Patient Medication Information: uses, side effects, how to take - Auro-Omeprazole
What is AURO-OMEPRAZOLE used for?
AURO-OMEPRAZOLE is used to treat problems caused by too much acid in the stomach such as:
- stomach ulcers (sores).
- duodenal ulcers (sores on the first part of the intestine).
- stomach and duodenal ulcers caused by a bacterium, Helicobacter pylori.
- ulcers caused by nonsteroidal anti-inflammatory drugs (drugs for pain and sore joints).
- reflux esophagitis (tissue damage caused by the stomach acid and juices moving up the food tube).
- symptoms of reflux disease (e.g. heartburn, backup of stomach contents to the throat).
- a rare condition where the stomach produces too much acid (Zollinger-Ellison syndrome).
How does AURO-OMEPRAZOLE work?
AURO-OMEPRAZOLE is a medicine called a proton pump inhibitor (PPI). AURO-OMEPRAZOLE works by reducing the amount of acid made in your stomach.
What are the ingredients in AURO-OMEPRAZOLE?
Medicinal ingredients: omeprazole
Non-medicinal ingredients:
Core granules ingredients:
Lactose Monohydrate, Sodium lauryl sulphate, Cellulose Microcrystalline, Hydroxy Propyl Cellulose, Mannitol & Disodium hydrogen phosphate dihydrate.
Sub coating ingredients:
Hypromellose, triethyl citrate & Talc.
Enteric coating ingredients:
Methacrylic acid: Ethyl acrylate copolymer (1:1) Dispersion, triethyl citrate, Mono and Di-Glycerides, Polysorbate 80, Talc & Titanium Dioxide.
Empty Hard Gelatin Capsule Shells ingredients:
Iron Oxide Red, Titanium Dioxide, Gelatin & Sodium Lauryl Sulfate.
Printing ink ingredients:
Shellac, Dehydrated Alcohol, Isopropyl alcohol, Butyl Alcohol, Propylene Glycol, Strong Ammonia solution, Black Iron Oxide & Potassium hydroxide.
Check with your doctor if you think you might be allergic to any of the above ingredients.
AURO-OMEPRAZOLE comes in the following dosage forms:
Capsules of omeprazole 10 mg and 20 mg
Do not use AURO-OMEPRAZOLE if:
- you are allergic to omeprazole, substituted benzimidazoles or any of the other ingredients in AURO-OMEPRAZOLE (see “What are the ingredients in AURO-OMEPRAZOLE?”).
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take AURO-OMEPRAZOLE. Talk about any health conditions or problems you may have, including if you:
- have had any health problems in the past.
- have severe liver problems now or have had in the past.
are pregnant, plan to become pregnant, are breastfeeding or planning to breastfeed.
- take any other medications, including ones you can buy without a prescription.
Other warnings you should know about:
AURO-OMEPRAZOLE is not recommended for use in patients under 18 years of age.
This medicine should be used at the lowest dose and for the shortest time suitable for your condition. Talk to your doctor if you have any concerns about your treatment.
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 a bacterial infection (Clostridium difficile). If this happens, stop taking the drug combination and call your healthcare professional immediately.
Tell your doctor or pharmacist about symptoms that may be a sign of a more serious problem in your stomach or intestine such as:
- trouble swallowing.
- unplanned weight loss.
- vomiting blood or food.
- black (blood-stained) stools.
Long-term use of PPIs may 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 about this risk.
Long-term use of PPIs may lead to low blood magnesium in some people. When blood magnesium is lower than normal, it may also lead to low blood calcium and low blood potassium.
Using PPIs 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.
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 AURO-OMEPRAZOLE:
- medication for HIV: AURO-OMEPRAZOLE may decrease the effectiveness of some drugs used for HIV treatment; atazanavir and nelfinavir should not be used with AURO-OMEPRAZOLE.
- a high-dose of methotrexate (a drug used in high doses to treat cancer): AURO-OMEPRAZOLE may need to be temporarily withdrawn.
- clopidogrel, which is used for the prevention of blood clots: AURO-OMEPRAZOLE may interact with this drug, therefore use with clopidogrel should be avoided.
- Drug effects may be influenced if AURO-OMEPRAZOLE is taken at the same time as some drugs used to prevent fungal infections (itraconazole, ketoconazole, voriconazole), anxiety (diazepam), epilepsy (phenytoin), blood clotting (warfarin or other vitamin K blockers), transplant rejection (tacrolimus), poor circulation in the legs (cilostazol)*, heart problems (digoxin), treatment for tuberculosis (rifampin), St John’s Wort (Hypericum performatum) or a certain type of anticancer drug (erlotinib or any other anticancer drug from the same class).
* not marketed in Canada
How to take AURO-OMEPRAZOLE:
Follow your doctor’s directions carefully. They may be different from the information contained in this leaflet.
- Take all doses of AURO-OMEPRAZOLE that your doctor prescribes even when you feel well. Doses every day are needed to help damaged areas heal.
- If you take AURO-OMEPRAZOLE with antibiotic drugs, it is important that you take all medications at the right time of day for the whole treatment period. Studies have shown that patients who take their medications as prescribed have better ulcer healing rates and greater success getting rid of their H. pylori infection.
- Take AURO-OMEPRAZOLE until your doctor tells you to stop. Even if you start to feel better in a few days, your symptoms may return if AURO-OMEPRAZOLE is stopped too soon. AURO-OMEPRAZOLE needs to be taken for the full treatment to help correct acid problems.
AURO-OMEPRAZOLE may be taken with food or on an empty stomach.
- Do not chew or crush your AURO-OMEPRAZOLE capsules. Swallow the capsule whole with half a glass of water.
Usual dose:
Your doctor may tell you to take AURO-OMEPRAZOLE:
- 10-40 mg once a day for 2-8 weeks to heal damaged areas.
- 10-40 mg to control symptoms of reflux disease or to stop reflux esophagitis from coming back.
- 20 mg to stop ulcers from returning while you take your medicine for pain and joint problems.
- 60 mg once a day to treat Zollinger-Ellison syndrome.
In combination with antibiotic drugs for one week to treat ulcers caused by Helicobacter pylori.
- o Take the 3 drugs (Omeprazole, clarithromycin and amoxicillin. OR omeprazole, clarithromycin and metronidazole) two times a day for one week.
o If your ulcer is bothering you, your doctor may recommend further treatment with AURO- OMEPRAZOLE to make sure that your ulcer is healed.
Overdose:
| If you think you have taken too much AURO-OMEPRAZOLE, 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 of AURO-OMEPRAZOLE and remember within 12 hours, take it as soon as possible. Then go back to your regular schedule. However, if more than 12 hours have passed when you remember, do not take the missed dose. Do not double the dose. Just take your next dose on time.
What are possible side effects from using AURO-OMEPRAZOLE?
Like all medicines, AURO-OMEPRAZOLE may cause side effects in some people. Side effects are usually mild and go away a short time after starting AURO-OMEPRAZOLE.
These are not all the possible side effects you may feel when taking AURO-OMEPRAZOLE. If you experience any side effects not listed here, contact your healthcare professional. Please also see Warnings and Precautions. These side effects may not be caused by AURO-OMEPRAZOLE in your case, but only a doctor can assess this.
Common side effects (≥ 1 in 100 patients):
- Headache.
- Diarrhea.
- Constipation.
- Abdominal pain.
- Nausea/ vomiting.
- Excess gas in stomach (flatulence).
Uncommon side effects (≥ 1 in 1000 patients, but < 1 in 100 patients):
- Dizziness.
- Feeling like you or your surroundings are moving (vertigo).
- Difficulty sleeping.
- Feeling sleepy.
- Sensation of burning/ prickling/ numbness.
Rare side effects (< 1 in 1000 patients):
- Dry mouth.
- Hair loss.
- Increased sweating.
- Taste disorders.
Stopping your PPI therapy after taking it for a long time may cause your symptoms to get worse and your stomach may increase acid production. Carefully follow your doctor’s instructions when stopping AURO-OMEPRAZOLE.
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 (≥ 1 in 1000 patients, but < 1 in 100 patients) | |||
Skin reactions (such as skin rash, dermatitis, itchy skin and/or hives) | X | ||
| feeling ill | X | ||
| RARE (≥ 1 in 10 000 patients, but < 1 in 1000 patients) | |||
| inflammation in the mouth | X | ||
| gastrointestinal fungal infection | X | ||
| inflammation of the kidney | X | ||
| liver problems, ie, inflammation of the liver with or without jaundice, impaired liver function | X | ||
| blood disorders (reduced number of cells in the blood, low blood sodium) | X | ||
| inflammation in the gut (leading to diarrhea) | X | ||
| sore joints and muscles | X | ||
| muscular weakness | X | ||
| development of breasts in males | X | ||
| sensitivity to sunlight | X | ||
| severe skin reactions | X | ||
| hypersensitive (allergic) reactions (such as swelling of tissues, fever, discomfort/ tightness in chest and anaphylactic shock) | X | ||
| blurred vision | X | ||
| if you already have severe liver disease, you may experience disorientation/ aggression/ confusion/ decreased consciousness | X | ||
| if you are very ill, you may feel confused, nervous, depressed or hallucinate | X | ||
| VERY RARE (< 1 in 10 000 patients) | |||
low blood magnesiumθ (which may result in low blood calcium and/or | X | ||
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 |
|---|---|
| low blood potassium) | |
θ These would only be seen if a blood test was taken.
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. Other situations may arise. Nothing in this leaflet should stop you from calling your doctor or pharmacist with any questions or concerns you have about using AURO-OMEPRAZOLE.
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:
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. |
Storage:
AURO-OMEPRAZOLE comes in a container with a drying agent. Keep all capsules in their container until it is time for a dose. If you do not, moisture from the air may damage the capsules.
Store at room temperature between 15 and 30°C. Protect from Moisture. Do not keep AURO-OMEPRAZOLE in the bathroom medicine cabinet or other warm, moist places.
Do not use AURO-OMEPRAZOLE after the expiry date marked on the pack.
Keep out of sight and reach of children.
If you want more information about AURO-OMEPRAZOLE:
- 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; (http://hc sc.gc.ca/index-eng.php); the manufacturer’s website www.auropharma.ca or by calling (1-855-648-6681)
NOTE: This PATIENT MEDICATION INFORMATION leaflet provides you with the most current information at the time of printing.
Auro Pharma Inc.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada.
Date of Revision: September 21, 2016