EMEND 80 mg Hard Capsule

Зміст інструкції

1. EMEND 125 mg hard capsules, 80 mg hard capsules
   1. What is EMEND and what is it used for
   2. What you need to know before you take or administer EMEND
   3. How to take EMEND
   4. Possible side effects
   5. How to store EMEND
   6. Contents of the pack and other information
2. EMEND 125 mg powder for oral suspension
   1. What is EMEND and what is it used for
   2. What you need to know before giving EMEND
   3. How to administer EMEND
   4. Possible side effects
   5. How to store EMEND
   6. Content of the pack and other information

EMEND 125 mg hard capsules, 80 mg hard capsules

aprepitant

Read this leaflet carefully before taking this medicine as it contains important information for you. If you are the parent of a child being treated with EMEND, read this information carefully.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed only for you or the child. Do not give it to other people, even if they have the same symptoms, as it could be harmful.
• If you or the child experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

• 1. What EMEND is and what it is used for
• 2. What you need to know before taking or administering EMEND
• 3. How to take EMEND
• 4. Possible side effects
• 5. How to store 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 (NK) receptor antagonists”. The brain has a specific area that controls
nausea and vomiting. EMEND works by blocking the signals sent to that area, thus reducing nausea
and vomiting. EMEND capsules are used in adults and adolescents 12 years of age and older together
with other medicinesto prevent nausea and vomiting caused by chemotherapeutic treatments (cancer treatments) that are strong and moderate inducers of nausea and vomiting
(e.g. cisplatin, cyclophosphamide, doxorubicin or epirubicin).

2. What you need to know before you take or administer EMEND

Do not take EMEND

• 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 (a substance used for the treatment of mental illnesses), terfenadine and astemizole (used for hay fever and other allergies), cisapride (used for the treatment of digestive problems). Tell your doctor if you or the child are taking these medicines as the therapy may need to be modified before you or the child start taking EMEND.

Warnings and precautions
Consult your doctor, pharmacist or nurse before taking EMEND or administering
this medicine to the child.
Before treatment with EMEND, tell your doctor if you or the child have a liver disease
because the liver is important for metabolizing the medicine within the body. Your doctor may
therefore need to check the condition of your liver or that of the child.

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

Other medicines and EMEND
EMEND can have effects on other medicines both during and after treatment with EMEND. There are some medicines that must 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 of other medicines may be affected if you or the child take
EMEND together with other medicines including those listed below. Tell your doctor or pharmacist
if you or the child are taking any of the following medicines:

• medicines for birth control that may include contraceptive pills, skin patches, implants, and some intrauterine devices (IUDs) that release hormones may not work properly when taken together with EMEND. During treatment with EMEND and for up to 2 months after use of EMEND, another or an additional non-hormonal method of birth control must be used,
• cyclosporine, tacrolimus, sirolimus, everolimus (immunosuppressants),
• alfentanil, fentanyl (used for the treatment of pain),
• quinidine (used for the treatment of an irregular heartbeat),
• irinotecan, etoposide, vinorelbine, ifosfamide (medicines used for the treatment of cancer),
• medicines containing alkaloids derived from ergot such as ergotamine and dihydroergotamine (used for the treatment of migraine),
• warfarin, acenocoumarol (anticoagulants; blood tests may be required),
• rifampicin, clarithromycin, telithromycin (antibiotics used for the treatment of infections),
• phenytoin (a medicine used for the treatment of seizures),
• carbamazepine (used for the treatment of depression and epilepsy),
• midazolam, triazolam, phenobarbital (medicines used to calm or help sleep),
• St. John's wort (a herbal remedy used for the treatment of depression),
• protease inhibitors (used for the treatment of HIV infections),
• ketoconazole except shampoo (used to treat Cushing's syndrome, characterized by excessive cortisol production by the body),
• itraconazole, voriconazole, posaconazole (antifungals),
• nefazodone (used for the treatment of depression),
• corticosteroids (such as dexamethasone and methylprednisolone),
• anti-anxiety medicines (such as alprazolam),
• tolbutamide (a medicine used for the treatment of diabetes).

Tell your doctor or pharmacist if you or the child are taking, have recently taken, or
may take any other medicine.

Pregnancy and breastfeeding
This medicine should not be used during pregnancy unless it is clearly
necessary. If you or the child are pregnant, suspect or are planning a
pregnancy or if you are breastfeeding, ask your doctor for advice before taking this
medicine.
For information on birth control, see “Other medicines and EMEND”.
It is not known whether EMEND is excreted in human milk; breastfeeding is therefore not recommended
during treatment with this medicine. It is important to tell
your doctor if you or the child are breastfeeding or are thinking of breastfeeding.

Driving and using machines
It should be taken into consideration that some people experience dizziness and drowsiness after
taking EMEND. If you or the child experience dizziness or drowsiness, avoid driving vehicles, riding a bicycle or using machinery or tools after taking this medicine
(see “Possible side effects”).

EMEND contains sucrose
EMEND capsules contain sucrose. If your doctor has diagnosed you or the child with an
intolerance to certain sugars, contact them before taking this medicine.

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

3. How to take EMEND

Always take this medicine or administer this medicine to the child exactly as
instructed by your doctor, pharmacist or nurse. If you have any doubts, ask your
doctor, pharmacist or nurse. Always take EMEND together with other medicines, to prevent
nausea and vomiting. After treatment with EMEND, your doctor may ask you or the child to
continue taking other medicines including a corticosteroid (such as dexamethasone) and an
“5-HT antagonist” (such as ondansetron) to prevent nausea and vomiting. Ask your 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 starting chemotherapy

and
Days 2 and 3:

• one 80 mg capsule each day.
• If chemotherapy is not administered, take EMEND in the morning.
• If chemotherapy is administered, take EMEND 1 hour before starting the chemotherapy session.

EMEND can be taken with or without food.
Swallow the capsule whole with liquids.

If you take more EMEND than you should
Do not take more capsules than recommended by your doctor. If you or the child has taken too
many capsules, call your doctor immediately.

If you forget to take EMEND
If you or the child forgets 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 go immediately to a doctor if you or the child notice any of the following side effects, which may be serious and for which you or the child might need urgent medical treatment:

• hives, rash, itching, difficulty breathing or swallowing (frequency not known, cannot be estimated based on 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 levels of liver enzymes in the blood.

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

• dizziness, drowsiness,
• acne, rash,
• anxiety,
• burping, nausea, vomiting, heartburn, stomach pain, dry mouth, passing gas,
• increased pain or burning when urinating,
• weakness, general feeling of being unwell,
• hot flushes/redness of the face or skin,
• fast or irregular heartbeats,
• fever with increased 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,
• skin sensitivity to the sun, excessive sweating, oily skin, skin lesions, itchy rash, Stevens-Johnson syndrome/toxic epidermal necrolysis (a rare, serious 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, intestinal gas,
• frequent urination, passing more urine than normal, presence of sugar or blood in the urine,
• chest discomfort, swelling, change in the way you walk,
• cough, mucus in the back of the throat, sore throat, sneezing, sore throat,
• eye secretion and itching,
• ringing in the ears,
• muscle spasms, muscle weakness,
• excessive thirst,
• slowed heartbeat, heart and blood vessel disease,
• decreased white blood cells, decreased sodium levels in the blood, weight loss.

Reporting of side effects
If you or the child gets any side effect, talk to your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system listed in Annex V.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store 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 the month.
Store in the original package to protect it from moisture.
Do not remove the capsule from the blister pack until you are ready to take it.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What EMEND contains

• The active ingredient 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), 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 how it is packaged
The 125 mg hard capsule is opaque with a white body and a pink cap with “462” and “125 mg”
printed radially on the body with black ink.
The 80 mg hard capsule is opaque with a white cap and a body with “461” and “80 mg” printed
radially on the body with black ink.
EMEND 125 mg and 80 mg hard capsules are available in the following pack sizes:

• Blister packs containing one 80 mg capsule
• Pack for a 2-day treatment containing two 80 mg capsules
• 5 blister packs each containing one 80 mg capsule
• Blister packs containing one 125 mg capsule
• 5 blister packs each containing one 125 mg capsule
• Pack for a 3-day treatment 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
Netherlands
For further information on this medicine, contact the local representative of the Marketing
Authorisation Holder.

Belgique/België/Belgien
MSD Belgium BVBA/SPRL
Tél/Tel: +32(0)27766211
[email protected]

Lietuva
UAB Merck Sharp & Dohme
Tel. + 370 5278 02 47
[email protected]

България
Мерк Шарп и Доум България ЕООД
Тел.: +359 2 819 3737
[email protected]

Luxembourg/Luxemburg
MSD Belgium BVBA/SPRL
Tél/Tel: +32(0)27766211
[email protected]

Česká republika
Merck Sharp & Dohme s.r.o.
Tel: +420 233 010 111
[email protected]

Magyarország
MSD Pharma Hungary Kft.
Tel.: +36 1 888 5300
[email protected]

Danmark
MSD Danmark ApS
Tlf: + 45 4482 4000
[email protected]

Malta
Merck Sharp & Dohme Cyprus Limited
Tel: 8007 4433 (+356 99917558)
[email protected]

Deutschland
MSD SHARP & DOHME GMBH
Tel: 0800 673 673 673 (+49 (0) 89 4561 2612)
[email protected]

Nederland
Merck Sharp & Dohme B.V.
Tel: 0800 9999000
(+31 23 5153153)
[email protected]

Eesti
Merck Sharp & Dohme OÜ
Tel.: +372 6144 200
[email protected]

Norge
MSD (Norge) AS
Tlf: +47 32 20 73 00
[email protected]

Eλλάδα
MSD Α.Φ.Β.Ε.Ε.
Τηλ: +30 210 98 97 300
[email protected]

Österreich
Merck Sharp & Dohme Ges.m.b.H.
Tel: +43 (0) 1 26 044
[email protected]

España
Merck Sharp & Dohme de España, S.A.
Tel: +34 91 321 06 00
[email protected]

Polska
MSD Polska Sp. z o.o.
Tel: +48 22 549 51 00
[email protected]

France
MSD France
Tél: +33 (0) 1 80 46 40 40

Portugal
Merck Sharp & Dohme, Lda
Tel: +351 21 4465700
[email protected]

Hrvatska
Merck Sharp & Dohme d.o.o.
Tel: + 385 1 6611 333
[email protected]

România
Merck Sharp & Dohme Romania S.R.L.
Tel: +40 21 529 29 00
[email protected]

Ireland
Merck Sharp & Dohme Ireland (Human Health)
Limited
Tel: +353 (0)1 2998700
[email protected]

Slovenija
Merck Sharp & Dohme, inovativna zdravila
d.o.o.
Tel: +386 1 5204 201
[email protected]

Ísland
Vistor hf.
Simi: +354 535 7000

Slovenská republika
Merck Sharp & Dohme, s. r. o.
Tel: +421 2 58282010
[email protected]

Ιtalia
MSD Italia S.r.l.
Tel: +39 06 361911
[email protected]

Suomi/Finland
MSD Finland Oy
Puh/Tel: +358 (0)9 804 650
[email protected]

Κύπρος
Merck Sharp & Dohme Cyprus Limited
Τηλ.: 800 00 673 (+357 22866700)
[email protected]

Sverige
Merck Sharp & Dohme (Sweden) AB
Tel: +46 77 5700488
[email protected]

Latvija
SIA Merck Sharp & Dohme Latvija
Tel: +371 67364224
[email protected]

United Kingdom
Merck Sharp & Dohme Limited
Tel: +44 (0) 1992 467272
[email protected]

Other sources of information
More detailed information on this medicine is available on the European Medicines Agency website, http://www.ema.europa.eu .

EMEND 125 mg powder for oral suspension

aprepitant

Read this leaflet carefully before using this medicine as it contains important
information for you. This leaflet is written for the parent or person who will be responsible for
administering this medicine to the child: read this information carefully.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed only for the child. Do not give it to other people, even if they have the same symptoms, as it could be dangerous.
• If the child experiences any side effects, including those not listed in this leaflet, ask your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

• 1. What EMEND is and what it is used for
• 2. What you need to know before you administer EMEND
• 3. How to administer EMEND
• 4. Possible side effects
• 5. How to store EMEND
• 6. Contents of the pack and other information

1. What is EMEND and what is it used for

EMEND contains the active ingredient “aprepitant”. It belongs to a group of medicines called
“neurokinin 1 (NK) receptor antagonists”. The brain has a specific area that controls
nausea and vomiting. EMEND works by blocking the signals sent to that area, thus reducing nausea and
vomiting. The oral suspension powder formulation is used in children from 6 months to
less than 12 years of age together with other medicinesto prevent nausea and vomiting
caused by chemotherapeutic treatments (cancer treatments) that are strong and moderate inducers
of nausea and vomiting (e.g. cisplatin, cyclophosphamide, doxorubicin or epirubicin).

2. What you need to know before giving EMEND

Do not give EMEND

• if the child is allergic to aprepitant or any of the other ingredients of this medicine (listed in section 6),
• if the child is taking medicines containing “pimozide” (for mental health problems),
• if the child is taking “terfenadine” or “astemizole” (for hay fever and other allergies),
• if the child is taking “cisapride” (for digestion problems). Do not give this medicine if any of the above situations apply to the child and inform the child's doctor about taking the above medicines. This is because the therapy may need to be adjusted before starting to use this medicine. If you have any doubts, ask your doctor, pharmacist or nurse before giving this medicine.

Warnings and precautions
Consult your doctor, pharmacist or nurse before giving this medicine to the
child.

Liver problems
Before starting treatment with EMEND, tell your doctor if the child has liver problems.
This is because the liver is important for metabolizing the medicine within the body. The doctor
may need to check the child's liver condition during treatment.

Children and adolescents
Do not give EMEND oral suspension powder to children under 6 months of age or weighing
less than 6 kg or to adolescents between the ages of 12 and 18 years, as the
powder for oral suspension formulation has not been studied in this population.

Other medicines and EMEND
Tell your doctor, pharmacist or nurse if the child is taking, has recently taken or
may take any other medicines because EMEND can affect the way other
medicines work, during and after treatment with EMEND. Also, some other medicines can
change the effect of this medicine.
Do not give EMEND and inform your doctor or pharmacist if the child is taking any
of the following medicines (see also “Do not give EMEND”) as their therapy
may need to be adjusted before starting to use EMEND:

• pimozide - for mental health problems,
• terfenadine and astemizole - for hay fever and other allergies,
• cisapride - for digestion problems. Do not give this medicine and inform your doctor or pharmacist if any of the above situations apply to the child.

Consult your doctor, pharmacist or nurse if the child is taking any of the following
medicines:

• medicines that act on the immune system - e.g. cyclosporine, tacrolimus, sirolimus and everolimus,
• alfentanil, fentanyl - for pain,
• quinidine - for irregular heartbeats,
• medicines for cancer - e.g. irinotecan, etoposide, vinorelbine, ifosfamide,
• medicines containing “alkaloids derived from ergot” - e.g. ergotamine and dihydroergotamine - for migraine,
• medicines that thin the blood - e.g. warfarin and acenocoumarol. The child may need to undergo blood tests during treatment with EMEND,
• antibiotics for the treatment of infections - e.g. rifampicin, clarithromycin and telithromycin,
• phenytoin - for convulsions,
• carbamazepine - for depression and epilepsy,
• midazolam, triazolam and phenobarbital - for a calming effect or to promote sleep,
• St. John's wort - a herbal medicine for depression,
• protease inhibitors - for HIV infections,
• ketoconazole except for shampoo (used to treat Cushing's syndrome, characterized by excessive cortisol production by the body),
• antifungal medicines e.g. itraconazole, voriconazole, posaconazole,
• nefazodone - for depression,
• corticosteroids - e.g. dexamethasone and methylprednisolone,
• medicines for anxiety e.g. alprazolam,
• tolbutamide - for diabetes,
• contraceptives, including pills, patches, implants and certain hormone-releasing intrauterine devices. These medicines may not work properly if taken together with this medicine. During treatment with this medicine and for 2 months after the end of treatment, it may be necessary to use a different or additional non-hormonal contraceptive. If any of the above situations apply to the child (or if you have any doubts), inform your doctor, pharmacist or nurse before giving this medicine.

Pregnancy and breastfeeding
This medicine should not be used during pregnancy and breastfeeding unless it is
clearly necessary.
For information on pregnancy, breastfeeding and contraception, ask your doctor for advice.

Driving and using machines
It should be considered that some people may experience dizziness and drowsiness after
taking EMEND. If the child experiences dizziness or drowsiness, they should not ride a bicycle or
use tools or machinery.

EMEND contains sucrose and lactose
The oral suspension powder contains sucrose and lactose. If the doctor has diagnosed the
child with an intolerance to certain sugars, contact them before giving this medicine to the
child.

EMEND contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per sachet, i.e. essentially “sodium-free”.

3. How to administer EMEND

Healthcare professionals:see the instructions for preparing the oral suspension for professionals
prepare a dose of EMEND powder for oral suspension.

Parents and caregivers:Always give this medicine to the child
exactly as your doctor, pharmacist or nurse tells you. If you have any doubts,
ask your child's doctor, pharmacist or nurse.

It is very important that this medicine is given exactly as
described below.
For each dose of EMEND, you will need a pre-filled oral dispenser containing the dose
that has been prescribed for the child.
Keep the dispenser in the refrigerator (between 2°C and 8°C) until you give the medicine to the
child.

Use this medicine within 2 days of receiving it from the healthcare
professional.
The medicine can be kept at room temperature (not above 30°C) for a
maximum of 3 hours, before administration.

The colour of the medicine in the oral dispenser may be of different shades of pink (from light
pink to dark pink). This is normal and the medicine is good to use.

• Remove the closing device from the oral dispenser.
• Position the tip of the oral dispenser inside the child's mouth on the left or right cheek.
• Slowly push the plunger all the way in to administer all the medicine contained in the oral dispenser.

If the child was unable to take the entire dose, contact your child's doctor.
When you have finished, do not dispose of any medicine in the water or household waste. Ask
your pharmacist how to dispose of medicines you no longer use. This will help to protect
the environment.

How much to administer

• The doctor will determine the correct dose of powder for oral suspension based on the child's weight.
• Do not change the dose or stop treatment without first consulting your doctor, pharmacist or nurse.

When to administer it
Day 1:

• Give this medicine one hour before the start of the chemotherapy session. Day 2 and day 3:
• If the child will not be undergoing chemotherapy - give this medicine in the morning.
• If the child will be undergoing chemotherapy - give this medicine one hour before the start of the chemotherapy session.

EMEND can be given with or without food.
Always give this medicine together with other medicines, to prevent nausea and
vomiting. After treatment with EMEND, the doctor may require the child to continue to
take other medicines to prevent nausea and vomiting including:

• a corticosteroid - such as dexamethasone and
• a “5-HT antagonist” - such as ondansetron. Ask your doctor, pharmacist or nurse if you have any doubts.

If you give more EMEND than you should
Do not give the child a quantity of medicine greater than that recommended by the doctor.
If you give the child an excessive amount of medicine, contact your doctor immediately.

If you forget to give EMEND
If the child misses a dose of this medicine, consult your doctor.
If you have any questions about 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.

Serious side effects
Stop giving this medicine and see a doctor immediately if you or the child notice any of the following serious side effects – the child may need urgent medical attention:

• allergic reaction - signs may include hives, rash, itching, difficulty breathing or swallowing (frequency not known). Stop giving this medicine and see a doctor immediately if you notice any of the serious side effects listed above.

Other side effects
Tell your doctor, pharmacist or nurse if you or the child notice any of the following side effects:

Common:may affect up to 1 in 10 people

• constipation or indigestion,
• headache,
• tiredness,
• loss of appetite,
• hiccups,
• increased amount of liver enzymes in the blood (shown in tests).

Uncommon:may affect up to 1 in 100 people

• dizziness or drowsiness,
• acne, rash,
• anxiety,
• burping, nausea, vomiting, heartburn, stomach pain, dry mouth, passing gas,
• pain or burning when urinating,
• weakness, general feeling of being unwell,
• hot flushes/redness of the face or skin,
• fast or irregular heartbeat,
• fever with increased risk of infection, low number of red blood cells (shown in tests).

Rare:may affect up to 1 in 1,000 people

• difficulty thinking, lack of energy, changes in taste,
• skin sensitivity to the sun, excessive sweating, oily skin, skin lesions, itchy rash, Stevens-Johnson syndrome or toxic epidermal necrolysis (rare, serious skin reactions),
• euphoria (feeling of extreme happiness), confusion,
• bacterial infection, fungal infection,
• severe constipation, stomach ulcer, inflammation of the small and large intestine, mouth sores, intestinal gas,
• need to urinate more frequently or produce a larger amount of urine than normal, sugar or blood in urine,
• chest discomfort, swelling, change in the way you walk,
• cough, mucus in the back of the throat, sore throat, sneezing, sore throat,
• eye secretion and itching,
• ringing in the ears,
• muscle spasms, muscle weakness,
• intense thirst,
• slowed heartbeat, heart and blood vessel disease,
• low number of white blood cells, low levels of sodium in the blood, weight loss.

Reporting of side effects
If 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 through the national reporting system listed in Annex V.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store EMEND

Keep this medicine out of the sight and reach of children.

Before reconstitution:
Generally Emend will be stored by healthcare professionals. The details regarding storage,
in case you should need them, are as follows:
Do not administer this medicine to the child after the expiry date which is stated on the pack and
on the sachet after EXP. The expiry date refers to the last day of that month.
This medicine does not require any particular storage temperature.
Store in the original package to protect the medicine from moisture.

After reconstitution:
The oral suspension can be kept at room temperature (not exceeding 30°C) for up to 3 hours,
before administration. It can also be stored in a refrigerator (between 2°C and 8°C) for up to 72 hours.
Do not dispose of any medicine in the wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Content of the pack and other information

What EMEND contains

• The active ingredient is aprepitant. Each sachet contains 125 mg of aprepitant. After reconstitution, 1 mL of oral suspension contains 25 mg of aprepitant.
• The other ingredients are hydroxypropylcellulose (E 463), sodium lauryl sulfate, sucrose and lactose (see point 2, paragraph “EMEND contains sucrose and lactose”), red iron oxide (E 172) and sodium stearyl fumarate.

Description of the appearance of EMEND and content of the pack
The powder for oral suspension is a powder of colour from pink to light pink enclosed in a single-dose
sachet.
Single-dose box
One box contains one sachet, one 1 mL and one 5 mL oral dispenser (in polypropylene with
silicone O-ring), a closing device and a mixing container (in
polypropylene).

Marketing Authorisation Holder and Manufacturer
Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
Netherlands
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder.

Belgique/België/Belgien
MSD Belgium BVBA/SPRL
Tél/Tel: +32(0)27766211
[email protected]

Lietuva
UAB Merck Sharp & Dohme
Tel.: +370 5 278 02 47
[email protected]

България
Мерк Шарп и Доум България ЕООД
Тел.: +359 2 819 3737
[email protected]

Luxembourg/Luxemburg
MSD Belgium BVBA/SPRL
Tél/Tel: +32(0)27766211
[email protected]

Česká republika
Merck Sharp & Dohme s.r.o.
Tel.: +420 233 010 111
[email protected]

Magyarország
MSD Pharma Hungary Kft.
Tel.: +36 1 888 53 00
[email protected]

Danmark
MSD Danmark ApS
Tlf: +45 44824000
[email protected]

Malta
Merck Sharp & Dohme Cyprus Limited
Tel: 8007 4433 (+356 99917558)
[email protected]

Deutschland
MSD SHARP & DOHME GMBH
Tel: 0800 673 673 673 (+49 (0) 89 4561 2612)
[email protected]

Nederland
Merck Sharp & Dohme B.V.
Tel: 0800 9999000 (+31 23 5153153)
[email protected]

Eesti
Merck Sharp & Dohme OÜ
Tel.: +372 6144 200
[email protected]

Norge
MSD (Norge) AS
Tlf: +47 32 20 73 00
[email protected]

Ελλάδα
MSD Α.Φ.Β.Ε.Ε.
Τηλ: + 30 210 98 97 300
[email protected]

Österreich
Merck Sharp & Dohme Ges.m.b.H.
Tel: +43 (0) 1 26 044
[email protected]

España
Merck Sharp & Dohme de España, S.A.
Tel: +34 91 321 06 00
[email protected]

Polska
MSD Polska Sp.z o.o.
Tel: +48 22 549 51 00
[email protected]

France
MSD France
Tél: +33 (0) 1 80 46 40 40

Portugal
Merck Sharp & Dohme, Lda
Tel: +351 21 4465700
[email protected]

Hrvatska
Merck Sharp & Dohme d.o.o.
Tel: + 385 1 6611 333
[email protected]

România
Merck Sharp & Dohme Romania S.R.L.
Tel: + 4021 529 29 00
[email protected]

Ireland
Merck Sharp & Dohme Ireland (Human Health)
Limited
Tel: +353 (0)1 2998700
[email protected]

Slovenija
Merck Sharp & Dohme, inovativna zdravila
d.o.o.
Tel: + 386 1 5204201
[email protected]

Ísland
Vistor hf.
Simi: +354 535 7000

Slovenská republika
Merck Sharp & Dohme, s. r. o.
Tel.: +421 2 58282010
[email protected]

Italia
MSD Italia S.r.l.
Tel: +39 06 361911
[email protected]

Suomi/Finland
MSD Finland Oy
Puh/Tel: +358 (0)9 804650
[email protected]

Κύπρος
Merck Sharp & Dohme Cyprus Limited
Τηλ: 80000 673 (+357 22866700)
[email protected]

Sverige
Merck Sharp & Dohme (Sweden) AB
Tel: +46 (0) 77 5700488
[email protected]

Latvija
SIA Merck Sharp & Dohme Latvija
Tel: +371 67364 224
[email protected]

United Kingdom
Merck Sharp & Dohme Limited
Tel: +44 (0) 1992 467272
[email protected]

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines
Agency, http://www.ema.europa.eu .
------------------------------------------------------------------------------------------------------------------------

The following information is intended exclusively for healthcare professionals:
Instructions for healthcare professionals on preparing the oral suspension
Each pack of EMEND contains one sachet
with the powder for oral suspension, one 1 mL and one 5 mL oral dispenser, a closing device and a mixing container.

Fill the mixing container with
drinking water at room temperature.

Fill the 5 mL oral dispenser with 4.6 mL
of water taken from the mixing container.

Make sure there is no air in the oral dispenser (if there is air, remove it).

Pour all unused water remaining in the
mixing container.

Add 4.6 mL of water taken from the
oral dispenser into the mixing container.

Each EMEND sachet for oral suspension
contains 125 mg of aprepitant which must be
suspended in 4.6 mL of water providing a
final concentration of 25 mg/mL.
Hold the EMEND powder sachet for
oral suspension in an upright position then
shake it to deposit the contents on the bottom before opening the sachet.
Pour all the contents of the sachet into the
mixing container containing the
4.6 mL of water and close the lid until you hear a click.
Mix the EMEND suspension
gently by rotating 20 times; then
gently invert the mixing container 5 times.
To prevent foaming, do not
shake the mixing container. The
mixture will be opaque pink to light pink in colour.

Check the EMEND mixture for
the presence of lumps or foam:

If there are lumps, repeat step 7 until
there are no more lumps.
If there is foam, wait for the
foam to disappear before proceeding to
step 9.

Fill the oral dispenser with the prescribed dose
taken from the mixing container
as reported in the
table below.

• Choose the oral dispenser based on the dose:
• Use the 1 mL oral dispenser if the dose is 1 mL or less.
• Use the 5 mL oral dispenser if the dose is greater than 1 mL.
• It is common to have a residue of medicine in the container. Make sure there is no air in the oral dispenser(if there is air, remove it).Make sure the oral dispenser contains the prescribeddose.

Day 1 Day 2 Day 3
EMEND suspension
oral
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
Insert the closing device on the oral
dispenser until you hear a click.
If the dose is not administered immediately after
measurement, store the filled oral dispenser(s) in the refrigerator between 2°C and 8°C
for up to 72 hours before use.
When delivering the dose(s)
to the people providing care, you must
instruct them to keep the oral dispenser(s)
in the refrigerator until they are ready to
administer the dose.

The oral suspension can be kept at
room temperature (not exceeding 30°C)
for up to 3 hours before
administration.