Famotin


Company name: Memphis Co. for Pharm. & Chem. Ind.

Trade name: Famotin tablets 20 mg & 40 mg

Generic name: Famotidine

Composition:
Each tablet contains:

Famotidine 20 mg 40 mg
Crosscarmellose sodium 10 mg 20 mg
Colloidal silicon dioxide 6 mg 2 mg
Microcrystalline cellulose 143 mg 296 mg
Polyethylene glycol 6000 20 mg 40 mg
Magnesium stearate 1 mg 2 mg

Pharmaceutical form: Tablets.

Pharmacological actions:
Famotin is a competitive inhibitor of histamine - H2 - receptors.
Famotin inhibits basal and nocturnal gastric secretion, as well as secretion stimulated by food and pentagastrin.

Pharmacokinetics:
After oral administration, the onset of antisecretory effect occurs within one hour. Duration of inhibition of secretion by doses of 20 and 40 mg is 10 to 12 hours.
Bioavailability of famotidine is 40-45%, peak plasma levels occur in 1–3 hours.
15–20% of Famotin in plasma is protein bound and it has an elimination half - life of 2.5–3.5 hours.
Famotin is eliminated by renal (65–70%) and metabolic (30–35%) routes.

Indications:
Famotin is indicated in:
- Short term treatment of active duodenal ulcer.
- Maintenance therapy of duodenal ulcer patients as reduced dosage after healing of an active ulcer.
- Short term treatment of gastroesophageal reflux disease, and esophagitis due to gastroesophageal reflux disease including erosive or ulcerative disease.
-Short term treatment of active benign gastric ulcer.
-Treatment of pathological hypersecretory conditions (e.g. Zollinger – Ellison syndrome, multiple endocrine adenomas)

Dosage and administration:
Duodenal ulcer:
Acute therapy: 40 mg once a day at bed time.
Maintenance therapy: 20 mg once a day at bed time.

Benign gastric ulcer:
Acute therapy: 40 mg once a day at bed time.

Gastroesophageal reflux disease:
20 mg two times daily for up to 6 weeks.
Esophagitis including erosions and ulcerations due to gastroesophageal reflux disease is 20 or 40 mg two times daily up to 12 weeks.

Contraindications:
Famotin is contraindicated in patients who have hypersensitivity to any component of this product or any other H2 - receptor antagonist.

Side effects:
Side effects of  Famotin include diarrhea and other gastrointestinal disturbances, altered liver function tests (rarely liver damage), headache, dizziness, rash and tiredness.
Rare side effects include acute pancreatitis, bradycardia, AV block, confusion, depression and hallucinations particularly in the elderly or the very ill, hypersensitivity reactions (including fever, arthralgia, myalgia, anaphylaxis), blood disorders (including agranulocytosis, leucopenia, pancytopenia, thrombocytopenia) and skin reactions (including erythema multiforme and toxic epidermal necrolysis).
There have been occasional reports of gynaecomastia and impotence.
Also very rarely, anxiety, anorexia, dry mouth, cholestatic jaundice.

Pregnancy:
Famotin should be used during pregnancy only if clearly needed.

Lactation:
A decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.


Precautions & Warnings:
-Symptomatic response to therapy with Famotin does not preclude the presence of gastric malignancy.
-Longer intervals between doses or lower doses may need to be used in patients with moderate or severe renal insufficiency.

Overdosage:

In the event of overdosage, treatment should be symptomatic and supportive.

Therapeutic category:
Histamine - H2 receptors antagonist.

Legal category:
Prescription only medicine (POM)

Package:
Box containing 20 tablets

Storage:
Store in a dry place at a temperature not exceeding 30º C, protect from light.

THIS IS A MEDICAMENT
Medicament is a product, which affects your health and its consumption contrary to instructions is dangerous for you. Follow strictly the doctor’s prescription, the method of use and the instructions of the pharmacist who sold the medicament.
- The doctor and the pharmacist are the experts in medicines, their benefits and risks.
- Do not by yourself interrupt the period of treatment prescribed.
- Do not repeat the same prescription without consulting your doctor.
- Keep all medicaments out of reach of children.

Council of Arab Health Ministers, Union of Arab Pharmacists.