Patient Medication Information: uses, side effects, how to take - Ava-Lansoprazole
ABOUT THIS MEDICATION
What the medication is used for:
AVA-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 (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:
AVA-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.
AVA-LANSOPRAZOLE helps reduce stomach acid production. In doing so, AVA-LANSOPRAZOLE helps reduce the amount of acid backing up into your esophagus.
When it should not be used:
You should not take AVA-LANSOPRAZOLE if you have an allergy to lansoprazole or to any of the nonmedicinal ingredients in AVA-LANSOPRAZOLE (see What the important nonmedicinal ingredients are below).
What the medicinal ingredient is:
lansoprazole
What the important nonmedicinal ingredients are:
magnesium hydroxide, methylcellulose 15 CPS, poloxamer 407 (micro), hydroxypropyl methylcellulose 2910 E5, polyethylene glycol 8000, triethylcitrate, talc (500 mesh) and methacrylic acid copolymer dispersion.
What dosage forms it comes in:
15 mg and 30 mg delayed-release capsules
WARNINGS AND PRECAUTIONS
Before you use AVA-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 are taking astemizole, terfenadine, cisapride (not currently marketed in Canada) or pimozide
- if you have any unusual or allergic reaction (rash, difficulty of breathing) to lansoprazole, any of the nonmedicinal ingredients in AVA-LANSOPRAZOLE (see What the important nonmedicinal 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 AVA-LANSOPRAZOLE include:
- ampicillin esters
- atazanavir
- digoxin
- iron salts
- ketoconazole
- sucralfate
- theophylline
- warfarin
PROPER USE OF THIS MEDICATION
Capsules should be swallowed whole. DO NOT open divide crush or chew the capsules.
Usual Dose:
The recommended dose of AVA-LANSOPRAZOLE is not the same for all the indications. Your doctor will tell you exactly which dose is better for your condition.
AVA-LANSOPRAZOLE capsules 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 AVA-LANSOPRAZOLE capsules. AVA-LANSOPRAZOLE capsules should be swallowed whole with sufficient water.
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, AVA-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.
This is not a complete list of side effects. For any unexpected effects while taking AVA-LANSOPRAZOLE, contact your doctor or pharmacist.
HOW TO STORE IT
Keep AVA-LANSOPRAZOLE and all other medicines out of reach of children.
Store between 15 and 25ºC. 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 concern, 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.
Overdose:
In the event of an overdose, you should
IMMEDIATELY contact either your doctor, the nearest hospital emergency department or poison control centre.
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
Address Locator: 0701D
Ottawa, ON K1A 0K9
Postage Paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM 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
For more information, please contact your doctor, pharmacist or other healthcare professional.
This document plus the full product monograph, prepared for health professionals, can be obtained by contacting the sponsor Avanstra Inc. at:
1-855-708-3678 or medinfo@avanstra.com
Date of Revision: May 6, 2011