Aprepitant Sandoz

Package Leaflet: Information for the Patient

Aprepitant Sandoz, 125 mg, hard capsules + Aprepitant Sandoz, 80 mg, hard capsules
Aprepitantum

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet

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

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

Aprepitant Sandoz contains the active substance aprepitant, a medicine from the group of so-called neurokinin 1 (NK1) receptor antagonists. In the brain, there is a specific area responsible for feeling nausea and vomiting. Aprepitant Sandoz blocks the signals to this area, reducing nausea and vomiting. The medicine is used in adults and adolescents from 12 years of age together with other medicinesto prevent nausea and vomiting caused by chemotherapy (cancer treatment) that causes severe and moderate nausea and vomiting (treatment with such medicines as cisplatin, cyclophosphamide, doxorubicin, or epirubicin).

2. Important information before taking Aprepitant Sandoz

When not to take Aprepitant Sandoz

• if you are allergic to aprepitant or any of the other ingredients of this medicine (listed in section 6);
• with medicines containing pimozide (used to treat mental disorders), terfenadine, and astemizole (used to treat hay fever and other allergic reactions), cisapride (used to treat digestive disorders). If you are taking any of these medicines, tell your doctor, as your treatment may need to be modified before starting Aprepitant Sandoz.

Warnings and precautions

Before taking Aprepitant Sandoz, discuss it with your doctor or pharmacist.

• Before starting Aprepitant Sandoz, tell your doctor if you have liver disease, as the liver plays an important role in the breakdown of the medicine in the body. Your doctor may need to monitor your liver function.

Children and adolescents

Aprepitant Sandoz 80 mg and 125 mg should not be used in children under 12 years of age, as the effect of these capsule strengths has not been studied in this age group.

Aprepitant Sandoz and other medicines

Aprepitant Sandoz may affect the action of other medicines, both during and after treatment with aprepitant. Some medicines (such as pimozide, terfenadine, astemizole, and cisapride) should not be taken at the same time as Aprepitant Sandoz or may require dose adjustment (see also "When not to take Aprepitant Sandoz"). Taking Aprepitant Sandoz with other medicines, including those listed below, may affect the action of Aprepitant Sandoz or other medicines. Tell your doctor or pharmacist if you are taking any of the following medicines:

• contraceptives, including hormone-releasing pills, patches, implants, and some intrauterine systems - when taken with Aprepitant Sandoz, they may not work properly. During treatment with Aprepitant Sandoz and for 2 months after the end of treatment, use other or additional non-hormonal methods of contraception;
• cyclosporine, tacrolimus, sirolimus, everolimus (immunosuppressive medicines);
• alfentanil, fentanyl (medicines used to treat pain);
• quinidine (a medicine used to treat irregular heartbeat);
• irinotecan, etoposide, vinorelbine, ifosfamide (medicines used to treat cancer);
• medicines containing ergot alkaloids, such as ergotamine and dihydroergotamine (medicines used to treat migraine);
• warfarin, acenocoumarol (blood-thinning medicines; blood tests may be necessary);
• rifampicin, clarithromycin, telithromycin (antibiotics used to treat infections);
• phenytoin (a medicine used to treat seizures);
• carbamazepine (a medicine used to treat depression and epilepsy);
• midazolam, triazolam, phenobarbital (sedatives or sleep aids);
• St. John's Wort (a herbal medicine used to treat depression);
• protease inhibitors (medicines used to treat HIV infection);
• ketoconazole, except when contained in a shampoo (a medicine used to treat Cushing's syndrome, when the body produces too much cortisol);
• itraconazole, voriconazole, posaconazole (antifungal medicines);
• nefazodone (a medicine used to treat depression);
• corticosteroids (such as dexamethasone and methylprednisolone);
• anxiolytics (such as alprazolam);
• tolbutamide (a medicine used to treat diabetes).

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take.

Pregnancy and breastfeeding

This medicine should not be used during pregnancy unless it is absolutely necessary. If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor for advice before taking this medicine. For information on contraception, see "Aprepitant Sandoz and other medicines". It is not known whether Aprepitant Sandoz passes into breast milk, so 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 starting treatment.

Driving and using machines

Remember that Aprepitant Sandoz may cause dizziness and drowsiness in some people. If this happens, do not drive or ride a bike, or operate machinery or tools (see "Possible side effects").

Aprepitant Sandoz contains sucrose

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

3. How to take Aprepitant Sandoz

Always take this medicine exactly as your doctor, pharmacist, or nurse has told you. If you are not sure, ask your doctor, pharmacist, or nurse. Aprepitant Sandoz is always taken with other medicines that prevent nausea and vomiting. After stopping Aprepitant Sandoz, your doctor may recommend continuing to take other medicines that prevent nausea and vomiting, including corticosteroids (such as dexamethasone) and 5HT3 antagonists (such as ondansetron). If you are unsure, ask your doctor, pharmacist, or nurse. The recommended dose is:

• on day 1: one 125 mg capsule 1 hour before the start of the chemotherapy session

and

• on days 2 and 3: one 80 mg capsule each day. If chemotherapy is not given, take the capsule in the morning. If chemotherapy is given, take the capsule 1 hour before the start of the chemotherapy session.

The medicine can be taken with or without food. Swallow the capsules whole with a drink of water.

Taking more Aprepitant Sandoz than prescribed

Do not take more medicine than your doctor has prescribed. If you have taken more than the prescribed dose, contact your doctor immediately.

Missing a dose of Aprepitant Sandoz

If you miss a dose, ask your doctor for advice. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Aprepitant Sandoz can cause side effects, although not everybody gets them.

If you experience any of the following side effects (which may be serious and require urgent medical attention), stop taking Aprepitant Sandoz and contact your doctor immediately:

• hives, rash, itching, difficulty breathing or swallowing (frequency not known, cannot be estimated from available data): these are symptoms of an allergic reaction. Other reported side effects are listed below:

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

• constipation, indigestion
• headache
• fatigue
• loss of appetite
• hiccups
• increased liver enzyme activity in the blood

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

• dizziness, drowsiness
• acne, rash
• restlessness
• belching, nausea, vomiting, heartburn, stomach pain, dry mouth, gas
• severe pain or burning when urinating
• weakness, general feeling of being unwell
• flushing, feeling of warmth or redness of the skin
• rapid or irregular heartbeat
• fever with increased risk of infection, reduced red blood cell count

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

• thought disorders, lack of energy, taste disorders
• increased sensitivity of the skin to sunlight, excessive sweating, oiliness of the skin, skin changes, itching rash, Stevens-Johnson syndrome/toxic epidermal necrolysis (a rare, severe skin reaction)
• euphoria (strong feeling of happiness), disorientation
• bacterial infection, fungal infection
• severe constipation, stomach ulcer, inflammation of the small and large intestine, mouth ulcers, bloating
• increased urination, passing more urine than usual, presence of sugar or blood in the urine
• discomfort in the chest, swelling, change in walking
• cough, phlegm in the back of the throat, throat irritation, sneezing, sore throat
• eye discharge and itching
• ringing in the ears
• muscle spasms, muscle weakness
• excessive thirst
• slow heartbeat, heart disease and blood vessel disorders
• reduced white blood cell count, low sodium levels in the blood, weight loss

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301/fax: +48 22 49 21 309/website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Aprepitant Sandoz

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of that month. There are no special storage instructions for this medicine. Take the capsule out of the blister pack immediately before taking the medicine. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Aprepitant Sandoz contains

The active substance is aprepitant. Aprepitant Sandoz, 80 mgEach hard capsule contains 80 mg of aprepitant. Aprepitant Sandoz, 125 mgEach hard capsule contains 125 mg of aprepitant. The other ingredients are sucrose, microcrystalline cellulose spheres 500, hydroxypropylcellulose, sodium lauryl sulfate, gelatin, titanium dioxide (E 171). The 125 mg capsules also contain iron oxide red (E 172).

What Aprepitant Sandoz looks like and contents of the pack

Aprepitant Sandoz, 80 mgOpaque white capsules with a white body and white cap, containing white or almost white pellets. Aprepitant Sandoz, 125 mgOpaque white capsules with a white body and pink cap, containing white or almost white pellets. The medicine is available in a 3-day treatment pack, containing one blister with a 125 mg capsule and one blister with 80 mg capsules.

Marketing authorization holder

Sandoz GmbH Biochemiestrasse 10 6250 Kundl, Austria

Manufacturer

Rontis Hellas Medical and Pharmaceutical Products S.A. P.O. Box 3012 Larissa Industrial Area 41 500 Larissa, Greece Lek Pharmaceuticals d.d. Verovškova ulica 57 1526 Ljubljana, Slovenia

For more information on this medicine and its authorized names in the European Economic Area, contact:

Sandoz Polska Sp. z o.o. ul. Domaniewska 50 C 02-672 Warsaw tel. 22 209 70 00 Date of last revision of the leaflet:03/2024 Sandoz logo