Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or your pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

• 1. What EMEND is and what it is used for
• 2. Before you take EMEND
• 3. How to take EMEND
• 4. Possible side effects
• 5. How to store EMEND
• 6. Further information

Pharmacotherapeutic group

EMEND is a neurokinin 1 (NK1) receptor antagonist.

Therapeutic indication

EMEND is used ALONG WITH OTHER MEDICINES to prevent nausea and vomiting caused by chemotherapy treatment.

Do not take EMEND

• If you are allergic (hypersensitive) to aprepitant or to any of its other ingredients.
• With medicines containing pimozide (used to treat psychiatric illnesses), terfenadine and astemizole (used for hay fever and other allergic conditions), cisapride (used for treating gastrointestinal motility disorders). Tell your doctor if you are taking these products since your treatment must be modified before you start taking EMEND.

Take special care with EMEND

• if you have liver disease

Use in children and adolescents

Do not give EMEND to patients under 18 years of age.

Use in elderly patients

No change in dose is necessary for elderly patients.

Taking EMEND with other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

EMEND can affect other medicines both during and after treatment with EMEND. There are some medicines that should not be taken with EMEND or that require a dosage adjustment (see also Do not take EMEND). EMEND should be used with caution when taken with many other medicines.

Taking EMEND with food and drink

EMEND can be taken with or without food.

Pregnancy and breast-feeding

You should not use EMEND during pregnancy unless clearly necessary. It is important that you tell your doctor if you are pregnant or are planning to become pregnant before taking EMEND.

Birth control medicines may not work as well; another form of birth control should be used during treatment with EMEND and for up to 2 months after using EMEND.

It is not known whether EMEND is excreted in human milk; therefore, breast-feeding is not recommended during treatment with EMEND. It is important that you tell your doctor if you are breast-feeding or are planning to breast-feed before taking EMEND.

Driving and using machines

EMEND is not expected to affect your ability to drive a car or operate machinery. However, individual responses to medication may vary.

Read all the information in this leaflet for guidance. Discuss with your doctor, nurse or pharmacist if you are unsure about anything.

Important information about some of the ingredients of EMEND

EMEND contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

The recommended dose of EMEND is

one 125 mg capsule by mouth 1 hour before you start your chemotherapy treatment

and

one 80 mg capsule each morning for the 2 days following your chemotherapy treatment.

EMEND should be swallowed whole.

If you take more EMEND than you should

Do not take more capsules than the doctor recommends. If you do take too many capsules, contact your doctor immediately.

If you forget to take EMEND

If you have missed a dose, contact your doctor for advice.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

The most common side effects (those likely to affect between 1 and 10 patients in every 100) are:

burping, constipation, diarrhoea, dizziness, fatigue, headache, hiccups, indigestion, loss of appetite, and increased liver enzymes.

Other uncommon side effects (those likely to affect between 1 and 10 patients in every 1,000) are:

abnormal dreaming, acne, anxiousness, bacterial infection, bloating, blood in the urine, chest discomfort, cough, difficulty thinking, disorientation, dry mouth, eye discharge and itching, euphoria, excessive sweating, excessive thirst, fever with increased risk of infection, fungal infection, heartburn, high sugar levels in the blood, hot flush, increased painful or burning urination, itching, low sodium levels in the blood, lowering of red blood cells, mucus in back of throat, muscle cramp or pain, nausea, oily skin, passing wind, rash, reddening of the face, ringing in the ear, sensitivity to light, slow heartbeat, sneezing, sore throat, sores in mouth, sores on skin, stomach pain, stomach ulcer, swelling, taste disturbance, vomiting, and weight gain or loss.

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), hydroxypropyl cellulose (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). The capsule shell may also contain sodium laurilsulfate and silica colloidal anhydrous.

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:

• Blister packs containing one EMEND 80 mg capsule
• Blister packs containing five EMEND 80 mg capsules
• 2-day treatment pack containing two EMEND 80 mg capsules
• Blister packs containing one EMEND 125 mg capsule
• Blister packs containing five EMEND 125 capsules
• 3-day treatment pack containing one EMEND 125 mg capsule and two EMEND 80 mg capsules

Not all pack sizes may be marketed.