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FAMOTIDINE (ACID CONTROLLER) is a brand name for Famotidine, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ....................................................................................... 3 CONTRAINDICATIONS............................................................................................................. 3 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Adverse Drug Reaction Overview Famotidine has been demonstrated to be generally well tolerated. Clinical Trial Adverse Drug Reactions The following adverse reactions have been reported in 1% of patients using Famotidine (Acid Controller) Tablets.
2%). These occurred with comparable frequency across treatment groups and control groups. Less Common Clinical Trial Adverse Drug Reactions (<1%) Other reactions reported in patients using famotidine in controlled clinical trials at rates <1%.
These observations are listed. 1%: bronchitis, congestion -nasal, cough, dry throat, influenza, sinus disorder, sneezing, wheezing. 1% edema - angioneurotic, infection -skin, laceration, measles. 1%: eustachian tube disorder, hemorrhage- corneal, pain-ear.
1%: benign prostatic hypertrophy, dysuria, hematuria, impotence, menstruation disorder, urinary frequency Abnormal Hematologic and Clinical Chemistry Findings Laboratory parameters may be affected during treatment with famotidine, but the changes are usually not considered serious.
Among the laboratory changes that were reported during clinical trials were increases in AST, ALT, and WBC count, and decreases in hemoglobin and hematocrit. These changes were rarely of clinical significance. No famotidine-treated patients/subjects had to be discontinued from therapy because of laboratory adverse experiences.
Post-Market Adverse Drug Reactions During marketed use of prescription doses, which are higher than those recommended for non- prescription use, the following adverse reactions have been reported; urticaria, liver enzymes abnormalities, cholestatic jaundice, asthenia, fatigue, somnolence, abdominal discomfort and pain, abdominal pain upper, diarrhoea, dry mouth, nausea, vomiting, pruritus, rash, hypersensitivity, malaise, anaphylaxis, angioedema, malaise, and somnolence.
Toxic epidermal necrolysis has been reported very rarely with H2-receptor antagonists. As with other H2-receptor antagonists, cases of bradycardia, A-V block and other arrhythmia have been reported rarely in patients treated with famotidine.
The following adverse reactions have been reported; however, a causal relationship to therapy with famotidine has not been established: agitation, confusion, hallucinations, depression, disorientation, mental disorder, insomnia, psychotic disorder, pruritus, alopecia, photosensitivity, Steven Johnson syndrome, hypotrichosis, neutropenia, anaemia, paraesthesia, dysgeusia, convulsions, syncope, grand mal seizures, rare cases of impotence, thrombocytopenia, pancytopenia, leukopenia, bone marrow depression and agranulocytosis.
IMPORTANT:
PLEASE READ PART III: CONSUMER INFORMATION Famotidine (Acid Controller) Tablets Famotidine Tablets This leaflet is part III of a three-part "Product Monograph". This leaflet is a summary and will not tell you everything about FAMOTIDINE (ACID CONTROLLER) TABLETS.
Contact your doctor or pharmacist if you have any questions about the drug.
ABOUT THIS MEDICATION What the medication is used for:
Each FAMOTIDINE (ACID CONTROLLER) TABLETS is clinically proven to give fast and effective relief from heartburn, acid indigestion and sour or upset stomach due to excess stomach acid. FAMOTIDINE (ACID CONTROLLER) TABLETS when taken 10 – 15 minutes before a meal, prevents these symptoms brought on by eating or drinking food and beverages.
What it does:
It is normal for the stomach to produce acid, especially after eating food and/or drinking beverages. However, too much acid, can cause, heartburn, acid indigestion and discomfort that interfere with everyday activities. FAMOTIDINE (ACID CONTROLLER) TABLETS contains a medicine that actually reduces the production of excess stomach acid that causes these symptoms.
FAMOTIDINE (ACID CONTROLLER) TABLETS is different from antacids that only neutralize existing stomach acid, but do not stop stomach acid from being produced. FAMOTIDINE (ACID CONTROLLER) TABLETS actually stops tough heartburn before it starts.
Just one FAMOTIDINE (ACID CONTROLLER) TABLETS tablet provides long lasting acid control, for up to 12 hours day or night. Acid control may not directly correlate to symptom relief. When it should not be used: • If you are allergic to famotidine or to any component in the medication (see non-medicinal ingredients); • If you are allergic to other acid reducers; • With another acid reducer.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Famotidine in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Gynecomastia has been reported rarely. In most cases that were followed up, it was reversible after discontinuing treatment. Post-Market Data Adverse drug reactions (ADRs) identified during Post-marketing experience with famotidine are included in Table 1 below.
05) In the above table, ADRs in the first frequency category column are presented based on incidence in adequately designed clinical trials or epidemiology studies, if available, or when incidence is unavailable, frequency category is listed as ‘Not known’.
In the second frequency category column the same ADRs are presented frequency categories estimated from spontaneous reporting rates where the numerator represents total number reported Company Adverse Events under given Preferred Terms or medical concept and denominator represents exposure data calculated from sales data.
Famotidine (Acid Controller) Tablets […]
What the medicinal ingredient is:
The medicinal ingredient is famotidine.
What the important nonmedicinal ingredients are:
FAMOTIDINE (ACID CONTROLLER) TABLETS also contains: colloidal silicon dioxide, hydroxypropyl methylcellulose, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, titanium dioxide.
What dosage forms it comes in:
FAMOTIDINE (ACID CONTROLLER) TABLETS is available as a 20 mg, film-coated tablet and thus easy-to-swallow. This medicine may not be suitable for some people. BEFORE you use FAMOTIDINE (ACID CONTROLLER) TABLETS talk to your doctor or pharmacist if: • You are pregnant or breast-feeding; • You have trouble swallowing, pain on swallowing, severe vomiting, passage of red/black blood in the stools, wheezing, choking, or your stomach pains continue; • You have kidney disease, as you may need a dose adjustment; • You have any other severe illnesses; • You are over 40 years of age and you are experiencing new or recently changed symptoms of acid indigestion or heartburn; • You are taking any prescription or over-the- counter medications such as nonsteroidal anti- inflammatory drugs [NSAIDs] (because NSAIDs may be causing your symptoms); • You have a previous history of erosive esophagitis, irritable bowel syndrome or ulcer disease complications; • You are experiencing unintended weight loss in association with your symptoms of acid indigestion or heartburn; • You are taking a proton pump inhibitor; • Your heartburn is frequent (>3 times per Famotidine (Acid Controller) Tablets Page 22 of 24 week) and or severe; • You have heartburn with light headedness, sweating and dizziness; • You have chest or shoulder pain with shortness of breath, sweating, pain spreading to arms or neck, or light headedness.
HEARTBURN WARNINGS Heartburn and acid indigestion are common, however heartburn can be a sign of a more serious medical condition, which requires medical intervention. Stop use of this product and any other nonprescription products you are taking for heartburn and see your doctor or pharmacist if: • you have had heartburn for over 3 months and haven’t seen a doctor about it • your heartburn continues, worsens or returns after using heartburn medication every day for 14 days • you often need to use heartburn medication for 14 consecutive days (for example every 6 weeks or more frequently) • your heartburn continues after using this or any other nonprescription heartburn product Before you use FAMOTIDINE (ACID CONTROLLER) TABLETS talk to your doctor or pharmacist if: • You are taking Itraconazole (for fungal infections).
• You are using calcium carbonate. INTERACTIONS WITH THIS MEDICATION Famotidine (Acid Controller) Tablets Page 23 of 24 IMPORTANT: PLEASE READ Usual dose: Adults and children 12 years of age or older: For relief of symptoms, swallow one (1) tablet with full glass of water.
For prevention of acid-related symptoms brought on by consuming food and/or beverage swallow one (1) tablet with full glass of water 10 to 15 minutes before eating. If symptoms return, you may take another tablet. Do not take more than two tablets during a 24-hour period.
If symptoms get worse or persist for more than two consecutive weeks, or if new symptoms develop, stop use and consult your physician. TIPS TO HELP AVOID ACID-RELATED SYMPTOMS • Do not lie down or bend over soon after eating. • If you are overweight, lose weight.
• If you smoke, stop or cut down. • Certain foods are more likely to cause acid- related symptoms, so you should consider reducing or avoiding foods such as caffeine, chocolate, fatty foods, spicy foods and alcohol. • Do not eat just before bedtime.
• Raise the head of your bed. • Wear loose fitting clothing around your stomach.
Overdose:
This is not a complete list of side effects. For any unexpected effects while taking FAMOTIDINE (ACID CONTROLLER) TABLETS, contact your doctor or pharmacist. • Store at room temperature (15°C - 30°C) in well- closed, light-resistant containers.
Keep this and all medicines out of the reach of children. FAMOTIDINE (ACID CONTROLLER) TABLETS is generally well tolerated. Side effects such as headache, diarrhea, lung […]