Patient Information Leaflet

Carboplatino Pharmacia 10 mg/ml Concentrate for Solution for Infusion EFG

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as 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 only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

1.What is Carboplatino Pharmacia and what it is used for

2.What you need to know before starting to use Carboplatino Pharmacia

3.How to use Carboplatino Pharmacia

4.Possible side effects

5.Storage of Carboplatino Pharmacia

6.Contents of the pack and additional information

Carboplatino Pharmacia is a medication used for the treatment of different types of tumors. Carboplatino acts by preventing the proliferation of cancerous cells.

Carboplatino Pharmacia maybe used alone or in combination with other medications, in the treatment of the following types of tumors:

• Advanced ovarian cancer
• Small cell lung cancer
• Advanced head and neck cancer
• Invasive and advanced bladder cancer

No use Carboplatino Pharmacia

• If you are allergic to the active ingredient or any of the other components of this medication (listed in section 6), or to any compound containing platinum.
• If you have severe kidney problems.
• If you have decreased bone marrow function.
• If you have significant bleeding associated with tumors.
• If you are to be vaccinated against yellow fever (see "Use of Carboplatino Pharmacia with other medications").

Warnings and precautions

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

• If you have headaches, mental function alterations, seizures, and visual disturbances that can range from blurred vision to loss of vision.
• If during treatment you experience bone marrow suppression associated with a decrease in the number of white blood cells (leucopenia, neutropenia) and platelets (thrombocytopenia). This alteration and/or kidney function impairment may be exacerbated if you have received or are receiving cancer treatment (particularly with cisplatino) or radiation.
• If during treatment you experience a decrease in the number of red blood cells in the blood (anemia).
• If during treatment you develop extreme fatigue with a decrease in the number of red blood cells in the blood and difficulty breathing (hemolytic anemia), alone or in combination with low platelet counts and abnormal cardinals (thrombocytopenia) and kidney disease characterized by urinating little or not at all (symptoms of hemolytic uremic syndrome).
• If you have a fever (temperature equal to or greater than 38°C), or chills, which may be signs of infection. It may pose a risk of developing a blood infection.
• If you have kidney problems and have received previous treatment with other cancer medications or other medications that may affect kidney function.
• If you have liver problems.
• If during treatment you develop any signs or symptoms of nerve damage such as tingling (paresthesia) or decreased reflexes such as osteotendinous, especially if you are over 65 years old or have received previous cancer treatment with cisplatino.
• If during treatment you experience visual disturbances (especially if you have kidney problems).
• If during treatment you notice hearing problems, consult your doctor, as you may require dose modifications or treatment interruption.
• If during treatment you experience vomiting. Since carboplatino can cause vomiting, your doctor may administer a medication before treatment to prevent or reduce its incidence and intensity.
• If you experience symptoms of an allergic reaction to the medication.
• If you need to be vaccinated while on treatment with this medication, as live or attenuated virus vaccines should not be administered and the response to inactivated or killed vaccines may be reduced (see Use of Carboplatino Pharmacia with other medications).
• If you are an elderly patient and are receiving treatment in combination with a medication called cyclophosphamide, as you may develop a more severe decrease in platelet count (thrombocytopenia).

If you find yourself in any of the cases listed above, consult your doctor before using Carboplatino Pharmacia.

During treatment with carboplatino, you will be administered medications to help reduce the risk of a potentially fatal complication known as tumor lysis syndrome, which is caused by chemical alterations in the blood due to the destruction of dead cancer cells that release their contents into the blood.

Effective contraceptive methods should be used during and after treatment with carboplatino. If patients wish to have children after completing treatment, genetic counseling is recommended (see Pregnancy, lactation, and fertility).

Your doctor will regularly monitor your condition to check if Carboplatino is having the expected effect.

Before starting treatment and while on treatment with Carboplatino, your doctor may perform periodic blood tests, kidney function tests, liver function tests, neurological exams, and hearing tests (audiometry).

Other medications and Carboplatino Pharmacia

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Carboplatino may increase the adverse effects and/or modify the action of other medications such as some cancer medications, radiation therapy, or medications that affect blood clotting (anticoagulants).

It is contraindicated to administer (contraindicated use) during treatment with carboplatino, the yellow fever vaccine.

It is not recommended to administer during treatment with carboplatino, live attenuated virus vaccines (except for the yellow fever vaccine) and medications for the treatment of epilepsy (phenytoin and fosphenytoin).

Your doctor will evaluate during treatment with carboplatino, the administration of medications that suppress bone marrow activity (ciclosporin, tacrolimus, and sirolimus), certain types of antibiotics (aminoglycosides), and certain types of diuretics (loop diuretics).

Pregnancy, lactation, and fertility
If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy:

You should not use Carboplatino Pharmacia during pregnancy. Your doctor will inform you of the potential risks of using Carboplatino Pharmacia during pregnancy.

Lactation:

You should not breastfeed while on treatment with Carboplatino Pharmacia and for at least one month after the last dose.

Fertility:

Due to the possible risk of severe birth defects, women of childbearing age should always use effective contraceptive methods (contraception) during treatment with Carboplatino Pharmacia and for at least seven months after the last dose.

Patients should always be advised to use effective contraceptive methods during treatment and for up to 4 months after completing treatment, as well as to receive prior counseling about sperm conservation before starting treatment, due to the possibility of irreversible infertility due to treatment with carboplatino.

Discuss with your doctor the contraceptive methods that are suitable for you and your partner.

Driving and operating machinery
No studies have been conducted on the influence of carboplatino on the ability to drive and operate machinery. However, due to the fact that carboplatino can cause nausea, vomiting, visual disturbances, and hearing loss (ototoxicity), it is not recommended to drive vehicles or operate machinery after administering the medication.

Carboplatino is administered only by intravenous route and under the supervision of a doctor with experience in the use of this type of treatment. In case of doubt, consult your doctor or pharmacist again.

Your doctor will establish the most suitable dose and treatment duration for you, according to your height and weight, the state of your hematopoietic system, kidney function, and response to treatment. Regular blood tests will be performed to monitor your condition.

Your doctor will indicate the number of treatment cycles you need. Normally, there will be a 4-week interval between each dose of carboplatino.

If you use more Carboplatino Pharmacia than you should

Although unlikely, if you receive more carboplatino than you should, your doctor will stop the treatment and treat the symptoms.

If you forgot a dose of Carboplatino Pharmacia

It is very unlikely that you will forget a dose because your doctor will have instructions on when to administer the medication. If you think you have missed a dose, contact your doctor as soon as possible.

If you have any other questions about the use of this medication, ask your doctor or nurse.

Inform your doctor immediately if you experience any of the following signs and symptoms that may indicate a severe allergic reaction:

• Chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome

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

Very common side effects (may affect more than 1 in 10 patients):

• Decreased platelets (thrombocytopenia), decreased different types of white blood cells (neutropenia, leucopenia), decreased red blood cells (anemia).
• Vomiting, nausea, abdominal pain.
• Abnormal blood test results (decreased creatinine clearance, increased blood urea levels, increased alkaline phosphatase levels, increased aspartate aminotransferase levels, decreased blood sodium levels, decreased blood potassium levels, decreased blood calcium levels, decreased blood magnesium levels) and abnormal liver function tests.

Common side effects (may affect up to 1 in 10 patients):

• Infections.
• Bleeding.
• Hypersensitivity and allergic reactions (anaphylactic).
• Abnormalities of the nervous system (peripheral neuropathy), tingling sensation (paresthesia), decreased some types of reflexes such as osteotendinous, sensory abnormalities, decreased sense of taste (dysgeusia).
• Abnormal vision, loss of vision.
• Abnormalities of the ears (ototoxicity).
• Abnormalities of the heart.
• Abnormalities of breathing, lung disorders (interstitial lung disease), contraction of the bronchial muscle (bronchospasm).
• Diarrhea, constipation, alteration of mucous membranes.
• Hair loss (alopecia), skin abnormalities.
• Abnormalities of muscles, tendons, nerves, and joints (musculoskeletal abnormalities).
• Genitourinary disorders.
• Feeling of fatigue (asthenia).
• Abnormal blood test results (increased bilirubin, increased creatinine, increased uric acid).

Side effects of unknown frequency (cannot be estimated from available data):

• Some types of leukemia (such as acute myeloid leukemia) and syndromes called myelodysplastic.
• Failure of the bone marrow, decreased white blood cells accompanied by fever (febrile neutropenia),condition that usually occurs when a gastrointestinal infection produces toxic substances that destroy red blood cells and causes kidney damage(hemolytic uremic syndrome), decreased red blood cells in the blood and difficulty breathing (hemolytic anemia).
• Dehydration, loss of appetite (anorexia), decreased blood sodium levels (hyponatremia).
• Decreased blood flow to the brain (stroke).
• Heart failure, chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome.
• Clot or bubble in the circulation (embolism), increased and decreased blood pressure.
• Inflammation of the mucous membrane of the mouth (stomatitis).
• Urticaria, rash, redness (erythema), itching (pruritus).
• Tissue damage (necrosis) at the injection site, reaction at the injection site, leakage of the medication from the injection site, redness (erythema) at the injection site, discomfort.
• Blindness caused by damage to some areas of the brain (cortical blindness) in patients with kidney abnormalities.
• Partial hearing loss (hypacusia), ringing in the ears (tinnitus).
• Inflammatory skin condition (dermatitis exfoliativa).
• Muscle pain (myalgia) and joint pain (arthralgia).
• Liver damage that can be fatal (fulminant hepatic necrosis).
• Fever.
• Chills.
• Symptoms such as headache, mental function abnormalities, seizures, and vision abnormalities that can range from blurred vision to loss of vision (are symptoms of posterior reversible encephalopathy syndrome, a rare neurological disease).
• Pancreatitis.
• Pulmonary infection.
• Muscle cramps, muscle weakness, confusion, loss or abnormalities of vision, irregular heartbeats, renal insufficiency, or abnormal blood test results (symptoms of tumor lysis syndrome, which can be caused by the rapid destruction of tumor cells) (see section 2).

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 leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not store at a temperature above 25°C. Do not refrigerate or freeze. Store in the original packaging to protect it from light.

Do not use this medication after the expiration date that appears on the outer packaging and the label after CAD. The expiration date is the last day of the month indicated.

Do not use any packaging that is damaged or open.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition ofCarboplatin Pharmacia

- The active ingredient is carboplatin.

- The other components (excipients) are: water for injection preparations.

Appearance of the product and contents of the package

Carboplatin Pharmacia 10 mg/ml concentrate for infusion EFG is presented in containers that contain a single glass Type I transparent vial with a chlorobutyl stopper of 15 ml and 45 ml.

Each 15 ml vial contains 150 mg of the active component carboplatin.

Each 45 ml vial contains 450 mg of the active component carboplatin.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Pharmacia Nostrum, S.A.

Avda. de Europa, 20 B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Responsible for manufacturing:

Pfizer Service Company BV

Hoge Wei 10

1930 Zaventem

Belgium

or

Hospira Australia Pty Ltd

1-5, 7-23, 25-39 Lexia Place

Mulgrave 3170

Victoria

Australia

Last review date of this leaflet: October 2023

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

IMPORTANT INFORMATION FOR HEALTHCARE PROFESSIONALS

Preparation for administration

Carboplatin Pharmacia does not contain any preservative or bacteriostatic agent. The vials are therefore for single use only and any unused portion must be discarded.

Carboplatin can be diluted in 0.9% saline solution or 5% dextrose solution, to concentrations of 0.5 mg/ml. To reduce the risk of microbiological contamination, the dilution should be made immediately before use. It is recommended to perform a visual inspection of the solution prior to administration to check that the solution is free of particles. The infusion should be completed within the first 24 hours after preparation and any unused portion must be discarded.

It is recommended to use Luer-Lock type syringes and large diameter needles to minimize pressure and the possible formation of aerosols. Aerosols can also be reduced by using a vented needle during preparation.

Precautions for administration in long-term infusion of the concentrate for infusion solution:

When carboplatin Pharmacia concentrate for infusion solution is dissolved in 0.9% saline solution and stored for 24 hours at 25°C, a 5% degradation of the active principle from the initial concentration occurs. Therefore, it is not considered suitable to dissolve carboplatin Pharmacia in 0.9% saline solution for long-term infusions, as it not only results in a loss of active principle but also a conversion of carboplatin to cisplatin, increasing the risk of toxicity.

Needles or intravenous administration devices containing aluminum parts that may come into contact with carboplatine should not be used for preparation or administration. Carboplatin interacts with aluminum, producing the formation of a precipitate and/or a loss of potency.

Protective measures

1. The handling of carboplatin should be performed by trained healthcare personnel in the use of chemotherapeutic agents.
2. Pregnant women should avoid handling this medication.
3. Trained healthcare personnel handling carboplatin should wear protective clothing: protective glasses, gown, gloves, and disposable masks.
4. The dilution should be performed in a designated area (preferably under a laminar flow system). The work surface should be protected with absorbent, plasticized, and disposable paper.
5. All materials used for reconstitution, administration, or cleaning should be disposed of in high-risk waste bags for destruction by high-temperature incineration.
6. Any spill or leak should be treated with diluted sodium hypochlorite solution (1% available chlorine), preferably by soaking, and then with water.
7. All cleaning materials should be disposed of as indicated above.
8. In the event of accidental contact with the eyes or skin, wash immediately with plenty of water, soap and water, or bicarbonate solution, and seek medical attention. A mild cream may be used to treat transient skin itching. If the eyes are affected, consult a doctor.
9. Wash hands thoroughly after removing gloves.

Disposal

The disposal of unused medication and all materials that have come into contact with it should be carried out in accordance with local regulations.