OXALIPLATIN SUN 5 mg/ml CONCENTRATE FOR INFUSION SOLUTION

Introduction

Package Leaflet: Information for the User

Oxaliplatin SUN 5 mg/ml concentrate for solution for infusion EFG

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 or pharmacist.
• 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 experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What Oxaliplatin SUN is and what it is used for
2. What you need to know before you use Oxaliplatin SUN
3. How to use Oxaliplatin SUN
4. Possible side effects

5 Conservation of Oxaliplatin SUN

1. Contents of the pack and further information

1. What Oxaliplatin SUN is and what it is used for

The active substance of Oxaliplatin Sun is oxaliplatin.

Oxaliplatin SUN is used for the treatment of colorectal cancer (treatment of stage III colon cancer after complete resection of the primary tumor; metastatic colon and rectal cancer).

Oxaliplatin SUN is used in combination with other anticancer medicines called 5-fluorouracil (5-FU) and folinic acid (FA).

Oxaliplatin SUN is an anticancer medicine that inhibits tumor growth and contains platinum.

2. What you need to know before you use Oxaliplatin SUN

Oxaliplatin SUN must not be given to you if:

• you are allergic to oxaliplatin or any of the other ingredients of this medicine (listed in section 6)
• you are breast-feeding
• you have a reduced number of blood cells (white blood cells and/or platelets)
• you have a sensation of tingling or numbness in your fingers and/or toes or have difficulty performing delicate tasks, such as buttoning a garment
• you have severe kidney problems

Warnings and precautions

Talk to your doctor or pharmacist before using Oxaliplatin SUN if

• you have previously suffered an allergic reaction to a medicine containing platinum, such as carboplatin or cisplatin. Allergic reactions may occur during any infusion of oxaliplatin.

• you have mild or moderate kidney problems
• you have liver problems or abnormal liver function tests during your treatment
• you have or have had heart disorders such as an abnormal electrical signal called QT interval prolongation, an irregular heartbeat, or a family history of heart problems.
• you have recently received or are scheduled to receive any vaccine. During treatment with oxaliplatin, you must not receive live or attenuated vaccines, such as the yellow fever vaccine.

If any of the following happen to you at any time, tell your doctor immediately. Your doctor may need to treat you for these events. Your doctor may need to reduce the dose of Oxaliplatin SUN, or delay or interrupt treatment with Oxaliplatin SUN.

• If you have an unpleasant sensation in your throat, particularly when swallowing, and have a feeling of shortness of breath, during treatment, tell your doctor.
• If you have nerve problems in your hands or feet such as tingling and numbness, or decreased sensation in your hands or feet, tell your doctor.
• If you have a headache, altered mental function, seizures, and abnormal vision, from blurred vision to loss of vision, tell your doctor.
• If you do not feel well (nausea and vomiting), tell your doctor.
• If you have severe diarrhea, tell your doctor.
• If you have pain in the lips or ulcers in the mouth (mucositis/stomatitis/inflammation of the mouth or other mucous membranes), tell your doctor.
• If you have diarrhea or a decrease in white blood cells or platelets, tell your doctor. Your doctor may need to reduce the dose of Oxaliplatin SUN or postpone your treatment with Oxaliplatin SUN.
• If you have unexplained respiratory symptoms such as cough or difficulty breathing, tell your doctor. Your doctor may stop your treatment with Oxaliplatin SUN.
• If you develop extreme fatigue, shortness of breath, or kidney problems that cause you to urinate very little or not at all (symptoms of acute kidney failure), tell your doctor.
• If you have a fever (temperature ≥ 38°C), or chills, contact your doctor immediately as they may be signs of infection. You may be at risk of developing a blood infection.
• If you have a fever > 38°C, consult your doctor. Your doctor may determine if you also have a decrease in white blood cells.
• If you unexpectedly experience bleeding or bruising (disseminated intravascular coagulation), tell your doctor as they may be signs of blood clots throughout the small blood vessels of your body.
• If you feel dizzy (loss of consciousness) or have an irregular heartbeat while taking Oxaliplatin SUN, consult your doctor immediately as it may be a sign of a serious heart disorder.
• If you develop muscle pain and swelling, along with weakness, fever, and reddish-brown urine, consult your doctor. These could be signs of muscle damage (rhabdomyolysis) and could lead to kidney problems or other complications.
• If you have abdominal pain (stomach), nausea, vomiting with blood or coffee grounds-like vomit, dark stools that may be signs of a gastrointestinal ulcer (gastrointestinal ulcer with potential bleeding or perforation), consult your doctor.

If you have abdominal pain (around the navel), bloody diarrhea, nausea, and/or vomiting that may be caused by a decrease in blood flow to the walls of your intestine (intestinal ischemia), consult your doctor.

Using Oxaliplatin SUN with other medicines

Tell your doctor or pharmacist that you are using, have recently used, or might use any other medicines.

Pregnancy, breast-feeding, and fertility

Pregnancy

• You must not become pregnant during treatment, and therefore, you must use a contraceptive method during treatment. It is recommended that you use a suitable contraceptive method until 9 months after the end of treatment.
• Male patients are advised not to father a child during treatment and for up to 6 months after treatment and to take adequate contraceptive measures during this time.

• If you are pregnant or planning to become pregnant, it is very important that you discuss this with your doctor beforereceiving any treatment.
• If you become pregnant during treatment, you must inform your doctor immediately.

Breast-feeding

• Breast-feeding is contraindicated during treatment with oxaliplatin.

Fertility in men and women

• Oxaliplatin may have an effect on fertility that could be irreversible. Male patients should seek advice on sperm conservation before treatment.

• After treatment with oxaliplatin, female patients who are planning to become pregnant are advised to seek genetic counseling.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Treatment with Oxaliplatin SUN may increase the risk of dizziness, nausea, and vomiting, and other neurological symptoms that may affect movement and balance. If this happens to you, do not drive or operate machinery. If you experience vision problems while receiving oxaliplatin, do not drive a vehicle, use heavy machinery, or perform hazardous activities.

3. How to use Oxaliplatin SUN

Oxaliplatin SUN is for adults only.

For single use.

Dose

The dose of Oxaliplatin SUN is based on your body surface area, which is calculated from your weight and height. The usual dose is 85 mg/m2 of body surface area in adults, including elderly patients. The dose will also depend on the results of your blood tests and whether you have previously experienced side effects as a result of Oxaliplatin SUN administration.

Form and route(s) of administration

• Oxaliplatin SUN must be administered under the supervision of a specialist in cancer treatment.
• You will be treated by a healthcare professional who will have determined the necessary dose of Oxaliplatin SUN.

Oxaliplatin SUN is administered by injection into a vein (intravenous infusion) over a period of 2 to 6 hours. Oxaliplatin SUN will be administered at the same time as folinic acid and before the infusion of 5-fluorouracil.

Frequency of administration

As a rule, you will receive an infusion every two weeks.

Duration of treatment

The duration of treatment will be determined by your doctor.

Treatment will continue for a maximum of 6 months when used after complete resection of the tumor.

If you use more Oxaliplatin SUN than you should

Since this medicine is administered by healthcare professionals, it is very unlikely that you will be given too little or too much. In case of overdose, you may experience an increase in side effects.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them. If you experience any adverse effect, it is essential that you inform your doctor before the next cycle.

The following effects are described.

The most severe adverse reactions

Inform your doctor immediately ifyou experience any of the following reactions:

• Symptoms of an allergic or anaphylactic reaction with sudden signs such as rash, itching, or hives on the skin, difficulty swallowing, swelling in the face, lips, tongue, or other parts of the body, shortness of breath, wheezing, or breathing problems, extreme fatigue (feeling like fainting). In most cases, these symptoms occurred during infusion or immediately after, but delayed allergic reactions have also been observed hours or even days after infusion,

• Abnormal bruising, bleeding, or signs of infection, such as sore throat or fever,

• Persistent or severe diarrhea or nausea,
• Vomiting blood or brown particles (like coffee grounds),
• Stomatitis/mucositis (sores on the lips, ulcers in the mouth),
• Respiratory symptoms such as dry cough, or cough with sputum, difficulty breathing, or wheezing, as these can be signs of a severe lung disease that can be fatal.
• A group of symptoms such as headache, altered mental function, seizures, and visual disturbances, from blurred vision to loss of vision (these are manifestations of a rare neurological disorder called posterior reversible leukoencephalopathy syndrome),

• Symptoms of a stroke (including sudden and severe headache, confusion, difficulty seeing with one or both eyes, numbness or weakness of the face, arm, or leg, usually on one side of the body, drooping face, difficulty walking, dizziness, loss of balance, and difficulty speaking),
• Extreme fatigue with a decrease in the number of red blood cells and shortness of breath (hemolytic anemia), alone or in combination with a decrease in platelets, abnormal bruising (thrombocytopenia), and/or kidney problems that cause you to urinate little or no urine (symptoms of hemolytic uremic syndrome),

Other known adverse effects are:

Very common:may affect more than 1 in 10 people

• Oxaliplatin SUN may have effects on the nerves (peripheral neuropathy). You may feel tingling and/or numbness of the fingers of the hands and feet, around the mouth, or in the throat, which in some cases are accompanied by cramps.

These effects are usually caused by exposure to cold, for example, when opening the freezer or holding a cold drink. Additionally, you may have difficulty performing fine tasks, such as buttoning a garment.

Although in most cases these symptoms disappear completely, there is a possibility that the symptoms of peripheral sensory neuropathy may persist after treatment is completed.

Some patients have experienced a tingling sensation, similar to an electric shock that runs through the arms or trunk when flexing the neck.

• Oxaliplatin SUN may occasionally cause an unpleasant sensation in the throat, particularly when swallowing, giving the sensation of difficulty breathing. This sensation, if it occurs, usually happens during infusion or a few hours after it and may be caused by exposure to cold. Although it is an unpleasant sensation, it does not last long and usually disappears without the need for treatment. Therefore, your doctor may modify the treatment.

• Oxaliplatin SUN may cause diarrhea, nausea (feeling of dizziness), vomiting (feeling unwell). Consequently, your doctor will prescribe medications to prevent it, which are usually administered before treatment. You can continue taking the medication after treatment. Oxaliplatin SUN causes a temporary reduction in the number of blood cells. The reduction of red blood cells can cause anemia (a reduction of red blood cells), abnormal bleeding, or bruising (due to a reduction of platelets). The reduction of white blood cells can make you prone to infections. Your doctor will take blood tests to check that you have enough blood cells before starting treatment and before each subsequent cycle.
• Feeling of discomfort near or at the injection site during infusion
• Fever, chills (shivering), mild or severe fatigue, body pain
• Weight changes, loss of appetite, taste disorders, constipation
• Headache, back pain
• Muscle spasms, stiffness of the neck, abnormal sensation in the tongue that can affect the ability to speak, inflammation of the mouth or other mucous membranes (lip pain or ulcers in the mouth).
• Stomach pain
• Abnormal bleeding, including nosebleeds
• Cough and difficulty breathing
• Allergic reactions, skin rashes that include itching and redness of the skin, mild hair loss (alopecia)

• Changes in blood tests, including those related to liver function abnormalities.

Common:may affect up to 1 in 10 people

• Infections caused by a reduction of white blood cells,
• Severe blood infection associated with a reduction in the number of white blood cells (neutropenic sepsis), which can be fatal.
• Decrease in white blood cell count, accompanied by fever above 38.3°C or prolonged fever above 38°C for more than 1 hour (febrile neutropenia),
• Indigestion, heartburn, belching, and dizziness
• Increased sweating and nail disorders, skin peeling
• Chest pain
• Lung disorders and runny nose
• Pain in the joints and bones
• Pain when urinating and changes in kidney function, change in urination frequency, dehydration

• Blood in the urine/stool, inflammation of the veins, blood clots in the lungs (pulmonary embolism)
• High blood pressure

• Depression, insomnia, conjunctivitis, and vision problems
• Decrease in calcium levels in the blood
• Falls.

Uncommon:may affect up to 1 in 100 people

• Severe blood infections (sepsis), which can be fatal,
• Obstruction or inflammation of the intestine,
• Nervousness

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

• Hearing loss
• Scarring and thickening of the lungs with difficulty breathing, which can be fatal (interstitial lung disease),
• Temporary and reversible loss of vision in the short term,
• Unexpected bleeding or bruising due to widespread blood clots in the small blood vessels of the body (disseminated intravascular coagulation), which can be fatal

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

• Appearance of blood or dark brown particles in the vomit.
• A kidney disease in which little or no urine is excreted (symptoms of acute renal failure).

Vascular diseases of the liver.

Frequency not known(cannot be estimated from the available data):

• Allergic vasculitis (inflammation of blood vessels)
• Autoimmune reaction that causes a reduction in all blood cell lines (autoimmune pancytopenia), pancytopenia,
• Severe blood infection and drop in blood pressure (septic shock), which can be fatal,
• Seizures (uncontrolled body agitation)
• Laryngospasm (throat spasms that cause difficulty breathing),
• Extreme fatigue with reduced red blood cell count and difficulty breathing (hemolytic anemia), alone or in combination with a low platelet count and kidney disease in which little or no urine is excreted (symptoms of hemolytic uremic syndrome). This has been reported to be fatal.
• Abnormal heart rhythm (prolonged QT interval), which can be seen on an electrocardiogram (ECG) and can be fatal
• Myocardial infarction (heart attack), angina pectoris (chest pain or discomfort)

• Muscle pain and swelling, along with weakness, fever, and reddish-brown urine (symptoms of muscle damage called rhabdomyolysis), which could be fatal,

• Abdominal pain, nausea, vomiting with blood or vomiting like coffee grounds, dark stools (symptoms of a gastrointestinal ulcer with potential bleeding or perforation), which can be fatal

• Esofagitis (inflammation of the inner lining of the esophagus - the tube that connects the mouth to the stomach - which causes pain and difficulty swallowing
• Reduced blood flow to the intestine (intestinal ischemia), which can be fatal,
• Risk of new cancers. Leukemia, a form of blood cancer, has been reported in patients after using oxaliplatin in combination with certain medications. Consult your doctor about the potential increased risk of this type of cancer when using Oxaliplatin SUN with certain medications.
• Abnormal benign nodules in the liver (focal nodular hyperplasia).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Oxaliplatin SUN

Keep this medicine out of sight and reach of children.

Do notstore at a temperature above 25°C.

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

Medicines should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medicines that are no longer needed. This will help protect the environment.

6. Container Content and Additional Information

Oxaliplatin SUN Composition5mg/ml concentrate for solution for infusion

• The active ingredient is oxaliplatin.
• One ml of concentrate contains 5 mg of oxaliplatin.
• A 10 ml vial of concentrate contains 50 mg of oxaliplatin.
• A 20 ml vial of concentrate contains 100 mg of oxaliplatin.
• A 40 ml vial of concentrate contains 200 mg of oxaliplatin.
• The other components are lactose monohydrate and water for injectable preparations.

Product Appearance and Container Content

Concentrate for solution for infusion: clear, colorless solution in a vial.

It is available in 10 ml, 20 ml, and 40 ml vials in packs of 1 or 5 vials.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

Local Representative

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya, 53-55

08007-Barcelona

Spain

Tel: +34 93 342 78 90

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of the last revision of this leaflet: May 2025

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.

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This information is intended only for healthcare professionals:

Oxaliplatino SUN 5 mg/ml concentrate for solution for infusion EFG

Handling and disposal instructions

As with other potentially toxic compounds, precautions should be taken when handling and preparing oxaliplatin solutions.

Handling

Handling of this cytotoxic agent by healthcare personnel requires the use of all necessary precautions to ensure the protection of the handler and the work area.

Preparation of injectable solutions of cytotoxic agents should be performed by specialized personnel in this class of medicines, under conditions that guarantee the integrity of the product, environmental protection, and, above all, the protection of the personnel handling these medicines, in accordance with hospital regulations. Preparation should be carried out in a designated area. In this area, smoking, eating, and drinking are prohibited.

Personnel should be provided with adequate materials for handling, especially long-sleeved gowns, masks, caps, protective glasses, sterile single-use gloves, protective suits for the work area, containers, and collection bags for waste materials.

Feces and vomit should be handled with care.

Pregnant women should be warned to avoid handling cytotoxic agents.

Any broken container should be treated with the same precautions and considered contaminated waste material. Contaminated waste should be incinerated in properly labeled rigid containers. See the "Disposal" section included below in this leaflet.

If the oxaliplatin concentrate or infusion solution comes into contact with the skin, wash immediately and abundantly with water.

If the oxaliplatin concentrate or infusion solution comes into contact with mucous membranes, wash immediately and abundantly with water.

Disposal

Medicinal waste and all materials used for reconstitution, dilution, and administration should be destroyed according to standard procedures applicable to cytotoxic agents and in accordance with local requirements for the disposal of hazardous waste.

Special administration precautions

DO NOT use injection material that contains aluminum.

DO NOT administer the medicine without dilution.

Only a 5% glucose solution (50 mg/ml) for infusion can be used as a diluent. DO NOT reconstitute or dilute for infusion with sodium chloride or solutions containing chlorides.

DO NOT mix with any other medicine in the same infusion bag or administer it simultaneously with other medicines through the same infusion line.

DO NOT mix with alkaline solutions or medicines, in particular 5-fluorouracil, folinic acid preparations containing tromethamine as an excipient, and tromethamine salts of other medicines. Alkaline medicines or their solutions may adversely affect the stability of oxaliplatin.

Instructions for use in combination with folic acid (as calcium folinate or sodium folinate)

Intravenous infusion of 85 mg/m² of oxaliplatin in 250 to 500 ml of 5% glucose solution (50 mg/ml) with an intravenous infusion of folic acid in 5% glucose solution, over 2 to 6 hours, through a Y-line placed immediately before the injection point.

These two medicines should not be combined in the same infusion bag. Folinic acid should not contain tromethamine as an excipient and should only be diluted with isotonic 5% glucose solutions, never in alkaline or sodium chloride solutions or solutions containing chlorides.

Instructions for use in combination with 5-Fluorouracil

Oxaliplatin should always be administered before fluoropyrimidines, i.e., 5-fluorouracil.

After administration of oxaliplatin, flush the line with water, and administer 5-fluorouracil. For more information on the concomitant administration of medicines with oxaliplatin, see the summary of product characteristics of these medicines.

Incompatibilities

This medicinal product should not be mixed with other medicines except those mentioned in the "Instructions for dilution" section.

Instructions for dilution

Only 5% glucose solution should be used to dilute the concentrate.

Extract the necessary amount of concentrate from the vial or vials and dilute with 250 to 500 ml of 5% glucose solution to obtain an oxaliplatin concentration of not less than 0.2 mg/ml - 0.7 mg/ml, the concentration interval for which the physicochemical stability of oxaliplatin has been demonstrated.

Inspect visually before use. Only clear solutions without particles should be used.

This medicinal product is for single use. Any unused portion of the infusion solution should be discarded.

NEVER use sodium chloride solutions or solutions containing chlorides for dilution.

The oxaliplatin infusion solution has been shown to be compatible with representative PVC administration equipment.

Infusion

Administration of oxaliplatin does not require prehydration.

Oxaliplatin diluted in 250 to 500 ml of 5% glucose solution with a concentration of not less than 0.2 mg/ml should be infused intravenously over 2 to 6 hours. When oxaliplatin is administered with 5-fluorouracil, the oxaliplatin infusion should precede the 5-fluorouracil infusion.

Storage conditions

Medicinal product packaged for sale:

Donot store above 25°C.

Infusion solution:

After dissolution in a 5% glucose solution, chemical and physical stability has been demonstrated for 24 hours at room temperature (15-25°C) or for 48 hours in the refrigerator (2-8°C).

From a microbiological point of view, the infusion preparation should be used immediately. If not, the storage times and conditions prior to use are the responsibility of the user and normally should not exceed 24 hours at 2-8°C, unless the dilution has been performed under validated and controlled aseptic conditions.