Flemoxin Solutab dispersible tablets 500 mg No. 20

Instructions for use Flemoxin Solutab dispersible tablets 500 mg No. 20

Composition

active ingredient: amoxicillin;

1 tablet contains amoxicillin (in the form of amoxicillin trihydrate) – 125 mg, 250 mg, 500 mg, 1000 mg;

excipients: microcrystalline cellulose, microcrystalline cellulose and carmellose sodium, crospovidone, vanillin, tangerine flavor, lemon flavor, saccharin, magnesium stearate.

Dosage form

Dispersible tablets.

Main physicochemical properties: tablets of white or almost white color (a light yellow tint may occur during storage), oblong shape with engraving "231" for Flemoxin Solutab® 125 mg, "232" for Flemoxin Solutab® 250 mg, "234" for Flemoxin Solutab® 500 mg, "236" for Flemoxin Solutab® 1000 mg, marked

on one side and a line on the other side.

Pharmacotherapeutic group

Antimicrobials for systemic use. Beta-lactam antibiotics. Broad-spectrum penicillins. Amoxicillin. ATX code J01CA04.

Pharmacological properties

Pharmacodynamics

Flemoxin Solutab® is a broad-spectrum bactericidal antibiotic from the group of semi-synthetic penicillins.

In vitro data on the susceptibility of some clinically significant microorganisms to amoxicillin.

Amoxicillin is inactive against microorganisms that produce beta-lactamases, such as Pseudomonas, Klebsiella, indole-positive strains of Proteus and Enterobacter strains. The level of resistance of susceptible microorganisms may vary in different areas.

Pharmacokinetics

Absorption. After oral administration of Flemoxin Solutab® tablets, amoxicillin is absorbed quickly and almost completely (85–90%), the drug is acid-resistant. Food intake has almost no effect on the absorption of the drug. The maximum concentration of the active substance in the blood plasma when taking Flemoxin Solutab® tablets is achieved after 1–2 hours. After oral administration of 375 mg of amoxicillin, the maximum concentration of the active substance in the blood plasma was recorded, which is 6 μg/l. When the dose of the drug is doubled (or reduced by 2 times), the maximum concentration in the blood plasma also changes (increases or decreases) by 2 times.

Distribution. Approximately 20% of amoxicillin binds to plasma proteins. Amoxicillin penetrates the mucous membranes, bone tissue and intraocular fluid, sputum in therapeutically effective concentrations. The concentration of amoxicillin in bile exceeds its concentration in the blood by 2-4 times. In the amniotic fluid and umbilical vessels, the concentration of amoxicillin is 25-30% of its level in the blood plasma of a pregnant woman. Amoxicillin penetrates poorly into the cerebrospinal fluid; however, in inflammation of the meninges (for example, in meningitis), the concentration in the cerebrospinal fluid is approximately 20% of the concentration in the blood plasma.

Metabolism. Amoxicillin is partially metabolized, most of its metabolites are inactive against microorganisms, but have allergenic properties.

Excretion. Amoxicillin is eliminated primarily by the kidneys, approximately 80% by tubular excretion, 20% by glomerular extraction. Approximately 90% of amoxicillin is excreted within 8 hours, 60–70% unchanged by the kidneys. In the absence of impaired renal function, the half-life of amoxicillin is 1–1.5 hours. In premature infants, newborns and infants up to 6 months of age, it is 3–4 hours.

In case of impaired renal function (creatinine clearance equal to or less than 15 ml/min), the half-life of amoxicillin increases and reaches 8.5 hours in anuria.

The half-life of amoxicillin is not altered by impaired liver function.

Indication

Infections caused by microorganisms sensitive to the drug:

respiratory system;

organs of the genitourinary system;

gastrointestinal tract (GI);

skin and soft tissues.

Contraindication

Hypersensitivity to the active substance, to other penicillins or to any of the excipients.

History of severe immediate hypersensitivity reaction (e.g. anaphylaxis) to another beta-lactam antibiotic (e.g. cephalosporin, carbapenem or monobactam).

Interaction with other medicinal products and other types of interactions

Isolated cases of increased international normalized ratio (INR) have been reported in patients receiving concomitant amoxicillin and acenocoumarol or warfarin. If such use is necessary, prothrombin time or INR should be closely monitored when amoxicillin is added or discontinued. In addition, dose adjustment of oral anticoagulants may be necessary.

Methotrexate

Penicillins may reduce the excretion of methotrexate, which may lead to increased toxicity of the latter.

During treatment with amoxicillin, non-enzymatic reactions with glucose oxidase should be used to determine the level of glucose in the urine, since non-enzymatic methods may give false-positive results.

Probenecid

Concomitant use with probenecid is not recommended. Probenecid reduces renal tubular secretion of amoxicillin. Concomitant use with probenecid may result in increased and prolonged blood levels of amoxicillin.

Phenylbutazone, oxyphenbutazone, and to a lesser extent acetylsalicylic acid, indomethacin, and sulfinpyrazone, inhibit the tubular secretion of penicillin drugs, which leads to an increase in the half-life and concentration of amoxicillin in blood plasma.

Like other antibiotics, amoxicillin may have an effect on the intestinal flora, leading to reduced reabsorption of estrogens and reduced efficacy of combined oral contraceptives.

Drugs with bacteriostatic function (tetracycline antibiotics, macrolides, chloramphenicol) can neutralize the bactericidal effect of amoxicillin. Parallel use of aminoglycosides is possible (synergistic effect).

Application features

Hypersensitivity.

Before initiating treatment with amoxicillin, it is necessary to accurately determine the presence of a history of hypersensitivity reactions to penicillins, cephalosporins or other allergens.

Serious and sometimes fatal cases of hypersensitivity (anaphylactoid reactions and severe cutaneous adverse reactions) have been observed in patients receiving penicillin therapy. Hypersensitivity reactions may also progress to Kounis syndrome, a serious allergic reaction that may lead to myocardial infarction (see section 4.8). Such reactions are more likely to occur in patients with a history of hypersensitivity to penicillins or hypersensitivity to various allergens. If an allergic reaction occurs, amoxicillin therapy should be discontinued and appropriate treatment should be initiated.

Drug-induced enterocolitis syndrome

Drug-induced enterocolitis syndrome (DIES) has been reported, predominantly in children receiving amoxicillin (see section 4.8). DIES is an allergic reaction characterized by prolonged vomiting (1–4 hours after drug administration) in the absence of allergic skin or respiratory symptoms. Additional symptoms may include abdominal pain, diarrhea, hypotension, or leukocytosis with neutrophilia. Severe cases have been reported, including progression to shock.

Non-susceptible microorganisms

Amoxicillin is not suitable for the treatment of certain infections where the pathogens are insensitive or likely to be resistant to amoxicillin; the susceptibility of the likely pathogen should be considered before treatment with amoxicillin (see section 5.1). This applies in particular to the treatment of patients with urinary tract infections and serious ear, nose and throat infections.

Infectious mononucleosis.

Patients with infectious mononucleosis or lymphoid leukemoid reactions have frequently (60–100%) experienced a rash that is not due to hypersensitivity to penicillins. Therefore, ampicillin-class antibiotics should not be used in patients with mononucleosis.

Amoxicillin is not recommended for the treatment of patients with acute lymphoblastic leukemia due to an increased risk of erythematous skin rashes.

Cross-resistance: Cross-hypersensitivity and cross-resistance may exist between penicillins and cephalosporins.

Resistance.

Prolonged use of the drug may sometimes cause overgrowth of insensitive microflora. As with other broad-spectrum penicillins, superinfections may occur.

Pseudomembranous colitis.

Antibiotic-associated colitis, ranging from mild to life-threatening, has been reported with virtually all antibacterial agents, including amoxicillin. Appropriate measures should be taken if antibiotic-associated colitis occurs. Appropriate measures should also be taken if hemorrhagic colitis or hypersensitivity reactions occur.

Medications that inhibit peristalsis are contraindicated in this case.

Kidney failure.

In patients with renal insufficiency, the elimination of amoxicillin may be reduced depending on the degree of renal insufficiency. In severe renal insufficiency, the dose of amoxicillin should be reduced.

Convulsions may occur in isolated cases in patients with impaired renal function. This applies in particular to patients taking high doses and/or patients with risk factors (e.g. history of epilepsy, predisposition to seizures, concomitant treatment for epilepsy or diseases of the central nervous system) (see section "Adverse reactions").

Crystalluria

When using high doses of the drug, it is necessary to drink a sufficient amount of fluid to prevent crystalluria (including acute kidney injury), which can be caused by amoxicillin. The presence of high concentrations of amoxicillin in the urine may cause precipitation in the urinary catheter, so it should be visually checked at regular intervals (see sections "Adverse reactions" and "Overdose").

Skin reactions

The appearance of generalized erythema with fever associated with pustules at the beginning of treatment may be a symptom of acute generalized exanthematous pustulosis. In such cases, treatment should be discontinued and further use of amoxicillin is contraindicated.

Amoxicillin can cause severe skin reactions such as toxic epidermal necrolysis, Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS). If severe skin reactions occur, amoxicillin should be discontinued and appropriate treatment and/or measures should be taken.

Jarish-Herxheimer reaction

Jarisch-Herxheimer reaction has been observed after initiation of amoxicillin therapy for Lyme disease (see Adverse Reactions). This is directly due to the bactericidal action of amoxicillin on the bacteria that cause Lyme disease, the spirochete Borrelia burgdorferi. Patients should be advised that this is a common side effect of antibiotic treatment for Lyme disease; symptoms usually resolve with recovery.

During long-term treatment, it is recommended to periodically assess the function of body systems, including the renal, hepatic and hematopoietic systems. During high-dose therapy, blood counts should be monitored regularly. Elevations in liver enzymes and changes in blood cell counts have been reported (see section 4.8).

Precautions for premature infants and newborns: kidney, liver and blood function should be monitored.

Anticoagulants

Prolongation of prothrombin time has been reported rarely in patients receiving amoxicillin.

Appropriate monitoring is necessary when anticoagulants are used concomitantly.

To maintain the desired level of blood clotting, dose adjustment of oral anticoagulants may be necessary (see sections “Interaction with other medicinal products and other types of interactions” and “Adverse reactions”).

Combination therapy for eradication of Helicobacter pylori: when using amoxicillin as part of combination therapy for eradication of Helicobacter pylori, the instructions for medical use of other medicinal products used for combination therapy should be consulted.

Impact on diagnostic test results

Increased serum and urine levels of amoxicillin may interfere with the results of some laboratory tests. Due to the high concentration of amoxicillin in urine, chemical methods often give false-positive results.

When determining glucose in urine during treatment with amoxicillin, it is recommended to use enzymatic glucose oxidase methods.

The presence of amoxicillin may affect the results of an estriol test in pregnant women.

Use during pregnancy or breastfeeding

Pregnancy

Animal studies do not indicate direct or indirect reproductive toxicity. Limited human data on the use of amoxicillin during pregnancy do not indicate an increased risk of congenital malformations. Amoxicillin may be used during pregnancy if the potential benefit outweighs the potential risk of treatment.

Breast-feeding

Amoxicillin is excreted in small amounts in breast milk, which poses a potential risk of sensitization. This may lead to diarrhea or fungal infection of the mucous membranes in infants and may require discontinuation of breastfeeding. Amoxicillin should be used during breastfeeding only after a physician has assessed the risk-benefit ratio.

Fertility

There are no data on the effect of amoxicillin on human fertility. Animal reproduction studies have not shown any effect on fertility.

Ability to influence reaction speed when driving vehicles or other mechanisms

No studies on the effects on the ability to drive and use machines have been conducted. However, adverse reactions (e.g. allergic reactions, dizziness, convulsions) may occur that may affect the ability to drive or use machines (see section "Side effects").

Method of administration and doses

For mild to moderate infections, the following doses are recommended:

Adults (including elderly patients): orally 500–750 mg 2 times a day or 500 mg 3 times a day.

The daily dose for children is 40–90 mg/kg/day, which should be divided into 2–3 doses (do not exceed a dose of 3 g/day), depending on the indications, severity of the disease and sensitivity of microorganisms (see sections “Special instructions for use”, “Pharmacological properties”).

Pharmacokinetic and pharmacodynamic data show that three times daily administration is more effective than twice daily (recommended if doses are at the upper end of the recommended doses).

Children weighing more than 40 kg should use the recommended adult doses.

Special recommendations.

Tonsillitis: 50 mg/kg/day, divided into 2 doses.

Acute otitis media: in areas with high prevalence of penicillin-susceptible pneumococci, the dosage regimen should be in accordance with local recommendations.

Early stage Lyme disease (isolated erythema migrans): 50 mg/kg/day, divided into 3 doses, for 14–21 days.

Prophylaxis of endocarditis: 50 mg amoxicillin/kg body weight – single dose 1 hour before a scheduled surgical procedure.

Gonorrhea (acute, uncomplicated): single dose of 3 g.

When treating infections with hard-to-reach foci, such as acute bacterial otitis media, a three-time administration of the drug is preferable.

For chronic diseases, relapses, and severe infections, it is recommended to take the drug 3 times a day in doses of 750–1000 mg; for children, up to 60 mg/kg/day (divided into 3 doses).

Duration of use.

In case of mild to moderate infections, the drug is taken for 5-7 days. However, in case of infections caused by streptococcus, the duration of treatment should be at least 10 days.

When treating chronic diseases, local infectious lesions, and severe infections, the dosage of the drug should be determined by the clinical picture of the disease.

The drug should be continued for 48 hours after the symptoms of the disease disappear.

Patients with renal impairment.

The dose of the drug should be reduced in patients with severe renal insufficiency.

In patients with creatinine clearance lower than 30 ml/min, it is recommended to increase the interval between taking the drug and reduce the daily dose of the drug (see section "Special instructions for use", "Pharmacological properties").

Renal failure in adult patients (including elderly patients)

Hemodialysis: 500 mg of amoxicillin should be taken at the end of the hemodialysis procedure.

Renal failure in children weighing less than 40 kg

Patients with liver dysfunction.

Liver dysfunction does not affect the half-life of the drug.

Method of application.

Flemoxin Solutab® is intended for oral use.

Food intake does not affect the absorption of the drug Flemoxin Solutab®.

Dissolve the tablet in a glass of water, mix well until a homogeneous suspension is obtained and drink immediately.

Children

For children weighing < 40 kg, the daily dose is 40–90 mg/kg/day, which should be divided into 2–3 doses (not to exceed 3 g/day), depending on the indications, severity of the disease, and susceptibility of microorganisms.

Pharmacokinetic/pharmacodynamic data show that better efficacy is observed with 3 times daily dosing, therefore twice daily dosing is recommended only if the upper recommended dose range is used.

Children weighing more than 40 kg should use the recommended adult doses.

Overdose

Symptoms: In case of overdose, gastrointestinal disturbances such as nausea, vomiting, diarrhea occur; this may result in a disturbance of the water and electrolyte balance. Cases of crystalluria have been reported, sometimes leading to renal failure (see section "Special instructions").

Treatment: induce vomiting or perform gastric lavage, followed by administration of activated charcoal and an osmotic laxative (sodium sulfate). Maintain fluid and electrolyte balance. Amoxicillin can be removed from the bloodstream by hemodialysis. No specific antidote is known.

Side effects

The most commonly reported adverse reactions were diarrhea, nausea, and vomiting.

Adverse reactions observed during clinical trials and post-marketing surveillance of amoxicillin are presented below according to the MEdDRA classification.

Adverse reactions are classified according to their frequency of occurrence:

very common (≥1/10),

common (≥1/100 and <1/10),

uncommon (≥1/1000 and <1/100),

rare (≥1/10,000 and <1/1,000),

very rare (<1/10,000),

frequency unknown (cannot be estimated from available data).

Leukopenia (including severe, reversible;

neutropenia or agranulocytosis), reversible thrombocytopenia and hemolytic anemia.

Increased bleeding time and prothrombin index (see section "Special warnings and precautions for use").

Expiration date

3 years.

Storage conditions

Store at a temperature not exceeding 25 °C in the original packaging.

Keep out of reach of children.

Packaging

5 tablets in a blister, 4 blisters in a cardboard pack.

Vacation category

According to the recipe.

Producer

Haupt Pharma Latina S.R.L.

Location of the manufacturer and address of its place of business. Strada Statale 156 KM 47,600 FR, Borgo San Michele LT, 04100 - Latina, Italy.

Applicant

CHEPLAPHARM Artsnaimittel GmbH

Applicant's location

Ziegelhof 24, 17489 Greifswald, Germany