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Gemcitabine 38 mg/ml - Pack Insert - UK (Medac)

PACKAGE LEAFLET: INFORMATION FOR THE USER

Gemcitabine 38 mg/ml

powder 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 further questions, please 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.

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 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.

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

Gemcitabine contains 3.5 mg (< 1 mmol) of sodium in each 200 mg vial, 17.5 mg (< 1 mmol) sodium in each 1000 mg vial, 26.3 mg (1.1 mmol) sodium in each 1500 mg vial and 35 mg (1.5 mmol) of sodium in each 2000 mg vial. To be taken into consideration by patients on a controlled sodium diet.

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 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.

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, 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 has less haemoglobin than normal which is very common).

• 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 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).

• 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)

• 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 of 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

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

Special precautions for disposal and other handling

Reconstitution:

For single use only.

This medicinal product has only been shown to be compatible with sodium chloride 9 mg/ml (0.9 %) solution for injection. Accordingly, only this diluent should be used for reconstitution. Compatibility with other active substances has not been studied. Therefore, it is not recommended to mix this medicinal product with other active substances when reconstituted.

Reconstitution at concentrations greater than 38 mg/ml may result in incomplete dissolution, and should be avoided. To reconstitute, slowly add the appropriate volume of sodium chloride 9 mg/ml (0.9 °%) solution for injection (as stated in the table below) and shake to dissolve.

Presentation	Presentation volume of sodium chloride 9 mg/ml (0.9 %) solution for injection to be added	Reconstituted volume	Final concentration
200 mg	5 ml	5.26 ml	38 mg/ml
1,000 mg	25 ml	26.3 ml	38 mg/ml
1,500 mg	37.5 ml	39.5 ml	38 mg/ml
2,000 mg	50 ml	52.6 ml	38 mg/ml

The appropriate amount of medicinal product may be further diluted with sodium chloride 9 mg/ml (0.9 °%) solution for injection.

Parenteral medicinal products should be inspected visually for particulate matter and discolouration, prior to administration, whenever solution and container permit.

Any unused solution should be discarded as described below.

Guidelines for the Safe Handling of Cytotoxic Medicinal Products:

Local guidelines on safe preparation and handling of cytotoxic medicinal products must be adhered to. Cytotoxic preparations should not be handled by pregnant staff. The preparation of injectable solutions of cytotoxic agents must be carried out by trained specialist personnel with knowledge of the medicines used. This should be performed in a designated area. The work surface should be covered with disposable plastic-backed absorbent paper.

Suitable eye protection, disposable gloves, face mask and disposable apron should be worn. Precautions should be taken to avoid the medicinal product accidentally coming into contact with the eyes. If accidental contamination occurs, the eye should be washed with water thoroughly and immediately.

Syringes and infusion sets should be assembled carefully to avoid leakage (use of Luer lock fittings is g recommended). Large bore needles are recommended to minimise pressure and the possible formation of aerosols. ’ The latter may also be reduced by the use of a venting needle. |

Actual spillage or leakage should be mopped up wearing protective gloves. Excreta and vomit must be handled with care.

Disposal:

Adequate care and precaution should be taken in the disposal of items used to reconstitute this medicinal product. Any unused dry product or contaminated materials should be placed in a high-risk waste bag. Sharp objects (needles, syringes, vials, etc) should be placed in a suitable rigid container. Personnel concerned with the collection and disposal of this waste should be aware of the hazard involved. Waste material should be destroyed by incineration. Any unused product or waste material should be disposed of in accordance with local requirements.

• Flu like symptoms including fever

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

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

• Poor appetite (anorexia)

• 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)

• 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, cause 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.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

Reporting of side effects

If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor. You can also report side effects directly via the national reporting scheme listed 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

5. HOW TO STORE GEMCITABINE

Keep 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.

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 35 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.

Do not use this medicine if you notice any particulate matter and/or discolouration

This medicine is for single use only. Do not throw away any medicines via waste water or household waste. Ask your pharmacists 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 vial contains 200, 1000, 1500 or 2000 mg of gemcitabine (as gemcitabine hydrochloride).

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

What Gemcitabine looks like and contents of the pack

Gemcitabine is a white to off-white powder, for solution for infusion in a vial. Each vial contains 200, 1000, 1500 and 2000 mg of gemcitabine. Each pack of Gemcitabine contains 1 vial.

Marketing Authorisation Holder

Fresenius Kabi Limited

Cestrian Court, Eastgate Way, Manor Park

Runcorn, Cheshire, WA7 1nT, UK

Manufacturer:

medac

Gesellschaft fur klinische Spezialpraparate mbH Fehlandtstr. 3 20354 Hamburg Germany

Tel.: +49 4103 8006-0 Fax: +49 4103 8006-100

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

Bulgaria Gemcit 38 mg/ml ripax 3a HH$y3MOHeH pa3TBop

Czech Republic Gemcirena 38 mg/ml prasek pro pripravu infuzniho roztoku

Denmark Gemcit

Estonia Gemcirena

Germany Gemcit 38 mg/ml Pulver zur Herstellung einer Infusionslosung

Greece Gemcirena 38 mg/ml Kovig yia biaAupa Tpog cyxuari

Latvia Gemcit 38 mg/ml pulveris infuziju sklduma pagatavosanai

Lithuania Gemcit 38 mg/ml milteliai infuziniam tirpalui

Netherlands Gemcirena 38 mg/ml poeder voor oplossing voor infusie

Norway Gemcit 38 mg/ml pulver til infusjonsvsske, opplosning

Poland Gemcit

Portugal Gemcit 38 mg/ml po para solugao para perfusao

Romania Gemcirena 38 mg/ml pulbere pentru solu(ie perfuzabila

Slovak Republic Gemcirena 38 mg/ml prasok na infuzny roztok

United Kingdom Gemcitabine 38 mg/ml powder for solution for infusion

This leaflet was last revised in January 2015