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The product code(s) for this leaflet is: PLGB 53095/0020.
EMEND 125 mg powder for oral suspension
EMEND® 125 mg powder for oral suspension
aprepitant
1. What EMEND is and what it is used for
2. What you need 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
EMEND contains the active substance ‘aprepitant.’ It 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.
The powder for oral suspension is used 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 triggers of nausea and vomiting (such as cisplatin, cyclophosphamide, doxorubicin or epirubicin).
Do not give this medicine if any of the above applies 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.
Talk to the doctor, pharmacist, or nurse before giving this medicine to the child.
Tell the doctor before treatment with EMEND starts, if the child has liver 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.
Do not give EMEND powder for oral suspension to children 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.
Tell the doctor, pharmacist or nurse if the child is using, has recently used or might use any other medicines. 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 and tell the doctor or pharmacist if the child is using any of the following medicines (see also ‘Do not give EMEND’). This is because their treatment will need to be changed before starting EMEND:
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 any of the following medicines:
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.
This medicine should not be used during pregnancy and breast-feeding unless clearly necessary.
For information regarding pregnancy, breast-feeding and contraception, ask your doctor for advice.
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 bicycle or use any tools or machines.
The powder for oral suspension contains sucrose and lactose. If a doctor has told you that the child has an intolerance to some sugars, contact the doctor before giving this medicine to the child.
This medicine contains less than 1 mmol sodium (23 mg) per sachet, that is to say essentially ‘sodium-free’.
Healthcare professionals: See the instructions for preparation of the oral suspension for healthcare professionals at the end of this package leaflet. This tells you how to prepare a dose of EMEND as an oral suspension.
Parents and caregivers: Always give this medicine to the child exactly as the doctor, pharmacist or nurse has told you. Check with the child’s doctor, pharmacist or nurse if you are not sure.
It is very important that this medicine is given exactly as directed below.
For each dose of EMEND, you will get a pre-filled oral dispenser that contains the child’s prescribed dose.
Keep the oral 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 getting the medicine from the healthcare provider.
The medicine can be kept at room temperature (not above 30°C) for up to 3 hours, prior to administration.
The colour of the medicine in the oral dispenser may be different shades of pink (light pink to dark pink). This is normal and the medicine is okay to use.
If the child could not take the whole dose, call the child’s healthcare provider.
When you have finished 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.
Day 1:
Day 2 and Day 3:
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 ask the child to continue taking other medicines for preventing nausea and vomiting which may include:
Check with the doctor, pharmacist or nurse if you are not sure.
Do not give the child more of this medicine than the doctor recommends. If you give the child more than you should, contact the doctor straight away.
If the child misses a dose of this medicine, talk to the doctor.
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 giving this medicine and see a doctor straight away if you or the child notice any of the following serious side effects – the child may need urgent medical treatment:
Stop giving this medicine and see a doctor straight away if you notice any of the serious side effects above.
Tell the 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
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
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. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. 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.
Emend will generally be stored by healthcare professionals. The storage details, should you need them, are as follows:
Do not give this medicine to the child 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 protect from moisture.
The oral suspension can be kept at room temperature (not above 30°C) for up to 3 hours, prior to administration. It can also be stored refrigerated (between 2°C and 8°C) for up to 72 hours.
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.
The powder for oral suspension is a pink to light pink powder in a single-use sachet.
Single-use carton
Pack size of one carton contains one sachet, one 1 mL and one 5 mL oral dispenser (polypropylene with silicone o-ring), one cap and one mixing cup (polypropylene).
Marketing Authorisation Holder in Great Britain:
Marketing Authorisation Holder in UK (Northern Ireland):
Manufacturer
For any information about this medicine, please contact:
This leaflet was last revised in April 2021.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
© Merck Sharp & Dohme (UK) Limited, 2021. All rights reserved.
PIL.EMD-PFS.21.GB-NI.7742.CoO-Art61(3).RCN020436