liver problems;
  • if you experience any symptoms including palpitations (rapid heartbeat), dizziness, seizures, twitching, spasms, cramps and convulsions. These may be signs of low magnesium levels in the body;
  • if you are taking astemizole†, terfenadine†, cisapride† (†not currently marketed in Canada), or pimozide;
  • if you are taking other medications (see The following may interact with LANSOPRAZOLE);
  • if you are pregnant, trying to get pregnant, breast-feeding or planning to breast-feed;
  • If you are due to have a specific blood test (Chromogranin A).

    • Other warnings you should know about:
    LANSOPRAZOLE may help your acid-related symptoms. However you could still have serious stomach problems. Talk to your doctor if your problems continue.

    Take LANSOPRAZOLE exactly as your doctor tells you. You will use the lowest dose and shortest time suitable for your condition. Talk to your doctor if you have any concerns about your treatment.

    Depending on your condition, your doctor may tell you to use LANSOPRAZOLE for a longer period.

    Using proton pump inhibitors like LANSOPRAZOLE 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 doctor 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 doctor.

    Using LANSOPRAZOLE for a long period of time may cause a growth in your stomach (polyp), especially after one year.

    Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
    Interactions with this medication

  • ampicillin esters
  • atazanavir
  • nelfinavir
  • saquinavir/ ritonavir
  • clopidogrel
  • digoxin
  • iron salts
  • ketoconazole
  • methotrexate
  • sucralfate
  • tacrolimus
  • theophylline
  • warfarin
    • Proper use of this medication

  • Take LANSOPRAZOLE daily:
  • Before breakfast
  • If your doctor tells you to take LANSOPRAZOLE twice daily, take:
  • One before breakfast
  • One with another meal
  • Do not crush or chew capsules.
  • Swallow whole with water.
  • If you can’t swallow capsules, then
  • Open capsule.
  • Sprinkle granules on one tablespoon of apple sauce and swallow immediately.
  • Do not crush or chew granules.

    • Usual dose:
    The recommended dose of LANSOPRAZOLE is not the same for all the indications. Your doctor will tell you exactly which dose is better for your condition.
    Condition Adult Dose Child Dose How Often How Long
    Duodenal Ulcer 15 mg -- Once daily
    before breakfast    		 2 to 4 weeks, as
    directed by
    doctor
    Triple Therapy 30 mg
    LANSOPRAZOL
    E
    500 mg
    clarithromycin
    1000 mg
    amoxicillin    		 -- Twice daily
    before breakfast
    and another
    meal    		 7, 10 or 14
    days, as directed
    by doctor
    Gastric Ulcer 15 mg -- Once daily
    before breakfast    		 4 to 8 weeks, as
    directed by
    doctor
    Healing of NSAID
    Associated Gastric
    Ulcer    		 15 to 30 mg -- Once daily
    before breakfast    		 Up to 8 weeks,
    as directed by
    doctor
    Reduction of Risk of
    NSAID-Associated
    Gastric Ulcer    		 15 mg -- Once daily
    before breakfast    		 Up to 12 weeks,
    as directed by
    doctor
    Reflux Esophagitis
    or Poorly
    Responsive Reflux
    Esophagitis
    Including Patients
    with Barrett’s
    Esophagus    		 30 mg -- Once daily
    before breakfast    		 4 to 8 weeks, as
    directed by
    doctor
    Maintenance
    Treatment of Healed
    Reflux Esophagitis    		 15 mg -- Once daily
    before breakfast    		 As directed by
    doctor
    Treatment and
    Maintenance of
    Pathological
    Hypersecretory
    Conditions Including
    Zollinger-Ellison
    Syndrome    		 Starting dose: 60
    mg once a day.
    Dose may be
    increased by
    doctor    		 -- Once daily
    before breakfast
    If dose is more
    than 120 mg per
    day: take in
    divided doses.    		 As directed by
    doctor
    Gastroesophageal
    Reflux Disease
    (GERD)    		 15 mg -- Once daily
    before breakfast    		 Up to 8 weeks,
    as directed by
    doctor.

    If symptoms do
    not stop within
    4 to 8 weeks,
    talk to your
    doctor.
    Pediatric GERD
    (erosive and non
    erosive esophagitis)    		 1 to 11 years
    of age
    weighing:
  • 30 kg or
    less: 15 mg

  • over 30 kg:
    30 mg

    • 12 to 17
    years of age:
    take adult
    dose     		Once daily
    before breakfast    		 Up to 12 weeks,
    as directed by
    doctor.

    Overdose:
    If you think you have taken too much LANSOPRAZOLE, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

    Missed Dose:
    If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose. Just take the next dose at your regular time. Do not take 2 doses at the same time. If you are not sure about dosing, call your doctor. If you take too much LANSOPRAZOLE, call your doctor right away.
    Side effects and what to do about them

    Like all medicines, LANSOPRAZOLE can cause side effects. However, most people do not have any side effects at all.

    The following side effects have been reported (occurring between 1% and 10% in clinical trials): arthralgia (muscle pain), belching, constipation, diarrhea, dizziness, dry mouth, gas, headache, indigestion, insomnia, nausea, rash, vomiting, weakness.

    If the following symptoms appear, consult your physician: bladder infection (pain, burning sensation upon urination) and upper respiratory tract infections (e.g., bronchitis, sinusitis, runny nose, sore throat).

    Tell your doctor 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

    • Serious side effects from lansoprazole are uncommon.

    After stopping your medication, your symptoms may get worse and your stomach may increase the acid production.

    Treatment in combination with antibiotics
    If you experience symptoms such as severe (bloody or repeated watery) diarrhea, with or without fever, abdominal pain or tenderness, you may have bowel inflammation caused by bacterial infection (Clostridium difficile). If this happens, stop taking the drug combination and call your healthcare professional immediately. *Uncommon: occurring between 0.2% and 1% in clinical trials
    Serious side effects and what to do about them
    Symptom / effect Talk with your doctor or pharmacist Only if severe Talk with your doctor or pharmacist In all cases Stop taking drug and get immediate medical help
    UNCOMMON*
    Abdominal pain   ✔  
    Severe diarrhea accompanied with blood and/or mucous     ✔

    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.

    How to store

    Keep LANSOPRAZOLE and all other medicines out of reach and sight of children. Store between 15ºC to 25ºC. Protect from light and moisture. Do not use beyond the expiration date.

    Reporting side effects

    You can report any suspected side effects associated with the use of health products to Health Canada by:

    • Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/healthcanada/services/drugs-health-products/medeffectcanada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
    • Calling toll-free at 1-866-234-2345.

    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.

    More information

    If you want more information about LANSOPRAZOLE:

  • 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://health-products.canada.ca/dpd-bdpp/index-eng.jsp). Find the Patient Medication Information on the manufacturer’s website www.sanis.com, or by contacting Sanis Health Inc. at:

    • 1-866-236-4076

    This leaflet was prepared by:
    Sanis Health Inc.
    1 President's Choice Circle
    Brampton, Ontario
    L6Y 5S5

    Date of Revision: December 10, 2020
    Date modified: