Aprepitant Viatris

Package Leaflet: Information for the User

Aprepitant Viatris, 125 mg, hard capsules

Aprepitant Viatris, 80 mg, hard capsules

aprepitant

Read all of this leaflet carefully before taking this medicine because it contains important information for you.

• You should keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

• 1. What Aprepitant Viatris is and what it is used for
• 2. Before you take Aprepitant Viatris
• 3. How to take Aprepitant Viatris
• 4. Possible side effects
• 5. How to store Aprepitant Viatris
• 6. Contents of the pack and other information

1. What Aprepitant Viatris is and what it is used for

Aprepitant Viatris contains the active substance aprepitant and belongs to a group of medicines called neurokinin 1 (NK1) receptor antagonists. The brain has a specific area that is responsible for nausea and vomiting. Aprepitant Viatris blocks the signals from this area, reducing the likelihood of nausea and vomiting. In adults and adolescents from 12 years of age, Aprepitant Viatris capsules are used in combination with other medicines to prevent nausea and vomiting caused by chemotherapy (cancer treatment) that is likely to cause nausea and vomiting (such as cisplatin, cyclophosphamide, doxorubicin, or epirubicin).

2. Before you take Aprepitant Viatris

When not to take Aprepitant Viatris

• if you are allergic to aprepitant or any of the other ingredients of this medicine (listed in section 6)
• if you are taking medicines containing pimozide (used to treat psychiatric disorders), terfenadine, and astemizole (used to treat hay fever and other allergic disorders), and cisapride (used to treat gastrointestinal disorders). You should tell your doctor if you are taking any of these medicines, as your treatment will need to be modified before you start taking Aprepitant Viatris

Warnings and precautions

Before taking or giving this medicine to your child, you should discuss this with your doctor, pharmacist, or nurse. If you have liver problems, you should tell your doctor before taking this medicine. The liver is an important organ for breaking down this medicine. Your doctor may need to monitor your liver function.

Children and adolescents

Aprepitant Viatris capsules (80 mg and 125 mg) should not be given to children under 12 years of age, as these capsules have not been studied in this age group.

Aprepitant Viatris and other medicines

Aprepitant Viatris may affect the way other medicines work, and other medicines may affect the way Aprepitant Viatris works. You should not take certain medicines with Aprepitant Viatris (such as pimozide, terfenadine, astemizole, and cisapride), and you may need to adjust the dose of others (see also "When not to take Aprepitant Viatris"). The effect of Aprepitant Viatris or other medicines may be affected if you take Aprepitant Viatris with other medicines. You should tell your doctor or pharmacist if you are taking any of the following medicines:

• contraceptives, including oral contraceptives, contraceptive patches, implants, and some intrauterine devices (IUDs), which may not work properly when taken with Aprepitant Viatris. During and for 2 months after treatment with Aprepitant Viatris, you should use other or additional non-hormonal methods of contraception
• cyclosporin, tacrolimus, sirolimus, everolimus (immunosuppressants)
• alfentanil, fentanyl (used to treat pain)
• quinidine (used to treat irregular heartbeat)
• irinotecan, etoposide, vinorelbine, ifosfamide (used to treat cancer)
• medicines containing ergot derivatives, such as ergotamine and dihydroergotamine (used to treat migraine)
• warfarin, acenocoumarol (blood thinners; blood tests may be necessary)
• rifampicin, clarithromycin, telithromycin (antibiotics used to treat infections)
• phenytoin (used to treat seizures)
• carbamazepine (used to treat depression and epilepsy)
• midazolam, triazolam, phenobarbital (sedatives or sleeping pills)
• preparations containing St. John's Wort (herbal preparations used to treat depression)
• protease inhibitors (used to treat HIV infections)
• ketoconazole (except for shampoo; used to treat Cushing's syndrome - when the body produces too much cortisol)
• itraconazole, voriconazole, posaconazole (antifungal medicines)
• nefazodone (used to treat depression)
• corticosteroids (such as dexamethasone and methylprednisolone)
• anxiolytics (such as alprazolam)
• tolbutamide (used to treat diabetes)

You should tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take.

Pregnancy and breastfeeding

This medicine should not be used during pregnancy unless clearly necessary. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Information on contraceptives is given in "Aprepitant Viatris and other medicines". It is not known whether Aprepitant Viatris passes into breast milk, and breastfeeding is not recommended during treatment with this medicine. It is important to tell your doctor if you are breastfeeding or planning to breastfeed before taking this medicine.

Driving and using machines

You should be aware that some patients taking Aprepitant Viatris may experience dizziness and somnolence. You should not drive or operate machinery if you experience dizziness or somnolence after taking this medicine (see "Possible side effects").

Aprepitant Viatris contains sucrose and sodium

Aprepitant Viatris capsules contain sucrose. If your doctor has told you that you have an intolerance to some sugars, you should contact your doctor before taking this medicine. This medicine contains less than 1 mmol (23 mg) of sodium per capsule, which is essentially "sodium-free".

3. How to take Aprepitant Viatris

This medicine should always be taken exactly as your doctor, pharmacist, or nurse has told you. If you are not sure, you should ask them again. Aprepitant Viatris should always be taken with other medicines to prevent nausea and vomiting. After you finish taking Aprepitant Viatris, your doctor will prescribe other medicines, including a corticosteroid (such as dexamethasone) and a 5-HT3 antagonist (such as ondansetron), to prevent nausea and vomiting. If you are unsure, you should ask your doctor, pharmacist, or nurse.

The recommended oral dose of Aprepitant Viatris is:

• 1. day
• one 125 mg capsule 1 hour before chemotherapy

and

• 2. and 3. day
• one 80 mg capsule each day
• if chemotherapy is not given, Aprepitant Viatris should be taken in the morning
• if chemotherapy is given, Aprepitant Viatris should be taken 1 hour before chemotherapy.

Aprepitant Viatris can be taken with or without food. The capsule should be swallowed whole with a glass of water.

If you take more Aprepitant Viatris than you should

You should not take more capsules than your doctor has prescribed. If you have taken too many capsules, you should contact your doctor immediately.

If you forget to take Aprepitant Viatris

If you miss a dose, you should contact your doctor. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You should stop taking Aprepitant Viatris and contact your doctor immediately if you experience any of the following serious side effects:

• hives, rash, itching, difficulty breathing or swallowing (frequency not known, cannot be estimated from the available data); these are symptoms of an allergic reaction

Other side effects have been reported:

Common side effects (may affect up to 1 in 10 people):

• constipation, dyspepsia
• headache
• fatigue
• loss of appetite
• hiccups
• increased liver enzyme levels in the blood

Uncommon side effects (may affect up to 1 in 100 people):

• Uncommon side effects (may affect up to 1 in 100 people):
• dizziness, somnolence
• acne, rash
• restlessness
• flatulence, nausea, vomiting, heartburn, stomach pain, dry mouth, belching
• increased or painful urination, or burning sensation while urinating
• weakness, general feeling of being unwell
• hot flashes/flushes
• rapid or irregular heartbeat
• fever with increased risk of infection, decreased red blood cell count

Rare side effects (may affect up to 1 in 1,000 people):

• difficulty thinking, lack of energy, taste disturbances
• skin sensitivity to sunlight, excessive sweating, seborrhoea, skin ulceration, pruritic rash, Stevens-Johnson syndrome/toxic epidermal necrolysis (rare, severe skin reaction)
• euphoria (feeling of unusual happiness), disorientation
• bacterial infections, fungal infections
• severe constipation, stomach ulcers, inflammation of the small and large intestines, mouth ulcers, bloating
• increased urination, urination of larger amounts than usual, presence of glucose or blood in the urine
• chest discomfort, swelling, changes in gait
• cough, presence of secretions in the back of the throat, throat irritation, sneezing, sore throat
• presence of secretions in the eyes and eye itching
• ringing in the ears
• muscle spasms, muscle weakness
• excessive thirst
• slow heartbeat, heart disease and blood vessel disorders
• decreased white blood cell count, decreased sodium levels in the blood, weight loss

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. 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 the "Contact details" section below. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Aprepitant Viatris

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 after "EXP". The expiry date refers to the last day of that month. There are no special storage requirements for this medicine. Do not remove the capsule from the blister pack until you are ready to take it. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Aprepitant Viatris contains:

• The active substance is aprepitant. Each 125 mg hard capsule contains 125 mg of aprepitant. Each 80 mg hard capsule contains 80 mg of aprepitant.
• The other ingredients are: hydroxypropylcellulose, sodium lauryl sulfate, sucrose, microcrystalline cellulose, titanium dioxide (E 171), gelatin, shellac, ammonia solution, propylene glycol, potassium hydroxide, iron oxide black (E 172). The 125 mg hard capsule also contains iron oxide red (E 172).

What Aprepitant Viatris looks like and contents of the pack

125 mg capsules: size 1 capsules with an opaque pink cap and an opaque white body with black printing "125 mg". 80 mg capsules: size 2 capsules with an opaque white cap and an opaque white body with black printing "80 mg". Aprepitant Viatris, 125 mg and 80 mg, hard capsules are available in the following packs: a 3-day treatment pack containing blisters of PA/Aluminum/PVC/Aluminum, perforated, and divisible into single doses containing 1x1 capsule (125 mg) and 2x1 capsules (80 mg), in a cardboard box. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Viatris Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland. Manufacturer: Ethypharm, Chemin de la Poudrière, 76120 Le Grand Quevilly, France; Ethypharm, Z.I de Saint Arnoult, 28170 Châteauneuf-en-Thymerais, France.

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

France: Aprepitant Viatris 125 mg, gélule and Aprepitant Viatris 80 mg, gélule; Poland: Aprepitant Viatris, 125 mg/80 mg, hard capsules. For further information, contact your local representative of the Marketing Authorisation Holder: Viatris Healthcare Sp. z o.o., tel. 22 546 64 00.

Date of last revision of the leaflet: 01/2024