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Package Leaflet: Information for the patient

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

Gemcitabine

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

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.

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

-    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

Gemcitabine 200 mg-1g-205x330mm-EUUK-REV4-16-11-13

16/11/2013 9:39:58 AM