Package Leaflet: Information for the User

Carboplatin Teva 10 mg/ml Concentrate for Solution for Infusion

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.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they appear in this leaflet. See section 4.

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

2. What you need to know before using Carboplatin Teva

3. How to use Carboplatin Teva

4. Possible side effects

5. Storage of Carboplatin Teva

6. Contents of the pack and additional information

Teva Carboplatin is a platinum compound. It is a cancer medication used alone or in combination with other medications.

Teva Carboplatin is used for ovarian cancer and lung cancer.

Ask your doctor or nurse if you need additional information.

No use Carboplatino Teva

-if you are allergic to carboplatino or any of the other components of this medication (listed in section 6) or to other compounds that contain platinum.

-if you are breastfeeding.

-if you have severe kidney problems.

-if you have any bone marrow problems.

-if you have a bleeding tumor.

- if you are to receive the yellow fever vaccine or have received it.

Advertencias and precautions

Consult your doctor before starting to use Carboplatino:

• ifyou have ever had an allergic reaction to medications that contain platinum, such as cisplatino or oxaliplatino (see “No use Carboplatino Teva”).
• if you are elderly (over 65 years)

Other precautions while on treatment with Carboplatino Teva

• You will need to check regularly the functioning of your nervous system.
• • Your doctor may send you for blood or urine tests to check the composition of your blood, the functioning of your kidneys or liver before, during and after treatment with Carboplatino Teva. This is necessary to continue treatment.
  • Your doctor may prescribe antiemetic medications to prevent nausea and vomiting.

• Good oral hygiene (frequent mouth rinsing and effective tooth brushing with a soft-bristled toothbrush 2-3 times a day) may help prevent the development of mouth ulcers.
• During treatment with carboplatino, you will be given medications that help reduce a potentially fatal complication known as tumor lysis syndrome, caused by chemical alterations in the blood due to the breakdown of cancer cells that die and release their contents into the bloodstream.
• If you have headaches, altered mental function, convulsions, and abnormal vision, from blurred vision to loss of vision, consult your doctor
• If you experience extreme fatigue with a decrease in the number of red blood cells, and difficulty breathing (hemolytic anemia), alone or combined with a low platelet count, abnormal bleeding (thrombocytopenia), and kidney disease if you urinate little or not at all (symptoms of hemolytic-uremic syndrome), consult your doctor.
• If you have a fever (temperature 38°C or higher), or chills, which may be signs of infection, consult your doctor immediately. You may be at risk of contracting blood infection.

Use of Carboplatino Teva with other medications

Inform your doctor or pharmacist if you are taking/using, have taken/used recently, or may need to take/use any other medication that may interact with carboplatino, for example:

• Anticoagulant medications such as warfarin. It is necessary to increase the frequency of blood coagulation monitoring.
• Live or live-attenuated vaccines (for the yellow fever vaccine see section 2 “No use Carboplatino Teva”)
• Any medication that has as a side effect the decrease of blood cells, such asclozapina, since this effect may be more severe if carboplatino is used in combination with these medications.
• Medications that damage both kidneys and ears, for example
• Capreomicina, an antibiotic used to treat tuberculosis
• Aminoglycoside antibioticssuch as gentamicin, streptomycin
• Polymyxin antibiotics,such as colistina
• Diureticssuch as bumetanida or furosemida

Carboplatino may increase the toxic effects of medications. Avoid combining carboplatino with these medications.

• Fenitoína and fosfenitoína(used to treat various types of seizures and attacks),since it may decrease the level of this medication in the blood when used in combination with carboplatino; this may cause the onset of seizures. It may be necessary to increase the dose of fenitoína.
• Other medications that decrease the activity of the immune system (e.g. ciclosporina, tacrolimus, sirolimus).
• Chelating medications (medications that bind to carboplatino and thereby decrease the effect of carboplatino).

Pregnancy, lactation and fertility

Pregnancy

• Carboplatino should not be used during pregnancy, unless your doctor advises you to, due to the possible risk of fetal abnormalities.
• • If during treatment you become pregnant or think you may be pregnant, you must inform your doctor immediately. If during treatment you are pregnant or become pregnant, they will provide you with genetic counseling.

• Pregnant womenshould use an effective contraceptive method, such as barrier methods or condoms, to avoid becoming pregnant during treatment and for 6 months after stopping treatment with carboplatino.

• Pregnant menin treatment with carboplatino should take the necessary contraceptive measures to ensure that their partner does not become pregnant during treatment, and for 6 months after stopping treatment.

Lactation

You should not breastfeed your child during treatment with carboplatino.

Fertility

Both men and women who are planning to have a child after treatment should discuss this with their doctor. Men should seek advice on sperm conservation before treatment due to the possibility of irreversible antifertility effects.

Driving and operating machinery

Carboplatino may cause you nausea or vomiting. Do not drive or operate machinery until you are sure it has not affected you.

• Carboplatino should only be administered by specialized doctors.
• Carboplatino will be diluted and then administered only by intravenous route (into a vein).
• Regular blood tests will be performed to monitor your condition.
• Normally, there will be a 4-week interval between each dose of carboplatino.

The recommended dose is:

• Adults

400 mg/m² administered by intravenous infusion (into a vein) over a period of 15 to 60 minutes.

• Older patients

In older patients (65 years of age or older), dose adjustment may be necessary depending on your physical condition.

• If you have received previous treatment or have kidney problems

Your dose will be adjusted to the appropriate amount for you.

• Children and adolescents

The use of carboplatino in children and adolescents is not recommended.

If you take more Carboplatino Teva than you should

There is no specific antidote for carboplatino overdose. If you receive too much carboplatino, your doctor will stop treatment and treat the symptoms.

In case of overdose or accidental ingestion, contact the Toxicological Information Service (91) 562 04 20; or consult your doctor as soon as possible after taking the medication or contact the Emergency Department of the nearest hospital.

If you forget to use Carboplatino Teva

Your doctor will decide when you will receive this medication. If you think you have missed a dose, contact your doctor as soon as possible.

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

If you experience any of the following serious side effects, inform your doctor immediately, or seek urgent medical attention:

• Abnormal bleeding, bruising, or signs of infection such as sore throat and high temperature
• Severe allergic reactions: swelling of the lips, face, mouth, or neck that causes severe difficulty breathing, skin rash, or urticaria; swelling of the hands, feet, and ankles.
• Chest pain that may be a sign of a potentially severe allergic reaction called Kounis syndrome.

Other side effects:

Very common: may affect more than 1 in 10 people

• Thrombocytopenia, associated with abnormal bleeding and bruising; leukopenia, neutropenia, associated with an increased risk of infection; anemia, which may cause fatigue.
• Nausea, abdominal pain, vomiting.
• Toxicity in the kidneys.
• Exceptionally high levels of uric acid in the blood (hyperuricemia),
• Abnormal values in liver function tests.
• Changes in the chemical composition of the blood (decreased levels of sodium, potassium, calcium, and magnesium in the blood).

Common: may affect up to 1 in 10 people

• Signs of infection such as fever and sore throat
• Bleeding complications (hemorrhages)

• Allergic reactions such as rash, fever without apparent cause, and itching

• A peripheral neuropathy disorder. You may feel tingling and/or numbness in the fingers of your hands, the fingers of your feet, around your mouth, or in your throat, which may occur along with cramps. These effects are often caused by exposure to cold, for example, when opening the refrigerator or holding a cold drink. You may also have difficulty performing delicate tasks, such as buttoning your clothes
• Tingling, pinpricking, or numbness in the skin without apparent physical cause (paresthesia), decreased tendon reflexes
• Altered taste
• Temporary worsening of vision or changes in your vision, loss of vision

• Loss of hearing, hearing problems
• Heart disorders
• Pressure in the chest or wheezing, chest pressure caused by muscle spasms in the respiratory tract (bronchospasm)

• Pulmonary interstitial disease (a group of lung disorders in which the deep lung tissue becomes inflamed)
• Diarrhea, constipation
• Pain in the lips or mouth ulcers (mucous membrane disorders)
• Problems with your kidneys or urine

• Loss of hair (alopecia)
• Rash and/or itching in the skin
• Pain or discomfort in the bones, joints, muscles, or adjacent structures (musculoskeletal disorders)
• Extreme fatigue (asthenia)
• Increased levels of bilirubin and creatinine in the blood
• Increased levels of uric acid in the blood, which may lead to gout.

• Not known (cannot be estimated from available data)

• Pneumonia
• Secondary malignant processes (cancerous tumors that spread from their original location to establish secondary tumors in other parts of the body)
• Decreased bone marrow function; reduced white blood cell count accompanied by fever (febrile neutropenia); a disease characterized by abnormal red blood cell breakdown, renal insufficiency, and a reduced platelet count (hemolytic-uremic syndrome)
• Dry mouth, fatigue, and headache due to excessive water loss (dehydration), loss of appetite (anorexia)
• Decreased sodium levels in the blood (hyponatremia)
• Cerebral hemorrhage
• A set of symptoms such as headache, altered mental function, seizures, and abnormal vision, from blurred vision to loss of vision (symptoms of reversible posterior leukoencephalopathy syndrome, a rare neurological disorder)
• Heart failure, vascular obstruction (embolism), high blood pressure, low blood pressure
• Pain or inflammation in the mouth or throat, red or swollen mouth, or mouth ulcers or throat ulcers (stomatitis)
• Pancreatitis
• Skin disorders such as urticaria, rash, skin redness (erythema), and itching
• Muscle cramps, muscle weakness, confusion, visual disturbances or loss of vision, irregular heartbeats, renal insufficiency, or abnormal blood test results (symptoms of tumor lysis syndrome that may be caused by the rapid breakdown of cancer cells) (see section 2).
• Reactions at the injection site such as pain, redness, swelling, urticaria, skin necrosis.
• General malaise, fever, and chills.

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 Medicines for Human Use Pharmacovigilance System Website:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of sight and reach of children.

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

Do not store at a temperature above 25 °C. Store the container in the outer packaging

After dilution in sodium chloride solution 0.9% or 5% glucose solution, conservation should be restricted to three hours when stored at room temperature protected from light or 24 hours when stored at 2 °C - 8 °C if the dilution is made under validated aseptic conditions. The conservation time refers to until the start of the drug administration.

Use the product only if the solution is transparent and colorless or pale yellow, without fibers and without particles of foreign nature

Once opened, any unused solution must be discarded using the necessary precautions. This will help protect the environment.

Composition of Carboplatino Teva

-The active ingredient of this medication is carboplatin. Each ml of concentrate contains 10 mg of carboplatin.

-The other components are mannitol and water for injection.

Aspect of the product and content of the packaging

The carboplatin concentrate for infusion solution is aclear, colorless to pale yellow solution, free of particles.

The medication is available in containers that contain a single vial of 5 ml, 15 ml, 45 ml or 60 ml and in containers that contain 10 vials of 5 ml and 10 vials of 15 ml.

Each 5 ml vial contains 50 mg of the active component carboplatin.

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

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

Each 60 ml vial contains 600 mg of the active component carboplatin.

Only some container sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Teva Pharma, S.L.U.

C/ Anabel Segura, Edificio Albatros B, 1st floor

28108 Alcobendas, Madrid

Spain

Responsible for manufacturing

Pharmachemie B.V.

2031 GA Haarlem

Netherlands

Or

TEVA PHARMA B.V.

Industrieweg 23, P.O. Box 217 (Michdrecht)

Netherlands

This medication is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Germany:Carboplatin-Gry 10mg/ml

Italy:Carboplatino Teva 10 mg/ml

Spain:Carboplatino Teva 10 mg/ml concentrate for infusion solution

United Kingdom (Northern Ireland):Carboplatin 10 mg/ml Concentrate for Infusion

Date of the last review of this leaflet: March 2024

The detailed information of 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

Carboplatino Teva 10 mg/ml concentrate for infusion solution

In addition to the information included in section 3, the following practical information is provided on the preparation/manipulation of the medication.

Incompatibilities

This medication should not be mixed with other medications except for 5% glucose for injection or 0.9% sodium chloride for injection.

This medication should not be used with infusion sets that contain aluminum, injection syringes and needles. The antineoplastic activity may be reduced.

Manipulation

The infusion solution should be visually inspected for particles before use.

Guidelines for safe handling of antineoplastic agents:

1. The medication should be handled by trained personnel.

2. This should be done in a designated area.

3. Protective gloves should be used.

4. Precautions should be taken to avoid accidental contact with the eyes. In case of eye contact, wash with water and/or saline solution.

5. The cytotoxic preparation should not be handled by pregnant women.

6. Care should be taken and the necessary precautions should be taken in the disposal of materials (syringes, needles, etc.) used to reconstitute cytotoxic medications. Used materials and waste can be disposed of by placing them in polyethylene bags with double seal and incinerating at a temperature of 1,000 °C. Liquid waste can be disposed of by flushing with a large amount of water.

Dilution

1. The work surface should be covered with absorbent paper with a plastic backing that can be disposed of.

2. Luer-Lock type closure accessories should be used on syringes and other materials. It is recommended to use large-caliber needles to reduce pressure and the possible formation of aerosols. These can also be reduced by using a needle with ventilation.

The medication can be diluted with 5% glucose for injection or 0.9% sodium chloride for injection to achieve concentrations as low as 0.5 mg/ml (500 micrograms/ml).

Administration form

This product should only be administered intravenously. The infusion solution isadministered by infusion over a short period of time (15 to 60 minutes).

Special precautions for storage

When diluted according to instructions, carboplatin solutions should be used within three hours when stored at room temperature (15 °C- 25 °C) protected from light or within 24 hours when stored at 2 °C-8 °C if the dilution is carried out in validated aseptic conditions. As the formulation does not contain antibacterial preservatives, any carboplatin solution should be discarded three hours after dilution if stored at room temperature protected from light or after 24 hours if stored in refrigerated conditions. This product is only for individual doses.