InfoCons Consumer Protection informs you – Zokovea – Package Leaflet

Before anything else

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 any further questions, ask your doctor or pharmacist.- This medicine has been prescribed for you only. Do not pass it on to others. It may harm 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.

ℹ️ 1. What Zokovea is and what it is used for

Zokovea contains the active substance ensitrelvir. This is a medicine that helps to fight viral infections throughout the whole body. This is an antiviral medicine used in adults and adolescents 12 years and older to prevent COVID -19 after exposure to SARS -CoV -2, the virus that causes the disease.

COVID -19 is caused by a virus called a coronavirus. Zokovea stops the virus multiplying in cells, which in turn stops the virus multiplying in the body. This can help your body overcome the virus infection and may prevent you from developing severe illness.

⚠️ 2. What you need to know before you take Zokovea

Do not take Zokovea if

• you are allergic to ensitrelvir or any of the other ingredients of this medicine (listed in section 6).
• you are pregnant.
• you are using any of the following medicines, since taking them with Zokovea may cause serious or life -threatening side effects or affect how Zokovea works :
• Quinidine , dronaderone , rano lazine (for irregular heart rhythm) -Colchicine ( for gout) -Pimozide (for severe tics)
• Lurasidone , cariprazine (for schizophrenia) -Quet iapine (for bipolar disorder) -Ticagrelor (for preventing blood clots) -Eplerenone, ivabradine, m avacamten (for heart problems)
• Dihydroergotamine, ergotamine , methylergometrine (for headaches) -Voclosporin ( for supressing the immune system) 31 -Simvastatin , lomitapide and lovastatin (for high cholesterol)
• Finerenone (for chronic kidney disease)
• Tadalafil (for pulmonary arterial hypertension) -Triazolam , or al midazolam and da ridorexant (for sleeping problems)
• Venetoclax, a p alutamide, e nzalutamide , and m itotane (for cancer) -Carbamazepine and phenytoin (for epilepsy)
• Rifampicin (for some serious infections including tuberculosis)
• Lumaca ft or and i vacaftor (for cystic fibrosis)
• St John’s wort (H ypericum perforatum ; a herbal medicine for depression and anxiety) -Terfenadine ( a ntihistamines) -Nalo xe gol and cisapride (for constipation) -Avan a fil and vardenafil (for ma le erectile dysfunction)

Warnings and precautions

Allergic reactions Allergic reactions, including severe allergic reactions (known as ‘anaphylaxis’), can happen in people ta king Zokovea – even after only 1 dose.

Liver disease Tell your doctor if you have or have had a liver disease.

Children and adolescents

Do not give Zokovea to children under 12 years because this medicinal product has not been studied in this age group.

Other medicines and Zokovea

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other med icines , including those used for:

Blood and heart (cardiovascular) diseases:

• uneven h eartbeats, such as disopyramide
• high blood pressure , such as amlodipine, nifedipine, felodipine, verapamil
• heart problems, such as guanfacine, riociguant, digoxin
• high blood cholesterol , such as atorvastatin, rosuvastatin Infectious diseases:
• infections, such as erythromycin, rifabutin ( antibiotics)
• fungal infections , such as itraconazole (anti-fungals)
• HIV infection , su ch as maraviroc, efav irenz, etravirine Mental health conditions:
• mental or mood disorders, such as haloperidol, aripiprazole
• psychosis such as bromocriptine ( do pamine receptor agonists )
• st ress such as zopiclone , parenteral midazolam (sedatives and hypnotics) Inflammatory disease s:
• inflammation , s uch as budesonide , ciclesonide , dexamethasone, methylprednisolone (steroids and corticosteroids )
• rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or ulcerative colitis , such as tofacitinib , methotrexate Other diseases:
• severe pain , s uch as fentanyl, oxycodone, methadone, buprenorphine
• lung problems, such as salmeterol
• ki dney disease, such as cinacalcet , t olvaptan 32 • digestive problems, such as aprepitant, loperamide
• overactive bladder , s uch as tolterodine, oxybutynin
• e rectile dysfunction (also known as impotence) such as sildenafil , tadal afil
• cancer , s uch as docetaxel, temsirolimus, gefitinib, dasatinib, erlotinib, lapatinib, bortezomib, imatinib, sunitinib, bosutinib, cabazitaxel, crizotinib, panobinostat, ponatinib ruxolitinib, axitinib, nilotinib, irinotecan, vincristine, vinblastine , ibrutinib, neratinib
• autoimmune disease or organ transplant, su ch as cyclosporine, tacrolimus, everolimus, sirolimus
• epilepsy (seizures), such as phenobarbital, primidone
• headaches, such as eletriptan
• thinning the blood (anti-coagulants), such as warfarin, apixaban, cilostazol, dabigatran, ri varoxaban
• benign prostatic hyperplasia such as alfuzosin, silodosin Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Many medicines interact with ensitrelvir . Keep a list of your medicines to show your doctor and pharmacist.

Do not start taking a new medicine without telling your doctor or pharmacist, they can tell you if it is safe to take Zokovea with other medicines.

Pregnancy, breast -feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take Zokovea if you are pregnant .

Women of childbearing potential have to use effective contraception (birth control) during treatment with ensitrelvir and for two weeks after the last dose of ensitrelvir. Pregnancy should be ruled out before starting treatment.

You should not breast-feed your baby while taking Zokovea, and for 2 weeks after stopping Zokovea as a precaution. This is because there is no information on the use of Zokovea in breast- feeding and it is not known whether the medicine passes into breast milk.

Driving and using machines

Zokovea is not expected to influence the ability to drive and use machines.

Zokovea contains s odium

This medicine contains less than 1 mmol sodium ( 23 mg) per tablet, that is to say essentially ‘sodium -free’.

💊 3. How to take Zokovea

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

How much to take A course of treatment lasts 5 days.

The recommended dose is:

33 • day 1: take 3 tablets at the same time (total dose 375 mg)

• days 2, 3, 4 and 5: take 1 ta blet per day (125 mg) How to take Zokovea should be taken as soon as possible and within 72 hours following close contact with an individual who has COVID-19.

Zokovea can be taken with or without food:

• Swallow the tablets whole with water
• Do not chew, break, or crush the tablets.

If you take more Zokovea than you should

If you take too much Zokovea, call your doctor or pharmacist straight away or go to the nearest hospital emergency room straight away.

If you forget to take Zokovea

If you forget a dose, take it as soon as you remember it. However, if it is almost time for the next dose, do not take the missed dose and take your next normal dose at its scheduled time. Do not take a double dose to make up for a forgotten one .

If you stop taking Zokovea

Even if you feel better, do not stop taking this medicine without talking to your doctor. However, you should stop taking this medicine if you have signs of a serious allergic reaction as stated in leaflet section 4.

If you have any questions about 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.

Serious side effects

Stop taking Zokovea and contact a doctor or go to your nearest emergency department immediately if you experience any of the following sym ptoms:

Signs of a serious allergic reaction (frequency not known)

• trouble swallowing or breathing
• swelling of the tongue, mouth, and face
• tight throat
• a hoarse voice
• itching
• skin rash

Other side effects

Talk to your doctor if you notice any of the following side effects:

Common (may affect up to 1 in 10 people)

• headache 34 • diarrhoea
• feeling sick ( na usea)
• i ncreased blood levels of certain fats (lipids) called triglycerides

Uncommon (may affect up to 1 in 100 people)

• increased levels of a substance produced by the liver (bilirubin) in the blood
• vo miting
• stomach (abdominal) discomfort
• indigestion (dyspepsia)
• skin r ash
• eczema
• itchy rash ( urticaria)
• itchy skin (p ruritus)

Rare (may affect up to 1 in 1000 people)

• skin allergy as rash, redness and small raised bumps (drug eruption)

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 Zokovea

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.

This medicine does not require any special storage conditions.

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 Zokovea contains

The active substance is ensitrelvir. Each tablet contains ensitrelvir fumaric acid , equivalent to 125 mg of ensitrelvir .

The other excipients are mannitol (E421), croscarmellose sodium (E468), hydroxypropyl cellulose (E463), silica colloidal anhydrous (E551), microcrystalline cellulose (E460) and magnesium stearate (E470b).

What Zokovea looks like and contents of the pack

Approximately 9 mm round, white to light yellow white, tablets debossed on one side with the company logo and “711”, and “125” on the other side.

Zokovea is packaged in a carton containing a PVC /PCTFE blister strip with a total of 7 tablets.

35 Marketing Authorisation Holder Shionogi B.V.

Herengracht 464, 1017 CA, Amsterdam, The Netherlands

Manufacturer

Shionogi B.V.

Herengracht 464, 1017 CA, Amsterdam, The Netherlands For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

AT, BE, BG, CY, CZ, DK, EE, EL, FI, HR, HU, IE, IS, LT, LU, LV, MT, NL, NO, PL, PT, RO, SE, SI, SK Shionogi B.V.

Tel/Tel./Teл./Tlf/Tél/Puh/Sími/Τηλ: +31 (0) 207038327 [email protected] Deutschland Shionogi GmbH Tel: +49 (0) 30 2062980 66 [email protected] España Shionogi SLU Tel: +34 911 239 258 c [email protected] France Shionogi SAS Tél: +33 (0)1 86 65 58 06 [email protected] Italia Shionogi Srl Tel: +39 06 94 805 118 c [email protected] This leaflet was last revised in .

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Zokovea (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/26/2062).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.