Details for: LANSOPRAZOLE
Company: SANIS HEALTH INC
DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
---|---|---|---|---|---|
02357682 | LANSOPRAZOLE | LANSOPRAZOLE | 15 MG | CAPSULE (DELAYED RELEASE) | ORAL |
02357690 | LANSOPRAZOLE | LANSOPRAZOLE | 30 MG | CAPSULE (DELAYED RELEASE) | ORAL |
Summary Reports
Summary Safety Review - Proton Pump Inhibitors (PPIs) - Assessing the risk of a type of skin reaction [Subacute Cutaneous Lupus Erythematosus (SCLE)]
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
LANSOPRAZOLE is used to treat conditions where reducing stomach acid production is needed, such as:
LANSOPRAZOLE is also indicated for the treatment of erosive and non-erosive GERD in children, aged 1 to 17 years.
What it does
LANSOPRAZOLE is a proton pump inhibitor (PPI).It helps reduce acid production in the stomach.
When it should not be used
What the medicinal ingredient is
LANSOPRAZOLE is a proton pump inhibitor (PPI).It helps reduce acid production in the stomach.
What the non-medicinal ingredients are
hydroxypropyl methylcellulose 2910 E5, magnesium hydroxide,
methacrylic acid copolymer dispersion, methylcellulose 15 CPS, poloxamer 407 (micro),
polyethylene glycol 8000, talc (500 mesh) and triethyl citrate.
15 mg caps composition:
Pink opaque cap: D&C red #28, FD&C blue #1, FD&C red #40, gelatin, titanium dioxide
Green opaque body: FD&C green #3, gelatin, titanium dioxide.
30 mg caps composition:
Pink opaque cap: D&C red #28, FD&C blue #1, FD&C red #40, gelatin, titanium dioxide
Black opaque body: FD&C blue #1, FD&C red #40, gelatin
What dosage form it comes in
15 mg and 30 mg delayed-release capsules
Warnings and precautions
If you are taking 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.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take LANSOPRAZOLE. Talk about any health conditions or problems you may have, including :
Other warnings you should know about:
LANSOPRAZOLE may help your acid-related symptoms. However you could still have serious stomach problems. Talk to your doctor if your problems continue.
Take 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 LANSOPRAZOLE for a longer period.
Using proton pump inhibitors like 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 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.
Interactions with this medication
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.
Condition | Adult Dose | Child Dose | How Often | How Long |
---|---|---|---|---|
Duodenal Ulcer | 15 mg | -- | Once daily before breakfast |
2 to 4 weeks, as directed by doctor |
Triple Therapy | 30 mg LANSOPRAZOL E 500 mg clarithromycin 1000 mg amoxicillin |
-- | Twice daily before breakfast and another meal |
7, 10 or 14 days, as directed by doctor |
Gastric Ulcer | 15 mg | -- | Once daily before breakfast |
4 to 8 weeks, as directed by doctor |
Healing of NSAID Associated Gastric Ulcer |
15 to 30 mg | -- | Once daily before breakfast |
Up to 8 weeks, as directed by doctor |
Reduction of Risk of NSAID-Associated Gastric Ulcer |
15 mg | -- | Once daily before breakfast |
Up to 12 weeks, as directed by doctor |
Reflux Esophagitis or Poorly Responsive Reflux Esophagitis Including Patients with Barrett’s Esophagus |
30 mg | -- | Once daily before breakfast |
4 to 8 weeks, as directed by doctor |
Maintenance Treatment of Healed Reflux Esophagitis |
15 mg | -- | Once daily before breakfast |
As directed by doctor |
Treatment and Maintenance of Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome |
Starting dose: 60 mg once a day. Dose may be increased by doctor |
-- | Once daily before breakfast If dose is more than 120 mg per day: take in divided doses. |
As directed by doctor |
Gastroesophageal Reflux Disease (GERD) |
15 mg | -- | Once daily before breakfast |
Up to 8 weeks, as directed by doctor. If symptoms do not stop within 4 to 8 weeks, talk to your doctor. |
Pediatric GERD (erosive and non erosive esophagitis) |
1 to 11 years of age weighing: less: 15 mg 30 mg 12 to 17 years of age: take adult dose |
Once daily before breakfast |
Up to 12 weeks, as directed by doctor. |
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 LANSOPRAZOLE, call your doctor right away.
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.
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:
Serious side effects from lansoprazole are uncommon.
After stopping your medication, your symptoms may get worse and your stomach may increase the acid production.
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.
Symptom / effect | Talk with your doctor or pharmacist Only if severe | Talk with your doctor or pharmacist In all cases | Stop taking drug and get immediate medical help |
---|---|---|---|
UNCOMMON* | |||
Abdominal pain | ✔ | ||
Severe diarrhea accompanied with blood and/or mucous | ✔ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
How to store
Keep LANSOPRAZOLE and all other medicines out of reach and sight of children. Store between 15ºC to 25ºC. Protect from light and moisture. Do not use beyond the expiration date.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/healthcanada/services/drugs-health-products/medeffectcanada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
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
If you want more information about LANSOPRAZOLE:
1-866-236-4076
This leaflet was prepared by:
Sanis Health Inc.
1 President's Choice Circle
Brampton, Ontario
L6Y 5S5
Date of Revision: December 10, 2020