125 mg and 80 mg capsules, hard
aprepitant
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 (NK 1 ) receptor antagonists”. There is a special area in the brain that controls nausea and vomiting. EMEND works by blocking signals to that area, thus reducing nausea and vomiting. EMEND capsules are used in adults and adolescents from 12 years of age in combination with other medicines to prevent nausea and vomiting caused by chemotherapy (cancer treatment) which very or often causes nausea and vomiting (such as cisplatin, cyclophosphamide, doxorubicin, or epirubicin).
2. What you need to know before taking or giving EMEND
Do not take EMEND
- if you or your child are allergic to aprepitant or any of the other ingredients of this medicine (listed in section 6).
- together with medicines containing pimozide (used to treat psychiatric illnesses), terfenadine and astemizole (used to treat hay fever and other allergic conditions), cisapride (used to treat indigestion). Tell your doctor if you or your child are using these medicines as the treatment needs to be adjusted before you or your child starts using EMEND.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before taking EMEND or giving this medicine to your child.
If you or the child have any liver disease, talk to a doctor before treatment with EMEND. The liver has an important function in breaking down the drug in the body. Your doctor may therefore need to monitor your or your child’s liver function.
Children and young people
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 age group.
Other medicines and EMEND
EMEND can affect other medicines both during and after treatment with EMEND. Some medicines should not be used with EMEND (eg pimozide, terfenadine, astemizole,e, and cisapride), or require a dose adjustment of that medicine (see also Do not take EMEND).
The effects of EMEND or other medicines may be affected if you or your child take EMEND with other medicines, including those mentioned below. Tell your doctor or pharmacist if you or your child are taking any of the following medicines:
- contraceptives such as birth control pills, birth control patches, implants, and certain uterine inserts ( IUDs ) that release hormones can have a worse effect if they are used together with EMEND. Alternative or complementary non-hormonal contraceptive methods should be used during ongoing treatment with EMEND and for up to 2 months after use of EMEND.
- ciclosporin, tacrolimus, sirolimus, everolimus (immunosuppressive drugs)
- alfentanil, fentanyl ( painkillers )
- quinidine (for the treatment of irregular heartbeat)
- irinotecan, etoposide, vinorelbine, ifosamide (cancer medicine)
- medicines containing ergot alkaloid derivatives such as ergotamine and ergotamine (used to treat migraines )
- warfarin, acenocoumarol (blood thinners, blood tests may be required)
- rifampicin, clarithromycin, telithromycin ( antibiotics, used to treat infections )
- phenytoin (an antispasmodic)
- carbamazepine (used to treat depression and epilepsy )
- midazolam, triazolam, phenobarbital (medicines that are sedative and help you sleep)
- St. John’s wort (a herbal remedy for depression)
- protease inhibitors (for treatment of HIV – infection s)
- ketoconazole excluding shampoo, (for the treatment of Cushing’s syndrome – when the body produces an excess of cortisol )
- itraconazole, voriconazole, posaconazole (for fungal infections)
- nefazodone (for the treatment of depression)
- corticosteroids (such as dexamethasone and methylprednisolone)
- antianxiety drugs (like alprazolam)
- tolbutamide (a medicine used to treat diabetes )
Tell your doctor or pharmacist if you or your child are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
This medicine should not be used if you or your baby are pregnant unless clearly necessary. If you or your baby are pregnant or breast-feeding, think you or your baby may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.
For information on contraceptive methods, see Other medicines and EMEND.
It is not known if EMEND passes into breast milk and therefore breastfeeding is not recommended during treatment with this medicine. It is important to tell your doctor if you or your baby are breast-feeding or planning to breast-feed before taking or giving this medicine.
Driving and using machines
It should be noted that some people experience dizziness and drowsiness after using EMEND.
If you or your child become dizzy or drowsy after using this medicine, avoid driving, cycling,g or using machines or tools (see section “Possible side effects”).
EMEND contains sucrose and sodium
EMEND contains sucrose
EMEND capsules contain sucrose. If you have been told by your doctor or child that you or your child is hypersensitive to certain sugars, contact your doctor before using this medicine.
EMEND contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per capsule, ie essentially ‘sodium-free’.
How to take or give EMEND
Always take this medicine or give this medicine to your child exactly as your doctor, pharmacist or nurse has told you. If you are not sure, talk to your doctor, pharmacist, or nurse. Always take EMEND with other medicines to prevent nausea and vomiting. After treatment with EMEND, your doctor will ask you or your child to continue taking other medicines including a corticosteroid (such as dexamethasone) and a “5HT 3antagonist” (such as ondansetron) to prevent nausea and vomiting. If you are not sure, talk to your doctor, pharmacist, or nurse.
The recommended oral dose of EMEND is:
Day 1:
- a 125 mg capsule 1 hour before starting your chemotherapy treatment
and
Day 2 and 3:
- one 80 mg capsule daily
- if no chemotherapy is given, take EMEND in the morning
- if chemotherapy is given, take EMEND 1 hour before starting chemotherapy.
EMEND can be taken with or without food.
The capsule should be swallowed 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 have taken too many capsules, contact your doctor immediately.
If you forget to take EMEND
If you or your child 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.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking EMEND and contact a doctor immediately if you or your child notice any of the following side effects that may be serious and for which you or your child may need emergency care:
- hives, rash, itching, difficulty breathing, or swallowing (no known frequency, can not be calculated from the available data) – these are signs of an allergic reaction.
Other side effects that have been reported are listed below.
Common side effects (may affect up to 1 in 10 people) are:
- constipation, indigestion
- headache
- fatigue
- decreased appetite
- hiccup
- elevated levels of liver enzymes in the blood.
Uncommon side effects (may affect up to 1 in 100 people) are:
- dizziness, drowsiness
- acne, skin rash
- anxiety
- belching, nausea, vomiting, heartburn, stomach pain, dry mouth, gas in the stomach
- increased painful or burning urination
- weakness, general malaise
- hot flashes/redness of the face or redness of the skin
- fast or irregular heartbeat
- fever with increased risk of infection, decreased number of red blood cells
Rare side effects (may affect up to 1 in 1,000 people) are:
- difficulty thinking, lack of energy, taste changes
- skin sensitivity to sunlight, increased sweating, oily skin, skin ulcers, itchy rash, Stevens-Johnson syndrome / toxic epidermal necrolysis (rare, severe skin reaction)
- euphoria (extreme happiness), disorientation
- bacterial infection, fungal infection
- severe constipation, gastric ulcer, inflammation of the small intestine and large intestine, ulcers in the mouth, bloating in the stomach
- denser urination, the greater amount of urine than usual, presence of sugar or blood in the urine
- the feeling of discomfort in the chest, swelling, altered gait
- cough, runny nose running down the throat, irritation of the throat, sneezing, sore throat
- watery and itchy eyes
- tinnitus
- muscle spasms, muscle weakness
- increased thirst
- slow heartbeat, cardiovascular disease
- fewer white blood cells, low sodium levels in the blood, weight loss.
5. How to store EMEND
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
Store in the original package. Moisture sensitive.
Do not push the capsule out of the blister until you take it.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
– 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 (E460), hydroxypropyl cellulose (E463), sodium lauryl sulfate, gelatin, titanium dioxide (E171), shellac, potassium hydroxide, and black iron oxide (E172); 125 mg hard capsule also contains red iron oxide (E172) and yellow iron oxide (E172).
What the medicine looks like and the contents of the pack
The 125 mg hard capsule is opaque with a white body and a pink body. “462” and “125 mg” are printed in black ink across the bottom of the capsule.
The 80 mg hard capsule is opaque with a white bottom and top, and with “461” and “80 mg” printed in black ink across the bottom of the capsule.
EMEND 125 mg and 80 mg hard capsules are supplied in the following pack sizes:
- Aluminum blister containing an 80 mg capsule
- Pack of 2 days treatment containing two 80 mg capsules
- 5 aluminum blisters each containing an 80 mg capsule
- Aluminum blister containing a 125 mg capsule
- 5 aluminum blisters each containing a 125 mg capsule
- Pack of 3 days treatment containing one 125 mg capsule and two 80 mg capsules.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Merck Sharp & Dohme BV
Waarderweg 39
2031 BN Haarlem
Netherlands
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