Nirmatrevir+Ritonavir 150 mg+100 mg tablets(Zhejiang Huahai Pharmaceutical Co. Ltd.), CV016

WHOPAR Part 3

March 2024

WHO-PQ RECOMMENDED
PATIENT INFORMATION LEAFLET

This patient information leaflet focuses on uses of the medicine covered by WHO’s Prequalification Team Medicines. The recommendations for use are based on WHO guidelines and on information from stringent
regulatory authorities.*
The medicine may be authorised for additional or different uses by national medicines regulatory
authorities.

*

https://extranet.who.int/prequal/sites/default/files/document_files/75%20SRA%20clarification_Feb2017_newtempl.pdf
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Nirmatrevir+Ritonavir 150 mg+100 mg tablets(Zhejiang Huahai Pharmaceutical Co. Ltd.), CV016

WHOPAR Part 3

March 2024

Information for the patient[CV016 trade name]†
Nirmatrevir + Ritonavir
The warnings and instructions in this leaflet are intended for the person taking the medicine.
If you are a parent or carer responsible for giving the medicine to someone else such as a child,
you will need to apply the instructions accordingly.
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 questions about the medicine, ask your health care provider.
This medicine is for you only. Do not pass it on to others. It may harm them, even if their illness seems
to be the same as yours.
If you are concerned about any side effects, talk to your health care provider. This includes unwanted
effects not listed in this leaflet. See section 4.

-

What is in this leaflet
1.
2.
3.
4.
5.
6.

What [CV016 trade name] is and what it is used for
What you need to know before you take [CV016 trade name]How to take [CV016 trade name]
Possible side effects
How to store [CV016 trade name]Contents of the pack and other information

1.

What [CV016 trade name] is and what it is used for

The medicine [CV016 trade name] contains two active substances, nirmatrelvir and ritonavir, each inseparate tablets. [CV016 trade name] is used for treating adults with COVID-19 who do not need treatment
with oxygen. The medicine is used if you are more likely to get seriously ill with COVID-19.
COVID-19 is caused by a virus called SARS-CoV-2, a type of coronavirus. The active substance,nirmatrelvir, stops the virus multiplying in the body and this can help stop you becoming seriously ill andneeding hospital treatment. The other active substance in the medicine, ritonavir, reduces the breakdown ofnirmatrelvir and so increases its effect against the virus.
2.

What you need to know before you take [CV016 trade name]

Do not take [CV016 trade name]• if you are allergic to nirmatrelvir, ritonavir, or to any of the other ingredients of this medicine (listed insection 6).
•†

if you are taking any of the following medicines. Taking [CV016 trade name] with these medicines may
cause serious or life-threatening side effects or affect how [CV016 trade name] works:-

Alfuzosin, silodosin (for treating prostate problems)-

Amiodarone, dronedarone, eplerenone, flecainide, ivabradine, propafenone, quinidine (for treatingheart conditions)-

Apalutamide, neratinib, venetoclax (for treating cancer)

Trade names are not prequalified by WHO. This is the national medicines regulatory agency’s responsibility.
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WHOPAR Part 3

March 2024-

Avanafil, sildenafil, tadalafil, vardenafil (for treating men with erectile disorder; sildenafil andtadalafil are also used for treating high blood pressure in the lungs)-

Carbamazepine, phenobarbital, phenytoin (for treating epilepsy)-

Clorazepate, diazepam, estazolam, flurazepam, triazolam, midazolam (for relieving anxiety andsleeping trouble or for controlling convulsions)-Clozapine, lurasidone, pimozide, quetiapine (for treating mental conditions such as abnormal
thoughts or feelings, schizophrenia, and bipolar disorder)-

Colchicine (for treating gout)-

Dihydroergotamine, eletriptan, ergotamine, (for treating migraine headaches)-

Ergometrine, methylergometrine (for treating excessive bleeding after childbirth)-

Fusidic acid, rifampicin (for treating bacterial infections)-

Lomitapide, lovastatin, simvastatin (used to lower blood cholesterol)-

Ranolazine (for treating angina, a chest pain)-

St John’s wort (Hypericum perforatum) (a herbal remedy for relieving depression and anxiety)-

Terfenadine (antihistamine for treating allergies such as hayfever)-Tolvaptan (for treating some kidney disorders and correcting low sodium levels in the blood)-

Voclosporin (for treating conditions caused by overactive immune system)

There may be other medicines that you must not take with [CV016 trade name]. Talk to your health careprovider about all the medicines you take before you start taking [CV016 trade name].
Warnings and precautions
Talk to your health care provider about any concerns before you take [CV016 trade name].
Allergic reactions
Allergic reactions, including severe allergic reactions (known as anaphylaxis), can happen in people taking[CV016 trade name], even after only 1 dose. Stop taking [CV016 trade name] and contract your health careprovider right away if you get any of the following:-

trouble swallowing or breathing-swelling of the tongue, mouth, and face-throat tightness-

hoarseness-itching-skin rash

Liver disease
Tell your health care provider if you have ever had liver disease. Liver injury can occur in patients taking theactive substance ritonavir.
Kidney disease
Tell your health care provider if you have ever had kidney disease.
High blood pressure
Tell your doctor if you have high blood pressure. Some people taking this medicine may develop increases intheir blood pressure, usually temporarily. Your health care provider may want to check your blood pressureduring treatment.

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WHOPAR Part 3March 2024

Risk of developing HIV-1 resistanceIf you have untreated HIV infection, treatment with [CV016 trade name] may reduce how well some HIV
medicines work.
Children and adolescents
Do not give [CV016 trade name] to children and adolescents because there is not enough information on its
use in children and adolescents aged under 18 years.
Other medicines and [CV016 trade name]Taking [CV016 trade name] at the same time as many other medicines can have unwanted effects. Tell yourhealth care provider about all the medicines you are taking, have recently taken or might take. Your healthcare provider can tell you if you need to change any of your treatment.
Some medicines that may have unwanted effects with [CV016 trade name] are listed below.
-for cancer—afatinib, abemaciclib, apalutamide, ceritinib, dasatinib, encorafenib, fostamatinib, ibrutinib,
nilotinib, vinblastine and vincristinefor preventing blood clots (anticoagulants)—warfarin, rivaroxaban, dabigatranfor epilepsy—divalproex (valproic acid and sodium valproate), lamotrigine
for help to stop smoking—bupropion
for allergies and hayfever—fexofenadine and loratadinefor fungal infections—itraconazole and voriconazole
for Cushing’s syndrome (when the body produces high levels of steroid hormones)—ketoconazolefor HIV infection—efavirenz, maraviroc, raltegravir and zidovudine
for various infections—atovaquone, bedaquiline, clarithromycin, delamanid, erythromycin, fusidic acid,rifabutin, sulfamethoxazole/trimethoprim
for some mental disorders—haloperidol, risperidone, thioridazine
for reducing high blood pressure in the lungs—bosentan, riociguat
for high blood pressure and preventing chest pain (angina)—amlodipine, diltiazem, lercanidipine,
nifedipine
for heart conditions—digoxin
for hepatitis C virus infection—glecaprevir/pibrentasvir
for lowering blood cholesterol—atorvastatin, fluvastatin, pravastatin, rosuvastatin
for reducing effects of the immune system—ciclosporin, everolimus, sirolimus, tacrolimus
for severe pain—buprenorphine, fentanyl, methadone, morphine, other morphine-like medicines,
piroxicam
for mood calming and help with sleeping—alprazolam, buspirone, zolpidem, and midazolam byinjection (often used before surgery or some medical procedures)
corticosteroids (often used to reduce inflammation)—betamethasone, budesonide, ciclesonide,
dexamethasone, fluticasone, prednisolone, prednisone, triamcinolone
for breathing problems such as asthma and chronic obstructive pulmonary disease—salmeterol,theophylline
for relieving depression—amitriptyline, fluoxetine, imipramine, nortriptyline, paroxetine, sertraline
for raising thyroid hormone levels—levothyroxine
for family planning—contraceptive medicine containing ethinylestradiol

Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant or you are planning to have a baby, talk to your health careprovider before taking this medicine.
There is not enough information to be sure that [CV016 trade name] is safe to take during pregnancy. If you
are pregnant, your health care provider will help you decide if you can take [CV016 trade name].
You should take precautions not to be become pregnant during treatment with [CV016 trade name]. Usecontraception while taking [CV016 trade name] and for 7 days after completing [CV016 trade name].
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WHOPAR Part 3March 2024

[CV016 trade name] may reduce how well some hormone contraceptive medicines work and you and yourpartner should use another contraceptive method (such as a condom)—your health care provider can give
you advice on the right contraception and how long to use it.
There is no information on taking [CV016 trade name] while breast-feeding. As a precaution, do not breastfeed your baby during treatment with [CV016 trade name] and for 7 days after you have finished taking thetablets.
Driving and using machines[CV016 trade name] is not likely to have an effect on yonot likely to have an effect on your ability to drive
and to use machines.
Other ingredients of [CV016 trade name][CV016 trade name] contains lactose. Lactose is a source of glucose and galactose. The small amount oflactose in each dose is unlikely to cause symptoms of lactose intolerance. If, however, you have one of therare genetic disorders galactosaemia, glucose-galactose intolerance or congenital lactase deficiency you musttalk to your health care provider before taking this medicine.
3.

How to take [CV016 trade name]

Always take this medicine exactly as your health care provider has told you. Take it regularly at around thesame times each day. Check with your health care provider if you are not sure.
The [CV016 trade name] pack contains two types of tablets: one type contains the active substancenirmatrelvir and the other contains ritonavir. The usual recommended dose is 2 tablets of nirmatrelvir(yellow tablet) together with 1 tablet of ritonavir (white tablet) twice daily, about 12 hours apart (in themorning and in the evening).
A course of treatment lasts 5 days. For each dose, take the nirmatrelvir and ritonavir together at the sametime.
If you have kidney disease, talk to your health care provider about the right dose of [CV016 trade name] foryou.
You can take [CV016 trade name] either with food or between meals.
Swallow the tablets whole with plenty of water. Do not chew, break, or crush the tablets.
If you take more [CV016 trade name] than you should
If you take more [CV016 trade name] than you should, or if somebody else takes it, contact your health careprovider straightaway.
If you forget to take [CV016 trade name]• You must not miss or skip doses of this medicine.
• If you forget to take a dose and your next regular dose is not due for at least 4 hours, take the dose atonce and take the next dose at the usual time.
• If you forget to take a dose and your next regular dose is due in less than 4 hours, do not take the missed
dose and instead take the next one at the usual time.
• Do not take a double dose to make up for a missed dose.
• If you are not sure what to do, ask your health care provider.
Do not stop taking [CV016 trade name]
Do not stop taking [CV016 trade name] without first checking with your health care provider. Taking themedicine regularly and finishing the 5-day course gives you the best chance of not falling very ill withCOVID-19.
4.

Possible side effects

Like all medicines, this medicine can cause side effects but not everybody gets them.
Common side effects that can affect up to 1 in 10 people are:Page 5 of 7

Nirmatrevir+Ritonavir 150 mg+100 mg tablets(Zhejiang Huahai Pharmaceutical Co. Ltd.), CV016

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•
•

WHOPAR Part 3March 2024

diarrhoea
vomitingnausea (feeling sick)altered sense of tasteheadache

Uncommon side effects that can affect up to 1 in 100 people are:••••allergic reactions (such as itching and skin rash)high blood pressure
abdominal (belly) pain
muscle pain

Rare side effects that can affect up to 1 in 1000 people••

severe allergic reactions (anaphylaxis), with swelling of the tongue, mouth and face, trouble swallowing
or breathing, throat tightness, hoarseness)feeling generally unwell.

Reporting of side effects
If you get a side effect, talk to your health care provider. This includes side effects not listed in this leaflet.
You may also be able to report such effects directly to your national reporting system if one is available. By
reporting side effects, you can help to improve the available information on this medicine.
5.

How to store [CV016 trade name]

Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Do not use this medicine after the expiry date stated on blister and carton after “EXP”. The expiry date refers
to the last day of that month.
Do not use this medicine if you notice description of the visible signs of deterioration that it is different fromthe description below.
Do not throw away any medicines in wastewater or household waste. Ask your health care provider how tothrow away medicines you no longer use. These measures will help protect the environment.
6.

Contents of the pack and other information

What [CV016 trade name] contains-

The active ingredient of nirmatrelvir tablet is 150 mg nirmatrelvir.
The active ingredient of ritonavir tablet is 100 mg ritonavir.

-The other ingredients of [CV016 trade name] are:Nirmatrelvir 150 mg film-coated tablets: microcrystalline cellulose, lactose monohydrate,croscarmellose sodium, colloidal silicon dioxide, sodium stearyl fumarate, hypromellose, titanium
dioxide, macrogol/PEG and iron oxide yellow.
Ritonavir100 mg film-coated tablets: colloidal silicon dioxide, anhydrous dibasic calcium phosphate,
copovidone, sorbitan monolaurate, sodium stearyl fumarate, titanium dioxide, hypromellose,
macrogol/PEG and polysorbate 80.

There is too little sodium in this medicine to have any effect, even if you are on a low-sodium diet.
What [CV016 trade name] looks like and contents of the packNirmatrelvir 150mg film-coated tablets
Yellow, oval, film- coated tablets. They are biconvex (rounded on top and bottom) with a flat edge. Thetablets have ‘150’ debossed (stamped into) one side and are plain on the other side.
Ritonavir 100mg film-coated tablets
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WHOPAR Part 3

March 2024

White, oval, film- coated tablets. They are biconvex (rounded on top and bottom) with a flat edge. Thetablets have “54” debossed (stamped into) on one side and “247” on the other side.
Pack size
Silvery white plastic and aluminium (PA/Alu/PVC) on aluminium foil blister cards, each containing 4nirmatrelvir 150 mg tablets and 2 ritonavir 100 mg tablets. Available in cartons of 5 × 6 tablets.
Supplier and Manufacturer
Supplier

Manufacturer

Zhejiang Huahai Pharmaceutical Co., Ltd.
Xunqiao Linhai
Zhejiang 317 024
P.R.China
Tel.:+86-576-85010288
Fax:+86-576-85016013
E-mail:http://www.huahaipharm.com

Zhejiang Huahai Pharmaceutical Co., Ltd.
Xunqiao Linhai
Zhejiang 317 024
P.R.ChinaTel.: +86-576-85010288
Fax:+86-576-85016013
E-mail: http://www.huahaipharm.com

For any information about this medicine, contact the supplier.
This leaflet was last revised in March 2024

Detailed information on this medicine is available on the World Health Organization (WHO)website: https://extranet.who.int/prequal/medicines/prequalified/finished-pharmaceutical-products

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