Details for: HEARTBURN CONTROL
Company: APOTEX INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02435683 | HEARTBURN CONTROL | OMEPRAZOLE | 20 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
HEARTBURN CONTROL 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.
HEARTBURN CONTROL 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
HEARTBURN CONTROL belongs to a group of medicines
called proton pump inhibitors which work by reducing the
amount of acid the stomach makes.
HEARTBURN CONTROL works differently from other nonprescription heartburn products, such as antacids
and other acid reducers. HEARTBURN CONTROL stops acid production at
the source, the acid pump inside your stomach that produces
acid.
Although HEARTBURN CONTROL 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
capsules 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 aftereating.
- Try to reduce stress.
- If you are overweight, try to reduce excessweight.
- If you smoke, try to stop smoking or reduce the amount you smoke.
When it should not be used
When it should NOT be used:
- You should not take HEARTBURN CONTROL if you think you might be allergic to omeprazole or any of the ingredients (see “What the nonmedicinal ingredients are”)
- are taking rilpivirine (medicines for HIV infection)
- are taking medicines for HIV (atazanavir, nelfinavir, and saquinavir)
- are taking medicines for heart disease (clopidogrel)
- have trouble or pain when swallowing food
- have bloody black stools or are vomiting with blood
- have chest or shoulder pain with shortness of breath sweating, pain spreading to arms, neck or shoulders
- have heartburn with light-headedness, sweating or dizziness
- These may be signs of serious condition. See your doctor immediately.
What the medicinal ingredient is
The medicinal ingredient is omeprazole.
What the non-medicinal ingredients are
Each 20 mg capsule contains the non-medicinal ingredients: D&C Red No. 28, D&C Red No. 33, D&C Yellow No. 10, eudragit, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium hydroxide, mannitol, povidone, pharmaceutical ink, titanium dioxide and triethyl citrate.
What dosage form it comes in
HEARTBURN CONTROL is available in capsules containing 20 mg of omeprazole.
Warnings and precautions
BEFORE you use HEARTBURN CONTROL, talk to your doctor or pharmacist if you:
- are taking any other medicines to reduce stomach acid
- have frequent wheezing, particularly with heartburn
- have unexplained weight loss
- have nausea or vomiting
- have stomach pain
- have jaundice or other liver problems now or in the past have had gastric ulcer or surgery on your stomach or bowels
- are pregnant, plan to become pregnant, or are breastfeeding
Tell your doctor before taking this medicine if:
- You are due to have a specific blood test (Chromogranin A)
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 HEARTBURN CONTROL include the following. Ask your doctor or pharmacist before use if you are taking:
- Atazanavir, Nelfinavir and Saquinavir (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)
- Rifampin (a medicine to treat tuberculosis)
- St John’s Wort (Hypericum perforatum)
- Tacrolimus (an immune system medicine)
- Warfarin (a blood-thinning medicine)
- Any other prescription drug
*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 capsule with a glass of water, before eating in the morning.
- Do NOT chew or crush capsules. This decreases how well HEARTBURN CONTROL works.
- Do NOT take more than 1 capsule 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 yourdoctor.
When to Take HEARTBURN CONTROL 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 HEARTBURN CONTROL 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 capsule. Just take your next dose on time.
Side effects and what to do about them
HEARTBURN CONTROL may cause side effects in some
people. Side effects are usually mild and go away a short time
after starting HEARTBURN CONTROL. 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 such as new or
worsening joint pain, rash on your cheeks or arms that gets
worse in the sun while using HEARTBURN CONTROL,
check with your doctor or pharmacist right away.
| 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 | ✔ | ||
| Confusion | ✔ | ||
| Depression | ✔ | ||
| Development of breasts in men | ✔ | ||
| Hallucinations | ✔ | ||
| Impaired liver function (skin and eyes appear yellow) | ✔ | ||
| Inflammation in the mouth | ✔ | ||
| Muscle pain | ✔ | ||
| Muscle weakness | ✔ | ||
| Restlessness | ✔ | ||
| Severe allergic reaction (such as swelling or anaphylactic reaction/shock) | ✔ | ||
| Severe skin reaction (rash with swelling, blisters and peeling of the skin, ulcers, often with high fever) | ✔ | ||
| Sore joints | ✔ | ||
| Very Rare (frequency of less than 1 in 10,000 patients) | |||
| Ear problems (pain, hearing loss, ringing sounds) | ✔ | ||
| Eye problems (edema, pain) | ✔ | ||
| Impotence | ✔ | ||
| Vertigo | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking HEARTBURN CONTROL, contact your doctor or pharmacist.
How to store
HEARTBURN CONTROL (omeprazole) 20 mg capsules
are two-piece hard gelatin capsules with an opaque pink
body and an opaque reddish-brown cap, imprinted “APO
020”.
Store at room temperature 15 - 30ºC. Protect from moisture.
Keep HEARTBURN CONTROL out of reach of children.
Do not keep HEARTBURN CONTROL in the bathroom
medicine cabinet or other warm, moist places.
Do not use HEARTBURN CONTROL after the expiry date
marked on the pack.
Reporting side effects
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:
- Online at MedEffect;
- By calling 1-866-234-2345 (toll-free);
- By completing a Consumer Side Effect Reporting Form and sending it by:
- Fax to 1-866-678-6789 (tollfree), or
- Mail to: Canada Vigilance Program
Health Canada, Postal Locator
0701E Ottawa, ON K1A 0K9
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 leaflet plus the full product monograph, prepared for health professionals, can be obtained by contacting DISpedia, Apotex's Drug Information Service at:
1-800-667-4708
This leaflet can also be found at:
http://www.apotex.ca/products.
This leaflet was prepared by Apotex Inc., Toronto, Ontario,
M9L 1T9.
Last revised: August 03, 2020