Lagevrio 200 mg hard capsules

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, or pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

• if you are allergic to molnupiravir or any of the other ingredients of this medicine (listed in section 6).

Talk to your doctor or pharmacist before taking molnupiravir.

During treatment, if you experience an allergic reaction (such as swelling of the mouth, lips or face, difficulty in breathing or swallowing, skin rash, reddening of the skin), contact your doctor straight away as you may need urgent medical treatment.

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’.

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.

• Swallow the capsule whole with plenty of fluid (for instance a glass of water)
• This medicine can be taken with or without food.

If you take more Lagevrio than you should, contact your doctor straight away.

• It is important that you do not miss or skip doses of this medicine.
• If you forget to take a dose within 10 hours of the time it is usually taken, you should take it as soon as possible and take the next one at the usual time.
• If you forget to take a dose by more than 10 hours, you should not take the missed dose and instead take the next one at the usual time.
• Do not take a double dose to make up for a missed dose.
• If you are not sure what to do, call your doctor or pharmacist.

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 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.

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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