GEMCITABINE FLYNN 1000 mg POWDER FOR SOLUTION FOR INFUSION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Gemcitabine FLYNN 1000 mg powder for solution for infusion EFG

Gemcitabine

Read all of this leaflet carefully before you start using this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack and other information:

1. What Gemcitabine FLYNN powder for solution for infusion is and what it is used for
2. Before you use Gemcitabine FLYNN powder for solution for infusion
3. How to use Gemcitabine FLYNN powder for solution for infusion
4. Possible side effects
5. Storing Gemcitabine FLYNN powder for solution for infusion
6. Further information

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

Gemcitabine FLYNN is a medicine used to treat cancer. It belongs to a group of medicines called cytotoxics. These medicines destroy cells that are dividing, including cancer cells.

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

Gemcitabine FLYNN is used to treat the following types of cancer:

• Non-small cell lung cancer (NSCLC), alone or in combination with cisplatin
• Pancreatic cancer
• Breast cancer, in combination with paclitaxel
• Ovarian cancer, in combination with carboplatin
• Bladder cancer, in combination with cisplatin

2. Before you use Gemcitabine Flynn powder for solution for infusion

Do not use Gemcitabine FLYNN powder for solution for infusion

• If you are allergic (hypersensitive) to gemcitabine or any of the other ingredients of Gemcitabine FLYNN powder for solution for infusion.
• If you are breast-feeding, you must stop breast-feeding before starting treatment with Gemcitabine.

Take special care with Gemcitabine FLYNN powder for solution for infusion

Before the first infusion, blood samples will be taken to check that your liver and kidneys are working correctly. Before each infusion, blood samples will also be taken to check that you have enough red blood cells to receive Gemcitabine. Your doctor may decide to change the dose or delay treatment depending on your general health and your blood cell counts. You will have regular blood tests to check how your kidneys and liver are working.

Tell your doctor if:

• You have or have had liver, heart or vascular disease.
• You have recently received or are going to receive radiotherapy.
• You have recently been vaccinated.
• You have difficulty breathing or feel very weak and very pale (this could be a sign of kidney failure).

Men are advised not to father a child during and for up to 6 months after treatment with Gemcitabine. If you wish to father a child during or after treatment, you should discuss this with your doctor or pharmacist. You may want to seek advice on conservation of sperm before starting treatment.

Using other medicines

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

Pregnancy and breast-feeding

If you are pregnant or think you may be pregnant, tell your doctor. Gemcitabine should be avoided during pregnancy. Your doctor will discuss with you the potential risks of taking Gemcitabine during pregnancy.

Tell your doctor if you are breast-feeding.

You must stop breast-feeding before starting treatment with Gemcitabine.

Driving and using machines

Gemcitabine may cause drowsiness, especially if you have consumed alcohol. Avoid driving or using machines until you are sure that the treatment with Gemcitabine does not make you drowsy.

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

Gemcitabine FLYNN powder for solution for infusion contains 17.5 mg (less than 1 mmol) of sodium per 1,000 mg vial. Patients on a controlled sodium diet should be aware of this.

3. How to use Gemcitabine Flynn powder for solution for infusion

The usual dose of Gemcitabine is 1,000-1,250 mg per square meter of your body surface area. Your height and weight will be measured to calculate the area of your body. Your doctor will use this body surface area to work out the correct dose for you. This dose may be adjusted or treatment delayed depending on your general health and your blood cell counts.

The frequency of your Gemcitabine infusion depends on the type of cancer being treated.

A hospital pharmacist or doctor will have dissolved the Gemcitabine FLYNN powder for solution for infusion before it is given to you.

You will always receive Gemcitabine by infusion into one of your veins. The infusion will take about 30 minutes.

If you have any other questions about 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.

The frequencies of side effects are defined as:

• Very common, affects more than 1 in 10 patients treated
• Common, affects between 1 and 10 in 100 patients treated
• Uncommon, affects between 1 and 10 in 1,000 patients treated
• Rare, affects between 1 and 10 in 10,000 patients treated
• Very rare, affects less than 1 in 10,000 patients treated
• Not known, frequency cannot be estimated from the available data

You should contact your doctor immediately if you notice any of the following

effects:

• Fever or infection (common): if you have a temperature of 38°C or higher, sweating or other signs of infection (as you may have a lower than normal white blood cell count, which is very common).
• Irregular heartbeat (frequency not known).
• Pain, redness, swelling or ulcers in the mouth (common).
• Allergic reactions: if you get a rash (very common) / itching (common), or fever (very common).
• Feeling weak, faint, breathless or pale (as you may have lower than normal red blood cells, which is very common).
• Bleeding from the gums, nose or mouth or any bleeding that does not stop, pink or red urine, unexpected bruising (as you may have lower than normal platelets, which is very common).
• Difficulty breathing (it is very common to have mild breathing difficulties immediately after Gemcitabine infusion, which soon pass; however, less commonly or rarely, more serious lung problems can occur)

The side effects of Gemcitabine may include:

Very common side effects

• Low red blood cell count (anaemia)
• Low white blood cell count
• Low platelet count
• Breathing difficulties
• Vomiting
• Feeling sick (nausea)
• Rash - allergic skin rash, often with itching
• Hair loss
• Liver problems: shown by abnormal blood test results
• Blood in the urine
• Abnormal urine tests: protein in the urine
• Pseudo-flu syndrome including fever
• Swelling (oedema) of the ankles, fingers, feet, face

Common side effects

• Fever with a low white blood cell count
• Lack of appetite (anorexia)
• Headache
• Insomnia
• Drowsiness
• Cough
• Stuffy nose
• Constipation
• Diarrhoea
• Pain, redness, swelling or ulcers in the mouth
• Itching
• Sweating
• Muscle pain
• Back pain
• Fever
• Weakness
• Chills

Uncommon side effects

• Interstitial pneumonitis (scarring of the air sacs in the lungs)
• Spasm of the airways (wheezing)
• Abnormal chest X-ray/scan (scarring of the lungs)

Rare side effects

• Heart attack (myocardial infarction)
• Low blood pressure
• Peeling of the skin, ulcers or blisters
• Reactions at the site of the infusion

Very rare side effects

• High platelet count
• Anaphylactic reactions (severe allergic reaction)
• Severe peeling of the skin and blistering

Side effects with unknown frequency

• Irregular heartbeat (arrhythmia)
• Adult respiratory distress syndrome (severe lung inflammation that causes breathing failure)
• Delayed radiation toxicity - skin burn-like reaction (a severe sunburn-like skin reaction) that can occur in skin that has been previously exposed to radiotherapy.
• Fluid in the lungs
• Radiation toxicity - scarring of the air sacs in the lungs associated with radiotherapy.
• Ischaemic colitis (inflammation of the lining of the large intestine, caused by reduced blood supply).
• Heart failure
• Kidney failure
• Gangrene of the fingers or toes
• Severe liver damage, including liver failure
• Stroke (cerebral infarction)

You may get any of these symptoms or conditions. You should tell your doctor as soon as possible if you start to get any of these side effects.

If you are concerned about any side effect, talk to your doctor.

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

5. Storing Gemcitabine Flynn powder for solution for infusion

Keep out of the reach and sight of children.

Do not use Gemcitabine FLYNN powder for solution for infusion after the expiry date (EXP) that is stated on the carton.

Sealed vial: store at a temperature below 25°C

Reconstituted solution: the product should be used immediately. When prepared according to the instructions, the chemical and physical properties of the reconstituted gemcitabine solutions have been shown to be stable for 24 hours at 20-25°C. Further dilution may be performed by a healthcare professional. Reconstituted gemcitabine solutions should not be refrigerated as crystallization may occur.

This medicinal product should be used only once. Disposal of unused medicinal product or waste material should be in accordance with local requirements.

6. Further information

What Gemcitabine FLYNN powder for solution for infusion contains

• The active substance is gemcitabine. Each vial contains 1,000 mg of gemcitabine (as gemcitabine hydrochloride).
• The other ingredients are mannitol (E421), sodium acetate, hydrochloric acid and sodium hydroxide.

Appearance of Gemcitabine FLYNN powder for solution for infusion and pack size

Gemcitabine FLYNN is a white or almost white powder or compacted powder for solution for infusion in a vial. Each vial contains 1,000 mg of gemcitabine. Each pack of Gemcitabine FLYNN powder for solution for infusion contains 1 vial.

Marketing authorisation holder

Flynn Pharma Ltd

Alton House, 4 Herbert Street, Dublin 2

Ireland

Manufacturer

THYMOORGAN PHARMAZIE GMBH

Schiffgraben, 23 (Vienenburg

Germany

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

This leaflet was last approved in April 2010

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INFORMATION FOR HEALTHCARE PROFESSIONALS

Gemcitabine FLYNN 1000 mg powder for solution for infusion

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

Instructions for use, handling and disposal

1. Use aseptic technique during the reconstitution and any subsequent dilution of gemcitabine for intravenous infusion.

1. Calculate the dose and the number of Gemcitabine vials needed.

1. Reconstitute each 200 mg vial with 5 ml of sterile sodium chloride injection solution, 9 mg/ml (0.9%), without preservatives, or each 1,000 mg vial with 25 ml of sterile sodium chloride injection solution, 9 mg/ml (0.9%), without preservatives. Shake to dissolve. The total volume after reconstitution is 5.26 ml (200 mg vial) or 26.3 ml (1,000 mg vial) respectively. The resulting concentration of gemcitabine is 38 mg/ml, taking into account the displacement volume of the lyophilised powder. Further dilution may be performed with sodium chloride injection solution, 9 mg/ml (0.9%), without preservatives. The reconstituted solution is a clear colourless or pale yellow solution.

1. Before administration, visually inspect the medicinal product for particulate matter or discolouration. If particulate matter is seen, do not administer.

1. The reconstituted gemcitabine solutions should not be refrigerated as crystallisation may occur. Chemical and physical stability of the reconstituted solutions has been demonstrated for 24 hours at 20-25°C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user and would not be longer than 24 hours at room temperature.

1. Gemcitabine solutions should be used only once. Any unused product or waste material should be disposed of in accordance with local requirements.

Precautions for preparation and administration

Normal safety precautions for handling cytotoxic agents should be taken when preparing and disposing of the infusion solution. Preparation should be performed in a safety cabinet and protective clothing should be worn, including gloves and a mask. If a safety cabinet is not available, a mask and protective glasses should be worn.

If the preparation comes into contact with the eyes, it may cause severe irritation. The eyes should be flushed immediately and thoroughly with water. If irritation persists, medical attention should be sought. If the solution is spilled on the skin, the area should be washed thoroughly with water.

Disposal

Disposal of unused medicinal product or waste material should be in accordance with local requirements for the disposal of cytotoxic medicines.