APREPITANT 125 mg/80 mg Kapsułki Twarde
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Jak stosować APREPITANT TEVA
Treść ulotki
Aprepitant Teva 125 mg + 80 mg hard capsules
Aprepitant
Generic medicine
Read this leaflet carefully before you start taking this medicine as it contains important information for you. If you are the parent of a child being treated with Aprepitant Teva, read this information carefully.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you or for your child only. Do not pass it on to others, even if they have the same symptoms, as it could be harmful.
- If you or your child gets any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet
- 1. What Aprepitant Teva is and what it is used for
- 2. What you need to know before you take Aprepitant Teva
- 3. How to take Aprepitant Teva
- 4. Possible side effects
- 5. How to store Aprepitant Teva
- 6. Contents of the pack and other information
1. What is Aprepitant Teva and what is it used for
Aprepitant Teva 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
controls nausea and vomiting. Aprepitant Teva works by blocking the signals sent to that area,
thus reducing nausea and vomiting. Aprepitant Teva capsules are used in adults and
adolescents 12 years and older together with other medicinesto prevent nausea and
vomiting caused by chemotherapy treatments (cancer treatments) that are strong and moderate
inducers of nausea and vomiting (e.g. cisplatin, cyclophosphamide, doxorubicin or epirubicin).
2. What you need to know before you take or administer Aprepitant Teva
Do not take Aprepitant Teva:
- if you or the child are allergic to aprepitant and any of the other ingredients of this medicine (listed in section 6),
- with medicines that contain pimozide (a substance used for the treatment of psychiatric illnesses), terfenadine and astemizole (used for hay fever and other allergies), cisapride (used for the treatment of digestive problems). Tell your doctor if you or the child are taking these medicines, as the therapy may need to be modified before you or the child start taking Aprepitant Teva.
Warnings and precautions
Consult your doctor, pharmacist or nurse before taking Aprepitant Teva or administering this medicine to the child.
Before treatment with Aprepitant Teva, tell your doctor if you or the child has a liver disease, because the liver is important for metabolizing the medicine within the body. Your doctor may therefore need to check the condition of your liver or that of the child.
Children and adolescents
Do not administer Aprepitant Teva 125 mg and 80 mg capsules to children under 12 years of age, because the 125 mg and 80 mg capsules have not been studied in this population.
Other medicines and Aprepitant Teva
Aprepitant Teva may have effects on other medicines both during and after treatment with Aprepitant Teva. There are some medicines that must not be taken with Aprepitant Teva (such as pimozide, terfenadine, astemizole, and cisapride) or that require an adjustment of the dose (see also “Do not take Aprepitant Teva”).
The effects of Aprepitant Teva or other medicines may be affected if you or the child take Aprepitant Teva together with other medicines including those listed below. Tell your doctor or pharmacist if you or the child are taking any of the following medicines:
- medicines for birth control including contraceptive pills, skin patches, implants, and some intrauterine devices (IUDs) with hormonal release may not work properly when taken together with Aprepitant Teva. During treatment with Aprepitant Teva and for up to 2 months after use of Aprepitant Teva, another or an additional non-hormonal method of birth control must be used,
- cyclosporine, tacrolimus, sirolimus, everolimus (immunosuppressants),
- alfentanil, fentanyl (used for the treatment of pain),
- quinidine (used for the treatment of irregular heartbeat),
- irinotecan, etoposide, vinorelbine, ifosfamide (medicines for the treatment of cancer),
- medicines containing ergot alkaloids such as ergotamine and dihydroergotamine (used for the treatment of migraine),
- warfarin, acenocoumarol (anticoagulants; blood tests may be required),
- rifampicin, clarithromycin, telithromycin (antibiotics for the treatment of infections),
- phenytoin (a medicine for the treatment of seizures),
- carbamazepine (used for the treatment of depression and epilepsy),
- midazolam, triazolam, phenobarbital (medicines used to calm or help sleep),
- St. John's wort (a herbal remedy used for the treatment of depression),
- protease inhibitors (used for the treatment of HIV infections),
- ketoconazole except for shampoo (used to treat Cushing's syndrome - characterized by excessive cortisol production by the body),
- itraconazole, voriconazole, posaconazole (antifungals),
- nefazodone (used to treat depression),
- corticosteroids (such as dexamethasone and methylprednisolone),
- anti-anxiety medicines (such as alprazolam),
- tolbutamide (a medicine for the treatment of diabetes). Tell your doctor or pharmacist if you or the child are taking, have recently taken or might take any other medicine.
Pregnancy, breastfeeding and fertility
This medicine should not be used during pregnancy unless it is clearly necessary. If you or your daughter are pregnant, suspect or are planning a pregnancy or if you are breastfeeding, ask your doctor for advice before taking this medicine.
For information on birth control, see “Other medicines and Aprepitant Teva”.
It is not known whether Aprepitant Teva is excreted in human milk; breastfeeding is therefore not recommended during therapy with this medicine. Before taking this medicine it is important to tell your doctor if you or your daughter are breastfeeding or if you are thinking of breastfeeding.
Driving and operating machinery
You should be aware that some people feel dizzy and sleepy after taking Aprepitant Teva. If you or the child feel dizzy or sleepy, avoid driving vehicles, riding a bicycle or using machinery or tools after taking this medicine (see “Possible side effects”).
Aprepitant Teva contains sucrose
If your doctor has diagnosed you or the child with intolerance to some sugars, contact them before taking this medicine.
3. How to take Aprepitant Teva
Always take this medicine or administer this medicine to the child following exactly the
instructions of the doctor, pharmacist or nurse. If you have any doubts, consult the
doctor, pharmacist or nurse. Always take Aprepitant Teva together with other medicines, to
prevent nausea and vomiting. After treatment with Aprepitant Teva, the doctor may ask you
or the child to continue taking other medicines including a corticosteroid (such as
desamethasone) and a “5-HT3 antagonist” (such as ondansetron) to prevent nausea and vomiting.
Consult the doctor, pharmacist or nurse if you are not sure.
The recommended oral dose of Aprepitant Teva is
Day 1:
- one 125 mg capsule 1 hour before starting the chemotherapy session.
and
Days 2 and 3:
- one 80 mg capsule each day,
- if chemotherapy is not administered, take Aprepitant Teva in the morning,
- if chemotherapy is administered, take Aprepitant Teva 1 hour before starting the chemotherapy session.
Aprepitant Teva can be taken independently of food.
Swallow the capsule whole with liquids.
If you take more Aprepitant Teva than you should
Do not take more capsules than recommended by the doctor. If you or the child have taken too
many capsules, seek immediate medical attention.
If you forget to take Aprepitant Teva
If you or the child forget a dose, ask your doctor for advice. Do not take a double dose to
make up for a missed dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Aprepitant Teva and go to a doctor immediately if you or the child
notice any of the following side effects, which may be serious and require urgent medical treatment:
- hives, rash, itching, difficulty breathing or swallowing (frequency not known, cannot be estimated based on available data); these are signs of an allergic reaction.
Other side effects that have been reported are listed below.
Common side effects (may affect up to 1 in 10 people) are:
- constipation, indigestion;
- headache;
- fatigue;
- loss of appetite;
- hiccups;
- increased liver enzymes in the blood.
Uncommon side effects (may affect up to 1 in 100 people) are:
- dizziness, drowsiness;
- acne, rash;
- anxiety;
- burping, nausea, vomiting, heartburn, stomach pain, dry mouth, passing gas;
- increased pain or burning when urinating;
- weakness, general feeling of discomfort;
- hot flashes/redness of the face or skin;
- fast or irregular heartbeat;
- fever with increased risk of infection, decreased red blood cells.
Rare side effects (may affect up to 1 in 1,000 people) are:
- difficulty thinking, lack of energy, altered taste;
- skin sensitivity to the sun, excessive sweating, oily skin, skin lesions, itchy rash, Stevens-Johnson syndrome/toxic epidermal necrolysis (a rare, serious skin reaction);
- euphoria (feeling of extreme happiness), disorientation;
- bacterial infection, fungal infection;
- severe constipation, stomach ulcer, inflammation of the small intestine and colon, mouth sores, intestinal gas;
- frequent urination, passing a larger amount of urine than normal, presence of sugar or blood in the urine
- chest discomfort, swelling, change in the way you walk;
- cough, mucus in the back of the throat, sore throat, sneezing, sore throat;
- eye secretion and itching;
- ringing in the ears;
- muscle spasms, muscle weakness;
- excessive thirst;
- slowed heartbeat, heart and blood vessel disease;
- decreased white blood cells, low sodium levels in the blood, weight loss.
Reporting of side effects
If you or the child experience any side effects, including those not listed in this
leaflet, tell your doctor, pharmacist or nurse. You can also report side effects
directly through the national reporting system at
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting
side effects you can help provide more information on the safety of this
medicine.
5. How to store Aprepitant Teva
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 box or blister after
“Exp”. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not remove the capsule from the blister until you are ready to take it.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
6. Package Contents and Other Information
What Aprepitant Teva contains
- The active ingredient is aprepitant. Each 125 mg capsule contains 125 mg of aprepitant. Each 80 mg capsule contains 80 mg of aprepitant.
- The other ingredients are: sucrose (see section 2 “Aprepitant Teva contains sucrose”), microcrystalline cellulose (E 460), hydroxypropylcellulose (E 463), sodium lauryl sulfate, gelatin, titanium dioxide (E 171): the 125 mg capsule also contains red iron oxide (E172).
Description of the appearance of Aprepitant Teva and package contents
The 125 mg capsules are opaque with a white body and a pink cap. They have a length of approximately
19.0 mm and contain granules ranging in color from white to almost white.
The 80 mg capsules are opaque with a white body and cap. They have a length of approximately 17.4
mm and contain granules ranging in color from white to almost white.
Aprepitant Teva is supplied in the following packs:
- Pack for a 3-day treatment: 1 blister with one 125 mg capsule and 1 single-dose blister with two 80 mg capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
TEVA B.V.
Swensweg 5,
2031 GA Haarlem
Manufacturer
Teva Operations Poland Sp. z.o.o,
ul. Mogilska 80, Kraków, 31-546, Poland
Merckle GmbH
Ludwig-Merckle-Strasse 3, Blaubeuren,Baden-Wuerttemberg, 89143, Germany
Rontis Hellas Medical and Pharmaceutical Products S.A.
P.O. BOX 3012, Larisa Industrial Area, Larisa 41004, Greece
This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
| g Netherlands: | Aprepitant Teva 125 mg + 80 mg, hard capsules |
| A Austria: | Aprepitant ratiopharm 80 mg/125 mg Hard capsules |
| Belgium: | Aprepitant Teva 125 mg + 80 mg harde capsules, gélules dures, Hartkapseln |
| Czech Republic: | Aprepitant Teva |
| Germany: | Aprepitant-ratiopharm 125 mg + 80 mg Hard capsules |
| France: | Aprepitant Teva 125 mg capsule and Aprepitant Teva 80 mg capsule |
| Croatia: | o Aprepitant Teva 125 mg + 80 mg hard capsules |
| Poland: | c Aprepitant Teva |
| Portugal: | a Aprepitant Teva |
| Slovenia: | Aprepitant Teva 125 mg hard capsules and Aprepitant Teva 80 mg hard capsules |
| Slovakia: | m Aprepitant Teva 80 mg and Aprepitant Teva 125 mg |
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- Kraj rejestracji
- Postać farmaceutycznaHard capsule, 125 MG + 80 MG
- Kod ATCA04AD12
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki APREPITANT TEVAPostać farmaceutyczna: Hard capsule, 80 MGSubstancja czynna: aprepitantProducent: SINTESY PHARMA S.R.L.Wymaga receptyPostać farmaceutyczna: Hard capsule, 80 MGSubstancja czynna: aprepitantProducent: MERCK SHARP & DOHME B.V.Wymaga receptyPostać farmaceutyczna: Powder for intravenous infusion solution, 150 MGSubstancja czynna: aprepitantProducent: ACCORD HEALTHCARE, S.L.U.Wymaga recepty
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Często zadawane pytania
APREPITANT TEVA wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w APREPITANT TEVA jest aprepitant. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
APREPITANT TEVA jest produkowany przez TEVA B.V.. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie APREPITANT TEVA jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
Polska posiada dobrze rozwiniętą infrastrukturę ochrony zdrowia w dużych miastach, takich jak Warszawa, Kraków, Wrocław i Gdańsk. Apteki są łatwo dostępne i działają zgodnie z obowiązującymi przepisami, zapewniając dostęp do leków na receptę.
Możesz kupić APREPITANT TEVA w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
Aby uzyskać receptę, możesz skorzystać z Oladoctor:
Inne leki zawierające tę samą substancję czynną (aprepitant) to m.in. ATANTO, EMEND, FOSAPREPITANT AKKORD. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
