Paxlovid 150 mg/100 mg Film-Coated Tablets

PAXLOVID is an antiviral medicine used for treating mild-to-moderate COVID-19. COVID-19 is caused by a virus. PAXLOVID stops the virus multiplying in cells and this stops the virus multiplying in the body. This can help your body to overcome the virus infection, and may help you get better faster. PAXLOVID contains the active substances nirmatrelvir and ritonavir. Nirmatrelvir is active against the virus that causes COVID-19. Ritonavir prolongs the therapeutic effect of nirmatrelvir. PAXLOVID is used in adults 18 years of age and older with mild-to-moderate COVID-19. It is only used in patients who are at high risk for progression to severe COVID-19, including hospitalisation or death. You must talk to a health care provider if you do not feel better or if you feel worse while on treatment with PAXLOVID.

Do not take PAXLOVID:

• if you are hypersensitive (allergic) to nirmatrelvir, ritonavir or any of the other ingredients of PAXLOVID (listed in section 6)
• if you have severe liver disease
• if you have severe kidney disease
• if you are taking any of the following medicines. Taking PAXLOVID with these medicines may cause serious or life-threatening side effects or affect how PAXLOVID works:

• alfuzosin (used to treat symptoms of an enlarged prostate)
• pethidine, piroxicam, propoxyphene (used to relieve pain)
• ranolazine (used to treat chronic chest pain [angina])
• neratinib, venetoclax (used to treat cancer)
• amiodarone, bepridil, dronedarone, encainide, flecainide, propafenone, quinidine (used to treat heart conditions and correct irregular heartbeats)
• fusidic acid (used to treat bacterial infections)
• colchicine (used to treat gout)
• astemizole, terfenadine (used to treat allergies)
• lurasidone (used to treat depression)
• pimozide, clozapine, quetiapine (used to treat schizophrenia, bipolar disorder, severe depression and abnormal thoughts or feelings)
• dihydroergotamine and ergotamine (used to treat migraine headaches)
• ergonovine, methylergonovine (used to stop excessive bleeding that may occur following childbirth or an abortion)
• cisapride (used to relieve certain stomach problems)
• lovastatin, simvastatin, lomitapide (used to lower blood cholesterol)
• avanafil, vardenafil (used to treat erectile dysfunction [also known as impotence])
• sildenafil (Revatio®) used to treat pulmonary arterial hypertension (high blood pressure in the pulmonary artery)
• clonazepam, diazepam, estazolam, flurazepam, triazolam, midazolam taken orally (used to relieve anxiety and/or trouble sleeping)
• carbamazepine, phenobarbital, phenytoin (used to prevent and control seizures)
• rifampin (used to treat tuberculosis)
• St. John’s Wort (Hypericum perforatum) (a herbal remedy used for depression and anxiety)

Warnings and precautions

Take special care with PAXLOVID: PAXLOVID treatment may result in medicines used to treat HIV becoming less effective. Liver disease Tell your health care provider if you have or have had a liver disease. Do not take PAXLOVID if you have severe liver disease.

Children and adolescents

Do not give PAXLOVID to children and adolescents under 18 years. PAXLOVID has not been studied in children and adolescents.

Other medicines and PAXLOVID

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) There are other medicines that may not be taken together with PAXLOVID. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Please tell your doctor if you are taking oral contraceptive pills as you may need to take extra contraceptive precautions such as using a condom (see below ‘Pregnancy, breast-feeding and fertility’).

Do not share medicines prescribed for you with any other person. Always take PAXLOVID exactly as your doctor has told you. You should check with your doctor or pharmacist if you are unsure. If you have kidney disease, please talk to your health care provider for an appropriate dose of PAXLOVID. If you have moderate kidney disease you will need a lower dose of PAXLOVID. If you have severe kidney disease you must not take PAXLOVID.

PAXLOVID consists of 2 medicines: nirmatrelvir and ritonavir. The recommended dose is 2 tablets of nirmatrelvir with 1 tablet of ritonavir by mouth twice daily (in the morning and at night). The blister foil for each day of treatment is divided in two different coloured sections to indicate which tablets need to be taken at each time of day – one side for the morning (AM) dose and the other side for the evening (PM) dose. A course of treatment lasts 5 days. For each dose, take all 3 tablets together at the same time. Swallow the tablets whole. Do not chew, break or crush the tablets. PAXLOVID can be taken with or without meals.

If you take more PAXLOVID than you should

If you take too much PAXLOVID, call your health care provider or go to the nearest hospital emergency room right away.

If you forget to take PAXLOVID

If you forget to take a dose of PAXLOVID, take it as soon as you remember. If more than 8 hours have passed since your missed dose, then do not take the missed dose and just carry on as before. Do not take a double dose to make up for a forgotten dose.

If you stop taking PAXLOVID

Even if you feel better, do not stop taking PAXLOVID without talking to your doctor. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

PAXLOVID can have side effects. Not all side effects reported for PAXLOVID are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking PAXLOVID, please consult your health care provider for advice. Tell your doctor if you notice the following:

Frequent side effects

• Altered sense of taste
• Diarrhoea
• Vomiting

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. 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 PAXLOVID.

• Store all medicines out of reach of children.
• Store at or below 25 °C.
• Do not refrigerate or freeze.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).