Gemcitabine Sun Pharma

Package leaflet: Information for the user

Gemcitabine SUN Pharma

10 mg/ml solution for infusion
Generic medicine
Please read this leaflet carefully before you start 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, pharmacist or nurse.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. See section 4.

What is in this leaflet:

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

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

Gemcitabine SUN Pharma belongs to a group of medicines called "cytotoxic agents". These medicines
inhibit cell division, including that of cancer cells.
Gemcitabine SUN Pharma may be administered alone or in combination with other anticancer
medicines, depending on the type of cancer.
Gemcitabine SUN Pharma is used in the treatment of 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 you are given Gemcitabine SUN Pharma

Gemcitabine SUN Pharma 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

Before each infusion, blood tests will be performed to assess whether you have adequate liver and kidney function.
Before each infusion, blood tests will be carried out to check that you have enough blood cells to receive Gemcitabine SUN Pharma. Your doctor may decide to adjust the dose or delay treatment depending on your general condition and if blood cell counts (white blood cells and platelets) are inadequate (too low). Periodically, blood tests will be performed to evaluate whether you have sufficient

Pregnancy, breastfeeding and fertility
Pregnancy
If you are pregnant, think you may be pregnant or are planning to become pregnant, or if you are breastfeeding,
ask your doctor for advice before taking this medicine. The use of Gemcitabine SUN Pharma during
pregnancy should be avoided. Your doctor will discuss with you the potential risks of taking Gemcitabine SUN
Pharma during pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding. Breastfeeding must be discontinued during treatment with
Gemcitabine SUN Pharma.
Fertility
Men are advised not to father a child during treatment with Gemcitabine SUN Pharma and for 6 months after
treatment. If you wish to father a child during treatment or within 6 months afterwards, consult your doctor or
pharmacist. You are advised to seek information on sperm preservation methods before starting therapy.
Driving and use of machines
Gemcitabine SUN Pharma may cause drowsiness, particularly if alcohol has been consumed. You must not
drive a vehicle or operate machinery until you are certain that treatment with Gemcitabine SUN Pharma has not
caused drowsiness.
Gemcitabina SUN Pharma contains sodium
One ml of infusion solution contains 4.575 mg of sodium.
This should be taken into consideration by patients on a low-sodium diet.
Gemcitabine SUN Pharma contains 549.00 mg (23.88 mmol) of sodium in each 120 ml infusion bag,
640.50 mg (27.86 mmol) of sodium in each 140 ml infusion bag, 732.00 mg (31.84 mmol) of sodium in each
160 ml infusion bag, 777.75 mg (33.83 mmol) of sodium in each 170 ml infusion bag, 823.50 mg (35.82 mmol)
of sodium in each 180 ml infusion bag, 915.00 mg (39.80 mmol) of sodium in each 200 ml infusion bag, and
1006.50 mg (43.78 mmol) of sodium in each 220 ml infusion bag.

3. How Gemcitabine SUN Pharma is administered

The recommended dose of Gemcitabine SUN Pharma 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 dose 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 Pharma infusion depends on the type of cancer
being treated.
You will always receive Gemcitabine SUN Pharma as an intravenous infusion. The infusion will last approximately 30 minutes.
If you have any 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.
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 no 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.

Serious side effects
You must 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 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)
• Bleeding from gums, nose or mouth, or any bleeding that does not stop easily, red or slightly pink urine, unexpected bruising (due to possibly having lower than normal platelet count).

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 cell count with fever, also known as febrile neutropenia)
• Pain, redness, swelling or sores in the mouth (stomatitis)
• Allergic reaction: if you develop itching
• Mild breathing difficulty (mild shortness of breath shortly after gemcitabine infusion is common and usually resolves quickly).

Uncommon: may affect up to 1 in 100 people

• Breathing difficulties due to more serious lung problems (interstitial pneumonia, bronchospasm)
• Irregular heartbeat (arrhythmia).

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

• Breathing difficulties due to more serious lung problems (pulmonary oedema, adult respiratory distress syndrome)
• Severe chest pain (myocardial infarction).

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

• Severe hypersensitivity/severe 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), shortness of breath, rapid heartbeat, and feeling faint (anaphylactic reaction)
• Generalised swelling, breathlessness or weight gain, due to possible 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, blistering or skin peeling (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Other side effects
Inform 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
• Breathing difficulties
• Vomiting
• Nausea
• Hair loss
• Liver problems: detected by abnormal blood test results
• Blood in urine
• Abnormal urine test: protein in urine
• Flu-like symptoms including fever
• Swelling of 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 lungs (interstitial pneumonia)
• Wheezing (spasm of the airways)
• Lung scarring (abnormal chest X-ray or 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 skin blisters
• Reactions at the injection site
• 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)
• 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 to damage organs
• Skin redness with swelling (pseudocellulitis).

Low levels of haemoglobin (anaemia), low white blood cell count, and low platelet count will be detected by a blood test.

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via the national reporting system at:
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 Gemcitabina SUN Pharma

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.
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 duration and conditions prior to use are the responsibility of the user.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Gemcitabine SUN Pharma 10 mg/ml solution for infusion contains

• 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 140 ml infusion bag contains 1400 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.

Description of the appearance of Gemcitabine SUN Pharma solution for infusion and contents of the
package
Gemcitabine SUN Pharma solution for infusion is a clear, colourless, sterile solution free from
visible particles.
Gemcitabine SUN Pharma solution for infusion is packaged in cardboard boxes, each containing 1, 5 or 10 single-use infusion bags of 120 ml, 140 ml, 160 ml, 170 ml, 180 ml, 200 ml or 220 ml, respectively.
Not all 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 in Italy:
Ranbaxy Italia S.p.A. – Viale Giulio Richard, 1 – 20143 Milano

This medicinal product is authorised in the European Economic Area (EEA) Member States 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
Denmark: Gemcitabin SUN 10 mg/ml infusionsvæske, opløsning
Finland: Gemcitabin SUN 10 mg/ml infuusioneste, liuos
France: Gemcitabine SUN 10 mg/ml solution pour perfusion
Germany: Gemcitabin SUN 10 mg/ml Infusionslösung
Italy: Gemcitabina SUN Pharma
Norway: Gemcitabin SUN 10 mg/ml infusjonsvæske, oppløsning
The Netherlands: Gemcitabine SUN 1200/1400/1600/1700/1800/2000/2200 mg oplossing voor infusie
Poland: Gemcitabine SUN
Czech Republic: Gemcitabin SUN 10 mg/ml infuzní roztok
Romania: Gemcitabina SUN 10 mg/ml soluţie perfuzabilă
United Kingdom: Gemcitabine 10 mg/ml solution for infusion
Slovakia: Gemcitabín SUN 10 mg/ml infúzny roztok
Spain: Gemcitabina SUN 10 mg/ml solución para perfusión
Sweden: Gemcitabin SUN 10 mg/ml infusionsvätska, lösning

The following information is intended for healthcare professionals only

Instructions for use, handling, and disposal
Handling

• Calculate the dose and determine the appropriate bag size for Gemcitabina SUN Pharma infusion bags. If the required dose cannot be achieved with the available pack sizes, it is recommended to use an alternative gemcitabine product, such as gemcitabine concentrate or gemcitabine as powder for infusion solution.
• Check the product packaging for any damage. Do not use if there are signs of tampering.
• Apply a patient-specific label to the outer pouch.

Removal from the pouch and inspection of the infusion bag

• Tear the pouch at the notch. Do not use if the pouch has been previously opened or damaged.
• Remove the infusion bag from the pouch.
• Use only if the infusion bags and seal are intact.
• Prior to administration, check for small leaks by firmly squeezing the bag. If leaks are detected, discard the bag and solution, as sterility may be compromised.
• Parenteral medicinal products should be visually inspected for particulate matter and discoloration prior to administration. Do not use if particles are observed.

Administration

• Break the seal of the Minitulipe cap by applying pressure to one side with the hand.
• Using aseptic technique, connect the sterile administration set.
• 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 duration and conditions of storage prior to use are the responsibility of the user.
• Gemcitabina infusion solution is for single use only.

Personnel must wear appropriate protective equipment when handling the product, including long-sleeved gowns, protective masks, head covers, protective eyewear, disposable sterile gloves, protective coverings for the work area, and appropriate containers and waste bags for disposal.
Pregnant women should be advised to avoid handling cytotoxic agents.
If the preparation comes into contact with the eyes, it may cause severe irritation. Eyes should 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. Body secretions and vomit should be handled with caution.

Disposal
Unused medicine and waste material derived from this medicine must be disposed of in accordance with local regulations governing the disposal of cytotoxic medicinal products.