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Document: leaflet MAH GENERIC_PL 20075-0026 change

• leaflet MAH GENERIC_PL 04515-0212
• leaflet MAH GENERIC_PL 20075-0026

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					Artwork No.	-		Colours Used
					Customer	Accord	■	Black
					Description	Gemcitabine 200 mg / 1 g / 2 g
					Market	UK / IE
					Language	English
		\			Size	300 x 300 mm PIL
advertising & communication services ltd.					Min. Font Size	8
					Version No.	5 (Page 1 of 2) (IA028)
					Date	28_09_15 (Gemcitabine (UK-IE)IA028-PIL)

PACKAGE LEAFLET: INFORMATION FOR THE USER

Gemcitabine 200 mg Powder for Solution for Infusion Gemcitabine 1 g Powder for Solution for Infusion Gemcitabine 2 g 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.

In this leaflet:

1.    What Gemcitabine powder for solution for infusion is and what it is used for

2.    Before you are given Gemcitabine powder for solution for infusion

3.    How Gemcitabine powder for solution for infusion is given

4.    Possible side effects

5.    How to store Gemcitabine powder for solution for infusion

6.    Further information

Gemcitabine powder for solution for infusion belongs to a group of medicines called “cytotoxics”. These medicines kill dividing cells, including cancer cells.

Gemcitabine powder for solution for infusion may be given alone or in combination with other anti-cancer medicines, depending on the type of cancer.

Gemcitabine powder for solution for infusion 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.

You should not be given Gemcitabine powder for solution for infusion:

•    if you are allergic (hypersensitive) to gemcitabine or any of the other ingredients of Gemcitabine powder for solution for infusion.

•    if you are breast-feeding

Take special care with Gemcitabine powder for solution for infusion:

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 powder for solution for infusion. 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 powder for solution for infusion. 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 counseling on sperm storage before starting your therapy.

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.

Pregnancy and breast-feeding

If you are pregnant, or thinking about becoming pregnant, tell your doctor. The use of Gemcitabine powder for solution for infusion should be avoided during pregnancy. Your doctor will discuss with you the potential risk of taking Gemcitabine powder for solution for infusion during pregnancy.

If you are breast-feeding, tell your doctor.

You must discontinue breast-feeding during Gemcitabine powder for solution for infusion treatment.

Driving and using machines

Gemcitabine powder for solution for infusion 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 powder for solution for infusion treatment has not made you feel sleepy.

Important information about some of the ingredients of Gemcitabine powder for solution for infusion

Gemcitabine powder for solution for infusion contains 3.5 mg (< 1 mmol) of sodium in each 200 mg vial, 17.5 mg (< 1 mmol) sodium in each 1000 mg vial and 35 mg (1.52 mmol) sodium in each 2000 mg vial. This should be taken into consideration by patients on a controlled sodium diet.

The usual dose of Gemcitabine is 1000-1250 mg for every square meter 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 powder for solution for 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 further questions on the use of this product ask your doctor or pharmacist.

Like all medicines, Gemcitabine powder for solution for infusion 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

The following information is intended for medical or

healthcare professionals only:

Instructions for use, handling and disposal.

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 powder for solution for infusion 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, or 50 ml sterile sodium chloride solution for injection, without preservative to the 2000 mg vial. Shake to dissolve. The total volume after reconstitution is 5.26 ml (200 mg vial) or 26.3 ml (1000 mg vial) or 52.6 ml (2000 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.

4. Parenteral medicinal products should be inspected visually for

particulate matter and discoloration prior to administration. If particulate matter is observed, do not administer.

5. Solutions of reconstituted gemcitabine should not be refrigerated, as crystallization may occur. Chemical and physical in-use stability has been demonstrated for 21 days at 25°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 controlled and validated aseptic conditions.

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 powder for solution for

infusion 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)

Common side effects

•    Fever accompanied by low white blood cell count (febrile neutropenia)

•    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 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)

Rare side effects

•    Heart attack (myocardial infarction)

•    Low blood pressure

•    Skin scaling, ulceration or blister formation

•    Injection site reactions

Very rare side effects

•    Increased platelet count

•    Anaphylactic reaction

(severe hypersensitivity/ allergic reaction)

•    Sloughing of skin and severe skin blistering

Side effects with frequency not known

•    Irregular heart beat (arrhythmia)

•    Adult Respiratory Distress Syndrome

(severe lung inflammation causing respiratory failure)

•    Radiation recall-(a skin rash like severe sunburn) which can occur on skin that has previously been exposed to radiotherapy.

•    Fluid in the lungs

•    Radiation toxicity- scarring of the air sacs of the lung associated with radiation therapy

•    Ischaemic colitis (inflammation of the lining of the large bowel, caused by reduced blood supply)

•    Heart failure

•    Kidney failure

•    Gangrene of fingers or toes

•    Serious liver damage, including liver failure

•    Stroke

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.

Keep out of the reach and sight of children.

Do not use Gemcitabine powder for solution for infusion after the expiry date, which is stated on the carton and vial. The expiry date refers to the last day of that month.

Unopened vial: This medicinal product does not require any special storage conditions.

Reconstituted solution: The product should be used immediately. When prepared as directed, chemical and physical in-use stability of reconstituted solutions of gemcitabine were demonstrated for 21 days at 25°C. Further dilution by a healthcare provider may be done. Solutions of reconstituted gemcitabine should not be refrigerated, as crystallisation may occur.

This medicine is for single use only; any unused solution should be discarded under the local requirements.

What Gemcitabine powder for solution for infusion contains

The active substance is gemcitabine. Each vial contains 200 or 1000 mg or 2000 mg of gemcitabine (as gemcitabine hydrochloride).

The other ingredients are mannitol (E421), sodium acetate, hydrochloric acid and sodium hydroxide.

What Gemcitabine powder for solution for infusion looks like and contents of the pack

Gemcitabine powder for solution for infusion is a white to off-white powder, for solution for infusion in a vial. Each vial contains 200 or 1000 or 2000 mg of gemcitabine. Each pack of Gemcitabine powder for solution for infusion contains 1 vial.

The 200 mg, 1 g and 2 g vials are sold separately in single packs.

Not all pack sizes may be marketed.

Marketing authorisation holder:

Accord Healthcare Limited,

Sage House, 319, Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

Manufacturers:

Accord Healthcare Limited,

Sage House, 319, Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom or

Wessling Hungray Limited 1047 Budapest, Foti ut 56,

Hungary

The leaflet was last revised in 09/2015.

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

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