Aprepitant sandoz

Package leaflet: Information for the patient

Aprepitant Sandoz, 125 mg, hard capsules + Aprepitant Sandoz, 80 mg, hard capsules
Aprepitantum
Please read carefully the entire leaflet before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

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

Aprepitant Sandoz contains the active substance aprepitant, a medicine belonging to the group of so-called neurokinin-1 (NK1) receptor antagonists. In the brain there is a specific area responsible for the sensation of nausea and vomiting. Aprepitant Sandoz blocks signals reaching this area, thereby reducing nausea and vomiting. This medicine is used in adults and adolescents aged 12 years and older in combination with other medicines to prevent nausea and vomiting caused by chemotherapy (anticancer treatment) that induces severe and moderate nausea and vomiting (treatment with medicines such as cisplatin, cyclophosphamide, doxorubicin or epirubicin).

2. Important information before using Aprepitant Sandoz

When not to use Aprepitant Sandoz

• if the patient is allergic to aprepitant or any of the other ingredients of this medicine (listed in section 6);
• together with medicines containing pimozide (used in the treatment of psychiatric disorders), terfenadine and astemizole (used in the treatment of hay fever and other allergic reactions), cisapride (used in the treatment of digestive disorders). If the patient is taking any of these medicines, inform the doctor, as treatment modification will be necessary before starting Aprepitant Sandoz.

Warnings and precautions
Before using Aprepitant Sandoz, discuss this with your doctor or pharmacist.

• Before starting treatment with Aprepitant Sandoz, inform the doctor if the patient has liver disease, as the liver plays an important role in the breakdown of the medicine in the body. The doctor may need to monitor liver function.

Children and adolescents
Aprepitant Sandoz 80 mg and 125 mg capsules should not be used in children under 12 years of age,
as the use of these strengths has not been studied in this age group.

Aprepitant Sandoz and other medicines
Aprepitant Sandoz may affect the action of other medicines both during and after treatment with
aprepitant (the active substance of the medicine). Some medicines (such as pimozide, terfenadine,
astemizole and cisapride) must not be used together with Aprepitant Sandoz, or may require dose adjustment (see also “When not to use Aprepitant Sandoz”).
Taking Aprepitant Sandoz together with other medicines, including those listed below, may affect
the action of Aprepitant Sandoz or other medicines. Inform your doctor or pharmacist if you are
taking any of the following medicines:

• hormonal contraceptives, including oral contraceptive pills, patches, implants and certain intrauterine systems – these may not work properly when used together with Aprepitant Sandoz. During treatment with Aprepitant Sandoz and for 2 months after stopping treatment, use other or additional non-hormonal methods of contraception;
• cyclosporine, tacrolimus, sirolimus, everolimus (immunosuppressive medicines);
• alfentanil, fentanyl (medicines used to treat pain);
• quinidine (a medicine used to treat irregular heart rhythm);
• irinotecan, etoposide, vinorelbine, ifosfamide (medicines used to treat cancer);
• medicines containing ergot alkaloids, such as ergotamine and dihydroergotamine (medicines used to treat migraine);
• warfarin, acenocoumarol (anticoagulant medicines; blood tests may be necessary);
• rifampicin, clarithromycin, telithromycin (antibiotics used to treat infections);
• phenytoin (a medicine used to treat seizures);
• carbamazepine (a medicine used to treat depression and epilepsy);
• midazolam, triazolam, phenobarbital (sedatives or medicines to help sleep);
• St John's wort (a herbal medicine used to treat depression);
• protease inhibitors (medicines used to treat HIV infection);
• ketoconazole, except when contained in shampoo (a medicine used to treat Cushing's syndrome, when the body produces too much cortisol);
• itraconazole, voriconazole, posaconazole (antifungal medicines);
• nefazodone (a medicine used to treat depression);
• corticosteroids (such as dexamethasone and methylprednisolone);
• anxiolytic medicines (such as alprazolam);
• tolbutamide (a medicine used to treat diabetes).

Inform your doctor about all medicines currently or recently taken, as well as any medicines you plan to take.

Pregnancy and breastfeeding
This medicine should not be used during pregnancy unless clearly necessary. If a woman is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor before using this medicine.
For information regarding contraception, see “Aprepitant Sandoz and other medicines”.
It is not known whether Aprepitant Sandoz passes into breast milk; therefore, breastfeeding is not recommended during treatment with this medicine. It is important to inform the doctor about breastfeeding or plans to breastfeed before starting treatment.

Driving and operating machinery
Be aware that Aprepitant Sandoz may cause dizziness and drowsiness in some people. If these occur, do not drive, ride a bicycle, or operate machinery or tools after taking the medicine (see “Possible side effects”).

Aprepitant Sandoz contains sucrose
If the patient has been previously diagnosed with intolerance to certain sugars, consult a doctor before taking this medicine.

3. How to use Aprepitant Sandoz

This medicine should always be taken exactly as instructed by your doctor, pharmacist, or nurse.
If in doubt, consult your doctor, pharmacist, or nurse. Aprepitant Sandoz must always be taken
together with other medicines that prevent nausea and vomiting. After completing treatment with
Aprepitant Sandoz, your doctor may recommend continuing with other anti-nausea and anti-vomiting
medicines, including a corticosteroid (e.g. dexamethasone) and a so-called "5HT antagonist" (e.g.
ondansetron). If in doubt, consult your doctor, pharmacist, or nurse.

The recommended dose is:
on Day 1:

• one 125 mg capsule taken 1 hour before the start of chemotherapy session

and
on Days 2 and 3:

• one 80 mg capsule each day
  o if chemotherapy is not administered, take the capsule in the morning;
  o if chemotherapy is administered, take the capsule 1 hour before the start of the chemotherapy session.

This medicine can be taken with food or independently of meals. Swallow the capsules whole with a
drink.

Taking more Aprepitant Sandoz than prescribed
Do not take more medicine than prescribed by your doctor. If you take more than the recommended
dose, contact your doctor immediately.

Missing a dose of Aprepitant Sandoz
If you miss a dose, consult your doctor.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the adverse reactions listed below occur (which may be severe and require urgent treatment),
you must stop taking Aprepitant Sandoz and contact a doctor immediately:

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

The following are other reported adverse reactions:

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, flatulence
• severe pain or burning during urination
• weakness, general malaise
• hot flushes/flushing of the face or skin
• fast or irregular heartbeat
• fever with increased risk of infection, decreased number of red blood cells

Rare (may affect up to 1 in 1000 people):

• disturbances in thinking, lack of energy, taste disturbances
• increased skin sensitivity to sunlight, excessive sweating, oily skin, skin changes, itchy rash, Stevens-Johnson syndrome/toxic epidermal necrolysis (rare, severe skin reaction)
• euphoria (intense feeling of well-being), disorientation
• bacterial infection, fungal infection
• severe constipation, stomach ulcer, inflammation of the small intestine and colon, oral ulceration, bloating
• frequent urination, increased volume of urine excreted, presence of sugar or blood in urine
• chest discomfort, swelling, change in gait
• cough, mucus in the back of the throat, throat irritation, sneezing, sore throat
• eye discharge and itching
• ringing in the ears
• muscle cramps, muscle weakness
• excessive thirst
• slow heart rate, cardiovascular disease
• decreased number of white blood cells, low sodium levels in blood, weight loss

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions 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
tel.: +48 22 49 21 301/fax: +48 22 49 21 309/website: https://smz.ezdrowie.gov.pl
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 Sandoz

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard package after EXP. The expiry date refers to the last day of the stated month.
There are no special requirements regarding the storage temperature of the medicine.
Remove the capsule from the blister immediately before taking the medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Aprepitant Sandoz contains
The active substance is aprepitant.
Aprepitant Sandoz, 80 mg
Each hard capsule contains 80 mg of aprepitant.
Aprepitant Sandoz, 125 mg
Each hard capsule contains 125 mg of aprepitant.
The other ingredients are: sucrose, microcrystalline cellulose spheres 500, hydroxypropylcellulose, sodium lauryl sulfate, gelatin, titanium dioxide (E 171). The 125 mg capsules additionally contain iron oxide red (E 172).

What Aprepitant Sandoz looks like and contents of the pack
Aprepitant Sandoz, 80 mg
Opaque capsules with a white body and a white cap, containing white or almost white pellets.
Aprepitant Sandoz, 125 mg
Opaque capsules with a white body and a pink cap, containing white or almost white pellets.
The medicine is available in a 3-day treatment pack containing one blister with one 125 mg capsule and one blister with 80 mg capsules.

Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria

Manufacturer
Rontis Hellas Medical and Pharmaceutical Products S.A.
P.O. Box 3012 Larissa Industrial Area
41 500 Larissa, Greece
Lek Pharmaceuticals d.d.
Verovškova ulica 57
1526 Ljubljana, Slovenia

For more detailed information about the medicine and its names in the European Economic Area countries, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warszawa
tel. 22 209 70 00