Prospect: information for the user

Aprepitant Sandoz 125 mg hard capsules EFG/Aprepitant Sandoz 80 mg hard capsules EFG

Read this prospect carefully before starting to take this medicine,

because it contains important information for you. If you are the parent of a child who

is taking Aprepitant Sandoz, please read this information carefully.

• Keep this prospect, as you may need to read it again.
• 1. If you have any doubts, consult yourdoctor orpharmacist.

-This medicine has been prescribedonlyto you, and you must not give it to other people even iftheyhavethe same symptomsas you,as it may harm them.

• If you experience any adverse effects,consult your doctor, pharmacist or nurse,evenifthey are not listed in this prospect. See section 4.

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

2.What you need to knowbeforestarting totake or give Aprepitant Sandoz

3.How to take Aprepitant Sandoz

4.Possible adverse effects

5Storage of Aprepitant Sandoz

6.Contents of the package and additional information

Aprepitant Sandoz contains the active ingredient aprepitant and belongs to a group of medicines called "neurokinin 1 (NK1) receptor antagonists". The brain has a specific area that controls nausea and vomiting. Aprepitant acts by blocking signals to this area, thereby reducing nausea and vomiting. Aprepitant is used in adults and adolescents aged 12 years and older,in combination with other medicinesto prevent nausea and vomiting caused by a type of chemotherapy (cancer treatment) that triggers strong to moderate nausea and vomiting (such as cisplatin, cyclophosphamide, doxorubicin, or epirubicin).

Do not take Aprepitant Sandoz:

• if you or the child are allergic to aprepitant or to any of the other components of this medication (listed in section 6).
• with medications that contain pimozide (used to treat psychiatric disorders), terfenadine and astemizol (used to treat allergic rhinitis and other allergic disorders), cisaprida (used to treat digestive problems). Inform your doctor if you or the child are taking these medications, as the treatment must be modified before you or the child start taking aprepitant.

Warnings and precautions:

Consult your doctor or pharmacist before starting to take aprepitant or giving the child this medication.

Before treatment with aprepitant, inform your doctor if you or the child have liver disease, as the liver is important for eliminating the medication from the body. Therefore, your doctor may need to monitor your liver function or that of the child.

Children and adolescents:

Do not give aprepitant 80 mg and 125 mg to children under 12 years of age, as the 80 mg and 125 mg capsules have not been studied in this population.

Use of Aprepitant Sandoz with other medications:

This medication may affect other medications during and after treatment with aprepitant (the active ingredient of Aprepitant Sandoz). There are some medications that should not be taken with aprepitant (such as pimozide, terfenadine, astemizol, and cisaprida) or that require a dose adjustment (see also ‘Do not take Aprepitant Sandoz’).

The effects of aprepitant or other medications may be influenced if you or the child take aprepitant with other medications, including the following. Consult your doctor or pharmacist if you or the child are taking any of the following medications:

• birth control medications that may include oral contraceptives, skin patches, implants, and certain intrauterine devices (IUDs) that release hormones, may not work properly when taken with aprepitant. During treatment with aprepitant and for up to 2 months after using this medication, other methods or additional non-hormonal methods of contraception should be used,
• ciclosporin, tacrolimus, sirolimus, everolimus (immunosuppressants),
• alfentanilo, fentanilo (used to treat pain),
• quinidina (used to treat irregular heartbeats),
• irinotecán, etopósido, vinorelbina, ifosfamida (medications used to treat cancer),
• medications that contain ergot alkaloids, such as ergotamine or dihydroergotamine (used to treat migraines),
• warfarina, acenocumarol (blood thinners; blood tests may be required),
• rifampicina, claritromicina, telitromicina (antibiotics used to treat infections),
• fenitoína (a medication used to treat seizures),
• carbamazepina (used to treat depression and epilepsy),
• midazolam, triazolam, fenobarbital (medications used to calm or help sleep),
• St. John's Wort (a herbal preparation used to treat depression),
• protease inhibitors (used to treat HIV infections),
• ketoconazol, except for shampoo (used to treat Cushing's syndrome - when the body produces an excess of cortisol),
• itraconazol, voriconazol, posaconazol (antifungals),
• nefazodona (used to treat depression),
• corticosteroids (such as dexametasona and metilprednisolona),
• anxiety medications (such as alprazolam),
• tolbutamida (a medication used to treat diabetes).

Inform your doctor if you or the child are taking, have taken recently, or may need to take any other medication.

Pregnancy and breastfeeding:

This medication should not be used during pregnancy unless it is clearly necessary. If you are pregnant or breastfeeding, or if you are planning to become pregnant, consult your doctor before using this medication.

For information related to birth control, see ‘Use of Aprepitant Sandoz with other medications’.

The passage of aprepitant into breast milk is unknown; therefore, breastfeeding is not recommended during treatment with this medication. It is essential to inform your doctor before taking this medication if you are breastfeeding your baby or plan to do so.

Driving and operating machinery:

Some people may feel dizzy and drowsy after taking aprepitant. If you or the child feel dizzy or drowsy, avoid driving, riding a bicycle, or using machines or tools after taking this medication (see ‘Possible side effects’).

Aprepitant Sandoz contains saccharose:

This medication contains saccharose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

Aprepitant Sandoz contains sodium:

This medication contains less than 23 mg of sodium (1 mmol) per capsule; this is, essentially “sodium-free”.

Follow exactly the administration instructions for this medication indicated for you or for the child by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse again. Take aprepitant always with other medications to prevent nausea and vomiting. After treatment with aprepitant, the doctor may ask you or the child to continue taking other medications to prevent nausea and vomiting, including corticosteroids (such as dexamethasone) and a '5-HT3 antagonist' (such as ondansetron). If in doubt, consult your doctor, pharmacist, or nurse again.

The recommended oral dose of aprepitant is

Day 1:

• one 125 mg capsule 1 hour before starting your chemotherapy session,

and

Days 2 and 3:

• one 80 mg capsule each day.
• If you are not receiving chemotherapy, take aprepitant in the morning.
• If you are receiving chemotherapy, take aprepitant 1 hour before starting your chemotherapy session.

Aprepitant can be taken with or without food. Swallow the entire capsule with some liquid.

If you take more Aprepitant Sandoz than you should

Do not take more aprepitant than your doctor recommends. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Aprepitant Sandoz

If you or the child have forgotten a dose, ask your doctor for advice.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Stop taking Aprepitant Sandoz and seek medical attention immediately if you or the child notice any of the following side effects, which may be serious, and for which you or the child may need urgent medical treatment:

• Hives, itching, difficulty breathing or swallowing (unknown frequency, cannot be estimated from available data); these are signs of an allergic reaction. The following are other side effects that have been reported.

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

• Constipation, indigestion,
• Headaches,
• Fatigue,
• Loss of appetite,
• Low blood pressure,
• Increased levels of liver enzymes in the blood.

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

• Dizziness, somnolence,
• Acne, hives,
• Anxiety,
• Belching, nausea, vomiting, heartburn, stomach pain, dry mouth, flatulence,
• Painful or itchy urination,
• Weakness, general discomfort,
• Flushes/redness of the face or skin,
• Irregular or rapid heartbeats,
• Fever with a high risk of infection, decreased red blood cells.

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

• Difficulty thinking, lack of energy, altered taste,
• Sensitivity to sunlight, excessive sweating, oily skin, skin lesions, itchy rash, Stevens-Johnson syndrome/toxic epidermal necrolysis (rare severe skin reaction),
• Euphoria (extreme feeling of happiness), disorientation,
• Bacterial infection, fungal infection,
• Severe constipation, stomach ulcer, inflammation of the small intestine and colon, mouth sores, abdominal swelling,
• Frequent urination, urinating more than usual, presence of sugar or blood in the urine,
• Chest discomfort, swelling, changes in gait,
• Cough, mucous in the back of the throat, throat irritation, sneezing, sore throat,
• Eye secretion and itching,
• Tinnitus,
• Muscle spasms, muscle weakness,
• Excessive thirst,
• Slow heartbeats, problems with blood vessels and veins,
• Decreased white blood cells, low sodium levels in the blood, weight loss,

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD/EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Do not remove the capsule from its blister pack until it is time to take it.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE Collection Pointat the pharmacy.Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Aprepitant Sandoz

• The active ingredient is aprepitant.

Aprepitant Sandoz 80 mg hard capsules

Each hard capsule contains 80 mg of aprepitant.

Aprepitant Sandoz 125 mg hard capsules

Each hard capsule contains 125 mg of aprepitant.

The other components are: sucrose, microcrystalline cellulose (E460), hydroxypropyl cellulose (E463), lauryl sulfate of sodium, gelatin, titanium dioxide (E171); the 125 mg hard capsule also contains iron oxide red (E172).

Appearance of the product and contents of the package

Packaging for a 3-day treatment that contains a blister with a 125 mg capsule and a blister with two 80 mg capsules.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer responsible

Rontis Hellas S.A.,

Medical and Pharmaceutical Products,

38, Sorou Str.

Atenas, Maroussi, 15125

Greece

or

Rontis Hellas S.A.,

Medical and Pharmaceutical Products

Larissa Industrial Area,

P.O. Box 3012,

Larissa 41500

Greece

or

Lek Pharmaceuticals d.d.

Verovškova ulica 57

Ljubljana 1526

Slovenia

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:June 2023

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.es/.