Patient Medication Information: uses, side effects, how to take - Ahi-Omeprazole
ABOUT THIS MEDICATION
What the medication is used for:
AHI-OMEPRAZOLE is recommended for Adults (18 years and older) to relieve frequent heartburn – when you have heartburn 2 or more days a week.
Heartburn is a painful burning feeling in the chest which rises up to the throat.
AHI-OMEPRAZOLE is not the right medicine for you if you suffer from heartburn once a week or less, or if you want immediate relief.
What it does:
AHI-OMEPRAZOLE belongs to a group of medicines called proton pump inhibitors which work by reducing the amount of acid the stomach makes.
AHI-OMEPRAZOLE works differently from other non-prescription heartburn products, such as antacids and other acid reducers. AHI-OMEPRAZOLE stops acid production at the source, the acid pump inside your stomach that produces acid.
Although AHI-OMEPRAZOLE will start to suppress acid within a few hours, it is not intended to give instant relief. You may have to wait 3 to 5 days to feel the full effect of the product on heartburn symptoms, although some people get complete relief of symptoms within 24 hours. Make sure you take the tablets for all 14 days even if you start to feel better.
What else can you do to help avoid your symptoms?
Avoid or limit foods such as: caffeine, chocolate, spicy
or fatty foods, and alcohol.
Eat smaller, more frequent meals. Avoid eating or
drinking late at night or 2-3 hours before bedtime.
- Avoid lying down or bending over soon after eating.
- Try to reduce stress.
- If you are overweight, try to reduce excess weight.
- If you smoke, try to stop smoking or reduce the amount you smoke.
When it should NOT be used:
You should not take AHI-OMEPRAZOLE if you think you might be allergic to omeprazole or any of the ingredients (see “What the nonmedicinal ingredients are”).
What the medicinal ingredient is:
The medicinal ingredient is omeprazole magnesium.
What the non-medicinal ingredients are:
Each 20 mg tablet contains the following non-medicinal ingredients (alphabetically): hydroxypropyl methylcellulose, methacrylic acid copolymer, iron oxide (red & yellow), mannitol, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, sodium stearyl fumarate, talc, titanium dioxide.
The imprinting ink consists of shellac, isopropyl alcohol, iron oxide black, N-butyl alcohol, propylene glycol, ammonium hydroxide
What dosage forms it comes in:
AHI-OMEPRAZOLE is available in tablets containing 20 mg of omeprazole.
WARNINGS AND PRECAUTIONS
Warnings. Do not use if:
These may be signs of a more serious condition. You may need different treatment. See your doctor immediately. AHI-OMEPRAZOLE may decrease the efficacy of some drugs used for HIV treatment (atazanavir and nelfinavir) or heart disease (clopidogrel); these drugs should not be used with AHI-OMEPRAZOLE. |
BEFORE you use AHI-OMEPRAZOLE, talk to your doctor or pharmacist if you:
- are taking any other medicines to reduce stomach acid
- have heartburn with light-headedness, sweating or
- dizziness
have chest pain or shoulder pain with shortness of breath;
sweating; pain spreading to arms, neck or shoulders
- have frequent wheezing, particularly with heartburn
- have unexplained weight loss
- have nausea or vomiting
- have stomach pain
- have jaundice or other liver problems
- now have or in the past have had a gastric ulcer or
- surgery on your stomach or bowels
are pregnant, plan to become pregnant, or are
breastfeeding.
STOP USE and ask your doctor if:
- you have severe and/or persistent diarrhea
- your heartburn continues or worsens
- you need to take this product for more than 14 days
you need to take more than 1 course of treatment within
a 4-month period
INTERACTIONS WITH THIS MEDICATION
Drugs that may interact with AHI-OMEPRAZOLE include the following. Askyour doctor or pharmacist before use if you are taking:
- Atazanavir, Nelfinavir (medicines for HIV infection)
- Cilostazol* (a medicine to treat leg pain)
- Clarithromycin, Erythromycin (antibiotics)
- Clopidogrel (a heart medicine)
- Diazepam (an anxiety medicine)
- Digoxin (a heart medicine)
Erlotinib (a medicine against cancer) or any other
anticancer drug from the same class
Ketoconazole, Itraconazole, Voriconazole (antifungal or
anti-yeast medicines)
- Methotrexate (a medicine used against cancer)
- Phenytoin (an epilepsy medicine)
- St John’s Wort (Hypericum perforatum)
- Tacrolimus (an immune system medicine)
- Warfarin (a blood-thinning medicine)
*not marketed in Canada
PROPER USE OF THIS MEDICATION
Usual dose: Adults (18 years of age and older)
14-Day Course of Treatment
- Take 1 tablet with a glass of water, before eating in the morning.
- Do NOT chew or crush tablets. This decreases how well AHI-OMEPRAZOLE works.
- Do NOT take more than 1 tablet every 24 hours.
- Take every day for 14 days.
- Do NOT use for more than 14 days unless directed by your doctor.
- Do NOT repeat a 14-day course of treatment within a period of 4 months unless directed by your doctor.
When to Take AHI-OMEPRAZOLE Again:
You should wait at least 4 months before taking another 14-day course of treatment.
Overdose:
In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
Missed Dose:
If you miss a dose of AHI-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 tablet. Just take your next dose on time.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
AHI-OMEPRAZOLE may cause side effects in some people. Side effects are usually mild and go away a short time after starting AHI-OMEPRAZOLE. Common side effects that may occur: cold or flu-like symptoms, diarrhea, excess gas, headache, nausea or vomiting, stomach pain.
Uncommon side effects that may occur: altered liver values, dizziness, feeling of burning/prickliness/numbness of the skin, feeling sleepy, insomnia, itching, skin rash.
Other unwanted effects may occur in rare cases. If you experience any bothersome or unusual effects while using AHI-OMEPRAZOLE, check with your doctor or pharmacist right away.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||
| Symptom / effect | Talk with your doctor or pharmacist in all cases | Stop taking drug and call your doctor or pharmacist |
| Rare (frequency of greater than or equal to 1 in 10,000 but less than 1 in 1,000 patients) | ||
| Blurred vision | x | |
| Confusion | x | |
| Depression | x | |
| Development of breasts in men | x | |
| Hallucinations | x | |
| Impaired liver function (skin and eyes appear yellow) | x | |
| Inflammation in the mouth | x | |
| Muscle pain | x | |
| Muscle weakness | x | |
| Restlessness | x | |
| Severe allergic reaction (such as swelling or anaphylactic reaction/shock) | x | |
| Severe skin reaction (rash with swelling, blisters and peeling of the skin, ulcers, often with high fever) | x | |
| Sore joints | x | |
| Very Rare (frequency of less than 1 in 10,000 patients) | ||
| Ear problems (pain, hearing loss, ringing sounds) | x | |
| Eye problems (edema, pain) | x | |
| Impotence | x | |
| Vertigo | x |
This is not a complete list of side effects. For any unexpected effects while taking AHI-OMEPRAZOLE, contact your doctor or pharmacist.
HOW TO STORE IT
Keep all tablets sealed in the blister strips until it is time for a dose. If you do not, moisture from the air may damage the tablets.
Keep AHI-OMEPRAZOLE out of reach of children.
Store the blisters packages between 15°C and 30°C. Protect from moisture.
Do not keep AHI-OMEPRAZOLE in the bathroom medicine cabinet or other warm, moist places.
Do not use AHI-OMEPRAZOLE after the expiry date marked on the pack.
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. 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
This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor, Accord Healthcare Inc.at:
1-866-296-0354
Accord Healthcare Inc.
Kirkland, QC Canada H9H 5B9