Package Leaflet: Information for the User

Topotecán Accord 1 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, consult your doctor, pharmacist or nurse.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they appear in this leaflet. See section 4.

1. What Topotecán Accord is and what it is used for

2. What you need to know before using Topotecán Accord

3. How to use Topotecán Accord

4. Possible side effects

5. Storage of Topotecán Accord

6. Contents of the pack and additional information

Topotecán Accord helps to eliminate tumors. A doctor or nurse will administer the medication through intravenous infusion in the hospital.

Topotecán Accord is used to treat:

• Ovarian cancer or microscopic lung cancerthat has recurred after chemotherapy.
• Advanced cervical cancerif surgery or radiation therapy is not possible. When treating cervical cancer, Topotecán Accord is combined with another medication called cisplatino.

Your doctor will decide with you whetherTopotecán Accordis better than continuing the initial chemotherapy treatment.

Do not receiveTopotecán Accord

• if you are allergic to topotecan or any of the other components of this medication (listed in section 6).
• if you are breastfeeding.
• if your blood cell count is too low. Your doctor will tell you if this is the case, based on the results of your last blood test.

Inform your doctorif you are in any of these situations.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before you are given this medication:

• if you have kidney or liver problems. It may be necessary to adjust the dose of Topotecán Accord.
• if you are pregnant or plan to become pregnant. See the section “Pregnancy, breastfeeding, and fertility” below.
• if you are a male and plan to father a child. See the section “Pregnancy, breastfeeding, and fertility” below.

Inform your doctorif you are in any of these situations.

Other medications and Topotecán Accord

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication,including those obtained without a prescription or any herbal medication.

Pregnancy, breastfeeding, and fertility

Administration of Topotecán Accord is not recommended for pregnant women. It may harm the fetus before, during, or after treatment. You must use an effective contraceptive method. Ask your doctor for advice. Do not attempt to become pregnant until your doctor assures you it is safe to do so.

Male patients who wish to father a child, should request family planning advice or treatment from their doctor. If your partner becomes pregnant during your treatment, inform your doctor immediately.

Avoid breastfeeding if you are being treated with Topotecán Accord. Do not resume breastfeeding until your doctor indicates it is safe to do so.

Driving and operating machinery

Topotecán Accord may cause fatigue.

If you feel tired or weak, do not drive or operate machinery.

Topotecán Accord contains sodium

This medication contains less than 23 mg of sodium (1mmol) per dose; that is, it is essentially “sodium-free”. If your doctor uses a saline solution to dilute Topotecán Accord, the sodium dose received will be higher.

Your doctor will calculate the dose of Topotecán Accord to be administered to you based on:

• your body size (surface area measured in square meters)
• the results of blood tests performed before treatment
• the disease being treated

The usual dose is

• Ovarian cancer and small cell lung cancer: 1.5 mg per square meter of body surface area per day You will receive treatment once a day for 5 days. This treatment regimen will be repeated normally every 3 weeks.
• Cervical cancer: 0.75 mg per square meter of body surface area per day You will receive treatment once a day for 3 days. This treatment regimen will be repeated normally every 3 weeks.

When treating cervical cancer, Topotecán Accord is combined with another medication called cisplatin. Your doctor will determine the correct dose of cisplatin for you.

How Topotecán Accord is administered

A doctor or nurse will administer Topotecán Accord through infusion in your arm for about 30 minutes.

Treatment may vary depending on the results of periodic blood tests.

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

Severe side effects: report to your doctor

These side effectsvery frequentmay affectmore than 1 in 10 peopletreated with topotecan:

• Signs of infections:Topotecan Accord may reduce the number of white blood cells and decrease their resistance to infection. This can be even fatal. The signs include:
• • fever
  • severe deterioration of your general condition
  • local symptoms such as sore throat or urinary tract problems (e.g., burning sensation while urinating, which may be a urinary tract infection)

• Occasionally, the presence of severe stomach pain, fever, and possibly diarrhea (rarely with blood) may indicate intestinal inflammation (colitis).

These side effectsare raremay affectup to 1 in 1,000 peopletreated with topotecan:

• Severe allergic or anaphylactic reactions that cause swelling of the lips, face, or neck and cause severe breathing difficulties, skin rash, or urticaria, anaphylactic shock (a severe drop in blood pressure, pallor, agitation, weak pulse, decreased level of consciousness).
• Pulmonary inflammation (interstitial lung disease):You are at higher risk if you have an existing lung disease, have received radiation therapy to the lungs, or have previously taken medications that can cause lung damage. The signs include:
• • difficulty breathing
  • cough
  • fever

Report to your doctor immediatelyif you notice any of these symptoms, as they may require hospitalization.

Very frequent side effects

May affectmore than 1 in 10 peopletreated with topotecan:

• General feeling of weakness and fatigue (transient anemia). In some cases, you may need a blood transfusion.
• Abnormal decrease in the number of white blood cells (neutropenia), which may be accompanied by fever and signs of infection (febrile neutropenia).
• Unusual bruises or bleeding, caused by a decrease in blood clotting cells. This may lead to severe bleeding from relatively small wounds such as a small cut. Rarely, it may cause more severe bleeding. Consult with your doctor to advise on how to minimize the risk of bleeding.
• Weight loss and loss of appetite (anorexia), fatigue, weakness.
• Nausea, vomiting, diarrhea, stomach pain, constipation.
• Mouth, tongue, or gum inflammation and ulcers.
• High body temperature (fever).
• Hair loss.

Frequent side effects

May affectup to 1 in 10 peopletreated with topotecan:

• Allergic or hypersensitivity reactions (including skin rash)
• Yellow skin discoloration
• Itching sensation
• Uncomfortable feeling
• Deficiency of the three blood cell components (red blood cells, white blood cells, and platelets) (pancytopenia).

Rare side effects

May affectup to 1 in 1,000 peopletreated with topotecan:

• Severe allergic or anaphylactic reactions.
• Swelling caused by fluid accumulation (angioedema)
• Mild pain and inflammation at the injection site
• Skin rash with itching (or hives)

Very rare side effects

May affectup to 1 in 10,000 peopletreated with topotecan:

• Bleeding in tissues (extravasation)

Side effects of unknown frequency

The frequency of some side effects is not known (side effects from spontaneous reports and the frequency can be estimated from available data):

• Severe stomach pain, nausea, vomiting with blood, black stools, or stools with blood (possible symptoms of gastrointestinal perforation).
• Mouth sores
• Difficulty swallowing
• Abdominal pain
• Nausea
• Vomiting
• Diarrhea
• Stools with blood (possible signs and symptoms of inflammation of the inner lining of the mouth, stomach, and/or intestine [mucosal inflammation]).

If you are being treated for cervical cancer, you may experience side effects related to the other medication(cisplatin) that will be administered with Topotecan Accord. These effects are described in the cisplatin prospectus.

Reporting side effects

If you experience side effects, consult your doctor, the hospital pharmacist, or nurse, even if they do not appear in this prospectus.You can also report them directly through theSpanish System for 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 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.
• Store below 25°C.
• Store the vial in the outer packaging to protect it from light.
• This medication is for single use. It must be diluted immediately after opening.
• Physical and chemical stability has been demonstrated in the use of the medication during 30 days at 25°C under normal light conditions and at 2-8°C when protected from light. From a microbiological standpoint, the product must be used immediately. If not used immediately, storage times and conditions before use will be the responsibility of the user and will normally not exceed 24 hours at 2-8°C, unless the dilution has taken place in controlled and validated aseptic conditions.
• Do not dispose of the medication through the drains or in the trash. Ask your pharmacist where to dispose of the unused medication. This will help protect the environment.

Composition of Topotecan Accord

• The active ingredient is topotecan hydrochloride. Each vial of 1 ml contains 1 mg of topotecan (as hydrochloride). Each vial of 4 ml contains 4 mg of topotecan (as hydrochloride).
• The other components (excipients) are: tartaric acid (E334), water for injection, hydrochloric acid (E507), and sodium hydroxide (for pH adjustment).

Appearance of the product and contents of the package

This medicine is a concentrate for solution for infusion.

The concentrate is a clear yellow solution. It is packaged in a sealed amber glass vial with a fluorotech rubber stopper and an aluminum removable seal.

Each vial of 1 ml contains 1 mg of topotecan (as hydrochloride).

Each vial of 4 ml contains 4 mg of topotecan (as hydrochloride).

This medicine is available in packages containing 1 vial or 5 vials.

Only some package sizes may be marketed.

Marketing Authorization Holder

Accord Healthcare S.L.U.

World Trade Center

Moll de Barcelona, s/n

Edifici Est, 6th floor

08039 Barcelona

Spain

Responsible for manufacturing

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50,95-200 Pabianice,

Poland

or

Accord Healthcare Single Member S.A.

64th Km National Road Athens,Lamia, Schimatari, 32009,

Greece

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

Last review date of this leaflet: May 2023.

For detailed and updated information on this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

This information is intended solely for medical professionals or healthcare professionals

Instructions on how to prepare, store, and dispose of Topotecan Accord

Instructions for dilution

The concentrate is a clear yellow solution containing 1 mg per ml of Topotecan. It requires dilution with the appropriate volume of sodium chloride 9 mg/ml (0.9%) or glucose 50 mg/ml (5%) injection solution to obtain a final concentration of Topotecan between 25 and 50 micrograms/ml in the infusion solution

Storage of the prepared solution

Physical and chemical stability has been demonstrated for the product in use for 30 days at 25°C under normal lighting conditions, or at 2-8°C when protected from light. From a microbiological point of view, the product should be used immediately. If not used immediately, storage times and conditions before use will be the responsibility of the user and will normally not exceed 24 hours at 2-8°C, unless the dilution has taken place in controlled and validated aseptic conditions.

Handling and disposal

Standard procedures for the proper handling and disposal of antineoplastic drugs should be adopted:

• Staff should be trained to dilute the medicine.
• Healthcare staff should not handle this medicine during pregnancy.
• Healthcare staff handling this medicine during dilution should wear protective clothing, including a mask, glasses, and gloves.
• All materials used for administration or cleaning, including gloves, should be placed in high-risk waste disposal bags for incineration at high temperature.

Accidental contact with the skin or eyes should be treated immediately with abundant water.