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Package leaflets: Information for the user

Gemcitabine 200 mg & 1000 mg powder for solution for infusion

gemcitabine

The name of this medicine is Gemcitabine 200 mg or 1000 mg powder for solution for infusion, which will be referred to as Gemcitabine throughout this leaflet

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

Gemcitabine is one of 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.

Do not use Gemcitabine

-    if you are allergic to gemcitabine hydrochloride or any other ingredient 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.

Tell to your doctor, nurse or pharmacist before using Gemcitabine:

-    if you have, or have previously had liver disease, heart disease, vascular disease or problems with your kidneys as you may not be able to receive Gemcitabine.

-    if you have recently had, or are going to have radiotherapy, as there may be an early or late radiation reaction with Gemcitabine.

-    if you have been vaccinated recently, as this can possibly cause bad effects with Gemcitabine.

-    if you develop breathing difficulties or feel very weak and are very pale, 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, as this may be a sign of fluid leaking from your small blood vessels into the tissue.

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THE FOLLOWING INFORMATION IS INTENDED FOR HEALTHCARE PROFESSIONALS ONLY

Below is a summary of information to assist in the administration of Gemcitabine. You should be experienced

in the handling and use of cytotoxic agents and be familiar with the SPC for

Gemcitabine.

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 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

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.

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

Tell your doctor or pharmacist if you are taking, or have recently taken or might take any other medicines, including vaccinations and medicines obtained without a prescription.

Pregnancy, breast-feeding and fertility

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.

Pregnancy

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 5 mg (< 1 mmol) of sodium in each 200 mg vial and 22. 985 mg (< 1 mmol) sodium in each 1000 mg vial i.e. essentially sodium free.

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

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 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.

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:

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

-    extreme tiredness and weakness, purpura or small areas of bleeding in the skin (bruises), acute renal failure (low urine /or no urine output), and signs of infection. These may be signs of a serious condition called haemolytic uraemic syndrome, which can be fatal.

-    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).

-    irregular heart rate (arrhythmia).

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(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.

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 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.

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

-    allergic reactions: mild to moderate skin rash itching, or fever.

-    tiredness, feeling faint, becoming easily breathless or if you look pale (since you might have less haemoglobin than normal).

-    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).

-    dif ficulty breathing

-    severe chest pain (heart attack).

-    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).

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

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

Other side effects with gemcitabine may include:

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

-    low white blood cells

-    dif ficulty 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

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

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

-    loss of appetite

-    headache

-    insomnia

-    sleepiness

-    cough

-    runny nose

-    constipation

-    diarrhoea

-    itching

-    sweating

-    muscle pain

-    back pain

-    fever

-    weakness

-    chills

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

-    inflammation and scarring air sacs of the lungs (interstitial pneumonia)

-    spasm of the airways (wheeze)

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

-    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 must tell your doctor as soon as possible 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 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 label and carton after EXP. The expiry date refers to the last day of that month.

Unopened vial: Store in the original package.

Reconstituted solution: The product should be used immediately. When prepared as directed, chemical and physical in-use stability of reconstituted solution of gemcitabine were demonstrated for 24 hours at 30°C. Further dilution by a healthcare provider may be done.

The reconstituted solution should not be refrigerated, as crystallisation may occur.

Do not use Gemcitabine if you notice a cloudy solution or an insoluble precipitate.

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

What Gemcitabine contains

-    The active substance is gemcitabine hydrochloride.

200mg: One vial contains gemcitabine hydrochloride equivalent to 200 mg gemcitabine.

1000mg: One vial contains gemcitabine hydrochloride equivalent to 1000 mg gemcitabine..

-    The other ingredients are mannitol, sodium acetate trihydrate, sodium hydroxide (for pH adjustment) and hydrochloric acid (for pH adjustment).

What Gemcitabine looks like and contents of the pack

Gemcitabine 200 mg powder for solution for infusion is white to off white freeze dried cake packaged in a 10 ml Type I moulded glass vial with bromobutyl rubber stopper and with 20 mm neck and flip off tear off aluminium seal.

Gemcitabine 1000 mg powder for solution for infusion is white to off white freeze dried cake packaged in a 50 ml type I moulded glass vial with bromobutyl rubber stopper and with 20 mm neck and flip off tear off aluminium seal.

Each pack of Gemcitabine powder for solution for infusion contains 1 vial.

Marketing Authorisation Holder

Cipla (EU) Limited, Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW, United Kingdom Manufacturer:

Cipla (EU) Limited, 20 Balderton Street, London W1K 6TL, United Kingdom Cipla Europe NV, Uitbreidingstraat 80, 2600 Antwerp, Belgium This leaflet was last revised in 10/2016

Cipla

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6. Gemcitabine solutions are for single use only. Any unused product or waste material should be    ^Di^sposal    . .    .    .

di_sp_osed _of i_{n accor}d_{ance w}ith l_ocal req_uir_ement_s    All items used for preparation, administration or otherwise coming into contact with gemcitabine

should undergo disposal according to local guidelines for the handling of cytotoxic compounds.

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.