Aprepitant Teva

Package Leaflet: Information for the User

Aprepitant Teva, 125 mg/80 mg, Hard Capsules

Aprepitant

Read all of this leaflet carefully before taking this medicine because it contains important information for you. Parents of children taking Aprepitant Teva should read this leaflet carefully.

• 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

• 1. What Aprepitant Teva is and what it is used for
• 2. Important information before taking or giving Aprepitant Teva
• 3. How to take Aprepitant Teva
• 4. Possible side effects
• 5. How to store Aprepitant Teva
• 6. Contents of the pack and other information

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

Aprepitant Teva 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 Teva blocks the signals from this area, reducing the likelihood of nausea and vomiting. In adults and adolescents from 12 years of age, Aprepitant Teva capsules are used in combination with other medicines to prevent nausea and vomiting caused by cancer chemotherapy (anti-cancer treatment) that is likely to cause nausea and vomiting (such as cisplatin, cyclophosphamide, doxorubicin, or epirubicin).

2. Important information before taking or giving Aprepitant Teva

When not to take Aprepitant Teva:

• if you or your child 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 these medicines because your treatment should be modified before taking Aprepitant Teva.

Warnings and precautions

Before taking Aprepitant Teva or giving it 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 Aprepitant Teva. The liver is an important organ for breaking down this medicine. Your doctor may need to monitor your liver function.

Children and adolescents

Aprepitant Teva 80 mg and 125 mg capsules should not be given to children under 12 years of age because these capsules have not been studied in this age group.

Aprepitant Teva and other medicines

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

• birth control pills, including oral contraceptives, contraceptive patches, implants, and some intrauterine devices (IUDs), which may not work properly when taken with Aprepitant Teva. During and for 2 months after treatment with Aprepitant Teva, you should use other or additional non-hormonal methods of birth control.
• cyclosporine, 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 needed);
• rifampicin, clarithromycin, telithromycin (antibiotics used to treat infections);
• phenytoin (used to treat seizures);
• carbamazepine (used to treat depression and seizures);
• midazolam, triazolam, phenobarbital (sedatives or sleeping pills);
• herbal preparations containing St. John's Wort (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 (antifungals);
• 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, as well as any medicines you plan to take.

Pregnancy, breastfeeding, and fertility

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 for advice before taking this medicine. Information on birth control is given in the section "Aprepitant Teva and other medicines". It is not known whether Aprepitant Teva 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 Teva may experience dizziness and sleepiness. You should avoid driving, riding a bike, or operating machinery or tools if you experience dizziness and sleepiness after taking this medicine (see section "Possible side effects").

Aprepitant Teva contains sucrose

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

Aprepitant Teva contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per capsule, which is essentially "sodium-free".

3. How to take Aprepitant Teva

This medicine should always be taken or given to your child exactly as your doctor, pharmacist, or nurse has told you. If you are not sure, ask your doctor, pharmacist, or nurse. Aprepitant Teva should always be used with other medicines to prevent nausea and vomiting. After you finish taking Aprepitant Teva, 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 not sure, ask your doctor, pharmacist, or nurse. The recommended oral dose of Aprepitant Teva is

• 1. Day 1:
• one 125 mg capsule 1 hour before the start of chemotherapy

and

• 2. and 3. Day
• one 80 mg capsule each day
• If chemotherapy is not given, take Aprepitant Teva in the morning.
• If chemotherapy is given, take Aprepitant Teva 1 hour before the start of chemotherapy.

Aprepitant Teva can be taken with or without food. Swallow the capsule whole with a glass of water.

If you take more Aprepitant Teva than you should

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

If you forget to take Aprepitant Teva

If you miss a dose, contact 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.

Stop taking Aprepitant Teva 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, indigestion;
• headache;
• fatigue;
• loss of appetite;
• hiccups;
• increased liver enzymes in the blood.

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

• dizziness, sleepiness;
• acne, rash;
• restlessness;
• belching, nausea, vomiting, heartburn, stomach pain, dry mouth, gas;
• painful urination or burning sensation while urinating;
• weakness, general feeling of being unwell;
• flushing or feeling of warmth in the face or skin;
• rapid or irregular heartbeat;
• fever with increased risk of infection, decreased red blood cell count.

Rare side effects (may affect up to 1 in 1000 people):

• Rare side effects (may affect up to 1 in 1000 people):
• difficulty concentrating, lack of energy, taste disorders;
• skin sensitivity to sunlight, excessive sweating, seborrhea, skin ulcers, itching rash, Stevens-Johnson syndrome/toxic epidermal necrolysis (a rare, severe skin reaction);
• euphoria (feeling of excessive happiness), disorientation;
• bacterial or fungal infections;
• severe constipation, stomach ulcers, inflammation of the small and large intestine, mouth ulcers, bloating;
• increased urination, excessive thirst;
• chest discomfort, swelling, changes in walking;
• cough, presence of mucus in the back of the throat, throat irritation, sneezing, sore throat;
• eye discharge and eye itching;
• ringing in the ears;
• muscle spasms, muscle weakness;
• excessive thirst;
• slow heartbeat, heart problems and blood vessel disorders;
• decreased white blood cell count, low 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" section below. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Aprepitant Teva

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 conditions. Do not remove the capsule from the blister 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 Teva contains

• The active substance is aprepitant. Each hard capsule contains 125 mg or 80 mg of aprepitant.
• The other ingredients are: hydroxypropylcellulose, sodium lauryl sulfate, sucrose (see section 2, "Aprepitant Teva contains sucrose"), microcrystalline cellulose; capsule shell - body (125 mg): titanium dioxide (E 171), gelatin; capsule shell - cap (125 mg): titanium dioxide (E 171), iron oxide red (E 172), gelatin; capsule shell - body and cap (80 mg): titanium dioxide (E 171), gelatin;

What Aprepitant Teva looks like and contents of the pack

The 125 mg capsule is a hard, non-transparent capsule consisting of a white body and a pink cap, approximately 19.0 mm in length, containing white or almost white pellets. The 80 mg capsule is a hard, non-transparent capsule consisting of a white body and a white cap, approximately 17.4 mm in length, containing white or almost white pellets. Aprepitant Teva is available in the following packs:

• a 3-day treatment pack containing one blister with one 125 mg capsule and one single-dose blister with two 80 mg capsules.

Marketing Authorisation Holder

Teva B.V., Swensweg 5, 2031GA Haarlem, The Netherlands

Manufacturer

Teva Operations Poland Sp. z o.o., ul. Mogilska 80, 31-546 Kraków, Merckle GmbH, Ludwig-Merckle-Strasse 3, 89143 Blaubeuren, Baden-Württemberg, Germany, Rontis Hellas Medical and Pharmaceutical Products S.A., P.O. Box 3012 Larisa Industrial Area, 41004 Larisa, Greece

Date of last revision of the leaflet: September 2020