SHORT PRODUCT INFORMATION SI:

NATURAL MEDICINAL PRODUCT NAME PENFLOKS® 500 mg film tabletActive substance:One film tablet equivalent to 500 mg Flucloxacillin Contains 544 mg Flucloxacillin Sodium Monohydrate.Excipient(s) :For each film-coated tablet; Lactose (cow origin). Typical indications are:Skin and soft tissue infections:•Ciban•Impetigo•Abscess•Infected wounds•Carbonculum•Infected burns•Fronculosis•Protection for skin graft•CelluliteRespiratory tract infections:•Pno Monimonium Pharyngitis Empyema Sinusitis Middle ear and outer ear inflammation Other infections caused by organisms sensitive to flucloxacillin: Bone infections Septicemia Intestinal inflammation Endocarditis Urinary tract infection PENFLOKS® tablet also cardiothoracic and orthopedic operations It can be used prophylactically during surgical procedures such as Posology and method of administration:

Oral: 250 mg 4 times a day, dosage can be doubled in severe infections. Other pharmaceutical forms are recommended. Pediatric population2 – 10 years: 125 mg 4 times a day below2: 62.5 mg 4 times a day Decrease in dosage in case of severe renal failure (creatinine clearance ? 10ml/min) It may be necessary.. Method of administration PENFLOKS® tablet is administered orally. PENFLOKS® tablet should be taken on an empty stomach. Kidney/Liver failure; Does not require dosage reduction in patients with renal failure. However, in case of severe renal failure (creatinine clearance less than 10ml/min), a decrease in the dose or an increase in the dose range should be considered due to the risk of neurotoxicity. Hepatitis and cholestatic jaundice have been reported. Contraindications Hypersensitivity to active substances, excipients listed in section 6.1, or beta-lactam antibiotics (eg penicillin).PENFLOKS® tablet, past It is contraindicated in patients with flucloxacillin-related jaundice/hepatic dysfunction. fUndesirable effects: lymphatic system disorders Very rare: Notropenia and thrombocytopenia. These are reversible as long as the treatment is not continued. Haemolytic anemia Immune system disorders Very rare: Anaphylactic shock (excluding oral administration), angioneurotic edema. If a hypersensitivity reaction occurs, treatment should not be continued. Gastrointestinal disorders *Common: Minor gastrointestinal disorders. Very rare: pseudomembranous colitis. If pseudomembranous colitis develops, treatment should be stopped and appropriate therapy instituted. Hepatobiliary disorders Very rare: Hepatitis and cholestatic jaundice. Changes in liver function laboratory test results are reversible if treatment is not continued. These reactions are not related to dose or administration. The onset of these effects may be delayed up to two months after treatment; In some cases, the course of the reactions was long and lasted for several months.. Skin and subcutaneous tissue disorders *Uncommon: Itching, urticaria, purpura (skin rash Rare: Erythema multiforme (usually a serious rash that can also be seen in children over 3 years old and adults (cold sores, boils, itching) skin rash such as musculoskeletal, connective tissue, Stevens-Johnson syndrome and toxic epidermal necrolysis and bone disorders Very rare: Arthralgia and myalgia sometimes develop 48 hours after the start of treatment. Renal and urinary disorders Very rare: Interstitial nephritis (reversible when treatment is discontinued). General disorders and administration site conditions Very rare: Fever may develop 48 hours after the start of treatment.*These adverse effects were obtained from clinical studies involving approximately 929 adult and pediatric patients. Healthcare professionals are required to report any suspected adverse reaction to the Turkish Pharmacovigilance Center (TUFAM) (www.titck.gov.tr ​​; e-mail: [email protected]) ; tel: 0800 314 00 08; fax: 0312 218 35 99). Overdose and treatment High doses (especially parenteral) may develop neurotoxicity. Gastrointestinal effects such as nausea, vomiting, diarrhea may occur and should be treated symptomatically. Incompatibilities Unknown. Shelf life 36 months Special precautions for storage Should be stored at room temperature below 25 °C and in a dry place. Quality and content of the package 16 film tablets blister LICENSE OWNER FARMAVI P PHARMACEUTICAL AND COSMETIC ·K INDUSTRY· and TI·CARET LTD S·TI·. Arabayatagˆı Mah. 2. Celik Sok. No:13/2Yıldırım/BURSATel: 0 224 341 10 55 e-mail: [email protected] LICENSE NUMBER 2017/107 FIRST LICENSE DATE HI / LICENSE RENOVATION DATE HI First license date: 13.03.2017 License renewal date:- KUB’S RENEWAL DATE