APREPITANT ACCORD 125 mg HARD CAPSULES / APREPITANT ACCORD 80 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Aprepitant Accord 125 mg hard capsules/Aprepitant Accord 80 mg hard capsules EFG

Read all of this 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 leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you or your child only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you or your child get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Aprepitant Accord and what is it used for
2. What you need to know before you take or give Aprepitant Accord
3. How to take Aprepitant Accord
4. Possible side effects
5. Storing Aprepitant Accord
6. Contents of the pack and other information

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

Aprepitant Accord 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. Aprepitant Accord works by blocking the signals to this area, thereby reducing nausea and vomiting.

Aprepitant Accord 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) that induces strong and moderate nausea and vomiting (such as cisplatin, cyclophosphamide, doxorubicin, or epirubicin).

2. What you need to know before you take or give Aprepitant Accord

Do not take Aprepitant Accord:

• if you or your child are allergic to aprepitant or any of the other ingredients of this medicine (listed in section 6).
• with medicines that contain:
• • pimozide (used to treat psychiatric disorders),
  • terfenadine and astemizole (used for allergic rhinitis and other allergic disorders),
  • cisapride (used to treat digestive problems).

Tell your doctor if you or your child are taking these medicines, as treatment needs to be changed before you or your child start taking Aprepitant Accord.

Warnings and precautions

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

Before treatment with Aprepitant Accord, tell your doctor if you or your child have liver disease, as the liver is important for removing the medicine from the body. Therefore, your doctor may need to monitor your liver or your child's liver.

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.

Using Aprepitant Accord with other medicines

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

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

• contraceptives that may include birth control pills, skin patches, implants, and certain intrauterine devices (IUDs) that release hormones; they may not work properly when taken with Aprepitant Accord. During treatment with Aprepitant Accord and up to 2 months after using Aprepitant Accord, non-hormonal methods or additional methods of contraception 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 that contain ergot derivatives, 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 too much cortisol),
• itraconazole, voriconazole, posaconazole (antifungals),
• nefazodone (used to treat depression),
• corticosteroids (such as dexamethasone and methylprednisolone),
• anxiety medicines (such as 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

Do not use this medicine during pregnancy unless clearly necessary. If you or your child are pregnant or breastfeeding, or think you may be pregnant or are planning to have a baby, consult your doctor before using this medicine.

For information on birth control, see 'Using Aprepitant Accord with other medicines'.

It is not known if Aprepitant Accord passes into breast milk; therefore, breastfeeding should not be done during treatment with this medicine. It is important to tell your doctor before taking this medicine if you or your child are breastfeeding or plan to breastfeed.

Driving and using machines

It should be taken into account that some people have dizziness and drowsiness after taking Aprepitant Accord. If you or your child feel dizzy or drowsy, avoid driving, cycling, or using machines or tools after taking this medicine (see 'Possible side effects).

Aprepitant Accord contains sucrose

Aprepitant Accord capsules contain sucrose. If your doctor has told you or your child that you have an intolerance to some sugars, consult with them before taking this medicine.

Aprepitant Accord contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule, i.e., essentially 'sodium-free'.

3. How to take Aprepitant Accord

Always take Aprepitant Accord exactly as your doctor, pharmacist, or nurse has told you or your child. If you are not sure, ask your doctor, pharmacist, or nurse.

Take Aprepitant Accord always with other medicines to prevent nausea and vomiting. After treatment with Aprepitant Accord, your doctor may ask you or your 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, ask your doctor, pharmacist, or nurse again.

The recommended oral doseof Aprepitant Accord is:

Day 1:

• one 125 mg capsule 1 hour before starting the 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 medicine is taken by mouth. 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 your child have taken too many capsules, contact your doctor immediately.

If you forget to take Aprepitant Accord

If you or your child have missed a dose, ask 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 Aprepitant Accord and contact your doctor immediately if you or your child notice any of the following side effects, which may be serious and require urgent medical attention:

• Hives, rash, itching, difficulty breathing or swallowing (frequency not known, cannot be estimated 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,
• loss of appetite,
• hiccups,
• increased amount of liver enzymes in the blood.

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

• dizziness, drowsiness,
• acne, rash,
• anxiety,
• belching, nausea, vomiting, heartburn, stomach pain, dry mouth, flatulence,
• increased painful or burning urination,
• weakness, general feeling of being unwell,
• flushing/redness of the face or skin,
• rapid or irregular heartbeat,
• fever with a high risk of infection, decrease in red blood cells.

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

• difficulty thinking, lack of energy, altered taste,
• sensitivity of the skin to sunlight, excessive sweating, oily skin, skin ulcers, itchy rash, Stevens-Johnson syndrome/toxic epidermal necrolysis (a rare, severe skin reaction),
• euphoria (feeling of extreme happiness), disorientation,
• bacterial infection, fungal infection,
• severe constipation, stomach ulcers, inflammation of the small intestine and colon, mouth ulcers, abdominal swelling,
• frequent need to urinate, 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 discharge and itching,
• ringing in the ears,
• muscle spasms, muscle weakness,
• excessive thirst,
• slow heartbeat, blood vessel problems,
• low white blood cell count, low sodium levels in the blood, weight loss

Reporting of side effects

If you or your child experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use, www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Aprepitant Accord

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 expiry date refers to the last day of the month shown.

Store in the original package to protect from moisture.

Do not remove the capsule from its blister until the moment of taking 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 protect the environment.

6. Contents of the pack and other information

Composition of Aprepitant Accord

• The active substance is aprepitant.

Each 125 mg capsule contains 125 mg of aprepitant.

Each 80 mg capsule contains 80 mg of aprepitant.

• The other ingredients 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 and packaging

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

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

Aprepitant Accord is presented in a cardboard box with an OPA/ALU/PVC-aluminum blister.

Aprepitant Accord 125 mg hard capsules/Aprepitant Accord 80 mg hard capsules are available in the following pack size:

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

Not all pack sizes may be marketed.

Marketing authorisation holder

Accord Healthcare

World Trade Center

c/ Moll de Barcelona, s/n

Ed. Est, 6ª planta

08039 Barcelona

Spain

Manufacturer

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 authorised in the Member States of the European Economic Area under the following names:

Austria:Aprepitant Accord 125mg plus 80mg, Hartkapseln

France:Aprepitant Accord

Ireland:Aprepitant Accord

Italy:Aprepitant Accord

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

Poland:Aprepitant Accord

United Kingdom:Aprepitant Accord

Czech Republic:Aprepitant Accord

Date of last revision of this leaflet:December 2018