Gemcitabine sun

Package leaflet: Information for the patient

Gemcitabine SUN, 10 mg/ml, infusion solution
Gemcitabinum
Please read all of this leaflet carefully before 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, please ask your doctor, pharmacist, or nurse.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, you must inform your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

1. What Gemcitabine SUN is and what it is 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 pack and other information

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

Gemcitabine SUN belongs to a group of medicines called "cytotoxic" agents. These medicines destroy dividing cells, including cancer cells.
Gemcitabine SUN may be used alone or in combination with other anticancer medicines, depending on the type of cancer.
Gemcitabine SUN is used in the treatment of the following types of cancer:

• non-small cell lung cancer (NSCLC), either as monotherapy 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

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

Warnings and precautions
Before the first infusion, medical staff will take blood samples from the patient to assess whether kidney and liver function are sufficient. Before each infusion, medical staff will take blood samples from the patient to assess whether there are enough blood cells for Gemcitabine SUN to be administered. Depending on the patient's general condition and in case of a significant decrease in blood cell count, the doctor may adjust the dose or delay administration of the medicine.
Blood samples will be taken periodically to monitor kidney and liver function.
Before receiving Gemcitabine SUN, discuss with the doctor if:

• the patient has or has had liver, heart or vascular disease, or kidney problems, as it may not be possible to administer Gemcitabine SUN;
• the patient has recently undergone or is scheduled to undergo radiotherapy, as early or late radiation reactions may occur;
• the patient has 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 the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Pregnancy, breastfeeding and fertility

Pregnancy
If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor before using this medicine. Use of Gemcitabine SUN during pregnancy should be avoided. The doctor will inform the patient about the potential risks associated with using Gemcitabine SUN during pregnancy.

Breastfeeding
The patient should inform the doctor if she is breastfeeding. Breastfeeding must be discontinued during treatment with Gemcitabine SUN.

Fertility
Men are advised not to plan fathering a child while being treated with Gemcitabine SUN and for 6 months after completion of treatment. Men who wish to have children during treatment or within 6 months after treatment ends should consult their doctor. Before starting treatment, patients may seek advice from a facility specializing in sperm storage.

Driving and using machines
Gemcitabine SUN may cause drowsiness, especially if alcohol is consumed. Patients should not drive or operate machinery until they know whether Gemcitabine SUN causes drowsiness.

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

3. How to take Gemcitabine SUN

The recommended dose of Gemcitabine SUN is 1000–1250 mg per square metre of the patient's body surface area. Body surface area is calculated based on the patient's height and weight. The dose is determined according to the calculated body surface area. The dose may be adjusted or treatment delayed depending on blood test results and the patient's overall condition.
The frequency of Gemcitabine SUN infusion depends on the type of tumour for which the patient is being treated.
Gemcitabine SUN is always administered as an intravenous infusion (drip). The infusion lasts approximately 30 minutes.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the symptoms listed below occur, you must immediately consult a doctor:
extreme tiredness and weakness, petechiae or minor bleeding under the skin (bruising), acute
kidney failure (very low urine output or no urine production), and signs of infection.
These may be symptoms indicating thrombotic microangiopathy (formation of blood clots in small
blood vessels) and hemolytic-uremic syndrome, which can lead to death.

Serious side effects
Tell your doctor immediately if you experience any of the following serious side effects:

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

• allergic reactions: if mild to moderate skin rash or fever occurs
• feeling of fatigue, fainting, rapidly worsening shortness of breath or paleness of the skin (the patient may have hemoglobin levels below normal)
• bleeding from gums, nose or mouth, or other bleeding that cannot be stopped, red or pink-tinged urine, unexpected bruising (the patient may have platelet count lower than normal).

Common (may affect up to 1 in 10 people)

• body temperature of 38°C or higher, excessive sweating, or other signs of infection (the patient may have lower than normal white blood cell count, accompanied by fever, also known as neutropenic fever)
• pain, redness, swelling or ulceration in the mouth (inflammation of the mouth)
• allergic reactions: if itching occurs
• mild breathing difficulties (mild breathing difficulties are common shortly after infusion of Gemcitabine SUN, but quickly resolve).

Uncommon (may affect up to 1 in 100 people)

• breathing difficulties due to severe lung condition (interstitial pneumonitis, 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 involving redness and itching of the skin, swelling of hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), wheezing, rapid heartbeat and the patient may feel faint (anaphylactic reaction)
• generalized swelling, shortness of breath or weight gain, due to leakage of fluid from small blood vessels into tissues (capillary leak syndrome)
• headache with visual disturbances, confusion, seizures or convulsions (reversible posterior leukoencephalopathy syndrome)
• severe rash with itching, blistering or peeling of the skin (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Other side effects
Inform your doctor as soon as possible if any of the following side effects occur:

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

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

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• pulmonary cystic scarring (interstitial pneumonitis)
• wheezing (bronchospasm)
• pulmonary fibrosis (abnormal chest X-ray/scan findings)
• 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, ulceration or blistering
• skin detachment and formation of large blisters
• reactions at the injection site
• skin rash resembling severe sunburn, which may occur on skin previously treated with radiotherapy (radiation recall)
• fluid in the lungs
• pulmonary cystic scarring related to radiotherapy (radiation 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 mucosa of the large intestine caused by reduced blood supply (ischemic colitis)
• thrombotic microangiopathy: formation of blood clots in small blood vessels

Not known (frequency cannot be estimated from available data)

• sepsis: a condition in which bacteria and their toxins circulate in the blood and begin to damage organs
• a condition in which eosinophils (a type of cell normally found in the blood) accumulate in the lungs (pulmonary eosinophilia)
• redness and swelling of the skin (pseudoscleroderma).

Low hemoglobin levels (anemia), low white blood cell count, and low platelet count will be detected through blood tests.

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Gemcitabine SUN

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the infusion bag and on the outer
packaging following “Expiry date (EXP)”. The expiry date refers to the last day of the specified month.
No special storage instructions apply. Do not store in a refrigerator or freeze.
After opening the infusion bag:
From a microbiological standpoint, the medicine should be used immediately.
If the product is not administered immediately, it is the user’s responsibility to ensure the
storage duration and conditions prior to use.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to
properly dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Gemcitabine SUN infusion solution contains

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

One infusion bag with a volume of 120 ml contains 1200 mg of gemcitabine (as hydrochloride).
One infusion bag with a volume of 130 ml contains 1300 mg of gemcitabine (as hydrochloride).
One infusion bag with a volume of 140 ml contains 1400 mg of gemcitabine (as hydrochloride).
One infusion bag with a volume of 150 ml contains 1500 mg of gemcitabine (as hydrochloride).
One infusion bag with a volume of 160 ml contains 1600 mg of gemcitabine (as hydrochloride).
One infusion bag with a volume of 170 ml contains 1700 mg of gemcitabine (as hydrochloride).
One infusion bag with a volume of 180 ml contains 1800 mg of gemcitabine (as hydrochloride).
One infusion bag with a volume of 200 ml contains 2000 mg of gemcitabine (as hydrochloride).
One infusion bag with a volume of 220 ml 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.

What Gemcitabine SUN infusion solution looks like and contents of the pack
Gemcitabine SUN is a clear, colourless, sterile infusion solution free from visible solid particles.

Single doses of Gemcitabine SUN are packed in cardboard boxes containing 1, 5 or 10 infusion bags with a volume 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 Authorisation Holder and Manufacturer/Importer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands

This medicinal product is authorised in the European Economic Area countries 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

Information intended exclusively for healthcare professionals

Instructions for use, preparation and disposal
Preparation of the medicinal product for administration

• Calculate the required dose and determine the appropriate bag size for the Gemcitabine SUN medicinal product.
• Check the packaging for any signs of damage. Do not use if any evidence of tampering is observed.
• Apply a patient-specific label to the foil.

Removing the infusion bag from the foil and inspection

• Tear open the foil using the notch. 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 seal are intact. Before administration, check for small leaks by firmly squeezing the bag. If leakage is detected, discard the bag, as the solution may not be sterile.
• Prior to parenteral administration, visually inspect the solution for the presence of particulate matter or discoloration. Do not administer if visible particulates are present in the solution.

Administration

• Break the seal of the Minitulipe-type stopper by pressing one side with the hand.
• Using aseptic technique, attach a sterile administration set.
• Refer to the instructions provided with the administration set.

Precautions

• Do not use in series connections.
• Do not add any substances to 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 product should be used immediately. If not used immediately, the user is responsible for the storage duration and conditions prior to use.
• Gemcitabine solution for infusion is for single use only.

Personnel must be equipped with appropriate protective materials, including long-sleeved gowns, protective masks, caps, protective eyewear, sterile disposable gloves, protective covers for work surfaces, and waste bags.
Pregnant women must not be employed in handling cytotoxic drugs.
If the product comes into contact with the eyes, it may cause severe irritation. Immediately rinse eyes thoroughly with water. If irritation persists, consult a physician. If the solution contacts the skin, wash the affected area thoroughly with water. Handle excreta and vomit with caution.

Disposal
Any unused medicinal product or waste material must be disposed of in accordance with applicable regulations governing cytotoxic drugs.