Prospecto: information for the user

Oxaliplatino SUN 5 mg/ml concentrate for infusion solution EFG

Read the entire prospect carefully before starting to use the medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you and should not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.Oxaliplatino SUN and its use

2.What you need to know before starting to use Oxaliplatino SUN

3.How to use Oxaliplatino SUN

4.Possible adverse effects

5Storage of Oxaliplatino SUN

6.Contents of the package and additional information

Oxaliplatino is a cancer drug that contains platinum.

Oxaliplatino SUN is used for the treatment of metastatic (advanced) colon cancer (large intestine) or rectal cancer (last segment of the intestine), or as additional treatment after surgical removal of a tumor in the colon. It is used in combination with other cancer drugs called 5-fluorouracil (5-FU) and folinic acid (FA).

You should not be given Oxaliplatino SUN if:

• You are allergic to oxaliplatino or any of the other components of this medication (listed in section 6)
• You are breastfeeding
• You have a reduced number of blood cells (white blood cells and/or platelets)
• You experience numbness or tingling in your fingers and/or toes or have difficulty performing delicate tasks, such as buttoning a shirt
• You have severe kidney problems

Even if you are a man, read carefully the section of this prospectus about pregnancy and breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Oxaliplatino SUN if

• You have previously had an allergic reaction to a medication containing platinum, such as carboplatino or cisplatino.
• You have moderate kidney problems
• You have liver problems or abnormal liver function test results during your treatment
• You have or have had heart problems such as an abnormal electrical signal, called prolonged QT interval, irregular heartbeat or a family history of heart problems.
• If you have recently received or are planning to receive any vaccine. During treatment with oxaliplatino, you should not receive "live" or "attenuated" vaccines, such as the yellow fever vaccine.

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

• If you have an unpleasant sensation in your throat, particularly when swallowing, and feel like you are short of breath, during treatment, inform your doctor.
• If you have nerve problems in your hands or feet, such as numbness and tingling, or a decrease in sensation in your hands or feet, inform your doctor.
• If you have headaches, altered mental function, convulsions and abnormal vision, from blurred vision to loss of vision, inform your doctor.
• If you do not feel well (nausea and vomiting), inform your doctor.
• If you have severe diarrhea, inform your doctor.
• If you have mouth pain or ulcers in your mouth (mucositis/stomatitis), inform your doctor.
• If you have diarrhea or a decrease in white blood cells or platelets, inform your doctor. Your doctor may need to reduce the dose of Oxaliplatino SUN or postpone treatment with Oxaliplatino SUN.
• If you have unexplained respiratory symptoms, such as coughing, or difficulty breathing, inform your doctor. Your doctor may stop your treatment with Oxaliplatino SUN.
• If you develop extreme fatigue, shortness of breath, or kidney problems that cause you to urinate little or not at all (symptoms of acute renal failure), inform your doctor.
• If you have a fever (temperature of 38°C or higher), 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 a bruise (disseminated intravascular coagulation), inform your doctor, as they may be signs of blood clots throughout your body.
• If you feel dizzy (loss of consciousness) or have an irregular heartbeat while taking Oxaliplatino SUN, consult your doctor immediately, as it may be a sign of a serious heart problem.
• If you develop muscle pain and swelling, along with weakness, fever and reddish-brown urine, consult your doctor. These may be signs of muscle damage (rhabdomyolysis) and may lead to kidney problems or other complications.
• If you have abdominal pain, nausea, vomiting with blood or vomiting like coffee grounds, or dark stools that may be signs of intestinal ulcer (gastrointestinal ulcer with potential for bleeding or perforation), consult your doctor.

If you have abdominal pain (around the navel), diarrhea with blood, 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.

Children

Oxaliplatino should not be used in children and adolescents under 18 years of age.

Use of Oxaliplatino SUN with other medications

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

Pregnancy, breastfeeding and fertility

Pregnancy

Pregnancy is not recommended during treatment with oxaliplatino and a reliable contraceptive method should be used. Women should use adequate contraceptive measures during and after the interruption of continuous therapy for 4 months.

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

Breastfeeding

• You should not breastfeed while being treated with Oxaliplatino SUN.

Fertility

• Oxaliplatino may have an antifertility effect that could be irreversible. Male patients should seek advice on sperm conservation before treatment.
• Men are advised not to have children during treatment and for 6 months after treatment and to take appropriate contraceptive measures during this time.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

Treatment with Oxaliplatino SUN may increase the risk of dizziness, nausea and vomiting and other neurological symptoms that may affect your ability to walk and balance. If this happens, do not drive or operate machinery. If you experience vision problems while taking Oxaliplatino SUN, do not drive, operate heavy machinery or engage in hazardous activities.

Oxaliplatino SUN is only for adults.

For single use.

Dose

The dose of Oxaliplatino SUN is based on your body surface area, which is calculated from your weight and height. The dose will also depend on the results of blood tests and if you have previously experienced adverse effects as a result of Oxaliplatino SUN administration.

The recommended dose for adult patients, including the elderly, is 85 mg/m2of body surface area.

Form and route of administration

• Oxaliplatino SUN must be administered under the supervision of a specialist in cancer treatment.
• You will be treated by a healthcare professional who has established the necessary dose of Oxaliplatino SUN.
• Oxaliplatino SUN is administered by intravenous injection in an interval of2 to6 hours.
• Oxaliplatino SUN will be administeredat the same time as folinic acid and before the infusion of 5-fluorouracil.
• The needle must remain in the vein during the administration of the medication. If the needle comes out or falls, the solution will go to the tissue outside the vein, and you may experience discomfort or pain, soyou must inform your doctor or nurse immediately.

Administration frequency

Generally, you will receive an infusion every two weeks.

Treatment duration

The duration of treatment must be determined by your doctor.

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

If you use more Oxaliplatino SUN than you should

Since this medicationis administered by healthcare professionals, it is very unlikely that you will receive a dose that is too small or too large.In case of overdose, you may experience an increase in side effects.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them. If you experience any side effect, it is essential to inform your doctor before the next cycle.

The following are the effects you may experience.

Most severe side effects

Inform your doctor immediately ifyou experience any of the following side effects:

Very common:may affect more than 1 in 10 people

• allergic reactions, which usually occur during infusion, sometimes can be fatal,
• stomatitis/mucositis (mouth sores, ulcers in the mouth),
• low platelet count, abnormal bruising (thrombocytopenia). Your doctor will perform blood tests to check that you have enough blood cells before starting treatment and before each cycle,
• unexplained respiratory symptoms such as dry cough, difficulty breathing, or crackles.

Common:may affect up to 1 in 10 people

• severe blood infection, as well as a reduction in white blood cells (septic neutropenia) that can be fatal,
• reduction in white blood cells accompanied by fever > 38.3°C or prolonged fever > 38°C for more than an hour (febrile neutropenia),
• allergic reaction or anaphylactic symptoms 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 difficulty breathing, extreme fatigue (feeling like you're going to faint). In most cases, these symptoms occurred during infusion or immediately after, but allergic reactions have also been observed hours or even days after infusion,
• chest pain or upper back pain, difficulty breathing, and coughing up blood (symptoms of pulmonary embolism).

Uncommon: may affect up to 1 in 100 people

• severe blood infection (sepsis) that can be fatal,
• obstruction or inflammation of the intestine,
• difficulty hearing, dizziness, ringing in the ears.

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

• unexpected bleeding or bruising due to increased blood clots spreading throughout the small blood vessels in your body (disseminated intravascular coagulation) that can be fatal,

• abnormal bruising, bleeding, or signs of infection, such as sore throat and high temperature,
• diarrhea or persistent vomiting,
• reversible short-term loss of vision,

• various symptomssuch as headache, altered mental state, seizures, and visual disturbances from blurred vision to loss of vision (symptoms of posterior reversible encephalopathy syndrome, a rare neurological disorder),
• extreme fatigue with a decrease in red blood cells and shortness of breath (hemolytic anemia), alone or in combination with low platelet count, abnormal bruising (thrombocytopenia), and/or kidney problems that cause you to urinate little or not at all (symptoms of hemolytic uremic syndrome),
• scarring and thickening of the lungs with difficulty breathing, sometimes fatal (interstitial lung disease),
• upper abdominal pain and pain associated with nausea and vomiting.

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

• kidney problems that cause you to urinate little or not at all (symptoms of acute renal failure),
• non-cancerous abnormal liver nodules (focal nodular hyperplasia)

Unknown: cannot be estimated from available data

• severe blood infection and low blood pressure (septic shock) that can be fatal,
• abnormal heart rhythm (prolonged QT) that can be seen on an electrocardiogram (ECG) that can be fatal,
• muscle pain and swelling accompanied by weakness, fever, or reddish-brown urine (symptoms of rhabdomyolysis) that can be fatal,
• abdominal pain, nausea, vomiting with blood or coffee ground-like vomit, dark stools (symptoms of gastrointestinal ulcer with potential hemorrhage or perforation) that can be fatal,
• reduced blood flow to the intestine (intestinal ischemia) that can be fatal
• throat spasms that can cause difficulty breathing,
• autoimmune reaction that causes a reduction in all blood cell lines (pancytopenia) (symptoms include easy bruising and bleeding, difficulty breathing, extreme fatigue, and an increased risk of infection due to compromised immune system),
• stroke symptoms (including severe headache, confusion, difficulty seeing with one or both eyes, numbness or weakness in the face, arm, or leg on one side, facial drooping, difficulty walking, dizziness, loss of balance, and difficulty speaking),
• pneumonia (severe lung infection) that can be fatal.
• abnormal liver nodules (focal nodular hyperplasia)

Other known side effects are:

Very common: may affect more than 1 in 10 people

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

These effects are usually caused by exposure to cold, for example, opening the freezer or holding a cold drink. You may also have difficulty with fine motor tasks, such as buttoning a shirt.

Although in most cases these symptoms disappear completely, there is a possibility that peripheral neuropathy symptoms will persist after completing treatment.

Some patients have experienced a tingling sensation in their arms or torso when flexing their neck.

• Oxaliplatino SUN, in some cases, can cause an unpleasant sensation in the throat, particularly when swallowing, giving the sensation of difficulty breathing. This sensation, if it occurs, usually occurs during infusion or a few hours after it and can 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.

• Oxaliplatino SUN can cause diarrhea, nausea (feeling of dizziness), vomiting (feeling unwell). Usually, medications are administered to prevent dizziness before starting treatment, which can continue to be used after treatment.
• Oxaliplatino SUN causes a temporary reduction in the number of blood cells.The reduction in red blood cells can cause anemia (a reduction in red blood cells), abnormal bleeding, or hematomas (due to a reduction in platelets). The reduction in white blood cells can make you prone to infections. Your doctor will draw blood to check that you have enough blood cells before starting treatment and before each subsequent cycle.
• sensation 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 disturbances, constipation
• headache, back pain
• abnormal sensation in the tongue that could alter speech
• stomach pain
• abnormal bleeding, including nasal bleeding

• abnormal blood tests showing changes in liver function.

Common:may affect up to 1 in 10 people

• indigestion and heartburn, hiccups, and dizziness
• increased sweating and nail changes, skin peeling
• chest pain
• respiratory and nasal congestion
• joint and bone pain
• painful urination and changes in kidney function,change in urination frequency, dehydration

• blood in urine/stool, vein inflammation
• high blood pressure
• depression, insomnia (sleeplessness)

• conjunctivitis and visual problems
• decreased calcium levels in the blood
• inflammation of nerves to muscles, neck stiffness
• fall.

Uncommon:may affect up to 1 in 100 people

• nervousness

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

• hearing loss

Frequency not known(cannotbe estimated from available data

):

• allergic vasculitis (inflammation of blood vessels)
• seizures(uncontrolled body agitation)
• heart attack (myocardial infarction), angina (chest pain or discomfort)
• esophageal inflammation (inflammation of the inner lining of the esophagus - the tube that connects the mouth to the stomach - causing pain and difficulty swallowing
• increased risk of new cancers. Leukemia, a type of blood cancer, has been reported in patients after using concentrated oxaliplatino solution for infusion in combination with certain medications. Consult your doctor about the potential increased risk of this type of cancer when using Oxaliplatino SUN 5 mg/ml concentrated solution for infusion with certain medications.

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 theSistema Español de Farmacovigilancia de medicamentos de Uso Humano:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Nodo not store at a temperature above 25 ° C.

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.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and the medication that you no longer need. In this way, you will help protect the environment.

Oxaliplatino SUN5mg/ml concentrated solution for infusion

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

Appearance of the product and contents of the pack

Concentrated solution for infusion: clear, colourless solution in a vial.

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

Only some pack sizes may be marketed.

Marketing authorisation holder and manufacturer responsible

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

Phone: +34 93 342 78 90

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

Last update of the summary of product characteristics: December 2023

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

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This information is intended solely for medical professionals or healthcare professionals:

Oxaliplatino SUN 5 mg/ml concentrated solution for infusion EFG

Handling and disposal instructions

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

Handling

The handling of this cytotoxic agent by healthcare personnel or medical staff requires the use of all necessary precautions to ensure the protection of the handler and their work area.

The preparation of injectable solutions of cytotoxic agents should be carried out by specialized personnel in this class of medicines, in conditions that guarantee the integrity of the product, the protection of the environment and, above all, the protection of the personnel handling these medicines in accordance with hospital regulations. Its preparation should be carried out in a reserved area for this purpose. In this area, smoking, eating and drinking will be prohibited.

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

Stool and vomit should be handled with care.

Women of childbearing age should be warned to avoid handling cytotoxic agents.

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

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

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

Disposal

The remains of the medicinal product, as well as all materials used for reconstitution, dilution and administration, must be destroyed in accordance with standard procedures applicable to cytotoxic agents and in accordance with local requirements for the disposal of hazardous waste.

Special precautions for administration

DO NOT use material for injection that contains aluminium.

DO NOT administer the medicinal product without dilution.

Only a glucose solution at 5% (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 medicinal product in the same infusion bag or administer simultaneously with other medicinal products through the same infusion line.

DO NOT mix with alkaline solutions, particularly 5-fluorouracil, folinic acid preparations containing trometamol as an excipient, and trometamol salts of other medicinal products. Alkaline solutions or their solutions may adversely affect the stability of oxaliplatine.

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

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

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

Instructions for use in combination with 5-Fluorouracil

Oxaliplatine must always be administered before fluoropyrimidines, i.e. 5-fluorouracil.

After administering oxaliplatine, clean the vein with water, and administer 5-fluorouracil. For more information on the concomitant administration of medicinal products with oxaliplatine, see the product information for these medicinal products.

Incompatibilities

This medicinal product should not be mixed with any other except those mentioned in the "Dilution instructions" section.

Dilution instructions

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

Extract the required amount of concentrate from the vial or vials, and dilute with 250 to 500 ml of glucose solution at 5%, to obtain a concentration of oxaliplatine not less than 0.2 mg/ml - 0.7 mg/ml, the concentration interval for which the physical and chemical stability of oxaliplatine has been demonstrated.

Visually inspect before use. Only transparent solutions without particles will be used.

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

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

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

Infusion

Oxaliplatine administration does not require prehydration.

Oxaliplatine diluted in 250 to 500 ml of glucose solution at 5% with a concentration not less than 0.2 mg/ml, should be infused via a peripheral or central vein, over 2 to 6 hours. When oxaliplatine is administered with 5-fluorouracil, the infusion of oxaliplatine should precede that of 5-fluorouracil.

Storage conditions

Medicinal product conditioned for sale:

Do not store above 25 °C.

Infusion solution::

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

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