GEMCITABINE 10 mg /Ml Solution

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Gemcitabine SUN, 10 mg/ml, solution for infusion
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Gemcitabine SUN and what is it used for
4. Important information before using Gemcitabine SUN
   1. When not to use Gemcitabine SUN
   2. Warnings and precautions
   3. Children and adolescents
   4. Gemcitabine SUN and other medicines
   5. Pregnancy, breastfeeding, and fertility
   6. Pregnancy
   7. Breastfeeding
   8. Fertility
   9. Driving and using machines
   10. Gemcitabine SUN contains sodium
5. How to use Gemcitabine SUN
6. Possible side effects
   1. If you experience any of the following symptoms, contact your doctor immediately:
   2. Severe side effects
   3. Tell your doctor immediately if you experience any of the following severe side effects: very common (may affect more than 1 in 10 people)
   4. Other side effects
   5. Tell your doctor as soon as possible if you experience any of the following side effects:
   6. Very common (may affect more than 1 in 10 people)
   7. Common (may affect up to 1 in 10 people)
   8. Uncommon (may affect up to 1 in 100 people)
   9. Rare (may affect up to 1 in 1000 people)
   10. Very rare (may affect up to 1 in 10,000 people)
   11. Unknown (frequency cannot be estimated from the available data)
   12. Reporting side effects
7. How to store Gemcitabine SUN
8. Contents of the packaging and other information
   1. What Gemcitabine SUN solution for infusion contains
   2. What Gemcitabine SUN solution for infusion looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
   5. Information intended for healthcare professionals only
   6. Instructions for use, preparation, and disposal

Leaflet attached to the packaging: patient information

Gemcitabine SUN, 10 mg/ml, solution for infusion

Gemcitabine

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

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

Gemcitabine SUN belongs to a group of medicines called cytotoxic medicines. These medicines destroy dividing cells, including cancer cells. Gemcitabine SUN can be used 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), as a single agent 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. Important information before using Gemcitabine SUN

When not to use Gemcitabine SUN

Warnings and precautions

Before the first infusion, medical staff will take blood samples from you to assess whether your kidney and liver function is sufficient. Before each infusion, medical staff will take blood samples from you to assess whether you have enough blood cells to receive Gemcitabine SUN. Depending on your general condition and in case of excessive reduction of blood cells, your doctor may change the dose or postpone the administration of the medicine. Periodically, blood samples will be taken from you to assess kidney and liver function. Before receiving Gemcitabine SUN, you should discuss with your doctor if:

• you have or have had liver, heart, or blood vessel diseases or kidney problems, as it may not be possible to administer Gemcitabine SUN;
• you have recently undergone or are going to undergo radiotherapy, as early or late radiation reaction may occur;
• you have recently received a vaccine.

Children and adolescents

Gemcitabine SUN is not recommended for use in children under 18 years of age due to insufficient data on safety and efficacy.

Gemcitabine SUN and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.

Pregnancy, breastfeeding, and fertility

Pregnancy

If you are pregnant, think you may be pregnant, or plan to have a child, consult your doctor before using this medicine. Gemcitabine SUN should be avoided during pregnancy. Your doctor will inform you about the potential risk associated with the use of Gemcitabine SUN during pregnancy.

Breastfeeding

Inform your doctor if you are breastfeeding. During treatment with Gemcitabine SUN, you should stop breastfeeding.

Fertility

Men are advised not to plan to conceive a child during treatment with Gemcitabine SUN and for 6 months after the end of treatment. Men should consult their doctor if they want to have a child during treatment or within 6 months after the end of treatment. Before starting treatment, patients may consult institutions that specialize in sperm storage.

Driving and using machines

Gemcitabine SUN may cause drowsiness, especially when combined with alcohol. Patients should not drive or operate machinery until it is established that Gemcitabine SUN does not cause drowsiness.

Gemcitabine SUN contains sodium

One milliliter of the solution for infusion contains 4.575 mg of sodium. The solution for infusion contains 549.00 mg (23.88 mmol) of sodium (the main component of common salt) per 120 ml infusion bag. This corresponds to 27.5% of the maximum recommended daily intake of sodium in the diet for adults. The solution for infusion contains 594.65 mg (25.87 mmol) of sodium (the main component of common salt) per 130 ml infusion bag. This corresponds to 29.7% of the maximum recommended daily intake of sodium in the diet for adults. The solution for infusion contains 640.50 mg (27.86 mmol) of sodium (the main component of common salt) per 140 ml infusion bag. This corresponds to 32% of the maximum recommended daily intake of sodium in the diet for adults. The solution for infusion contains 686.25 mg (29.85 mmol) of sodium (the main component of common salt) per 150 ml infusion bag. This corresponds to 34.3% of the maximum recommended daily intake of sodium in the diet for adults. The solution for infusion contains 732.00 mg (31.84 mmol) of sodium (the main component of common salt) per 160 ml infusion bag. This corresponds to 36.6% of the maximum recommended daily intake of sodium in the diet for adults. The solution for infusion contains 777.75 mg (33.83 mmol) of sodium (the main component of common salt) per 170 ml infusion bag. This corresponds to 38.8% of the maximum recommended daily intake of sodium in the diet for adults. The solution for infusion contains 823.50 mg (35.82 mmol) of sodium (the main component of common salt) per 180 ml infusion bag. This corresponds to 41.2% of the maximum recommended daily intake of sodium in the diet for adults. The solution for infusion contains 915.00 mg (39.80 mmol) of sodium (the main component of common salt) per 200 ml infusion bag. This corresponds to 45.8% of the maximum recommended daily intake of sodium in the diet for adults. The solution for infusion contains 1006.50 mg (43.78 mmol) of sodium (the main component of common salt) per 220 ml infusion bag. This corresponds to 50.3% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Gemcitabine SUN

The recommended dose of Gemcitabine SUN is 1000-1250 mg per square meter of body surface area. The body surface area is calculated based on the patient's height and weight. The dose is determined based on the calculated body surface area. The dose may be changed or treatment may be delayed depending on blood test results and the patient's general condition. The frequency of Gemcitabine SUN infusion depends on the type of cancer being treated. Gemcitabine SUN is always administered by intravenous infusion (drip). The infusion lasts about 30 minutes. If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Gemcitabine SUN can cause side effects, although not everybody gets them.

If you experience any of the following symptoms, contact your doctor immediately:

severe fatigue and weakness, petechiae or minor bleeding under the skin (bruises), acute kidney failure (little or no urine production) and signs of infection. These may be signs of thrombotic microangiopathy (formation of blood clots in small blood vessels) and hemolytic-uremic syndrome, which can lead to death.

Severe side effects

Tell your doctor immediately if you experience any of the following severe side effects: very common (may affect more than 1 in 10 people)

• allergic reactions: if you experience a mild to moderate skin rash or fever
• feeling tired, fainting, rapidly increasing shortness of breath or paleness of the skin (you may have a low hemoglobin level)
• bleeding from the gums, nose, or mouth, or other bleeding that cannot be stopped, red or pink urine, unexpected bruising (you may have a low platelet count)

common (may affect up to 1 in 10 people)

• body temperature of 38°C or higher, excessive sweating, or other signs of infection (you may have a low white blood cell count, accompanied by fever, also known as febrile neutropenia)
• pain, redness, swelling, or ulcers in the mouth (stomatitis)
• allergic reactions: if you experience itching
• mild breathing difficulties (mild breathing difficulties are common soon after Gemcitabine SUN infusion, but they quickly pass)

uncommon (may affect up to 1 in 100 people)

• breathing difficulties due to severe lung condition (interstitial lung disease, bronchospasm)
• irregular heart rhythm (arrhythmia)

rare (may affect up to 1 in 1000 people)

• breathing difficulties due to severe lung condition (pulmonary edema, adult respiratory distress syndrome)
• severe chest pain (myocardial infarction)

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

• severe hypersensitivity/allergic reaction with severe skin rash, including redness and itching of the skin, swelling of the hands, feet, ankles, face, lips, or tongue (which may cause difficulty swallowing or breathing), wheezing, rapid heartbeat, and you may feel like you are about to faint (anaphylactic reaction)
• generalized edema, shortness of breath, or weight gain, as fluid may leak from small blood vessels into tissues (capillary leak syndrome)
• headache with vision changes, confusion, seizures, or convulsions (reversible posterior leukoencephalopathy syndrome)
• severe skin rash with itching, blistering, or peeling (Stevens-Johnson syndrome, toxic epidermal necrolysis)

Other side effects

Tell your doctor as soon as possible if you experience any of the following side effects:

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

• low white blood cell count
• breathing difficulties
• vomiting
• nausea
• hair loss
• liver function disorders: detected after blood tests
• blood in the urine
• abnormal urine test results: protein in the urine
• flu-like symptoms, including fever
• swelling (of the ankles, fingers, feet, and face)

Common (may affect up to 1 in 10 people)

• decreased appetite (anorexia)
• headache
• insomnia
• drowsiness
• cough
• runny nose
• constipation
• diarrhea
• itching
• excessive sweating
• muscle pain
• back pain
• fever
• weakness
• chills
• infections

Uncommon (may affect up to 1 in 100 people)

• scarring of the lung tissue (interstitial lung disease)
• wheezing (bronchospasm)
• lung fibrosis (abnormal chest X-ray/computed tomography)
• heart failure
• kidney failure
• severe liver damage, including liver failure
• stroke

Rare (may affect up to 1 in 1000 people)

• low blood pressure
• skin peeling, blistering, or shedding
• skin peeling and blistering, with large blisters
• reactions at the injection site
• skin rash, similar to severe sunburn, which may occur on skin previously exposed to radiotherapy (radiation recall)
• fluid in the lungs
• scarring of the lung tissue associated with radiotherapy (radiation toxicity)
• gangrene of the fingers or toes
• inflammation of the blood vessels (peripheral vasculitis)

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

• increased platelet count
• inflammation of the colon due to reduced blood flow (ischemic colitis)
• thrombotic microangiopathy: formation of blood clots in small blood vessels

Unknown (frequency cannot be estimated from the available data)

• sepsis: a condition in which bacteria and their toxins circulate in the blood and start damaging organs
• a condition in which eosinophils (a type of cell usually found in the blood) accumulate in the lungs (eosinophilic pneumonia)
• redness and swelling of the skin (pseudoscleroderma)

Low hemoglobin, low white blood cell count, and low platelet count will be detected after blood tests.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49 21 301; fax: 22 49 21 309; Website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Gemcitabine 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 after "EXP". The expiry date refers to the last day of the month. There are no special precautions for storage. Do not store in a refrigerator or freeze. After opening the infusion bag: From a microbiological point of view, the product should be used immediately. If the product is not used immediately, the responsibility for the storage time and storage conditions before use lies with the user. Gemcitabine SUN is for single use only. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What Gemcitabine SUN solution for infusion contains

• The active substance is gemcitabine (as hydrochloride).
• The other ingredients are sodium chloride, water for injections, sodium hydroxide, and (or) hydrochloric acid (for pH adjustment).

One 120 ml infusion bag contains 1200 mg of gemcitabine (as hydrochloride). One 130 ml infusion bag contains 1300 mg of gemcitabine (as hydrochloride). One 140 ml infusion bag contains 1400 mg of gemcitabine (as hydrochloride). One 150 ml infusion bag contains 1500 mg of gemcitabine (as hydrochloride). One 160 ml infusion bag contains 1600 mg of gemcitabine (as hydrochloride). One 170 ml infusion bag contains 1700 mg of gemcitabine (as hydrochloride). One 180 ml infusion bag contains 1800 mg of gemcitabine (as hydrochloride). One 200 ml infusion bag contains 2000 mg of gemcitabine (as hydrochloride). One 220 ml infusion bag contains 2200 mg of gemcitabine (as hydrochloride). One milliliter of the solution for infusion contains 10 mg of gemcitabine. One milliliter of the solution for infusion contains 4.575 mg of sodium.

What Gemcitabine SUN solution for infusion looks like and contents of the pack

Gemcitabine SUN is a clear, colorless, sterile solution for infusion, which does not contain visible particles. Single doses of Gemcitabine SUN are packaged in cardboard boxes containing 1, 5, or 10 infusion bags of 120 ml, 130 ml, 140 ml, 150 ml, 160 ml, 170 ml, 180 ml, 200 ml, or 220 ml. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Sun Pharmaceutical Industries Europe B.V. Polarisavenue 87 2132 JH Hoofddorp Netherlands

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

Belgium: Gemcitabine SUN 10 mg/ml oplossing voor infusie Gemcitabine SUN 10 mg/ml solution pour perfusion Gemcitabin SUN 10 mg/ml Infusionslösung Czech Republic: Gemcitabin SUN 10 mg/ml infuzní roztok Denmark: Gemcitabin SUN 10 mg/ml infusionsvæske, opløsning Finland: Gemcitabin SUN 10 mg/ml infuusioneste, liuos Germany: Gemcitabin SUN 10 mg/ml Infusionslösung Spain: Gemcitabina SUN 10 mg/ml solución para perfusión France: Gemcitabine SUN 10 mg/ml solution pour perfusion Italy: Gemcitabina SUN Pharma 10 mg/ml soluzione per infusion Netherlands: Gemcitabine SUN 1200/1400/1600/1700/1800/2000/2200 mg oplossing voor infusie Norway: Gemcitabin SUN 10 mg/ml infusjonsvæske, oppløsning Poland: Gemcitabine SUN Romania: Gemcitabina SUN 10 mg/ml soluţie perfuzabilă Slovakia: Gemcitabín SUN 10 mg/ml infúzny roztok Sweden: Gemcitabin SUN 10 mg/ml infusionsvätska, lösning United Kingdom (Northern Ireland): Gemcitabine 10 mg/ml solution for infusion Date of last revision of the leaflet:13.10.2022

Information intended for healthcare professionals only

Instructions for use, preparation, and disposal

Preparation of the medicine for use

• The dose should be calculated and the required infusion bag size determined.
• The packaging should be inspected for any damage. Do not use if there are any signs of opening.
• A label with the patient's details should be attached to the foil.

Removing the infusion bag from the foil and inspecting

• Open the foil using the tear line. Do not use if the foil has been previously opened or is damaged.
• Remove the infusion bag from the foil.
• Use only if the infusion bag and the seal are intact. Before administration, check for any minor leaks by firmly squeezing the bag. If a leak is detected, discard the bag, as the solution may not be sterile.
• Before parenteral administration, the solution should be inspected visually for particulate matter and changes in color. If the solution contains visible particles, do not administer the medicine.

Administration

• Break the seal of the Minitulipe cap by pressing one side with your hand.
• Using aseptic technique, attach a sterile administration set.
• See the instructions provided with the administration set.

Precautions

• Do not use in series connections.
• Do not add anything to the infusion bag.
• The solution for infusion is ready for use and should not be mixed with other medicines.
• After opening the infusion bag: From a microbiological point of view, the product should be used immediately. If the product is not used immediately, the responsibility for the storage time and storage conditions before use lies with the user.
• Gemcitabine SUN solution for infusion is for single use only.

Staff should be equipped with appropriate protective equipment, including long-sleeved gowns, protective masks, caps, protective glasses, sterile single-use gloves, protective covers for the work area, and waste bags. Pregnant women should not be employed to work with cytotoxic medicines. If the product comes into contact with the eyes, it may cause severe irritation. Rinse the eyes immediately with plenty of water. If irritation persists, consult a doctor. If the solution comes into contact with the skin, wash the affected area thoroughly with water. Handle excreta and vomit with caution. Disposal All unused product or waste material should be disposed of in accordance with local requirements for cytotoxic medicines.