Aprepitant Stada

Leaflet attached to the packaging: Information for the user

Aprepitant Stada, 125 mg, hard capsules

Aprepitant Stada, 80 mg, hard capsules

Aprepitant Stada, 125 mg/80 mg, hard capsules

Aprepitant

Read the leaflet carefully before taking the medicine, as it contains important information for the patient. Parents of children taking Aprepitant Stada should read the leaflet carefully.

• 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 adult or child. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in the leaflet. See section 4.

Table of contents of the leaflet

• 1. What is Aprepitant Stada and what is it used for
• 2. Important information before taking or administering 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 is Aprepitant Stada and what is it used for

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

2. Important information before taking or administering Aprepitant Stada

When not to take Aprepitant Stada:

• 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 taking Aprepitant Stada.

Warnings and precautions

Before taking or administering Aprepitant Stada to a child, you should discuss this with your doctor, pharmacist, or nurse.
If you have liver problems, you should tell your doctor before taking Aprepitant Stada. The liver is an important organ in the breakdown of this medicine. Your doctor may need to monitor your liver function.

Children and adolescents

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

Aprepitant Stada and other medicines

Aprepitant Stada may affect the way other medicines work, both during and after treatment. Some medicines should not be taken at the same time as Aprepitant Stada (such as pimozide, terfenadine, astemizole, and cisapride), and others may require a dose adjustment (see also the section "When not to take Aprepitant Stada").
The effect of Aprepitant Stada or other medicines may be affected if you take Aprepitant Stada with other medicines. You should tell your doctor or pharmacist if you are taking any of the following medicines:

• contraceptives, including oral contraceptives, contraceptive patches, implants, and some intrauterine devices (IUDs), which may not work properly if taken with Aprepitant Stada. During and for 2 months after treatment with Aprepitant Stada, you should use other or additional non-hormonal methods of contraception;
• cyclosporin, tacrolimus, sirolimus, everolimus (immunosuppressants);
• alfentanil, fentanyl (used to treat pain);
• quinidine (used to treat irregular heart rhythm);
• 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);
• preparations containing St. John's Wort (herbal preparations 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 (antifungals);
• 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 medicines you plan to take.

Pregnancy and breastfeeding

This medicine should not be used during pregnancy unless clearly necessary. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Information on contraceptives is given in the section "Aprepitant Stada and other medicines".
It is not known whether Aprepitant Stada 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 plan to breastfeed before taking this medicine.

Driving and using machines

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

Aprepitant Stada contains sucrose

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

Aprepitant Stada contains sodium

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

3. How to take Aprepitant Stada

This medicine should always be taken or administered to a child exactly as directed by your doctor, pharmacist, or nurse. If you are unsure, ask your doctor, pharmacist, or nurse.
Aprepitant Stada should always be taken with other medicines to prevent nausea and vomiting. After stopping treatment with Aprepitant Stada, your doctor may prescribe other medicines, including a corticosteroid (such as dexamethasone) and a 5-HT3 receptor antagonist (such as ondansetron), to prevent nausea and vomiting. If you are unsure, ask your doctor, pharmacist, or nurse.
Recommended dosesof Aprepitant Stada are:

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

and:

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

If chemotherapy is not given, Aprepitant Stada should be taken in the morning.
If chemotherapy is given, Aprepitant Stada should be taken 1 hour before the start of chemotherapy.
The medicine is for oral use. The capsules should be swallowed whole with a liquid. Aprepitant Stada can be taken with or without food.

Taking a higher dose of Aprepitant Stada than recommended

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 Stada

If you miss a dose of Aprepitant Stada, 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 Stada can cause side effects, although not everybody gets them.

You should stop taking Aprepitant Stada 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, somnolence;
• acne, rash;
• restlessness;
• belching, nausea, vomiting, heartburn, stomach pain, dry mouth, flatulence;
• painful urination or burning sensation while urinating;
• weakness, general feeling of being unwell;
• flushing;
• 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 disturbances;
• increased sensitivity of the skin to the sun, excessive sweating, oily skin, skin ulcers, itching rash, Stevens-Johnson syndrome/toxic epidermal necrolysis (a rare, severe skin reaction);
• euphoria (excessive happiness), disorientation;
• bacterial infections, fungal infections;
• severe constipation, stomach ulcers, inflammation of the small and large intestines, mouth ulcers, bloating;
• increased urination, passing more urine than usual, presence of sugar 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 disorders and blood vessel disorders;
• decreased white blood cell count, decreased sodium levels in the blood, weight loss.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, 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 authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Aprepitant Stada

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 that month.
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. This will help protect the environment.

6. Contents of the pack and other information

What Aprepitant Stada contains

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

What Aprepitant Stada looks like and contents of the pack

The 125 mg hard capsules are non-transparent, hard gelatin capsules, size 1, with a pink cap and a white body, with black ink printing on the body "125mg".
The 80 mg hard capsules are non-transparent, hard gelatin capsules, size 2, with a white cap and a white body, with black ink printing on the body "80mg".
Aprepitant Stada is packaged in a cardboard box containing the appropriate number of blisters made of OPA/Aluminum/PVC/Aluminum foil, together with the patient information leaflet.
Aprepitant Stada 125 mg, hard capsules are available in the following pack sizes:

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

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

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

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

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

Not all pack sizes may be marketed.

Marketing authorization 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
Netherlands

This medicinal product is authorized 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 capsules, hard
Aprepitant STADA 125 mg capsules, hard
Aprepitant STADA 80 mg capsules, hard and 125 mg capsules, hard
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 capsule, hard
Aprepitant STADA 125 mg capsule, hard
Aprepitant STADA 80 mg capsule, hard and 125 mg capsule, hard
Slovakia
Aprepitant Stada 80 mg
Aprepitant Stada 125 mg
Aprepitant Stada 80 mg and Aprepitant Stada 125 mg

Date of last revision of the leaflet: 07.12.2021