PAXLOVID 150 mg + 100 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Paxlovid 150mg+100mg film-coated tablets

nirmatrelvir + ritonavir

This medicine is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of section 4 will tell you how to report side effects.

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, you may need to read it again.

• If you have any further questions, ask your doctor or pharmacist.
• 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.

Contents of the pack

1. What is Paxlovid and what is it used for
2. What you need to know before you take Paxlovid
3. How to take Paxlovid
4. Possible side effects
5. Storage of Paxlovid
6. Contents of the pack and other information

1. What is Paxlovid and what is it used for

Paxlovid contains two active substances: nirmatrelvir and ritonavir in two different tablets. Paxlovid is an antiviral medicine used to treat adults with COVID-19 who do not require supplemental oxygen and who are at high risk of progressing to severe illness.

COVID-19 is caused by a virus called coronavirus. This medicine works by stopping the virus from multiplying in the cells and this stops the virus from multiplying in the body. This can help your body get rid of the viral infection and may prevent you from developing a severe illness.

You should consult a doctor if you do not feel better after 5 days or if you feel worse.

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2. What you need to know before you take Paxlovid

Do not take Paxlovid

• if you are allergic to nirmatrelvir, ritonavir or any of the other ingredients of this medicine (listed in section 6);
• 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 well Paxlovid works:

• Alfuzosin (used to treat symptoms of enlarged prostate).
• Ranolazine (used to treat chronic chest pain [angina]).
• Dronedarone, propafenone, quinidine (used to treat heart disease and correct irregular heartbeats).
• Rifampicin, rifapentine (used to treat bacterial infections).
• Apalutamide, enzalutamide, neratinib, venetoclax (used to treat cancer).
• Carbamazepine, phenobarbital, phenytoin, primidone (used to prevent and control seizures).
• Colchicine (used to treat gout).
• Terfenadine (used to treat allergies).
• Cariprazine and lurasidone (used to treat schizophrenia).
• Pimozide, quetiapine (used to treat schizophrenia, bipolar disorder, major depression, and abnormal thoughts or feelings).
• Silodosin (used to treat enlarged prostate).
• Eplerenone and ivabradine (used to treat heart problems and/or blood vessel problems).
• Dihydroergotamine and ergotamine (used to treat migraines).
• Ergonovine and methylergonovine (used to stop excessive bleeding that may occur after childbirth or abortion).
• Cisapride (used to relieve certain stomach problems).
• St. John's Wort (Hypericum perforatum) (a herbal remedy used for depression and anxiety).
• Voclosporin (used to treat immune system disorders).
• Lovastatin, simvastatin, lomitapide (used to lower blood cholesterol).
• Eletriptan (used to treat migraines).
• Lumacaftor/ivacaftor (used to treat cystic fibrosis).
• Finerenone (used to treat chronic kidney disease related to type 2 diabetes).
• Naloxegol (used to treat opioid-induced constipation).
• Avanafil, vardenafil (used to treat erectile dysfunction [also known as impotence]).
• Sildenafil, tadalafil (used to treat erectile dysfunction [also known as impotence] or pulmonary arterial hypertension [high blood pressure in the pulmonary artery]).
• Chlordiazepoxide, diazepam, estazolam, flurazepam, triazolam, midazolam by mouth (used to relieve anxiety and/or sleep problems).
• Tolvaptan (used to treat hyponatremia [low sodium levels in the blood]).

Warnings and precautions

Allergic reactions

Allergic reactions, including serious allergic reactions (known as “anaphylaxis”) and severe skin reactions (known as “toxic epidermal necrolysis” and “Stevens-Johnson syndrome”), can occur in people taking this medicine, even after a single dose. Stop taking this medicine and call your doctor right away if you have any of the following symptoms of an allergic reaction:

• difficulty swallowing or breathing;
• swelling of the tongue, mouth, and face;
• throat tightness;
• hoarseness;
• itching;
• rash;
• red and painful skin;
• blisters and peeling of the skin;
• blisters or sores in the mouth or on the lips.

Liver disease

Tell your doctor if you have or have had liver disease. Abnormalities of liver enzymes, hepatitis, and jaundice have occurred in patients receiving ritonavir.

Kidney disease

Tell your doctor if you have or have had kidney disease.

High blood pressure

Tell your doctor if you have high blood pressure. Your doctor may need to check your blood pressure before you take this medicine and while you are taking this medicine. Cases of high blood pressure have been reported in people taking this medicine, especially in older people.

Risk of developing HIV-1 resistance

If you have an untreated or uncontrolled HIV infection, Paxlovid may cause some HIV medicines to not work as well in the future.

Children and adolescents

Do not give this medicine to children and adolescents under 18 years of age because this medicine has not been studied in children and adolescents.

Other medicines and Paxlovid

There are other medicines that may not be taken with Paxlovid. Tell your doctor(s) or pharmacist if you are taking, have recently taken, or might take any other medicines:

• Medicines used to treat cancer, such as afatinib, abemaciclib, ceritinib, dasatinib, encorafenib, fostamatinib, ibrutinib, ivosidenib, nilotinib, vinblastine, and vincristine.
• Medicines used to thin the blood (anticoagulants), such as warfarin, rivaroxaban, dabigatran, and apixaban.
• Medicines used to treat seizures, such as divalproex, lamotrigine, and clonazepam.
• Medicines used to help stop smoking, such as bupropion.
• Medicines used to treat allergies, such as fexofenadine and loratadine.
• Medicines used to treat fungal infections (antifungals), such as itraconazole and voriconazole
• Medicines used to treat Cushing's syndrome (when the body produces too much cortisol) such as ketoconazole tablets.
• Medicines used to treat HIV infection, such as efavirenz, maraviroc, raltegravir, zidovudine, and bictegravir/emtricitabine/tenofovir.
• Medicines used to treat infections (e.g., antibiotics and antimycobacterials), such as atovaquone, clarithromycin, erythromycin, fusidic acid (by mouth or given intravenously), bedaquiline, rifabutin, delamanid, and sulfamethoxazole/trimethoprim.
• Medicines used to treat schizophrenia and abnormal thoughts or feelings, such as clozapine.
• Medicines used to treat mental or mood disorders, such as haloperidol, risperidone, and thioridazine.
• Medicines used to treat high blood pressure in the blood vessels that supply the lungs, such as bosentan and riociguat.
• Medicines used to treat high blood pressure (hypertension), such as amlodipine, diltiazem, felodipine, lercanidipine, nicardipine, nifedipine, and verapamil.
• Medicines used to treat heart and/or blood vessel problems, such as aliskiren, ticagrelor, cilostazol, and clopidogrel.
• Medicines used to treat heart disease and correct irregular heartbeats, such as digoxin, amiodarone, flecainide, and disopyramide.
• Medicines used to treat cystic fibrosis, such as ivacaftor, elexacaftor/tezacaftor/ivacaftor, and tezacaftor/ivacaftor.
• Medicines used to treat diabetes, such as saxagliptin.
• Medicines used to treat hepatitis C virus infection, such as glecaprevir/pibrentasvir and sofosbuvir/velpatasvir/voxilaprevir.
• Medicines used to lower blood cholesterol, such as atorvastatin, fluvastatin, pravastatin, and rosuvastatin.
• Medicines used to treat migraines, such as rimegepant.
• Medicines used to treat urinary incontinence, such as darifenacin and solifenacin.
• Medicines used to treat mental health problems, such as aripiprazole and brexpiprazole.
• Medicines used to suppress your immune system, such as cyclosporine, everolimus, sirolimus, and tacrolimus.
• Medicines used to treat autoimmune disorders, including rheumatoid arthritis, psoriatic arthritis, or ulcerative colitis, such as tofacitinib and upadacitinib.
• Medicines used to treat severe pain, such as morphine, fentanyl, oxycodone, methadone, buprenorphine, other morphine-like medicines, pethidine, and piroxicam.
• Medicines used as sedatives, sleep aids, and sleep inducers such as alprazolam, buspirone, and zolpidem.
• Medicines used to treat attention deficit hyperactivity disorder or a sleep disorder called narcolepsy, such as amphetamines.
• Steroids, including corticosteroids used to treat inflammation, such as budesonide, dexamethasone, fluticasone, prednisolone, and triamcinolone.
• Medicines used to treat asthma and other lung problems, such as chronic obstructive pulmonary disease (COPD), such as salmeterol and theophylline.
• Medicines used to treat depression, such as amitriptyline, fluoxetine, imipramine, nortriptyline, paroxetine, and sertraline.
• Medicines used as thyroid hormone replacement therapy, such as levothyroxine.
• Medicines used to treat enlarged prostate, such as tamsulosin.
• Any of the following specific medicines:
• Oral contraceptive or contraceptive patch with ethinylestradiol used to prevent pregnancy.
• Midazolam given by injection (used for sedation [a state of being awake but very relaxed and calm or drowsy during a medical examination or operation] or anesthesia).

Many medicines interact with Paxlovid. Keep a list of your medicines to show your doctor(s) and pharmacist. Do not start taking a new medicine without talking to your doctor(s) first. Your doctor(s) may tell you if it is safe to take Paxlovid with other medicines.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

There is not enough information to guarantee that the use of Paxlovid is safe during pregnancy. If you are pregnant, do not take this medicine unless your clinical situation requires this treatment. It is recommended that you abstain from sexual activity or use a contraceptive method while taking this medicine and, as a precaution, for 7 days after completing treatment. If you are taking oral contraceptives, since this medicine may reduce the effectiveness of this medicine, it is recommended to use a condom or another non-hormonal contraceptive method. Your doctor will inform you of the duration of this adjustment in contraceptive measures.

A small amount of Paxlovid passes into breast milk. You should not breastfeed your baby while taking this medicine and, as a precaution, for 48 hours after completing treatment.

Driving and using machines

Paxlovid is not expected to affect your ability to drive or use machines.

Paxlovid contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

Paxlovid contains sodium

The nirmatrelvir and ritonavir tablets contain less than 1 mmol of sodium (23 mg) per dose; this is essentially “sodium-free”.

3. How to take Paxlovid

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist again

Paxlovid consists of 2 medicines: nirmatrelvir and ritonavir.

Treatment lasts for 5 days.

Swallow the tablets whole. Do not chew, break, or crush the tablets. This medicine can be taken with or without food.

Recommended dose

Without kidney disease or with mild kidney disease

If you DO NOT have any kidney disease or have MILD kidney disease, the recommended dose is 2 pink tablets of nirmatrelvir with 1 white tablet of ritonavir, by mouth, twice a day (in the morning and at night).

Moderate kidney disease

If you have MODERATE kidney disease, the recommended dose is 1 pink tablet of nirmatrelvir with 1 white tablet of ritonavir, by mouth, twice a day (in the morning and at night).

Severe kidney disease

If you have SEVERE kidney disease, the recommended dose is 2 pink tablets of nirmatrelvir with 1 white tablet of ritonavir, by mouth, once on DAY 1, and then 1 pink tablet of nirmatrelvir with 1 white tablet of ritonavir, by mouth, once a day on DAYS 2 to 5.

If you take more Paxlovid than you should

If you take too much of this medicine, call your healthcare provider or go to the emergency room of the nearest hospital right away.

If you forget to take Paxlovid

If you miss a dose of this medicine and it is within 8 hours of the usual time you take it, take it as soon as you remember. If you miss a dose and it has been more than 8 hours, skip the missed dose and take the next dose at the usual time. Do not take 2 doses at the same time.

Do not take a double dose to make up for missed doses.

If you stop taking Paxlovid

Even if you feel better, do not stop taking this medicine without talking to your doctor.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common:may affect up to 1 in 10 people

• Diarrhea
• Vomiting
• Nausea
• Altered taste (such as metallic, bitter taste)
• Headache

Uncommon:may affect up to 1 in 100 people

• Allergic reactions
• High blood pressure
• Abdominal pain
• Muscle pain
• Rash (also reported as part of an allergic reaction)

Rare:may affect up to 1 in 1,000 people

• Severe allergic reaction known as “anaphylaxis” (such as swelling of the tongue, mouth, and face, difficulty swallowing or breathing, throat tightness, or hoarseness)
• Severe skin reactions known as “toxic epidermal necrolysis” and “Stevens-Johnson syndrome” (such as red and painful skin, blisters, and peeling of the skin, blisters or sores in the mouth or on the lips)
• Malaise
• Itching (also reported as part of an allergic reaction)

Reporting of side effects

If you experience 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 through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Paxlovid

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 blister after “EXP”. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Additional Information

Paxlovid Composition

• The active ingredients of this medication are nirmatrelvir and ritonavir.
• Each film-coated pink nirmatrelvir tablet contains 150 mg of nirmatrelvir.
• Each film-coated white ritonavir tablet contains 100 mg of ritonavir.

• The other ingredients of the nirmatrelvir tablet are microcrystalline cellulose, lactose monohydrate (see section 2 "Paxlovid contains lactose"), sodium croscarmellose, colloidal silicon dioxide, and sodium stearyl fumarate (see section 2 "Paxlovid contains sodium"). The coating contains hypromellose, titanium dioxide, macrogol/polyethylene glycol, and red iron oxide.

• The other ingredients of the ritonavir tablet are copovidone, sorbitan laurate, anhydrous colloidal silica, calcium hydrogen phosphate, and sodium stearyl fumarate. The coating contains hypromellose, titanium dioxide, macrogol/polyethylene glycol, hydroxypropylcellulose, talc, anhydrous colloidal silica, and polysorbate 80.

Product Appearance and Package Contents

The 150 mg nirmatrelvir film-coated tablets are pink, oval in shape, and have "PFE" engraved on one side and "3CL" on the other.

The 100 mg ritonavir film-coated tablets are white to off-white, capsule-shaped, and have "H" engraved on one side and "R9" on the other.

Package for Twice-Daily Dosing Regimen

The Paxlovid film-coated tablets are presented in 5 blisters, one for each day, with a total of 30 tablets packaged in a cardboard box.

Each daily blister contains 4 nirmatrelvir tablets (150 mg each) and 2 ritonavir tablets (100 mg each) and indicates which tablets should be taken in the morning and at night (sun and moon symbols).

Package for Once-Daily Dosing Regimen

The Paxlovid film-coated tablets are presented in a 5-day blister with a total of 11 tablets packaged in a cardboard box.

The 5-day blister contains 6 nirmatrelvir tablets (150 mg each) and 5 ritonavir tablets (100 mg each) and indicates which tablets should be taken once daily for 5 days.

Only certain package sizes may be marketed.

Marketing Authorization Holder

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Brussels

Belgium

Manufacturer

Pfizer Manufacturing Deutschland GmbH

Mooswaldallee 1

79108 Freiburg Im Breisgau

Germany

Pfizer Italia S.r.L

Localita Marino del Tronto

63100 Ascoli Piceno

Italy

Pfizer Ireland Pharmaceuticals Unlimited Company

Little Connell

Newbridge

County Kildare

Ireland

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet:05/2025.

Scan the code with a mobile device to obtain the leaflet in different languages.

URL: www.covid19oralrx.com

Other Sources of Information

Detailed information on this medication is available on the European Medicines Agency website: https://www.ema.europa.eu.

The leaflet can be found in all languages of the European Union/European Economic Area on the European Medicines Agency website.