Lansoprazole-30: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Lansoprazole is a medicine that is indicated in the treatment of conditions where the reduction of gastric acid secretion is required, such as:

• 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.

• Symptomatic gastroesophageal reflux disease (sGERD)

  sGERD 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.

What it does:

Lansoprazole is a type of medication called a proton pump inhibitor, commonly known as PPI.

There are cells in the lining of your stomach that produce the acid your body uses during digestion. The burning pain from acid reflux disease is caused when this stomach acid backs up, or refluxes, into the esophagus.

Lansoprazole helps reduce stomach acid production. In doing so, Lansoprazole helps reduce the amount of acid backing up into your esophagus.

When it should not be used:

You should not take Lansoprazole if you have an allergy to lansoprazole or to any of the nonmedicinal ingredients in Lansoprazole (see What the nonmedicinal ingredients are below).

What the medicinal ingredient is:

Lansoprazole

What the nonmedicinal ingredients are:

D&C yellow No. 10, FD&C blue No. 1 (30 mg capsules only), FD&C green No. 3 (15 mg capsules only), FD&C red No. 3, gelatin, hydroxypropyl cellulose, hypromellose, macrogols, maize starch, magnesium carbonate, methacrylic acid-ethyl acrylate copolymer, polysorbate 80, silica colloidal anhydrous, sucrose, sugar spheres, talc, titanium dioxide.

What dosage forms it comes in:

LANSOPRAZOLE is available in capsules of 15 mg and LANSOPRAZOLE-30 is available in capsules of 30 mg.

WARNINGS AND PRECAUTIONS

BEFORE you use Lansoprazole talk to your doctor or pharmacist:

• about all health problems you have now or have had in the past;
• about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products;
• if you have or develop severe diarrhea as this may be a sign of a more serious condition;
• if you have kidney problems;
• if you have a malignant gastric ulcer;
• 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, and tetany (muscle condition with symptoms such as twitching, spasms, cramps and convulsions) as these may be signs of hypomagnesemia (low magnesium levels in the body);

• if you are taking astemizole^†, terfenadine^†, cisapride^†

  (^†not currently marketed in Canada), or pimozide;

• if you have any unusual or allergic reaction (rash, difficulty breathing) to lansoprazole or any of the nonmedicinal ingredients in Lansoprazole (see What the nonmedicinal ingredients are), other medicines, foods, dyes, or preservatives.

• if you are pregnant, trying to get pregnant or are breast-feeding.

People who take multiple daily doses of proton pump inhibitor medicines for a long period of time (a year or longer) may have an increased risk of fractures of the hip, wrist or spine. You should take Lansoprazole exactly as prescribed, at the lowest dose possible for your treatment and for the shortest time needed. Talk to your doctor about your risk of bone fracture if you take Lansoprazole.

INTERACTIONS WITH THIS MEDICATION

Drugs that may interact with Lansoprazole include:

• ampicillin esters
• atazanavir
• digoxin
• iron salts
• ketoconazole
• methotrexate
• sucralfate
• theophylline
• warfarin

PROPER USE OF THIS MEDICATION

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.

Lansoprazole should be taken daily before breakfast. Where the product may be used twice daily, it should be taken prior to breakfast and another meal. You should not chew or crush Lansoprazole capsules. Lansoprazole capsule should be swallowed whole with sufficient water.

Overdose:

In case of drug overdose, 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 can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

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. Talk to your doctor or pharmacist if any of these side effects persist or become bothersome.

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 not common.

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

This is not a complete list of side effects. For any unexpected effects while taking, Lansoprazole, contact your doctor or pharmacist.

HOW TO STORE IT

HOW DO I STORE LANSOPRAZOLE?

Keep Lansoprazole and all other medicines out of reach of children.

Store at room temperature (15°C - 30°C). Protect from light and moisture. Do not use beyond the expiration date.

GENERAL ADVICE ABOUT PRESCRIPTION MEDICINES:

Talk to your doctor or other health care provider if you have any questions about this medicine or your condition. Medicines are sometimes prescribed for purposes other than those listed in a CONSUMER INFORMATION Leaflet. If you have any concerns about this medicine, ask your doctor. Your doctor or pharmacist can give you information about this medicine that was written for health care professionals. Do not use this medicine for a condition for which it was not prescribed. Do not share this medicine with other people.

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

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• Report online at www.healthcanada.gc.ca/medeffect
• Call toll-free at 1-866-234-2345

• Complete a Canada Vigilance Reporting Form and:

  • Fax toll-free to 1-866-678-6789, or

  • Mail to: Canada Vigilance Program Health Canada

    Postal Locator 0701E

    Ottawa, Ontario

    K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect^™ Canada Web site at

www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

This document, plus the full Product Monograph prepared for health professionals, can be obtained by contacting the sponsor, Sivem Pharmaceuticals ULC, at:

1-855-788-3153

or by written request at:

4705 Dobrin Street

Saint-Laurent

Quebec, H4R 2P7

or at:

www.sivem.ca

Last revised: March 6, 2015.