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Gemcitabine Medac 38 Mg/Ml Powder For Solution For Infusion

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Gemcitabine 38 mg/ml • 90700-VPGB • CB • 11.14 • Pharma-Code: 748

Format: 592 x132 mm • HKS 44 - Corrective action: KV01_osc_28.11.14 / KV02_osc_

28.11.14/ KV03_osc_01.12.14

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

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 is and what it is used for

2. Before you are given Gemcitabine

3. How Gemcitabine is given

4. Possible side effects

5. How to store Gemcitabine

6. Further 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. No sufficient data are available about the safety and efficacy of gemcitabine in children.

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. BEFORE YOU ARE GIVEN GEMCITABINE

You should not be given Gemcitabine

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

• if you are breast-feeding.

Take special care with 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.

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 should be avoided during pregnancy. Your doctor will discuss with you the potential risk of taking Gemcitabine during pregnancy.

If you are breast-feeding, tell your doctor.

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.

Important information about some of the ingredients of Gemcitabine

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 and 26.3 mg (> 1 mmol) sodium in each 1500 mg vial. To be taken into consideration by patients on a controlled sodium diet.

3. HOW GEMCITABINE IS GIVEN

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, Gemcitabine 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

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) (uncommon).

• 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).

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.

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 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.

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

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.

Side effects with Gemcitabine 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)

• Sweating

• Sleeping difficulties

90700-VPGB

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

• Muscle pain

III

• Back pain

• Fever

• Weakness

• Chills

Uncommon side effects

• Interstitial pneumonitis(scarringoftheairsacsofthelung)

• Spasm of the airways (wheeze)

• Abnormal chest X ray/scan (scarring of the lungs)

• Irregular heart beat (arrhythmia)

• Heart failure

• Stroke

• Serious liver damage, including liver failure

• Kidney failure

• Haemolytic uraemic syndrome (low red blood cell count with renal insufficiency)

Rare side effects

• 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)

• 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 side effects

• Increased platelet count

• Anaphylactic reaction (severe hypersensitivity/ allergic reaction)

• Sloughing of skin and severe skin blistering

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

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.

Reporting of side effects

If you get any side effects, talk to your doctor or nurse.

This includes any possible side effects not listed in this leaflet. You can also report side effects directly via 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 out of the reach and sight of children.

Do not use after the expiry date which is stated on the carton after EXP.

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 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.

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

6. FURTHER INFORMATION

What Gemcitabine contains

The active substance is gemcitabine.

Each vial contains 200, 1000 or 1500 mg of gemcitabine (as gemcitabine hydrochloride).

The other ingredients are mannitol (E421), sodium acetate, 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 or 1500 mg of gemcitabine. Each pack of Gemcitabine contains 1 vial.

Marketing Authorisation Holder and Manufacturer:

medac

Gesellschaft fur klinische Spezialpraparate mbH Theaterstr. 6 22880 Wedel Germany

Phone: +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:

Czech Republic Gemcitabine medac 38 mg/ml

prasek pro pffpravu infuznfho roztoku Germany Gemedac 38 mg/ml

Pulver zur Plerstellung einer Infusionslosung

Lithuania Gemcitabine medac 38 mg/ml

milteliai infuziniam tirpalui

Poland

Gemcitabine medac

Slovak Republic Gemcitabine medac 38 mg/ml prasok na infuzny roztok United Kingdom Gemcitabine 38 mg/ml

powder for solution for infusion

This leaflet was last revised in 11/2014.

90700-VPGB