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GEMCITABINE SUN 200 MG POWDER FOR SOLUTION FOR INFUSION

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Taking other medicines
Please tell your doctor or hospital pharmacist if you are taking or have recently taken any
other medicines, including vaccinations and medicines obtained without a prescription.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Gemcitabine SUN 200 mg
Powder for Solution for Infusion
Gemcitabine SUN 1000 mg
Powder for Solution for Infusion
Gemcitabine
Read all of this leaflet carefully before you start receiving this medicine.
- Keep this leaflet. You may need to read it again.
- If you have further questions, please ask your doctor, nurse or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
- If any of the side effects get serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor, nurse or pharmacist.

Pregnancy and breast-feeding
If you are pregnant, or thinking about becoming pregnant, tell your doctor. The use of
Gemcitabine SUN should be avoided during pregnancy. Your doctor will discuss with you
the potential risk of taking Gemcitabine SUN during pregnancy.
If you are breast-feeding, tell your doctor.
You must discontinue breast-feeding during Gemcitabine SUN treatment.
Driving and using machines
Gemcitabine SUN 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 SUN treatment has
not made you feel sleepy.
Important information about some of the ingredients of Gemcitabine SUN
Gemcitabine SUN 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 SUN IS GIVEN
The usual dose of Gemcitabine SUN 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.

In this leaflet:
1. What Gemcitabine SUN is and what it is used for
2. Before you are given Gemcitabine SUN
3. How Gemcitabine SUN is given
4. Possible side effects
5. How to store Gemcitabine SUN
6. Further information

How frequently you receive your Gemcitabine SUN infusion depends on the type of cancer
that you are being treated for.
A hospital pharmacist or doctor will have dissolved the Gemcitabine SUN powder before it is
given to you.

1. WHAT GEMCITABINE SUN IS AND WHAT IT IS USED FOR
Gemcitabine SUN belongs to a group of medicines called "cytotoxics". These medicines kill
dividing cells, including cancer cells.
Gemcitabine SUN may be given alone or in combination with other anti-cancer 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), alone or together with cisplatin
- pancreatic cancer
- breast cancer, together with paclitaxel
- ovarian cancer, together with carboplatin
- bladder cancer, together with cisplatin.

2. BEFORE YOU ARE GIVEN GEMCITABINE SUN
You should not be given Gemcitabine SUN:
- if you are allergic (hypersensitive) to gemcitabine or any of the other ingredients of
Gemcitabine SUN
- if you are breast-feeding.
Take special care with Gemcitabine SUN:
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 SUN. 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).

You will always receive Gemcitabine SUN by infusion into one of your veins. The infusion will
last approximately 30 minutes.
If you have further questions on the use of this product ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Gemcitabine SUN can cause side effects, although not everybody gets
them.
Frequencies of the observed side effects are defined as:
- very common: affects more than 1 user in 10
- common: affects 1 to 10 users in 100
- uncommon: affects 1 to 10 users in 1,000
- rare: affects 1 to 10 users in 10,000
- very rare: affects less than 1 user in 10,000
- not known: frequency can't 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 a 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 SUN infusion which soon passes, however uncommonly or rarely there can
be more severe lung problems).

Folding
205 mm----2----51.25
330 mm----3----41.25

1. Use aseptic techniques during the
reconstitution and any further dilution of
gemcitabine for intravenous infusion
administration.
2. Calculate the dose and the number of
Gemcitabine SUN vials needed.
3. 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 strawcoloured.
4. Parenteral medicinal products should be
inspected visually for particulate matter and
discolouration prior to administration. If
particulate matter is observed, do not
administer.
5. 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

Instructions for use, handling and disposal

The following information is intended for
medical or healthcare professionals only:

Gemcitabine

Gemcitabine SUN 200 mg
Powder for Solution for
Infusion
Gemcitabine SUN 1000 mg
Powder for Solution for
Infusion

Men are advised not to father a child during and up to 6 months following treatment with
Gemcitabine SUN. 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.

Size: 330x205 mm
EUUK

Side effects with Gemcitabine SUN may include:
Very common side effects
Low haemoglobin level (anaemia)
Low white blood cells
Low platelet count
Difficulty breathing
Vomiting
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)

5. HOW TO STORE GEMCITABINE SUN
Keep out of the reach and sight of children.
Gemcitabine SUN should not be used 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.

Common side effects
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

The reconstituted solution should not be refrigerated.
Do not use if you notice a cloudy solution or an insoluble precipitate.
Medicine should not be disposed of via wastewater or household waste

6. FURTHER INFORMATION
What Gemcitabine SUN 200 mg / Gemcitabine SUN 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.

Uncommon side effects
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

[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).

Very rare side effects
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)
Stevens-Johnson syndrome
You might have any of these symptoms and/or conditions. You must tell your doctor as soon
as possible when you start experiencing any of these side effects.
If you are concerned about any side effects, talk to your doctor.
If any of the side effects gets serious, or if you notice any side effects not mentioned in this
leaflet, please tell your doctor.

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 B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands.
Further Information
For any information about this product, please contact the local representative of the
Marketing Authorisation Holder:
Sun Pharmaceuticals UK Limited
4100 Park Approach
Thorpe Park
Leeds
LS15 8GB
United Kingdom
This leaflet was last approved in 05/2011

responsibility of the user and would normally
not be longer than 24 hours at room
temperature, unless reconstitution/dilution
has taken place in controlled and validated
aseptic conditions.
6. 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

Folding
205 mm----2----51.25
330 mm----3----41.25

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

044BP1545D

What Gemcitabine SUN 200 mg /Gemcitabine SUN 1000 mg Powder for Solution for
Infusion looks like and contents of the pack

044BP1545D

Rare side effects
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

Size: 330x205 mm
EUUK

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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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