Phlamifiks 100, Phlamifiks 200

cefiximе

Capsules 100 mg, 200 mg

PACKAGE INSERT. INFORMATION FOR THE PATIENT

Please, read this package insert carefully before using the pteraration!

Keep this package insert. You may need to read it again.

If you have any additional questions, please, consult your doctor.

This preparation is indicated for you personally and should not be given to other individuals. Doing so may harm their health even if their symptoms are similar to yours.

Composition of the medicinal preparation:

Active substance: 1 capsule consist cefiximeу trihydrate equivalent cefiximeу 100 mg or 200 mg;

Auxiliary substances: microcrystalline cellulose, magnesium stearate, colloidal silicon dioxide, sodium lauryl sulphate.

Medicinal form. Capsules.

Pharmacotherapeutical group. Antimicrobial agents for systemic use.

Pharmacological properties. Cefixime semisynthetic antibiotic of Cephalosporin group of the ІІІ generation. The peculiarities of the chemical structure of the preparation provide its high activity against aerobic and anaerobic microorganisms. The preparation has a wide spectrum of bactericidal action, it is effective against the majority of gram-negative and gram-positive microorganisms, resistant to other cephalosporins, penicillins and other chematherapeutic agents, as well as blue pus bacillus. Stable to beta-lactamase of gram-negative and gram-positive microorganisms.

Indications. Іnfections caused by the microorganisms susceptible to the action of the preparation: infections of the respiratory apparatus (including pneumonia); infections of ear, nose and throat; infections of kidneys and urinary tract; gynecological infections, gonorrhea.

Contraindications. Hypersensitivity to cephalosporin antibiotics, hepatic dysfunction, pregnancy and lactation, bronchial asthma, children under 7 years old.

Precautions at use. If you are pregnant or nursing mother, tell you doctor about it before using the preparation.

Cross allergy to penicillins is possible. Indicate with caution to the patients with dysfunction of kidneys, liver, digestive tract, especially with colitis. In case of renal insufficiency dose of the preparation is adjusted according to creatinine clearance. The preparation should be used with caution when treating patients with epilepsy or with impaired activity of the central nervous system. During treatment impaired ability of driving and operating complicated mechanisms is possible. During treatment with the preparation breast-feeding should be discontinued.

If you have history of allergic reactions, tell your doctor about it.

Interaction with other drugs. If you receive any other medicinal preparations tell your doctor about it.

Enhances nephrotoxicity of amino glycosides. At concomitant use of cefixime and carbamazepine, plasma concentration of the last increases.

Way of introduction and doses. The dose of the preparation depends on the susceptibility of microorganisms, severity of infection, age, body weight and functional state of kidneys.

Adults and children over 12 years old with body weight over 50 kg are indicated 400 mg of the preparation as a single dose or 200 mg twice a day. Daily dose for children 7-12 years old - 100 mg twice a day or 200 mg once a day. Duration of the course – from 3 (in case of non-complicated cystitis) to 10-14 days. In case of infections caused by Streptococcus pyodenes, the duration of the course should be at least 10 days.

In case of renal dysfunction (creatinine clearance 21-60 ml/min) or in patients being on haemodialysis, daily dose is decreased by 25 %. At creatinine clearance <20 ml/min or in patients being on peritoneal dialysis, daily dose is twice decreased.

Overdose. Symptoms: leucopenia, thrombocytopenia, acute hemolytic anemia, skin reactions, dyspnea, stomatitis, anorexia, temporary hearing loss, renal insufficiency, diarrhea.

Treatment – gastric lavage, antihistamine preparations, symptomatic treatment. There is no specific antidote, at haemodialysis the preparation is excreted in insignificant quantity.

Side effects. Appear seldom. Possible allergic reactions, hepatic and duodenal dysfunction, nausea, vomiting, diarrhea, decreased appetite, increased level of liver transaminases, bilirubin in the blood serum, leucopenia; renal tubule necrosis, nephritis, headache, visual impairment, irritation at the site of injection of the preparation. Long-term use of the preparation may lead to the development of dysbiosis and superinfection (candidiasis).

In case of these adverse effects stop using the preparation and immediately consult the doctor!

Shelf life. 3 years. Do not use the preparation after the expiary date indicated on the package.

Storage conditions. Keep out of the reach of children in dry place at temperature below 30ºC.

Packing. 10 tablets in a blister; 1 blister in a carton.

Terms of dispensing. On prescription.

Name and adress of an applicant. Flamingo Pharmaceuticals Ltd.

7/1, Corporate Park, Sion-Trombay Road, Chembur, Mumbai – 400071, India.

Name and adress of marketed company. Ananta Medicare Ltd.

Suite 1, 2 Station Court, Imperial Wharf, Townmead Road, Fulham, London, U.K.