InfoCons Consumer Protection informs you – Emend – Package Leaflet
Emend – Package Leaflet: InfoCons – Consumer Protection presents, in an accessible format, the official package leaflet of the medicine Emend, as authorised in the European Union and published in the Union Register of medicinal products.
Before anything else
ℹ️ 1. What EMEND is and what it is used for
EMEND c ontains the active substance aprepitant and belongs to a group of medicines called “neurokinin 1 (NK 1) receptor antagonists”. The brain has a specific area that controls nausea and vomiting. EMEND works by blocking signals to that area, thereby reducing na usea 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 v omiting (such as cisplatin, cyclophosphamide, doxorubicin or epirubicin) .
⚠️ 2. What you need t oknow before you take or give EMEND
Do not take EMEND
- if you or the child is allergic to aprepitant or any of the other ingredients of this medicine (listed insection 6).
- with medicines containing pimozide (used to treat psychiatric illnesses), terfenad ine 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 EMEN D, 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 tochildren under 12 years of age , because the 80mg and 125 mg c apsules have not been studied in this population .
60Other 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, astemizol e, 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 afte rusing 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 cance r),
- medicines containing ergot alkaloid derivatives such as ergotamine and diergotamine (used fo r treating migraines),
- warfarin, acenocoumarol (blood thinners; blood tests may be required),
- rifampicin, clarithromycin, telithromycin (antibiotics used to tre at infections),
- phenytoin (a medicine used to treat seizures),
- carbamazepine (used to treat depr ession 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 sha mpoo(used to treat Cushing’s syndrome -when the body produces an excess of cortisol) ,
- itraconazole, voriconazole, posaconazole (antifungals),
- nefazodone (use dto 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 recen tly 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 pregna nt 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 plann ing 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 bi cycleor using machi nes or tools after taking this medicine (see ‘Possible side effects ’).
EMEND contains sucrose
EMEND capsules contain sucrose. If you or the child have been tol dby your doctor that you or the child have an intolerance to some sugars, contact the doctor be fore taking this medicine.
61EMEND contains s odium
This medicine conta ins less than 1mmol sodium (2 3mg) per capsule, that is to say essentially ‘sodium-free’.
💊 3. How to take EMEND
Always take this medicine or give this medicine to the child exactly as t he 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 me dicines, to prevent nausea and vomiting. After treatment with EMEND, the doctor may ask you or t he child to continue taking other me dicines including a corticosteroid (such as dexamethasone) and a ‘5HT 3antagonist’ (such as ondansetron) for preventing nauseaand vomiting. Check with the doctor, pharmacist or nurse if you are not sure.
The recommende doral dose of EMEND is :
Day 1:
- one 125mg capsule 1 hour before you start your chemotherapy session and Days 2 and 3:
- one 80 mg capsule each day
- If no chem otherapy 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 s hould Do not take more capsules than the doctor recommends. If you or the child has taken too ma ny capsules, contact your doctor imme diately.
If you forget to take EMEND
If you or the child has missed a dose, contact your doctor for advice.
If you have anyfurther questions on the use of this medicine, ask the doctor or pharmacist.
❗ 4. Possible s ide effects
Like all medicines, thi s medicine can cause side effects, although not everybody gets them.
Stop taking EMEND and see a doctor immediately if yo uor the child notice any of the following side effects, which may be serious, and for which youor the child may need urgent medical treatment:
- Hives, rash, itching, difficulty breathing or swallowing (frequency not known, cannot be estimated from the ava ilable data); these are signs of an allergic reaction.
Other side effects that have been report ed are listed below.
Common side eff ects (may affect up to 1 in 10 people) are:
- constipation, indigestion,
- headache,
- tiredness,
- loss of appetite,
- hiccups, 62- 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 bu rning urination,
- weakness, generally feeling unwell,
- hot flush /reddening of the face or skin ,
- fast or irregular heartbeats,
- fever wi thincreased risk of infection, lowering of red blood cells.
Rare side effects (may affect up to1 in 1 ,000people) are
- difficulty thinking, lack of energy, taste disturbance,
- sensitivity of the skin to sun, excessive sweating, oily skin, sores on skin, i tching 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 inte stine and colon, sores in mouth, bloating,
- frequent urination, passing more urine than normal, presence of sugar or blood i nurine,
- chest discomfort, swelling, change in the manner of walking,
- cough, mucus in back of th roat, throat irritation, sneezing, so rethroat,
- 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 effec ts If you or the child gets any side effects , talk to your doctor, pharmacist, or nurse. This includes any possible side ef fects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V . By reporting si de effects you can help provide more information on the sa fety of this medicine.
🌡️ 5. How to sto re EMEND
Keep this medicine out of t hesight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. Th eexpiry date refers to the last day of that month.
Store in the original package in order to p rotect 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 w aste. Ask your pharmacist how to throw away medicines you no longer use. These measures will hel pprotect the environment.
636. Conte nts of the pack and other information
What EMEND contains
- The active substance is aprepitant. Each 125 mg hard capsule c ontains 125 mg of aprepitant.
Each 80 mg hard capsule cont ains 80 mg of aprepitant.
- The other ingredients are sucrose, microcrysta lline cellulose (E 460), hydroxypropylcellulose (E463), sodium laurilsulfate , gelatin, titanium dioxide (E 171), s hellac, p otassium hydroxide,
and black iron oxide (E 172); the 125 mg hard capsule also contains red iron oxide (E 172) and yellow iron oxide (E172).
What EMEND looks like and contents of the pack
The 125 mg hard capsule is opaque with a white body and p inkcap w ith “462” and “125 mg” printed radially in black ink on t he body.
The 80 mg hard capsule is opaq ue with a white cap and body with “4 61” and “80 mg” printed radially in black ink on the body.
EMEND 125 mg and 80 mg hard capsules are supplied in th efollowi ng pack size s:
- Aluminium blister containing one 80 mg cap sule
- 2-day treatment pack containing tw o80mg capsules
- 5 Aluminium blister s each containing one 80 mg capsule
- Aluminium blister containing one 125 mg capsule
- 5 Aluminium blisters each conta ining one 125mg capsule
- 3-day treatment pack containing one 125 mg capsule and two 80 mg capsules Not a ll pack sizes may be marketed.
Mark eting Authorisation Holder and Manufacturer Merck Sharp & Dohme B.V.
Waarderweg 39 2031 BN Haarlem The Netherlands For a ny information about this medicine, please contact the lo cal representative of the Marketing Authorisation Holder.
Belgique/België/ Belgien MSD Belgium BVBA/SPRL Tél/Tel: +32(0)27766211 [email protected] UAB Merck Sharp & Dohme Tel.+3705278 0247 [email protected] България Мерк Шарп и Доум България ЕООД Тел.: +359 28193737 [email protected]/Luxemburg MSD Belgium BVBA/SPRL Tél/Tel: +32(0)27766211 [email protected] Česká republika Merck Sharp & Dohme s.r.o.
Tel:+420233010111 dpoc_czechslovak@ merck.comMagyarország MSD Pharma Hungary Kft.
Tel.: +3618885300 [email protected] Danmark MSD Danmark ApS Tlf:+454482 4000 [email protected] Merck Sharp & Dohme Cyprus Limited Tel:8007 4433 (+356 99917558 ) [email protected] 64Deuts chland MSD SHARP & DOHME GMBH Tel:0800 673673673(+49 (0)8945612612) [email protected] Merck Sharp & Dohme B .V.
Tel:0800 9999000 (+31 235153153) [email protected] Eesti Merck Sharp & Dohme O Ü Tel.:+3726144 200 [email protected] MSD (Norge) AS Tlf:+4732207300 [email protected] Eλλάδα MSD Α.Φ.Β.Ε.Ε.
Τηλ: +302109897300 [email protected]Österreich Merck Sharp & Dohme Ges.m.b.H.
Tel:+43(0)126044 [email protected] España Merck Sharp & Dohme de España, S.A.
Tel:+34913210600 [email protected] MSD Pols ka Sp. zo.o.
Tel:+48225495100 [email protected] France MSD France Tél:+33(0)180464040Portugal Merck Sharp & Dohme, Lda Tel:+351 214465700 [email protected] Hrvatska Merc k Sharp & Dohme d.o.o.
Tel:+38516611 333 croatia_info@merc k.comRomânia Merck Sharp & Dohme Romania S.R.L.
Tel:+40215292900 [email protected] Ireland Merck Sharp & Dohme Ireland (Human Health) Limited Tel:+353 (0)1 2998700 medinfo_ireland@m erck.comSlovenija Merck Sharp & Dohme, inovativna zdravila d.o.o.
Tel:+386 15204 201 [email protected] Ísland Vistor hf.
Simi: +354 5357000Slovenská republika Merck Sharp & Dohme, s. r. o.
Tel:+421 258282010 [email protected] Ιtalia MSD Italia S.r.l.
Tel:+3906361911 medicalinformation.it @merck.comSuomi/Finland MSD Finland Oy Puh/Tel: +358 (0)9 804650 [email protected] Κύπρος Merck Sharp & Dohme Cyprus Limited Τηλ.: 80000673(+357 22866700) [email protected] Merck Sharp & Dohme (Sweden) AB Tel:+46775700488 medicinskinfo@me rck.com Latvija SIA Merck Sharp & Dohme Latvija Tel:+371 67364224 [email protected] Kingdom Merck Sharp & Dohme Limited Tel:+44(0)1992 467272 [email protected] 65This leaflet was last revised in Other sources of information Deta iled information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu .
66Package leaflet: Information for theuser EMEND 125 mg powder for oral suspension aprepitant Read all of this leaflet carefully before you start using this medicine because it contains important information. This leaflet has been written for the parent or carer who will give this medici ne to the child -please read this information carefully.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask the doctor, pharmacist, or nurse.
- This medicine has been prescribed for the child only. Do not pass it on to others. It may harm them, even if their signs of illness ar e the same.
- If the child gets any side effects, talk to the doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet 1. What EMEND is and what it is used for 2. What you ne ed to know before you give EMEND 3. How to give EMEND 4. Possible side effects 5. How to store EMEND
📦 6. Contents of the pack and other information
1. What EMEND is and what it is used for EMEN D contains the active substance ‘aprepitant.’ It belongs to a group of medicines called ‘neurokinin 1 (NK 1) receptor antagonists ’.The brain has a specific area that controls nausea and vomiting. EMEND works by blocking signals to that area, thereby r educing nausea and vomiting. The powder for oral suspension is use d in children aged 6 months to less than 12 years in combination with other medicines to prevent nausea and vomiting caused by chemotherapy (cancer treatment) that are strong and moderate t riggers of nausea and vomiting (such as cisplatin, cyclophosphamide , doxorubicin or epirubicin) .
2. What you need to know before you give EMEND Do not give EMEND
- if the child is allergic to aprepitant or any of the other ingredients of this medicine (l isted in section 6).
- if the child is using medicines that contain ‘p imozide’ (for mental health problems ).
- if the child is using ‘terfenadine’ or ‘astemizole’ (for hay fever and other allergies ).
- if the child is using ‘cisapride’ -(for problems with diges tion).
Do not give this medicine if any of the above appl ies to the child and tell the child’s doctor if they are using any of the medicines above. This is because their treatment will need to be changed before starting this medicine . If you are not sure, talk to the doctor, pharmacist or nurse before giving this medicine .
Warnings and precautions
Talk to the doctor, pharmacist, or nurse before giving this medicine to the child.
Liver problems Tell the doctor before treatment with EMEND starts, if the chi ld hasliver problems. This is because the liver is important in breaking down the medicine in the body. The doctor may have to check the condition of the child’s liver during treatment .
67Children and adolescents Do not give EMEND powder for oral suspensio n tochildren under 6 months of age or who weigh less than 6 kg, or to adolescents between 12 and 18 years ,because the powder for oral suspension has not been studied in this population .
Other medicines and EMEND
Tell the doctor, pharmacist or nurse if t he child is using, has recently used or might use any other medicine s. This is because EMEND can affect how other medicines work, during and after treatment with EMEND. Also, some other medicines can affect the way this medicine works.
Do not give EMEND a nd tell the doctor or pharmacist if the child is using any of the fo llowing medicines (see also ‘Do not give EMEND’) . This is because their treatment will need to be changed before starting EMEND:
- pimozide -for mental health problems ,
- terfenadine an dastemizole -for hay fever and other allergies ,
- cisapride -for problems with digestion .
Do not give this medicine and tell the doctor or pharmacist if any of the above apply to the child.
Talk to the doctor, pharmacist or nurse if the child is taking a ny of thefollowing medicines:
- medicines that affect the immune system –such as cyclosporine, tacrolimus, sirolimus, everolimus ,
- alfentanil, fentanyl –for pain ,
- quinidine –for irregular heart beat ,
- medicines for cancer –such as irinotecan, etoposide, v inorel bine, ifosfamide ,
- medicines containing ‘ergot alkaloid derivatives’ -such as ergotamine and diergotamine -for migraines ,
- medicines that thin the blood –such as warfarin, acenocoumarol. You r child may need blood tests during treatment with EMEND ,
- antibiotic s to treat infections –such as rifampicin, clarithromycin, telit hromycin ,
- phenytoin -for fits (seizures) ,
- carbamazepine -for depression and epilepsy ,
- midazolam, triazolam, phenobarbital -to produce calmness or help you sleep ,
- St. John’s Wort -a herbal med icine for depression ,
- protease inhibitors -for HIV infection s,
- ketoconazole except shampoo (used to treat Cushing’s syndrome -when the body produces an excess of cortisol) ,
- antifungal medicines such as itraconazole, voriconazole, posaconazol e,
- nefazodone -for depression ,
- corticosteroids -such as dexamethasone an d methylprednisolone ,
- medicines for anxiety such as alprazolam ,
- tolbutamide -for diabetes ,
- contraceptive medicines including pills, patches, implants, and some Intrauterine devices (IUDs) that release h ormones. These may not work properly when taken with this medicine .
You may need to use a different or an extra non -hormonal contraceptive during treatment with this medicine and for up to 2 months after treatment has finished.
If any of the above apply to the child (or you are not sure), talk to the doctor, pharmacist or nurse before giving this medicine .
Pregnancy and breast -feeding This medicine should not be used during pregnancy and breast -feeding unless clearly necessary.
For in formation regarding p regnancy, breast -feeding and contraception, ask your doctor for advice.
Driving and using machines
It should be taken into account that some people may feel dizzy and sleepy after taking EMEND. If the child feels dizzy or sleepy, they should not ride a bi cycle or use any tools or machines.
68EMEND contains s ucrose and lactose
Thepowder for oral suspension contains sucrose and lactose. If adoctor has told you that the child has an intolerance to some sugars, contact the doctor before g iving this medicine t o the child.
EMEND contains s odium
This medicine contains less than 1mmol sodium (23 mg) per sachet , that is to say essentially ‘sodium- free’.
3. How to give EMEND Healthcare professionals: See the instructions for preparation of the oral suspension for hea lthcare professionals at the end of this package leaflet . This tells you how to prepare a dose of EMEND as an oral suspension.
Pare nts and caregivers :Always give this medicine to the child exactly as the doctor, pharmacist or nurse has told you. Che ck wi th the child’s doctor, pharmacist or nurse if yo u are not sure.
It is very important that this medicine is given exactly as directed below .
For each dose of EMEND, you willget a pre -filled oral dispenser that contains the child’ s prescribed dose.
Keep th e oral dispenser in the refrigerator (between 2ºCand 8ºC) until you give the medicine to the child .
Use this medicine within 2 d ays of getting the medicine from the healthcare provider .
The medicine can be kept at room tempe rature (not above 30°C)for upto 3hours , prior to administration .
Thecolour of the medicine in the oral dispenser may be different shades of pink (light p ink to dark pink). This is normal and the medicine is okay to use. -Take the cap off the oraldispenser. -Place the t ipof theoraldispenser in the child’s mouth along in the inner cheek on either the right or left side. -Slowly push the plunger all the way down togive all the medicine in the oral dispenser .
If the child could not take the whole do se, call the child’s healthcar e provider.
69When you have finished d o not thr ow away any medicines via wastewater or household waste.
Ask your pharmacist how to th row away medicines you no longer use. These measures will help protect the environment.
How m uch to give
- The d octor will wo rk out the right dose of powder for oral suspe nsion based on the weight of the child.
- Do not change the dose or stop treatment witho ut first talking to the doctor, pharmacist or nurse.
When to give Day 1:
- Give this me dicine onehour befor e the star t of th e chemotherapy session.
Day 2 and Day 3:
- If the child will not have chemotherapy -give this medicine in the morning.
- If the child will have chemotherapy -give this medicine onehour before the start of the chemother apy session.
EMEND c an be given with or without food.
Always give this medicine to gether with other medicines, to prevent nausea and vomiting. After treatment with EMEN D, the doctor may ask the child to continue taking other medicines for preventing nausea and vomiting which may inclu de:
- a corticosteroid -such as dexamethasone and
- a ‘5-HT3antagonist’ -such as ondansetron Check with the doctor, pharmacist or nurse if you are not sure.
If you give more EMEND than you should Do not give the child m ore of this medicine than the doctor recomm ends. If you give the child more than you shou ld, contact the doctor straight away.
If you forget to give EMEND If the child misses a dose of this medicine , talk to the doctor.
If you have any further questions o n the use of this med icine, ask the doctor or pharmacist.
4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets the m.
Serious side effects
Stop giving this medicine and see a doctor straight awa y if you or the child notice any of the fol lowing serious side effects –the child may ne ed urgent medical treatment:
- allergic reaction –the signs may include hives, rash, it ching, difficulty breathing or swallowing (it is not known how often this happens ).
Stop giving this m edicine and see a doct or straight away if you notice any of the seri ous side effects above.
Other side effects
Tell the doctor, pharmacist or nurse if yo uor the child notice any of the following side effects:
Common: may affect up t o 1 in 10 people
- constipation or ind igestio n,
- headache ,
- feeling tired ,
- loss of appetite ,
- hiccups , 70- increased amount of liver enzymes in theblood (shown in tests).
Uncommon: may af fect up to 1 in 100 people
- feeling dizzy or sleepy ,
- acne, rash ,
- feeling anxi ous,
- burping, nausea, vomitin g, heartburn, s tomach pain, dry mouth, passing wind ,
- pain or burning when urinating ,
- feeling weak, generally feeling unwell ,
- hot flushes /reddening of the face or skin ,
- fast or irregular heart beat ,
- fever with increased risk of infection, low number of red blood cells (shown i n tests ).
Rare: may affect up to 1 in 1 ,000 people
- difficulty thinking, lack of energy, changes in taste ,
- sensitivity o f the skin to sun, exc essive sweating, oily skin, sores on the skin, itchy rash, Stevens -Johnson syndrome or toxic epidermal necrolysis (rare severe skin reactions) ,
- euphoria ( feeling of extreme happiness), feeling confused ,
- bacterial infection, fungal infec tion,
- severe constip ation, stomach ulcer, inflamed small intestine and colon, sores in the mouth, bloating ,
- urinating more often or passing more urine than normal, sugar or b lood in urine ,
- chest discomfort, swelling, change in the manner of walking ,
- cough, muc us in th e back o f the throat, throat irritation, sneezing, sore throat ,
- eye discharge and itching ,
- ringing in the ears ,
- muscle spasms, muscle weakness ,
- feeling very thirs ty,
- slow heartbeat, heart and blood vessel disease ,
- low number of white blood cells, low sod ium leve lsin the bloo d, weight loss.
Reporting of side effects
If the child gets any side effects, talk to the doctor, pharmacist, or nurse. This includes any pos sible side effects not listed in this leaflet. You can also report side effects directly via the nat ional reportin g system listed in Appendix V . By reporting side effects you can help provide more information on the safety of this medicine .
5. Howto store EM END Keep this medicine out of the sight and reach of children.
Before reconstitution :
Emend will generally be stored by healthcare professi onals. The storage details, should you need them, are as follows:
Do not give this medicine to the c hild after the expiry date which is stated on the carton and sachet after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special temperature storage conditions.
Store in the original package in order to prot ect from moist ure.
After reconstitution:
The oral suspension can be kept at room temperature (not above 30oC) for up to 3 hours, prior to administration . It can also be stored refrigerated (between 2oC and 8oC) for up to72hours .
71Do 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 enviro nment.
6. Contents of the pack and other information
What EMEND contains
- The active sub stance i s aprepitant. Each sachet contains 125 mg of aprepitant. After reconstitution, 1 mL oral suspension contains 25 mg of aprepitant .
- The other ingredients ar ehydroxypropyl -cellulose (E 463), sodium laurilsul fate, sucrose and
lactose (see s ection 2 under ‘EMEND contains suc rose and lactose’) , red iron oxide (E 172) and sodium stearyl fumarate .
What EMEND looks like and contents of the pack
The powder for oral suspension is a pink to light pink powder in a single -use sachet.
Single -use carto n Pack size ofone carton contains one sachet, one 1 mL and one 5mL oral dispenser (polypropylene with silicone o -ring),onecap and one mixing cup (polypropylene ).
Marke ting Authorisation Holder and Manufacturer Merck Sharp & Dohme B.V.
Waarde rweg 39 2031 BN Haarle m The Netherlands For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Belgique/België/B elgien MSD Belgium BVBA/SPRL Tél/Tel: +32(0)27766211 [email protected] UAB Merck Sha rp & Dohme Tel.: +370 52780247 [email protected] България Мерк Шарп и Доум България ЕООД Тел.: +359 2 819 3737 [email protected]/Luxemb urg MSD Belgium BVBA/SPRL Tél/Tel: +32(0)27766211 [email protected] Česká repub lika Merck Sha rp & Dohme s.r.o.
Tel.: +420 233010111 dpoc_czechslovak @merck.comMagyarország MSD Pharma Hungary Kft.
Tel.: +3618885300 [email protected] Danmar k MSD Danmark ApS Tlf: +45 44824000 [email protected] Merck Sharp & D ohme Cypr us Limited Tel:8007 4433 (+356 99917558) [email protected] Deuts chland MSD SHARP & DOHME GMBH Tel: 0800 673 673 673 (+49 (0) 89 4561 2612) [email protected] Merck Sharp & Dohme B .V.
Tel: 0800 9999000 (+31 23 5153153) medicalinfo.nl@m erck.com 72Eesti Merck Sharp & Dohme OÜ Tel.: +372 6144 200 [email protected] 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] MSD Pol ska Sp.z o.o.
Tel:+48225495100 [email protected] France MSD France Tél: +33 (0)180464040Portugal Merck Sharp & Dohme, Lda Tel: +351 21 4465700 [email protected] Hrvatska Merck Sharp & Dohme d.o.o.
Tel: + 385 1 6611 333 croatia_info@merc k.comRomânia Merck Sharp & Dohme Romania S.R.L.
Tel: + 4021 529 29 00 [email protected] Ireland Merck Sharp & Dohme Ire land (Human He alth) Limited Tel: +353 (0)1 2998700 medinfo_ireland@merc k.comSlovenija Merck Sharp & Dohme, inovativna zdravila d.o.o.
Tel:+38615204201 [email protected] Ísland Vistor hf.
Simi: +354 535 7000Slovenská republika Merck Sharp & D ohme, s. r. o.
Tel.: +421 258282010 [email protected] Ιtalia MSD Italia S.r.l.
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This leaflet was last revised in
Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu .
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🩺 Information intended for healthcare professionals only
Instructions for healthcare professionals on the preparation of the oral suspension
Each pack of EMEND contains a sachet with the
powder for oral suspensi on, a 1mLand a 5mLoral dispenser, one cap and one mixing cup .
1.Fill the mixing cup with room temperature drinking water.
2.Fill the 5 mL oral dispenser with 4.6 mL of water from t hemixing cup.
Make sure no air is in the oral dispenser (if air ispresent, remove ).
3.Discard all the unused water remaining in the mixing cup.
4.Add the 4.6 mL of water from the oral dispenser back into the mixing cup.
5.Each sachet of EMEND for or alsuspension contains 125 mg of aprepitant which is to be suspen ded 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 .
6.Pour the entire contents of the sachet into the 4.6 mL of water in th e 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 m ixture will be cloudy pink to light pink.
748.Check the EMEND mixt ure 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 accordi ng to the table below . -Choose the oral dispenser based on dose: -Use 1 mL oral dispenser if dose is 1mL or less. -Use 5 mL oraldispenser if dose is more than 1 mL. -It is common to have med icineleftover in the cup.
Make sure no air is in the oral dispense r (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/mL3 mg/kg orally Maximum dose 125 mg2 mg/kg or ally Maximum dose 80 mg2 mg/kg orally Maximum dose 80 mg 10.Place t he 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 hou rs prior to use. When dispensing dose(s) to the caregiver, instruc t 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 30oC)for up to 3 hours , prior to adm inistration .
Discard any remaining suspension and waste material.
Any unused medicinal product or waste material should be disposed of in accordance with local regulations.
📄 Package Leaflet – official source
This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Emend (PDF, ec.europa.eu).
You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/03/262).
⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.
