aprepitant: package leaflet

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 signals to that area, thereby reducing nausea and vomiting.
EMEND capsules are used in adults and adolescents from the age of 12 years in combination with other medicines to prevent nausea and vomiting caused by chemotherapy (cancer treatment) that are strong and moderate triggers of nausea and vomiting (such as cisplatin, cyclophosphamide, doxorubicin or epirubicin).

Do not take EMEND
- if you or the child is allergic to aprepitant or any of the other ingredients of this medicine (listed in section 6).
- with medicines containing pimozide (used to treat psychiatric illnesses), terfenadine and astemizole (used for hay fever and other allergic conditions), cisapride (used for treating digestive problems). Tell the doctor if you or the child is taking these medicines since the treatment must be modified before you or the child start taking EMEND.
Warnings and precautions
Talk to the doctor, pharmacist, or nurse before you take EMEND or give this medicine to the child.
Before treatment with EMEND, tell the doctor if you or the child have liver disease because the liver is important in breaking down the medicine in the body. The doctor may therefore have to monitor the condition of your or the child’s liver.
Children and adolescents
Do not give EMEND 80 mg and 125 mg capsules to children under 12 years of age, because the 80 mg and 125 mg capsules have not been studied in this population.

Other medicines and EMEND
EMEND can affect other medicines both 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 might be influenced if you or the child take EMEND together with other medicines including those listed below. Please talk to the doctor or pharmacist if you or the child is taking any of the following medicines:
- birth control medicines which can include birth control pills, skin patches, implants, and certain Intrauterine devices (IUDs) that release hormones may not work adequately when taken together with EMEND. Another or additional non-hormonal form of birth control should be used during treatment with EMEND and for up to 2 months after using EMEND,
- cyclosporine, tacrolimus, sirolimus, everolimus (immunosuppressants),
- alfentanil, fentanyl (used to treat pain),
- quinidine (used to treat an irregular heart beat),
- irinotecan, etoposide, vinorelbine, ifosfamide (medicines used to treat cancer),
- medicines containing ergot alkaloid derivatives such as ergotamine and diergotamine (used for treating 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 produce calmness or help you sleep),
- St. John’s Wort (an 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 an excess of cortisol),
- itraconazole, voriconazole, posaconazole (antifungals),
- nefazodone (used to treat depression),
- corticosteroids (such as dexamethasone and methylprednisolone),
- anti-anxiety medicines (such as alprazolam),
- tolbutamide (a medicine used to treat diabetes).
Tell the doctor or pharmacist if you or the child are taking, have recently taken, or might take any other medicines.
Pregnancy and breast-feeding
This medicine should not be used during pregnancy unless clearly necessary. If you or the child are pregnant or breast-feeding, may be pregnant or are planning to have a baby, ask the doctor for advice before taking this medicine.
For information regarding birth control, see ‘Other medicines and EMEND’.
It is not known whether EMEND is excreted in human milk; therefore, breast-feeding is not recommended during treatment with this medicine. It is important to tell the doctor if you or the child are breast-feeding or are planning to breast-feed before taking this medicine.
Driving and using machines
It should be taken into account that some people feel dizzy and sleepy after taking EMEND. If you or the child feels dizzy or sleepy, avoid driving, riding a bicycle or using machines or tools after taking this medicine (see ‘Possible side effects’).
EMEND contains sucrose
EMEND capsules contain sucrose. If you or the child have been told by your doctor that you or the child have an intolerance to some sugars, contact the doctor before taking this medicine.

EMEND contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.

Always take this medicine or give this medicine to the child exactly as the doctor, pharmacist or nurse has told you. You should check with the doctor, pharmacist or nurse if you are not sure. Always take EMEND together with other medicines, to prevent nausea and vomiting. After treatment with EMEND, the doctor may ask you or the child to continue taking other medicines including a corticosteroid (such as dexamethasone) and a ‘5-HT3 antagonist’ (such as ondansetron) for preventing nausea and vomiting. Check with the doctor, pharmacist or nurse if you are not sure.
The recommended oral dose of EMEND is:
Day 1:
- one 125 mg capsule 1 hour before you start your chemotherapy session and
Days 2 and 3:
- one 80 mg capsule each day
- If no chemotherapy is given, take EMEND in the morning.
- If chemotherapy is given, take EMEND 1 hour before you start 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 the doctor recommends. If you or the child has taken too many capsules, contact your doctor immediately.
If you forget to take EMEND
If you or the child has missed a dose, contact your doctor for advice.
If you have any further questions on the use of this medicine, ask the doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking EMEND and see a doctor 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, 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,
- tiredness,
- loss of appetite,
- hiccups,

- increased amount of liver enzymes in your blood.
Uncommon side effects (may affect up to 1 in 100 people) are:
- dizziness, sleepiness,
- acne, rash,
- anxiousness,
- burping, nausea, vomiting, heartburn, stomach pain, dry mouth, passing wind,
- increased painful or burning urination,
- weakness, generally feeling unwell,
- hot flush/reddening of the face or skin,
- fast or irregular heartbeats,
- fever with increased risk of infection, lowering of red blood cells.
Rare side effects (may affect up to1 in 1 000 people) are:
- difficulty thinking, lack of energy, taste disturbance,
- sensitivity of the skin to sun, excessive sweating, oily skin, sores on skin, itching 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, sores in mouth, bloating,
- frequent urination, passing more urine than normal, presence of sugar or blood in urine,
- chest discomfort, swelling, change in the manner of walking,
- cough, mucus in back of throat, throat irritation, sneezing, sore throat,
- eye discharge and itching,
- ringing in the ear,
- muscle spasms, muscle weakness,
- excessive thirst,
- slow heartbeat, heart and blood vessel disease,
- lowering of white blood cells, low sodium levels in the blood, weight loss.
Reporting of side effects
If you or the child gets 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.

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 in order to protect from moisture.
Do not remove the capsule from its blister until you are ready to take it.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What EMEND contains
- 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 laurilsulfate, gelatin, titanium dioxide (E 171), shellac, potassium hydroxide, and black iron oxide (E 172); the 125 mg hard capsule also contains red iron oxide (E 172) and yellow iron oxide (E 172).
What EMEND looks like and contents of the pack
The 125 mg hard capsule is opaque with a white body and pink cap with “462” and “125 mg” printed radially in black ink on the body.
The 80 mg hard capsule is opaque with a white cap and body with “461” and “80 mg” printed radially in black ink on the body.
EMEND 125 mg and 80 mg hard capsules are supplied in the following pack sizes:
- Aluminium blister containing one 80 mg capsule
- 2-day treatment pack containing two 80 mg capsules
- 5 Aluminium blisters each containing one 80 mg capsule
- Aluminium blister containing one 125 mg capsule
- 5 Aluminium blisters 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 Authorisation Holder and Manufacturer
Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
België/Belgique/Belgien
MSD Belgium
Tél/Tel: +32(0)27766211 dpoc_belux@msd.com
Lietuva
UAB Merck Sharp & Dohme
Tel. +370 5 2780 247 dpoc_lithuania@msd.com
България
Мерк Шарп и Доум България ЕООД
Тел.: +359 2 819 3737 info-msdbg@msd.com
Luxembourg/Luxemburg
MSD Belgium
Tél/Tel: +32(0)27766211 dpoc_belux@msd.com
Česká republika
Merck Sharp & Dohme s.r.o.
Tel.: +420 277 050 000 dpoc_czechslovak@msd.com
Magyarország
MSD Pharma Hungary Kft.
Tel.: +36 1 888 5300 hungary_msd@msd.com
Danmark
MSD Danmark ApS
Tlf.: +45 4482 4000 dkmail@msd.com
Malta
Merck Sharp & Dohme Cyprus Limited
Tel: 8007 4433 (+356 99917558) dpoccyprus@msd.com

Deutschland
MSD Sharp & Dohme GmbH
Tel.: +49 (0) 89 20 300 4500 medinfo@msd.de
Nederland
Merck Sharp & Dohme B.V.
Tel: 0800 9999000
(+31 23 5153153) medicalinfo.nl@msd.com
Eesti
Merck Sharp & Dohme OÜ
Tel: +372 614 4200 dpoc.estonia@msd.com
Norge
MSD (Norge) AS
Tlf: +47 32 20 73 00 medinfo.norway@msd.com
Eλλάδα
MSD Α.Φ.Ε.Ε.
Τηλ: +30 210 98 97 300 dpoc.greece@msd.com
Österreich
Merck Sharp & Dohme Ges.m.b.H.
Tel: +43 (0) 1 26 044 dpoc_austria@msd.com
España
Merck Sharp & Dohme de España, S.A.
Tel: +34 91 321 06 00 msd_info@msd.com
Polska
MSD Polska Sp. z o.o.
Tel.: +48 22 549 51 00 msdpolska@msd.com
France
MSD France
Tél: +33 (0)1 80 46 40 40
Portugal
Merck Sharp & Dohme, Lda
Tel.: +351 21 4465700 inform_pt@msd.com
Hrvatska
Merck Sharp & Dohme d.o.o.
Tel: +385 1 6611 333 dpoc.croatia@msd.com
România
Merck Sharp & Dohme Romania S.R.L.
Tel.: +40 21 529 29 00 msdromania@msd.com
Ireland
Merck Sharp & Dohme Ireland (Human
Health) Limited
Tel: +353 (0)1 2998700 medinfo_ireland@msd.com
Slovenija
Merck Sharp & Dohme, inovativna zdravila d.o.o.
Tel: +386 1 520 4201 msd.slovenia@msd.com
Ísland
Vistor ehf.
Sími: +354 535 7000
Slovenská republika
Merck Sharp & Dohme, s. r. o.
Tel.: +421 2 58282010 dpoc_czechslovak@msd.com
Ιtalia
MSD Italia S.r.l.
Tel: 800 23 99 89 (+39 06 361911) dpoc.italy@msd.com
Suomi/Finland
MSD Finland Oy
Puh/Tel: +358 (0)9 804 650 info@msd.fi
Κύπρος
Merck Sharp & Dohme Cyprus Limited
Τηλ: 800 00 673 (+357 22866700) dpoccyprus@msd.com
Sverige
Merck Sharp & Dohme (Sweden) AB
Tel: +46 77 5700488 medicinskinfo@msd.com
Latvija
SIA Merck Sharp & Dohme Latvija
Tel.: +371 67025300 dpoc.latvia@msd.com

This leaflet was last revised in
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site:
https://www.ema.europa.eu.

drinking water.

from the mixing cup.
Make sure no air is in the oral dispenser (if air is present, remove).

mixing cup.

back into the mixing cup.

contains 125 mg of aprepitant which is to be suspended in 4.6 mL of water giving a final concentration of 25 mg/mL.
Hold the EMEND powder for oral suspension sachet upright and shake the contents to the bottom before opening the sachet.

4.6 mL of water in the mixing cup and snap the lid shut.
7.
Mix the EMEND suspension gently by swirling
20 times; then gently invert the mixing cup
5 times.
To prevent foaming, do not shake the mixing cup.
The mixture will be cloudy pink to light pink.

8.
Check the EMEND mixture for any clumps or foaming:
- If any clumps are present, repeat Step 7 until there are no clumps.
- If there is any foam, wait for the foam to disappear before going on to Step 9.
9.
Fill the oral dispenser with the prescribed dose from the mixing cup according to the table below.
- Choose the oral dispenser based on dose:
- Use 1 mL oral dispenser if dose is
1 mL or less.
- Use 5 mL oral dispenser if dose is more than 1 mL.
- It is common to have medicine leftover in the cup.
Make sure no air is in the oral dispenser (if air is present, remove).
Make sure the oral dispenser contains the prescribed dose.

Day 1
Day 2
Day 3
EMEND oral suspension
25 mg/mL
3 mg/kg orally
Maximum dose 125 mg
2 mg/kg orally
Maximum dose 80 mg
2 mg/kg orally
Maximum dose 80 mg
10. Place the cap on the oral dispenser until it clicks.
11. If the dose is not administered immediately after measuring, store filled oral dispenser(s) in the refrigerator between 2 °C-8 °C for up to 72 hours prior to use. When dispensing dose(s) to the caregiver, instruct them to refrigerate the oral dispenser(s) until they are ready to administer the dose.
12. The oral suspension can be kept at room temperature (not above 30 °C) for up to 3 hours, prior to administration.
Discard any remaining suspension and waste material.
Any unused medicinal product or waste material should be disposed of in accordance with local regulations.