Package Leaflet: Information for the User

Aprepitant Accord 125 mg Hard Capsules/Aprepitant Accord 80 mg Hard Capsules EFG

Read this package leaflet carefully before you start taking this medicine because it contains important information for you. If you are the parent of a child who is taking Aprepitant Accord, read this information carefully.

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

1. What Aprepitant Accord is and what it is used for

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

3. How to take Aprepitant Accord

4. Possible side effects

5. Storage of Aprepitant Accord

6. Contents of the pack and additional information

Aprepitant Accord contains the active ingredient 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. Aprepitant Accord acts by blocking signals to this area, thereby reducing nausea and vomiting.

Aprepitant Accord capsules are used in adults and adolescents aged 12 years or older, in combination with other medicines to prevent nausea and vomiting caused by a type of chemotherapy (cancer treatment) that triggers strong to moderate nausea and vomiting (such as cisplatin, cyclophosphamide, doxorubicin, or epirubicin).

Do not take Aprepitant Accord:

• if you or the child are allergic to aprepitant or any of the other components of this medication (listed in section 6).
• with medications that contain:
• • pimozide (used to treat psychiatric disorders),
  • terfenadine and astemizol (used to treat allergic rhinitis and other allergic conditions),
  • cisapride (used to treat digestive problems).

Inform your doctor if you or the child are taking these medications, as the treatment must be modified before you or the child start taking Aprepitant Accord.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Aprepitant Accord or giving the child this medication.

Before treatment with Aprepitant Accord, inform your doctor if you or the child have liver disease, as the liver is important for eliminating the medication from the body. Your doctor may need to monitor your liver function or that of the child.

Children and adolescents

Do not give Aprepitant Accord 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.

Use of Aprepitant Accord with other medications

Aprepitant Accord may affect other medications during and after treatment with Aprepitant Accord. There are some medications that should not be taken with Aprepitant Accord (such as pimozide, terfenadine, astemizol, and cisapride) or that require a dose adjustment (see also ‘Do not take Aprepitant Accord’).

The effects of Aprepitant Accord or other medications may be influenced if you or the child take Aprepitant Accord with other medications, including the following. Consult your doctor or pharmacist if you or the child are taking any of the following medications:

• birth control medications that may include oral contraceptives, skin patches, implants, and certain intrauterine devices (IUDs) that release hormones, may not work properly when taken with Aprepitant Accord. During treatment with Aprepitant Accord and for up to 2 months after taking Aprepitant Accord, other methods or additional non-hormonal methods of contraception should be used,
• ciclosporin, tacrolimus, sirolimus, everolimus (immunosuppressants),
• alfentanil, fentanyl (used to treat pain),
• quinidine (used to treat irregular heartbeats),
• irinotecan, etoposide, vinorelbine, ifosfamide (medications used to treat cancer),
• medications that contain ergot alkaloids, such as ergotamine or dihydroergotamine (used to treat migraines),
• warfarin, acenocoumarol (blood thinners; blood tests may be required),
• rifampicin, clarithromycin, telithromycin (antibiotics used to treat infections),
• phenytoin (a medication used to treat seizures),
• carbamazepine (used to treat depression and epilepsy),
• midazolam, triazolam, phenobarbital (medications used to tranquilize 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 an excess of cortisol),
• itraconazole, voriconazole, posaconazole (antifungals),
• nefazodone (used to treat depression),
• corticosteroids (such as dexamethasone and methylprednisolone),
• anxiety medications (such as alprazolam),
• tolbutamide (a medication used to treat diabetes)

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

Pregnancy and breastfeeding

This medication should not be used during pregnancy unless it is clearly necessary. If you or the child are pregnant or breastfeeding, or intend to become pregnant, consult your doctor before using this medication.

For information related to birth control, see ‘Use of Aprepitant Accord with other medications’.

The passage of Aprepitant Accord into breast milk is unknown; therefore, breastfeeding is not recommended during treatment with this medication. It is essential to inform your doctor before taking this medication if you or the child are breastfeeding or plan to do so.

Driving and operating machinery

Some people may experience dizziness and sleepiness after taking Aprepitant Accord. If you or the child feel dizzy or drowsy, avoid driving, riding a bicycle, or using machines or tools after taking this medication (see ‘Possible side effects’).

Aprepitant Accord contains sucrose

Aprepitant Accord capsules contain sucrose. If your doctor has indicated that you or the child have an intolerance to certain sugars, consult with them before taking this medication.

Aprepitant Accord contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per capsule, which is essentially “sodium-free”.

Follow exactly the administration instructions for this medication indicated for you or for the child by your doctor, pharmacist, or nurse. In case of doubt, consult your doctor, pharmacist, or nurse again.

Take Aprepitant Accord always with other medications to prevent nausea and vomiting. After treatment with Aprepitant Accord, the doctor may ask you or the child to continue taking other medications to prevent nausea and vomiting, including corticosteroids (such as dexamethasone) and a '5-HT3 antagonist' (such as ondansetron). In case of doubt, consult your doctor, pharmacist, or nurse again.

Recommended oral dose of Aprepitant Accord is:

Day 1:

• one 125 mg capsule 1 hour before starting chemotherapy session

and

Days 2 and 3:

• one 80 mg capsule each day.

If you are not receiving chemotherapy, take Aprepitant Accord in the morning.

If you are receiving chemotherapy, take Aprepitant Accord 1 hour before starting your chemotherapy session.

This medication is taken orally. Swallow the capsule whole with some liquid.

Aprepitant Accord can be taken with or without food.

If you take more Aprepitant Accord 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 forgot to take Aprepitant Accord

If you or the child have forgotten a dose, ask your doctor for advice.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Stop taking Aprepitant Accord and seek medical attention immediately if you or the child notice any of the following side effects, which may be serious, and for which you or the child may need urgent medical treatment:

• Hives, itching, difficulty breathing or swallowing (unknown frequency, cannot be estimated from 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,
• Headaches,
• Fatigue,
• Loss of appetite,
• Low blood pressure,
• Increased levels of liver enzymes in the blood.

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

• Dizziness, somnolence,
• Acne, hives,
• Anxiety,
• Belching, nausea, vomiting, heartburn, stomach pain, dry mouth, flatulence,
• Painful or burning urination,
• Weakness, general feeling of being unwell,
• Flushes/redness of the face or skin,
• Irregular or rapid heartbeats,
• Fever with a high risk of infection, decreased red blood cells.

Rare side effects (may affect up to 1 in 1,000 people) are:

• Difficulty thinking, lack of energy, altered taste,
• Sensitivity to sunlight, excessive sweating, oily skin, skin lesions, itchy rash, Stevens-Johnson syndrome/toxic epidermal necrolysis (rare severe skin reaction),
• Euphoria (extreme feeling of happiness), disorientation,
• Bacterial infection, fungal infection,
• Severe constipation, stomach ulcer, inflammation of the small intestine and colon, mouth sores, abdominal swelling,
• Frequent urination, urinating more than usual, presence of sugar or blood in the urine,
• Chest discomfort, swelling, changes in gait,
• Cough, mucous in the back of the throat, throat irritation, sneezing, sore throat,
• Eye secretion and itching,
• Tinnitus,
• Muscle spasms, muscle weakness,
• Excessive thirst,
• Slow heartbeats, problems with blood vessels and veins,
• Decreased white blood cells, low sodium levels in the blood, weight loss

Reporting of side effects

If you or the child experience any type of side effect, consult your doctor, pharmacist or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use, www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture.

Do not remove the capsule from its blister until the time of taking it.

Medications should not be disposed of through drains or trash. Deposit the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Aprepitant Accord

• The active ingredient is aprepitant.

Each 125 mg capsule contains 125 mg of aprepitant.

Each 80 mg capsule contains 80 mg of aprepitant.

• The other components are: hypromellose, poloxamer, sucrose, microcrystalline cellulose (E-460), gelatin, sodium lauryl sulfate (E-487), titanium dioxide (E-171), lacquer, iron oxide black (E-172), propylene glycol (E-1520). The 125 mg capsule also contains iron oxide red (E-172)

Appearance of the product and contents of the package

The 125 mg hard capsule is a hard gelatin capsule, opaque, with a pink cap and white body, and “125 mg” printed on the body.

The 80 mg hard capsule is a hard gelatin capsule, opaque, with a white cap and white body, and “80 mg” printed on the body.

Aprepitant Accord is presented in a carton package with an OPA/ALU/PVC-Aluminum blister.

Aprepitant Accord 125 mg hard capsules/Aprepitant Accord 80 mg hard capsules is supplied in the following package size:

• Package for a 3-day treatment containing one 125 mg capsule and two 80 mg capsules.

Only some package sizes may be commercially available.

Marketing Authorization Holder

Accord Healthcare

World Trade Center

c/ Moll de Barcelona, s/n

Ed. Est, 6th floor

08039 Barcelona

Spain

Responsible for manufacturing

Pharmathen International S.A.

Sapes Industrial Park Block 5

Rodopi, 69300

Greece

or

Pharmathen S.A.

6, Dervenakion Str

Pallini, Attiki, 15351

Greece

This medicine is authorized in the member states of the European Economic Area with the following names:

Austria:Aprepitant Accord 125mg plus 80mg, Hartkapseln

France:Aprepitant Accord

Ireland:Aprepitant Accord

Italy:Aprepitant Accord

Netherlands:Aprepitant Accord 125 mg hard capsules plus 80 mg hard capsules

Poland:Aprepitant Accord

United Kingdom:Aprepitant Accord

Czech Republic:Aprepitant Accord

Last review date of this leaflet:December 2018