Patient Information Leaflet for Paxlovid – GOV.UK

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Updated 11 January 2022

© Crown copyright 2022
This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: psi@nationalarchives.gov.uk.
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This publication is available at https://www.gov.uk/government/publications/regulatory-approval-of-paxlovid/patient-information-leaflet-for-paxlovid
Paxlovid 150 mg/100 mg film-coated tablets
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.
Keep this leaflet. You may need to read it again.
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 PF-07321332 and ritonavir. PF-07321332 is active against the virus that causes COVID-19. Ritonavir prolongs the therapeutic effect of PF-07321332.
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 doctor if you do not feel better or if you feel worse while on treatment with Paxlovid.
Do not take Paxlovid:
Paxlovid treatment may result in medicines used to treat HIV becoming less effective.
Tell your healthcare provider if you have or have had a liver disease. Do not take Paxlovid if you have severe liver disease.
Do not give Paxlovid to children and adolescents under 18 years because Paxlovid has not been studied in children and adolescents.
There are other medicines that may not mix with Paxlovid. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including prescription and over the counter medicines, vitamins and herbal supplements.
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’).
In particular, you should inform your doctor or pharmacist if you are taking any of the following:
Many medicines interact with Paxlovid. Keep a list of your medicines to show your doctor and pharmacist. Do not start taking a new medicine without telling your doctor. Your doctor can tell you if it is safe to take Paxlovid with other medicines.
Paxlovid is not recommended during pregnancy. There is not enough information to be sure that Paxlovid is safe for use in pregnancy and it is not known if Paxlovid 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, it is recommended that you refrain from sexual activity or use effective barrier contraception while taking Paxlovid and until after one full menstrual cycle is completed after stopping Paxlovid treatment.
If you are breast-feeding or are planning to breastfeed, tell your healthcare provider before taking this medicine. Breast-feeding is not recommended during treatment and for 7 days after the last dose of Paxlovid. This is because it is not known if Paxlovid gets into breast milk and will be passed to the baby.
Paxlovid has not been specifically tested for its possible effects on the ability to drive a car or operate machines.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
This medicine contains less than 1 mmol sodium (23 mg) per dose, 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.
If you have kidney disease, please talk to your healthcare 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: PF-07321332 and ritonavir. The recommended dose is 2 tablets of PF-07321332 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.
Paxlovid is not used to treat children and adolescents (under 18 years old).
If you take too much Paxlovid, call your healthcare provider or go to the nearest hospital emergency room right away.
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.
Even if you feel better, do not stop taking Paxlovid without talking to your healthcare provider.
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. Not many people have taken Paxlovid. Serious and unexpected side effects may happen. Paxlovid is still being studied, so it is possible that all of the risks are not known at this time.
If you get any side effects, talk to your doctor or pharmacist. 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 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 or the blister after ‘EXP’. The expiry date refers to the last day of that month.
Store below 25 °C.
Do not refrigerate or freeze.
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 protect the environment.
Paxlovid tablets are available in 5 daily dose blister cards with a total of 30 tablets packaged in a carton.
Each daily blister card contains 4 PF-07321332 tablets (150 mg each) and 2 ritonavir tablets (100 mg each) and indicates which tablets need to be taken in the morning and evening.
PF 07321332 150 mg film-coated tablets are pink, oval-shaped and debossed with ‘PFE’ on one side and ‘3CL’ on the other side.
Ritonavir 100 mg film-coated tablets are white to off white, capsule shaped and debossed with ‘H’ on one side and ‘R9’ on the other side.
Pfizer Limited Ramsgate Road Sandwich, Kent CT13 9NJ United Kingdom
Pfizer Manufacturing Deutschland GmbH
Betriebsstätte Freiburg
Mooswaldallee 1
79090 Freiburg
Germany

Pfizer Italia S.r.l.
Localita Marino del Tronto
631000 Ascoli, Piceno
Italy

For any information about this medicine, please contact:
Medical Information,
Pfizer Ltd,
Walton Oaks,
Dorking Road,
Tadworth, Surrey,
KT20 7NS.
Telephone 01304 616161.

This medicine has been given ‘conditional approval’.
This means that there is more evidence to come about this medicine.
The Agency will review new information on this medicine at least every year and this leaflet will be updated as necessary.
Ref: PX 2_0
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