APREPITANT QILU 80 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Aprepitant Qilu 80 mg Hard Capsules EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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 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 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 Package Leaflet

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

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

This medicine 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 works by blocking the signals in this area, thereby reducing nausea and vomiting. Aprepitant capsules are used in adults and adolescents from 12 years of age, in combination with other medicinesto prevent nausea and vomiting caused by cancer chemotherapy (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 Aprepitant Qilu

Do not take Aprepitant Qilu

• if you 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). Inform your doctor if you are taking these medicines, as treatment should be modified before starting aprepitant.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take this medicine.

Before treatment with this medicine, inform your doctor if you have liver disease, as the liver is important for removing the medicine from the body. Therefore, your doctor may need to monitor your liver condition.

Children and adolescents

Do not give this medicine to children under 12 years of age, as the 80 mg capsules have not been studied in this population.

Other medicines and Aprepitant Qilu

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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

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

• contraceptive medicines 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 this medicine. During treatment with this medicine and up to 2 months after using aprepitant.
• cyclosporine, tacrolimus, sirolimus, everolimus (immunosuppressants used to prevent organ rejection after a transplant);
• alfentanil, fentanyl (used to treat pain);
• quinidine (used to treat irregular heartbeats);
• irinotecan, etoposide, vinorelbine, ifosfamide (cancer medicines);
• 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 (used to treat seizures);
• carbamazepine (used to treat depression and epilepsy);
• midazolam, triazolam, phenobarbital (medicines used to calm or help you 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 (used to treat fungal infections);
• nefazodone (used to treat depression);
• corticosteroids (such as dexamethasone and methylprednisolone);
• anxiety medicines (such as alprazolam);
• tolbutamide (used to treat diabetes).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

This medicine should not be used during pregnancy unless strictly necessary.

For information on birth control, see ‘Using Aprepitant Qilu with other medicines’.

It is not known if this medicine is excreted in breast milk; therefore, breastfeeding is not recommended during treatment with this medicine. It is important to inform your doctor before starting to take this medicine if you 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 this medicine. If you feel dizzy or drowsy, avoid driving, cycling, or using machines or tools after taking this medicine (see ‘Possible side effects’).

Aprepitant Qilu contains sucrose

This medicine contains sucrose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

Aprepitant Qilu contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; this is, essentially ‘sodium-free’.

3. How to take Aprepitant Qilu

Always take this medicine exactly as your doctor, pharmacist, or nurse has told you. If you are not sure, check with your doctor, pharmacist, or nurse.

Take aprepitant always with other medicines to prevent nausea and vomiting. After treatment with this medicine, your doctor may ask you to continue taking other medicines to prevent nausea and vomiting, including corticosteroids (such as dexamethasone) and a ‘5-HT3 antagonist’ (such as ondansetron).

The recommended oral dose of this medicine 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 this medicine in the morning.
• if you are receiving chemotherapy, take this medicine 1 hour before starting your chemotherapy session.

Aprepitant can be taken with or without food.

Swallow the capsule whole with some liquid.

If you take more Aprepitant Qilu than you should

Do not take more capsules than your doctor recommends. If you have taken too many capsules, contact your doctor immediately.

If you forget to take Aprepitant Qilu

If you have missed a dose, consult your doctor.

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

4. Possible side effects

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

Stop taking this medicine and contact your doctor immediately if you notice any of the following serious side effects, which may require urgent medical attention:

Frequency not known (cannot be estimated from the available data)

• Hives, rash, itching, difficulty breathing or swallowing; these are signs of an allergic reaction.

Other side effects that have been reported are listed below.

Common (may affect up to 1 in 10 people):

• constipation, indigestion
• headache
• fatigue
• loss of appetite
• hiccups
• increase in liver enzymes in the blood.

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

• 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 (may affect up to 1 in 1,000 people):

• 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 (rare severe skin reactions)
• euphoria (extreme feeling of happiness), disorientation
• bacterial infection, fungal infection
• severe constipation, stomach ulcers, inflammation of the small intestine and colon, mouth ulcers, abdominal distension
• frequent urination, urinating more than usual, presence of sugar or blood in the urine
• chest discomfort, swelling, changes in walking
• 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
• decrease in white blood cells, low sodium levels in the blood, weight loss.

Reporting of side effects

If you get 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 to the Spanish Medicines Agency (AEMPS) at www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Aprepitant Qilu

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 and blister after EXP. The expiry date refers to the last day of the month.

This medicine does not require any special storage conditions.

Store in the original package to protect from moisture.

Do not remove the capsule from the blister until you are ready to 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 protect the environment.

6. Contents of the pack and other information

Composition of Aprepitant Qilu

• The active substance is aprepitant. Each 80 mg hard capsule contains 80 mg of aprepitant.
• The other ingredients are: hypromellose, sodium lauryl sulfate, sucrose (see section 2, “Aprepitant Qilu contains sucrose”), microcrystalline cellulose, talc, gelatin, titanium dioxide (E 171), lacquer, potassium hydroxide, iron oxide black (E 172).

Appearance and packaging

The 80 mg hard capsule is a size 2 opaque capsule with a white body and cap, with “29” and “80 mg” printed in black ink on the body.

Aprepitant 80 mg hard capsules are available in the following pack sizes:

• 1 aluminum blister pack containing one 80 mg capsule.
• 1 aluminum blister pack containing two 80 mg capsules (2-day treatment pack).
• 2 aluminum blister packs, each containing one 80 mg capsule.
• 5 aluminum blister packs, each containing one 80 mg capsule.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

QILU PHARMA SPAIN S.L.

Paseo De La Castellana 40

8th floor, 28046 - Madrid

Spain

Manufacturer

KYMOS, S.L.

Ronda de Can Fatjó 7b, Parc Tecnológic el Vallès

Cerdanyola del Vallès, 08290,

Spain

Netpharmalab Consulting Services

Carretera de Fuencarral 22,

Alcobendas, 28108, Madrid

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet:September 2020.

Other sources of information

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/