Paxlovid 150 mg + 100 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Paxlovid 150mg+100mg film-coated tablets

nirmatrelvir + ritonavir

This medicinal product is subject to additional monitoring, which will allow for faster identification of new safety information. You can help by reporting any adverse reactions you may experience. Section 4 includes information on how to report adverse reactions.

Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Paxlovid is and what it is used for

Paxlovid contains two active substances: nirmatrelvir and ritonavir in two separate tablets. Paxlovid is an antiviral medicine used to treat adults and children and adolescents aged 6 to 18 years weighing at least 20 kg with COVID-19 who do not require supplemental oxygen and who are at high risk of progressing to severe disease.

COVID-19 is caused by a virus called coronavirus. This medicine interrupts the virus's replication within cells, thereby halting the spread of the virus in the body. This may help your body overcome the viral infection and may prevent you from developing severe illness.

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

2. What you need to know before taking 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 potentially fatal side effects or affect the way Paxlovid works:

• Alfuzosin (used to treat symptoms of an enlarged prostate).

• Ranolazine (used to treat chronic chest pain [angina]).

• Dronedarone, propafenone, quinidine (used to treat heart conditions 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, severe depression, and abnormal thoughts or feelings).

• Silodosin (used to treat an enlarged prostate).

• Eplerenone and ivabradine (used to treat heart 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 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 lung artery]).

• Chlordiazepoxide, diazepam, estazolam, flurazepam, triazolam, oral midazolam (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 severe allergic reactions (known as “anaphylaxis”) and serious skin reactions (known as “toxic epidermal necrolysis” and “Stevens-Johnson syndrome”), may occur in people taking this medicine, even after a single dose. Stop taking this medicine and contact your doctor immediately if you experience any of the following symptoms of an allergic reaction:

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

Liver disease

Inform your doctor if you have or have had liver disease. Abnormal liver enzymes, hepatitis, and jaundice have been reported in patients receiving ritonavir.

Kidney disease

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

High blood pressure

Inform your doctor if you have high blood pressure. Your doctor may need to check your blood pressure before and during treatment with this medicine. Cases of high blood pressure have been reported in people taking this medicine, especially in elderly individuals.

Risk of developing resistance to HIV-1

If you have untreated or uncontrolled HIV infection, Paxlovid may cause certain HIV medicines to be less effective in the future.

Children and adolescents

Do not give this medicine to children under 6 years of age or to children and adolescents between 6 and 18 years of age who weigh less than 20 kg, as this medicine has not been studied in this group.

Other medicines and Paxlovid

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

• 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 parasitic infections, such as albendazole.
• 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 (oral or intravenous), bedaquiline, rifabutin, delamanid, and sulfamethoxazole/trimethoprim.
• Medicines used to treat schizophrenia and abnormal thoughts or feelings, such as clozapine.
• Medicines used to treat mental disorders or mood conditions, such as haloperidol, risperidone, and thioridazine.
• Medicines used to treat high blood pressure in the blood vessels supplying 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 conditions 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 conditions, such as aripiprazole and brexpiprazol.
• 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, meperidine, and piroxicam.
• Medicines used as sedatives, sleeping pills, or sleep inducers, such as alprazolam, buspirone, and zolpidem.
• Medicines used to treat attention deficit 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-related conditions, 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 for thyroid hormone replacement therapy, such as levothyroxine.
• Medicines used to treat an enlarged prostate, such as tamsulosin.
• Any of the following specific medicines:
• Oral contraceptive or contraceptive patch containing ethinylestradiol used to prevent pregnancy.
• Midazolam administered by injection (used for sedation [a wakeful but very relaxed state of calm or drowsiness during a medical examination or procedure] 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 first consulting your doctor(s). Your doctor(s) can tell you whether it is safe to take Paxlovid with other medicines.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

There is insufficient information to confirm that the use of Paxlovid is safe during pregnancy. If you are pregnant, this medicine is not recommended unless your clinical condition requires this treatment. You are advised to abstain from sexual activity or use contraception while taking this medicine and, as a precaution, for 7 days after completing treatment. If you are taking oral contraceptives, because this medicine may reduce their effectiveness, the use of condoms or another non-hormonal contraceptive method is recommended. Your doctor will advise you on how long this adjustment to contraceptive measures should last.

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 the ability to drive or use machines.

Paxlovid contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Paxlovid contains sodium

Each nirmatrelvir and ritonavir tablet contains less than 1 mmol of sodium (23 mg) per dose; essentially “sodium-free”.

3. How to take Paxlovid

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Paxlovid consists of 2 medicines: nirmatrelvir and ritonavir.

The treatment lasts 5 days.

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

Recommended dose

Adults

The recommended dose is 2 pink nirmatrelvir tablets with 1 white ritonavir tablet, taken orally, every 12 hours (in the morning and at night).

Children and adolescents aged 6 to less than 18 years

• Weighing between 20 kg and less than 40 kg:

The recommended dose is 1 pink nirmatrelvir tablet with 1 white ritonavir tablet, taken orally, every 12 hours (in the morning and at night).

• Weighing at least 40 kg:

The recommended dose is 2 pink nirmatrelvir tablets with 1 white ritonavir tablet, taken orally, every 12 hours (in the morning and at night).

If you or your child has kidney disease, the dose of Paxlovid should be reduced. Consult your healthcare professional for the appropriate dose of Paxlovid.

Severe kidney disease

If you have SEVERE kidney disease, the recommended dose is 2 pink nirmatrelvir tablets with 1 white ritonavir tablet, taken orally, once on Day 1, followed by 1 pink nirmatrelvir tablet with 1 white ritonavir tablet, taken orally, once daily on Days 2 to 5.

If you take more Paxlovid than you should

If you take too much of this medicine, call your healthcare professional or go immediately to the nearest hospital emergency department.

If you forget to take Paxlovid

If you forget to take a dose and it is within 8 hours of your usual dosing time, take it as soon as you remember. If you forget to take a dose and more than 8 hours have passed, skip the missed dose and take the next dose at your regular time. Do not take 2 doses at the same time.

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

If you stop taking Paxlovid

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Frequent: may affect up to 1 in 10 people

• Diarrhoea
• Vomiting
• Nausea
• Altered taste (such as metallic or bitter taste)
• Headache

Uncommon: may affect up to 1 in 100 people

• Allergic reactions
• High blood pressure
• Abdominal pain
• Muscle pain
• Skin rash (also reported as part of 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, tightness in the throat or hoarseness)
• Serious skin reactions known as "toxic epidermal necrolysis" and "Stevens-Johnson syndrome" (such as red, painful skin, blisters and peeling skin, blisters or sores in the mouth or lips)
• Malaise
• Itching (also reported as part of allergic reaction)

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a side effect not listed in this leaflet. You can also report them directly through the national reporting system detailed in Appendix V. By reporting adverse 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 stated on the carton or blister pack after “EXP”. The expiry date refers to the last day of the month indicated.

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 and packaging when no longer needed. This will help protect the environment.

6. Contents of the pack and other information

Composition of Paxlovid

• The active substances in this medicine are nirmatrelvir and ritonavir.

• Each pink film-coated tablet of nirmatrelvir contains 150 mg of nirmatrelvir.

• Each white film-coated tablet of ritonavir contains 100 mg of ritonavir.

• The other components 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 components 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.

Nature of the product and contents of the container

The 150 mg film-coated nirmatrelvir tablets are pink, oval-shaped, and marked with “PFE” on one side and “3CL” on the other.

The 100 mg film-coated ritonavir tablets are white to off-white, capsule-shaped, and marked with “H” on one side and “R9” on the other.

Paxlovid film-coated tablets are supplied in 5 blisters, one for each day, containing a total of 30 tablets or 20 tablets packed in a cardboard box.

In the 30-tablet pack, each daily blister contains 4 nirmatrelvir tablets (150 mg each) and 2 ritonavir tablets (100 mg each), indicating which tablets should be taken in the morning and at night (sun and moon symbols).

In the 20-tablet pack, each daily blister contains 2 nirmatrelvir tablets (150 mg each) and 2 ritonavir tablets (100 mg each), indicating which tablets should be taken in the morning and at night (sun and moon symbols).

Paxlovid film-coated tablets are also available in a 5-day blister pack containing a total of 11 tablets packed in a cardboard box. The 5-day blister pack contains 6 nirmatrelvir tablets (150 mg each) and 5 ritonavir tablets (100 mg each), indicating which tablets should be taken once daily over 5 days.

Only certain pack sizes may be marketed.

Marketing Authorisation 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

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Date of the most recent review of this leaflet: 11/2025.

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

URL: www.covid19oralrx.com/en

Other sources of information

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

This leaflet is available in all languages of the European Union/European Economic Area on the European Medicines Agency website.