Allergex Elixir

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

The usual adult dose is:

* NIDASALL is only recommended if the children in this age group can swallow tablets. Children who cannot swallow tablets should take Metronidazole suspension. (NIDASALL is not available in a suspension)

Anaerobic infections

a) Treatment: NIDASALL may be given alone or concurrently with other bacteriologically appropriate antibacterial agents. They should be given for 7 days or longer depending on clinical and bacteriological assessments of the patient's condition.

Adults: Initially, 800 mg followed by 400 mg by mouth every 8 hours.

Children: 7.5 mg/kg body mass by mouth every 8 hours.

b) Prevention: Adults: Administered in doses similar to those used for the treatment of established infection. 400 mg may be given every 8 hours in the 24 hours before surgery followed postoperatively by intravenous or rectal administration until oral therapy is possible.

Children: as for treatment (a).

Method of administration: The tablets should be taken with or after food.

• Hypersensitivity to metronidazole and other imidazoles.
• Co-administration with busulfan (see section 4.4).

• Patients should be advised not to take alcohol during NIDASALL therapy and for at least one to three days afterwards because of the possibility of a disulfiram-like reaction (see section 4.5).
• 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 NIDASALL.
• Studies have shown NIDASALL to be mutagenic in bacteria and carcinogenic in some animals.
• NIDASALL should be administered with caution to patients with hepatic encephalopathy.
• NIDASALL 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 NIDASALL 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.
• NIDASALL has anti-treponemal activity and may mask the immunological response seen in untreated early syphilis; contacts of syphilis receiving NIDASALL should probably be screened for an additional 4 to 8 weeks.
• Patients should be warned that NIDASALL may darken urine (due to metronidazole metabolite).
• NIDASALL film-coated tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take NIDASALL.

• Disulfiram: Acute psychoses or confusion have been associated with the concomitant use of NIDASALL and disulfiram.
• Alcohol: When given in conjunction with alcohol, NIDASALL 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, pallor 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 section 4.4).
• 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 NIDASALL.
• Lithium: Plasma levels of lithium may be increased by NIDASALL. Plasma concentrations of lithium, creatinine and electrolytes should be monitored in patients under treatment with lithium while they receive NIDASALL.
• 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 NIDASALL. Plasma concentrations of NIDASALL are decreased by the concomitant administration of phenobarbital, with a consequent reduction in the effectiveness of NIDASALL.
• 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 NIDASALL, which may lead to severe busulfan toxicity and death (see section 4.3 and 4.4).
• Cimetidine: Hepatic metabolism may be decreased when NIDASALL and cimetidine are used concurrently, possibly resulting in delayed elimination and increased serum metronidazole concentrations with an increased risk of neurological side effects.

• Pregnancy: Safety in pregnancy and lactation has not been established.
• Breastfeeding: NIDASALL crosses the placental barrier and is excreted in breast milk. Women using NIDASALL should not breastfeed their infants.

Patients should be warned about the potential for confusion, dizziness, hallucinations, convulsions or eye disorders (see section 4.8), and advised not to drive or operate machinery if these symptoms occur.

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 dysarthria, 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 NIDASALL or prolonged treatment

Eye disorders:

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

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 NIDASALL in combination with other antibiotic medication

Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are requested to report any suspected adverse drug reactions to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website.

Treatment is symptomatic and supportive.