Famatel-zdorovya forte

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT FAMATEL-ZDOROVYE FORTE (FAMATEL-ZDOROVYE FORTE)

Composition:

Active substance: famotidine;

One tablet contains famotidine 40 mg;

Excipients: microcrystalline cellulose, lactose monohydrate, copovidone, sodium croscarmellose, magnesium stearate, colloidal anhydrous silicon dioxide, azorubine (E 122); dry mixture "Opadry II white" containing titanium dioxide (E 171), talc, polyethylene glycol, polyvinyl alcohol.

Pharmaceutical form. Coated tablets.

Main physicochemical properties: coated tablets, pink to dark pink in color. Two layers are visible in cross-section.

Pharmacotherapeutic group. Drugs for treatment of peptic ulcer and gastroesophageal reflux disease. H₂-receptor antagonists. Famotidine. ATC code A02BA03.

Pharmacological Properties

Pharmacodynamics. Famotidine is a selective H2-histamine receptor antagonist of the third generation.

The mechanism of action is due to competitive inhibition of H2-histamine receptors in the gastric wall, thereby reducing gastric juice secretion (its volume). It suppresses basal and stimulated production of hydrochloric acid and increases the pH of gastric juice. Simultaneously, it reduces pepsin activity.

It enhances protective mechanisms of the gastric mucosa by increasing gastric mucus production and its glycoprotein content, promoting healing of mucosal damage (including scarring of stress ulcers).

After oral administration, the effect begins within 1 hour, reaches maximum within 3 hours, and lasts, depending on the dose, from 10 to 24 hours. The action of famotidine at a dose of 20–40 mg lasts for 10–12 hours.

Pharmacokinetics. After oral administration, famotidine is rapidly absorbed in the gastrointestinal tract; concomitant food intake does not affect absorption. Cmax in plasma is reached within 1–3 hours. Plasma protein binding is 15–20%. Relative bioavailability of famotidine is 40–45%. Gastric filling status does not influence bioavailability. It penetrates into cerebrospinal fluid, crosses the placental barrier, and is excreted in breast milk.

The drug is metabolized in the liver forming an inactive sulfone metabolite. It is excreted primarily by the kidneys (65–70%) via glomerular filtration and tubular secretion; 25–30% of the administered dose is excreted unchanged. The elimination half-life (T½) from plasma is approximately 3 hours.

In patients with severe renal impairment (creatinine clearance less than 10 mL/min), T½ is prolonged and may exceed 20 hours; in patients with anuria, it is approximately 24 hours.

Clinical characteristics.

Indications.

• Benign gastric ulcer.
• Duodenal peptic ulcer (treatment and prevention of recurrences).
• Hypersecretory conditions, such as Zollinger-Ellison syndrome.
• Treatment of gastroesophageal reflux disease (reflux esophagitis).

Contraindications. Hypersensitivity to the components of the drug, other H2-histamine receptor antagonists.

Paediatric age, pregnancy or lactation (due to lack of sufficient clinical experience).

Interaction with other medicinal products and other forms of interaction. Absorption of certain medicinal products (e.g., ketoconazole, amoxicillin, iron preparations) depends on gastric acidity. Therefore, famotidine should be administered at least 2 hours after taking such medicinal products.

Concomitant use with other H2-receptor antagonists may significantly reduce the effectiveness of tolazoline. Although there is no confirmed interaction between famotidine and tolazoline, the likelihood of such interaction is high enough; therefore, the effect of tolazoline should be monitored at the beginning and after completion of concomitant therapy. If the effect of tolazoline is reduced, its dose should be gradually increased or famotidine treatment discontinued.

Food and antacids do not have a significant effect on famotidine treatment.

Famotidine does not affect the cytochrome P450 hepatic oxidase system; therefore, the metabolism of oral anticoagulants, antipyrine, aminopyrine, theophylline, phenytoin, diazepam, ethanol, and propranolol remains unchanged.

Probenecid may slow the elimination of famotidine.

Concomitant use of posaconazole oral suspension and famotidine should be avoided, if possible, because famotidine may reduce the absorption of posaconazole oral suspension when administered simultaneously.

Concomitant use of famotidine with tyrosine kinase inhibitors (TKIs), such as dasatinib, erlotinib, gefitinib, pazopanib, may lead to reduced plasma concentrations of TKIs and, consequently, to reduced efficacy. Therefore, concomitant use of famotidine with these TKIs is not recommended. For further additional recommendations, refer to the instructions for medical use of individual medicinal products containing TKIs.

Special precautions for use.

Treatment with the drug may mask the symptoms of gastric malignancy; therefore, the presence of stomach cancer must be ruled out before initiating therapy.

The drug should be used with caution and at low doses in patients with hepatic insufficiency.

Use with caution in patients with acute porphyria (including in medical history) and immunodeficiency.

Since cross-sensitivity between H₂-receptor antagonists has been reported, famotidine is contraindicated in patients with hypersensitivity to other H₂-receptor antagonists.

Symptoms of duodenal ulcer may resolve within 1–2 weeks, but therapy should be continued until healing is confirmed by endoscopic or X-ray examination.

Regular monitoring is required for patients (especially elderly patients and those with a history of peptic ulcer of the stomach and/or duodenum) who are taking the drug concomitantly with nonsteroidal anti-inflammatory drugs (NSAIDs).

When used in combination with antacids, an interval of at least 1–2 hours should be maintained between administration of the drug and antacids.

If a dose is missed, it should be taken as soon as possible; however, the dose should not be doubled if it is almost time for the next dose.

Treatment with this drug must not be initiated without a physician's prescription or prior appropriate medical examination in patients with kidney or liver disease. In elderly patients with impaired liver or kidney function, confusion may occur, requiring dose reduction. Medical evaluation is necessary in elderly patients presenting with heartburn, symptoms of hyperacidic state, stomach pain, or postprandial hyperacidity, as well as in cases of changes in the nature of these symptoms; in patients with complaints of gastric discomfort and weight loss; in patients with black stools; and in patients with swallowing difficulties and/or chronic abdominal pain.

The drug contains lactose; therefore, if a patient has been diagnosed with carbohydrate intolerance, consultation with a physician is recommended before taking this medicinal product.

Use during pregnancy or breastfeeding.

Pregnancy. Famotidine crosses the placenta. Adequate and well-controlled studies in pregnant women have not been conducted.

The drug is not recommended for use during pregnancy.

Breastfeeding. Famotidine is excreted in human breast milk; therefore, breastfeeding should be discontinued during treatment with this drug.

Ability to affect reaction speed when driving or operating machinery. Patients should exercise caution when performing potentially hazardous activities that require increased attention and rapid psychomotor responses, as this drug may cause dizziness.

Method of Administration and Dosage

Administer orally, without chewing, with a sufficient amount of water, regardless of food intake.

Treatment of benign gastric ulcer and duodenal peptic ulcer. Administer 40 mg (1 tablet) once daily at bedtime for 4–8 weeks.

For prevention of relapses after achieving therapeutic effect, switch to maintenance therapy with Famotidine-Zdorovya (containing 20 mg famotidine per tablet) at a dose of 20 mg (1 tablet) once daily at bedtime for 1–4 weeks.

Gastroesophageal reflux disease (reflux esophagitis). Administer 20 mg (using Famotidine-Zdorovya containing 20 mg famotidine per tablet) or 40 mg (1 tablet) twice daily (in the morning and evening), depending on disease severity, for 6–12 weeks. For gastroesophageal reflux disease associated with erosive esophagitis or ulceration, administer 40 mg (1 tablet) twice daily for 6–12 weeks.

Zollinger-Ellison syndrome. The dosage should be individually adjusted. For patients previously treated with other H₂-histamine receptor antagonists, initiate therapy with 40 mg (1 tablet) every 6 hours. For patients not previously treated with antisecretory agents, the initial dose should be 20 mg (1 tablet) four times daily (every 6 hours). In this case, use Famotidine-Zdorovya (containing 20 mg famotidine per tablet). Subsequently, adjust the dose according to gastric acid secretion levels and the patient's clinical condition. Continue treatment while clinical symptoms of the disease persist.

If necessary, gradually increase the daily dose according to individual response until the optimal dose is achieved. Data indicate that the highest doses of famotidine administered to patients with severe forms of the disease reached up to 160 mg every 6 hours.

Discontinue the drug gradually to avoid rebound syndrome associated with abrupt withdrawal.

Patients with severe renal impairment (creatinine clearance less than 30 mL/min, serum creatinine level above 3 mg/100 mL) should have the dosing interval extended to 36–48 hours or the daily dose reduced to 20 mg (using Famotidine-Zdorovya containing 20 mg famotidine per tablet).

Elderly patients do not require dose adjustment unless they have renal impairment.

Children. Do not administer the drug to children due to lack of experience with its use in this patient population.

Overdose.

Symptoms: vomiting, motor agitation, tremor, decreased arterial pressure, tachycardia, collapse.

Treatment: discontinue the drug, induce vomiting and/or perform gastric lavage. If necessary, provide appropriate symptomatic and supportive therapy: administer diazepam intravenously in case of seizures; atropine in case of bradycardia; lidocaine in case of ventricular arrhythmias. Hemodialysis is effective.

Adverse reactions.

The drug is generally well tolerated; however, the following adverse reactions may occur:

Blood system disorders: thrombocytopenia, agranulocytosis, pancytopenia, leukopenia, neutropenia.

Gastrointestinal disorders: dry mouth, nausea, vomiting, dysgeusia, cholestatic jaundice, acute pancreatitis, hepatitis, diarrhea, constipation, anorexia, flatulence, stomach pain, increased liver enzymes.

Nervous system disorders: headache, dizziness, convulsions, paresthesia, balance disorders.

Psychiatric disorders: depression, hallucinations, agitation, fear, insomnia, somnolence, confusion.

General disorders: fatigue, fever.

Sensory organ disorders: conjunctivitis, tinnitus.

Cardiovascular disorders: arrhythmia, atrioventricular block, hypotension, bradycardia, tachycardia.

Respiratory system disorders: airway obstruction.

Skin disorders: acne, alopecia, dry skin, pruritus, rash, Lyell's syndrome, Stevens-Johnson syndrome, exfoliative dermatitis, erythema, xeroderma.

Musculoskeletal system disorders: myalgia, bone pain or arthralgia.

Reproductive system and breast disorders: gynecomastia (very rare, reversible upon discontinuation of treatment); decreased libido, impotence.

Immune system disorders: hypersensitivity reactions, including anaphylaxis, angioedema, urticaria, eye swelling.

If any serious adverse reactions occur, treatment with the drug must be discontinued.

Shelf life. 3 years.

Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C. Keep out of reach of children.

Packaging. Tablets, 10 in a blister; 10, 10×2 in blisters in a box.

Prescription category. Prescription only.

Manufacturer: Limited Liability Company "Pharmaceutical Company "Zdorovya".

Manufacturer's address and place of business: 22, Shevchenka Street, Kharkiv, Kharkiv region, 61013, Ukraine.