NAME OF THE MEDICINAL PRODUCT CEFIXIMA 400 mg film-coated tablet. ACTIVE SUBSTANCE: Each film-coated tablet contains 447,629 mg cefixime trihydrate equivalent to 400 mg cefixime. PHARMACOLOGICAL PROPERTIES: Pharmacotherapeutic group: Third generation cephalosporins ATC code: J01DD08 Cefixime, an orally administered cephalosporin, is similar to cefotaxime, a parenterally used cephalosporin, in its structure, spectrum and beta-lactamase resistance. Cefixime, like all representatives of this group of molecules, has a bactericidal effect. The mechanism of action of cefixime is based on inhibition of bacterial cell wall synthesis. THERAPEUTIC INDICATIONS: Acute otitis media-Acute sinusitis-Acute tonsillopharyngitis or pharyngitis. Acute bacterial exacerbation of chronic bronchitis – In uncomplicated urinary tract infections – In the treatment of uncomplicated gonococcal infections. POSOLOGY/FREQUENCY AND DURATION OF APPLICATION: Adults and children over 12 years of age: The recommended daily dose is 400 mg. Clinical use is recommended as 400 mg once daily or 200 mg divided into two equal doses. CEFIXIMA can be used with or without food. CONTRAINDICATIONS Cefixime should not be used in people who are sensitive to other cephalosporins or any of its ingredients. SPECIAL WARNINGS AND PRECAUTIONS FOR USE: CEFIXIMA should be used with caution in patients with known hypersensitivity to other drugs. Particularly, since partial cross-allergenicity is known between penicillins and cephalosporins, caution should be exercised when using cephalosporins in patients with known penicillin allergy. Allergic and anaphylactic reactions have been reported due to drugs in both groups. If an allergic reaction occurs during the use of CEFIXIMA, the drug should be discontinued and appropriate treatment should be initiated. INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER MODES OF INTERACTION: The use of cephalosporins may affect the results of some laboratory tests. False positive results can be obtained with the Benedict, Fehling and Clinitest methods. When another drug is used together, the treating physician should be informed. Probenecid increases the concentration of cefixime. Cefixime increases the level of carbamazepine. Foods can delay the absorption of cefixime. As with other cephalosporins, in some patients on prothrombin time. PREGNANCY CATEGORY B. LACTATION PERIOD: Cefixime was not detected in breast milk. However, cefixime should not be administered to nursing mothers without adequate clinical trial results. UNDESIRED EFFECTS: Infections and infestations Not known: Pseudomembranous enterocolitis Blood and lymphatic system disorders Rare: Change in haemogram Very rare: Blood coagulation disorders Immune system disorders Rare: Urticaria or angioedema Nervous system disorders Rare: Headache, vertigo. Very rare: Transient hyperactivity, tendency to convulsions. QUALITY AND CONTENT OF THE PACKAGING: In the box, PVC/
5-10 film tablets in Al foil blister pack. REPORTING SUSPICIOUS ADVERSE REACTIONS: Reporting suspected adverse reactions of drugs after authorization is of great importance.
Reporting allows continuous monitoring of the benefit/risk balance of the drug. Any suspected adverse reaction of healthcare professionals Turkish Pharmacovigilance Center
(TÜFAM) (www.titck.gov.tr; e-mail: [email protected]; tel: 0 800 314 00 08; fax: 0 312 218 35 99). LICENSE OWNER İstanbul İlaç San. ve Tic. Inc. Kartal/Istanbul
LICENSE NUMBER 2021/213 FIRST LICENSE DATE / LICENSE RENEWAL DATE 16.07.2021 SALES AND MARKETING: FARMAVİP İLAÇ VE KOZMETİK SANAYİ ve TİCARET A.Ş. Arabayatagi Mah. 2nd.
Çelik Sok. No:13/2 Yıldırım/BURSA Tel: 0 224 341 10 55 e-mail: [email protected] For more information, contact our company.