Source: Registered Drug Product Database (NG) Publisher: Applicant (MAH): ORANGE DRUGS LIMITED, 66/68 Town Planning Way, Ilupeju, Lagos, Nigeria, Phone.: +2348036005454, Email: eojukwu@orangegroups.com Manufactured by: PT. Dankos Farma, Jl. Rawa Gatel Blok III S, Kav. 36-38, Kawasan Industri Pulo Gadung, Jakarta 13930 - Indonesia
A large amount of data on pregnant women indicate neither malformative, nor feto/neonatal toxicity. Epidemiological studies on neurodevelopment in children exposed to paracetamol in utero show inconclusive results. If clinically needed, paracetamol can be used during pregnancy however it should be used at the lowest effective dose for the shortest possible time and at the lowest possible frequency.
Paracetamol is excreted in breast milk but not in a clinically significant amount.
Not to be used during lactation unless considered essential by a physician.
No adverse effects known.
Paracetamol may cause hepatotoxic effect.
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.
None.
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