INGREDIENT FORMULA:

Each film-coated tablet contains

Active ingredient: Amoxicillin trihydrate is equivalent to amoxicillin 500mg and Potassium clavulanat is equivalent to aicd clavulanic 125mg.
Ingredients excipients: Crospovidon-type A, croscarmellose sodium, aerosol 200, magnesium stearate.

Dosage form: Film-coated tablets.

POINT

Short-term treatment of the following infections:

– Infections of upper respiratory tract: tonsillitis, sinusitis, otitis media have been treated with normal antibiotics but not reduced.

– Infections of the lower respiratory tract by strains of H. influenzae and Branhamella catarrariis produce beta-lactamase: acute and chronic bronchitis, pneumonia – bronchitis.

– Severe urinary tract infections – genital by strains of E. coli, Klebsiella and Enterobacter producing beta-lactamase: Cystitis, urethritis, pyelonephritis (female genital tract infections).

– Skin and soft tissue infections: Acne, abscess, wound infection.

– Bone and joint infections: Osteomyelitis.

– Dental infections: Abscess tooth drive.

DOSAGE AND ADMINISTRATION:

Administration: oral route.

Usual dose: 1 capsule / time x 3 times / day (in adults).

Dosage: calculated according to the content of amoxicillin in the drug.

Adults and children ≥ 12 years:

– Mild and moderate infections: 1 tablet (500mg amoxicillin) every 12 hours.

– Severe infections: 1 tablet (500 mg amoxicillin) every 8 hours.

Children 6 years old and weighing <25kg should be treated in suspension or packet form.
It should be taken at the beginning of the meal to minimize gastrointestinal intolerance.
Treatment should not exceed 14 days without re-examination.
Special patient group:

+ When there is kidney damage, the dose and / or number of medications must be changed to respond to kidney damage.

CONTRAINDICATIONS

Allergy to beta – lactam antibiotics (penicillins and cephalosporins).
Attention should be paid to the possibility of cross-allergic with beta-lactam antibiotics such as Cephalosporins. Attention should be paid to patients with a history of jaundice / hepatic dysfunction due to amoxicillin and clavulanate or penicillin because clavulanic acid increases the risk of cholestasis in the liver.

WARNING / PRECAUTIONS

Serious anaphylaxis (hypersensitivity) is occasionally reported in patients receiving penicillin, which is more common in people with a history of hypersensitivity to penicillin and / or a history of hypersensitivity to many Different antigens have also been reported, with a history of hypersensitivity to penicillin and a severe cross-reactivity when used with cephalosporins, so before starting BILCLAMOS, it is necessary to carefully examine the patient There have been hypersensitivity reactions to penicillin, cephalosporins or other causes.In case of an allergic reaction, the drug must be stopped immediately and appropriate measures are taken. , emergency treatment with epinephrine should be immediately indicated xy, intravenous corticosteroids and airway ventilation.
Although penicillins are of very low toxicity, regular assessment of organ function, such as kidneys, liver, and hematopoietic function, is necessary for prolonged use. A high proportion of patients with mononuclear leukocytosis and ampicillin-containing erythematosus have been found. Therefore, ampicillin cannot be given to anyone with mononucleosis.
During treatment with BILCLAMOS, always be aware of the potential for superinfection with bacterial or fungal sprouts. If you encounter superinfection (usually Pseudomonas or Candida), you must stop the drug and take appropriate treatment.

Period of pregnancy and breastfeeding:

There is no clear evidence about the safety of BILCLAMOS during pregnancy, so only use this drug for pregnant women when clearly needed.

Semi-synthetic penicillin antibiotics are excreted in milk, caution should be exercised when BILCLAMOS is administered to a nursing mother.

EFFECTS TO THE DRIVING AND OPERATION OF MACHINERY.

Does not affect the ability to drive and operate machines.

UNWANTED EFFECTS

Adverse reactions: Well tolerated bilclamos, common adverse effects are diarrhea, nausea, rash, urticaria, vomiting, vaginitis. The incidence of common adverse effects, especially diarrhea, often increases with the recommended high dose. Other less common reactions include: abdominal discomfort, flatulence, headache. And <1% of patients taking BILCLAMOS experienced mild thrombocytopenia. There is also a moderate increase in SGOT, but not yet clinically significant. Sometimes anemia, thrombocytopenia, purpura due to thrombocytopenia, eosinophilia, leukopenia, agranulocytosis.

Hypersensitivity reactions: Including rash, pruritus, urticaria, erythema multiforme. These reactions can be controlled with H1 antihistamines and systemic corticosteroids should be used whenever necessary. Any such reaction should be discontinued, unless the physician has a different opinion. Rare hyperactivity, agitation, anxiety, insomnia, confusion, and / or dizziness.

OVERDOSE AND TREATMENT

Overdose, the drug causes less risk, because well tolerated even at high doses. However, generally the acute reactions occur depending on the individual’s hypersensitivity. The risk is definitely hyperkalemia when used in very high doses because clavulanic acid is used in the form of potassium salts. Hemodialysis can be used to remove medications from the circulation.

STORAGE: Store in a well-closed container, at a temperature below 30 ° C.

SHELF LIFE: 2 years from date of manufacture. Do not use the medicine after the expiry date shown on the bottle or medicine box.

Standard manufacturer.

To medicines out of reach of children

Read the directions carefully before use

If you need further information, please consult your doctor

MADE BY:

BILIM ILAҪ SANAYI VE TICARET A.S – Turkey.