Abiklav film-coated tablets 500mg/125mg 20 pieces

Treatment of bacterial infections caused by microorganisms sensitive to the drug, such as:

• acute bacterial sinusitis;
• acute otitis media;
• confirmed exacerbation of chronic bronchitis;
• community-acquired pneumonia;
• cystitis;
• pyelonephritis;
• skin and soft tissue infections, including cellulitis, animal bites, severe dentoalveolar abscesses with widespread cellulitis;
• Bone and joint infections, including osteomyelitis.

• active ingredients: 1 film-coated tablet contains amoxicillin trihydrate equivalent to 500 mg of amoxicillin and potassium clavulanate equivalent to 125 mg of clavulanic acid or amoxicillin trihydrate equivalent to 875 mg of amoxicillin and potassium clavulanate equivalent to 125 mg of clavulanic acid;
• excipients: microcrystalline cellulose, sodium starch glycolate (type A), colloidal anhydrous silica, magnesium stearate, opadry white (06B58855).

• Hypersensitivity to the active substances, to any drug from the penicillin group or to any excipient.
• History of a severe immediate-type hypersensitivity reaction (e.g. anaphylaxis) to another β-lactam drug (e.g. cephalosporin, carbapenem or monobactam).
• History of jaundice/liver dysfunction due to amoxicillin and clavulanic acid.

Infections and infestations: candidiasis of the skin and mucous membranes, overgrowth of non-susceptible microorganisms.

From the blood system: reversible leukopenia (including neutropenia) and thrombocytopenia, reversible agranulocytosis and hemolytic anemia, increased bleeding time and prothrombin index.

Cardiac: Kunis syndrome.

On the part of the immune system: angioedema, anaphylaxis, serum sickness syndrome, allergic vasculitis.

Nervous system: dizziness, headache, reversible hyperactivity, aseptic meningitis and convulsions. Convulsions may occur in patients with impaired renal function or in those receiving high doses of the drug.

Gastrointestinal: diarrhea, nausea, vomiting, indigestion, antibiotic-associated colitis (including pseudomembranous colitis and hemorrhagic colitis), black “hairy” tongue, drug-induced enterocolitis syndrome (DIES). Nausea is more often associated with high doses of the drug. The above-mentioned gastrointestinal symptoms may be reduced by taking the drug at the beginning of a meal.

Hepatobiliary: Moderate elevations of AST and/or ALT have been reported in patients treated with β-lactam antibiotics, but the clinical significance of this has not been established; hepatitis and cholestatic jaundice. These events have occurred with other penicillins and cephalosporins.

The product should be used in accordance with official antibiotic treatment guidelines and local antibiotic susceptibility data. Susceptibility to amoxicillin/clavulanate varies between regions and may change over time. Local susceptibility data should be consulted, if available, and microbiological identification and susceptibility testing should be performed as appropriate.

The duration of treatment is determined by the patient’s clinical response to treatment. Some infections (e.g. osteomyelitis) require longer treatment.

For optimal absorption and reduction of possible side effects from the digestive tract, the drug should be taken at the beginning of a meal.

The duration of treatment is determined individually. Treatment should not be continued for more than 14 days without assessing the patient’s condition.

Treatment can be started with parenteral administration and then continued with oral administration.

The tablet should be swallowed whole, without chewing.

Tablets of 500 mg/125 mg

For adults and children weighing ≥ 40 kg, the daily dose is 1500 mg amoxicillin/375 mg clavulanic acid (3 tablets), when administered as indicated below.

For children aged 6 years and over and weighing 25 to 40 kg, the maximum daily dose is 2400 mg amoxicillin/600 mg clavulanic acid (4 tablets), when administered as indicated below.

If higher doses of amoxicillin are required for treatment, other forms of the drug should be used to avoid prescribing excessively high doses of clavulanic acid.

Adults and children weighing ≥ 40 kg: 1 tablet of Abiklav 500 mg/125 mg 3 times a day.

Children aged 6 years and over with a body weight of 25 to 40 kg: dose from 20 mg/5 mg/kg body weight/day to 60 mg/15 mg/kg body weight/day, divided into 3 doses.

Since the tablet cannot be divided, this form of the drug should not be prescribed to children weighing less than 25 kg.

Use during pregnancy or breastfeeding

The use of the drug should be avoided during pregnancy, especially in the first trimester, unless the benefit of using the drug outweighs the potential risk.

The drug can be used during breastfeeding only if, in the opinion of the doctor, the benefit of use outweighs the risk.

Children

Abiklav 500 mg/125 mg is used in children aged 6 years and over with a body weight of at least 25 kg.

Abiklav 875/125 mg is not recommended for the treatment of children under 12 years of age.

Ability to influence reaction speed when driving vehicles or other mechanisms

No studies have been conducted to study the ability of the drug to affect the reaction speed when driving or using other mechanisms. However, adverse reactions may occur (e.g. allergic reactions, dizziness, seizures, which may affect the ability to drive or use other mechanisms).

Overdose may be accompanied by symptoms from the digestive tract and disorders of water and electrolyte balance. These phenomena are treated symptomatically, paying attention to the correction of water and electrolyte balance. Cases of crystalluria have been reported, which in some cases can cause renal failure. The drug can be removed from the bloodstream by hemodialysis.

Store out of the reach of children at a temperature not exceeding 25 °C.