GEMCITABINE SUN 10 mg/ml SOLUTION FOR INFUSION

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

Do not use Gemcitabina SUN:

• if you are allergic to gemcitabine or to any of the other ingredients of this medicine (listed in section 6)
• if you are breast-feeding.

Warnings and precautions

Before the first infusion, blood samples will be taken to assess whether your liver and kidney function is correct. Similarly, before each infusion, blood samples will be taken to assess whether 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 assess the function of your kidneys and liver.

Tell your doctor before starting Gemcitabina SUN if:

• you have or have had previously any liver, heart, blood vessel disease, or kidney problems, as you may not be able to receive Gemcitabina SUN
• you have recently had, or are going to receive radiotherapy, as Gemcitabina SUN can cause an early or late reaction to radiation
• you have been vaccinated recently.
• you have ever presented a severe skin rash, skin peeling, blisters, or sores in the mouth after using gemcitabine.

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

Children and adolescents

The use of this medicine is not recommended in children under 18 years of age due to the lack of safety and efficacy data in this population.

Using Gemcitabina SUN with other medicines

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

Pregnancy, breast-feeding, and fertility

Pregnancy

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. The use of Gemcitabina SUN should be avoided during pregnancy. Your doctor will discuss with you the potential risks of taking Gemcitabina SUN during pregnancy.

Breast-feeding

Tell your doctor if you are breast-feeding. You must stop breast-feeding during treatment with Gemcitabina SUN.

Fertility

Men are advised not to father a child during treatment with Gemcitabina SUN and for up to 6 months after treatment. If you wish to father a child during treatment or in the 6 months after treatment, seek advice from your doctor. You may want to ask for information on sperm conservation before starting your treatment.

Driving and using machines

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

Gemcitabina SUN contains sodium

One milliliter of the solution for infusion contains 4.575 mg of sodium.

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

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

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

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

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

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

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

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

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

3. How to use Gemcitabina SUN

The recommended dose of Gemcitabina SUN is 1,000-1,250 mg per square meter of your body surface area. Your height and weight are measured to calculate the area of your body. 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 general health and your 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 by infusion into one of your veins. The infusion will take approximately 30 minutes.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

Extreme tiredness and weakness, purple spots or small areas of bleeding on the skin (bruises), acute kidney injury (low urine production or absence of urine), and signs of infection. These may be signs of thrombotic microangiopathy (clots forming in small blood vessels) and hemolytic uremic syndrome, which can be fatal.

A red, scaly, and widespread rash with bumps under the inflamed skin (including skin folds, trunk, and upper limbs) and blisters accompanied by fever (acute generalized exanthematous pustulosis (AGEP)) (frequency not known).

Serious side effects

You should contact your doctor immediately if you notice any of the following serious side effects

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

• allergic reactions: if you have a mild to moderate skin rash or fever
• fatigue, feeling faint, getting breathless easily, or if you are pale (as you may have lower than normal hemoglobin levels, which is very common)
• bleeding from the gums, nose, or mouth, or any bleeding that does not stop, red or pink urine, unexpected bruising (as you may have lower than normal 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 (as you may have lower than normal white blood cell levels, accompanied by fever, also known as febrile neutropenia)
• pain, redness, swelling, or sores in the mouth (stomatitis)
• allergic reactions: if you have itching
• difficulty breathing (it is common to have mild difficulty breathing immediately after the infusion of Gemcitabina SUN, which passes soon).

Uncommon (may affect up to 1 in 100 people)

• difficulty breathing due to more serious lung problems (interstitial pneumonitis, bronchospasm)
• irregular heartbeat (arrhythmia).

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

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

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

• severe allergic reaction with severe skin rash, including red skin with itching, swelling of hands, feet, ankles, face, lips, mouth, or throat (which can cause difficulty swallowing or breathing), difficulty breathing, rapid heartbeat, and you may feel like you are going to faint (anaphylactic reaction)
• generalized swelling, shortness of breath, or weight gain, as you may have fluid leakage from your small blood vessels to your tissues (capillary leak syndrome)
• headache with changes in vision, confusion, seizures, or epileptic fits (reversible posterior encephalopathy syndrome)
• severe skin rash with itching, blisters, or skin peeling (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Other side effects

Tell your doctor as soon as possible if you notice 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 tests: protein in the urine
• pseudo-flu syndrome including fever
• swelling of ankles, fingers, feet, face (edema).

Common (may affect up to 1 in 10 people)

• loss of 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/scan)
• heart failure
• kidney failure
• severe liver damage, including liver failure
• stroke.

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

• low blood pressure
• skin peeling, ulceration, or blistering
• severe skin peeling and blistering
• reactions at the injection site
• severe sunburn-like rash that can occur in skin that has been previously exposed to radiotherapy (radiation-induced dermatitis)
• fluid in the lungs
• hardening of the walls of the alveoli in the lungs associated with radiotherapy (radiation-induced toxicity)
• gangrene of the toes or fingers
• inflammation of the blood vessels (peripheral vasculitis).

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

• increase in platelet count
• inflammation of the lining of the large intestine, caused by reduced blood supply (ischemic colitis)
• clots forming in small blood vessels (thrombotic microangiopathy).

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

• sepsis: when bacteria and their toxins circulate in your blood and start damaging your organs
• a condition where eosinophils, a type of cell normally found in the blood, accumulate in the lungs (pulmonary eosinophilia)
• redness of the skin with swelling (pseudocellulitis).

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

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Gemcitabina SUN

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

Do not use this medicine after the expiry date which is stated on the infusion bag and the outer packaging. The expiry date is the last day of the month stated.

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

After opening the infusion bag:

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Content and Additional Information

Composition of Gemcitabine SUN 10 mg/ml Solution for Infusion

• The active ingredient is: gemcitabine (as hydrochloride)
• The other components are: sodium chloride, water for injectable preparations, 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 solution for infusion contains 10 mg of gemcitabine.

One ml of solution for infusion contains 4.575 mg of sodium.

Appearance of the Product and Container Content

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

Gemcitabine SUN solution for infusion 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 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:

Germany: Gemcitabin SUN 10 mg/ml Infusionslösung

Belgium: Gemcitabine SUN 10 mg/ml oplossing voor infusie

Gemcitabine SUN 10 mg/ml solution pour perfusion

Gemcitabin SUN 10 mg/ml Infusionslösung

Denmark: Gemcitabin SUN 10 mg/ml infusionsvæske, opløsning

Slovakia: Gemcitabín SUN 10 mg/ml infúzny roztok

Spain: Gemcitabina SUN 10 mg/ml solución para perfusión

Finland: Gemcitabin SUN 10 mg/ml infuusioneste, liuos

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

Date of Last Revision of this Leaflet: March 2024

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/.

This Information is Intended Only for Healthcare Professionals

Instructions for Use, Handling, and Disposal

Handling

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

Disposal of the Infusion Bag Packaging and Inspection of the Infusion Bag

• Tear the packaging at the notch. 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 seal are intact. Before administration, check for small leaks by squeezing the bag firmly. If leaks exist, discard the bag and solution as it may not be sterile.
• Parenteral medications must be visually inspected for particles and discoloration before administration. Do not administer if particles are observed.

Administration

• Break the Minitulipe cap seal by applying pressure with the hand on one side.
• Attach the sterile administration equipment using an aseptic technique.
• Consult the instructions for use accompanying the administration equipment.

Precautions

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

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

• After Opening the Infusion BagFrom a microbiological point of view, the solution should be used immediately. If not used immediately, the conditions and periods of storage before use will be the responsibility of the user.

• Gemcitabine solution for infusion is for single use

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

Pregnant women should be warned to avoid handling cytotoxic agents.

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

Disposal

Any unused product should be disposed of in accordance with standard procedures applicable to cytotoxic agents.