FDA label 316c5c93-5923-5146-e063-6394a90a694b

Long-term use of TURKFLEKS 0.5% METRONIDAZOL in treatment should be carefully evaluated (see section 5.3). In case of longer-than-planned use, regular blood tests should be performed, and leukocytes should be monitored in particular and attention should be paid to the development of neuropathy. Due to the risk of exacerbation of neurological symptoms, active or chronic peripheral or Should be used with caution in patients with central neurological disorders. Patients should be warned not to drink alcohol during treatment and for at least two days after stopping treatment, as it may cause a disulfiram-like reaction. It should be used with caution in patients with blood dyscrasia findings or history. Leukocyte count should be performed before and after treatment. In cases with blood dyscrasia or high dose and/or long-term treatment, the decision on whether to continue treatment should be made according to the severity of the infection. Adverse reactions should be monitored in treatments longer than 10 days. Metronidazole should be used with caution in cases of hepatic encephalopathy. The daily dose should be reduced to one third and used as a single dose. It may darken the urine color due to its metabolites; patients should be informed about this. • Oral, vaginal or intestinal candidiasis after intravenous metronidazole use may develop. It has no direct activity against aerobic and facultative anaerobic bacteria. After Trichomonas vaginalis is eliminated, a gonococcal infection does not remain There is a possibility. In case of renal failure, the elimination half-life of metronidazole does not change. Therefore, there is no need to reduce the dose of metronidazole. However, metronidazole metabolites remain in these patients. The clinical significance of this is unknown. In patients receiving hemodialysis, metronidazole and its metabolites are effectively removed within an 8- hour dialysis period. Therefore, metronidazole should be re-administered immediately after hemodialysis. There is no routine dosage adjustment necessary in patients with renal failure receiving intermittent peritoneal dialysis (IPD) or continuous ambulatory peritoneal dialysis (CAPD). If ataxia, vertigo, hallucinations or confusion are observed, treatment should be discontinued. Metronidazole potentiates the effect of vecuronium, which is used to create non-depolarizing neuromuscular blockade. Although metronidazole has been found to be carcinogenic in a certain mouse species, this effect has not been demonstrated in rats and hamsters. The preparation has no such effect in humans. Due to insufficient evidence of mutagenicity risk in humans Use of TURKFLEKS 0.5% METRONIDAZOL for a longer period than usual should be carefully evaluated. This medicinal product contains 13 mmol sodium per 100 ml. Patients on a low sodium and low salt diet should be careful. It should also be administered with caution to those prone to oedema. Should be stored at room temperature below 25 °C.

Adverse reactions reported more frequently than placebo in clinical trials and defined as at least possibly attributable to metronidazole treatment based on the best assessment of causality from available data are listed below using the following classification: Very common (ÿ1/10); common (ÿ1/100 to <1/10); uncommon (ÿ1/1000 to <1/100); rare (ÿ1/10000 to <1/1000); very rare (ÿ1/10000), not known (cannot be estimated from the available data). Blood and lymphatic system diseases Very rare: Agranulocytosis, neutropenia, thrombocytopenia, pancytopenia. Unknown: Leukopenia Immune system diseases Rare: Anaphylaxis Not known: Angioedema, urticaria, fever Metabolism and nutritional diseases Unknown: Anorexia Psychiatric diseases Very rare: Psychotic disorders including confusion and hallucinations. Unknown: Depressed mood Nervous system diseases Very rare: Encephalopathy (e.g., confusion, headache, hallucination, paralysis, photosensitivity, movement disorder, neck stiffness) and subacute cerebellar syndrome (e.g., ataxia, dysarthria, gait disturbance, nystagmus, and tremor), reversible on discontinuation of the drug. Dizziness, lightheadedness, convulsions, headache. Not known: Peripheral sensory neuropathy or transient epileptiform seizures have been reported during intensive and/or prolonged metronidazole therapy. In many cases, the neuropathy resolved after discontinuation of therapy or reduction of dosage. Aseptic meningitis. Eye diseases Very rare: Visual disturbances such as diplopia or myopia, mostly transient, blurred vision, decreased visual acuity, changes in colour vision. Not known: Optic neuropathy/neuritis Gastrointestinal diseases Not known: Taste changes, oral mucositis, furry tongue, tongue discoloration/hairiness, gastrointestinal disorders such as nausea, vomiting, epigastric pain and diarrhoea. Cases of reversible pancreatitis. Hepatobiliary diseases Very rare: Increases in liver enzymes (AST, ALT, ALP), sometimes with jaundice, cholestatic hepatitis or mixed hepatitis and hepatocellular liver damage have been reported. Cases of liver failure requiring liver transplantation have been reported in patients treated with metronidazole in combination with other antibiotics. Skin and subcutaneous tissue diseases Very rare: Skin rash, pustular rash, pruritus, flushing Not known: Including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis. Musculoskeletal disorders, connective tissue and bone diseases Very rare: Myalgia, arthralgia Kidney and urinary diseases Very rare: Darkening of urine colour (due to metronidazole metabolite) General disorders and diseases related to the application area Uncommon: Fever Reporting of suspected adverse reactions Reporting of suspected adverse reactions after licensing is of great importance. Reporting allows continuous monitoring of the benefit/risk balance of the drug. Healthcare professionals are required to report any suspected adverse reactions to the Turkish Pharmacovigilance Center (TÜFAM) (www.titck.gov.tr ; e-mail: tufam@titck.gov.tr ; tel: 0 800 314 00 08, fax: 0 312 218 35 99).