Label: information for the user

Gemcitabina SUN 10 mg/ml infusion solution

Read this label carefully before starting to use this medication, because it contains important information for you.

• Keep this label, as you may need to read it again.
  If you have any questions, consult your doctor, pharmacist, or nurse.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label. See section 4.

1. What isGemcitabina SUNand what is it used for

2. What you need to know before starting to useGemcitabina SUN

3. How to useGemcitabina SUN

4. Possible adverse effects

5. Storage ofGemcitabina SUN

6. Contents of the package and additional information

Gemcitabina SUN is a medication used to treat cancer that belongs to the group of medications called "cytotoxics". These medications destroy cells that are dividing, including cancerous cells.

Gemcitabina SUN may be administered alone or in combination with other anticancer medications, depending on the type of cancer.

Gemcitabina SUN is used in the treatment of the following types of cancer:

• non-small cell lung cancer (NSCLC), alone or in combination with cisplatin
• pancreatic cancer
• breast cancer, in combination with paclitaxel
• ovarian cancer, in combination with carboplatin
• bladder cancer, in combination with cisplatin.

No use Gemcitabina SUN:

• If you are allergic to gemcitabine or any of the other components of this medication (listed in section 6)
• If you are breastfeeding.

Contraindications and Precautions

Before the first infusion, blood samples will be taken to evaluate your liver and kidney function. Similarly, before each infusion, blood samples will be taken to evaluate if you have enough red blood cells to receive Gemcitabina SUN. Your doctor may decide to change the dose or delay treatment depending on your overall condition and if your blood cell counts are too low. Periodically, blood samples will be taken to evaluate your kidney and liver function.

Inform your doctor before starting to use Gemcitabina SUN if:

• You have or have had any liver, heart, blood vessel, or kidney problems, as you may not be able to receive Gemcitabina SUN
• You have recently had or are about to receive radiation therapy, as Gemcitabina SUN may cause an early or late radiation reaction
• You have recently been vaccinated.
• You have ever had severe skin rash, skin peeling, blisters, or mouth sores after using gemcitabine.

Severe skin reactions, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized pustular psoriasis (PEGA), have been associated with gemcitabine treatment. Seek medical attention immediately if you notice any symptoms related to these severe skin reactions described in section 4.

Children and Adolescents

This medication is not recommended for use in children under 18 years due to a lack of safety and efficacy data in this population.

Use of Gemcitabina SUN with other Medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use another medication.

Pregnancy, Breastfeeding, and Fertility

Pregnancy

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication. Gemcitabina SUN should be avoided during pregnancy. Your doctor will discuss the potential risk of taking Gemcitabina SUN during pregnancy.

Breastfeeding

Inform your doctor if you are breastfeeding. You should stop breastfeeding during treatment with Gemcitabina SUN.

Fertility

Men are advised not to father a child during treatment with Gemcitabina SUN or for 6 months after treatment. If you wish to father a child during treatment or in the 6 months after treatment, consult your doctor. You may want to ask about sperm preservation before starting treatment.

Driving and Operating Machines

Gemcitabina SUN may cause drowsiness, especially if you have consumed alcohol. Avoid driving or operating machines until you are sure that the treatment with Gemcitabina SUN does not cause drowsiness.

Gemcitabina SUN contains sodium

One milliliter of infusion solution contains 4,575 mg of sodium.

This medication contains 549.00 mg (23.88 mmol) of sodium (main component of table salt/for cooking) in each 120 ml infusion bag, which is equivalent to 27.5% of the recommended daily maximum sodium intake for an adult.

This medication contains 594.65 mg (25.87 mmol) of sodium (main component of table salt/for cooking) in each 130 ml infusion bag, which is equivalent to 29.7% of the recommended daily maximum sodium intake for an adult.

This medication contains 640.50 mg (27.86 mmol) of sodium (main component of table salt/for cooking) in each 140 ml infusion bag, which is equivalent to 32% of the recommended daily maximum sodium intake for an adult.

This medication contains 686.25 mg (29.85 mmol) of sodium (main component of table salt/for cooking) in each 150 ml infusion bag, which is equivalent to 34.3% of the recommended daily maximum sodium intake for an adult.

This medication contains 732.00 mg (31.84 mmol) of sodium (main component of table salt/for cooking) in each 160 ml infusion bag, which is equivalent to 36.6% of the recommended daily maximum sodium intake for an adult.

This medication contains 777.75 mg (33.83 mmol) of sodium (main component of table salt/for cooking) in each 170 ml infusion bag, which is equivalent to 38.8% of the recommended daily maximum sodium intake for an adult.

This medication contains 823.50 mg (35.82 mmol) of sodium (main component of table salt/for cooking) in each 180 ml infusion bag, which is equivalent to 41.2% of the recommended daily maximum sodium intake for an adult.

This medication contains 915.00 mg (39.80 mmol) of sodium (main component of table salt/for cooking) in each 200 ml infusion bag, which is equivalent to 45.8% of the recommended daily maximum sodium intake for an adult.

This medication contains 1006.50 mg (43.78 mmol) of sodium (main component of table salt/for cooking) in each 220 ml infusion bag. This is equivalent to 50.3% of the recommended daily maximum sodium intake for an adult.

The recommended dose of Gemcitabina SUN is 1,000-1,250 mg per square meter of your body surface. Your height and weight will be measured to calculate your body surface area. Your doctor will use this body surface area to calculate the correct dose for you. This dose may be adjusted or treatment delayed depending on your overall health and blood cell counts.

The frequency at which you receive your Gemcitabina SUN infusion depends on the type of cancer you are being treated for.

You will always receive Gemcitabina SUN through an infusion into one of your veins. The infusion will last approximately 30 minutes.

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

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

Contact your doctor immediately if you notice any of the following:

Extreme fatigue and weakness, purple spots or small areas of bleeding on the skin (petechiae), acute kidney injury (low urine output or absence of urine), and signs of infection. These may be signs of microangiopathic thrombosis (clots that form in small blood vessels) and hemolytic uremic syndrome, which can be fatal.

A red, scaly, and generalized rash with inflamed skin (including skin folds, trunk, and upper limbs) and blisters accompanied by fever (acute generalized pustular psoriasis) (unknown frequency).

Severe side effects

You must contact your doctor immediately if you observe any of the following severe side effects

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

• Allergic reactions: if you experience mild to moderate skin rash or fever
• Extreme fatigue, feeling faint, easily getting winded, or looking pale (since you may have low hemoglobin levels, which is very common)
• Bleeding gums, nose, or mouth, or any bleeding that does not stop, pink or red urine, unexpected bruises (since you may have low platelet levels, which is very common).

Common (may affect up to 1 in 10 people)

• Temperature of 38°C or higher, sweating, or other signs of infection (since you may have low white blood cell counts with fever, also known as febrile neutropenia)
• Mouth pain, redness, swelling, or sores (stomatitis)
• Allergic reactions: if you experience itching
• Difficulty breathing (it is common to have mild difficulty breathing immediately after the Gemcitabine SUN infusion, which passes quickly).

Uncommon (may affect up to 1 in 100 people)

• Difficulty breathing due to more severe lung problems (interstitial pneumonitis, bronchospasm)
• Irregular heart rate (arrhythmia).

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

• Difficulty breathing due to more severe lung problems (more severe lung problems, adult respiratory distress syndrome)
• Intense chest pain (myocardial infarction).

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

• Severe allergic reaction or hypersensitivity with severe skin rash including red skin with itching, swelling of hands, feet, ankles, face, lips, mouth, or throat (which may cause difficulty swallowing or breathing), difficulty breathing, rapid heartbeat, and may feel like fainting (anaphylactic reaction)
• Generalized swelling, shortness of breath, or weight gain, since you may have fluid leaking from your smallest blood vessels into your tissues (capillary leak syndrome)
• Headache with changes in vision, confusion, seizures, or convulsions (posterior reversible encephalopathy syndrome)
• Severe rash with itching, appearance of blisters, or skin peeling (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Other side effects

Inform your doctor as soon as possible if you observe any of the following side effects:

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

• Low white blood cell count in the blood
• Difficulty breathing
• Vomiting
• Nausea
• Hair loss
• Liver problems: identified through abnormal blood test results
• Blood in the urine
• Abnormal urine test results: protein in the urine
• Pseudo-grip syndrome including fever
• Swelling of ankles, fingers, feet, face (edema).

Common (may affect up to 1 in 10 people)

• Poor appetite (anorexia)
• Headache
• Insomnia
• Drowsiness
• Cough
• Runny nose
• Constipation
• Diarrhea
• Itching
• Sweating
• Muscle pain
• Back pain
• Fever
• Weakness
• Chills
• Infections.

Uncommon (may affect up to 1 in 100 people)

• Hardening of the walls of the alveoli in the lungs (interstitial pneumonitis, bronchospasm)
• Wheezing (bronchospasm)
• Hardening of the walls of the lungs (abnormal chest X-ray or CT scan)
• Heart failure
• Kidney failure
• Severe liver damage, including liver failure
• Cerebral infarction.

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

• Low blood pressure
• Peeling of the skin, ulceration, or blistering
• Severe peeling of the skin and appearance of blisters on the skin
• Reactions at the injection site
• Rash similar to sunburn, severe, which may occur in skin that has been previously exposed to radiation (radiodermatitis associated with radiation)
• Liquid in the lungs
• Hardening of the walls of the alveoli in the lungs associated with radiation (radiation toxicity)
• Foot or hand gangrene
• Peripheral vasculitis.

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

• Increased platelet count
• Inflammation of the intestinal membrane, caused by reduced blood supply (ischemic colitis).
• Clots that form in small blood vessels (microangiopathic thrombosis).

Unknown frequency (cannot be estimated from available data)

• Sepsis: when bacteria and their toxins circulate in your blood and start to damage your organs
• A condition where eosinophils, a type of cell normally found in the blood, accumulate in the lungs (eosinophilic pneumonia)
• Redness of the skin with swelling (pseudocellulitis).

Through a blood test, it will be detected if there are low hemoglobin levels (anemia), low white blood cell count in the blood, and low platelet count.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is possible side effects that do not appear in this prospectus. You can also report them directly through the Spanish System for the 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.

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

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

This medication does not require special storage conditions. Do not refrigerate or freeze.

After opening the infusion bag:

From a microbiological point of view, the solution must be used immediately. If not used immediately, storage times in use and conditions before use are the responsibility of the user.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Gemcitabina SUN 10 mg/ml infusion solution

• The active ingredient is: gemcitabine (as hydrochloride)
• The other components are: sodium chloride, water for injection, sodium hydroxide and/or hydrochloric acid (for pH adjustment)

Each 120 ml infusion bag contains 1200 mg of gemcitabine (as hydrochloride).

Each 130 ml infusion bag contains 1300 mg of gemcitabine (as hydrochloride).

Each 140 ml infusion bag contains 1400 mg of gemcitabine (as hydrochloride).

Each 150 ml infusion bag contains 1500 mg of gemcitabine (as hydrochloride).

Each 160 ml infusion bag contains 1600 mg of gemcitabine (as hydrochloride).

Each 170 ml infusion bag contains 1700 mg of gemcitabine (as hydrochloride).

Each 180 ml infusion bag contains 1800 mg of gemcitabine (as hydrochloride).

Each 200 ml infusion bag contains 2000 mg of gemcitabine (as hydrochloride).

Each 220 ml infusion bag contains 2200 mg of gemcitabine (as hydrochloride).

One ml of infusion solution contains 10 mg of gemcitabine.

One ml of infusion solution contains 4.575 mg of sodium.

Appearance of the product and contents of the package

Gemcitabina SUN infusion solution is a sterile, transparent, and colorless solution without visible particles.

Gemcitabina SUN infusion solution is packaged in boxes containing 1, 5, or 10 single-dose infusion bags of 120 ml, 130 ml, 140 ml, 150 ml, 160 ml, 170 ml, 180 ml, 200 ml, or 220 ml, respectively.

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible 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

Phone: +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:

Germany: Gemcitabin SUN 10 mg/ml Infusionslösung

Belgium: Gemcitabine SUN 10 mg/ml oplossing voor infusie

France: Gemcitabine SUN 10 mg/ml solution pour perfusion

Italy: Gemcitabina SUN Pharma 10 mg/ml soluzione per infusione

Norway: Gemcitabin SUN 10 mg/ml infusjonsvæske, oppløsning

Netherlands: Gemcitabine SUN 1200/1300/1400/1500/1600/1700/1800/2000/2200 mg oplossing voor infusie

Poland: Gemcitabine SUN

Czech Republic: Gemcitabin SUN

Romania: Gemcitabina SUN 10 mg/ml solutie perfuzabila

United Kingdom (Northern Ireland): Gemcitabine 10 mg/ml solution for infusion

Sweden: Gemcitabin SUN 10 mg/ml infusionsvätska, lösning

Last revision date of this leaflet: March 2, 2024

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/.

This information is intended solely for healthcare professionals

Instructions for use, handling, and disposal

Handling

• Calculate the dose, and decide which size of Gemcitabina SUN infusion bag is needed. If the required dose cannot be achieved with the available presentations, the use of an alternative gemcitabine product, including gemcitabine as a concentrate or gemcitabine in the form of a powder for infusion solution, is recommended.
• Inspect the packaging of the product for any signs of damage. Do not use if damaged.
• Attach the patient-specific label to the packaging.

Disposal of the infusion bag packaging and inspection of the infusion bag

• Open the packaging by tearing along the perforation. Do not use if the packaging has been previously opened or is damaged.
• Remove the infusion bag from the packaging.
• Use only if the infusion bag and the cap are intact. Before administration, check for small leaks by pressing the bag firmly. If leaks are present, discard the bag and solution as it may not be sterile.
• Parenteral medications should be visually inspected for particles and discoloration before administration. Do not administer if particles are observed.

Administration

• Break the cap of the Minutulipe by applying pressure with your hand on one side.
• Attach the sterile administration equipment using an aseptic technique.
• Consult the instructions for use that accompany the administration equipment.

Precautions

• Do not use in series connection.
• Do not introduce additives into the infusion bag.

• The infusion solution is ready for use and should not be mixed with other medications.

• After opening the infusion bag
  From a microbiological point of view, the solution should be used immediately. If not used immediately, the storage conditions and periods before use will be the responsibility of the user.

• Gemcitabina infusion solution is for single use only.

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

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

If the preparation comes into contact with the eyes, it may cause severe irritation. The eyes should be rinsed thoroughly with plenty of water. If irritation persists, a doctor should be consulted. If the solution spills on the skin, it should be rinsed thoroughly with plenty of water.The feces and vomit should be handled with care.

Disposal

The unused product should be disposed of in accordance with the standard procedures applicable for cytotoxic agents.