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GEMCITABINE 1000 MG POWDER FOR SOLUTION FOR INFUSION

Active substance(s): GEMCITABINE HYDROCHLORIDE / GEMCITABINE HYDROCHLORIDE / GEMCITABINE HYDROCHLORIDE

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Other medicines and Gemcitabine
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.

Package Leaflet: Information for the patient

Gemcitabine 200 mg,
powder for solution for infusion
Gemcitabine 1000 mg,
powder for solution for infusion
Gemcitabine
Read all of 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 further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may
harm them, even if their signs of illness are the same as yours.
- If you get any side effects talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4.

What is in this leaflet
1. What Gemcitabine is and what it is used for
2. What you need to know before you are given Gemcitabine
3. How Gemcitabine is given
4. Possible side effects
5. How to store Gemcitabine
6. Contents of the pack and other information
1. What Gemcitabine is and what it is used for
Gemcitabine belongs to a group of medicines called "cytotoxics". These medicines kill
dividing cells, including cancer cells.
Gemcitabine may be given alone or in combination with other anti-cancer medicines,
depending on the type of cancer.
Gemcitabine is used in the treatment of the following types of cancer:
- non-small cell lung cancer (NSCLC), alone or together with cisplatin
- pancreatic cancer
- breast cancer, together with paclitaxel
- ovarian cancer, together with carboplatin
- bladder cancer, together with cisplatin.
2. What you need to know before you are given Gemcitabine
You should not be given Gemcitabine:
- if you are allergic to gemcitabine or any of the other ingredients of this medicine
(listed in section 6)
- if you are breast-feeding

You must discontinue breast-feeding during Gemcitabine treatment.
Driving and using machines
Gemcitabine may make you feel sleepy, particularly if you have consumed any alcohol.
Do not drive a car or use machinery until you are sure that Gemcitabine treatment has
not made you feel sleepy.
Gemcitabine contains sodium
Gemcitabine contains 3.5 mg (< 1 mmol) of sodium in each 200 mg vial and 17.5 mg
(< 1 mmol) sodium in each 1000 mg vial. To be taken into consideration by patients on
a controlled sodium diet.

3. How Gemcitabine is given
The recommended dose of Gemcitabine is 1000-1250 mg for every square metre of
your body's surface area. Your height and weight are measured to work out the surface
area of your body. Your doctor will use this body surface area to work out the right dose
for you. This dosage may be adjusted, or treatment may be delayed depending on your
blood cell counts and on your general condition.
How frequently you receive your Gemcitabine infusion depends on the type of cancer
that you are being treated for.
A hospital pharmacist or doctor will have dissolved the Gemcitabine powder before it is
given to you.
You will always receive Gemcitabine by infusion into one of your veins. The infusion will
last approximately 30 minutes.
If you have any further questions on the use of this medicine ask your doctor or
pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets
them.
Frequencies of the observed side effects are defined as:
- Very common: may affect more than 1 in 10 users
- Common: may affect up to 1 in 10 users
- Uncommon: may affect up to 1 in 100 users
- Rare: may affect up to 1 in 1,000 users
- Very rare: may affect up to 1 in 10,000 users
- Not known: frequency cannot be estimated from the available data
You must contact your doctor immediately if you notice any of the following:
- Fever or infection (common): if you have a temperature of 38°C or greater, sweating
or other signs of infection (since you might have less white blood cells than normal
which is very common).
- Irregular heart rate (arrhythmia) (frequency not known)
- Pain, redness, swelling or sores in your mouth (common)
- Allergic reactions: if you develop skin rash (very common) / itching (common), or
fever (very common).
- Tiredness, feeling faint, becoming easily breathless or if you look pale (since you
might have less haemoglobin than normal which is very common).
- Bleeding from the gums, nose or mouth or any bleeding that would not stop, reddish
or pinkish urine, unexpected bruising (since you might have less platelets than normal
which is very common).
- Difficulty breathing (it is very common to have mild breathing difficulty soon after the
Gemcitabine infusion which soon passes, however uncommonly or rarely there can
be more severe lung problems)
Side effects with Gemcitabine may include:
Very common: may affect more than 1 in 10 users
- Low haemoglobin level (anaemia)
- Low white blood cells
- Low platelet count
- Difficulty breathing
- Vomiting

The following information is intended for
healthcare professionals only
Instructions for use, handling and disposal.
- Use aseptic techniques during the
reconstitution and any further dilution of
gemcitabine for intravenous infusion
administration.
- Calculate the dose and the number of
Gemcitabine vials needed.
- Reconstitute 200 mg vials with 5 ml of
9 mg/ml (0.9 %) sterile sodium chloride
solution for injection, without preservative,
or 25 ml sterile sodium chloride solution for
injection, without preservative to the
1000 mg vial. Shake to dissolve. The total
volume after reconstitution is 5.26 ml
(200 mg vial) or 26.3 ml (1000 mg vial)
respectively. This dilution yields a
gemcitabine concentration of 38 mg/ml,
which includes accounting for the
displacement volume of the lyophilised
powder. Further dilution with sterile sodium
chloride 9 mg/ml (0.9%) solution for
injection, without preservative may be
done. The resulting solution is clear and
ranges in colour from colourless to light
straw-coloured.
- Parenteral medicinal products should be
inspected visually for particulate matter and
discolouration prior to administration. If
particulate matter is observed, do not
administer.
- Solutions of reconstituted gemcitabine
should not be refrigerated, as crystallisation
may occur. Chemical and physical in-use
stability has been demonstrated for
24 hours at 30°C. From a microbiological
point of view, the product should be used
immediately. If not used immediately, in-use
storage times and conditions prior to use
are the responsibility of the user and would
normally not be longer than 24 hours at
room temperature, unless
reconstitution/dilution has taken place in

Gemcitabine

Gemcitabine 200 mg,
powder for solution for
infusion
Gemcitabine 1000 mg,
powder for solution for
infusion

Warnings and precautions
Talk to your doctor before you are given Gemcitabine.
Before the first infusion you will have samples of your blood taken to evaluate if you
have sufficient kidney and liver function. Before each infusion you will have samples of
your blood taken to evaluate if you have enough blood cells to receive Gemcitabine. Your
doctor may decide to change the dose or delay treating you depending on your general
condition and if your blood cell counts are too low. Periodically you will have samples of
your blood taken to evaluate your kidney and liver function.
Please tell your doctor if:
- you have, or have previously had liver disease, heart disease or vascular disease
- you have recently had, or are going to have radiotherapy
- you have been vaccinated recently
- you develop breathing difficulties or feel very weak and are very pale (may be a sign
of kidney failure).
Men are advised not to father a child during and up to 6 months following treatment with
Gemcitabine. If you would like to father a child during the treatment or in the 6 months
following treatment, seek advice from your doctor or pharmacist. You may want to seek
counselling on sperm storage before starting your therapy.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have
a baby, ask your doctor or pharmacist for advice before taking this medicine. The use of
Gemcitabine should be avoided during pregnancy. Your doctor will discuss with you the
potential risk of taking Gemcitabine during pregnancy.

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Nausea
Skin rash- allergic skin rash, frequently itchy
Hair loss
Liver problems: found through abnormal blood test results
Blood in urine
Abnormal urine tests: protein in urine
Flu like symptoms including fever
Oedema (swelling of ankles, fingers, feet, face)

Common: may affect up to 1 in 10 users
- Fever accompanied by low white blood cell count (febrile neutropaenia)
- Anorexia (poor appetite)
- Headache
- Insomnia
- Sleepiness
- Cough
- Runny nose
- Constipation
- Diarrhoea
- Pain, redness, swelling or sores in the mouth
- Itching
- Sweating
- Muscle pain
- Back pain
- Fever
- Weakness
- Chills
Uncommon: may affect up to 1 in 100 users
- Interstitial pneumonitis (scarring of the air sacs of the lung)
- Spasm of the airways (wheeze)
- Abnormal chest X ray/scan (scarring of the lungs)
- Stroke
- Irregular heart beat (arrhythmia)
- Heart failure
- Serious liver damage, including liver failure and death
- Kidney failure
- Haemolytic uraemic syndrome
Rare: may affect up to 1 in 1,000 users
- Heart attack (myocardial infarction)
- Low blood pressure
- Skin scaling, ulceration or blister formation
- Injection site reactions
- Gangrene of fingers or toes
- Fluid in the lungs
- Adult Respiratory Distress Syndrome (severe lung inflammation causing respiratory
failure)
- Sloughing of skin and severe skin blistering
- Radiation recall-(a skin rash like severe sunburn) which can occur on skin that has
previously been exposed to radiotherapy.
- Radiation toxicity- scarring of the air sacs of the lung associated with radiation
therapy
Very rare: may affect up to 1 in 10,000users
- Increased platelet count
- Anaphylactic reaction (severe hypersensitivity/ allergic reaction)
- Ischaemic colitis (inflammation of the lining of the large bowel, caused by reduced
blood supply)
- Lyell's syndrome (toxic epidermal necrolysis)
- Steven-Johnson Syndrome
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. You can also report side effects directly via
the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store Gemcitabine
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 vial and carton. The
expiry date refers to the last day of that month.
This medicinal product 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 point of view, the product should be used immediately. If not
used immediately, in-use storage times and conditions prior to use are the responsibility
of the user and would normally not be longer than 24 hours at 30°C.
The reconstituted solution should not be refrigerated.
Do not use this medicine if you notice a cloudy solution or an insoluble precipitate.
Do not throw away any medicines via waste water or house hold waste. Ask your
pharmacist how to throw away medicines you no longer use. These measures will help
protect the environment.

6. Contents of the pack and other information
What Gemcitabine 200 mg / Gemcitabine 1000 mg Powder for Solution for Infusion
contains
- The active substance is: gemcitabine (as hydrochloride)
- The other ingredients are: mannitol, sodium acetate trihydrate, sodium hydroxide,
hydrochloric acid.
[For 200 mg strength]
One vial contains 200 mg gemcitabine (as hydrochloride).
[For 1000 mg strength]
One vial contains 1 g gemcitabine (as hydrochloride).
One ml of the reconstituted solution for infusion contains 38 mg gemcitabine (as
hydrochloride).
What Gemcitabine 200 mg /Gemcitabine 1000 mg Powder for Solution for Infusion
looks like and contents of the pack
Powder for solution for infusion
White to off-white lyophilized cake.
For 200 mg strength
1 vial of 10 ml.
For 1 g strength
1 vial of 50 ml.

Marketing Authorisation Holder and Manufacturer
Sun Pharmaceutical Industries Europe BV
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
This leaflet was last revised in: June 2013

controlled and validated aseptic conditions.
- Gemcitabine solutions are for single use
only. Any unused product or waste material
should be disposed of in accordance with
local requirements.

Preparation and administration precautions
The normal safety precautions for cytostatic
agents must be observed when preparing and
disposing of the infusion solution. Handling of
the solution for infusion should be done in a
safety box and protective coats and gloves
should be used. If no safety box is available,
the equipment should be supplemented with a
mask and protective glasses.
If the preparation comes into contact with the
eyes, this may cause serious irritation. The
eyes should be rinsed immediately and
thoroughly with water. If there is lasting
irritation, a doctor should be consulted. If the
solution is spilled on the skin, rinse thoroughly
with water.

Disposal
Any unused product should be disposed of in
accordance with local requirements.

044BP1545E

044BP1545E

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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