Zeffix Adverse Reactions

Summary of the Safety Profile: The incidence of adverse reactions and laboratory abnormalities (with the exception of elevations of ALT and CPK, see Table 4) were similar between placebo and lamivudine treated patients. The most common adverse reactions reported were malaise and fatigue, respiratory tract infections, throat and tonsil discomfort, headache, abdominal discomfort and pain, nausea, vomiting and diarrhoea.
Tabulated List of Adverse Reactions: Adverse reactions are listed as follows by system organ class and frequency. Frequency categories are only assigned to those adverse reactions considered to be at least possibly causally related to lamivudine. Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
The frequency categories assigned to the adverse reactions are mainly based on experience from clinical trials including a total of 1,171 patients with chronic hepatitis B receiving lamivudine at 100 mg. (See Table 4.)

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Paediatric Population: Based on limited data in children aged 2 to 17 years, there were no new safety issues identified compared to adults.
Other Special Populations: In patients with HIV infection, cases of pancreatitis and peripheral neuropathy (or paresthesia) have been reported. In patients with chronic hepatitis B there was no observed difference in incidence of these events between placebo and lamivudine treated patients.
Cases of lactic acidosis, sometimes fatal, usually associated with severe hepatomegaly and hepatic steatosis, have been reported with the use of combination nucleoside analogue therapy in patients with HIV. There have been rare reports of lactic acidosis in patients receiving lamivudine for hepatitis B.
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.