Q-Lansoprazole: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Q-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

  (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.

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

What it does:

Q-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.

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

When it should not be used:

You should not take Q-LANSOPRAZOLE if you have an allergy to lansoprazole or to any of the non-medicinal ingredients in Q-LANSOPRAZOLE (see What the important non-medicinal ingredients are).

What the medicinal ingredient is:

lansoprazole

What the non-medicinal ingredients are:

Colloidal silicon dioxide, corn starch, D&C Red #28, FD&C Blue #1, FD&C Red #40, FD&C Yellow #6 (15 mg capsules only), gelatin, hydroxypropyl cellulose, iron oxide black (30 mg capsules only), magnesium carbonate, methacrylic acid copolymer, polyethylene glycol 6000, polysorbate 80, silicon dioxide, sucrose pulverized sugar, sugar spheres, talc, titanium dioxide, white imprinting ink (butyl alcohol, dehydrated alcohol, isopropyl alcohol, povidone, propylene glycol, shellac, sodium hydroxide, and titanium dioxide).

What dosage forms it comes in:

Q-LANSOPRAZOLE is available in 15 mg (pink and green) and 30 mg (pink and black) delayed-release capsules.

WARNINGS AND PRECAUTIONS

BEFORE you use Q-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 are taking HIV protease inhibitors (e.g., atazanavir, nelfinavir) as your doctor may recommend that these medications should not be taken at the same time as Q-LANSOPRAZOLE;
• if you have any unusual or allergic reaction (rash, difficulty breathing) to lansoprazole, any of the

nonmedicinal ingredients in Q-LANSOPRAZOLE (see What the important non-medicinal ingredients are), other medicines, foods, dyes, or preservatives.

• if you are pregnant, trying to get pregnant,

  breastfeeding or planning to breastfeed.

Q-LANSOPRAZOLE may help your acid-related symptoms, but you could still have serious stomach problems. Talk to your doctor.

Under rare circumstances, supervised by your doctor, proton pump inhibitors might be used for long periods.

You should take Q-LANSOPRAZOLE exactly as prescribed, at the lowest dose possible for your treatment and for the shortest time needed.

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. Talk to your doctor about your risk of bone fracture if you take Q-LANSOPRAZOLE.

Long term use of proton pump inhibitors may prevent normal absorption of Vitamin B12 from the diet and could lead to Vitamin B12 deficiency. Talk to your doctor.

INTE

INTERACTIONS WITH THIS MEDICATION

MEDICATION

Drugs that may interact with Q-LANSOPRAZOLE include:

• ampicillin esters
• HIV protease inhibitors (e.g., atazanavir, nelfinavir)
• clopidogrel
• digoxin
• iron salts
• ketoconazole
• methotrexate
• sucralfate
• tacrolimus
• theophylline
• warfarin

PROPER USE OF THIS MEDICATION

Usual Dose:

The recommended dose of Q-LANSOPRAZOLE is not the same for all the indications. Your doctor will tell you exactly which dose is better for your condition.

Reflux Esophagitis or Poorly Responsive Reflux Esophagitis Including Patients with Barrett’s Esophagus:

The recommended adult oral dose is 30 mg once daily before breakfast for 4 to 8 weeks.

Maintenance Treatment of Healed Reflux Esophagitis:

The recommended adult oral dose is 15 mg once daily before breakfast.

Treatment and Maintenance of Pathological

Hypersecretory Conditions Including Zollinger-Ellison Syndrome: The recommended adult oral starting dose is 60 mg once a day. Your doctor may adjust this dose. Daily dosages of greater than 120 mg should be taken in divided doses.

Gastroesophageal Reflux Disease (GERD): The recommended adult oral dose for the treatment of heartburn and other symptoms associated with GERD is 15 mg once daily before breakfast for up to 8 weeks. If significant symptom relief is not obtained within 4 to 8 weeks, talk to your doctor.

Pediatric GERD (erosive and non-erosive esophagitis): The recommended pediatric oral dose for children 1 to 11 years of age is 15 mg (for children weighing 30 kg or less) and 30 mg (for children weighing more than 30 kg) once daily for up to 12 weeks. Your doctor may change your dose. For adolescents of 12 to 17 years, the adult dose can be used.

Q-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 Q-LANSOPRAZOLE capsules. Q-

LANSOPRAZOLE capsules should be swallowed whole with sufficient water.

Overdose:

If you think you have taken too much Q-

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 Q-LANSOPRAZOLE, call your doctor right away.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like all medicines, Q-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 Q-LANSOPRAZOLE, contact your doctor or pharmacist.

HOW TO STORE IT

HOW DO I STORE Q-LANSOPRAZOLE?

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

Store at room temperature (15°C - 25°C / 59°F - 77°F) in the original package. Protect from light and moisture. Do not use beyond the expiration date.

REPORTING SIDE EFFECTS

You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information. 3 ways to report:

• Online at MedEffect (http://hc-sc.gc.ca/dhp-mps/medeff/index-eng.php);
• By calling 1-866-234-2345 (toll-free);

• By completing a Consumer Side Effect Reporting

  Form and sending it by:

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

  • Mail to: Canada Vigilance Program

    Health Canada

    Postal Locator 0701E

    Ottawa, Ontario

    K1A 0K9

Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect (http://hc-sc.gc.ca/dhp-mps/medeff/index-eng.php).

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

This document can be found at: www.qdpharmaceuticals.ca.

The full Product Monograph prepared for health professionals can be obtained by contacting the sponsor, QD Pharmaceuticals ULC at: 1-800-661-3429.

Date of revision: August 18, 2015