Label: information for the user

EMEND 125mg hard capsules

EMEND 80mg hard capsules

aprepitant

Read this label carefully before starting to take this medication, as it contains important information for you.If you are the parent of a child taking EMEND, read this information carefully.

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you or the child, and should not be given to otherseven if they have the same symptoms, as it may harm them.
• If you or the child experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label.See section4.

1.What is EMEND and what it is used for

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

3.How to take EMEND

4.Adverse effects

5.Storage of EMEND

6.Contents of the package and additional information

EMEND contains the active ingredient aprepitant and belongs to a group of medications called "NK1receptor antagonists". The brain has a specific area that controls nausea and vomiting. EMEND acts by blocking signals to this area, thereby reducing nausea and vomiting. EMEND capsules are used in adults and adolescents aged 12years or older,in combinationwith other medicationsto 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 EMEND

• If you or the child are allergic to aprepitant or any of the other components of this medication (listed in section6).
• 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 EMEND.

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to take EMEND or giving the child this medication.

Before treatment with EMEND, 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 the condition of your liver or the child's liver.

Children and adolescents

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

Other medications and EMEND

EMEND may affect other medications during and after treatment with EMEND. There are some medications that should not be taken with EMEND (such as pimozide, terfenadine, astemizol and cisaprida) or that require a dose adjustment (see also‘Do not take EMEND’).

The effects of EMEND or other medications may be influenced if you or the child take EMEND 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 EMEND. During treatment with EMEND and for up to 2 months after using EMEND, 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 tranquilize or to 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),
• Medications for anxiety (such as alprazolam),
• Tolbutamida (a medication used to treat diabetes).

Inform your doctor or pharmacist 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 or the child are pregnant or breastfeeding, or intend to become pregnant, consult your doctor before using this medication.

For information related to birth control, see‘Other medications and EMEND’.

The safety of EMEND during breastfeeding 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 or the child are breastfeeding or plan to breastfeed.

Driving and operating machinery

Some people may experience dizziness and sleepiness after taking EMEND. If you or the child feel dizzy or sleepy, avoid driving, riding a bicycle, or using machines or tools after taking this medication (see‘Side effects’).

EMEND contains sucrose

EMEND capsules contain sucrose. If your doctor has indicated that you or the child have an intolerance to certain sugars, consult with them before taking this medication.

EMEND contains sodium

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

Follow exactly the administration instructions for this medication as indicated for you or for the child by your doctor, pharmacist, or nurse.If in doubt, consult your doctor, pharmacist, or nurse again.Take EMEND always with other medications to prevent nausea and vomiting.After treatment with EMEND, your 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 EMEND is:

Day 1:

• one 125 mg capsule 1 hour before starting chemotherapy

and

Days 2 and 3:

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

EMEND can be taken with or without food.

Swallow the entire capsule with some liquid.

If you take more EMEND than you should

Do not take more capsules than your doctor recommends. If you or the child have taken too many capsules, contact your doctor immediately.

If you forgot to take EMEND

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 medicinecan cause side effects, although not everyone will experience them.

Stop taking EMEND 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.

Other side effects that have been reported are listed below.

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

• 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 1in 100people)are:

• Dizziness, somnolence,
• Acne, hives,
• Anxiety,
• Belching, nausea, vomiting, heartburn, stomach pain, dry mouth, flatulence,
• Painful or burning urination,
• Weakness, general feeling of illness,

• Flushes/flushing 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 1in 1,000people)are:

Reporting of side effects

If you or the child 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 thenational notification system included in theAppendix V. 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. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture.

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

Medicines should not be disposed of through drains or in the trash.Ask your pharmacist how to dispose of the packaging and unused medications. This will help protect the environment.

Composition of EMEND

• The active ingredient is aprepitant. Each hard capsule of 125 mg contains 125 mg of aprepitant. Each hard capsule of 80 mg contains 80 mg of aprepitant.
• The other components are sucrose, microcrystalline cellulose (E-460), hydroxypropyl cellulose (E-463), lauryl sulfate of sodium, gelatin, titanium dioxide (E-171), lacquer, potassium hydroxide, and iron oxide black (E-172); the hard capsule of 125 mg also contains iron oxide red (E-172) and iron oxide yellow (E-172).

Appearance of the product and contents of the pack

The hard capsule of 125 mg is opaque with a white body and a pink cap with “462” and “125 mg” printed in black ink in a radial manner on the body.

The hard capsule of 80 mg is opaque with a white body and cap with “461” and “80 mg” printed in black ink in a radial manner on the body.

The hard capsules of EMEND 125 mg and 80 mg are supplied in the following pack sizes:

• Aluminium blister containing one 80 mg capsule
• Package for a 2-day treatment containing two 80 mg capsules
• 5 aluminium blisters containing one 80 mg capsule each
• Aluminium blister containing one 125 mg capsule
• 5 aluminium blisters containing one 125 mg capsule each
• Package for a 3-day treatment containing one 125 mg capsule and two 80 mg capsules

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Responsible Person

For more information about this medicinal product, please contact the local representative of the marketing authorisation holder:

Last update of this leaflet:

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.