Famotidine tablets p / o 20mg, No. 30

- Peptic ulcer and 12 duodenal ulcer, prevention of relapse;
- Erosive gastroduodenitis;
- Functional dyspepsia associated with increased secretory function;
- Symptomatic and stressful gastrointestinal ulcers;
- Reflux esophagitis;
- prevention of relapses associated with long-term use of non-steroidal anti-inflammatory drugs;
- Zollinger-Ellison syndrome;
- Systemic mastocytosis;
- Polyendocrine adenomatosis,
- Prevention of recurrent bleeding in the postoperative period.
- Prevention of gastric juice aspiration in patients undergoing surgery under general anesthesia (Mendelssohn's syndrome);
- Prevention of aspiration pneumonitis;
- Dyspepsia with epigastric or chest pain that occurs at night or associated with food intake.

Inside, without chewing, drinking plenty of water.
Adults:
In case of gastric ulcer and duodenal ulcer in the acute phase, symptomatic ulcers, erosive gastroduodenitis, it is usually prescribed 20 mg 2 times a day or but 40 mg 1 time per day at night. If necessary, the daily dose can be increased to 80Ц160 mg. The course of treatment is 4Ц8 weeks.
For dyspepsia associated with increased gastric secretory function , appoint 20 mg 1-2 times a day.
In order to prevent recurrence of peptic ulcer disease , 20 mg is prescribed 1 time per day before bedtime.
With reflux esophagitis, 20-40 mg twice a day for 6-12 weeks.
With Zollinger-Ashison syndromethe dose of the drug and the duration of the course of treatment are set individually. The starting dose is usually 20 mg every 6 hours and can be increased to 160 mg every 6 hours.
For the prevention of gastric juice aspiration under general anesthesia , 40 mg is prescribed in the evening and / or in the morning before surgery. Famotidine tablets should be swallowed without chewing, pouring enough water.
In renal failure , if creatinine clearance is less than 30 ml / min or serum creatinine content is more than 3 mg / 100 ml, the daily dose of the drug must be reduced to 20 mg.

1 film-coated tablet 20 mg, contains the active ingredient famotidine 20 mg.
Excipients: corn starch - 16.0 mg, microcrystalline cellulose - 78.35 mg, silicon dioxide - 1.4 mg, talc - 5.625 mg, magnesium stearate - 1.125 mg, croscarmellose sodium - 2.5 mg.
Sheath: hypromellose - 2.5 mg, titanium dioxide - 1.53 mg, lactose monohydrate - 1.313 mg, macrogol-4000 - 0.5 mg, triacetin - 0.375 mg, iron dye yellow oxide [E172] - 0.021 mg, iron dye red oxide [E172] - 0.006 mg, iron dye black oxide [E172] - 0.005 mg.
1 film-coated tablet 40 mg, contains the active substance famotidine 40 mg.
Excipients:corn starch - 32.0 mg, microcrystalline cellulose - 156.7 mg, silicon dioxide - 2.8 mg, talc - 11.25 mg, magnesium stearate - 2.25 mg, croscarmellose sodium - 5.0 mg.
Sheath: hypromellose - 5.0 mg, titanium dioxide - 2.61 mg, lactose monohydrate - 2.625 mg, macrogol-4000 - 1.0 mg, triacetin - 0.75 mg, iron dye yellow oxide [E172] - 0.375 mg, iron dye red oxide [E172] - 0.125 mg, iron dye black oxide [E172] -0.015 mg.

Pregnancy, lactation, hypersensitivity to famotidine and other blockers of H2-histamine receptors, childhood.
With care: hepatic and / or renal failure, liver cirrhosis with portosystemic encephalopathy (in history), immunodeficiency.

Trade name: Famotidine

International non-proprietary name:

Famotidine

Dosage form:

film-coated tablets.

COMPOSITION
1 film-coated tablet 20 mg, contains active ingredient famotidine 20 mg.
Excipients: corn starch - 16.0 mg, microcrystalline cellulose - 78.35 mg, silicon dioxide - 1.4 mg, talc - 5.625 mg, magnesium stearate - 1.125 mg, croscarmellose sodium - 2.5 mg.
Sheath: hypromellose - 2.5 mg, titanium dioxide - 1.53 mg, lactose monohydrate - 1.313 mg, macrogol-4000 - 0.5 mg, triacetin - 0.375 mg, iron dye yellow oxide [E172] - 0.021 mg, iron dye red oxide [E172] - 0.006 mg, iron dye black oxide [E172] - 0.005 mg.
1 film-coated tablet 40 mg, contains the active substance famotidine 40 mg.
Excipients:corn starch - 32.0 mg, microcrystalline cellulose - 156.7 mg, silicon dioxide - 2.8 mg, talc - 11.25 mg, magnesium stearate - 2.25 mg, croscarmellose sodium - 5.0 mg.
Sheath: hypromellose - 5.0 mg, titanium dioxide - 2.61 mg, lactose monohydrate - 2.625 mg, macrogol-4000 - 1.0 mg, triacetin - 0.75 mg, iron dye yellow oxide [E172] - 0.375 mg, iron dye red oxide [E172] - 0.125 mg, iron dye black oxide [E172] -0.015 mg.

DESCRIPTION:
Film-coated tablets 20 mg: round, biconvex film-coated tablets, pale pink with a grayish tinge, white at a break.
Film-coated tablets 40 mg: round, biconvex film-coated tablets, pale brown with a slightly pinkish tinge, white at a break.

Pharmacotherapeutic group
Stomach glands secretion lowering agent - H2-histamine receptor blocker

ATX code: [A02BA03].

PHARMACOLOGICAL PROPERTIES
Pharmacodynamics. Famotidine is a competitive histamine antagonist. Acting on histamine H2 - receptors of parietal cells, it significantly reduces the secretion of hydrochloric acid caused by various stimuli. The basal secretion of hydrochloric acid also decreases. The induced secretion of pepsinogen is inhibited to a lesser extent. Causes a dose-dependent suppression of hydrochloric acid production and a decrease in pepsin activity. Does not significantly alter plasma gastrin levels. The duration of action of the drug with a single dose depends on the dose and ranges from 12 to 24 hours.
Pharmacokinetics.After oral administration, it is rapidly absorbed from the gastrointestinal tract. After oral administration, the maximum concentration in blood plasma is reached within 1Ц3.5 hours. Plasma protein binding 15Ц20%. 30Ц35% of famotidine is metabolized in the liver (with the formation of S-oxide). Elimination mainly occurs through the kidneys: 27-40% of the drug is excreted in the urine unchanged. The half-life is 2.5-4 hours, in patients with creatinine clearance below 30 ml / min increases to 10-12 hours. Penetrates the placental barrier and is excreted in breast milk.

INDICATIONS FOR USE
- Peptic ulcer and 12 duodenal ulcer, prevention of relapse;
- Erosive gastroduodenitis;
- Functional dyspepsia associated with increased secretory function;
- Symptomatic and stressful gastrointestinal ulcers;
- Reflux esophagitis;
- prevention of relapses associated with long-term use of non-steroidal anti-inflammatory drugs;
- Zollinger-Ellison syndrome;
- Systemic mastocytosis;
- Polyendocrine adenomatosis,
- Prevention of recurrent bleeding in the postoperative period.
- Prevention of gastric juice aspiration in patients undergoing surgery under general anesthesia (Mendelssohn's syndrome);
- Prevention of aspiration pneumonitis;
- Dyspepsia with epigastric or chest pain that occurs at night or associated with food intake.

CONTRAINDICATIONS
Pregnancy, lactation, hypersensitivity to famotidine and other blockers of H2-histamine receptors, childhood.
With care: hepatic and / or renal failure, liver cirrhosis with portosystemic encephalopathy (in history), immunodeficiency.

APPLICATION DURING PREGNANCY AND DURING LACTATION
During pregnancy and lactation - the use of the drug is contraindicated.

DOSAGE AND METHOD OF APPLICATION
Inside, without chewing, drinking plenty of water.
Adults:
In case of gastric ulcer and duodenal ulcer in the acute phase, symptomatic ulcers, erosive gastroduodenitis, it is usually prescribed 20 mg 2 times a day or but 40 mg 1 time per day at night. If necessary, the daily dose can be increased to 80Ц160 mg. The course of treatment is 4Ц8 weeks.
For dyspepsia associated with increased gastric secretory function , appoint 20 mg 1-2 times a day.
In order to prevent recurrence of peptic ulcer disease , 20 mg is prescribed 1 time per day before bedtime.
With reflux esophagitis, 20-40 mg twice a day for 6-12 weeks.
With Zollinger-Ashison syndromethe dose of the drug and the duration of the course of treatment are set individually. The starting dose is usually 20 mg every 6 hours and can be increased to 160 mg every 6 hours.
For the prevention of gastric juice aspiration under general anesthesia , 40 mg is prescribed in the evening and / or in the morning before surgery. Famotidine tablets should be swallowed without chewing, pouring enough water.
In renal failure , if creatinine clearance is less than 30 ml / min or serum creatinine content is more than 3 mg / 100 ml, the daily dose of the drug must be reduced to 20 mg.

SIDE EFFECTS
- Dry mouth, nausea, vomiting, abdominal pain, flatulence, constipation, diarrhea, impaired appetite;
- Increased activity of 'liver' enzymes, hepatitis, acute pancreatitis;
- Headache, dizziness, insomnia, anxiety, tinnitus;
- Increased fatigue, drowsiness, depression, nervousness, psychosis;
- Blurred vision, paresis of accommodation;
- Confusion of consciousness, hallucinations, hyperthermia;
- Fever;
- bradycardia, arrhythmia, vasculitis, lowering blood pressure, antrioventricular block;
- Muscle pain, joint pain;
- Dry skin, alopecia, acne vulgaris, skin rash, itching, bronchospasm, angioedema, anaphylactic shock, other manifestations of hypersensitivity;
- Increased blood urea, leukopenia, thrombocytopenia, agranulocytosis, pancytopenia, hypoplasia, bone marrow aplasia.
- With long-term use of large doses - hyperprolactinemia, gynecomastia, amenorrhea, decreased libido, impotence.

OVERDOSE
Symptoms: vomiting, motor agitation, tremors, decreased blood pressure, tachycardia, collapse.
Treatment: for oral administration, induction of vomiting and / or gastric lavage is indicated. Symptomatic and supportive therapy: for convulsions - intravenous diazepam; with bradycardia - atropine; with ventricular arrhythmias - lidocaine. Hemodialysis is effective.

INTERACTION WITH OTHER MEDICINAL PRODUCTS
Increases the absorption of amoxicillin and clavulanic acid.
Compatible with 0.18 and 0.9% NaCl solution, 4 and 5% dextrose solution, 4.2% sodium bicarbonate solution.
When used simultaneously with antacids containing magnesium and aluminum, sucralfate decreases the intensity of absorption of famotidine, so the interval between taking these drugs should be at least 1-2 hours.
Due to an increase in the pH of the contents of the stomach with simultaneous administration, the absorption of ketoconazole and itraconazole may decrease.
Medicines that suppress the bone marrow increase the risk of developing neutropenia.
Inhibits the metabolism in the liver of diazepam, hexobarbital, propranolol, lidocaine, phenytoin, theophylline, indirect anticoagulants.

SPECIAL INSTRUCTIONS
Before starting treatment, it is necessary to exclude the possibility of a malignant disease of the esophagus, stomach or duodenum, since Famotidine can mask the symptoms.
The symptoms of duodenal ulcer can disappear within 1-2 weeks, therapy should be continued until scarring is confirmed by endoscopic or X-ray examination.
Famotidine is canceled gradually due to the risk of developing the 'ricochet' syndrome with abrupt withdrawal.
With prolonged treatment in debilitated patients, as well as under stress, bacterial lesions of the stomach are possible with the subsequent spread of infection. Famotidine (a blocker of H2-histamine receptors) should be taken 2 hours after taking itraconazole or ketoconazole to avoid a significant decrease in their absorption.
It counteracts the effect of pentagastrin and histamine on the acid-forming function of the stomach; therefore, Famotidine is not recommended for the 24 hours preceding the test.
Famotidine suppresses the skin reaction to histamine, thus leading to false negative results (it is recommended to stop using Famotidine before performing diagnostic skin tests to detect an immediate allergic skin reaction).
During treatment, you should avoid eating food, drinks and other drugs that can irritate the gastric mucosa.
The effectiveness of Famotidine in inhibiting nocturnal gastric acid secretion may be reduced by smoking.
Patients with burns may need to increase the dose of the drug due to increased clearance.
If a dose is missed, it must be taken as soon as possible; do not take if it is time to take the next dose; do not double the dose. If there is no improvement, a doctor's consultation is necessary.

RELEASE FORM
Tablets film-coated 20 mg and 40 mg.
10 film-coated tablets in a PVC / AL blister. 2 or 3 blisters with instructions for use in a cardboard box.

STORAGE CONDITIONS
List B.
In a dry, dark place at a temperature of 15 to 25 ? C.
Keep out of the reach of children.

SHELF LIFE
3 years.
Do not use after the expiration date printed on the package.

TERMS OF RELEASE FROM PHARMACIES
By prescription.