Pro-Lansoprazole: Uses, Side Effects and Dosage

Serious Warnings and Precautions

If you are taking PRO-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.

What is PRO-LANSOPRAZOLE used for?

PRO-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.

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

How does PRO-LANSOPRAZOLE work?

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

What are the ingredients in PRO-LANSOPRAZOLE?

Medicinal ingredients: Lansoprazole

Non-medicinal ingredients: Ammonium hydroxide, D&C red #28, FD&C blue #1, FD&C green #3 (15 mg capsules only), FD&C red #40, gelatin, hydroxypropyl methylcellulose, magnesium hydroxide, methacrylic acid copolymer dispersion, methylcellulose, poloxamer, polyethylene glycol, shellac glaze, simethicone, talc, titanium dioxide and triethyl citrate.

PRO-LANSOPRAZOLE comes in the following dosage forms:

Delayed-release capsules: 15 mg and 30 mg

Do not use PRO-LANSOPRAZOLE if:

• you have an allergy to:

  • PRO-LANSOPRAZOLE or
  • any of the nonmedicinal ingredients in PRO-LANSOPRAZOLE (see What are the ingredients in PRO-LANSOPRAZOLE?).
• you are taking rilpivirine

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

• have or develop severe diarrhea. This may be a sign of a more serious condition;
• have kidney problems;
• have stomach cancer;
• have liver problems;
• experience palpitations (rapid heartbeat), dizziness, seizures, twitching, spasms, cramps and convulsions. These may be signs of low magnesium levels in the body;
• are taking astemizole^†, terfenadine^†, cisapride^† (^†not currently marketed in Canada), or pimozide;
• are taking other medications (see The following may interact with PRO-LANSOPRAZOLE);
• are pregnant, trying to get pregnant, breastfeeding or planning to breastfeed;
• are due to have a specific blood test (Chromogranin A).

Other warnings you should know about:

Tell your doctor if you experience the following symptoms before taking PRO-LANSOPRAZOLE:

• unexplained weight loss.
• severe or persistent diarrhea.
• repeated vomiting.
• vomiting blood.
• dark stools.
• tiredness (anemia).
• difficulty in swallowing.

PRO-LANSOPRAZOLE may help your acid-related symptoms. However you could still have serious stomach problems. Talk to your doctor if your problems continue.

Take PRO-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 PRO-LANSOPRAZOLE for a longer period.

Using proton pump inhibitors like PRO-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 PRO-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.

The following may interact with PRO-LANSOPRAZOLE:

• ampicillin esters
• atazanavir
• nelfinavir
• saquinavir/ ritonavir
• clopidogrel
• digoxin
• iron salts
• ketoconazole
• methotrexate
• sucralfate
• tacrolimus
• theophylline
• warfarin
• fluvoxamine

How to take PRO-LANSOPRAZOLE:

• Take PRO-LANSOPRAZOLE daily:

  • Before breakfast

• If your doctor tells you to take PRO-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 PRO-LANSOPRAZOLE is not the same for all the indications. Your doctor will tell you exactly which dose is better for your condition.

Overdose:

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 PRO-LANSOPRAZOLE, call your doctor right away.

What are possible side effects from using PRO-LANSOPRAZOLE?

Like all medicines, PRO-LANSOPRAZOLE can cause side effects. However, most people do not have any side effects at all. If you experience any side effects not listed here, tell your healthcare professional.

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 PRO-LANSOPRAZOLE are uncommon.

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

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

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

Store between 15°C to 25°C. Protect from light and moisture. Do not use beyond the expiration date.

If you want more information about PRO-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://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); or by contacting Pro Doc Ltée : 1-800-361-8559, www.prodoc.qc.ca, medinfo@prodoc.qc.ca.

Last Revised: APR 11, 2025