BRIEF PRODUCT INFORMATION:
NAME OF THE MEDICINAL PRODUCT PENFLOKS® 500 mg film tabletActive substance:One film tablet contains 544 mg Flucloxacillin Sodium Monohydrate equivalent to 500 mg Flucloxacillin. Excipient(s): For each film tablet; Lactose (cow origin).. 55.00 mg Excipients. Therapeutic indications for PENFLOKS® tablet is indicated for the treatment of infections caused by susceptible Gram-positive organisms, including infections caused by Staphylococcal and streptococci. Typical indications are: Skin and soft tissue infections: Ciban Impetigo Abscesses Infected wounds Carbuncles Infected burns Furnculosis Skin graft protection Cellulitis Respiratory tract infections: Pneumonia Pharyngitis Empyema Sinusitis Middle ear and outer ear inflammation Other infections caused by organisms susceptible to flucloxacillin: Bone infections Septicemia Intestinal inflammation Endocarditis Urinary tract infection PENFLOKS® tablet can also be used prophylactically during surgical procedures such as cardiothoracic and orthopedic operations. Posology and method of administration:
Oral: 250 mg 4 times a day In severe infections, the dosage can be doubled. Other pharmaceutical forms are recommended. Pediatric population 2 – 10 years of age: 125 mg 4 times a day Under 2 years: 62.5 mg 4 times a day In case of severe renal impairment (creatinine clearance ≤ 10 ml/min), a reduction in dosage may be required. Method of administration PENFLOKS® tablet is administered orally. PENFLOKS® tablet should be taken on an empty stomach. Kidney/Liver failure; Dosage reduction is not required in patients with renal failure. However, in severe renal impairment (creatinine clearance less than 10 ml/min), dose reduction or increase in dose range should be considered due to the risk of neurotoxicity. Hepatitis and cholestatic jaundice have been reported. Contraindications To active substances, excipients listed in section 6.1, or beta- Hypersensitivity to lactam antibiotics (eg penicillin). PENFLOKS® tablet is contraindicated in patients with a history of jaundice/hepatic dysfunction associated with flucloxacillin. fUndesirable effects: lymphatic system disorders Very rare: Neutropenia and thrombocytopenia. These are reversible unless treatment continues. Haemolytic anemia Immune system disorders Very rare: Anaphylactic shock (except for oral administration), angioneurotic oedema. 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 discontinued. 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 is long-lasting and lasted for several months. Skin and subcutaneous tissue disorders *Uncommon: Itching, urticaria, purpura (skin rash) Rare: Erythema multiforme (a serious rash (usually a severe rash that can also occur in children over 3 years old and adults) , boils, pruritus) type.), Stevens-Johnson syndrome and toxic epidermal necrolysis Musculoskeletal, connective tissue 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 reactions were obtained from clinical studies involving approximately 929 adult and pediatric patients. (www.titck.gov.tr; e-mail: [email protected]; tel: 0800 314 00 08; fax: 0312 218 35 99). Overdose and its treatment Neurotoxicity may develop at high doses (especially parenteral). Gastrointestinal effects such as nausea, vomiting and diarrhea may occur and should be treated symptomatically. Incompatibilities Unknown. Shelf life 36 months Special precautions for storage It should be stored at a room temperature below 25 °C and in a dry place. The nature and content of the packaging 16 film tablets blister LICENSE OWNER FARMAVIP ILAC VE KOZMETIK SANAYİ ve TİCARET LTD ŞTİ. Arabayatagi Mah. 2. Celik Sok. No:13/2Yıldırım/BURSATel: 0 224 341 10 55 e-mail: [email protected] LICENSE NUMBER 2017/107 FIRST LICENSE DATE/LICENSE RENEWAL DATE First license date: 13.03.2017 License renewal date:- RENEWAL OF CUB HISTORY- SALES-MARKETING: Intraline pharmaceutical services import export industry. Trade Ltd. Sti.