Lagevrio ™ Capsules

LAGEVRIO™ is an antiviral medicine that works against the virus that causes coronavirus disease 2019 (COVID-19). LAGEVRIO™ is a medicine used to treat mild to moderate COVID-19 in adults who do not currently need oxygen due to COVID-19 and are at risk for progressing to severe illness. Your healthcare provider has recommended or given you LAGEVRIO™ (molnupiravir) for the treatment of COVID-19. LAGEVRIO™ may help people with COVID-19 stay out of the hospital and feel better.

Do not take LAGEVRIO ™ if:

• you are allergic to molnupiravir or any of the other ingredients of LAGEVRIO ™ (listed in section 6).

2.1 What should I tell my doctor before and while taking LAGEVRIO™ ?

Tell your healthcare provider about all of your medical conditions, including if you:

• are pregnant or plan to become pregnant.
• are breastfeeding or plan to breastfeed.
• have any allergies.
• have any serious illnesses.
• are taking any medicines (prescription, over-the-counter, vitamins, or herbal products)

Other medicines and LAGEVRIO™

Always tell your health care provider if you are taking other medicines. (This includes complementary or traditional medicines).

2.2 Pregnancy

• Your doctor will advise you regarding the safety of LAGEVRIO ™ during pregnancy.
• LAGEVRIO™ has not been studied in pregnancy and it is not known if LAGEVRIO™ will harm your baby while you are pregnant.
• LAGEVRIO™ is not recommended in pregnancy.
• If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice.
• If you can become pregnant, you should use effective birth control while you are taking LAGEVRIO™ and for 4 days after stopping.

2.3 Breastfeeding

• Do not breastfeed your child if you are taking LAGEVRIO™ and for 4 days after the last dose of LAGEVRIO™.
• It is not known if LAGEVRIO™ gets into breast milk and will be passed to the baby.
• If you are breastfeeding or are planning to breastfeed, tell your doctor before taking LAGEVRIO™.

Driving and using machines

Some patients have reported dizziness during treatment with LAGEVRIO™. If you experience this effect, do not drive or use machines until the effect wears off (see Section 4, possible side effects).

Do not share medicines prescribed for you with any other person. Always take LAGEVRIO™ exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Take 4 capsules of LAGEVRIO™ every 12 hours (for example, at 8 am and at 8 pm). Take LAGEVRIO™ for 5 days.

Take LAGEVRIO™ with or without food.

Do not open, break, or crush the capsules. If you cannot swallow capsules whole, tell your healthcare provider.

3.1 If you take more LAGEVRIO™ than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

3.2 If you forget to take LAGEVRIO™

• It is important that you do not miss or skip doses of this medicine.
• What to do if you miss a dose:
1. If it has been less than 10 hours since the missed dose, take it as soon as you remember
2. If it has been more than 10 hours since the missed dose, skip the missed dose and take your dose at the next scheduled time.
• Do not double the dose of LAGEVRIO™ to make up for a missed dose.
• If you are not sure what to do, call your doctor or pharmacist.

LAGEVRIO™ can cause side effects. Not all side effects reported for LAGEVRIO are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking LAGEVRIO please consult your doctor, pharmacist or other healthcare professional for advice.

If any of the following happens, stop taking LAGEVRIO ™ and tell your doctor immediately or go to the casualty department at your nearest hospital:

• allergic reaction (hypersensitivity) – the signs may include wheezing, difficulty breathing, rashes or hives, itchiness, swelling. These are all very serious side effects. If you have them, you may have had a serious reaction to LAGEVRIO ™. You may need urgent medical attention or hospitalisation.

The most common side effects of LAGEVRIO™ in adults are:

• diarrhoea
• dizziness
• nausea
• headache

Tell your healthcare provider about these side effects or any other unusual symptoms that develop after you receive LAGEVRIO™. There may be side effects that are not listed here. Ask your healthcare provider for more information. If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of LAGEVRIO™.

Store LAGEVRIO TM in the original bottle. Store at or below 25 °C. Store all medicines out of the reach of children. Do not use after the expiry date stated on the label.