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

Patient Information Leaflet

Introduction

Patient Information Leaflet

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

Read the entire leaflet carefully before you start taking this medicine,

because it contains important information for you. If you are the parent of a child taking Aprepitant Sandoz, please read this information carefully.

• Keep this leaflet, as you may need to read it again.

  1. If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.

  • If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if these effects are not listed in this leaflet. See section 4.

Leaflet Contents

1. What Aprepitant Sandoz is and what it is used for
2. What you need to know before taking or giving Aprepitant Sandoz
3. How to take Aprepitant Sandoz
4. Possible side effects

5 Storage of Aprepitant Sandoz

1. Contents of the pack and other information

1. What Aprepitant Sandoz is and what it is 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 signals to this area, thereby reducing nausea and vomiting. Aprepitant is used in adults and adolescents from 12 years of age, in combination with other medicines, to prevent nausea and vomiting caused by a type of chemotherapy (cancer treatment) that strongly or moderately triggers nausea and vomiting (such as cisplatin, cyclophosphamide, doxorubicin or epirubicin).

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

Do not take Aprepitant Sandoz:

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take aprepitant or giving this medicine to the child.

Before treatment with aprepitant, inform your doctor if you or the child have liver disease, as the liver plays an important role in eliminating the medicine from the body. Therefore, your doctor may need to monitor the condition of your liver or that of the child.

Children and adolescents

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

Use of Aprepitant Sandoz with other medicines

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

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

• contraceptive medicines, which may include oral contraceptive pills, skin patches, implants, and certain hormone-releasing intrauterine devices (IUDs), may not work properly when taken with aprepitant. During treatment with aprepitant and for up to 2 months after using this medicine, additional non-hormonal 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 containing ergot alkaloids, such as ergotamine or dihydroergotamine (used to treat migraines),
• warfarin, acenocoumarol (blood thinners; blood tests may be required),
• 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 herbal 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 excess cortisol),
• itraconazole, voriconazole, posaconazole (antifungals),
• nefazodone (used to treat depression),
• corticosteroids (such as dexamethasone and methylprednisolone),
• medicines for anxiety (such as alprazolam),
• tolbutamide (a medicine used to treat diabetes).

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

Pregnancy and breastfeeding

You should not use this medicine during pregnancy unless clearly necessary. If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

For information regarding contraception, see ‘Use of Aprepitant Sandoz with other medicines’.

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

Driving and use of machines

Be aware that some people may feel dizzy or drowsy after taking aprepitant. If you or the child feel dizzy or drowsy, avoid driving, cycling, or operating machinery or tools after taking this medicine (see ‘Possible side effects’).

Aprepitant Sandoz contains sucrose

This medicine contains sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, consult your doctor before taking this medicine.

Aprepitant Sandoz contains sodium

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

3. How to take Aprepitant Sandoz

Follow exactly the instructions for taking this medicine given to you or to the child by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse again. Always take aprepitant together with other medicines used to prevent nausea and vomiting. After treatment with aprepitant, your doctor may instruct 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 in doubt, consult your doctor, pharmacist, or nurse again.

The recommended oral dose of aprepitant is:

Day 1:

• one 125 mg capsule, taken 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 may be taken with or without food. Swallow the capsule whole with a 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 Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Aprepitant Sandoz

If you or the child have forgotten a dose, seek advice from your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

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

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

• Constipation, indigestion,
• Headaches,
• Tiredness,
• Loss of appetite,
• Hiccups,
• Increased levels of liver enzymes in the blood.

Uncommon adverse 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 sensation,
• Weakness, general malaise,
• Hot flushes/flushing of the face or skin,
• Rapid or irregular heartbeat,
• Fever with increased risk of infection, decrease in red blood cells.

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

• Difficulty thinking, lack of energy, altered taste,
• Skin sensitivity to sunlight, excessive sweating, oily skin, skin sores, itchy rash, Stevens-Johnson syndrome/toxic epidermal necrolysis (rare severe skin reaction),
• Euphoria (feeling of extreme 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 normal, presence of sugar or blood in the urine,
• Chest discomfort, swelling, changes in walking pattern,
• Cough, mucus in the back of the throat, throat irritation, sneezing, sore throat,
• Eye discharge and itching,
• Tinnitus (ringing in the ears),
• Muscle spasms, muscle weakness,
• Excessive thirst,
• Slow heartbeat, problems with blood vessels of the heart and veins,
• Decrease in white blood cells, low sodium levels in the blood, weight loss.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 stated on the packaging after CAD/EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Do not remove the capsule from its blister until the time of administration.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other 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 components 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).

Nature of the product and contents of the pack

Pack for a 3-day treatment containing one blister with one 125 mg capsule and one blister with two 80 mg capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Parque Norte Business Park

Roble Building

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

Date of the last review of this leaflet: June 2023

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