APREPITANT SANDOZ 125 mg HARD CAPSULES / APREPITANT SANDOZ 80 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

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

Read all of this leaflet carefully before you start taking 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 leaflet, you may need to read it again.
• 1. 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, 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 is Aprepitant Sandoz and what is it used for
2. What you need to know before you take or give Aprepitant Sandoz
3. How to take Aprepitant Sandoz
4. Possible side effects

5 Storage of Aprepitant Sandoz

1. Contents of the pack and further information

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

Aprepitant Sandoz 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 controls nausea and vomiting. Aprepitant works by blocking the signals to this area, and thus reducing nausea and vomiting. Aprepitant is used in adults and adolescents from 12 years of age, in combination with other medicinesto prevent nausea and vomiting caused by a type of chemotherapy (cancer treatment) that induces strong and moderate nausea and vomiting (such as cisplatin, cyclophosphamide, doxorubicin or epirubicin).

2. What you need to know before you take or give Aprepitant Sandoz

Do not take Aprepitant Sandoz:

• if you or the child are allergic to aprepitant or any of the other ingredients of this medicine (listed in section 6).
• with medicines that contain pimozide (used to treat psychiatric disorders), terfenadine and astemizole (used for allergic rhinitis and other allergic disorders), cisapride (used to treat digestive problems). Tell your doctor if you or the child are taking these medicines, as the treatment must be modified before you or the child start taking aprepitant.

Warnings and precautions

Talk to your doctor or pharmacist before you start taking aprepitant or give it to the child.

Before treatment with aprepitant, tell your doctor if you or the child have liver disease, because the liver is important for removing the medicine from the body. Therefore, your doctor may need to check the state of your liver or the child's liver.

Children and adolescents

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

Using Aprepitant Sandoz with other medicines

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

The effects of aprepitant or other medicines may be influenced if you or the child take aprepitant with other medicines, including those listed below. Talk to your doctor or pharmacist if you or the child are taking any of the following medicines:

• contraceptives that may include birth control pills, skin patches, implants and certain intrauterine devices (IUDs) that release hormones, may not work properly when taken with aprepitant. During treatment with aprepitant and up to 2 months after using this medicine, non-hormonal methods or additional methods of contraception should be used,
• cyclosporine, tacrolimus, sirolimus, everolimus (immunosuppressants),
• alfentanil, fentanyl (used to treat pain),
• quinidine (used to treat irregular heartbeats),
• irinotecan, etoposide, vinorelbine, ifosfamide (medicines used to treat cancer),
• medicines that contain ergot derivatives, such as ergotamine or dihydroergotamine (used to treat migraines),
• warfarin, acenocoumarol (blood thinners; blood tests may be needed),
• rifampicin, clarithromycin, telithromycin (antibiotics used to treat infections),
• phenytoin (a medicine used to treat seizures),
• carbamazepine (used to treat depression and epilepsy),
• midazolam, triazolam, phenobarbital (medicines used to calm or help sleep),
• St. John's Wort (a plant-based preparation used to treat depression),
• protease inhibitors (used to treat HIV infections),
• ketoconazole, except 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),
• medicines for anxiety (such as alprazolam),
• tolutamide (a medicine used to treat diabetes).

Tell your doctor if you or the child are taking, have recently taken or might take any other medicines.

Pregnancy and breastfeeding

Do not use this medicine during pregnancy unless clearly necessary. If you are pregnant or breastfeeding, may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

For information on birth control, see ‘Using Aprepitant Sandoz with other medicines’.

It is not known if aprepitant passes into breast milk; therefore, breastfeeding is not recommended during treatment with this medicine. It is important to tell your doctor before taking this medicine if you are breastfeeding or plan to breastfeed.

Driving and using machines

It should be taken into account that some people feel dizzy and drowsy after taking aprepitant. If you or the child feel dizzy or drowsy, avoid driving, cycling or using machines or tools after taking this medicine (see ‘Possible side effects’).

Aprepitant Sandoz contains sucrose

This medicine contains sucrose. If your doctor has told you that you have an intolerance to some sugars, talk to them before taking this medicine.

Aprepitant Sandoz contains sodium

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

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, talk to your doctor, pharmacist or nurse. Take aprepitant always with other medicines to prevent nausea and vomiting. After treatment with aprepitant, your doctor may ask you or the child to continue taking other medicines to prevent nausea and vomiting, including corticosteroids (such as dexamethasone) and a ‘5-HT3 antagonist’ (such as ondansetron). If you are in doubt, talk to your doctor, pharmacist or nurse again.

The recommended oral dose of aprepitant is

Day 1:

• one 125 mg capsule 1 hour before starting 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 capsule whole 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, talk to your doctor or pharmacist or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Aprepitant Sandoz

If you or the child have missed 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, this medicine can cause side effects, although not everybody gets them.

Stop taking Aprepitant Sandoz and contact your doctor immediately if you or the child notice any of the following side effects, which may be serious and require urgent medical attention:

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

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

• constipation, indigestion,
• headache,
• fatigue,
• loss of appetite,
• hypo,
• increase in liver enzymes in the blood.

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

• dizziness, drowsiness,
• acne, rash,
• anxiety,
• belching, nausea, vomiting, heartburn, stomach pain, dry mouth, flatulence,
• increased painful urination or burning,
• weakness, general malaise,
• flushing/redness of the face or skin,
• rapid or irregular heartbeat,
• fever with high risk of infection, decrease in red blood cells.

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

• difficulty thinking, lack of energy, alteration of taste,
• sensitivity of the skin to the sun, excessive sweating, oily skin, skin ulcers, 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 ulcers, abdominal swelling,
• frequent urination, urinating more than usual, presence of sugar or blood in the urine,
• chest discomfort, swelling, changes in gait,
• cough, mucus 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, blood vessel problems and vein problems,
• decrease in white blood cells, low sodium levels in the blood, weight loss,

Reporting of side effects

If you experience 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 Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Aprepitant Sandoz

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 the month shown.

This medicine does not require any special storage conditions.

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 further information

Composition of Aprepitant Sandoz

• The active substance 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 ingredients are: sucrose, microcrystalline cellulose (E460), hydroxypropylcellulose (E463), sodium lauryl sulfate, gelatin, titanium dioxide (E171); the 125 mg hard capsule also contains red iron oxide (E172).

Appearance and packaging

A 3-day treatment pack containing one blister pack with one 125 mg capsule and one blister pack with two 80 mg capsules.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Rontis Hellas S.A.,

Medical and Pharmaceutical Products,

38, Sorou Str.

Athens, 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 authorised in the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet:June 2023

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.es/.