Paxlovid 150 mg + 100 mg comprimidos recubiertos con pelicula

Label: information for the patient

Paxlovid 150mg+100mg film-coated tablets

nirmatrelvir+ritonavir

This medication is subject to additional monitoring, which will expedite the detection of new information about its safety. You may contribute by reporting any adverse effects you experience. The final part of section4 includes information on how to report these adverse effects.

Read this label carefully before starting to take this medication, as it contains important information for you.

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section4.

Paxlovid contains two active ingredients: nirmatrelvir and ritonavir in two different tablets. Paxlovid is an antiviral medication used to treat adults with COVID-19 who do not require supplemental oxygen and have a high risk of progressing to severe disease.

COVID-19 is caused by a virus called coronavirus. Paxlovid interrupts the virus multiplication in cells and this interrupts the virus multiplication in the body. This may help your body overcome the viral infection and may prevent you from developing severe disease.

If your symptoms worsen or do not improve after 5days, consult a doctor.

Do not take Paxlovid

• if you are allergic to nirmatrelvir, ritonavir, or any of the other ingredients in this medication (listed in section6);
• if you are taking any of the following medications. Taking Paxlovid with these medications may cause severe or potentially life-threatening side effects or affect the functioning of Paxlovid:

• Alfuzosin (used to treat symptoms of an enlarged prostate).
• Ranolazine (used to treat chronic chest pain [angina]).
• Dronedarone, propafenone, quinidine (used to treat heart diseases 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 to treat depression and anxiety).
• Voclosporin (used to treat immunological disorders).
• Lovastatin, simvastatin, lomitapide (used to reduce cholesterol in the blood).
• Eletriptan (used to treat migraines).
• Lumacaftor/ivacaftor (used to treat cystic fibrosis).
• Finerenone (used to treat chronic kidney disease related to type2 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]).
• Clorazepate, diazepam, estazolam, flurazepam, triazolam, midazolam by oral route (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 severe skin reactions (known as “toxic epidermal necrolysis” and “Stevens-Johnson syndrome”), may occur in people taking Paxlovid, even after a single dose. Stop taking Paxlovid and call your doctor immediately if you experience any of the following symptoms of an allergic reaction:

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

Liver disease

Inform your doctor if you have or have had liver disease. Abnormal liver enzymes, hepatitis, and jaundice have occurred 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 taking Paxlovid and while you are taking this medication. Cases of high blood pressure have been reported in people taking Paxlovid, especially in older adults.

Risk of developing resistance to HIV-1

If you have untreated or uncontrolled HIV infection, Paxlovid may cause some HIV medications to work less well in the future.

Children and adolescents

Do not administer Paxlovid to children and adolescents under 18 years of age because Paxlovid has not been studied in children and adolescents.

Other medications and Paxlovid

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

• Medications used to treat cancer, such as afatinib, abemaciclib, ceritinib, dasatinib, encorafenib, fostamatinib, ibrutinib, ivosidenib, nilotinib, vinblastine, and vincristine.
• Medications used to thin the blood (anticoagulants), such as warfarin, rivaroxaban, dabigatran, and apixaban.
• Medications used to treat seizures, such as divalproex, lamotrigine, and clonazepam.
• Medications used to quit smoking, such as bupropion.
• Medications used to treat allergies, such as fexofenadine and loratadine.
• Medications used to treat fungal infections (antifungals), such as itraconazole and voriconazole.
• Medications used to treat Cushing's syndrome (when the body produces too much cortisol) such as ketoconazole tablets.
• Medications used to treat HIV infection, such as efavirenz, maraviroc, raltegravir, zidovudine, and bictegravir/emtricitabine/tenofovir.
• Medications 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.
• Medications used to treat schizophrenia and abnormal thoughts or feelings, such as clozapine.
• Medications used to treat mental health or mood disorders, such as haloperidol, risperidone, and thioridazine.
• Medications used to treat high blood pressure in blood vessels that supply the lungs, such as bosentan and riociguat.
• Medications used to treat high blood pressure (hypertension), such as amlodipine, diltiazem, felodipine, lercanidipine, nicardipine, nifedipine, and verapamil.
• Medications used to treat heart and/or blood vessel problems, such as aliskiren, ticagrelor, cilostazol, and clopidogrel.
• Medications used to treat heart diseases and correct irregular heartbeats, such as digoxin, amiodarone, flecainide, and disopyramide.
• Medications used to treat cystic fibrosis, such as ivacaftor, elexacaftor/tezacaftor/ivacaftor, and tezacaftor/ivacaftor.
• Medications used to treat diabetes, such as saxagliptin.
• Medications used to treat hepatitis C infection, such as glecaprevir/pibrentasvir and sofosbuvir/velpatasvir/voxilaprevir.
• Medications used to reduce cholesterol in the blood, such as atorvastatin, fluvastatin, pravastatin, and rosuvastatin.
• Medications used to treat migraines, such as rimegepant.
• Medications used to treat urinary incontinence, such as darifenacin and solifenacin.
• Medications used to treat mental health disorders, such as aripiprazole and brexpiprazole.
• Medications used to suppress the immune system, such as cyclosporine, everolimus, sirolimus, and tacrolimus.
• Medications used to treat autoimmune disorders, including rheumatoid arthritis, psoriatic arthritis, or ulcerative colitis, such as tofacitinib and upadacitinib.
• Medications used to treat intense pain, such as morphine, fentanyl, oxycodone, methadone, buprenorphine, other morphine-like medications, meperidine, and piroxicam.
• Medications used as sedatives, hypnotics, and sleep inducers, such as alprazolam, buspirone, and zolpidem.
• Medications used to treat attention deficit disorder or a sleep disorder called narcolepsy, such as amphetamines.
• Glucocorticoids, including corticosteroids used to treat inflammation, such as budesonide, dexamethasone, fluticasone, prednisolone, and triamcinolone.
• Medications used to treat asthma and other lung problems, such as chronic obstructive pulmonary disease (COPD), such as salmeterol and theophylline.
• Medications used to treat depression, such as amitriptyline, fluoxetine, imipramine, nortriptyline, paroxetine, and sertraline.
• Medications used as thyroid hormone replacement therapy, such as levothyroxine.
• Medications used to treat an enlarged prostate, such as tamsulosin.
• Some of the following other specific medications:

• Oral contraceptive or transdermal contraceptive patch with ethinylestradiol used to prevent pregnancy.
• Midazolam administered by injection (used for sedation [a state of being awake but very calm or drowsy during a medical examination or operation] or anesthesia).

Many medications interact with Paxlovid. Carry a list of your medications to show your doctor(s) and pharmacist. Do not start taking a new medication without consulting your doctor(s). Your doctor(s) may tell you if it is safe to take Paxlovid with other medications.

Pregnancy and breastfeeding

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

There is not enough information to guarantee that the use of Paxlovid is safe during pregnancy. If you are pregnant, it is not recommended to use Paxlovid unless your clinical situation requires this treatment. It is recommended to abstain from sexual activity or use a contraceptive method while taking Paxlovid and, as a precaution, for 7 days after completing Paxlovid treatment. If you are taking oral contraceptives, since Paxlovid may reduce the effectiveness of this medication, 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. Do not breastfeed your baby while taking Paxlovid and, as a precaution, for 48 hours after completing Paxlovid treatment.

Driving and operating machines

Paxlovid is expected to have no influence on the ability to drive or operate machines.

Paxlovid contains lactose

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

Paxlovid contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Paxlovid consists of 2medicines: nirmatrelvir and ritonavir. The recommended dose is 2tablets of nirmatrelvir (pink tablet) with 1tablet of ritonavir (white tablet) taken orally twice a day (in the morning and at night).

The treatment lasts 5days. For each dose, take the 3tablets together at the same time.

If you have kidney disease, consult your healthcare professional to know the suitable dose of Paxlovid.

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

If you take more Paxlovid than you should

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

If you forget to take Paxlovid

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

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

If you interrupt treatment with Paxlovid

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

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Frequent:may affect up to 1 in 10people

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

Infrequent:may affect up to 1 in 100people

• Allergic reactions
• High blood pressure
• Abdominal pain
• Muscle pain
• Skin rash (also reported as part of the allergic reaction)

Rare:may affect up to 1 in 10,000people

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect not listed in this prospectus. You can also report them directly through the national notification system included in theAppendix V.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box or blister after “EXP”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of Paxlovid

• The active ingredients of this medication are nirmatrelvir and ritonavir.

• Each film-coated tablet of nirmatrelvir contains 150 mg of nirmatrelvir.
• Each 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”), croscarmellose sodium, colloidal silicon dioxide, and stearate and sodium fumarate (see section 2 “Paxlovid contains sodium”). The coating contains hydroxypropylmethylcellulose, titanium dioxide, macrogol/poloxylglycerol, and red iron oxide.
• The other components of the ritonavir tablet are copovidone, sorbitan laurate, anhydrous colloidal silica, calcium hydrogen phosphate, and stearate and sodium fumarate. The coating contains hypromellose, titanium dioxide, macrogol/poloxylglycerol, hydroxypropylcellulose, talc, anhydrous colloidal silica, and polisorbate 80.

Appearance of the product and contents of the package

Paxlovid film-coated tablets are presented in 5 blister packs for a daily dose with a total of 30 tablets conditioned in a cardboard box.

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

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

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

Marketing authorization holder

Pfizer Europe MA EEIG

Boulevard de la Plaine17

1050Brussels

Belgium

Responsible for manufacturing

Pfizer Manufacturing Deutschland GmbH

Mooswaldallee 1

79108 FreiburgIm 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 more information about this medication, please contact the local representative of the marketing authorization holder:

Last update of this leaflet:02/2025.

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

URL:https://pfi.sr/c19oralrx

Other sources of information

More detailed information about this medication is available on the website of the European Medicines Agency:https://www.ema.europa.eu.

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