RIFAXIMIN

2). 1). Rifaximin 550mg can be administered with or without food. Paediatric population The safety and efficacy of Rifaximin 550mg in paediatric patients (aged less than 18 years) have not been established. Elderly No dosage adjustment is necessary as the safety and efficacy data of Rifaximin 550mg showed no differences between the elderly and the younger patients.

4). 2). Method of administration Orally with a glass of water.

4).

Clinical Trials:

The safety of rifaximin in patients in remission from hepatic encephalopathy (HE) was evaluated in two studies, a randomised, double-blind, placebo-controlled phase 3 study RFHE3001 and a long-term, open-label study RFHE3002. 5 days.

In addition, in three supportive studies 152 HE patients were treated with varying doses of rifaximin from 600 mg to 2400 mg per day for up to 14 days. All adverse reactions that occurred in patients treated with rifaximin at an incidence ≥ 5% and at a higher incidence (≥1%) than placebo patients in RFHE3001 are reported in the following table.

Table 1:

Adverse reactions occurring in ≥ 5% of patients receiving rifaximin and at a higher incidence than placebo in RFHE3001. 0 Table 2 includes adverse reactions observed in the placebo-controlled study RFHE3001, long term study RFHE3002 and from post-marketing experience, listed by MedDRA system organ class and frequency category.

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). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

Table 2:

Adverse reactions listed by MedDRA system organ class and frequency category. MedDRA System Organ Class Common Uncommon Rare Not known Infections and infestations Clostridial infection, urinary tract infection, candidiasis Pneumonia, cellulitis, upper respiratory tract infections, rhinitis Blood and lymphatic system disorders Anaemia Thrombocytopenia Immune system disorders Anaphylactic reactions, angioedemas, hypersensitivity Metabolism and nutrition disorders Anorexia, hyperkalaemia Dehydration Psychiatric disorders Depression Confusional state, anxiety, hypersomnia, insomnia Nervous system disorders Dizziness, headache Balance disorders, amnesia, convulsion, attention disorders, hypoesthesia, memory impairment Vascular disorders Hot flush Hypertension, hypotension Presyncope, syncope Respiratory, thoracic, and mediastinal disorders Dyspnoea Pleural effusion Chronic obstructive pulmonary disease Gastrointestinal disorders Abdominal pain upper, abdominal distension, diarrhoea, nausea, vomiting, ascites Abdominal pain, oesophageal varices haemorrhage, dry mouth, stomach discomfort Constipation Hepatobiliary disorders Liver function tests abnormalities Skin and subcutaneous tissue disorders Rashes, pruritus Stevens-Johnson syndrome(SJS), Toxic epidermal necrolysis(TEN), Dermatitis, eczema Musculoskeletal and connective tissue disorders Muscle spasms, arthralgia Myalgia Back pain MedDRA System Organ Class Common Uncommon Rare Not known Renal and urinary disorders Dysuria, pollakiuria Proteinuria, General disorders and administration site conditions Oedema peripheral Oedema, pyrexia Asthenia Investigations International normalised ratio abnormalities Injury, poisoning and procedural complications Fall Contusions, procedural pain Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Severe skin reactions Severe cutaneous adverse reactions (SCAR) 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. 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.

Clostridium 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.

Due to the lack of data and the potential for severe disruption of gut flora with unknown consequences, concomitant administration of rifaximin with other rifamycins is not recommended. 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.

2). 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. If co-administration is necessary, the international normalized ratio should be carefully monitored with the addition or withdrawal of treatment with rifaximin.

5). This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

1. • Cases of intestinal obstruction.