Fametol (Chewable tablets.)
(Famotidine, calcium carbonate, magnesium hydroxide)
A chewable tablet contains:
Famotidine 10 mg
Calcium carbonate 800 mg
Magnesium hydroxide 165 mg
Fametol is a combined drug containing a H2-receptor blocker, famotidine and antacids - calcium carbonate and magnesium hydroxide. Famotidine is a selective histamine H2-blocker that inhibits gastric juice acid concentration and decreases the amount of gastric secretion. Famotidine inhibits the basal, night and stimulated (by food, histamine, caffeine, gastrin etc.) secretions. Famotidine effect is powerful and prolonged and it starts 1-2 hours after peroral intake, the maximum effectiveness is observed 1-3 hours after drug administration. The effect of acid inhibition lasts for 10 to 12 hours.
Magnesium hydroxide and calcium carbonate act by neutralizing stomach acids already produced.
The optimal proportion of H2-blockers and antacids provides a decrease of acidity and leads to the rapid stomach pain and discomfort relief.
Pharmacokinetic of famotidine is not changed when co-administrated with calcium carbonate and magnesium hydroxide.
Famotidine follows linear kinetics. Famotidine is rapidly absorbed and peak plasma concentration is dose-related and it is reached 1-3 hours after drug administration. The average bioavailability is 4045%. The bioavailability is not affected by food intake. The primary metabolism is minimal. The repeated drug intake does not cause an accumulation of the drug. The plasma protein binding is relatively low (15-20%). The plasma half-life after a single oral dose or multiple repeated doses (for 5 days) is approximately 3 hours. The metabolism of the drug occurs in the liver with the formation of an inactive metabolite sulfoxide. After oral administration the average urinary excretion of the absorbed dose of famotidine is 65-70%, of which 25% -30% is eliminated as unchanged drug. The renal clearance is 250 to 450 ml/min and shows some tubular excretion. A small amount may be excreted in the form of sulfoxide. The half-life is prolonged in the patients with the impaired renal function and could exceed 20 hours in the patients with severe renal insufficiency.
Antacids are not resorbed in gastro-intestinal tract. Thus, they don’t make clinically significant plasma concentrations when applied according to the recommended daily dosage and recommended duration of the treatment.
Calcium carbonate and magnesium hydroxide transform into soluble chlorides by the influence of gastric acid. Approximately 10% of the absorbed drug is calcium and magnesium and 15-20% of the remaining soluble chlorides transforms into insoluble salts that are eliminated in the feces. In the individuals with normal renal function small amounts of calcium and magnesium are rapidly excreted by the kidneys.
Fametol is indicated for the short-term, symptomatic treatment of the conditions of increased gastric acid (heartburn, pain, heaviness, abdominal bloating, flatulence, nausea, acid eructation) that are caused by acute and chronic gastritis, peptic stomach or duodenal ulcer, reflux, pylorospasm, including symptoms appeared due to the malnutrition, treatment with drugs, abuse of alcohol beverages and smoking.
hypersensitivity to famotidine or other components of the drug, as well as to the acid-reducing drugs (ranitidine, cimetidine and others);
- severe renal and hepatic impairment; - children and adolescents under 16 years old;
- pregnancy and lactation.
Undesirable effects during Fametol administration occur rarely. They are usually mild and quickly resolved, as well as they are reversible when the drug intake is discontinued.
Nervous system: headache, nervousness.
Gastrointestinal tract: rarely - nausea, diarrhea, abdominal bloating caused by an excessive accumulation of gas, dyspepsia, eructation, dry mouth, thirst perception.
Disorders of musculoskeletal system, joint tissue and bones: rarely - sensation of pins and needle in the hands and legs (paresthesia).
DOSAGE AND ADMINISTRATION
Fametol chewable tablets are indicated for adults and adolescents over 16 years old.
For inhibition of acid secretion in the stomach and for symptoms relief chew one tablet for 15-60 minutes before meal. Don’t swallow a tablet wholly.
The recommended daily dose shouldn’t exceed 2 tablets during 24 hours.
It is recommended to take the drug without interruptions for more than 6 days.
6 chewable tablets in a blister.
4 blisters together with leaflet in a carton box.