Consumer Medicine Information

EMEND^®

Aprepitant

80 mg or 125 mg capsule

What is in this leaflet

This leaflet answers some common questions about EMEND. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking EMEND against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What EMEND is used for

Your doctor has prescribed EMEND for the prevention of nausea and vomiting associated with your cancer chemotherapy treatment.

How EMEND works

EMEND is a member of a class of medicines called neurokinin 1 (NK₁) receptor antagonists that is used ALONG WITH OTHER MEDICINES to prevent and control nausea (sick feeling in the back of throat and stomach) and vomiting (throwing up) caused by your cancer chemotherapy treatment.

Before you take EMEND

When you must not take it

Do not take EMEND if:

you have an allergy to EMEND or any of the ingredients listed at the end of this leaflet
the packaging is torn or shows signs of tampering
the expiry date on the pack has passed.
If you take this medicine after the expiry date has passed, it may not work.

If you are not sure whether you should start taking EMEND, talk to your doctor.

EMEND has not been adequately studied in children. Therefore, EMEND should not be given to children.

EMEND works equally well in and is equally well-tolerated by older and younger adult patients. No dosage adjustment is necessary for older patients.

Before you start to take it

Tell your doctor if you:

are pregnant or intend to become pregnant
are breast-feeding or plan to breast-feed
have any past or present medical problems
have any allergies.

If you have not told your doctor about any of the above, tell them before you take any EMEND.

Taking other medicines

Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from your pharmacy, supermarket or health food shop.

Do not take EMEND with pimozide, terfenadine, astemizole, or cisapride. Taking EMEND with these medications could result in serious or life-threatening problems.

Your doctor may check that your medicines are working properly together if you are taking other medicines such as:

anti-anxiety drugs (such as alprazolam)
birth control medicines (which may not work as well)
warfarin (a blood thinner)
ketoconazole (an antifungal)
rifampin (an antibiotic)
paroxetine (a medicine used to treat a certain type of depression)
diltiazem (a medicine used to treat high blood pressure)
tolbutamide (a medicine used to treat diabetes)
phenytoin (a medicine used to treat seizures)

Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking EMEND.

How to take EMEND

How much to take and when to take it

Take EMEND only when prescribed by your doctor.

The recommended dose of EMEND is one 125-mg capsule by mouth 1 hour before you start your chemotherapy treatment on Day 1 and one 80-mg capsule by mouth each morning for the 2 days following your chemotherapy treatment.

Your doctor may substitute EMEND IV™ (fosaprepitant) for intravenous administration for oral EMEND (125 mg), 30 minutes prior to chemotherapy, on Day 1 only. You will still need to take one 80-mg capsule by mouth each morning for the 2 days following your chemotherapy treatment.

EMEND may be taken with or without food.

Follow all directions given to you by your doctor carefully. They may differ from the information contained in this leaflet.

If you do not understand the instructions on the box, ask your doctor or pharmacist for help.

How to take it

EMEND comes as capsules.

When taking the capsules, swallow them with a glass of water.

How long to take it

Do not use EMEND for longer than your doctor says.

If you are not sure how long to take EMEND, talk to your doctor.

If you forget to take it

Try to take EMEND as prescribed. However, if you miss a dose, contact your doctor for further instructions.

Do not take a double dose to make up for the dose that you missed.

If you have trouble remembering to take your capsules, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or National Poisons Centre (telephone 0800 POISON or 0800 764 766), or go to accident and emergency at your nearest hospital, if you think that you or anyone else may have taken too much EMEND. Do this even if there are no signs of discomfort or poisoning.

While you are using EMEND

Things you must do

If you become pregnant while taking EMEND, tell your doctor immediately.

If you are about to be started on any new medicine, tell your doctor and pharmacist that you are taking EMEND.

Things you must not do

Do not give EMEND to anyone else, even if they have the same condition as you.

Things to be careful of

There have been side effects reported with EMEND that may affect your ability to drive or operate machinery. Individual responses to EMEND may vary. (See Adverse Effects.)

Things that would be helpful to manage your nausea and vomiting

While good nutrition is important for everyone, it is especially important for people on chemotherapy. Small, frequent meals or eating a snack before your chemotherapy treatment may also help you tolerate it better. Talk to your healthcare professional for further information.

Adverse Effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking EMEND.

EMEND helps most people with nausea and vomiting associated with cancer chemotherapy treatment, but it may have unwanted adverse effects in a few people. All medicines can have adverse effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the adverse effects.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice or have any of the following and they worry you:

hiccups
fatigue
constipation
headache
loss of appetite

These are usually the mild adverse effects of EMEND.

Also, tell your doctor if you notice:

dizziness
diarrhoea
indigestion
belching

Your doctor may find an increase in some of your blood tests (eg ALT & AST).

These are other adverse effects that have been reported with EMEND.

Other adverse effects not listed above may also occur in some patients. Tell your doctor if you notice any other effects.

The following side effects have been reported in general use with EMEND:

Allergic reactions, which may be serious, and may include hives, rash and itching and cause difficulty in breathing or swallowing. If you have an allergic reaction, stop taking EMEND and call your doctor right away.

Do not be alarmed by this list of possible adverse effects. You may not experience any of them.

After using EMEND

Storage

Keep your capsules in the blister pack until it is time to take them. If you take the capsules out of the blister pack they may not keep well.

Keep EMEND in a cool dry place where the temperature stays at or below 30°C. Do not store it or any other medicine in the bathroom or near a sink. Do not leave it in the car or on window sills. Heat and dampness can destroy some medicines.

Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking EMEND, or the capsules have passed their expiry date, ask your pharmacist what to do with any that are left over.

Product description

What it looks like

EMEND comes as two strengths of capsule:

80 mg capsule - white, opaque hard gelatin capsule with 461 and 80 mg printed radially in black ink.
125 mg capsule - opaque, hard gelatin capsule with white body and pink cap with 462 and 125 mg printed radially in black ink.

Ingredients

Active ingredient:

EMEND 80 mg capsule contains 80 mg of aprepitant.

EMEND 125 mg capsule contains 125 mg of aprepitant.

Inactive ingredients:

sucrose
microcrystalline cellulose
hydroxypropyl cellulose
sodium lauryl sulphate
The capsule shell excipients are gelatin and titanium dioxide, and may contain sodium lauryl sulfate and silicon dioxide.
The 125 mg capsule shell also contains red ferric oxide and yellow ferric oxide.

Manufacturer/Supplier

EMEND is marketed in New Zealand by:

Merck Sharp & Dohme (New Zealand) Limited
P O Box 99 851
Newmarket
Auckland
NEW ZEALAND
Tel: 0800 500 673

This leaflet was prepared on 2 May 2008

CP-EMD-0408(020508)

INFORMATION FOR CONSUMERS