Unknown: Shock, flushing, vasculitis

Respiratory, thoracic and mediastinal disorders

Unknown: Dyspnoea, wheezing, sputum discoloured

Gastrointestinal disorders

Common: Nausea, vomiting

Uncommon: Diarrhea

Unknown: Gastrointestinal disorder, abdominal discomfort

Hepatobiliary disorders

Unknown: Hepatitis, hyperbilirubinaemia (see section 4.4: Special warnings and precautions for use)

Skin and subcutaneous tissue disorders

Unknown: Erythema multiforme including Stevens-Johnson syndrome and toxic epidermal necrolysis, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome (See section 4.4), skin reaction, pruritus, rash pruritic, urticaria, dermatitis allergic, pemphigoid, sweat discoloration.

Musculoskeletal and connective tissue disorders

Unknown: Muscle weakness, myopathy, bone pain

Renal and urinary disorders

Unknown: acute kidney injury usually due to renal tubular necrosis or tubulointerstitial nephritis, chromaturia

Pregnancy, puerperium and perinatal conditions

Unknown: Post-partum haemorrhage, fetal-maternal haemorrhage

Reproductive system and breast disorders

Unknown: Menstrual disorder

Congenital, familial and genetic disorders

Unknown: Porphyria

General disorders and administration site conditions

Unknown: Edema

Investigations

Common: Blood bilirubin increased, aspartate aminotransferase increased, alanine aminotransferase increased

Unknown: Blood pressure decreased, blood creatinine increased, hepatic enzyme increased

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. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
4.9 Overdose
Human Experience

• Signs and Symptoms:

Nausea, vomiting, abdominal pain, pruritus, headache and increasing lethargy will probably occur within a short time after acute ingestion; unconsciousness may occur when there is severe hepatic disease. Transient increases in liver enzymes and/or bilirubin may occur. Brownish-red or orange colouration of the skin, urine, sweat, saliva, tears and faeces will occur, and its intensity is proportional to the amount ingested. Facial or periorbital oedema has also been reported in paediatric patients. Hypotension, sinus tachycardia, ventricular arrhythmias, seizures and cardiac arrest were reported in some fatal cases.

The minimum acute lethal or toxic dose is not well established. However, nonfatal acute overdoses in adults have been reported with doses ranging from 9 to 12 g rifampicin. Fatal acute overdoses in adults have been reported with doses ranging from 14-60 g. Alcohol or a history of alcohol abuse was involved in some of the fatal and nonfatal reports.

Nonfatal overdoses in paediatric patients ages 1 to 4 years old of 100 mg/kg for one to two doses have been reported.

• Management:

Intensive supportive measures should be instituted and individual symptoms treated as they arise. Since nausea and vomiting are likely to be present, gastric lavage is probably preferable to induction of emesis. Following evacuation of the gastr