Patient Information Leaflet

Carboplatin Hikma 10 mg/ml Infusion Solution EFG

Read this leaflet carefully before you start using this medicine, as 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 or nurse.
• This medicine has been prescribed for you only. Do 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 or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before using Carboplatin Hikma

3. How to use Carboplatin Hikma

4. Possible side effects

5. Storage of Carboplatin Hikma

6. Contents of the pack and additional information

Carboplatino Hikma is an anticancer medication that contains carboplatin in the form of a perfusion solution (a solution that must be administered as a slow infusion via an intravenous catheter).

Cancer treatment with a medication may be referred to as chemotherapy.

This medication is used to combat some types of lung cancer, advanced ovarian cancer, and as an adjuvant in the treatment of testicular germ cell tumors.

No use Carboplatino Hikma

Warnings and precautions

Consult your doctor or nurse before being administered Carboplatino Hikma:

Carboplatino should be administered with particular caution in:

Carboplatino may react with aluminum, it should not be used for the preparation or administration of Carboplatino, needles or intravenous infusion equipment containing aluminum particles to avoid interactions.

During treatment with carboplatino, medications may be administered to help reduce potentially fatal complications known as tumor lysis syndrome, caused by chemical changes in the blood given by the rupture of dead cancer cells that release their content into the bloodstream.

Use of Carboplatino Hikma with other medications

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

The treatment of patients with oral anticoagulants involves a decrease in the frequency of INR monitoring.

Carboplatino Hikma administration:

The treatment associated with other myelosuppressive agents (medications that lead to a decrease in red blood cells) may require a dose adjustment.

Pregnancy, lactation and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor before being treated with this medication.

Pregnancy

The safe use of carboplatin during pregnancy is unknown but it is suspected to cause serious birth defects when administered during pregnancy. Carboplatin is not indicated in pregnant women or in women of childbearing age who wish to become pregnant, unless the potential benefits to the mother outweigh the possible risks to the fetus..

If you are being treated with carboplatin while pregnant, you should discuss the possible risks to the fetus with your doctor. Women of childbearing age should use an effective contraceptive method before and during treatment with carboplatin.

Fertility

Most forms of chemotherapy have been associated with a decrease in oogenesis (maturation and development of female sex cells in the ovary) and spermatogenesis (formation of sperm cells). It may decrease gonadal function (testicles and ovaries) causing amenorrhea (absence of menstruation) or azoospermia (decrease in sperm count in semen) in patients who have received anticancer therapy.

Men treated with carboplatino are advised to avoid conception during and up to 6 months after treatment. You should seek advice on sperm conservation before treatment because carboplatino may cause irreversible infertility.

Lactation

Although it is unknown whether carboplatin is excreted in breast milk, breastfeeding is not recommended in mothers under carboplatino treatment to avoid harmful effects on the infant. If treatment is necessary, breastfeeding should be discontinued..

Driving and operating machinery

Carboplatino does not affect the ability to drive and operate machinery. However, carboplatino may cause nausea, vomiting, vision problems and ototoxicity, so patients should be informed of the potential effects on driving or operating machinery.

Always use this medication exactly as your doctor has instructed. If you are unsure, check with your doctor.

The dose prescribed to you depends on your age, health, and the proper functioning of your kidneys and other medications you are taking.

The product must be diluted with glucose (sugar solution) or sodium chloride (dextrose solution) before being administered. It will be administered slowly, usually through intravenous infusion by drip, and will last between 15 and 60 minutes. You may receive another dose of this medication in 4 weeks.

While you are receiving carboplatin, your doctor should perform regular blood tests. This will allow your doctor to evaluate the medication's effectiveness and if additional doses are needed.

This medication will be administered during your hospital stay, so in rare cases you may receive more or fewer doses. However, if you have any doubts, ask your doctor or pharmacist.

Measures of safety used in the preparation and administration of substances classified as hazardous should be applied. The preparation must be carried out by trained professionals for safe use, using protective glasses, masks, and protective clothing.

If you have any doubts about the use of this medication, ask your doctor or pharmacist.

Use in children and adolescents

There is not enough data available on the use of carboplatin in children, so it is not recommended for use.

Si receive more Carboplatino Hikma than I should

This medication will be administered in the hospital under the supervision of a doctor. Therefore, it is unlikely that you will receive an insufficient or excessive amount of the medication. Nevertheless, you may consult with your doctor or nurse who administers the medication or callthe Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount administered.

There is no known antidote for carboplatin overdose.

No cases of overdose have been reported during clinical trials. In the event of an overdose, the patient may require appropriate supportive treatment for complications related to myelosuppression, kidney, liver, and hearing function.

Cases have been reported of patients who felt extremely ill, had diarrhea, and alopecia when they received doses of up to 1,600 mg/m2. The use of doses above the recommended carboplatin doses has been associated with vision loss

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

The frequency of observed side effects is defined as:

Very common (may affect more than 1 in 10 people)

Common (may affect up to 1 in 10 people)

Uncommon (may affect up to 1 in 100 people)

Rare (may affect up to 1 in 1,000 people)

Very rare (may affect up to 1 in 10,000 people)

Unknown (cannot be estimated from available data)

Inform your doctor immediately if you observe any of the following side effects:

Other side effects may be detected during treatment are:

Very common: may affect more than 1 in 10 people

• Reduction of platelets, which increases the risk of hematomas and hemorrhages (thrombocytopenia)
• Anemia (a disorder in which the red blood cells decrease and cause fatigue)
• Decreased creatinine clearance
• Elevated levels of urea, alkaline phosphatase, aspartate aminotransferase, liver function tests in blood
• Decreased levels of salts in your blood (sodium, potassium, calcium, magnesium)

Common: may affect up to 1 in 10 people

• Hypersensitivity (allergies)
• Peripheral neuropathy, decreased reflexes, change in sensitivity
• Musculoskeletal disorders
• Urinary or reproductive tract disorders
• Increased bilirubin, creatine, and uric acid in blood

Uncommon: may affect up to 1 in 100 people

• Cancer caused by chemotherapy or radiation (secondary malignant neoplasms)
• Fever and chills without signs of infection.
• Redness, swelling, and pain, or dead skin around the injection site (reaction at the injection site).

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

• Temporary loss of vision

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

• Pulmonary fibrosis that causes difficulty breathing and/or cough (pulmonary fibrosis)

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

• Treatment-related neoplasia secondary reaction
• Suppression of the bone marrow (decreased ability to produce blood cells), febrile neutropenia (fever accompanied by low white blood cell levels), hemolytic-uremic syndrome
• Dehydration, anorexia (loss of appetite), hyponatremia (low sodium levels)
• Stomatitis
• A set of symptoms, such as headache, altered mental function, cramps, and abnormal vision (from blurriness to loss of vision) (symptoms of posterior reversible encephalopathy syndrome, a rare neurological disorder)
• Pancreatitis
• Pulmonary infection
• Muscle cramps, muscle weakness, confusion, loss or alteration of vision, irregular heartbeats, or abnormal blood test results (symptoms of tumor lysis syndrome, which may 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 or pharmacist, 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

Store below 25°C.

Do not refrigerate or freeze.

Store the vial in the outer packaging to protect it from light.

Keep this medication out of sight and reach of children.

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

Do not dispose of any medication through the drains or trash. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

Composition of Carboplatino Hikma

The active ingredient is carboplatin. Each milliliter of infusion solution contains 10 mg of carboplatin.

The other components are water for injection, hydrochloric acid (pH adjustment) and sodium hydroxide (pH adjustment).

Appearance of the product and contents of the container

Carboplatino Hikma is a transparent, colorless solution contained in amber glass vials with a rubber stopper and aluminum closure cap.

The containers contain a vial of 5 ml, 15 ml, 45 ml or 60 ml of infusion solution, respectively.

Only some container sizes may be commercially marketed.

Marketing Authorization Holder

Hikma Farmacêutica (Portugal) S.A.

Estrada do Rio da Mó, 8, 8A e 8B, Fervença

2705-906 Terrugem SNT

Portugal

Responsible for manufacturing:

Thymoorgan Pharmazie GmbH

Schiffgraben 23, 38690 Goslar

Germany

For more information about this medication, please contact the local representative of the marketing authorization holder:

Hikma España, S.L.U.

Calle Anabel Segura nº11, Edificio A, planta 1ª, oficina 2

28108 - Alcobendas, Madrid

Spain

Last review date of this leaflet: October 2024

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