Tarlige | Adverse Reactions

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Full Prescribing Info

Adverse Reactions

Summary of the safety profile: The safety profile of TARLIGE is based on three Phase 3 and one Phase 2 studies (854 patients with diabetic peripheral neuropathic pain, 553 patients with postherpetic neuralgia and 306 patients with central neuropathic pain), and from post-authorisation experience.
The most commonly reported adverse reactions associated with TARLIGE treatment in clinical trials are somnolence (16.8%), dizziness (9.7%) and oedema (7.5%).
Tabulated list of adverse reactions: Adverse reactions from TARLIGE in clinical trials, post-authorisation safety studies and spontaneous reporting are summarized in Table 9.
The following terminologies have been used in order to classify the occurrence of adverse reactions: 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 (cannot be estimated from the available data). (See Table 9.)

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Tarlige Adverse Reactions

Manufacturer:

Daiichi Sankyo Thailand

Distributor:

Zuellig Pharma

Marketer:

Daiichi Sankyo Thailand