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Package leaflet: Information for the user

Gemcitabine 38 mg/ml

concentrate for solution for infusion Gemcitabine

Read all of this leaflet carefully before you start using 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, nurse or pharmacist.

-    If you get any side effects, talk to your doctor, pharmacist or nurse. 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 use Gemcitabine

3.    How to use Gemcitabine

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.

This medicine may be given alone or in combination with other anti-cancer medicines, depending on the type of cancer.

This medicine 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 use Gemcitabine Do not use 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:

Before the first infusion you will have samples of your blood taken to check if your liver and kidneys are working well enough for you to receive this medicine. Before each infusion you will have samples of your blood taken to check 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 check how well your kidneys and liver are working.

Talk to your doctor, nurse or hospital pharmacist before using gemcitabine.

If you have, or have previously had liver disease, heart disease, vascular disease or problems with your kidneys talk to your doctor or hospital pharmacist as you may not be able to receive gemcitabine.

If you have recently had, or are going to have radiotherapy, please tell your doctor as there may be an early or late radiation reaction with gemcitabine.

If you have been vaccinated recently, please tell your doctor as this can possibly cause bad effects with gemcitabine.

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If during treatment with this medicine, you get symptoms such as headache with confusion, seizures (fits) or changes in vision, call your doctor right away. This could be a very rare nervous system side effect named posterior reversible encephalopathy syndrome.

If you develop breathing difficulties or feel very weak and are very pale, please tell your doctor as this may be a sign of kidney failure or problems with your lungs.

If you develop generalised swelling, shortness of breath or weight gain, please tell your doctor as this may be a sign of fluid leaking from your small blood vessels into the tissue.

Children and adolescents

This medicine is not recommended for use in children under 18 years of age due to insufficient data on safety and efficacy.

Other medicines and Gemcitabine

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, breast-feeding and fertility

Pregnancy

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

Breast-feeding

If you are breast-feeding, tell your doctor.

You must discontinue breast-feeding during gemcitabine treatment.

Fertility

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.

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:

This medicine contains 3.16 mg/ml to 3.74 mg/ml (0.14 mmol/ml to 0.16 mmol/ml) sodium. This should be taken into consideration by patients on a controlled sodium diet. Gemcitabine contains propylene glycol which may cause alcohol-like symptoms.

3. How to use Gemcitabine

The usual 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 diluted the Gemcitabine concentrate before it is given to you.

You will always receive this medicine only after dilution 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.

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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:

-    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).

-    Tiredness, feeling faint, becoming easily breathless or if you look pale (since you might have less haemoglobin than normal which is very common).

-    Mild to moderate skin rash (very common) / itching (common), or fever (very common); (allergic reactions).

-    Temperature of 38°C or greater, sweating or other signs of infection (since you might have less white blood cells than normal accompanied by fever also known as febrile neutropenia) (common).

-    Pain, redness, swelling or sores in your mouth (stomatitis) (common).

-    Irregular heart rate (arrhythmia) (uncommon)

-    Extreme tiredness and weakness, purpura or small areas of bleeding in the skin (bruises), acute renal failure (low urine output /or no urine output), and signs of infection (haemolytic uraemic syndrome). It may be fatal (uncommon).

-    Difficulty breathing (it is 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)

-    Severe chest pain (myocardial infarction) (rare).

-    Severe hypersensitivity/allergic reaction with severe skin rash including red itchy skin, swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), wheezing, fast beating heart and you may feel you are going to faint (anaphylactic reaction) (very rare).

-    Generalised swelling, shortness of breath or weight gain, as you might have fluid leakage from small blood vessels into the tissues (capillary leak syndrome) (very rare)

-    Headache with changes in vision, confusion, seizures or fits (posterior reversible encephalopathy syndrome) (very rare)

-    Severe rash with itching, blistering or peeling of the skin (Stevens-Johnson syndrome, toxic epidermal necrolysis) (very rare).

Other side effects with Gemcitabine may include:

Very common side effects (may affect more than 1 in 10 people)

-    Low white blood cells

-    Difficulty breathing

-    Vomiting

-    Nausea

-    Hair loss

-    Liver problems: found through abnormal blood test results

-    Blood in urine

-    Abnormal urine tests: protein in urine

-    Flu like symptoms including fever,

-    Swelling of ankles, fingers, feet, face (oedema)

Common side effect (may affect up to 1 in 10 people)

-    Poor appetite (anorexia)

-    Headache

-    Insomnia

-    Sleepiness    §

-    Cough

-    Runny nose    jj

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-    Constipation

-    Diarrhoea

-    Itching

-    Sweating

-    Muscle pain

-    Back pain

-    Fever

-    Weakness

-    Chills

Uncommon side effect (may affect up to 1 in 100 people)

-    Scarring of the air sacs of the lung (interstitial pneumonitis)

-    Wheeze (spasm of the airways )

-    Scarring of the lungs (abnormal chest X ray/scan)

-    Heart failure

-    Kidney failure

-    Serious liver damage, including    liver failure

-    Stroke

Rare side effects (may affect up to 1 in 1,000 people)

-    Low blood pressure

-    Skin scaling, ulceration or blister formation

-    Sloughing of the skin and severe skin blistering

-    Injection site reactions

-    Severe lung inflammation causing respiratory failure (adult respiratory distress syndrome)

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

-    Fluid in the lungs

-    Scarring of the air sacs of the lung associated with radiation therapy (radiation toxicity)

-    Gangrene of fingers or toes

-    Inflammation of the blood vessels (peripheral vasculitis)

Very rare side effects (may affect up to 1 in 10,000 people)

-    Increased platelet count

-    Inflammation of the lining of the large bowel, caused by reduced blood supply (ischaemic colitis)

-    Low haemoglobin level (anaemia), low white blood cells and low platelet count will be detected by a blood test.

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.

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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

Ireland

HPRA Pharmacovigilance Earlsfort Terrace IRL - Dublin 2 Tel: +353 1 6764971

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Fax: +353 1 6762517 Website: www.hpra.ie e-mail: medsafety@hpra.ie.

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 carton and label after EXP. The expiry date refers to the last day of that month.

Store below 25°C. Do not refrigerate or freeze.

Shelf life after dilution(Solution for Infusion):

Chemical and physical in-use stability after dilution in 0.9 % w/v sodium chloride solution at a concentration of 0.1 mg/ml and 5 mg/ml has been demonstrated for 7 days at 2°C to 8°C or 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 2°C to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.

This medicine is for single use only. Discard any unused contents.

If the solution appears discoloured or contains visible particles, it should be discarded. Do not throw away any medicines via wastewater or household 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 contains

The active substance is gemcitabine.

Each ml of concentrate for solution for infusion contains gemcitabine hydrochloride, equivalent to 38 mg gemcitabine.

Each vial contains 200 mg gemcitabine (as hydrochloride)

Each vial contains 1000 mg gemcitabine (as hydrochloride)

Each vial contains 2000 mg gemcitabine (as hydrochloride).

The other ingredients are: Propylene Glycol, Macrogol 400, Sodium hydroxide (E524) (for pH adjustment), Hydrochloric acid, concentrated (E507) (for pH adjustment) and water for injections

What Gemcitabine looks like and contents of the pack

This medicinal product is a concentrate for solution for infusion.

Gemcitabine is a concentrate for solution for infusion and a clear, colourless to light straw colored solution, free from visible particles.

Each pack contains 1 vial of 5.26 ml, 26.3 ml or 52.6 ml of solution.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Fresenius Kabi Oncology Plc.

Lion Court, Farnham Road, Bordon Hampshire, GU35 0NF United Kingdom

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This medicinal product is authorised in the Member States of the EEA under the following names:

Austria	Gemcitabin Kabi 38 mg/ml Konzentrat zur Herstellung einer Infusionslosung
Belgium	Gemcitabine Fresenius Kabi 38 mg/ml concentraat voor oplossing voor infusie (200 mg/5.26 ml) Gemcitabine Fresenius Kabi 38 mg/ml concentraat voor oplossing voor infusie (1000 mg/26.3 ml) Gemcitabine Fresenius Kabi 38 mg/ml concentraat voor oplossing voor infusie (2000 mg/52.6 ml)
Cyprus	Gemcitabine Kabi 38 mg/ml nuKvo SiaXu^a yia rcapacK£ur| SiaXu^axot; rcpot; eyxuan
Czech Republic	Gemcitabine Kabi 38 mg/ml koncentrat pro infuzm roztok
Germany	Gemcitabin Kabi 38 mg/ml Konzentrat zur Herstellung einer Infusionslosung
Denmark	Gemkabi
Estonia	Gemcitabine Kabi 38 mg/ml
Greece	Gemcitabine Kabi 38 mg/ml nuKvo SiaXu^a yia napaoKeu^ SiaXu^axot; rcpot; ey^uon
Spain	Gemcitabina FK 200 mg concentrado para solucion para perfusion, Gemcitabina FK 1000 mg concentrado para solucion para perfusion, Gemcitabina FK 2000 mg concentrado para solucion para perfusion
Finland	Gemkabi
France	Gemcitabine Kabi 38 mg/ml solution a diluer pour perfusion
Hungary	Gemcitabin Kabi 38 mg/ml koncentratum oldatos infuziohoz
Ireland	Gemcitabine 38 mg/ml concentrate for solution for infusion
Iceland	Gemkabi
Italy	Gemcitabina Fresenius
Latvia	Gemcitabine Kabi 38 mg/ml koncentrats infuziju skfduma pagatavosanai
Lithuania	Gemcitabine Kabi 38 mg/ml koncentratas infuziniam tirpalui
Luxembourg	Gemcitabin Kabi 38 mg/ml Konzentrat zur Herstellung einer Infusionslosung
Malta	Gemcitabine 38 mg/ml concentrate for solution for infusion
The	Gemcitabine Fresenius Kabi 38 mg/ml concentraat voor oplossing
Netherlands	voor infusie
Norway	Gemkabi
Poland	Gemcitabine Kabi
Portugal	Gemcitabina Kabi
Romania	Gemcitabina Kabi 38 mg/ml concentrat pentru solutie perfuzabila
Sweden	Gemkabi
Slovenia	Gemcitabin Kabi 38 mg/ml koncentrat za raztopino za infundiranje
Slovak Republic	Gemcitabine Kabi 38 mg/ml, infuzny koncentrat
United Kingdom	Gemcitabine 38 mg/ml concentrate for solution for infusion

This leaflet was last revised in 10/2014.

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