NTP-Lansoprazole: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

NTP-LANSOPRAZOLE is a medicine that is indicated in the treatment of the following conditions where a reduction of gastric acid secretion is required:

• 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)

  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.

What it does:

NTP-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.

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

When it should not be used:

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

What the medicinal ingredient is:

Lansoprazole

What the non-medicinal ingredients are:

Brilliant blue (FD&C Blue 1), Erythrosin (FD&C Red 3), Fast Green FCF (FD&C Green 3), Gelatin, Hypromellose, Magnesium Carbonate, Methacrylic acid ethylacrylate copolymer, Povidone, Propylene glycol, Shellac, Sodium hydroxide, Sugar spheres, Sunset yellow (FD&C Yellow 6), Talc, Titanium dioxide and Triethyl citrate

What dosage forms it comes in:

Delayed release capsules, 15 mg and 30 mg

WARNINGS AND PRECAUTIONS

BEFORE you use NTP-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 nonprescription 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 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, any of the non-medicinal ingredients in NTP-LANSOPRAZOLE (see “What the non-medicinal ingredients are”), other medicines, foods, dyes or preservatives;

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

INTERACTIONS WITH THIS MEDICATION Drugs that may interact with NTP-LANSOPRAZOLE include:

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

PROPER USE OF THIS MEDICATION

Usual Dose:

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

NTP-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 NTP-

LANSOPRAZOLE capsules. NTP-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, 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, NTP-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.

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, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM

Symptom / effect

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

HOW TO STORE IT

Keep NTP-LANSOPRAZOLE and all other medicines out of reach of children.

NTP-LANSOPRAZOLE (Lansoprazole delayed-release capsules) should be stored in a tight container protected from light and moisture. Do not use beyond the expiration date.

Store between 15 – 25^oC.

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:

• 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 0701D

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 Teva Canada Ltd at: 1-800-268-4127 ext. 5005 (English); 1-877-777-9117 (French) or druginfo@tevacanada.com

Teva Canada Ltd.

30 Novopharm Court

Toronto, Ontario

M1B 2K9

Canada

Date of Preparation: August 29, 2013