Consumer Information for: PMS-LANSOPRAZOLE

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

pms-LANSOPRAZOLE is a medicine that is indicated in the treatment of conditions where the reduction of gastric acid secretion is required, 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.

pms-LANSOPRAZOLE is also indicated for the treatment of erosive and non-erosive GERD in children, aged 6 to 17 years.

What it does

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

What the medicinal ingredient is

Lansoprazole

What the non-medicinal ingredients are

Colloidal silicon dioxide, D&C Red No. 28, eudagrit, FD&C Blue No. 1, FD&C Red No. 40, gelatin, hydroxypropyl methylcellulose, magnesium carbonate, non-pareils, plasacryl, polyethylene glycol, polysorbate 80, talc, and titanium dioxide. In addition, the 15 mg capsules also contain: FD&C Green No. 3.

What dosage form it comes in

Capsules: 15 mg and 30 mg

When it should not be used
  • you have an allergy to:
    • lansoprazole or
    • any of the nonmedicinal ingredients in pms-LANSOPRAZOLE (see What are the ingredients in pms-LANSOPRAZOLE?).
  • you are taking rilpivirine
Warnings and precautions

Serious Warnings and Precautions

If you are taking pms-LANSOPRAZOLE amd 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 pms-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 cardiovascular (e.g., heart) or neurological (e.g., brain) 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 pms- LANSOPRAZOLE);
  • if you are pregnant, trying to get pregnant, breastfeeding or planning to breastfeed.
  • if you are due to have a specific blood test (Chromogranin A).

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

Take pms-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 pms-LANSOPRAZOLE for a longer period.

Using proton pump inhibitors 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.

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

Interactions with this medication

Drugs that may interact with pms-LANSOPRAZOLE includes:

  • ampicillin esters
  • HIV protease inhibitors (e.g., atazanavir, nelfinavir)
  • clopidogrel
  • digoxin
  • iron salts
  • ketoconazole
  • methotrexate
  • sucralfate
  • tacrolimus
  • theophylline
  • warfarin
Proper use of this medication
  • Take pms-LANSOPRAZOLE daily:
    • Before breakfast
  • If your doctor tells you to take pms-LANSOPRAZOLE twice daily, take:
    • One before breakfast
    • One with another meal
  • Do not crush or chew capsules.
  • Swallow whole with water.

Usual dose

The recommended dose of pms-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 pms-LANSOPRAZOLE
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 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) 6 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 pms-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 pms-LANSOPRAZOLE, call your doctor right away.

Side effects and what to do about them

Like all medicines, pms-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).

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.

Serious side effects and what to do about them
Symptom / effect Talk to your healthcare professional Only if severe Talk to your healthcare professional In all cases Stop taking drug and get immediate medical help
UNCOMMON*
Abdominal pain   ✔  
Severe diarrhea accompanied with blood and/or mucous     ✔
* Uncommon: occurring between 0.2% and 1% in clinical trials

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.

How to store

Keep pms-LANSOPRAZOLE out of reach and sight of children.

Store at room temperature (15°C to 25°C) in the original package. Protect from light and moisture. Do not use beyond the expiration date.

More information
  • Talk to your healthcare professional

This document plus the full Product Monograph, prepared for health professionals, can be obtained by contacting Pharmascience Inc. at 1-888-550-6060.

This leaflet was prepared by
        Pharmascience Inc.
        Montreal, Canada
        H4P 2T4

www.pharmascience.com

Last revised: October 23, 2017

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