NORMICRON

Posology 200 mg every 8 hours for three days (total 9 doses). 4). Rifaximin can be administered with or without food. Paediatric population The safety and efficacy of Normicron 200 mg film-coated tablets in children (aged less than 18 years) have not been established.

Elderly No dosage adjustment is necessary as the safety and efficacy data of Normicron 200 mg film-coated tablets showed no differences between the elderly and the younger patients. 2). 2). Method of administration Orally with a glass of water.

Summary of safety profile Severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in association with rifaximin treatment. 4). In clinical studies in subjects who received rifaximin for treatment of travellers’ diarrhoea, Adverse reactions considered as being at least possibly related to rifaximin have been categorised by organ system and frequency.

Post-marketing experience During post-approval use of rifaximin further undesirable effects have been reported. The frequency of these reactions is not known (cannot be estimated from the available data).

Frequency categories are defined using the following convention:

Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000), Not known (frequency cannot be estimated from the available data). MedDRA System Organ Class Common Uncommon Frequency not Known Infections and infestations Candidiasis, Herpes simplex, Nasopharyngitis, Pharyngitis, Upper respiratory tract infection Clostridial infections Blood and lymphatic system disorders Lymphocytosis, Monocytosis, Neutropenia Thrombocytopenia Immune system disorders Anaphylactic reactions, Hypersensitivity Metabolism and nutrition disorders Decreased appetite, Dehydration Psychiatric disorders Abnormal dreams, Depressed mood, Insomnia, Nervousness Nervous system disorders Dizziness, Headache Hypoesthesia, Migraine, Paraesthesia, Sinus headache, Somnolence Presyncope Eye disorders Diplopia Ear and labyrinth disorders Ear pain, Vertigo Cardiac disorders Palpitations Vascular disorders Blood pressure increased, Hot flush Respiratory, thoracic, and mediastinal disorders Cough, Dry throat, Dyspnoea, Nasal congestion, Oropharyngeal pain, Rhinorrhea Gastrointestinal disorders Abdominal pain, Constipation, Defecation urgency, Diarrhoea, Flatulence, Abdominal distension, Nausea, Abdominal pain upper, Dry lips, Dyspepsia, Gastrointestinal motility disorder, Faeces hard, Haematochezia, Mucous stools, Taste disorders Hepatobiliary disorders Aspartate aminotransferase increased Liver function test abnormalities Skin and subcutaneous tissue disorders Rashes, Eruptions and exanthemas, Sunburn Stevens-Johnson syndrome (SJS) Toxic epidermal Necrolysis(TEN) Angioedemas Dermatitis Dermatitis exfoliative Eczema Erythemas Pruritus Purpura Urticarias Musculoskeletal and connective tissue disorders Back pain, Muscle spasms, Muscular weakness, Myalgia, Neck pain, Renal and urinary disorders Blood in urine, Glycosuria, Pollakiuria, Polyuria, Proteinuria Reproductive system and breast disorders Polymenorrhoea General disorders and administration site conditions Pyrexia Asthenic conditions, Chills, Cold sweat, Hyperhidrosis, Influenza like illness, Oedema peripheral, Pain and discomfort Investigations International normalised ratio abnormalities Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

Severe skin reactions Severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), which can be life-threatening or fatal, have been reported [frequency unknown] in association with rifaximin treatment.

Most of the cases were reported in patients with liver disease (such as cirrhosis or hepatitis). At the time of prescription patients should be advised of the signs and symptoms and monitored closely for skin reactions. If signs and symptoms suggestive of these reactions appear, rifaximin should be withdrawn immediately and an alternative treatment considered (as appropriate).

If the patient has developed a serious reaction such as SJS or TEN with the use of rifaximin, treatment with rifaximin must not be restarted in this patient at any time. Clinical data have shown that rifaximin is not effective in the treatment of traveller’s diarrhoea caused by invasive enteric pathogens such as Campylobacter jejuni, Salmonella spp.

and Shigella spp, which typically produce dysentery-like diarrhoea characterised by fever, blood in the stool and high stool frequency. If symptoms worsen treatment with rifaximin should be interrupted. If symptoms have not resolved after 3 days of treatment, or recur shortly afterwards, a second course of rifaximin should not be administered.

Clostridioides difficile associated diarrhoea (CDAD) has been reported with use of nearly all antibacterial agents, including rifaximin. The potential association of rifaximin treatment with CDAD and pseudomembranous colitis (PMC) cannot be ruled out.

Patients should be informed that despite the negligible absorption of the drug (less than 1%), like all rifamycin derivatives, rifaximin may cause a reddish discolouration of the urine. 5). Both decreases and increases in international normalized ratio (in some cases with bleeding events) have been reported in patients maintained on warfarin and prescribed rifaximin.

g. 1). Cases of intestinal obstruction.