Barcode: 8935206015614



Famotidine ..............................40 mg

Excipients q.s ........................1 tablet

(Lactose, pregelatinized starch, avicel, PVP K30, sodium lauryl sulfate, sodium starch glycolate, magnesium stearate, talc, HPMC, PEG 6000, titanium dioxide, E110 orange, yellow ferric oxide).

DOSAGE FORM: Film coated tablet

PRESENTATIONS: Box of 10 blisters x 10 tablets.

PHARMACODYNAMICS: Famotidine competitively inhibits histamine at the H2-receptors located on the parietal cell, resulting in reduced gastric acid secretion both day and night, and when stimulated by food, histamine or pentagastrin. The H2-receptor antagonists activity of Famotidine is slowly reversible since the drug dissociates slowly from the H2-receptors.

After oral administration, the onset of the antisecretory effect occurred within one hour; the maximum effect occurred within one to three hours. Duration of inhibition of secretion by doses of 20 and 40 mg was 10 to 12 hours.

PHARMACOKINETICS: After oral administration, Famotidine is incompletely absorbed from the gastrointestinal tract, its bioavailability of oral doses is 40 - 45%. Famotidine undergoes minimal first-pass metabolism, peak plasma levels occur in 1- 3 hours, 15 - 20% of Famotidine binds with plasma proteins. Half-life is from 2.5 to 3.5 hours, it is eliminated by renal (65 - 70%) and metabolic (30 - 35%) routes.

INDICATIONS: Acute benign gastric ulcer, acute duodenal ulcer.

Gastroesophageal reflux disease.

Pathological hypersecretory conditions (Zollinger-Ellison syndrome, multiple endocrine adenomas).

CONTRAINDICATIONS: Hypersensitivity to any components of the drug. 


Before giving Famotidine to patients, the possibility of malignancy should be excluded since these drugs may mask symptoms and delay diagnosis.

Longer intervals between doses or lower doses may need to be used in patients with renal insufficiency (creatinine clearance < 10 ml/min).

If symptoms continue within two weeks of completing a course of Famotidine, stop using the drug and consult the physician for more information. 

PREGNANCY AND LACTATION: Experimentally, the drug does not show to harm fetus, but pregnant women are advisable to take it if clearly needed.

Famotidine is excreted via human milk; therefore, breast-feeding mothers should stop nursing during the time of taking the drug.


Cautions should be taken when driving or using machines because the drug can induce headache, dizziness in certain subjects.

INTERACTIONS: The bioavailability of Famotidine may be slightly increased by food, or slightly decreased by antacids; however, these effects are of no clinical consequence. Unlike cimetidine and ranitidine, Famotidine does not inhibit metabolism by the hepatic cytochrome P450 system. 

ADVERSE EFFECTS: Common: headache, dizziness, constipation, diarrhea.

Uncommon: fever, fatigue, depression, arrhythmias, cholestatic jaundice, liver enzyme abnormalities, nausea, vomiting, anorexia, abdominal discomfort, dry mouth, anaphylactic shock, angioedema, eye oedema, facial oedema, urticaria, rash, conjunctival congestion, musculoskeletal pain, full body convulsions, hallucinations, confusion, agitation, depression, anxiety, decreased libido, paresthesia, insomnia, drowsiness, bronchospasm, loss of taste, tinnitus.

Rarely: atrial ventricular block, palpitations, granulocytopenia, pancytopenia, leukopenia, thrombocytopenia, toxic epidermal necrolysis, hair loss, acne, itching, dried skin, flushing, erectile dysfunction, gynecomastia.

Inform your physician about any adverse effects occur during the treatment.

OVERDOSAGE: The events of acute overdosage have not been reported. Oral doses of up to 800 mg/day have been given to adult patients with pathological hypersecretory conditions with no serious adverse effects. In the event of overdosage, unabsorbed material should be removed from the gastrointestinal tract the patient should be monitored, and supportive therapy should be employed.


Acute benign gastric ulcer: 1 tablet a day at bedtime.

Acute duodenal ulcer: 1 tablet a day at bedtime for 4 - 8 weeks.

Esophagitis including erosions and ulcerations and accompanying symptoms due to Gastroesophageal reflux disease (GERD): 1 tablet twice a day for up to 12 weeks.

Pathological hypersecretory conditions (Zollinger-Ellison syndrome, multiple endocrine adenomas): The recommended adult oral starting dose is 20 mg once every 6 hours. In some patients, a higher starting dose may be required; doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg once every 6 hrs have been administered to some adult patients with severe Zollinger-Ellison Syndrome, antacids may be given concomitantly if needed.

In patients with renal insufficiency (creatinine clearance < 10 ml/min): The dosing interval may be prolonged to 36 - 48 hours.

Or as directed by the physician.

Read the directions carefully before use.         

Consult the physician for more information.             

This drug is for prescriptions only.

Shelf-life: 36 months from the manufacturing date.

Storage conditions: Store in dry places, not exceeding 30oC, protect from light.

Specifications: Manufacturer's.


There are yet no reviews for this product.