125 mg & 80 mg & 125 mg + 80 mg hard capsules 
aprepitant

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, 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 you or your baby. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you or your child get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Aprepitant STADA is and what it is used for 
2. What you need to know before you use Aprepitant STADA 
3. How to use 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 1 ) receptor antagonists”. There is a special area in the brain that controls nausea and vomiting. Aprepitant Stada works by blocking signals to that area, thus reducing nausea and vomiting.

Aprepitant Stada capsules are used in adults and adolescents from the age of 12 in combination with other medicines to prevent nausea and vomiting caused by chemotherapy (cancer treatment) which very or often causes nausea and vomiting (such as cisplatin, cyclophosphamide, doxorubicin, or epirubicin). ).

Aprepitant contained in Aprepitant Stada may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before you use Aprepitant STADA

Do not use Aprepitant STADA

  • if you or your child are allergic to aprepitant or any of the other ingredients of this medicine (listed in section 6).
  • together with medicines containing:
    • pimozide (used to treat psychiatric illnesses)
    • terfenadine and astemizole (used in hay fever and other allergic conditions)
    • cisapride (used to treat indigestion).

Tell your doctor if you or the child are using these medicines as the treatment must be adjusted before you or the child starts taking Aprepitant Stada.

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before taking Aprepitant Stada or giving this medicine to your child.

If you or your child have any liver disease talk to your doctor before taking Aprepitant Stada. The liver has an important function in breaking down the drug in the body. Your doctor may therefore need to monitor your or your child’s liver function.

Children and young people

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

Other medicines and Aprepitant STADA

Aprepitant Stada can affect other medicines both during and after treatment with Aprepitant Stada. Some medicines should not be used with Aprepitant Stada (eg pimozide, terfenadine, astemizole, and cisapride), or require a dose adjustment of that medicine (see also Do not take Aprepitant Stada).

The effects of Aprepitant Stada or other medicines may be affected if you or your child take Aprepitant Stada with other medicines, including those mentioned below. Tell your doctor or pharmacist if you or your child are taking any of the following medicines:

  • contraceptives such as birth control pills, contraceptive patches, implants, and certain uterine implants ( IUDs ) that release hormones can have a worse effect if used together with Aprepitant Stada. Alternative or complementary non-hormonal contraceptive methods should be used during ongoing treatment with Aprepitant Stada and for up to 2 months after the use of Aprepitant Stada.
  • ciclosporin, tacrolimus, sirolimus, everolimus (immunosuppressive drugs)
  • alfentanil, fentanyl ( painkillers )
  • quinidine (for the treatment of irregular heartbeat)
  • irinotecan, etoposide, vinorelbine, ifosfamide (cancer medicine)
  • medicines containing ergot alkaloid derivatives such as ergotamine and dihydroergotamine (used to treat migraines )
  • warfarin, acenocoumarol (blood thinners, blood tests may be required)
  • rifampicin, clarithromycin, telithromycin ( antibiotics, used to treat infections )
  • phenytoin (an antispasmodic)
  • carbamazepine (used to treat depression and epilepsy )
  • midazolam, triazolam, phenobarbital (medicines that are sedative and help you sleep)
  • St. John’s wort (a traditional herbal medicine used for mild depression and mild anxiety)
  • protease inhibitors (for treatment of HIV – infection s)
  • ketoconazole except for shampoo (for the treatment of Cushing’s syndrome – when the body produces an excess of cortisol )
  • itraconazole, voriconazole, posaconazole (for fungal infections)
  • nefazodone (for the treatment of depression)
  • corticosteroids (such as dexamethasone and methylprednisolone)
  • antianxiety drugs (like alprazolam)
  • tolbutamide (a medicine used in diabetes ).

Tell your doctor or pharmacist if you or your child are taking, have recently taken, or might take any other medicines.

Pregnancy, breastfeeding, and fertility

This medicine should not be used if you or your baby are pregnant unless clearly necessary. If you or your baby are pregnant or breast-feeding, think you or your baby may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.

For information on contraceptive methods, see Other medicines and Aprepitant Stada.

It is not known if Aprepitant Stada passes into breast milk and therefore breastfeeding is not recommended during treatment with this medicine. It is important to tell your doctor if you or your baby are breast-feeding or planning to breast-feed before taking or giving this medicine.

Driving and using machines

It should be noted that some people experience dizziness and drowsiness after using Aprepitant Stada. If you or your child become dizzy or drowsy after using this medicine, avoid driving, cycling, or using machines or tools (see section “Possible side effects”).

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Aprepitant STADA contains sucrose and sodium

Aprepitant Stada contains sucrose

Aprepitant Stada capsules contain sucrose. If your doctor has informed you or your child that you or your child are hypersensitive to certain sugars, contact your doctor before using this medicine.

Aprepitant Stada contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per capsule, ie essentially ‘ sodium-free’ . next to “sodium-free”.

3. How to use Aprepitant STADA

Always take this medicine or give this medicine to your child exactly as your doctor, pharmacist or nurse has told you. If you are not sure, talk to your doctor, pharmacist, or nurse.

Always take Aprepitant Stada with other medicines to prevent nausea and vomiting. After treatment with Aprepitant Stada, your doctor will ask you or your child to continue taking other medicines including a corticosteroid (such as dexamethasone) and a “5HT 3 antagonist” (such as ondansetron) to prevent nausea and vomiting. If you are not sure, talk to your doctor, pharmacist, or nurse.

The recommended dose of one of Aprepitant Stada is:

Day 1:

  • a 125 mg capsule 1 hour before starting your chemotherapy treatment

and

Day 2 and 3:

  • one 80 mg capsule daily

If no chemotherapy is given, take Aprepitant Stada in the morning.

If chemotherapy is given, take Aprepitant Stada 1 hour before starting chemotherapy.

This medicine should be swallowed. The capsule should be swallowed whole with liquid. Aprepitant Stada can be taken with or without food.

If you use more Aprepitant STADA than you should  

Do not take more capsules than your doctor recommends. If you or your child have taken too many capsules,

If you forget to use Aprepitant STADA

If you or your child have missed a dose, contact your doctor for advice.

If you have any further questions on the use of this product, 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 Stada and contact a doctor immediately if you or the child notice any of the following side effects that may be serious and for which you or the child may need emergency care:

Hives, rash, itching, difficulty breathing or swallowing (has been reported, occurs in an unknown number of users) – these are signs of an allergic reaction.

Other side effects are

Common: may affect up to 1 in 10 users

  • constipation, indigestion
  • headache
  • fatigue
  • decreased appetite
  • hiccup
  • elevated levels of liver enzymes in the blood.

Uncommon: may affect up to 1 in 100 people

  • dizziness, drowsiness
  • acne, skin rash
  • anxiety
  • belching, nausea, vomiting, heartburn, stomach pain, dry mouth, gas in the stomach
  • increased painful or burning urination
  • weakness, general malaise
  • hot flashes/redness of the face or redness of the skin
  • fast or irregular heartbeat
  • fever with increased risk of infection decreased the number of red blood cells.

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

  • difficulty thinking, lack of energy, taste changes
  • skin sensitivity to sunlight, increased sweating, oily skin, skin ulcers, itchy rash, Stevens-Johnson syndrome / toxic epidermal necrolysis (rare, severe skin reaction)
  • euphoria (extreme happiness), disorientation
  • bacterial infection, fungal infection
  • severe constipation, gastric ulcer, inflammation of the small intestine and large intestine, ulcers in the mouth, bloating in the stomach
  • denser urination, a greater amount of urine than usual, presence of sugar or blood in the urine
  • a feeling of discomfort in the chest, swelling, altered gait
  • cough, runny nose that runs down the throat, irritation of the throat, sneezing, sore throat
  • watery and itchy eyes
  • tinnitus
  • muscle spasms, muscle weakness
  • increased thirst
  • slow heartbeat, cardiovascular disease
  • fewer white blood cells, low sodium levels in the blood, weight loss.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.

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 expiration date is the last day of the specified month.

Store in the original package. Moisture sensitive.

Do not push the capsule out of the blister until you take it.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substance is aprepitant.

Each 80 mg capsule contains 80 mg of aprepitant.

Each 125 mg capsule contains 125 mg of aprepitant.

The other ingredients are hypromellose, poloxamer, sucrose, microcrystalline cellulose, gelatin, sodium lauryl sulfate (E487), titanium dioxide (E171), shellac, black iron oxide (E172), propylene glycol (E1520). The 125 mg capsule also contains red iron oxide (E172).

What the medicine looks like and the contents of the pack

The 125 mg capsules are opaque hard gelatin capsules size 1, with a pink top and white bottom, with “125 mg” printed in black ink on the bottom.

The 80 mg capsules are opaque hard gelatin capsules size 2, with white bottom and top, and with “80 mg” printed in black ink on the bottom.

Aprepitant Stada is packaged in a carton containing the appropriate number of OPA / ALU / PVC aluminum blisters with a package leaflet.

Aprepitant Stada 125 mg hard capsules are supplied in the following pack sizes:

  • Aluminum blister containing a 125 mg capsule
  • 5 aluminum blisters containing a 125 mg capsule.

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

  • Aluminum blister containing an 80 mg capsule
  • 2-day treatment pack containing two 80 mg capsules
  • 5 aluminum blisters containing an 80 mg capsule.

Aprepitant Stada 125 mg and 80 mg hard capsules are supplied in the following pack sizes:

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

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Other manufacturers

Pharmathen International SA

Sapes Industrial Park Block 5, Rodopi, 69300

Greece

Pharmathen SA

6, Dervenakion str., Pallini, Attiki, 15351

Greece

Centrafarm Services BV

New Donk 9

NL-4879 AC Etten-Leur

Netherlands

Local representative

STADA Nordic ApS

Marielundvej 46A

2730 Herlev

Denmark

Muhammad Nadeem

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