Carboplatin Eugia

Package Leaflet: Information for the User

Carboplatin Eugia, 10 mg/mL, Concentrate for Solution for Infusion

Carboplatin

Read All of This Leaflet Carefully Before You Start Using This Medicine Because It Contains Important Information for You.

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 you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Pack and Other Information

• 1. What Carboplatin Eugia is and what it is used for
• 2. What you need to know before you are given Carboplatin Eugia
• 3. How Carboplatin Eugia is given
• 4. Possible side effects
• 5. How to store Carboplatin Eugia
• 6. Contents of the pack and other information

1. What Carboplatin Eugia is and what it is used for

What Carboplatin Eugia is

Carboplatin Eugia contains the active substance carboplatin, which belongs to a group of medicines known as platinum compounds. These are used in the treatment of cancer.

What Carboplatin Eugia is used for

Carboplatin Eugia is used to treat advanced ovarian cancer and small cell lung cancer.

2. What you need to know before you are given Carboplatin Eugia

When You Should Not Be Given Carboplatin Eugia

• If you are allergic to carboplatin or any of the other ingredients of this medicine (listed in section 6)
• If you have severe kidney problems (creatinine clearance equal to or less than 30 mL/min)
• If you have a low blood cell count (severe bone marrow suppression)
• If you have a bleeding tumor
• If you are receiving live vaccines (e.g., yellow fever vaccine) at the same time.

If any of the above applies to you, and you have not discussed this with your doctor or nurse before, you must tell your doctor or nurse before you are given the infusion. Carboplatin Eugia is usually given to patients in a hospital. Under normal circumstances, you will not come into contact with the medicine. Your doctor or nurse will give you the medicine and will closely and frequently monitor your condition during and after the infusion. Usually, before each dose of the medicine, a blood test will be performed.

Warnings and Precautions:

Before you start using Carboplatin Eugia, you should discuss this with your doctor or nurse.

• If you are pregnant or think you may be pregnant.
• If you are breast-feeding.
• If there is a chance that you may drink alcohol during treatment.
• If you have a headache, changes in consciousness, seizures, and changes in vision from blurred vision to loss of vision, you should inform your doctor.
• If you experience extreme fatigue, shortness of breath with a reduced red blood cell count (symptoms of hemolytic anemia), alone or in combination with a low platelet count, unusual bruising (thrombocytopenia), and kidney disease with decreased urine output or anuria (symptoms of hemolytic-uremic syndrome), you should inform your doctor.
• If you have a fever (temperature greater than or equal to 38°C) or chills, which may be signs of infection, you should immediately inform your doctor. You may have a blood infection.

In patients with impaired kidney function, the effect of Carboplatin Eugia on the blood (hematopoietic system) is increased and prolonged compared to patients with normal kidney function. In cases of impaired kidney function, your doctor will monitor your condition more frequently. During treatment with Carboplatin Eugia, you will be given medicines to reduce the likelihood of a life-threatening complication known as tumor lysis syndrome, caused by biochemical disturbances in the blood resulting from the breakdown of dying cancer cells, which release their contents into the bloodstream. If any of the above applies to you and has not been previously discussed with your doctor or nurse, you should inform your doctor or nurse before receiving this medicine. Before administration, the medicine may be diluted with another solution. You should discuss this with your doctor and ensure it is suitable for you.

Carboplatin Eugia with Other Medicines

Tell your doctor, pharmacist, or nurse about all medicines you are taking or have recently taken, as well as any medicines you plan to take. You should inform your doctor if you are taking any of the following medicines, as they may interact with Carboplatin Eugia.

• Other medicines with known toxic effects on the kidneys (e.g., aminoglycoside antibiotics)
• Other medicines known to cause hearing or balance problems (e.g., aminoglycoside antibiotics, furosemide used to treat heart failure and edema)
• Other medicines that reduce the activity of the immune system (e.g., cyclosporine, tacrolimus, sirolimus, and other anticancer medicines)
• Yellow fever vaccine and other live vaccines
• Anticoagulant medicines, e.g., warfarin
• Phenytoin and fosphenytoin (medicines used to treat various types of seizures and epilepsy)
• Chelating agents (substances capable of binding to Carboplatin Eugia and reducing its effect)
• Loop diuretics (medicines used to treat high blood pressure and edema).

Carboplatin Eugia with Food, Drink, and Alcohol

It is not known whether Carboplatin Eugia interacts with alcohol. However, you should consult your doctor, as Carboplatin Eugia may affect the liver's ability to process alcohol.

Pregnancy, Breast-Feeding, and Fertility

If you are pregnant or breast-feeding, think you may be pregnant, or plan to have a child, you should consult your doctor before using this medicine. If any of the above applies to you and has not been previously discussed with your doctor or nurse, you should inform your doctor or nurse before receiving this medicine.

Pregnancy

Carboplatin Eugia should not be used during pregnancy unless clearly indicated by your doctor. Animal studies have shown a possible risk of birth defects. If you are treated with Carboplatin Eugia during pregnancy, you should discuss the possible risk to your unborn child with your doctor. Women of childbearing age must use effective contraception both before and during treatment with Carboplatin Eugia. Because Carboplatin Eugia may cause genetic damage, genetic counseling is recommended if you become pregnant during treatment with Carboplatin Eugia. Genetic counseling is also recommended for patients who wish to have children after treatment with Carboplatin Eugia.

Breast-Feeding

It is not known whether Carboplatin Eugia passes into breast milk. Therefore, breast-feeding should be discontinued during treatment with Carboplatin Eugia.

Fertility

Carboplatin Eugia may cause genetic damage. Women are advised to avoid becoming pregnant during treatment and to use effective contraception before and during treatment. Women who are pregnant or become pregnant during treatment should be offered genetic counseling. Men treated with Carboplatin Eugia should not plan to father a child during treatment and for up to 6 months after treatment. They should also seek advice on sperm conservation before treatment, due to the possibility of irreversible infertility. You should consult your doctor or nurse before taking any medicine.

Driving and Using Machines

Carboplatin Eugia has no known effect on the ability to drive or use machines. However, you should exercise caution after receiving Carboplatin Eugia for the first time, especially if you experience dizziness or do not feel well enough.

3. How Carboplatin Eugia is Given

This medicine will always be given by a nurse or doctor. It is usually given by infusion, by slow injection into a vein, and the infusion usually takes 15 to 60 minutes. If you need more information, you should ask your doctor or nurse, who will give you or has given you the infusion. The dose of the medicine will depend on your height and weight, the function of your bone marrow (hematopoietic system), and your kidney function. Your doctor will choose the best dose for you. The medicine should be diluted before use.

Adults

The usual dose is 400 mg/m² body surface area (calculated based on height and weight).

Elderly

The usual dose given to adults may be used, although your doctor may decide to use a different dose.

Kidney Problems

The dose given may vary depending on your kidney function. If you have kidney problems, your doctor may reduce the dose of the medicine and perform more frequent blood tests and monitor your kidney function. This medicine will be given by a doctor with experience in cancer treatment.

Children and Adolescents

There is not enough data on the use of Carboplatin Eugia in children to recommend a dose. During treatment with Carboplatin Eugia, you may experience nausea. Before starting treatment with this medicine, your doctor may give you another medicine to reduce these symptoms. Between doses of Carboplatin Eugia, a four-week interval is usually used. Your doctor will perform blood tests every week after giving you this medicine. This will allow your doctor to decide whether to adjust the next dose of the medicine for you.

Overdose

It is unlikely that you will be given too much Carboplatin Eugia. However, if this happens, you may experience kidney, liver, vision, or hearing problems, as well as a low white blood cell count. If you have any concerns about the dose you have been given or have any questions, you should talk to your doctor who gave you the medicine.

Missed Dose

It is very unlikely that you will miss a dose because your doctor will have instructions on when to give you the medicine. If you think you may have missed a dose, you should inform your doctor or nurse. If you have any further questions on the use of this medicine, you should ask your doctor or nurse.

4. Possible Side Effects

Like all medicines, Carboplatin Eugia can cause side effects, although not everybody gets them. You should tell your doctor immediately if you experience any of the following:

• Unusual bruising or bleeding or signs of infection such as sore throat and high temperature.
• Persistent itching of the skin (with raised lumps) or swelling of the face, lips, tongue, and/or throat, which may cause difficulty in swallowing or breathing (angioedema) and chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome, feeling as if you are about to lose consciousness.

Very common: may affect more than 1 in 10 people

• Bone marrow suppression characterized by a significant decrease in the number of white blood cells, which increases the risk of infection (leukopenia, neutropenia)
• Decreased platelet count, which increases the risk of bruising and bleeding (thrombocytopenia)
• Anemia (a condition in which there is a decrease in the number of red blood cells, leading to fatigue)
• Impaired kidney function (increased creatinine and urea levels in the blood). Your doctor will monitor your condition.
• Mild hearing loss (high-frequency hearing loss)
• Abnormal liver enzyme activity and abnormal liver function test results. Your doctor will monitor your condition.
• Increased uric acid levels in the blood, which may lead to gout (hyperuricemia)
• Nausea or vomiting
• Abdominal pain and cramps
• Unusual feeling of tiredness or weakness
• Decreased levels of salts in the blood (sodium, potassium, calcium, and magnesium). Your doctor will monitor your condition.

Common: may affect up to 1 in 10 people

• Unusual bruising or bleeding (hemorrhagic complication)
• Diarrhea, constipation, mouth pain, or mouth ulcers (mucositis)
• Allergic reactions including rash, hives, redness of the skin, itching, high temperature
• Ringing in the ears (tinnitus), hearing problems, and hearing loss
• Numbness (peripheral neuropathy), weakness, tingling, or numbness
• Hair loss
• Feeling unwell
• Flu-like symptoms
• Lack of energy
• Lung problems, scarring, and thickening in the lungs with breathing difficulties, sometimes fatal (interstitial lung disease), breathing difficulties
• Decreased reflexes
• Infections
• Sensitivity disturbances
• Taste disturbances
• Vision disturbances, including transient loss of vision
• Cardiovascular disorders
• Skin disorders
• Itchy skin rash (hives)
• Itching sensation (pruritus)
• Red skin rash (erythematous rash)
• Musculoskeletal disorders
• Disorders of the urinary and reproductive systems (urinary and reproductive disorders)
• Increased creatinine, bilirubin, and uric acid levels in the blood. Your doctor will monitor your condition.

Uncommon: may affect up to 1 in 100 people

• Secondary tumors caused by chemotherapy or radiotherapy
• Fever and chills without signs of infection
• Redness, swelling, and pain or necrosis of the skin at the injection site (injection site reaction).

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

• Feeling unwell with high temperature due to low white blood cell count (febrile neutropenia)
• Lack of appetite (anorexia)
• Severe liver problems, damage, or necrosis. Your doctor will monitor your condition.
• Optic neuritis, which may cause total or partial loss of vision. Your doctor will monitor your condition.
• Severe allergic reactions (anaphylaxis/anaphylactoid reactions)
• Symptoms of severe allergic reactions include sudden wheezing, chest tightness, swelling of the eyelids, face, lips, and/or throat, which may cause difficulty in swallowing or breathing, redness of the face, low blood pressure, rapid heart rate, hives, difficulty breathing, dizziness, and anaphylactic shock
• Low sodium levels in the blood (hyponatremia)

Very Rare: may affect up to 1 in 10,000 people

• Heart failure
• Bleeding in the brain, which may lead to stroke or loss of consciousness
• Sudden blockage of an artery (embolism), high blood pressure, low blood pressure.

Side Effects with Unknown Frequency (Frequency Cannot Be Estimated from the Available Data):

• Hemolytic-uremic syndrome (a condition characterized by acute kidney failure, decreased urine output or anuria, decreased red blood cell count with extreme fatigue, and low platelet count)
• Unusual bruising or bleeding and signs of infection
• Dehydration
• Mouth pain or mouth ulcers (stomatitis)
• Muscle cramps, muscle weakness, confusion, loss of vision, or vision disturbances, irregular heartbeat, kidney failure, or abnormal blood test results (symptoms of tumor lysis syndrome, which may be caused by the rapid breakdown of dying cancer cells) (see section 2)
• A group of symptoms such as headache, changes in consciousness, seizures, and vision disturbances from blurred vision to loss of vision (symptoms of reversible posterior leukoencephalopathy syndrome, a rare neurological disorder)
• Pancreatitis
• Lung infection.

Reporting Side Effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. Side effects can be reported to the Medicines and Healthcare products Regulatory Agency (MHRA) using the Yellow Card Scheme. You can also report side effects directly to the manufacturer.

5. How to Store Carboplatin Eugia

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 vials after EXP. The expiry date refers to the last day of that month. Store in a refrigerator (2°C - 8°C). Store the vials in the outer carton in order to protect from light. You should not allow carboplatin to come into contact with your eyes or skin. In case of accidental spillage, you should immediately inform your doctor or nurse. After the infusion is completed, Carboplatin Eugia will be disposed of with caution by your doctor or nurse. 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 protect the environment.

6. Contents of the Pack and Other Information

What Carboplatin Eugia Contains

The active substance is carboplatin. 1 mL of the concentrate for solution for infusion contains 10 mg of carboplatin. The medicine is also available in strengths of 50 mg, 150 mg, 450 mg, and 600 mg of carboplatin. The other ingredients are mannitol and water for injections.

What Carboplatin Eugia Looks Like and Contents of the Pack

Concentrate for solution for infusion. Clear, colorless to pale yellow solution, free from visible particles. Each vial contains 5 mL, 15 mL, 45 mL, or 60 mL of the concentrate for solution for infusion. Pack sizes: 1 vial and 10 vials, in a cardboard carton. Not all pack sizes may be marketed.

Marketing Authorization Holder:

Eugia Pharma (Malta) Ltd. Vault 14, level 2, Valletta Waterfront, Floriana, FRN 1914, Malta, e-mail: medicalinformation@aurovitas.pl

Manufacturer/Importer:

APL Swift Services (Malta) Ltd. HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG 3000, Malta. Generis Farmacêutica, S.A. Rua João de Deus 19, Venda Nova, 2700-487 Amadora, Portugal. Arrow Génériques, 26 Avenue Tony Garnier, 69007 Lyon, France.

This Medicinal Product is Authorized in the Member States of the European Economic Area Under the Following Names:

Belgium: Carboplatin Eugia 10 mg/ml concentraat voor oplossing voor infusie/solution à diluer pour perfusion/Konzentrat zur Herstellung einer Infusionslösung France: Carboplatine Arrow Lab 10 mg/ml, solution à diluer pour perfusion Germany: Carboplatin PUREN 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung Italy: Carbolpatino Aurobindo Italia Poland: Carbolpatin Eugia Portugal: Carbolpatina Generis Spain: Carboplatino Aurovitas 10 mg/ml concentrado para solución para perfusión EFG

Date of Last Revision of the Leaflet:

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Information Intended for Healthcare Professionals Only:

This medicinal product is for single use only. Any unused solution should be discarded.

Instructions for Dilution

Carboplatin may react with aluminum, forming a black precipitate and/or reducing its effectiveness. Needles, syringes, catheters, or infusion sets containing aluminum parts should not be used for the preparation or administration of the medicinal product, as carboplatin reacts with aluminum. Before infusion, the medicinal product should be diluted with 5% glucose solution for injection or 0.9% sodium chloride solution for injection, to a concentration as low as 0.5 mg/mL (500 micrograms/mL). The Carboplatin Eugia product may be further diluted in 5% glucose solution and administered as an intravenous infusion. The chemical and physical stability of the infusion solution has been demonstrated for 56 days at concentrations of 0.2 mg/mL and 3.5 mg/mL when stored at 2°C - 8°C in non-PVC infusion bags (polyolefin), protected from light. The Carboplatin Eugia product may also be further diluted in 0.9% sodium chloride solution and administered as an intravenous infusion. The chemical and physical stability of the infusion solution has been demonstrated for 24 hours at 2°C - 8°C and up to 8 hours at 22°C in non-PVC infusion bags (polyolefin), protected from light. However, from a microbiological point of view, the product should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user. Normally, the storage time should not exceed 24 hours at 2°C - 8°C, unless dilution has been made in controlled and validated aseptic conditions. Before administration, the solution should be inspected visually for particulate matter and discoloration. The solution should only be used if it is clear and free from particles.

Guidelines for the Safe Handling of Cytotoxic Medicines:

• 1. Carboplatin should only be prepared for administration by personnel trained in the safe handling of cytotoxic medicines.
• 2. Preparation of the medicinal product should be carried out in a designated area.
• 3. Protective clothing, including gloves, face masks, and protective gowns, should be worn.
• 4. Precautions should be taken to avoid accidental contact of the medicinal product with the eyes. In case of contact with the eyes, they should be flushed with water and/or saline solution.
• 5. Cytotoxic medicines should not be handled by pregnant women.
• 6. Due care and precautions should be taken in the disposal of waste materials (e.g., needles, syringes, etc.) used in the reconstitution of cytotoxic medicines. Disposable materials and biological waste should be disposed of by incineration at 1000°C.
• 7. The work surface should be covered with a disposable, plastic-backed absorbent pad.
• 8. All syringes and sets should have Luer-lock fittings. It is recommended to use needles with a large diameter to minimize pressure and potential aerosol formation. Aerosol formation can also be reduced by using a vented needle.

Disposal

"Any unused medicinal product or waste material should be disposed of in accordance with local requirements and current guidelines for the disposal of cytotoxic medicines, taking into account the current regulations regarding the disposal of hazardous waste".