Aprepitant stada

Package leaflet: Information for the user

Aprepitant Stada, 125 mg, hard capsules
Aprepitant Stada, 80 mg, hard capsules
Aprepitant Stada, 125 mg/80 mg, hard capsules
Aprepitantum
Please read this leaflet carefully before taking this medicine because it contains important information for you. Parents of children taking Aprepitant Stada should read this leaflet carefully.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific adult person or child. Do not pass it on to others. It may harm them even if their symptoms are the same.
• If you experience any side effects, please consult your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Aprepitant Stada contains the active substance aprepitant and belongs to a group of medicines called
neurokinin-1 (NK ) receptor antagonists. The brain has a specific area responsible for nausea and
vomiting. Aprepitant Stada blocks signals reaching this area, thereby reducing the frequency of
nausea and vomiting.
In adults and adolescents aged 12 years and older, Aprepitant Stada capsules are used in combination with other medicines to prevent nausea and vomiting caused by chemotherapy (anticancer treatment) that is likely to cause severe or moderate nausea and vomiting (such as cisplatin, cyclophosphamide, doxorubicin, or epirubicin).

2. Important information before using or administering Aprepitant Stada

When not to use Aprepitant Stada:

• if the patient is allergic to aprepitant or any of the other ingredients of this medicine (listed in section 6);
• concomitantly with medicines containing: o pimozide (used in the treatment of psychiatric disorders); o terfenadine and astemizole (medicines used to treat hay fever and other allergic conditions); o cisapride (used to treat gastrointestinal disorders). Inform the treating doctor if the patient is taking any of the above-mentioned medicines, as treatment must be adjusted before starting Aprepitant Stada.

Warnings and precautions
Before starting administration of Aprepitant Stada to a child, discuss this with a doctor, pharmacist, or nurse.
If the patient has impaired liver function, inform the doctor before starting treatment with Aprepitant Stada. The liver is an important organ in the breakdown of this medicine. Therefore, the treating doctor may monitor liver function.

Children and adolescents
Do not give Aprepitant Stada 80 mg and 125 mg capsules to children under 12 years of age, as these capsule strengths have not been studied in this patient group.

Aprepitant Stada and other medicines
Aprepitant Stada may affect the action of other medicines both during and after treatment. Some medicines must not be taken together with Aprepitant Stada (such as pimozide, terfenadine, astemizole, and cisapride), while for others, dose adjustment may be required (see also section "When not to take Aprepitant Stada").
The effect of Aprepitant Stada or other medicines may be altered when Aprepitant Stada is taken together with the following medicines. Inform 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 Stada. During treatment and for 2 months after treatment with Aprepitant Stada, another 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 heart rhythm disorders);
• irinotecan, etoposide, vinorelbine, ifosfamide (medicines used to treat cancer);
• medicines containing ergot alkaloids such as ergotamine and dihydroergotamine (used to treat migraine);
• warfarin, acenocoumarol (anticoagulants; 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 hypnotics);
• herbal products containing St. John's wort (herbal medicines used to treat depression);
• protease inhibitors (used to treat HIV infection);
• ketoconazole, except shampoos (used to treat Cushing's syndrome – when the body produces excess 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).

Tell your doctor or pharmacist about all medicines currently used, recently taken, or planned to be used.

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

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

Aprepitant Stada contains sucrose
Aprepitant Stada capsules contain sucrose. If the doctor has informed the patient of an intolerance to certain sugars, the patient should consult the doctor before taking this medicine.

Aprepitant Stada contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per capsule, i.e. it is considered "sodium-free".

3. How to use Aprepitant Stada

This medicine should always be taken or given to a child exactly as prescribed by the doctor,
pharmacist, or nurse. If in doubt, consult the doctor, pharmacist, or nurse.
Aprepitant Stada should always be taken together with other medicines to prevent nausea and
vomiting. After completing treatment with Aprepitant Stada, the doctor may recommend continuing
with other medicines, including a corticosteroid (such as dexamethasone) and a 5-HT receptor antagonist
(such as ondansetron), to prevent nausea and vomiting. If in doubt, consult the doctor, pharmacist, or nurse.
Recommended doses of Aprepitant Stada are:
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, Aprepitant Stada should be taken in the morning.
If chemotherapy is being administered, Aprepitant Stada should be taken 1 hour before the start of
chemotherapy.
This medicine is for oral use. The capsules should be swallowed whole with liquid. Aprepitant Stada may be taken with or without food.
Taking more than the recommended dose of Aprepitant Stada
Do not take more capsules than prescribed by the doctor. If too many capsules have been taken, contact the doctor immediately.
Missing a dose of Aprepitant Stada
If a dose of Aprepitant Stada is missed, contact the doctor.
If there are any further doubts regarding the use of this medicine, consult the doctor or pharmacist.

4. Possible adverse reactions

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

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

Other adverse reactions
Common: may affect up to 1 in 10 patients

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

Uncommon: may affect up to 1 in 100 patients

• dizziness, drowsiness;
• acne, rash;
• anxiety;
• belching, nausea, vomiting, heartburn, stomach pain, dry mouth, passing wind;
• increased 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, decreased number of red blood cells.

Rare (may affect up to 1 in 1,000 patients)

• difficulty thinking, lack of energy, taste disturbances;
• photosensitivity, excessive sweating, oily skin, skin ulcers, itchy rash, Stevens-Johnson syndrome/toxic epidermal necrolysis (a rare, severe skin reaction);
• euphoria (feeling of excessive happiness), 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 sugar or blood in urine;
• chest discomfort, swelling, gait disturbances;
• cough, postnasal drip, throat irritation, sneezing, sore throat;
• eye discharge and eye itching;
• ringing in the ears;
• muscle cramps, muscle weakness;
• excessive thirst;
• slow heartbeat, heart and blood vessel disorders;
• decreased number of white blood cells, decreased sodium concentration in blood, weight loss.

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

5. How to store Aprepitant Stada

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister marked "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 until the patient is ready to take the medicine.
Medicines must not be disposed of via the sewage system or household waste. Ask a pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Aprepitant Stada contains

• The active substance is aprepitant. Each Aprepitant Stada capsule, 125 mg, contains 125 mg of aprepitant. Each Aprepitant Stada capsule, 80 mg, contains 80 mg of aprepitant.
• 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 Aprepitant Stada 125 mg capsule also contains iron oxide red (E 172).

What Aprepitant Stada looks like and contents of the pack
Hard capsules 125 mg are opaque, hard gelatin capsules of size 1, with a pink cap and a white body, printed in black ink on the body with "125mg".
Hard capsules 80 mg are opaque, hard gelatin capsules of size 2, with a white cap and a white body, printed in black ink on the body with "80mg".
Aprepitant Stada is packed in a cardboard box containing the appropriate number of blisters made of OPA/Aluminium/PVC/Aluminium foil, together with the package leaflet.
Aprepitant Stada 125 mg, hard capsules, is available in the following pack sizes:

• 1 aluminium blister containing one 125 mg capsule,
• 5 aluminium blisters each containing one 125 mg capsule.

Aprepitant Stada 80 mg, hard capsules, is available in the following pack sizes:

• 1 aluminium blister containing one 80 mg capsule,
• a two-day treatment pack containing two 80 mg capsules,
• 5 aluminium blisters each containing one 80 mg capsule.

Aprepitant Stada 125 mg/80 mg, hard capsules, is available in the following pack sizes:

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

Not all pack sizes may be marketed.
Marketing Authorisation Holder
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Manufacturer
Pharmathen International S.A.
Sapes Industrial Park Block 5
69300 Rodopi
Greece
Pharmathen S.A.
6 Dervenakion str.
15351 Pallini, Attiki
Greece
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Centrafarm Services B.V.
Van de Reijtstraat 31-E
4814 NE Breda
The Netherlands
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Netherlands Aprepitant CF 80 mg, hard capsules
Aprepitant CF 125 mg, hard capsules
Aprepitant CF 80 mg plus 125 mg, hard capsules
Germany Aprepitant AL 80 mg Hartkapseln
Aprepitant AL 125 mg Hartkapseln
Aprepitant AL 125 mg und 80 mg Hartkapseln
Denmark Aprepitant STADA
Finland Aprepitant STADA 80 mg kapseli, kova
Aprepitant STADA 125 mg kapseli, kova
Aprepitant STADA 80 mg kapseli, kova ja 125 mg kapseli, kova
France APREPITANT EG 80 mg, gélule
APREPITANT EG 125 mg, gélule
APREPITANT EG 125 mg, gélule et 80 mg, gélule
Iceland Aprepitant STADA 80 mg hörð hylki
Aprepitant STADA 125 mg hörð hylki
Aprepitant STADA 80 mg hörð hylki og 125 mg hörð hylki
Poland Aprepitant Stada
Sweden Aprepitant STADA 80 mg kapsel, hård
Aprepitant STADA 125 mg kapsel, hård
Aprepitant STADA 80 mg kapsel, hård och 125 mg kapsel, hård
Slovakia Aprepitant Stada 80 mg
Aprepitant Stada 125 mg
Aprepitant Stada 80 mg a Aprepitant Stada 125 mg