Composition, form of production and packaging
? The tablets covered with a film cover of light pink color, round, biconcave, with marking "10" on one side.
1 tab.
famotidine 10 mg
Auxiliary substances: silicon dioxide colloid - 0.5 mg, magnesium stearate - 1 mg, povidone K90 - 2 mg, sodium carboxymethyl starch (type A) - 3 mg, talc - 3 mg, corn starch - 28 mg, lactose monohydrate - 52.5 mg.
The composition of the shell: iron oxide red - 0.002 mg, silicon dioxide colloid - 0.044 mg, titanium dioxide - 0.148 mg, macrogol 6000 - 0.2495 mg, sepiphilm 003 - 3.3065 mg (macrogol-40 stearate (type I) - 8-12%, cellulose microcrystalline - 35-45%, hypromellose - 45-55%).
14 pcs. - blisters (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
The product description was approved by the manufacturer for the 2009 print edition.
PHARMACHOLOGIC EFFECT
Famotidine is a blocker of histamine H 2 -receptors of parietal cells of the gastric mucosa. Reduces basal and stimulated secretion of hydrochloric acid, caused by irritation of baroreceptors, food load, action of hormones and biogenic stimulants (gastrin, histamine, pentagastrin). Famotidine reduces the volume of gastric juice and the content of hydrochloric acid in it, increases the pH of the contents of the stomach, which leads to a decrease in the activity of pepsin.
PHARMACOKINETICS
Absorption is incomplete, C max - after 1-3 hours Bioavailability - 40-45%, increases with food intake and decreases with the intake of antacids. Binding to plasma proteins - 10-20%.
T 1/2 from the plasma - 2.3-3.5 h, and with creatinine clearance <10 ml / min can reach 20 h (dose adjustment is required). 30-35% of the drug is metabolized in the liver to form an S-oxide. When administered 30-35% of famotidine is excreted by the kidneys in an unchanged form.
It penetrates through the placental and blood-brain barrier, as well as into breast milk.
INDICATIONS
- symptomatic treatment of dyspepsia associated with increased acidity of gastric juice (heartburn, acidic eructation, etc.).
DOSING MODE
In case of heartburn or other symptoms of dyspepsia, 1 tablet should be taken. The tablet should be swallowed whole, washed down with a small amount of water. Do not use more than 2 tablets / day. If symptoms persist for at least 2 weeks, the doctor should be consulted.
SIDE EFFECT
Rarely: allergic reactions (rash, itching of the skin, difficulty breathing), headache, dizziness, tinnitus, fatigue, drowsiness, changes in taste, dry mouth, nausea, vomiting, constipation, diarrhea, abdominal pain, decrease appetite, acute pancreatitis, bloating, impaired liver function, muscle and joint pain, dry skin, alopecia, heart rhythm disturbance.
Very rarely: hemolytic anemia, angioedema, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, anaphylactic shock, anxiety, nervousness, depression, psychosis, confusion, hallucinations, gynecomastia, agranulocytosis, pancytopenia, neutropenia, leukopenia, thrombocytopenia.
CONTRAINDICATIONS
- Pregnancy;
- the period of breastfeeding;
- Children's age till 16 years;
- Hypersensitivity to famotidine or other components of the drug.
With caution - hepatic and / or renal failure, cirrhosis with portosystemic encephalopathy (in the anamnesis), immunodeficiency.
PREGNANCY AND LACTATION
The drug is contraindicated for use during pregnancy and during breastfeeding.
APPLICATION FOR FUNCTIONS OF THE LIVER
With caution - kidney failure.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
With care - liver failure, cirrhosis with portosystemic encephalopathy (in the anamnesis).
APPLICATION FOR CHILDREN
Contraindicated in children under 16 years.
SPECIAL INSTRUCTIONS
Before taking the drug, Kwamatel Mini should consult a doctor in cases of a history of peptic ulcer disease of the stomach and duodenum, porphyria, heart rhythm disturbances, liver and kidney failure, unmotivated weight loss, and other medications.
Smoking reduces the effectiveness of treatment.
Impact on the ability to drive vehicles and manage mechanisms
The possibility of developing side effects should be taken into account when driving vehicles and performing work that requires a high rate of mental and physical reactions.
OVERDOSE
Symptoms: vomiting, motor excitation, tremor, lowering blood pressure, tachycardia, collapse.
Treatment: induction of vomiting and / or gastric lavage. Conduct symptomatic and supportive therapy: with convulsions - diazepam IV; with bradycardia, atropine;when ventricular arrhythmias - lidocaine. Hemodialysis is effective.
DRUG INTERACTION
Increases the absorption of amoxicillin and clavulanic acid.
Antacids and sucralfate slow the absorption of famotidine.
Reduces the absorption of itraconazole and ketoconazole.
Drugs that depress the bone marrow increase the risk of developing neutropenia.
TERMS OF RELEASE FROM PHARMACY
The drug is approved for use as a means of OTC.
TERMS AND CONDITIONS OF STORAGE
Storage conditions:
Store in a place inaccessible to children at a temperature of 15-30 В° C, in a place protected from light.
Shelf life:
3 years.
Do not use after the expiry date printed on the package.
