LAGEVRIO

Posology Adults The recommended dose of Lagevrio is 800 mg (four 200 mg capsules) taken orally every 12 hours for 5 days. 1). 1). Missed dose If the patient misses a dose of Lagevrio within 10 hours of the time it is usually taken, the patient should take as soon as possible and resume the normal dosing schedule.

If a patient misses a dose by more than 10 hours, the patient should not take the missed dose and instead take the next dose at the regularly scheduled time. The patient should not double the dose to make up for a missed dose. 2). 2).

2). Paediatric population The safety and efficacy of Lagevrio in patients below 18 years of age have not been established. 1). Method of administration For oral use. Lagevrio 200 mg capsules can be taken with or without food. , a glass of water).

The capsules should not be opened, crushed or chewed.

Summary of safety profile Data from a Phase 3 trial of subjects with mild to moderate COVID-19 treated with molnupiravir (n=710), the most common adverse reactions (≥1% of subjects) reported during treatment and during 14 days after the last dose were diarrhoea (2%), nausea (1%) and dizziness (1%) all of which were Grade 1 (mild) or Grade 2 (moderate).

Tabulated list of adverse reactions Adverse reactions in the Phase 3 trial and post marketing experience are listed below by system organ class and frequency.

Frequencies are defined as follows:

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).

Table 1:

Tabulated list of adverse reactions Frequency Adverse Reaction Immune System Disorders Uncommon hypersensitivity Nervous system disorders Common dizziness Uncommon headache Gastrointestinal disorders Common diarrhoea, nausea Uncommon vomiting Skin and subcutaneous tissue disorders Uncommon angioedema, erythema, rash, urticaria, pruritus 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/ or search for MHRA Yellow Card in the Google Play or Apple App Store.

8). If signs or symptoms of a clinically significant hypersensitivity reaction occur, immediately discontinue Lagevrio and initiate appropriate medications and/or supportive care. Sodium This medicinal product contains less than 1 mmol sodium (23 mg) per dose of 4 capsules, that is to say essentially ‘sodium-free’.

1.