Aprepitant aurovitas

Package leaflet: Information for the patient

Aprepitant Aurovitas, 125 mg/80 mg, hard capsules
Aprepitantum
Please read all of this leaflet carefully before 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 a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Leaflet contents:

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 responsible for nausea and vomiting. Aprepitant Aurovitas blocks signals from this area, thereby reducing the frequency of nausea and vomiting.
In adults and adolescents aged 12 years and older, Aprepitant Aurovitas in capsule form is used in combination with other medicines to prevent nausea and vomiting caused by chemotherapy (anticancer treatment) that induces high or moderate levels of nausea and vomiting (such medicines include cisplatin, cyclophosphamide, doxorubicin, or epirubicin).

2. Important information before using Aprepitant Aurovitas

When not to use Aprepitant Aurovitas

• If the patient is allergic to aprepitant or any of the other ingredients of this medicine (listed in section 6).
• Concurrently with medicines containing pimozide (used in the treatment of psychiatric disorders); terfenadine and astemizole (medicines used to treat hay fever and other allergic conditions); cisapride (a medicine used to treat digestive disorders). Patients should inform their doctor if they are taking any of the above-mentioned medicines, as treatment must be adjusted before starting Aprepitant Aurovitas.

Warnings and precautions
Before starting treatment with Aprepitant Aurovitas, discuss this with your doctor, pharmacist, or nurse.
If the patient has liver function disorders, inform the doctor before starting treatment with Aprepitant Aurovitas. The liver is an important organ in the breakdown of this medicine. Therefore, the treating doctor may decide to monitor 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 capsule strengths have not been studied in this patient group.

Aprepitant Aurovitas and other medicines
Aprepitant Aurovitas may affect the action of other medicines both during and after treatment. Some medicines must not be taken together with Aprepitant Aurovitas (such as pimozide, terfenadine, astemizole, and cisapride), while others require dose adjustment (see also section "When not to take Aprepitant Aurovitas").
The effect of Aprepitant Aurovitas or other medicines may be altered when Aprepitant Aurovitas is taken together with the following medicines or contraceptives. Please consult your doctor or pharmacist if you are taking any of the following:

• Contraceptives, including oral contraceptives, contraceptive patches, implants, and certain hormone-releasing intrauterine devices (IUDs), may not work properly when taken together with Aprepitant Aurovitas. During treatment and for 2 months after treatment with Aprepitant Aurovitas, an alternative or additional non-hormonal method of contraception should be used.
• Cyclosporine, tacrolimus, sirolimus, everolimus (immunosuppressive medicines);
• Alfentanil, fentanyl (used to treat pain);
• Quinidine (used to treat irregular heartbeat);
• Irinotecan, etoposide, vinorelbine, ifosfamide (medicines used to treat cancer);
• Medicines containing ergot alkaloid derivatives such as ergotamine and dihydroergotamine (used to treat migraine);
• Warfarin, acenocoumarol (anticoagulant medicines; blood tests may be required);
• Rifampicin, clarithromycin, telithromycin (antibiotics used to treat infections);
• Phenytoin (used to treat seizures);
• Carbamazepine (used to treat depression and epilepsy);
• Midazolam, triazolam, phenobarbital (sedative or sleep-inducing medicines);
• Herbal products containing St. John's wort (herbal remedies used to treat depression);
• Protease inhibitors (used to treat HIV infections);
• Ketoconazole, except for shampoos (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);
• Anxiolytic medicines (such as alprazolam);
• Tolbutamide (used to treat diabetes).

Please inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Pregnancy and breastfeeding
This medicine should not be used during pregnancy unless absolutely necessary. If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before taking this medicine.
Information regarding contraceptives is provided in the section "Aprepitant Aurovitas and other medicines".
It is not known whether Aprepitant Aurovitas passes into human breast milk; therefore, breastfeeding is not recommended during treatment with this medicine. It is important to inform the treating doctor if you are breastfeeding or intend to breastfeed before taking this medicine.

Driving and operating machinery
Please be aware that dizziness and drowsiness may occur in some patients after taking Aprepitant Aurovitas. Avoid driving, cycling, or operating machinery or tools if dizziness or drowsiness occurs after taking this medicine (see section "Possible side effects").

Aprepitant Aurovitas contains sucrose
Aprepitant Aurovitas capsules contain sucrose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

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

3. How to use Aprepitant Aurovitas

This medicine should always be taken or administered to a child exactly as directed by the doctor, pharmacist, or nurse. If in doubt, consult the doctor, pharmacist, or nurse.
Aprepitant Aurovitas must always be used together with other medicines to prevent nausea and vomiting. After completing treatment with Aprepitant Aurovitas, your doctor will recommend continuing with other medicines, including a corticosteroid (such as dexamethasone) and a 5-HT receptor antagonist (such as ondansetron), to help prevent nausea and vomiting. If in doubt, consult the doctor, pharmacist, or nurse.
Recommended oral dose of Aprepitant Aurovitas:

Day 1:

• one 125 mg capsule taken 1 hour before starting chemotherapy

and

Days 2 and 3:

• one 80 mg capsule each day.

If chemotherapy is not being administered, take Aprepitant Aurovitas in the morning.
If chemotherapy is being administered, take Aprepitant Aurovitas 1 hour before the start of chemotherapy.
This medicine is for oral use. The capsule should be swallowed whole with a small amount of water. Aprepitant Aurovitas may be taken with or without food.
Taking more Aprepitant Aurovitas than recommended
Do not take more capsules than prescribed by your doctor. If too many capsules have been taken, contact your doctor immediately.
Missing a dose of Aprepitant Aurovitas
If a dose of Aprepitant Aurovitas is missed, contact your doctor.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
You must stop taking Aprepitant Aurovitas and contact your doctor immediately if you experience any of
the following side effects, which may be severe and require immediate medical attention:

• hives, rash, itching, difficulty breathing or swallowing (frequency unknown, cannot be estimated from 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 blood.

Uncommon: may affect up to 1 in 100 people.

• dizziness, drowsiness;
• acne, rash;
• anxiety;
• belching, nausea, vomiting, heartburn, stomach pain, dry mouth, passing wind;
• painful urination or burning sensation during urination;
• weakness, general malaise;
• hot flushes/flushing of the face or skin;
• rapid or irregular heartbeat;
• fever with increased risk of infection, reduced number of red blood cells.

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

• difficulty concentrating, lack of energy, taste disturbances;
• photosensitivity, excessive sweating, seborrhoea, skin ulceration, itchy rash, Stevens-Johnson syndrome/toxic epidermal necrolysis (rare, serious skin reactions);
• euphoria (feeling of excessive well-being), disorientation;
• bacterial infections, fungal infections;
• severe constipation, gastric ulcer, inflammation of the small and large intestine, oral ulcers, bloating;
• frequent urination, increased volume of urine passed, presence of glucose or blood in urine;
• chest discomfort, oedema, gait disturbances;
• cough, postnasal drip, throat irritation, sneezing, sore throat;
• eye discharge and itchy eyes;
• tinnitus (ringing in the ears);
• muscle cramps, muscle weakness;
• excessive thirst;
• slow heartbeat, heart and blood vessel disorders;
• decreased number of white blood cells, reduced sodium levels in blood, weight loss.

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C, 02-222 Warsaw, Poland, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309,
e-mail: [email protected]
Side effects can also be reported to the marketing authorisation holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Aprepitant Aurovitas
Keep the medicine out of 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 the stated month.
Store in the original packaging to protect from moisture.
Do not remove the capsule from the blister pack earlier than 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 of aprepitant. Each 80 mg capsule contains 80 mg of 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 hard capsule additionally contains iron oxide red (E 172).

What Aprepitant Aurovitas looks like and contents of the pack
The 125 mg hard capsule is opaque, gelatin, size "1", consisting of a pink cap and a white body with black printing "125mg".
The 80 mg hard capsule is opaque, gelatin, size "2", white with black printing "80mg".
Aprepitant Aurovitas is available in blisters made of OPA/Aluminum/PVC/Aluminum foil, packed in a cardboard carton.
The 125 mg and 80 mg hard capsules are available in the following pack sizes:

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

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
Sokratesa 13D, lok. 27
01-909 Warsaw
Poland

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 authorised in the Member States of the European Economic Area under the following names:
Netherlands: Aprepitant Aurobindo 80 mg, harde capsules
Aprepitant Aurobindo 125 mg, harde capsules
Aprepitant Aurobindo 125 mg en 80 mg, harde capsules
France: Aprepitant Arrow
Poland: Aprepitant Aurovitas