Paxlovid - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Paxlovid 150 mg + 100 mg film-coated tablets

PF-07321332 + ritonavir

This medicine is subject to additional monitoring. This will allow quick identification of new afetyinformation. You canhelp by reporting anyside effects you may get. See the end ofsection 4 forhow 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 youhave any further questions, ask your doctor or pharmacist.

• – This medicinehas been prescribed for you only. Do not pass it on to others. It mayharm 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.

What is in this leaflet

• 1. What Paxlovid is and what it is used for

• 2. What you need to know before you take 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 PF-07321332 and ritonavir in two different tablets. Paxlovid is an antiviral medicine used for treating adults who do not require supplemental oxygen and who are at increased risk for progressing to severe COVID-19.

COVID-19 is caused by a virus called a coronavirus. Paxlovid stops the virus multiplying in cells and tis stops the virus multiplying in the body. This canhelp your body to overcome the virus infection, and may prevent you from developing severe illness.

If your symptoms worsen or do not improve after 5 days, talk to your doctor.

2. What you need to know before you take Paxlovid

Do not take Paxlovid

• – if you are allergic to PF-07321332, ritonavir or any of the other ingredients of Paxlovid (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 affecthow 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 treatheart conditions and correct irregularhear­tbeats)

• – Fusidic acid, rifampicin (used to treat bacterial infections)

• – Carbamazepine, phenobarbital, phenytoin (used to prevent and control seizures)

• – Colchicine (used to treat gout)

• – Astemizole, terfenadine (used to treat allergies)

• – Lurasidone (used to treat schizophrenia)

• – 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 and methylergonovine (used to stop excessive bleeding that may occur following childbirth or an abortion)

• – Cisapride (used to relieve certain stomach problems)

• – St. John’s wort (Hypericum perforatum ) (a herbal remedy used for depression and anxiety)

• – Lovastatin, simvastatin, lomitapide (used to lower blood cholesterol)

• – Avanafil, vardenafil (used to treat erectile dysfunction [also known as impotence])

• – Sildenafil used to treat pulmonary arterial hypertension (high blood pressure in the

pulmonary artery)

• – Clorazepate, diazepam, estazolam, flurazepam, triazolam, midazolam taken orally (used to relieve anxiety and/or trouble sleeping)

Warnings and precautions

Liver disease

Tell your doctor if you have or have had a liver disease. Liver enzyme abnormalities, hepatitis and jaundice have occurred in patients receiving ritonavir.

Kidney disease

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

Risk of HIV-1 resistance development

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

Children and adolescents

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

Other medicines and Paxlovid

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:

• – medicines used to treat cancer, such as afatinib, abemaciclib, apalutamide, ceritinib, dasatinib, encorafenib, fostamatinib, ibrutinib, nilotinib, vinblastine and vincristine

• – medicines used to thin the blood (anticoagulants), such as warfarin, rivaroxaban, vorapaxar

• – medicines used to treat convulsions, such as divalproex, lamotrigine

• – medicines used for smoking cessation, 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 an excess of cortisol—

such as ketoconazole tablets

• – medicines used to treat HIV infection, such as efavirenz, maraviroc, raltegravir and zidovudine

• – medicines used to treat infections (e.g., antibiotics and antimycobacte­rials), such as atovaquone,

fusidic acid, clarithromycin, erythromycin, bedaquiline, rifabutin, delamanid and sulfamethoxazo­le/trimethoprim

• – 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 and nifedipine

• – medicines used to treat heart conditions and correct irregular heartbeats, such as digoxin

• – medicines used to treat hepatitis C virus infection, such as glecaprevir/pi­brentasvir

• – medicines used to lower blood cholesterol, such as atorvastatin, fluvastatin, pravastatin and rosuvastatin

• – medicines used to suppress your immune system, such as cyclosporine, tacrolimus and everolimus

• – medicines used to treat severe pain, such as morphine, fentanyl, methadone, buprenorphine, norbuprenorphine and other morphine-like medicines

• – medicines used as sedatives, hypnotics, and sleeping agent, such as alprazolam, buspirone and zolpidem

• – steroids including corticosteroids used to treat inflammation, such as betamethasone,

budesonide, ciclesonide, dexamethasone, fluticasone, prednisolone, methylprednisolone, mometasone, prednisone and triamcinolone

• – medicines used to treat asthma and other lung-related 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, sertraline and desipramine

• – medicines used to treat erectile dysfunction (also known as impotence), such as sildenafil and tadalafil

• – medicines used as thyroid replacement therapy, such as levothyroxine

• – any of the following other specific medicines:

• – oral or patch contraceptive containing ethinyl estradiol used to prevent pregnancy

• – midazolam administered by injection (used for sedation [an awake but very relaxed state of calm or drowsiness during a medical test or procedure] or anaesthesia)

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.

Pregnancy and breast-feeding

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 be sure that Paxlovid is safe for use in pregnancy. If you are pregnant, it is not recommended to use Paxlovid unless your clinical condition requires this treatment. It is recommended that you refrain from sexual activity or use contraception while taking Paxlovid and for 7 days after completing Paxlovid as a precaution. If you are taking hormonal contraception, as Paxlovid may reduce the effectiveness of this medicine, it is recommended that a condom or other non hormonal method of contraception is used. Your doctor will advise you on the duration of this required adjustment of your contraceptive measures.

There is no information on the use of Paxlovid in breast-feeding. You should not breast-feed your baby while taking Paxlovid and for 7 days after completing Paxlovid as a precaution.

Driving and using machines

Paxlovid is expected to have no influence on the ability to drive and use machines.

Paxlovid contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Paxlovid contains sodium

PF-07321332 and ritonavir tablets each contain less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‚sodium-free‘.

3. How to take Paxlovid

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Paxlovid consists of 2 medicines: PF-07321332 and ritonavir. The recommended dose is 2 tablets of PF-07321332 (pink tablet) with 1 tablet of ritonavir (white tablet) by mouth twice daily (in the morning and in the evening).

A course of treatment lasts 5 days. For each dose, take all 3 tablets together at the same time.

If you have kidney disease, please talk to your healthcare provider for an appropriate dose of Paxlovid.

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 healthcare provider or go to the nearest hospital emergency room right away.

If you forget to take Paxlovid

If you miss a dose of Paxlovid within 8 hours of the time it is usually taken, take it as soon as you remember. If you miss a dose by more than 8 hours, skip the missed dose and take the next dose at your regular time. Do not take 2 doses of Paxlovid at the same time.

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.

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

• – Altered sense of taste

• – Diarrhoea

• – Vomiting

• – Headache

Reporting of side effects

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

5. How to store 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 the blister after ‘EXP’. The expiry date refers to the last day of that month.

Do not store above 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.

6. Contents of the pack and other information

What Paxlovid contains

• – The active substances in this medicine are PF-07321332 and ritonavir.

• – Each pink film-coated PF-07321332 tablet contains 150 mg of PF-07321332.

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

• – The other ingredients in the PF-07321332 tablet are microcrystalline cellulose, lactose monohydrate (see section 2, ‘Paxlovid contains lactose’), croscarmellose sodium, colloidal silicon dioxide and sodium stearyl fumarate (see section 2, ‘Paxlovid contains sodium’). The film-coating contains hydroxypropyl methylcellulose, titanium dioxide, polyethylene glycol and iron oxide red.

• – The other ingredients in the ritonavir tablet are copovidone, sorbitan laureate, colloidal anhydrous silica, anhydrous calcium hydrogen phosphate, sodium stearyl fumarate. The film-coating contains hypromellose, titanium dioxide, macrogol, hydroxypropyl cellulose, talc, colloidal anhydrous silica and polysorbate 80.

What Paxlovid looks like and contents of the pack

Paxlovid film-coated 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 (sun and moon symbols).

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.

Marketing Authorisation Holder

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Brussels

Belgium

Manufacturer

Pfizer Manufacturing Deutschland GmbH

Betriebsstätte Freiburg

Mooswaldallee 1

79090 Freiburg

Germany

Pfizer Italia S.r.L.

Localita Marino del Tronto

63100 Ascoli, Piceno

Italy

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

België/Belgiqu­e/Belgien Luxembourg/Lu­xemburg Pfizer NV/SA

Lietuva Pfizer Luxembourg SARL filialas Lietuvoje Tel: +370 5 251 4000

Tél/Tel: +32 (0)2 554 62 11

BtnrapuH n<|)aÜ3ep ^æKceMÔypr CAP.ÏÏ, K.toh Btnrapun Ten.: +359 2 970 4333	Magyarország Pfizer Kft. Tel.: + 36 1 488 37 00
Česká republika Pfizer, spol. s r.o. Tel: +420 283 004 111	Malta Vivian Corporation Ltd. Tel: +356 21344610
Danmark Pfizer ApS Tlf: +45 44 20 11 00	Nederland Pfizer bv Tel: +31 (0)10 406 43 01
Deutschland PFIZER PHARMA GmbH Tel: +49 (0)30 550055–51000	Norge Pfizer AS Tlf: +47 67 52 61 00
Eesti Pfizer Luxembourg SARL Eesti filiaal Tel: +372 666 7500	Österreich Pfizer Corporation Austria Ges.m.b.H Tel: +43 (0)1 521 15–0
EZZàôa Pfizer EÂÂàc A.E. TnÀ: +30 210 6785800	Polska Pfizer Polska Sp. z o.o. Tel.: +48 22 335 61 00
España Pfizer, S.L. Tel: +34 91 490 99 00	Portugal Laboratórios Pfizer, Lda. Tel: +351 21 423 5500
France Pfizer Tél: +33 (0)1 58 07 34 40	România Pfizer Romania S.R.L Tel: +40 (0) 21 207 28 00
Hrvatska Pfizer Croatia d.o.o. Tel: +385 1 3908 777	Slovenija Pfizer Luxembourg SARL Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana Tel: +386 (0)1 52 11 400
Ireland Pfizer Healthcare Ireland Tel: 1800 633 363 (toll free) +44 (0)1304 616161	Slovenská republika Pfizer Luxembourg SARL, organizačná zložka Tel: + 421 2 3355 5500
Ísland Icepharma hf. Sími: +354 540 8000	Suomi/Finland Pfizer Oy Puh/Tel: +358 (0)9 430 040

This leaflet was last revised in

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

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URL:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:.

This leaflet is available in all EU/EEA languages on the European Medicines Agency website.

ANNEX IV

CONCLUSIONS ON THE GRANTING OF THE CONDITIONAL MARKETING AUTHORISATION AND PRESENTED BY THE EUROPEAN MEDICINES AGENCY

Conclusions presented by the European Medicines Agency on:

• Conditional marketing authorisation

The CHMP having considered the application is of the opinion that the risk-benefit balance is favourable to recommend the granting of the conditional marketing authorisation as further explained in the European Public Assessment Report.

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