Prospect: information for the user

Gemcitabine SUN 1000 mg powder for solution for infusion EFG

Gemcitabine

Read this prospect carefully before starting to use the medicine, because 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 medicine has been prescribed only to you and should not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospect. See section 4.

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

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

3.How to use Gemcitabine SUN

4.Possible adverse effects

5.Storage of Gemcitabine 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 gemcitabina or any of the other components of this medication (listed in section 6).
• If you are breastfeeding, you must stop breastfeeding during treatment with Gemcitabina SUN.

Advertencias y precauciones

Consult your doctor before starting to use Gemcitabina SUN.

Before the first infusion, blood samples will be taken to evaluate if your liver and kidney function is correct. 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 general condition and if your blood cell counts are too low. Periodically, blood samples will be taken to evaluate the function of your kidney and liver.

Inform your doctor 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 will receive radiation therapy, as Gemcitabina SUN may cause an early or late radiation reaction.
• You have recently been vaccinated.
• You experience symptoms such as headache with confusion, seizures (epileptic crises) or changes in vision, consult your doctor immediately. This could be a rare side effect of the nervous system called reversible posterior encephalopathy syndrome.
• You experience difficulty breathing or feel very weak and pale, as this may be a sign of kidney failure or lung problems.
• You experience generalized swelling, shortness of breath or weight gain, as this may be a sign of fluid leakage from your smallest blood vessels into your tissues.
• You have ever developed a severe skin rash or skin peeling, blisters, and/or mouth sores after using gemcitabina.
• Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized pustular psoriasis (PEGA), have been reported in association with gemcitabina treatment. Seek medical attention immediately if you observe any of the symptoms related to these severe skin reactions described in section 4.

Niños y adolescentes

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

Uso de Gemcitabina SUN conotros medicamentos

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

Embarazo, lactancia y fertilidad

If you are pregnant orin lactation, believe you may be pregnant or intend tobecome pregnant, consult your doctor before using this medication. Use of Gemcitabina SUN should be avoided during pregnancy. Your doctor will discuss the potential risk of taking Gemcitabina SUN during pregnancy with you.

You must stop breastfeeding during treatment with Gemcitabina SUN.

Men are advised not to decide to have a child during treatment with Gemcitabina SUN or during the 6 months following it. If you wish to have a child during treatment or in the 6 months following it, consult your doctor or pharmacist. You may wish to request information on sperm conservation before starting your treatment.

Conducción y uso de máquinas

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

Gemcitabina SUN contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per vial; it is essentially “sodium-free”.

.

The recommended dose of Gemcitabina SUN is 1,000-1,250 mg per square meter of your body surface area. 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.

A hospital pharmacist or doctor will have dissolved the Gemcitabina SUN powder before it is administered to you.

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 or pharmacist.

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 beneath (including skin folds, trunk, and upper limbs) and blisters accompanied by fever (acute generalized pustular psoriasis [AGPP]) (unknown frequency).

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 present a mild to moderate skin rash or fever
• Extreme fatigue, feeling faint, easily getting winded, or being pale (since you might 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 might 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 might have low white blood cell counts with fever, also known as febrile neutropenia)
• Mouth pain, redness, swelling, or sores (stomatitis)
• Allergic reactions: if you present itching, difficulty breathing (it is common to have a mild breathing difficulty immediately after the Gemcitabine SUN infusion, which passes quickly)

Uncommon:may affect up to 1 in 100 people

• Difficulty breathing (more severe lung problems)
• Irregular heart rate (arrhythmia)

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

• Difficulty breathing (more severe lung problems)
• Intense chest pain (myocardial infarction)

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

• Severe hypersensitivity/allergic reaction 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 might have capillary leakage from your smallest blood vessels to your tissues (capillary leak syndrome)
• Severe headache with vision changes, confusion, seizures, or convulsions (posterior reversible encephalopathy syndrome)
• Severe rash with itching, blistering, or skin peeling (Stevens-Johnson syndrome, toxic epidermal necrolysis)

Unknown frequency (cannot be estimated from available data)

• Generalized red and scaly rash with inflamed skin beneath (including skin folds, trunk, and upper limbs) and blisters accompanied by fever (Pustulosis Exanthemática Generalizada Aguda [PEGA]) (unknown frequency).

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

Very common:mayaffect 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
• Symptoms of a viral infection, 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
• Sneezing
• Constipation
• Diarrhea
• Itching
• Sweating
• Muscle pain
• Back pain
• Fever
• Weakness
• Chills
• Infections

Uncommon:may affect up to 1 in 100 people

• Interstitial lung disease (neumonitis intersticial)
• Wheezing (bronchospasm)
• Abnormal chest X-ray/CT scan
• Heart failure
• Kidney failure
• Severe liver damage, including liver failure
• Cerebral infarction (stroke)

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

• Low blood pressure
• Skin peeling, ulceration, or blistering
• Skin peeling and severe blistering on the skin
• Reactions at the injection site
• Severe lung inflammation causing respiratory failure (adult respiratory distress syndrome)
• Severe skin rash similar to sunburn that may occur on previously irradiated skin (radiodermatitis associated with radiation therapy)
• Liquid in the lungs
• Interstitial lung disease associated with radiation therapy (radiation therapy toxicity)
• Finger or hand gangrene
• Peripheral vasculitis

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

• Increased platelet count
• Inflammation of the large intestine caused by reduced blood supply (ischemic colitis)

• Through a blood test, you will be detected if you have low hemoglobin levels (anemia), low white blood cell count in the blood, and low platelet count.
• 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 damaging your organs

• Redness of the skin with swelling (pseudocelulitis).
• A condition in which eosinophils, a type of cell that is usually found in the blood, accumulate in the lungs (eosinophilic pneumonia).

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 for the Pharmacovigilance of Medicines for Human Use, website: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 vial and on the packaging. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

After reconstitution:

Chemical and physical stability has been demonstrated for use over 24 hours at 30?°C.

From a microbiological standpoint, the product should be used immediately. If not used immediately, storage times in use and conditions prior to use are the responsibility of the user and should normally not exceed 24hours at 30?°C.

The reconstituted solution should not be refrigerated.

Do not use this medication if you observe that the solution is cloudy or note an insoluble precipitate.

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

Composition of Gemcitabine SUN 1.000 mg powder for solution for infusion EFG

• The active ingredient is: gemcitabine (as hydrochloride)
• The other components are: mannitol, sodium acetate trihydrate, sodium hydroxide, hydrochloric acid.

One vial contains 1g of gemcitabine (as hydrochloride).

One ml of the reconstituted infusion solution contains 38 mg of gemcitabine (as hydrochloride).

Appearance of the product and contents of the package

Powder for infusion solution

Compressed lyophilized white or off-white powder.

1 vial of 50 ml.

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

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) with the following names:

Germany:Gemcitabine SUN 1.000 mg Powder for the preparation of an infusion solution

Spain:Gemcitabina SUN 1.000 mg powder for solution for infusion EFG

Italy:Gemcitabina SUN1.000 mgpolvere per soluzione per infusione

Netherlands:Gemcitabine SUN 1.000 mg poeder voor oplossing voor infusie

Romania:Gemcitabina SUN1.000 mgpulbere pentru solutie perfuzabila

United Kingdom (Northern Ireland):Gemcitabine 1.000 mg Powder for Solution for Infusion

Date of the last review of this leaflet:February 2024.

The detailed and updated informationof 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

• Use aseptic techniques during reconstitution and any subsequent dilution of gemcitabine for intravenous infusion.
• Calculate the dose and number of vials of Gemcitabine SUN required.
• Reconstitute each vial of 1.000 mg with 25 ml of sterile sodium chloride injection, 9 mg/ml (0.9%), without preservatives. Shake to dissolve. The total volume after reconstitution is 26.3 mlThe resulting concentration of gemcitabine from this dilution is 38 mg/ml, including consideration of the volume displacement of the lyophilized powder. It can be further diluted with a sodium chloride injection, 9 mg/ml (0.9%), without preservatives. The reconstituted solution is a clear, colorless or pale yellow solution.
• Before administration, visually inspect the medicines for possible particulate matter and/or discoloration. If particulate matter is observed, do not administer.
• The gemcitabine solutions reconstituted should not be refrigerated as it may cause crystallization. Chemical and physical stability has been demonstrated in use for 24 hours at 30°C. From a microbiological point of view, the product should be used immediately. If not used immediately, the storage conditions and periods before use will be the responsibility of the user and should not be greater than 24 hours at a temperature below30°C, unless the reconstitution/dilution is carried out in controlled and validated aseptic conditions.
• The Gemcitabine solutions must be used once. Any unused or waste product should be disposed of in accordance with local regulations.

Precautions for preparation and administration

Normal safety precautions for cytostatic agents should be taken when preparing and disposing of the infusion solution. The manipulation of the solution should be carried out in a safety cabinet and protective clothing and gloves should be used. If a safety cabinet is not available, the equipment should be supplemented with masks and eye protection.

If the preparation comes into contact with the eyes, it may cause severe irritation. The eyes should be rinsed immediately with plenty of water. If the irritation persists, a doctor should be consulted. If the solution is spilled on the skin, it should be rinsed thoroughly with plenty of water.

Disposal

Any unused product should be disposed of in accordance with local regulations.