Aprepitant Aurovitas

Package Leaflet: Information for the Patient

Aprepitant Aurovitas, 125 mg/80 mg, Hard Capsules

Aprepitant

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. See section 4.

Contents of the Package Leaflet:

• 1. What Aprepitant Aurovitas is and what it is used for
• 2. Important information before taking Aprepitant Aurovitas
• 3. How to take Aprepitant Aurovitas
• 4. Possible side effects
• 5. How to store Aprepitant Aurovitas
• 6. Contents of the pack and other information

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

Aprepitant Aurovitas 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 is responsible for nausea and vomiting. Aprepitant Aurovitas blocks the signals from this area, reducing the likelihood of nausea and vomiting.
In adults and adolescents from 12 years of age, Aprepitant Aurovitas capsules are used in combination with other medicines to prevent nausea and vomiting caused by chemotherapy (cancer treatment) that is likely to cause significant nausea and vomiting (such as cisplatin, cyclophosphamide, doxorubicin, or epirubicin).

2. Important information before taking Aprepitant Aurovitas

When not to take Aprepitant Aurovitas

• If you are allergic to aprepitant or any of the other ingredients of this medicine (listed in section 6).
• if you are taking medicines containing pimozide (used to treat psychiatric disorders); terfenadine and astemizole (used to treat hay fever and other allergic disorders); cisapride (used to treat gastrointestinal disorders). You should tell your doctor if you are taking any of these medicines, as your treatment may need to be modified before starting Aprepitant Aurovitas.

Warnings and precautions

Before taking Aprepitant Aurovitas, you should discuss this with your doctor, pharmacist, or nurse.
If you have liver problems, you should tell your doctor before taking Aprepitant Aurovitas. The liver is an important organ for breaking down this medicine. Your doctor may need to monitor your liver function.

Children and adolescents

Aprepitant Aurovitas 80 mg and 125 mg capsules should not be given to children under 12 years of age, as these capsules have not been studied in this age group.

Aprepitant Aurovitas and other medicines

Aprepitant Aurovitas may affect the way other medicines work, and other medicines may affect how Aprepitant Aurovitas works. Some medicines must not be taken with Aprepitant Aurovitas (such as pimozide, terfenadine, astemizole, and cisapride), and the dose of others may need to be adjusted (see also the section "When not to take Aprepitant Aurovitas").
The action of Aprepitant Aurovitas or other medicines may be affected if you take Aprepitant Aurovitas with other medicines or birth control pills. You should tell your doctor or pharmacist if you are taking any of the following medicines:

• birth control pills, including oral contraceptives, contraceptive patches, implants, and some intrauterine devices (IUDs), which release hormones, may not work properly when taken with Aprepitant Aurovitas. During and for 2 months after treatment with Aprepitant Aurovitas, you should use other or additional non-hormonal methods of birth control.
• cyclosporin, tacrolimus, sirolimus, everolimus (immunosuppressants);
• alfentanil, fentanyl (used to treat pain);
• quinidine (used to treat irregular heartbeat);
• irinotecan, etoposide, vinorelbine, ifosfamide (used to treat cancer);
• medicines containing ergot derivatives, such as ergotamine and dihydroergotamine (used to treat migraine);
• warfarin, acenocoumarol (blood thinners; blood tests may be necessary);
• rifampicin, clarithromycin, telithromycin (antibiotics used to treat infections);
• phenytoin (used to treat seizures);
• carbamazepine (used to treat depression and epilepsy);
• midazolam, triazolam, phenobarbital (sedatives or sleeping pills);
• St. John's Wort (herbal preparations used to treat depression);
• protease inhibitors (used to treat HIV infections);
• ketoconazole (except for shampoo) (used to treat Cushing's syndrome - when the body produces too much cortisol);
• itraconazole, voriconazole, posaconazole (antifungal medicines);
• nefazodone (used to treat depression);
• corticosteroids (such as dexamethasone and methylprednisolone);
• anxiolytics (such as alprazolam);
• tolbutamide (used to treat diabetes).

You should tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and any you plan to take.

Pregnancy and breastfeeding

This medicine should not be used during pregnancy unless it is clearly necessary. 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.
Information on birth control is given in the section "Aprepitant Aurovitas and other medicines".
It is not known whether Aprepitant Aurovitas passes into breast milk, and breastfeeding is not recommended during treatment with this medicine. It is important to tell your doctor if you are breastfeeding or planning to breastfeed before taking this medicine.

Driving and using machines

You should be aware that some patients may experience dizziness and sleepiness after taking Aprepitant Aurovitas. You should avoid driving, cycling, or operating machinery or tools if you experience dizziness or sleepiness after taking this medicine (see also section "Possible side effects").

Aprepitant Aurovitas contains sucrose

Aprepitant Aurovitas capsules contain sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Aprepitant Aurovitas contains sodium

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

3. How to take Aprepitant Aurovitas

This medicine should always be taken or given to a child exactly as instructed by your doctor, pharmacist, or nurse. If you are unsure, ask your doctor, pharmacist, or nurse.
Aprepitant Aurovitas should always be taken with other medicines to prevent nausea and vomiting. After completing treatment with Aprepitant Aurovitas, your doctor will advise you to take other medicines, including a corticosteroid (such as dexamethasone) and a 5-HT3 antagonist (such as ondansetron), to prevent nausea and vomiting. If you are unsure, ask your doctor, pharmacist, or nurse.
The recommended oral dose of Aprepitant Aurovitas is

• 1. day:
• one 125 mg capsule 1 hour before the start of chemotherapy

and

• 2. and 3. day:
• one 80 mg capsule each day.

If chemotherapy is not given, Aprepitant Aurovitas should be taken in the morning.
If chemotherapy is given, Aprepitant Aurovitas should be taken 1 hour before the start of chemotherapy.
This medicine should be taken by mouth. The capsule should be swallowed whole with a small amount of water. Aprepitant Aurovitas can be taken with or without food.

Taking more Aprepitant Aurovitas than prescribed

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

Missing a dose of Aprepitant Aurovitas

If you miss a dose of Aprepitant Aurovitas, contact your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Aprepitant Aurovitas can cause side effects, although not everybody gets them.

Stop taking Aprepitant Aurovitas and contact your doctor immediately if you experience any of the following serious side effects:

• hives, rash, itching, difficulty breathing or swallowing (frequency not known, cannot be estimated from the available data); these are symptoms of an allergic reaction.

Other side effects

Common: may affect up to 1 in 10 people.

• constipation, indigestion;
• headache;
• fatigue;
• loss of appetite;
• hiccups;
• increased liver enzyme activity in the blood.

Uncommon: may affect up to 1 in 100 people.

• dizziness, sleepiness;
• acne, rash;
• restlessness;
• belching, nausea, vomiting, heartburn, stomach pain, dry mouth, passing gas;
• painful urination or burning sensation while urinating;
• weakness, general feeling of being unwell;
• hot flashes/flushing of the face or skin;
• rapid or irregular heartbeat;
• fever with increased risk of infection, decreased red blood cell count.

Rare: may affect up to 1 in 1,000 people.

• difficulty thinking, lack of energy, taste disorders;
• skin sensitivity to sunlight, excessive sweating, seborrhoea, skin ulcers, itching rash, Stevens-Johnson syndrome/toxic epidermal necrolysis (rare, severe skin reaction);
• euphoria (excessive happiness), disorientation;
• bacterial infections, fungal infections;
• severe constipation, stomach ulcers, inflammation of the small and large intestine, mouth ulcers, bloating;
• frequent urination, passing more urine than usual, presence of glucose or blood in the urine;
• chest discomfort, swelling, changes in gait;
• cough, presence of mucus in the back of the throat, throat irritation, sneezing, sore throat;
• presence of mucus in the eyes and eye itching;
• ringing in the ears;
• muscle spasms, muscle weakness;
• excessive thirst;
• slow heartbeat, heart disease and blood vessel disorders;
• decreased white blood cell count, low sodium levels in the blood, weight loss.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported to the Medicines and Healthcare products Regulatory Agency (MHRA) using the Yellow Card Scheme (www.mhra.gov.uk/yellowcard).
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Aprepitant Aurovitas

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of that month.
Store in the original package to protect from moisture.
Do not remove the capsule from the blister until immediately before taking it.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Aprepitant Aurovitas contains

• The active substance is aprepitant. Each 125 mg capsule contains 125 mg aprepitant. Each 80 mg capsule contains 80 mg aprepitant.
• The other ingredients are: hypromellose 2910, poloxamer 407, sucrose, microcrystalline cellulose, gelatin, sodium lauryl sulfate (E 487), titanium dioxide (E 171), shellac, iron oxide black (E 172), propylene glycol (E 1520). The 125 mg capsule also contains iron oxide red (E 172).

What Aprepitant Aurovitas looks like and contents of the pack

The 125 mg hard capsule is a non-transparent, gelatin capsule, size 1, with a pink cap and a white body with black printing "125mg".
The 80 mg hard capsule is a non-transparent, gelatin capsule, size 2, white with black printing "80mg".
Aprepitant Aurovitas is available in blisters of OPA/Aluminum/PVC/Aluminum, in a cardboard box.
The 125 mg and 80 mg hard capsules are available in the following packs:

• 3-day treatment pack, containing 1 capsule of 125 mg and 2 capsules of 80 mg

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warszawa

Manufacturer:

Pharmathen International S.A.

Industrial Park Sapes, Rodopi Prefecture, Block No 5
69300 Rodopi
Greece

Pharmathen S.A.

6, Dervenakion str.
15351 Pallini Attiki
Greece

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

Netherlands:
Aprepitant Aurobindo 80 mg, hard capsules
Aprepitant Aurobindo 125 mg, hard capsules
Aprepitant Aurobindo 125 mg and 80 mg, hard capsules
France:
Aprepitant Arrow
Poland:
Aprepitant Aurovitas

Date of last revision of the leaflet: