Flagyl 200mg. 400mg Tablet

a) In the oral treatment of:

• urogenital trichomoniasis
• non-specific vaginitis
• all forms of amoebiasis
• giardiasis
• acute ulcerative gingivitis (Vincent's)
• acute pericoronitis

b) Treatment of infections in which anaerobic bacteria have been identified or are suspected as pathogens, particularly Bacteroides fragilis and other species of Bacteroides and including other species for which metronidazole is bactericidal, such as fusobacteria, clostridia, eubacteria and anaerobic streptococci. FLAGYL has been used successfully for anaerobic infections in the following conditions: pelvic inflammatory disease and postoperative wound infections. Combined therapy is often indicated as there are usually mixed infections.

c) Prevention of postoperative infections due to anaerobic bacteria:

• Given before and after gynaecological surgery
• Given before and after appendectomy
• Given before and after colonic surgery

d) Treatment of Helicobacter pylori-associated gastritis and duodenal ulcer. FLAGYL is used in combination with bismuth subsalicylate or colloidal bismuth subcitrate and appropriate antibiotic therapy.

The tablets should be taken with or after food. FLAGYL SUSPENSION is administered orally. It is recommended that it be taken at least 1 hour before food. Immature children and babies weighing less than 10 kg should receive proportionally smaller doses, as advised by the medical practitioner. Children over 10 years may be given a suitable proportion of the adult dosage according to body mass.

Hypersensitivity to metronidazole and other imidazoles. Co-administration with busulfan (see WARNINGS AND SPECIAL PRECAUTIONS and INTERACTIONS).

Patients should be advised not to take alcohol during FLAGYL therapy and for at least one to three days afterwards because of the possibility of a disulfiram-like reaction (see INTERACTIONS). Co-administration with busulfan: As plasma levels of busulfan may be increased significantly, it may lead to severe busulfan toxicity and death. Pseudomembranous colitis has been reported with the use of FLAGYL. Studies have shown FLAGYL to be mutagenic in bacteria and carcinogenic in some animals.

FLAGYL should be administered with caution to patients with hepatic encephalopathy. FLAGYL should be used with great care in patients with blood dyscrasias or with active or chronic disease of the central and peripheral nervous system. All patients receiving FLAGYL for more than 10 days should be monitored and treatment discontinued if signs of peripheral neuropathy or central nervous system toxicity develop. Doses should be reduced in patients with severe liver disease. FLAGYL has anti-treponemal activity and may mask the immunological response seen in untreated early syphilis; contacts of syphilis receiving FLAGYL should probably be screened for an additional 4 to 8 weeks. Patients should be warned that FLAGYL may darken urine (due to metronidazole metabolite).

Driving a vehicle or performing hazardous tasks: Patients should be warned about the potential for confusion, dizziness, hallucinations, convulsions or eye disorders (see SIDE EFFECTS), and advised not to drive or operate machinery if these symptoms occur. FLAGYL SUSPENSION contains sucrose which may have an effect on the glycaemic control of patients with diabetes mellitus. Patients with rare hereditary conditions such as fructose intolerance, glucose-galactose mal-absorption or sucrase-isomaltase insufficiency should not take Flagyl suspension.

Disulfiram: Acute psychoses or confusion have been associated with the concomitant use of FLAGYL and disulfiram. Alcohol: When given in conjunction with alcohol, FLAGYL may provoke a disulfiram-like reaction in some individuals (effects include intense vasodilation and flushing of the face and neck, restlessness, anxiety, tachycardia, tachypnoea, headache, nausea, vomiting, hyperpnoea, chest pains, sweating, pallour and hypotension); reactions have occurred after the administration of pharmaceutical preparations formulated with alcohol, including injections, as well as after drinking alcohol. Alcoholic beverages and medicine containing alcohol should not be consumed during therapy and for at least 1 to 3 days afterwards (see WARNINGS AND SPECIAL PRECAUTIONS).

Oral anticoagulant therapy (warfarin type): Potentiation of the anticoagulant effect and increased haemorrhagic risk. In case of co-administration with warfarin, prothrombin time/INR should be more frequently monitored and warfarin therapy/dose adjusted during treatment with FLAGYL.

Lithium: Plasma levels of lithium may be increased by FLAGYL. Plasma concentrations of lithium, creatinine and electrolytes should be monitored in patients under treatment with lithium while they receive FLAGYL.

Ciclosporin: Risk of elevation of ciclosporin serum levels. Serum ciclosporin and serum creatinine should be closely monitored when co-administration is necessary.

Phenytoin or phenobarbital: There is evidence that phenytoin might accelerate the metabolism of FLAGYL. Plasma concentrations of FLAGYL are decreased by the concomitant administration of phenobarbital, with a consequent reduction in the effectiveness of FLAGYL.

5-Fluorouracil: Reduced clearance of 5-fluorouracil resulting in increased toxicity of 5-fluorouracil may occur.

Busulfan: Plasma levels of busulfan may be increased by FLAGYL, which may lead to severe busulfan toxicity and death (see CONTRAINDICATIONS and WARNINGS AND SPECIAL PRECAUTIONS).

Cimetidine: Hepatic metabolism may be decreased when FLAGYL and cimetidine are used concurrently, possibly resulting in delayed elimination and increased serum metronidazole concentrations with an increased risk of neurological side effects.

Safety in pregnancy and lactation has not been established. FLAGYL crosses the placental barrier and is excreted in breast milk. Women using Flagyl should not breastfeed their infants.

Patients should be warned about the potential for confusion, dizziness, hallucinations, convulsions or eye disorders (see SIDE EFFECTS), and advised not to drive or operate machinery if these symptoms occur.

The adverse effects of FLAGYL are generally dose related. The following side effects have been reported:

Blood and the lymphatic system disorders: Less frequent: Agranulocytosis, neutropenia and thrombocytopenia. Frequency unknown: Leucopenia.

Immune system disorders: Less frequent: Anaphylaxis. Frequency unknown: Angioedema, urticaria.

Metabolism and nutrition disorders: Frequency unknown: Anorexia.

Psychiatric disorders: Less frequent: Psychotic disorders including confusion, irritability and hallucinations, changes in mood or mental state such as depression or confusion.

Nervous system disorders: Less frequent: Weakness, dizziness, drowsiness, insomnia, cases of encephalopathy (e.g. confusion) and subacute cerebellar syndrome (e.g. ataxia dysathria, gait impairment, nystagmus and tremor), which may resolve with discontinuation of the medicine. Frequency unknown: Peripheral neuropathy, usually presenting as numbness or tingling in the extremities, and epileptiform seizures are serious adverse effects on the nervous system that have been associated especially with high doses of FLAGYL or prolonged treatment.

Eye disorders: Less frequent: The occurrence of transient vision disorders such as diplopia and myopia may follow the use of FLAGYL.

Respiratory, thoracic and mediastinal disorders: Frequency unknown: Nasal congestion.

Gastrointestinal disorders: Frequent: Gastrointestinal disturbances, especially nausea and taste disorders; nausea is sometimes accompanied by headache, and vomiting. Diarrhoea, dry mouth, a furred tongue, oral mucositis and stomatitis. Less frequent: Pseudomembranous colitis.

Hepato-biliary disorders: Less frequent: Increase in liver enzymes (AST, ALT, alkaline phosphatase) and cholestatic hepatitis sometimes with jaundice. Frequency unknown: Pancreatitis and raised liver enzyme values.

Skin and subcutaneous tissue disorders: Less frequent: Pustular eruptions, mild erythematous eruptions with fleeting joint pains resembling serum sickness. Frequency unknown: Skin rashes, flushing, and pruritus.

Musculoskeletal, connective tissue and bone disorders: Frequency unknown: Myalgia and arthralgia.

Renal and urinary disorders: Less frequent: Urethral discomfort and darkening of the urine.

General disorders and administration site conditions: Frequency unknown: Fever.

Post marketing experience: The adverse effects listed below are based on data from post-marketing experience:

Nervous system disorders: Headache, aseptic meningitis.

Eye disorders: Transient vision disorders such as blurred vision, decreased visual acuity, changes in colour vision, optic neuropathy/neuritis.

Gastrointestinal disorders: Epigastric pain.

Hepato-biliary disorders: Mixed hepatitis and hepatocellular liver injury. Cases of liver failure requiring liver transplant have been reported in patients treated with FLAGYL in combination with other antibiotic medication.

See SIDE EFFECTS above. Treatment is symptomatic and supportive.