Emend 125 mg hard capsules / Emend 80 mg hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

EMEND 125 mg hard capsules

EMEND 80 mg hard capsules

aprepitant

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you. If you are the parent of a child taking EMEND, please read this information carefully.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed only for you or for the child; do not give it to other people, even if they have the same symptoms as you or the child, as it may harm them.
• If you or the child experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What EMEND is and what it is used for
2. What you need to know before taking or giving EMEND
3. How to take 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

EMEND contains the active substance aprepitant and 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 this area, thereby reducing nausea and vomiting. EMEND capsules are used in adults and adolescents aged 12 years and older, in combination with other medicines, to prevent nausea and vomiting caused by a type of chemotherapy (cancer treatment) that strongly or moderately triggers nausea and vomiting (such as cisplatin, cyclophosphamide, doxorubicin or epirubicin).

2. What you need to know before you start taking or giving EMEND

Do not take EMEND

• if you or the child are allergic to aprepitant or to any of the other ingredients of this medicine (listed in section 6).
• with medicines containing pimozide (used to treat psychiatric disorders), terfenadine and astemizole (used for allergic rhinitis and other allergic conditions), or cisapride (used to treat digestive problems). Inform your doctor if you or the child are taking these medicines, as treatment must be adjusted before starting EMEND.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before you start taking EMEND or before giving this medicine to the child.

Before treatment with EMEND, inform your doctor if you or the child have liver disease, as the liver is important for eliminating the medicine from the body. Therefore, your doctor may need to monitor the condition of your liver or the child's liver.

Children and adolescents

Do not give EMEND 80 mg and 125 mg capsules to children under 12 years of age, as the 80 mg and 125 mg capsules have not been studied in this population.

Other medicines and EMEND

EMEND may affect other medicines during and after treatment with EMEND. There are some medicines that must not be taken with EMEND (such as pimozide, terfenadine, astemizole, and cisapride) or that require a dose adjustment (see also ‘Do not take EMEND’).

The effects of EMEND or other medicines may be affected if you or the child take EMEND together with other medicines, including those listed below. Consult your doctor or pharmacist if you or the child are taking any of the following medicines:

• contraceptive medicines, which may include oral contraceptives, contraceptive patches, implants, and certain hormone-releasing intrauterine devices (IUDs), may not work properly when taken with EMEND. During treatment with EMEND and for up to 2 months after taking EMEND, other non-hormonal or additional non-hormonal contraceptive methods should be used,
• cyclosporine, tacrolimus, sirolimus, everolimus (immunosuppressants),
• alfentanil, fentanyl (used to treat pain),
• quinidine (used to treat irregular heartbeats),
• irinotecan, etoposide, vinorelbine, ifosfamide (medicines used to treat cancer),
• medicines containing ergot alkaloids, such as ergotamine or dihydroergotamine (used to treat migraines),
• warfarin, acenocoumarol (blood thinners; blood tests may be needed),
• rifampicin, clarithromycin, telithromycin (antibiotics used to treat infections),
• phenytoin (a medicine used to treat seizures),
• carbamazepine (used to treat depression and epilepsy),
• midazolam, triazolam, phenobarbital (medicines used to calm or help sleep),
• St. John’s wort (a herbal preparation used to treat depression),
• protease inhibitors (used to treat HIV infections),
• ketoconazole, except shampoo (used to treat Cushing's syndrome—when the body produces excess cortisol),
• itraconazole, voriconazole, posaconazole (antifungals),
• nefazodone (used to treat depression),
• corticosteroids (such as dexamethasone and methylprednisolone),
• medicines for anxiety (such as alprazolam),
• tolbutamide (a medicine used to treat diabetes).

Inform your doctor or pharmacist if you or the child are taking, have recently taken, or might need to take any other medicine.

Pregnancy and breastfeeding

You should not use this medicine during pregnancy unless clearly necessary. If you or the girl are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

For information regarding contraception, see ‘Other medicines and EMEND’.

It is unknown whether EMEND passes into breast milk; therefore, breastfeeding is not recommended during treatment with this medicine. It is important to inform your doctor before taking this medicine if you or the girl are breastfeeding or planning to breastfeed.

Driving and using machines

It should be noted that some people may experience dizziness and drowsiness after taking EMEND. If you or the child feel dizzy or drowsy, avoid driving, cycling, or operating machinery or tools after taking this medicine (see ‘Possible side effects’).

EMEND contains sucrose

EMEND capsules contain sucrose. If your doctor has diagnosed you or the child with an intolerance to certain sugars, consult him before taking this medicine.

EMEND contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per capsule; therefore, it is essentially “sodium-free”.

3. How to take EMEND

Follow exactly the dosing instructions for this medicine given to you or to the child by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse again. Always take EMEND together with other medicines used to prevent nausea and vomiting. After treatment with EMEND, your doctor may instruct you or the child to continue taking other medicines to prevent nausea and vomiting, including corticosteroids (such as dexamethasone) and a '5-HT3 antagonist' (such as ondansetron). If in doubt, consult your doctor, pharmacist, or nurse again.

The recommended oral dose of EMEND is:

Day 1:

• one 125 mg capsule, taken 1 hour before starting chemotherapy

and

Days 2 and 3:

• one 80 mg capsule each day.
• if you are not receiving chemotherapy, take EMEND in the morning.
• if you are receiving chemotherapy, take EMEND 1 hour before starting your chemotherapy session.

EMEND may be taken with or without food.

Swallow the capsule whole with liquid.

If you take more EMEND than you should

Do not take more capsules than your doctor recommends. If you or the child has taken too many capsules, contact your doctor immediately.

If you forget to take EMEND

If you or the child has forgotten a dose, seek advice from your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Stop taking EMEND and contact your doctor immediately if you or the child experience any of the following adverse effects, which may be serious and for which you or the child may require urgent medical treatment:

• Hives, rash, itching, difficulty breathing or swallowing (frequency not known, cannot be estimated from available data): these are signs of an allergic reaction.

Other adverse effects that have been reported are listed below.

Common adverse effects (may affect up to 1 in 10 people) are:

• constipation, indigestion,
• headaches,
• fatigue,
• loss of appetite,
• hiccups,
• increased levels of liver enzymes in the blood.

Uncommon adverse effects (may affect up to 1 in 100 people) are:

• dizziness, drowsiness,
• acne, rash,
• anxiety,
• burping, nausea, vomiting, heartburn, stomach pain, dry mouth, flatulence,
• increased painful or burning urination,
• weakness, general malaise,
• hot flushes/flushing of the face or skin,
• rapid or irregular heartbeat,
• fever with increased risk of infection, decrease in red blood cells.

Rare adverse effects (may affect up to 1 in 1000 people) are:

• difficulty thinking, lack of energy, altered taste,
• skin sensitivity to sunlight, excessive sweating, oily skin, skin sores, itchy 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 intestine and colon, mouth sores, abdominal swelling,
• frequent urge to urinate, urinating more than normal, presence of sugar or blood in the urine,
• chest discomfort, swelling, changes in walking pattern,
• cough, mucus in the back of the throat, throat irritation, sneezing, sore throat,
• eye discharge and itching,
• tinnitus (ringing in the ears),
• muscle spasms, muscle weakness,
• excessive thirst,
• slow heartbeat, problems with blood vessels of the heart and veins,
• decrease in white blood cells, low sodium levels in the blood, weight loss.

Reporting of adverse effects

If you or the child experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of EMEND

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Store in the original packaging to protect from moisture.

Do not remove the capsule from its blister pack until the time of administration.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of any unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of EMEND

• 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 components are sucrose, microcrystalline cellulose (E-460), hydroxypropylcellulose (E-463), sodium lauryl sulfate, gelatin, titanium dioxide (E-171), lacquer, 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).

Nature of the product 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 body and white cap, 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:

• Aluminium blister containing one 80 mg capsule
• 2-day treatment pack containing two 80 mg capsules
• 5 aluminium blisters, each containing one 80 mg capsule
• Aluminium blister containing one 125 mg capsule
• 5 aluminium blisters, each containing one 125 mg capsule
• 3-day treatment pack containing one 125 mg capsule and two 80 mg capsules

Some pack sizes may not be marketed.

Marketing Authorization Holder and Manufacturer

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN Haarlem

The Netherlands

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

Other sources of information

Detailed information on this medicine is available on the website of the European Medicines Agency: https://www.ema.europa.eu.