Molnupiravir Capsules

MOLNUPIRAVIR 200 DRL contains the active substance molnupiravir. MOLNUPIRAVIR 200 DRL 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. MOLNUPIRAVIR 200 DRL may help people with COVID - 19 stay out of the hospital and feel better.

What is COVID - 19?

COVID - 19 is caused by a virus called SARS CoV - 2. You can get COVID - 19 through contact with another person who has the virus. COVID - 19 illnesses have ranged from very mild (including some with no reported symptoms) to severe, including illness resulting in death. While information so far suggests that most COVID - 19 illness is mild, serious illness, including breathing problems, can happen and may cause some of your other medical conditions to become worse. Older people and people of all ages with severe, long lasting (chronic) medical conditions like heart disease, lung disease and diabetes, for example seem to be at higher risk of being hospitalized for COVID - 19.

What are the Symptoms of COVID - 19?

The symptoms of COVID - 19 may include fever, cough, and shortness of breath.

Do not take MOLNUPIRAVIR 200 DRL:

• if you are allergic (hypersensitive) to molnupiravir or any of the other ingredients of MOLNUPIRAVIR 200 DRL (listed in section 6).

Warnings and precautions

Tell your healthcare provider about all our 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).

Children and adolescents

Do not give MOLNUPIRAVIR 200 DRL to children and adolescents aged less than 18 years. The use of MOLNUPIRAVIR 200 DRL in persons aged less than 18 years has not yet been studied.

Other medicines and MOLNUPIRAVIR 200 DRL

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

MOLNUPIRAVIR 200 DRL with food and drink

MOLNUPIRAVIR 200 DRL may be taken with or without food. It is advised not to drink alcohol while you are taking MOLNUPIRAVIR 200 DRL.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking MOLNUPIRAVIR 200 DRL. MOLNUPIRAVIR 200 DRL has not been studied in pregnancy and it is not known if MOLNUPIRAVIR 200 DRL will harm your baby while you are pregnant. MOLNUPIRAVIR 200 DRL is not recommended in pregnancy. If you can become pregnant, you should use effective birth control while you are taking MOLNUPIRAVIR 200 DRL and for 4 days after the last dose of MOLNUPIRAVIR 200 DRL. If you are breastfeeding or are planning to breastfeed, tell your doctor before taking this medicine. Breastfeeding is not recommended during treatment and for 4 days after the last dose of MOLNUPIRAVIR 200 DRL. This is because it is not known if MOLNUPIRAVIR 200 DRL gets into breast milk and will be passed to the baby.

Driving and using machines

It is not always possible to predict to what extent MOLNUPIRAVIR 200 DRL may interfere with the daily activities of a patient. Patients should ensure that they do not engage in the above activities until they are aware of the measure to which MOLNUPIRAVIR 200 DRL affects them. Some patients have reported dizziness during treatment with MOLNUPIRAVIR 200 DRL. 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 MOLNUPIRAVIR 200 DRL exactly as your doctor has told you. Check with your doctor if you are not sure. Your doctor will determine what dose is appropriate for you. You should start MOLNUPIRAVIR 200 DRL within 5 days of the onset of COVID - 19 symptoms.

How much to take:

The recommended dose is: four 200 mg capsules, every 12 hours for 5 days.

How to take:

• Swallow the capsule whole with plenty of fluid (for instance a glass of water)
• Do not open, break, or crush the capsules.
• This medicine can be taken with or without food.

If you have the impression that the effect of MOLNUPIRAVIR 200 DRL is too strong or too weak, tell your doctor or pharmacist.

If you take more MOLNUPIRAVIR 200 DRL than you should

If you take more MOLNUPIRAVIR 200 DRL than you should, contact your doctor or pharmacist straight away. If neither is available, contact the nearest hospital or poison centre.

If you forget to take MOLNUPIRAVIR 200 DRL

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 MOLNUPIRAVIR 200 DRL without talking to your doctor first.

MOLNUPIRAVIR 200 DRL can have side effects. Not all side effects reported for MOLNUPIRAVIR 200 DRL are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking MOLNUPIRAVIR 200 DRL, please consult your doctor, pharmacist or other healthcare professional for advice.

If any of the following happens, stop taking MOLNUPIRAVIR 200 DRL 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 MOLNUPIRAVIR 200 DRL. You may need urgent medical attention or hospitalisation.

The frequent side effects are:

• feeling dizzy
• headache
• loose or runny stools (diarrhoea)
• feeling sick (nausea)

The less frequent side effects are:

• throwing up (vomiting)
• swelling of the skin
• skin redness
• rash
• hives

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, 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 MOLNUPIRAVIR 200 DRL.

Store at or below 30 °C. Store all medicines out of reach of children. Do not use after the expiry date stated on the carton and blister labels. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets).