Gemcitabine Sun 10 mg/ml solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Gemcitabine SUN 10 mg/ml solution for infusion

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

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

Leaflet contents

1. What Gemcitabine SUN is and what it is used for
2. What you need to know before using Gemcitabine SUN
3. How to use Gemcitabine SUN
4. Possible side effects
5. How to store Gemcitabine SUN
6. Contents of the pack and other information

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

Gemcitabine SUN is a medicine used to treat cancer and belongs to a group of medicines called "cytotoxic agents". These medicines destroy cells that are dividing, including cancer cells.

Gemcitabine SUN may be given alone or in combination with other anticancer medicines, depending on the type of cancer.

Gemcitabine SUN is used to treat 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.

2. What you need to know before using Gemcitabine SUN

Do not use Gemcitabine SUN:

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

Warnings and precautions

Before the first infusion, blood samples will be taken to assess whether your liver and kidney function are normal. Likewise, prior to each infusion, blood samples will be taken to evaluate whether you have enough red blood cells to receive Gemcitabine SUN. Your doctor may decide to adjust the dose or delay treatment depending on your general condition and whether your blood cell counts are too low. Blood samples will be taken periodically to monitor your kidney and liver function.

Inform your doctor before starting Gemcitabine SUN if:

• you have or have previously had any liver, heart, blood vessel, or kidney problems, as you may not be able to receive Gemcitabine SUN
• you have recently undergone or are scheduled to receive radiotherapy, as delayed or early radiation reactions may occur with Gemcitabine SUN
• you have recently been vaccinated
• you have ever experienced a 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 exanthematous pustulosis (AGEP), have been reported with gemcitabine treatment. Seek immediate medical attention if you notice any 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 lack of safety and efficacy data in this population.

Use of Gemcitabine SUN with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Pregnancy, breastfeeding, and fertility

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine. The use of Gemcitabine SUN should be avoided during pregnancy. Your doctor will discuss with you the potential risks of taking Gemcitabine SUN during pregnancy.

Breastfeeding

Inform your doctor if you are breastfeeding. You must discontinue breastfeeding during treatment with Gemcitabine SUN.

Fertility

Men are advised not to father a child during treatment with Gemcitabine SUN or during the 6 months following treatment. If you wish to father a child during treatment or within 6 months after treatment, consult your doctor. You may wish to seek information about sperm preservation before starting treatment.

Driving and use of machines

Gemcitabine SUN may cause drowsiness, especially if you have consumed alcohol. Avoid driving or operating machinery until you are certain that treatment with Gemcitabine SUN does not cause drowsiness.

Gemcitabine SUN contains sodium

One millilitre of infusion solution contains 4.575 mg of sodium.

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

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

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

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

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

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

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

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

This medicine contains 1006.50 mg (43.78 mmol) of sodium (the main component of table/cooking salt) in each 220 ml infusion bag. This corresponds 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 your body surface area. Your doctor will use this body surface area to determine the correct dose for you. This dose may be adjusted or the treatment may be delayed depending on your general health and your blood cell counts.

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

Gemcitabina SUN will always be administered to you by intravenous infusion into one of your veins. The infusion will last approximately 30 minutes.

If you have any further questions about 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 everyone gets them.

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

Extreme tiredness and weakness, purpura or small areas of bleeding under the skin (bruising), acute kidney injury (low urine output or absence of urine), and signs of infection. These may be signs of thrombotic microangiopathy (blood clots forming in small blood vessels) and hemolytic uremic syndrome, which can be life-threatening.

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

Serious adverse effects

You must contact your doctor immediately if you experience any of the following serious adverse effects

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

• allergic reactions: if you develop a mild to moderate skin rash or fever
• tiredness, feeling faint, becoming breathless easily, or looking pale (as you may have lower than normal hemoglobin levels, which is very common)
• bleeding from gums, nose or mouth, or any bleeding that does not stop, pink or reddish urine, unexpected bruising (as you may have lower than normal platelet counts, 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 counts with fever, also known as febrile neutropenia)
• pain, redness, swelling, or sores in the mouth (stomatitis)
• allergic reactions: if you develop itching
• difficulty breathing (it is common to experience mild breathing difficulty shortly after Gemcitabine SUN infusion, which soon passes).

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

Other adverse effects

Inform your doctor as soon as possible if you notice any of the following adverse effects:

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

• low white blood cell count
• 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
• flu-like 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 lung alveoli (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
• sunburn-like skin rash, which may occur on skin previously exposed to radiotherapy (radiation-induced dermatitis)
• fluid in the lungs
• hardening of the walls of the lung alveoli associated with radiotherapy (radiation-associated toxicity)
• gangrene of fingers or toes
• inflammation of blood vessels (peripheral vasculitis).

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

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

Frequency not known (cannot be estimated from available data)

• sepsis: when bacteria and their toxins circulate in your blood and start damaging 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).

Blood tests will detect low hemoglobin levels (anemia), low white blood cell count, and low platelet count.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 stated on the infusion bag and outer packaging. The expiry date refers to the last day of the month indicated.

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

After opening the infusion bag:

From a microbiological standpoint, the solution should be used immediately. If not used immediately, the storage times and conditions prior to use 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 and packaging you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Gemcitabine SUN 10 mg/ml solution for infusion

• The active substance is: gemcitabine (as hydrochloride)
• The other components are: sodium chloride, water for injections, sodium hydroxide and/or hydrochloric acid (to adjust pH)

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 container

Gemcitabine SUN solution for infusion is a sterile, clear, colourless solution free from visible particles.

Gemcitabine SUN solution for infusion is packaged in cartons 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 certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

The 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 authorised in the European Economic Area member states and 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

The 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 the most recent review of this leaflet: March 2024

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

This information is intended for healthcare professionals only

Instructions for use, handling and disposal

Handling

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

Removal of the infusion bag wrapper and inspection of the infusion bag

• Tear the wrapper at the notch. Do not use if the wrapper has been previously opened or is damaged.
• Remove the infusion bag from the wrapper.
• Use only if the infusion bag and seal are intact. Before administration, check for small leaks by firmly squeezing the bag. If leaks are present, discard the bag and solution, as sterility may be compromised.
• Parenteral medicines should be visually inspected for particles and discoloration prior to administration. Do not administer if particles are observed.

Administration

• Break the seal of the Minitulipe closure by applying hand pressure on one side.
• Attach a sterile administration set using an aseptic technique.
• Refer to the instructions for use accompanying the administration set.

Precautions

• Do not use in series connection.

• Do not introduce additives into the infusion bag.

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

• After opening the infusion bag From a microbiological standpoint, the solution should be used immediately. If not used immediately, the conditions and duration of storage prior to use are the responsibility of the user.

• Gemcitabine solution for infusion is for single use only.

Personnel should use appropriate protective materials when handling, especially long-sleeved gowns, masks, caps, protective eyewear, sterile disposable gloves, protective clothing for the work area, and containers and bags for collecting waste materials.

Pregnant women should be warned to avoid handling cytotoxic agents.

If the solution comes into contact with the eyes, it may cause severe irritation. Immediately rinse eyes thoroughly with copious amounts of water. If irritation persists, consult a physician. If the solution is spilled on the skin, wash thoroughly with copious amounts of water. Faeces and vomit should be handled with care.

Disposal

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