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

Patient Information Leaflet

Introduction

Patient Information Leaflet

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, as it contains important information for you. If you are the parent or guardian of a child taking Aprepitant Accord, please read this information carefully.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask 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 you or your child, as it may harm them.
• If you or your child experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of this leaflet

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

1. What Aprepitant Accord is and what it is 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 signals to this area, thereby reducing nausea and vomiting.

Aprepitant Accord capsules are used in adults and adolescents aged 12 years and older, in combination with other medicines, to prevent nausea and vomiting caused by chemotherapy (cancer treatment) that is highly or moderately likely to cause nausea and vomiting (such as cisplatin, cyclophosphamide, doxorubicin or epirubicin).

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

Do not take Aprepitant Accord:

• 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),
  • 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 Aprepitant Accord.

Warnings and precautions

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

Before treatment with Aprepitant Accord, 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 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.

Taking Aprepitant Accord with other medicines

Aprepitant Accord may affect other medicines during and after treatment with Aprepitant Accord. There are some medicines that must 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 altered if you or the child take Aprepitant Accord 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 contraceptive pills, skin patches, implants, and certain hormone-releasing intrauterine devices (IUDs), may not work properly when taken with Aprepitant Accord. During treatment with Aprepitant Accord and for up to 2 months after stopping Aprepitant Accord, 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 too much 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 medicines.

Pregnancy and breastfeeding

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

For information regarding contraception, see 'Taking Aprepitant Accord with other medicines'.

It is unknown whether Aprepitant Accord 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 plan to breastfeed.

Driving and using machines

It should be noted that some people may experience dizziness and drowsiness after taking Aprepitant Accord. 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').

Aprepitant Accord contains sucrose

Aprepitant Accord capsules contain sucrose. If your doctor has diagnosed you or the child with an intolerance to certain sugars, consult your doctor 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

Follow exactly the instructions for administration of this medicine as 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 Aprepitant Accord together with other medicines used to prevent nausea and vomiting. After treatment with Aprepitant Accord, 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 Aprepitant Accord is:

Day 1:

• one 125 mg capsule taken 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 liquid.

Aprepitant Accord may 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 has taken too many capsules, contact your doctor immediately.

If you forget to take Aprepitant Accord

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 gets them.

Stop taking Aprepitant Accord and see 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 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 urination or burning sensation when urinating,
• 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 1,000 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, increased urination, 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 levels of sodium in the blood, weight loss.

Reporting of adverse effects

If you or the child experience any 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 via the Spanish Pharmacovigilance System for Human Medicines at www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Aprepitant Accord

Keep this medicine out of 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 it from moisture.

Do not remove the capsule from its blister pack until just before taking it.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of containers and unused medicines at the SIGRE Point located at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This way, you 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 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 pack

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

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

Aprepitant Accord is supplied in a cardboard 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 pack size:

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Accord Healthcare
World Trade Center
c/ Moll de Barcelona, s/n
Ed. Est, 6th floor
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 medicinal product is authorized 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 the most recent review of this leaflet: December 2018