EMEND 40 mg hard capsules

EMEND is used to prevent nausea and vomiting after surgery.

Do not take EMEND

• If you are allergic (hypersensitive) to aprepitant or any of the other ingredients of EMEND.

Take special care with EMEND

• if you have liver disease

EMEND is not for use in children and adolescents under 18 years.

Using other medicines

EMEND can affect other medicines.

EMEND should be used with caution when taken with some medicines.

The effects of EMEND or other medicines might be influenced if you take EMEND together with other medicines including those listed below.

• pimozide (used to treat psychiatric illnesses),
• terfenadine; astemizole (used for hay fever and other allergic conditions),
• cisapride (used for treating digestive problems),
• medicines containing ergot alkaloid derivatives (used for treating migraines),
• birth control medicines (which may not work as well; another or additional form of birth control should be used for up to 2 months after using EMEND),
• rifampin, clarithromycin, telithromycin (antibiotics used to treat infections),
• phenytoin, (a medicine used to treat seizures),
• carbamazepine (used to treat depression and epilepsy),
• midazolam, phenobarbital (medicines used to produce calmness or help you sleep),
• St. John?s Wort (an herbal preparation used to treat depression),
• protease inhibitors (used to treat HIV infections),
• nefazodone (used to treat depression),
• ketoconazole itraconazole, voriconazole, and posaconazole (antifungals), and
• corticosteroids (such as dexamethasone)

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

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 (these can include birth control pills, skin patches, implants, and certain Intrauterine devices [IUDs] that release hormones)may not work adequately; another or additional form of contraception 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

It should be taken into account that some people feel dizzy and sleepy after taking EMEND. If you feel dizzy or sleepy, you should avoid driving or operating machines after taking EMEND. (See POSSIBLE SIDE EFFECTS).

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 medicine.

Always take EMEND exactly as your doctor has instructed you.

The recommended oral dose of EMEND is one 40 mg capsule within 3 hours prior to the start of anesthesia.

EMEND should be swallowed whole with some liquid.

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

Like all medicines, EMEND can cause side effects, although not everybody gets them.

The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10)
common (affects 1 to 10 users in 100)
uncommon (affects 1 to 10 users in 1,000)
rare (affects 1 to 10 users in 10,000)
very rare (affects less than 1 user in 10,000)
not known (frequency cannot be estimated from the available data).

Common side effects:

• Increased liver blood tests.

Uncommon side effects:

• upper stomach pain, bowel sounds abnormal, dry mouth, nausea, stomach discomfort,
• decreased feeling or sensitivity (especially in skin), sensory disturbance, difficulty in speaking,
• decrease in pupil size, decrease in sharpness of vision (vision loss),
• inability to sleep,
• slow heartbeat,
• whistling sound while breathing, shortness of breath.

Single cases of the following have been reported:

• Stevens-Johnson syndrome (rare severe skin reaction),
• angioedema (swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing),
• serious constipation, small bowel not working properly (sub-ileus),
• urticaria (hives).

Since the product has been on the market, the following side effects have been reported (frequency not known):

• 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.

If any of the side effects gets serious, or if you experience any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not use EMEND after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Store in the original package in order to protect from moisture.

Do not remove the capsule from its blister until you are ready to take it.

Medicines should not be disposed of via wastewater or house hold waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What EMEND contains

The active substance is aprepitant. Each capsule contains 40 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, black 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 40 mg hard capsule is opaque with a white body and mustard yellow cap with ?464? and ?40 mg? printed radially in black ink on the body.

EMEND 40 mg hard capsules are supplied in the following pack sizes:

• Aluminium blister containing one 40 mg capsule
• 5 Aluminium blisters each containing one 40 mg capsule

Not all pack sizes may be marketed.

Marketing AuthorisationHolder
Merck Sharp & Dohme Ltd.
Hertford Road, Hoddesdon
UK - Hertfordshire EN11 9BU
United Kingdom

Manufacturer
Merck Sharp & Dohme B. V.
Waarderweg 39, Postbus 581
NL-2003 PC Haarlem
The Netherlands

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

BelgiqueBelgiëBelgien Merck Sharp Dohme B.V. Succursale belgeBelgisch bijhuis TélTel 32 0 800 38693 MSDBelgiuminfomerck.com LuxembourgLuxemburg Merck Sharp Dohme B.V. Succursale belge Tél 32 0 800 38693 MSDBelgiuminfomerck.com

. 359 2 819 3740 info-msdbgmerck.com Magyarország MSD Magyarország Kft. Tel. 361 888 53 00 hungarymsdmerck.com

eská republika Merck Sharp Dohme, IDEA, Inc. org. sl. Tel. 420 233 010 111 msdcrmerck.com Malta Merck Sharp Dohme Middle East LimitedTel 357 22866700 infocyprusmerck.com ipru

Danmark Merck Sharp Dohme Tlf 45 43 28 77 66 dkmailmerck.com Nederland Merck Sharp Dohme BV Tel 31 0 23 5153153 msdbvnlmerck.com

Deutschland MSD SHARP DOHME GMBH Tel 49 0 89 4561 2612 Infocentermsd.de Norge MSD Norge AS Tlf 47 32 20 73 00 msdnorgemsd.no

Eesti Merck Sharp Dohme OÜ Tel. 372 613 9750 msdeestimerck.com Österreich Merck Sharp Dohme G.m.b.H. Tel 43 0 1 26 044 msd-medizinmerck.com

E BIANE . 3 0210 80091 11 Mailboxvianex.gr. Polska MSD Polska Sp.z o.o. Tel. 48 22 549 51 00 msdpolskamerck.com

España Merck Sharp Dohme de España, S.A. Tel 34 91 321 06 00 Emendmsd.es Portugal Merck Sharp Dohme, Lda Tel 351 21 4465700 informacaodoentemerck.com

France Laboratoires Merck Sharp Dohme Chibret Tél 33 0 1 47 54 87 00 contactmsd-france.com România Merck Sharp Dohme Romania S.R.L. Tel 4021 529 29 00 msdromaniamerck.com

Ireland Merck Sharp and Dohme Ireland Human Health Limited Tel 353 01 2998700 medinfoirelandmerck.com Slovenija Merck Sharp Dohme, inovativna zdravila d.o.o. Tel 386 1 5204201 msdsloveniamerck.com

Ísland Icepharma hf.Simi 354 540 8000 ISmailmerck.com Slovenská republika Merck Sharp Dohme IDEA, Inc. Tel. 421 2 58282010 msdskmerck.com

talia Merck Sharp Dohme Italia S.p.A. Tel 39 06 361911 doccenmerck.com SuomiFinland MSD Finland Oy PuhTel 358 0 9 804650 infomsd.fi

Merck Sharp Dohme Middle East Limited. 357 22866700 infocyprusmerck.com Sverige Merck Sharp Dohme Sweden AB Tel 46 0 8 626 1400 medicinskinfomerck.com

Latvija SIA Merck Sharp Dohme Latvija. Tel 371 67364 224 msdlvmerck.com. United Kingdom Merck Sharp and Dohme Limited Tel 44 0 1992 467272 medinfoukmerck.com

Lietuva
UAB ?Merck Sharp & Dohme?.
Tel.: +370 5 278 02 47msd_lietuva@merck.com

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