Gemcitabine Sun

Package leaflet: Information for the user

Gemcitabine SUN

200 mg powder for solution for infusion
1 g powder for solution for infusion
Generic medicine
Read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Gemcitabine SUN is and what it is used for
2. What you need to know before being given Gemcitabine SUN
3. How Gemcitabine SUN is administered
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
block cell division, including that of 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 should know before being given Gemcitabina SUN

Gemcitabina SUN must not be administered:

• 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
Talk to your doctor before you are given Gemcitabina SUN.
Before each infusion, blood tests will be performed to assess whether you have sufficient

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding with
breast milk, ask your doctor for advice before taking this medicine. The use of Gemcitabine SUN during
pregnancy must be avoided. Your doctor will discuss with you the potential risks of taking Gemcitabine SUN
during pregnancy.
Breastfeeding must be discontinued during treatment with Gemcitabine SUN.
Men are advised not to father a child during treatment with Gemcitabine SUN and for 6 months after. If you
wish to father a child during treatment or within 6 months after, consult your doctor or pharmacist. You may
wish to be informed about sperm preservation methods before starting therapy.
Driving and using machines
Gemcitabine SUN may cause drowsiness, particularly if you have consumed alcohol. You must not drive a
vehicle or operate machinery until you are certain that treatment with Gemcitabine SUN has not caused
drowsiness in you.
Gemcitabine SUN contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. essentially ‘sodium-free’.

3. How Gemcitabine SUN is administered

The recommended dose of Gemcitabine SUN is generally 1,000–1,250 mg per square metre of 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 determine the correct dose for you. This dosage may be adjusted or the treatment may be delayed depending on blood test results and your general condition.

The frequency with which you receive Gemcitabine SUN infusion depends on the type of cancer for which you are being treated.

A hospital pharmacist or doctor will have reconstituted the Gemcitabine SUN powder before administering it to you.

You will always receive Gemcitabine SUN as an intravenous infusion. The infusion will last approximately 30 minutes.

If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You must 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 failure (low urine output or absence of urine), and signs of infection. These
may be characteristics of thrombotic microangiopathy (blood clots forming in small blood
vessels) and haemolytic uraemic syndrome, which can be fatal.
You must immediately contact your doctor if you notice any of the following serious side effects

Very common: may affect more than 1 in 10 people

• allergic reaction: if you develop a rash or fever
• tiredness, feeling faint, shortness of breath, or paleness (due to possibly having lower than normal haemoglobin levels, which is very common)
• bleeding from gums, nose or mouth, or any bleeding that does not stop, red or slightly pink urine, unexpected bruising (due to possibly having lower than normal platelet counts, which is very common)

Common: may affect up to 1 in 10 people

• body temperature of 38°C or higher, sweating, or other signs of infection (due to possibly having lower than normal white blood cells, also known as febrile neutropenia)
• mouth pain, redness, swelling, or sores (stomatitis)
• allergic reaction: if you develop itching
• breathing difficulties (shortly after Gemcitabina SUN infusion, mild breathing difficulty is common and resolves quickly)

Uncommon: may affect up to 1 in 100 people

• breathing difficulties (due to more severe lung problems)
• irregular heartbeat (arrhythmia)

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

• breathing difficulties (due to more severe lung problems)
• severe chest pain (myocardial infarction)

Very rare: may affect less than 1 in 10,000 people

• severe hypersensitivity/allergic reaction with severe skin rash including red streaks on the skin, swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty swallowing or breathing), laboured breathing, rapid heartbeat, and feeling faint (anaphylactic reaction)
• generalised 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 encephalopathy syndrome)
• severe skin rash with itching, accompanied by blistering or peeling of the skin (Stevens-Johnson syndrome, toxic epidermal necrolysis)

Side effects with Gemcitabina SUN may include:

Very common: may affect more than 1 in 10 people

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

Common: may affect up to 1 in 10 people

• loss of appetite (anorexia)
• headache
• insomnia
• drowsiness
• cough
• runny nose
• constipation
• diarrhoea
• itching
• sweating
• muscle pain
• back pain
• fever
• weakness
• chills
• infections

Uncommon: may affect up to 1 in 100 people

• scarring of air sacs in the lung (interstitial pneumonia)
• wheezing (spasm of the airways)
• scarring of the lungs (abnormal chest X-ray/scan)
• heart failure
• kidney failure
• severe liver damage, including liver failure
• stroke (cerebrovascular accident)

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

• low blood pressure
• skin peeling, ulceration, or blistering rash
• skin sloughing and severe blisters on the skin
• reaction at injection site
• severe lung inflammation causing respiratory failure (adult respiratory distress syndrome)
• skin rash resembling a severe sunburn, occurring in areas of skin previously exposed to radiotherapy (radiation recall phenomena)
• fluid in the lungs
• scarring of air sacs in the lung associated with radiotherapy (radiation toxicity)
• gangrene of fingers or toes
• inflammation of blood vessels (peripheral vasculitis)

Very rare: may affect less than 1 in 10,000 people

• increased platelet count
• inflammation of the colon lining due to reduced blood supply (ischaemic colitis)
• low haemoglobin levels (anaemia), low white blood cell count, and low platelet count detectable by blood test
• blood clots forming in small blood vessels (thrombotic microangiopathy)

Not known (frequency cannot be estimated from available data)

• sepsis: when bacteria and their toxins circulate in the blood and begin damaging organs
• skin redness with swelling (pseudocellulitis)

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your
doctor or pharmacist. You can also report side effects directly via the national reporting system
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
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 stated on the vial and carton. The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
After reconstitution:
Chemical and physical in-use stability has been demonstrated for 24 hours at 15-30 °C.
From a microbiological standpoint, the product should be used immediately. If not used immediately, the period of in-use storage and the conditions prior to use are the responsibility of the user and should normally not exceed 24 hours at 30 °C.
The reconstituted solution must not be refrigerated.
Do not use this medicine if you notice a cloudy solution or an insoluble precipitate.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Gemcitabine Sun 200 mg/Gemcitabine Sun 1 g powder for solution for infusion contains

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

200 mg
Each vial contains 200 mg of gemcitabine (as hydrochloride).
1 g
Each vial contains 1 g of gemcitabine (as hydrochloride).
Each ml of the reconstituted infusion solution contains 38 mg of gemcitabine (as hydrochloride).

Description of the appearance of Gemcitabine Sun 200 mg/1 g powder for solution for infusion and contents of the pack
Powder for solution for infusion.
White to off-white lyophilized powder.

200 mg
1 vial of 10 ml.
1 g
1 vial of 50 ml.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands

Italian Representative:
Ranbaxy Italia S.p.A. - Viale Giulio Richard, 1 - 20143 Milano

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

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Denmark: Gemind 200 mg og 1 g, pulver til infusionsvæske, opløsning
Germany: Gemcitabine SUN 200 mg und 1 g Pulver zur Herstellung einer Infusionslösung
Spain: Gemcitabina SUN 200 mg y 1000 mg polvo para solución inyectable EFG
The Netherlands: Gemcitabine SUN 200 mg en 1000 mg poeder voor oplossing voor infusie
Romania: Gemcitabină SUN 200 mg şi 1 g pulbere pentru soluţie perfuzabilă
United Kingdom: Gemcitabine 200 mg and 1 g Powder for Solution for Infusion

The following information is intended exclusively for physicians or healthcare professionals:
Instructions for use, handling, and disposal

• During reconstitution and any further dilution of gemcitabine for intravenous infusion administration, aseptic techniques must be used.
• Calculate the required dose and number of Gemcitabine SUN vials needed.
• Reconstitute the 200 mg vials with 5 ml of sterile sodium chloride solution 9 mg/ml (0.9%) for injection, without preservatives, or reconstitute the 1,000 mg vials with 25 ml of sterile sodium chloride solution 9 mg/ml (0.9%) for injection, without preservatives. Shake to aid dissolution. The total volume after reconstitution is 5.26 ml (200 mg vial) or 26.3 ml (1,000 mg vial), respectively. The resulting concentration is 38 mg/ml of gemcitabine, accounting for the volume displaced by the lyophilized powder. Further dilutions may be made using sterile sodium chloride solution 9 mg/ml (0.9%) for injection, without preservatives. The resulting solution ranges from clear and colourless to pale yellow.
• Prior to administration, parenteral medicinal products should be inspected visually for particulate matter and discoloration. Do not administer if particulate matter is observed.
• Reconstituted gemcitabine solutions must not be refrigerated, as crystallization may occur. The chemical and physical stability of the reconstituted solution has been demonstrated for 24 hours at 30°C. From a microbiological standpoint, the product should be used immediately. If not used immediately, the storage times and conditions prior to use are the responsibility of the user and normally should not exceed 24 hours at room temperature, unless reconstitution/dilution was performed under controlled and validated aseptic conditions.
• Gemcitabine solutions are for single use only. Unused product and waste materials arising from this medicinal product must be disposed of in accordance with local legal requirements.

Precautions for preparation and administration:
Standard safety precautions for cytotoxic agents must be observed when preparing and disposing of the infusion solution. The handling of the infusion solution should be performed in a safe environment, and protective clothing and gloves must be worn. If a safe environment is not available, protective face mask and goggles should be added to the equipment. If the solution comes into contact with the eyes, it may cause severe irritation. The eyes must be immediately and thoroughly rinsed with water. If irritation persists, medical advice must be sought. If the solution contacts the skin, wash thoroughly with water.

Disposal
Unused product must be disposed of in accordance with local legal requirements.