Patient Medication Information: uses, side effects, how to take - Apo-Lansoprazole
Serious Warnings and Precautions
If you are taking APO-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.
What is APO-LANSOPRAZOLE used for?
APO-LANSOPRAZOLE is used to treat conditions where reducing stomach acid production is needed, 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 (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.
- Treatment of the bacterial infection caused by Helicobacter pylori (H.pylori) in combination with other medications (e.g., the antibiotics clarithromycin and amoxicillin) to treat stomach ulcers.
APO-LANSOPRAZOLE is also indicated for the treatment of erosive and non-erosive GERD in children, aged 1 to 17 years.
How does APO-LANSOPRAZOLE work?
APO-LANSOPRAZOLE is a proton pump inhibitor (PPI). It helps reduce acid production in the stomach.
What are the ingredients in APO-LANSOPRAZOLE?
Medicinal ingredients: lansoprazole
Non-medicinal ingredients: Ammonium hydroxide, D&C red #28, FD&C blue #1, FD&C green #3 (15 mg capsules only), FD&C red #40, gelatin, hydroxypropyl methylcellulose, magnesium hydroxide, methacrylic acid copolymer dispersion, methylcellulose, poloxamer, polyethylene glycol, shellac glaze, simethicone, talc, titanium dioxide and triethyl citrate.
APO-LANSOPRAZOLE comes in the following dosage forms:
Delayed-release capsules: 15 mg and 30 mg
Do not use APO-LANSOPRAZOLE if:
you have an allergy to:
- lansoprazole or
- any of the nonmedicinal ingredients in APO-LANSOPRAZOLE (see What are the ingredients in APO-LANSOPRAZOLE?).
- you are taking rilpivirine
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take APO-LANSOPRAZOLE. Talk about any health conditions or problems you may have, including if you:
- have or develop severe diarrhea. This may be a sign of a more serious condition;
- have kidney problems;
- have stomach cancer;
- have liver problems;
- experience palpitations (rapid heartbeat), dizziness, seizures, twitching, spasms, cramps and convulsions. These may be signs of low magnesium levels in the body;
- are taking astemizole†, terfenadine†, cisapride† (†not currently marketed in Canada), or pimozide;
- are taking other medications (see The following may interact with APO-LANSOPRAZOLE);
- are pregnant, trying to get pregnant, breastfeeding or planning to breastfeed;
- are due to have a specific blood test (Chromogranin A).
Other warnings you should know about:
Tell your doctor if you experience the following symptoms before taking APO-LANSOPRAZOLE:
- unexplained weight loss.
- severe or persistent diarrhea.
- repeated vomiting.
- vomiting blood.
- dark stools.
- tiredness (anemia).
- difficulty in swallowing.
APO-LANSOPRAZOLE may help your acid-related symptoms. However you could still have serious stomach problems. Talk to your doctor if your problems continue.
Take APO-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 APO-LANSOPRAZOLE for a longer period.
Using proton pump inhibitors like APO-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 APO-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.
The following may interact with APO-LANSOPRAZOLE:
- ampicillin esters
- atazanavir
- nelfinavir
- saquinavir/ ritonavir
- clopidogrel
- digoxin
- iron salts
- ketoconazole
- methotrexate
- sucralfate
- tacrolimus
- theophylline
- warfarin
- fluvoxamine
How to take APO-LANSOPRAZOLE:
Take APO-LANSOPRAZOLE daily:
- Before breakfast
If your doctor tells you to take APO-LANSOPRAZOLE twice daily, take:
- One before breakfast
- One with another meal
- Do not crush or chew capsules.
- Swallow whole with water.
If you can’t swallow capsules, then
- Open capsule.
- Sprinkle granules on one tablespoon of apple sauce and swallow immediately.
- Do not crush or chew granules.
Usual dose:
The recommended dose of APO-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 APO-LANSOPRAZOLE 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 |
| Condition | Adult Dose | Child Dose | How Often | How Long |
|---|---|---|---|---|
| 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:
30 mg | Once daily before breakfast | Up to 12 weeks, as directed by doctor. |
| Condition | Adult Dose | Child Dose | How Often | How Long |
|---|---|---|---|---|
| 12 to 17 years of age: take adult dose | ||||
Overdose:
| If you think you, or a person you are caring for, have taken too much APO-LANSOPRAZOLE, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
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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 APO-LANSOPRAZOLE, call your doctor right away.
What are possible side effects from using APO-LANSOPRAZOLE?
Like all medicines, APO-LANSOPRAZOLE can cause side effects. However, most people do not have any side effects at all. If you experience any side effects not listed here, tell your healthcare professional.
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:
- New or worsening joint pain
- Rash on your cheeks or arms that gets worse in the sun
Serious side effects from lansoprazole are uncommon.
After stopping your medication, your symptoms may get worse and your stomach may increase the acid production.
| Serious side effects and what to do about them | |||
|---|---|---|---|
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| UNCOMMON* | |||
| Abdominal pain |
| ||
| Severe diarrhea accompanied with blood and/or mucous |
| ||
| UNKNOWN | |||
| Clostridium difficile colitis (Bowel inflammation): Symptoms include severe (watery or bloody) diarrhea, fever, abdominal pain or tenderness. |
| ||
| Clostridium difficile colitis (Bowel inflammation): If you are currently taking or have recently taken antibiotics and you develop diarrhea, contact your doctor, even if the diarrhea is relatively mild. |
| ||
| Microscopic colitis (inflammation of the gut): symptoms include chronic watery diarrhea, abdominal pain, cramps or bloating weight loss, nausea, uncontrollable bowel movement, signs of dehydration such as: extreme thirst, less frequent urination, dark-coloured urine, fatigue, dizziness, confusion. The symptoms of microscopic colitis can come and go frequently. If you have watery diarrhea that lasts more than a few days, contact your doctor. |
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| Severe Cutaneous Adverse Reactions (SCAR) (Severe Skin Reactions): Skin rash which may have blistering, peeling or | ✓ | ||
| Serious side effects and what to do about them | ||
|---|---|---|
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help |
| Only if severe | In all cases | |
bleeding on any part of your skin (including your lips, eyes, mouth, nose, genitals, hands or feet). You may also experience fever, chills, body aches, shortness of breath, or enlarged lymph nodes. These serious skin reactions may need to be treated in a hospital and may be life threatening. | ||
| Tubulointerstitial Nephritis (Kidney Problems): decreases in urination, blood in your urine. | ||
| ✓ | ||
| * Uncommon: occurring between 0.2% and 1% in clinical trials | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
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. |
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Storage:
Keep APO-LANSOPRAZOLE out of reach and sight of children.
Store between 15°C to 25°C. Protect from light and moisture. Do not use beyond the expiration date.
If you want more information about APO-LANSOPRAZOLE:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (http://www.apotex.ca/products), or by calling 1-800-667-4708.