This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
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Lagevrio 200 mg hard capsules
Lagevrio® 200 mg hard capsules
▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
1. What Lagevrio is and what it is used for
2. What you need to know before you take Lagevrio
3. How to take Lagevrio
4. Possible side effects
5. How to store Lagevrio
6. Contents of the pack and other information
Lagevrio contains the active substance molnupiravir. Lagevrio is an antiviral medicine used to treat mild to moderate COVID-19 (caused by SARS-CoV-2) in adults who are at risk for developing severe illness.
Lagevrio may help people with COVID-19 stay out of the hospital and feel better.
Talk to your doctor or pharmacist before taking molnupiravir.
Do not give this medicine to children and adolescents aged less than 18 years. The use of Lagevrio in persons aged less than 18 years has not yet been studied.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Animal studies with molnupiravir have shown harmful effects to the unborn animal. Lagevrio is not recommended in pregnancy. Lagevrio has not been studied in pregnancy and it is not known if Lagevrio will harm your baby while you are pregnant.
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 the last dose of Lagevrio.
If you are breast-feeding or are planning to breastfeed, tell your doctor before taking this medicine. Breast-feeding is not recommended during treatment and for 4 days after the last dose of Lagevrio. This is because it is not known if Lagevrio gets into breast milk and will be passed to the baby.
No studies on the effects on the ability to drive and use machines have been performed.
This medicine contains less than 1 mmol sodium (23 mg) per dose of 4 capsules, that is to say essentially ‘sodium-free’.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
You should start Lagevrio within 5 days of the onset of COVID-19 symptoms.
The recommended dose of Lagevrio is four 200 mg capsules, every 12 hours for 5 days. It is important that you complete the full 5 days of treatment with molnupiravir. Do not stop taking molnupiravir before you complete the full 5 days of treatment, even if you feel better.
If you take more Lagevrio than you should, contact your doctor straight away.
Do not stop taking Lagevrio without talking to your doctor first. This will give the medicine the best chance to keep you from becoming severely ill from COVID-19.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Coronavirus Yellow Card Reporting site at https://coronavirus-yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and bottle label after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special temperature storage conditions. Store in the original package.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
The active substance is molnupiravir. Each hard capsule contains 200 mg of molnupiravir.
The other ingredients are:
Capsule content: Croscarmellose sodium (E468), hydroxypropyl cellulose (E463), magnesium stearate (E470b), microcrystalline cellulose (E460).
Capsule shell: Hypromellose (E464), titanium dioxide (E171), red iron oxide (E172).
Printing ink: Butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol (E1520), purified water, shellac, strong ammonia solution, and titanium dioxide (E171).
Lagevrio 200 mg hard capsule is a Swedish Orange opaque, size 0 (approximately 21.7 mm x 7.6 mm) hard capsule, printed with MSD corporate logo on the cap and “82” on the body in white ink.
Lagevrio 200 mg hard capsules are supplied in high-density polyethylene (HDPE) bottles with a polypropylene cap containing 40 capsules.
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This leaflet was last revised in January 2023
This medicine has been given ‘conditional approval’. This means that there is more evidence to come about this medicine.
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