Product Information for the User

Fosaprepitant Zentiva150 mg Powder for Solution for Infusion EFG

Read this entire product information carefully before starting to use this medicine, as it contains important information for you.

• Keep this product information, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this product information. See section 4.

FosaprepitantZentivacontains the active ingredient fosaprepitant, which is converted into aprepitant in the body. It belongs to a group of medicines called "neurokinin 1 (NK1) receptor antagonists". The brain has a specific area that controls nausea and vomiting. FosaprepitantZentivaworks by blocking signals to this area, thereby reducing nausea and vomiting. FosaprepitantZentivais used in adults, adolescents, and children aged 6 months and older,in combination with other medicines,to prevent nausea and vomiting caused by a type of chemotherapy (cancer treatment) that triggers strong or moderate nausea and vomiting.

Do not use Fosaprepitant Zentiva:

• if you are allergic to fosaprepitant, aprepitant, or to polysorbate 80 or any of the other ingredients of this medicine (listed in section 6).
• with medicines that contain pimozide (used to treat psychiatric disorders), terfenadine and astemizol (used to treat allergic rhinitis and other allergic disorders), cisaprida (used to treat digestive problems). Inform your doctor if you are taking these medicines as the treatment needs to be modified before starting to use Fosaprepitant.

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to use Fosaprepitant.

Before treatment with this medicine, inform your doctor if you have liver disease, as the liver is important for eliminating the medicine from the body. Your doctor may need to monitor your liver function.

Children and adolescents

Do not give Fosaprepitant to children under 6 months of age or weighing less than 6 kg, as the use of this medicine has not been studied in this population.

Use of Fosaprepitant Zentiva with other medicines

Fosaprepitant may affect other medicines both during and after treatment with Fosaprepitant. There are some medicines that should not be used with Fosaprepitant (such as pimozide, terfenadine, astemizol and cisaprida) or that require a dose adjustment (see also ‘Do not use Fosaprepitant Zentiva’).

The effects of Fosaprepitant or other medicines may be influenced if you take Fosaprepitant with other medicines, including the following. Consult your doctor or pharmacist if you are taking any of the following medicines:

• contraceptives that may include birth control pills, skin patches, implants and certain intrauterine devices (IUDs) that release hormones, may not work properly when taken with Fosaprepitant. During treatment with Fosaprepitant and for up to 2 months after using Fosaprepitant, other methods or additional non-hormonal methods of contraception should be used,
• ciclosporin, tacrolimus, sirolimus, everolimus (immunosuppressants),
• alfentanilo, fentanilo (used to treat pain),
• quinidina (used to treat irregular heartbeats),
• irinotecan, etopósido, vinorelbina, ifosfamida (medicines used to treat cancer),
• medicines that contain ergotamine alkaloids, such as ergotamine and dihydroergotamine (used to treat migraines),
• warfarina, acenocumarol (blood thinners; blood tests may be needed),
• rifampicina, claritromicina, telitromicina (antibiotics used to treat infections),
• fenitoína (a medicine used to treat seizures),
• carbamazepina (used to treat depression and epilepsy),
• midazolam, triazolam, fenobarbital (medicines used to calm or to help sleep),
• St. John's Wort (a herbal preparation used to treat depression),
• protease inhibitors (used to treat HIV infections),
• ketoconazol, except shampoo (used to treat Cushing's syndrome - when the body produces an excess of cortisol),
• itraconazol, voriconazol, posaconazol (antifungals),
• nefazodona (used to treat depression),
• diltiazem (a medicine used to treat high blood pressure),
• corticosteroids (such as dexametasona),
• anxiety medicines (such as alprazolam),
• tolbutamida (a medicine used to treat diabetes).

Inform your doctor if you are using, have used recently or may need to use any other medicine or herbal remedy.

Pregnancy and breastfeeding

This medicine should not be used during pregnancy unless it is clearly necessary. If you are pregnant or breastfeeding, or think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

For information related to birth control, see ‘Use of Fosaprepitant with other medicines’.

The passage of Fosaprepitant into breast milk is unknown; therefore, breastfeeding is not recommended during treatment with this medicine. It is essential to inform your doctor before receiving this medicine, if you are breastfeeding or plan to do so.

Driving and operating machines

Some people experience dizziness and drowsiness after using Fosaprepitant. If you feel dizzy or drowsy, avoid driving or operating machines after using this medicine (see ‘Possible side effects’).

Fosaprepitant Zentiva contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per dose, which is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor again.

The recommended dose of fosaprepitant in adults (18 years of age or older) is 150 mg of fosaprepitant on day 1 (chemotherapy day).

The recommended dose of Fosaprepitant in children and adolescents (6 months to 17 years of age) is based on the patient's age and weight. Depending on the chemotherapy received, fosaprepitant may be administered in one of two ways:

Fosaprepitant is administered only on day 1 (single-day chemotherapy).

Fosaprepitant is administered on days 1, 2, and 3 (chemotherapy of one or multiple days).

• Days 2 and 3 may be prescribed oral presentations of aprepitant instead of fosaprepitant.

The powder is reconstituted and diluted before use. The infusion solution is administered by a healthcare professional, such as a doctor or nurse, via intravenous infusion (drip) approximately 30 minutes before chemotherapy begins in adults or 60-90 minutes before chemotherapy begins in children and adolescents. Your doctor may ask you to take other medications to prevent nausea and vomiting, including corticosteroids (such as dexamethasone) and a 5-HT3 antagonist (such as ondansetron). If in doubt, consult your doctor or pharmacist.

If you use more Fosaprepitant Zentiva than you should:

In case ofoverdose, consult your doctor or pharmacist or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop taking Fosaprepitant and see your doctor immediately if you notice any of the following side effects, which may be serious, and for which you may need urgent medical treatment:

• Hives, itching, difficulty breathing or swallowing, or a severe drop in blood pressure (unknown frequency, cannot be estimated from available data): these are signs of a severe allergic reaction.
• Reactions at the infusion site or near it. The most severe reactions at the infusion site have occurred with a certain type of chemotherapy that can burn or form blisters on your skin (vesicant) with side effects that include pain, swelling, and redness. In some people who receive this type of chemotherapy, there has been skin tissue death (necrosis).

Other side effects that have been reported are listed below.

Frequent side effects (may affect up to 1 in 10 people) are::

• Constipation, indigestion,
• Headache,

• Fatigue,
• Loss of appetite,
• Low blood pressure,
• Increased liver enzyme levels in the blood.

Less frequent side effects (may affect up to 1 in 100 people) are:

• Dizziness, somnolence,
• Acne, hives,
• Anxiety,
• Belching, nausea, vomiting, heartburn, stomach pain, dry mouth, flatulence,
• Increased frequency of urination with pain or burning,
• Weakness, general feeling of illness,
• Face/ skin redness, hot flashes,
• Irregular or rapid heartbeats, increased blood pressure,
• Fever with increased risk of infection, decreased red blood cell count,
• Pain at the injection site, redness at the injection site, itching at the injection site, inflammation of the veins at the injection site.

Rare side effects (may affect up to 1 in 1,000 people) are:

• Difficulty thinking, lack of energy, altered taste,
• Sensitivity to sunlight, excessive sweating, oily skin, skin lesions, itching, Stevens-Johnson syndrome/toxic epidermal necrolysis (rare severe skin reaction),
• Euphoria (extreme feeling of happiness), disorientation,
• Bacterial infection, fungal infection,
• Severe constipation, stomach ulcer, inflammation of the small intestine and colon, mouth sores, abdominal swelling,
• Frequent urination, urinating more than usual, presence of sugar or blood in the urine,
• Chest discomfort, swelling, changes in gait,
• Cough, mucous in the back of the throat, throat irritation, sneezing, sore throat,
• Eye secretion and itching or eye irritation,
• Tinnitus,
• Muscle spasms, muscle weakness,
• Excessive thirst,
• Slow heartbeats, cardiovascular and blood vessel disease,
• Decreased white blood cell count, low sodium levels in the blood, weight loss,
• Hardening of the injection site.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe box and in the vialafter CAD. The expiration date is the last day of the month indicated.

Store in refrigerator between 2°C and 8°C.

The reconstituted and diluted solution is stable for 24 hours at 25°C.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Composition of Fosaprepitant Zentiva

• The active ingredient is fosaprepitant. Each vial contains fosaprepitant dimeglumine equivalent to 150 mg of fosaprepitant. After reconstitution and dilution, 1 ml of solution contains 1 mg of fosaprepitant (1 mg/ml).
• The other components are disodium edetate (E‑386), polysorbate 80 (E‑433), anhydrous lactose, sodium hydroxide (E‑524) (to adjust the pH) and/or diluted hydrochloric acid (E‑507) (to adjust the pH).

Appearance of the product and contents of the package

Fosaprepitant Zentiva is a white to off-white powder for solution for infusion.

The powder is included in a transparent glass vial with a rubber stopper and an aluminum seal with a green plastic flip-top cap.

Each vial contains 150 mg of fosaprepitant. Package sizes: 1 vial.

Marketing Authorization Holder

Zentiva, k.s.,

U kabelovny 130,

Dolní Mecholupy,

102 37 Prague 10

Czech Republic

Responsible for manufacturing

MIAS Pharma Limited

Suite 2, Stafford House, Strand Road,

Portmarnock, Co. Dublin,

Ireland

Tillomed Malta Limited,

Malta Life Sciences Park,

LS2.01.06 Industrial Estate,

San Gwann, SGN 3000, Malta

Pharmadox Healthcare Limited

KW20A Kordin Industrial Park,

Paola PLA 3000, Malta

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Zentiva Spain S.L.U.,

Avenida de Europa, 19, Edificio 3, Planta 1.

28224 Pozuelo de Alarcón, Madrid

Spain

This medication is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:March 2023

Other sources of information

The detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)

-----------------------------------------------------------------------------------------------------------------

This information is intended solely for healthcare professionals:

Instructions for reconstitution and dilution of Fosaprepitant Zentiva 150 mg:

1. Inject 5 ml of sodium chloride solution 9 mg/ml (0.9 %) into the vial. Ensure that the sodium chloride solution 9 mg/ml (0.9 %) is added to the vial along the wall of the vial to avoid foam formation. Gently move the vial. Avoid agitating and shaking the sodium chloride solution 9 mg/ml (0.9 %) inside the vial.
2. Prepare an infusion bag that contains145 mlof sodium chloride solution 9 mg/ml (0.9 %) (for example, by removing 105 ml of sodium chloride solution 9 mg/ml (0.9 %) from an infusion bag of 250 ml of sodium chloride solution 9 mg/ml (0.9 %)).
3. Remove the entire volume from the vial and transfer it into the infusion bag containing 145 ml of sodium chloride solution 9 mg/ml (0.9 %) toobtain a total volume of 150 ml and a final concentration of 1 mg/ml. Gently invert the bag 2‑3 times (see ‘How to use Fosaprepitant Tillomed’).
4. Determine the volume to be administered from this prepared infusion bag, in accordance with the recommended dose (see the Summary of Product Characteristics or Product Information Leaflet, section 4.2).

Adults

The entire volume of the prepared infusion bag (150 ml) must be administered.

Pediatric population

In patients aged 12 years or older, the volume to be administered is calculated as follows:

• The volume to be administered (ml) is equal to the recommended dose (mg)

In patients aged 6 months to 12 years, the volume to be administered is calculated as follows:

• Volume to be administered (ml) = recommended dose (mg/kg) x weight (kg)

• Nota: Do not exceed the maximum doses (see the Summary of Product Characteristics or Product Information Leaflet, section 4.2).

1. For volumes less than 150 ml, if necessary, the calculated volume can be transferred to a suitable infusion bag or syringe before administration by infusion.

The final reconstituted and diluted solution is stable for 24 hours at 25 °C.

When the solution and the container permit, a visual inspection of parenteral medicines should be performed before administration to check for the presence of particles or discoloration.

The appearance of the reconstituted solution is the same as the appearance of the diluent used.

Dispose of any remaining solution and residual material. The disposal of unused medication and all materials that have come into contact with it will be in accordance with local regulations.

The medication should not be reconstituted or mixed with solutions for which physical and chemical compatibility has not been established (see the Summary of Product Characteristics or Product Information Leaflet, section 6.2).