EMEND 125 mg powder for oral suspension

• 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 are 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.

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

• if the child is allergic to aprepitant or any of the other ingredients of this medicine (listed in section 6).
• if the child is using medicines that contain ‘pimozide’ (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 digestion).

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:

• pimozide - for mental health problems,
• terfenadine and astemizole - 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 any of the following medicines:

• medicines that affect the immune system – such as cyclosporine, tacrolimus, sirolimus, everolimus,
• alfentanil, fentanyl – for pain,
• quinidine – for irregular heartbeat,
• medicines for cancer – such as irinotecan, etoposide, vinorelbine, ifosfamide,
• medicines containing ‘ergot alkaloid derivatives’ - such as ergotamine and diergotamine - for migraines,
• medicines that thin the blood – such as warfarin, acenocoumarol. Your child may need blood tests during treatment with EMEND,
• antibiotics to treat infections – such as rifampicin, clarithromycin, telithromycin,
• 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 medicine for depression,
• protease inhibitors - for HIV infections,
• ketoconazole except shampoo (used to treat Cushing’s syndrome - when the body produces an excess of cortisol),
• antifungal medicines such as itraconazole, voriconazole, posaconazole,
• nefazodone - for depression,
• corticosteroids - such as dexamethasone and methylprednisolone,
• medicines for anxiety such as alprazolam,
• tolbutamide - for diabetes,
• contraceptive medicines including pills, patches, implants, and some Intrauterine devices (IUDs) that release hormones. 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.

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’.

• The doctor will work out the right dose of powder for oral suspension based on the weight of the child.
• Do not change the dose or stop treatment without first talking to the doctor, pharmacist or nurse.

Day 1:

• Give this medicine one hour before the start of the 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 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 ask the child to continue taking other medicines for preventing nausea and vomiting which may include:

• a corticosteroid - such as dexamethasone and
• a ‘5-HT₃ antagonist’ - such as ondansetron

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.

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:

• allergic reaction – the signs may include hives, rash, itching, difficulty breathing or swallowing (it is not known how often this happens).

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

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

Uncommon: may affect up to 1 in 100 people

• feeling dizzy or sleepy,
• acne, rash,
• feeling anxious,
• burping, nausea, vomiting, heartburn, stomach 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 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,
• sensitivity of the skin to sun, excessive 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 infection,
• severe constipation, stomach ulcer, inflamed small intestine and colon, sores in the mouth, bloating,
• urinating more often or passing more urine than normal, sugar or blood in urine,
• chest discomfort, swelling, change in the manner of 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,
• feeling very thirsty,
• slow heartbeat, heart and blood vessel disease,
• low number of white blood cells, low sodium levels in the blood, weight loss.

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.

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 active substance is aprepitant. Each sachet contains 125 mg of aprepitant. After reconstitution, 1 mL oral suspension contains 25 mg of aprepitant.
• The other ingredients are hydroxypropyl-cellulose (E 463), sodium laurilsulfate, sucrose and lactose (see section 2 under ‘EMEND contains sucrose and lactose’), red iron oxide (E 172) and sodium stearyl fumarate.

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).

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Marketing Authorisation Holder in UK (Northern Ireland):

Manufacturer