EMEND 125 mg HARD CAPSULES / EMEND 80 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

EMEND 125mg hard capsules

EMEND 80mg hard capsules

aprepitant

Read all of this leaflet carefully before you or your child start taking this medicine, because it contains important information for you.If you are the parent of a child who is taking EMEND, read this information carefully.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you or your child only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you or your child 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

1. What is EMEND and what is it used for
2. What you need to know before you or your child take EMEND
3. How to take EMEND
4. Possible side effects
5. Storage of EMEND
6. Contents of the pack and other information

1. What is EMEND and what is it used for

EMEND 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. EMEND works by blocking the signals to this area, and thus reducing nausea and vomiting. EMEND hard capsules are used in adults and adolescents from 12 years of age, in combinationwith 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 or your child take EMEND

Do not take EMEND

• if you or your 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 your child are taking these medicines, as treatment needs to be modified before you or your child start taking EMEND.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before you or your child start taking EMEND.

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

Children and adolescents

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

Other medicines and EMEND

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

The effects of EMEND or other medicines may be influenced if you or your child take EMEND with other medicines, including those listed below. Talk to your doctor or pharmacist if you or your 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 EMEND. During treatment with EMEND and for 2 months after using EMEND, non-hormonal methods or additional methods of contraception should be used,
• ciclosporin, 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 alkaloids, 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 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 too much cortisol),
• itraconazole, voriconazole, posaconazole (antifungals),
• nefazodone (used to treat depression),
• corticosteroids (such as dexamethasone and methylprednisolone),
• anxiety medicines (such as alprazolam),
• tolutamide (a medicine used to treat diabetes).

Tell your doctor or pharmacist if you or your 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 or your child are pregnant or breastfeeding, or think you 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 ‘Other medicines and EMEND’.

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

Driving and using machines

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

EMEND contains sucrose

EMEND hard capsules contain sucrose. If your doctor has told you or your child that you have an intolerance to some sugars, talk to your doctor before taking this medicine.

EMEND contains sodium

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

3. How to take EMEND

Always take this medicine exactly as your doctor, pharmacist, or nurse has told you or your child. If you are not sure, talk to your doctor, pharmacist, or nurse. Take EMEND with other medicines to prevent nausea and vomiting. After treatment with EMEND, your doctor may ask you or your 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 unsure, talk to your doctor, pharmacist, or nurse.

The recommended oral dose of EMEND is:

Day 1:

• one 125 mg capsule 1 hour before starting the chemotherapy session

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 capsule whole with some liquid.

If you take more EMEND than you should

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

If you forget to take EMEND

If you or your 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 EMEND and contact your doctor immediately if you or your child notice any of the following serious side effects, for which you or your child may need urgent medical treatment:

• Hives, rash, itching, difficulty breathing or swallowing (frequency not known, cannot be estimated from the available data): these are signs of an allergic reaction.

Other side effects that have been reported are listed below.

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

• constipation, indigestion,
• headache,
• fatigue,
• loss of appetite,
• hiccups,
• increased amount of liver enzymes in the blood.

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

• dizziness, drowsiness,
• acne, rash,
• anxiety,
• belching, nausea, vomiting, heartburn, stomach pain, dry mouth, flatulence,
• increased painful or burning urination,
• weakness, general feeling of being unwell,

• flushing/redness of the face or skin,

• rapid or irregular heartbeat,
• fever with a high risk of infection, decreased red blood cells.

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

• difficulty thinking, lack of energy, altered taste,
• sensitivity of the skin to sunlight, excessive sweating, oily skin, skin ulcers, itchy rash, Stevens-Johnson syndrome/toxic epidermal necrolysis (a rare, severe skin reaction),
• euphoria (feeling of extreme happiness), disorientation,
• bacterial infection, fungal infection,
• severe constipation, stomach ulcers, inflammation of the small intestine and colon, mouth ulcers, abdominal swelling,
• increased need to urinate, urinating more than usual, presence of sugar or blood in the urine,
• chest discomfort, swelling, changes in walking,
• 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 and vein problems,
• decreased white blood cells, low sodium levels in the blood, weight loss,

Reporting of side effects

If you or your child 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 national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of EMEND

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 that month.

Store in the original package to protect from moisture.

Do not remove the capsule from the blister 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 other information

Composition of EMEND

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

Appearance and packaging

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

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

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

• Aluminum blister pack containing one 80 mg capsule
• 2-day treatment pack containing two 80 mg capsules
• 5 aluminum blister packs, each containing one 80 mg capsule
• Aluminum blister pack containing one 125 mg capsule
• 5 aluminum blister packs, each containing one 125 mg capsule
• 3-day treatment pack containing one 125 mg capsule and two 80 mg capsules

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

For further information on this medicine, contact the local representative of the marketing authorization holder:

Date of last revision of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu.