Patient Medication Information: uses, side effects, how to take - Heartburn Control
What is HEARTBURN CONTROL 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.
How does HEARTBURN CONTROL work?
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 non- prescription 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 to 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.
What are the ingredients in HEARTBURN CONTROL?
Medicinal ingredients: Omeprazole
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, pharmaceutical ink, povidone, titanium dioxide and triethyl citrate.
HEARTBURN CONTROL comes in the following dosage forms:
Capsules: 20 mg
Do not use HEARTBURN CONTROL if:
- you are allergic to omeprazole or any of the other ingredients in HEARTBURN CONTROL (see “What are the ingredients in HEARTBURN CONTROL?”)
- you are taking rilpivirine (medicines for HIV infection)
- you are taking medicines for HIV (atazanavir, nelfinavir, and saquinavir)
- you are taking medicines for heart disease (clopidogrel)
- you have trouble or pain when swallowing food
- you have bloody black stools or are vomiting with blood
- you have chest or shoulder pain with shortness of breath sweating, pain spreading to arms, neck or shoulders
- you have heartburn with light-headedness, sweating or dizziness
These may be signs of serious condition. See your healthcare professional immediately.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take HEARTBURN CONTROL. Talk about any health conditions or problems you may have, including if you:
- are taking any other medicines to reduce stomach acid.
- have frequent wheezing, particularly with heartburn.
- have frequent chest pain.
- 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 or plan to become pregnant.
- are breastfeeding or planning to breastfeed, as omeprazole is excreted in breast milk.
- are due to have a specific blood test (Chromogranin A).
Other warnings you should know about:
STOP USE and ask your healthcare professional 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
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 healthcare professional 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 healthcare professional about this risk.
Using HEARTBURN CONTROL 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.
Serious Drug Interactions
|
|---|
The following may interact with HEARTBURN CONTROL:
- Atazanavir, Nelfinavir and Saquinavir (medicines used for HIV infection)
- Cilostazol* (a medicine used to treat leg pain)
- Clarithromycin, Erythromycin (antibiotics)
- Clopidogrel (a medicine used for the prevention of blood clots)
- Diazepam (a medicine used to treat anxiety)
- Digoxin (a medicine used for heart problems)
- Erlotinib (a medicine used to treat cancer) or any other anticancer drug from the same class
- Ketoconazole, Itraconazole, Voriconazole (antifungal or anti-yeast medicines)
- Methotrexate (a medicine used to treat cancer)
- Phenytoin (a medicine used to treat epilepsy)
- Rifampin (a medicine used 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
How to take HEARTBURN CONTROL:
- 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.
Usual dose:
Adults (18 years of age and older) 14-Day Course of Treatment
- 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 healthcare professional.
- Do NOT repeat a 14-day course of treatment within a period of 4 months unless directed by your healthcare professional.
When to Take HEARTBURN CONTROL Again:
You should wait at least 4 months before taking another 14-day course of treatment.
Overdose:
| If you think you, or a person you are caring for, have taken too much HEARTBURN CONTROL, contact a 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 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.
What are possible side effects from using HEARTBURN CONTROL?
These are not all the possible side effects you may have when taking HEARTBURN CONTROL. If you experience any side effects not listed here, tell your healthcare professional.
Tell your healthcare professional 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.
Common side effects (≥ 1 in 100 patients):
- cold or flu-like symptoms,
- diarrhea,
- excess gas,
- headache,
- nausea or vomiting,
- stomach pain.
Uncommon side effects (≥ 1 in 1,000 patients, but < 1 in 100 patients):
- altered liver enzyme values,
- dizziness,
- feeling of burning/prickliness/numbness of the skin,
- feeling like you or your surroundings are moving (vertigo),
- feeling sleepy,
- insomnia,
- itching,
- skin rash.
Rare side effects (< 1 in 1,000 patients):
- dry mouth,
- hair loss,
- increased sweating,
- taste disorders.
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 | ||
| COMMON | |||
Gastrointestinal disorders diarrhea, constipation, abdominal pain, nausea/vomiting and flatulence. | √ | ||
Nervous system disorders headache. | √ | ||
| UNCOMMON | |||
| Gastrointestinal disorders: Withdrawal of long-term PPI therapy can lead to aggravation of acid related symptoms and may result in rebound acid hypersecretion. | √ | ||
Microscopic colitis: inflammation of the gut
| √ | ||
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 | ||
The symptoms of microscopic colitis can come and go frequently. If you have watery diarrhea that lasts more than a few days, contact your healthcare professional. | |||
General disorders and administration site conditions malaise. | √ | ||
Hepatobiliary disorders increased liver enzyme levels. | √ | ||
Immune system disorders hypersensitive reactions including urticaria, itchy welts. | √ | ||
Nervous system disorders dizziness, tingling sensation in the limbs, increased sleep and sensation of you or your environment moving. | √ | ||
| Musculoskeletal and Connective Tissue: Osteoporosis and osteoporosis-related fractures. | √ | ||
Psychiatric disorders insomnia. | √ | ||
Skin and subcutaneous tissue disorders rash, dermatitis and/or pruritus, and urticaria. | √ | ||
acute generalized exanthematous pustulosis (AGEP, pustular drug eruptions with superficial pustules everywhere), drug rash with eosinophilia and systemic symptoms (DRESS): extensive mucocutaneous rash, accompanied by fever, lymphadenopathy, hepatitis, haematologic abnormalities with eosinophilia and | √ | ||
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 | ||
atypical lymphocytes, subacute cutaneous lupus erythematosus (SCLE): rash typically occurs on sun-exposed areas of your body, such as your neck, chest, back and arms, rash with ring-shaped, raised lesions that can form interlocking circles. | |||
| RARE | |||
Blood and lymphatic system disorders Abnormal blood cell count: leukopenia, thrombocytopenia, agranulocytosis and pancytopenia. | √ | ||
Eye disorders blurred vision | √ | ||
Gastrointestinal disorders dry mouth, swelling and redness of mouth, gastrointestinal candidiasis (Fungal infection in the GI tract): abdominal pain, diarrhea, constipation, bloating, gas, nausea | √ | ||
| Pancreatitis: sudden, severe upper abdominal pain, often spreading through to your back and eased by leaning forward, it often feels worse after eating. nausea and vomiting. fevers and sweating. | √ | ||
| Microscopic colitis: inflammation of the large intestine (colon), persistent watery diarrhea | √ | ||
General disorders and administration site conditions increased sweating, swelling of feet and hands. | √ | ||
| Hepatobiliary disorders encephalopathy in patients with pre-existing severe liver disease: brain decline, seizure disorder, confusion, drowsiness, shaky hands, musty sweet odour, acute liver disorder or chronic liver disorder | √ | ||
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 | ||
| hepatocellular necrosis requiring liver transplantation | √ | ||
| hepatitis with or without jaundice and hepatic failure. | √ | ||
Immune system disorders hypersensitive reactions including angioedema (welts, hives, swelling around eyes, lips and cheeks, mild pain in swollen areas), fever | √ | ||
| anaphylactic shock: severe, life-threatening allergic reaction, itchy skin or a raised, red skin rash, swollen eyes, lips, hands, and feet, swelling of the mouth, throat or tongue, which can cause breathing and swallowing difficulties, abdominal pain, nausea, vomiting, wheezing, unconscious | √ | ||
Metabolism and nutrition disorders Hyponatremia: nausea, vomiting, muscle weakness, spasms, loss of energy | √ | ||
Musculoskeletal and Connective Tissue Painful joints, muscular weakness and pain in muscles. | √ | ||
Nervous system disorders taste disturbances. | √ | ||
Psychiatric disorders reversible mental confusion, agitation, aggression, depression and hallucination occurring predominantly in severely ill patients. | √ | ||
Renal and urinary disorders interstitial nephritis: kidney condition characterized by swelling in between the kidney tubules., glucose in urine, blood in urine and pus in urine, decreased volume of urine, fever, rash, joint stiffness. | √ | ||
| Reproductive system and breast disorders | √ | ||
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 | ||
| Gynaecomastia (development of breasts in males). | |||
Respiratory, thoracic and mediastinal disorders Bronchospasm: wheeze, cough | √ | ||
| Skin and subcutaneous tissue disorders: sensitivity to sunlight, erythema multiforme (rash of spots with dark centers and pale red rings that look like a target or "bullseye."), and alopecia. | √ | ||
Stevens-Johnsons syndrome: acute, serious, and potentially fatal skin reaction in which there are sheet-like skin and mucosal loss accompanied by systemic symptoms, painful blisters and lesions on the skin and mucous membranes. Toxic epidermal necrolysis (TEN): potentially life-threatening condition characterized by extensive exfoliation of the epidermis and mucous membrane, which may result in sepsis and death | √ | ||
| VERY RARE | |||
Blood and lymphatic system disorders Abnormal blood count: aplastic anemia (body stops producing enough new blood cells): symptoms may include fatigue, frequent infections, rapid heart rate and bleeding bone marrow suppression: (bone marrow doesn't make enough blood cells or platelets): fatigue, paleness of skin, lips and nail beds, increased heart rate, easy tiring with exertion, dizziness, shortness of breath | √ | ||
Cardiac disorders serious arrhythmia (increased QT interval, torsade de pointes, ventricular fibrillation, ventricular tachycardia). | √ | ||
Ear and labyrinth disorders ringing in ears, vertigo (sensation of the environment | √ | ||
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 | ||
| around you, is moving or spinning), hearing loss and ear pain. | |||
Eye disorders eye pain, papilledema (swelling of both optic discs in your eyes), optic atrophy (blurred vision, difficulties with peripheral vision, and color vision). | √ | ||
Metabolism and nutrition disorders Abnormal level of blood salts: hypomagnesemia (severe hypomagnesemia may result in hypocalcemia, and hypomagnesemia may also result in hypokalemia). | √ | ||
Neoplasms Benign, Malignant and Unspecified (including cysts and polyps) gastric polyps, gastric cancer and gastric carcinoids. | √ | ||
Reproductive system and breast disorders impotence, decreased fertility. | √ | ||
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 healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
|---|
Storage:
Store at room temperature 15ᵒC - 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.
If you want more information about HEARTBURN CONTROL:
- 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.