Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about taking this medicine,
speak to your doctor or pharmacist.
This medicine is new or being used differently. Please report side effects. See the
full CMI for further details.
1. Why am I taking PAXLOVID?
PAXLOVID is a medicine that has two different tablets; one containing the active ingredient,
nirmatrelvir and the other containing the active ingredient, ritonavir.
PAXLOVID is used to treat COVID-19 in adults who are at increased risk of progression
to hospitalisation or death.
For more information, see Section
1. Why am I taking PAXLOVID? in the full CMI.
2. What should I know before I take PAXLOVID?
Do not take if you have ever had an allergic reaction to PAXLOVID or any of the ingredients
listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions or if you have reduced
kidney or liver function. You must not take PAXLOVID with certain medicines because
these medicines may cause serious or life-threatening side effects or affect how PAXLOVID
works.
Tell your doctor if you are pregnant or plan to become pregnant, breastfeeding or
planning to breastfeed. You should not be taking PAXLOVID if you are pregnant. Women
of childbearing potential should be on an effective contraceptive method before starting
treatment and for 7 days after stopping treatment. Tell your doctor if you are pregnant
or plan to become pregnant, breastfeeding or planning to breastfeed.
For more information, see Section
2. What should I know before I take PAXLOVID? in the full CMI.
3. What if I am taking other medicines?
4. How do I take PAXLOVID?
You doctor will decide how much PAXLOVID you will need to take. It will depend on
whether you have kidney problems. Nirmatrelvir must be taken together with ritonavir.
5. What should I know while taking PAXLOVID?
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Things you should do
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If you are of childbearing age, you should be taking a contraception while taking
PAXLOVID and for 7 days after stopping treatment.
Call your doctor straight away if you become pregnant while taking this medicine.
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Things you should not do
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Do not stop taking this medicine or change the dosage without checking with your doctor.
Do not give your medicine to anyone else, even if they have the same condition as
you.
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Driving or using machines
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There is no specific information on the effect of PAXLOVID on your ability to drive
or use machines.
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Looking after your medicine
|
Store PAXLOVID below 25°C.
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6. Are there any side effects?
Side effects may include diarrhoea, vomiting, headache, allergic reactions, high blood
pressure, aching muscle, muscle tenderness or weakness not due to exercise, changes
in taste or a metallic taste in the mouth, nausea, abdominal pain and generally feeling
unwell.
This medicine is subject to additional monitoring. This will allow quick identification
of new safety information. You can help by reporting any side effects you may get.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems .
Active ingredient(s):
nirmatrelvir and ritonavir
This medicine has provisional approval in Australia to treat COVID-19 in adults who are at increased risk of progression
to hospitalisation or death. This approval has been granted on the basis of short-term
efficacy and safety data. Evidence of efficacy and safety from ongoing trials continues
to be gathered and assessed.
Full Consumer Medicine Information (CMI)
This leaflet provides important information about taking PAXLOVID. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about taking PAXLOVID.
Where to find information in this leaflet:
1. Why am I taking PAXLOVID?
PAXLOVID
contains the active ingredients nirmatrelvir and ritonavir.
PAXLOVID is used to treat COVID-19 in adults who are at increased risk of progression
to hospitalisation or death.
2. What should I know before I take PAXLOVID?
Warnings
Do not take PAXLOVID if:
You are allergic to nirmatrelvir and/or ritonavir or any of the ingredients listed
at the end of this leaflet.
You are taking any of these medicines. Taking PAXLOVID with these medicines may cause
serious or life-threatening side effects or affect how PAXLOVID work:
alfuzosin, silodosin, medicine to treat symptoms of an enlarged prostate
ranolazine, medicine to treat chronic chest pain (angina)
pethidine, medicine to relieve pain
amiodarone, flecainide medicine to correct or change heart rhythm or lower blood pressure
neratinib, apalutamide, venetoclax, medicine to treat certain types of cancers
colchicine, medicine to treat gout
lurasidone, clozapine medicine to treat certain mental and emotional health conditions
eplerenone, ivabradine, medicine used to treat heart failure; eplerenone, medicine
for high blood pressure
ergometrine, medicine to stop excessive bleeding that may occur following childbirth,
miscarriage or termination of pregnancy
simvastatin, medicine to lower blood cholesterol
eletriptan, medicine used to treat migraine headaches
finerenone, medicine used to treat kidney disease and type 2 diabetes
naloxegol, medicine used to treat constipation
avanafil, vardenafil, when used for erectile dysfunction
sildenafil, when used to treat high blood pressure in the lungs
diazepam, medicine to assist anxiety, agitation or muscle spasms, spasticity
triazolam, zolpidem, medicine that works in the brain to help you sleep
tolvaptan, medicine used to treat kidney problems or low sodium levels in the blood
carbamazepine, phenobarbital, phenytoin, primidone, medicine to treat epilepsy to
prevent convulsions, fits
rifampicin, medicine to treat tuberculosis
lumacaftor/ivacaftor, medicine used to treat cystic fibrosis
St. John’s Wort (hypericum perforatum), a herbal remedy used for depression and anxiety.
Check with your doctor if you:
Have or have had problems with your liver.
Have or have had problems with your kidneys.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Tell your doctor if you become pregnant or plan to become pregnant, breastfeeding
or plan to breast feed. You should not breast-feed your baby while taking PAXLOVID
and for 7 days after stopping treatment.
You should not be taking PAXLOVID if you are pregnant.
Women of childbearing potential should be on an effective contraceptive method before
starting treatment and for 7 days after stopping treatment.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins, or supplements that you buy without a prescription from your
pharmacy, supermarket, or health food shop.
Some medicines may cause serious or life-threatening side effects or affect how PAXLOVID
work. These include:
tamsulosin, medicine to treat symptoms of an enlarged prostate
fentanyl, hydrocodone, oxycodone, methadone, piroxicam, medicine to treat pain
digoxin, medicine to treat certain heart conditions
lidocaine, disopyramide, medicine to correct or change heart rhythm
afatinib, abemaciclib, ceritinib, dasatinib, nilotinib, encorafenib, ibrutinib, vinblastine,
vincristine, medicine to treat certain types of cancer
aripiprazole, brexpiprazole, cariprazine, haloperidol, risperidone, quetiapine, medicine
to treat certain mental and emotional conditions
apixaban, clopidogrel, dabigatran, rivaroxaban, ticagrelor, warfarin, medicine to
treat or prevent blood clots
clonazepam, lamotrigine, medicine to prevent or treat convulsions, fits
amitriptyline, fluoxetine, imipramine, nortriptyline, paroxetine, sertraline, medicine
to treat depression
loratadine, medicine to treat allergies
atovaquone, clarithromycin, erythromycin, rifabutin, ketoconazole, isavuconazonium
sulfate, voriconazole, itraconazole, medicine to treat infections
atazanavir, darunavir, efavirenz, fosamprenavir, maraviroc, nevirapine, saquinavir,
tipranavir, raltegravir, zidovudine, bictegravir/ emtricitabine/ tenofovir, medicine
to treat HIV
glecaprevir/pibrentasvir or sofosbuvir/ velpatasvir/ voxilaprevir, medicine to treat
hepatitis C
salmeterol, medicine to treat severe lung conditions, including asthma and chronic
obstructive pulmonary disease (COPD)
amlodipine, diltiazem, felodipine, nifedipine, verapamil, medicine to treat angina
or lower blood pressure
ivacaftor, elexacaftor/tezacaftor/ivacaftor, tezacaftor/ivacaftor, medicine used to
treat cystic fibrosis
saxagliptin, medicine used to lower blood sugar levels in patients with type 2 diabetes
mellitus
ethinylestradiol, medicine to treat hormone deficiency or for contraception
ciclosporin, everolimus, tacrolimus, sirolimus, medicine to suppress the immune system
tofacitinib, upadacitinib, medicine used to treat inflammatory conditions including
rheumatoid arthritis, psoriatic arthritis or ulcerative colitis
darifenacin, medicine used to decrease the urgency and the frequency of urination
sildenafil, when used to treat erectile dysfunction
tadalafil, medicine used to treat erectile dysfunction or high blood pressure in the
lungs
bosentan, riociguat, medicine to treat high blood pressure in the lungs
atorvastatin, rosuvastatin, medicine to lower cholesterol
alprazolam, midazolam, suvorexant, medicine to help you sleep
clorazepate, medicine used to treat anxiety, convulsions, fits or help you sleep
bupropion, a medicine to assist in giving up smoking
betamethasone, budesonide, ciclesonide, dexamethasone, fluticasone, methylprednisolone,
mometasone, triamcinolone, medicine to treat various inflammatory conditions including
allergies, asthma or eczema.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect PAXLOVID.
4. How do I take PAXLOVID?
How much to take
Your doctor will decide how much PAXLOVID you will need to take. It will depend on
whether you have kidney problems.
The standard dose is two 150 mg tablets of nirmatrelvir together with one 100 mg tablet
of ritonavir.
If you suffer from reduced kidney function, your doctor may tell you to only take
one 150 mg tablet of nirmatrelvir with one 100 mg tablet of ritonavir.
Nirmatrelvir and ritonavir tablets can be taken with or without food.
Nirmatrelvir must be taken together with ritonavir.
The tablets should be swallowed whole and not chewed, broken, or crushed.
When to take PAXLOVID
Take PAXLOVID tablets every 12 hours at about the same time each morning and evening.
It will help you remember when to take it.
How to long to take PAXLOVID
PAXLOVID is to be taken for 5 days.
Continue taking PAXLOVID until you finish the pack or until your doctor recommends.
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.
If you take too much PAXLOVID
If you think that you have taken too much PAXLOVID, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while taking PAXLOVID?
Things you should do
Tell your doctor if you become pregnant or plan to become pregnant, breastfeeding
or plan to breast feed. Call your doctor straight away if you become pregnant while
taking this medicine.
Things you should not do
Do not stop taking this medicine or change the dosage without consulting with your
doctor.
Do not give your medicine to anyone else, even if they have the same condition as
you.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how PAXLOVID
affects you.
Drinking alcohol
No information is available
Looking after your medicine
Store PAXLOVID below 25°C.
Store it in a cool dry place away from moisture, heat, or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on windowsills.
Do not take this medicine after the expiry date.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If you no longer need to take this medicine or it is out of date, take it to any pharmacy
for safe disposal.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Side effects
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
What PAXLOVID contains
Nirmatrelvir tablet
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Active ingredient
(main ingredient)
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nirmatrelvir
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Other ingredients
(inactive ingredients)
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Microcrystalline cellulose
Lactose monohydrate
Croscarmellose sodium
Colloidal silicon dioxide
Sodium stearylfumarate
Opadry Complete Film Coating System 05B140011 Pink.
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Ritonavir tablet
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Active ingredient
(main ingredient)
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Ritonavir
|
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Other ingredients
(inactive ingredients)
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Copovidone
Calcium hydrogen phosphate
Sorbitan monolaurate
Hypromellose
Colloidal anhydrous silica
Titanium dioxide
Sodium stearylfumarate
Macrogol 400
Hyprolose
Purified talc
Macrogol 3350
Polysorbate 80
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Do not take this medicine if you are allergic to any of these ingredients.
What PAXLOVID looks like
Nirmatrelvir tablet
A pink, oval film-coated tablet debossed with ‘PFE’ on one side and ‘3CL’ on the other
side.
Ritonavir tablet
A white to off-white coated, oval tablet marked with the "a" logo and "NK"; or
A white to off-white coated, oval tablet marked with "NK" on one side.
Pack size
PAXLOVID is supplied in a carton of 30 tablets in five PA/Al/PVC/Al blister cards
marked as "Morning Dose" and "Evening Dose" for the tablets to be taken each morning
and each evening.
Australian Registration Number
PAXLOVID: AUST R 377572.
Who distributes PAXLOVID
Pfizer Australia Pty Ltd
Sydney NSW
Toll Free Number: 1800 675 229
This leaflet was prepared in February 2024.