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Gemcitabine 200mg Powder For Solution For Infusion

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160 mm

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Gemcitabine 200 mg and 1000 mg 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.

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.

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 of sodium in each 200 mg vial and 17.5 mg sodium in each 1000 mg vial. To be taken into consideration by patients on a controlled sodium diet.

2. BEFORE YOU ARE GIVEN GEMCITABINE I ³- ^H0W GEMCITABINE IS GIVEN

You should not be given Gemcitabine if you:

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

• 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 previously 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.

Gemcitabine is given by infusion (drop) into a vein. The infusion will last approximately 30 minutes.

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

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.

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

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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).

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)

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

• Sweating

• Muscle pain

• Back pain

• Fever

• Weakness

• Chills

Uncommon side effects

• Stroke

• Irregular heart beat (arrhythmia)

• Heart failure

• Interstitial pneumonitis (scarring of the air sacs of the lung)

• Spasm of the airways (wheeze)

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

• Serious liver damage, including liver failure

• Kidney failure

Rare side effects

• Heart attack (myocardial infarction)

• Gangrene of fingers or toes

• Low blood pressure

• Fluid in the lungs

• Adult Respiratory Distress Syndrome (severe lung inflammation causing respiratory failure)

• Skin scaling, ulceration or blister formation

• Sloughing of skin and severe skin blistering

• Injection site reactions

• Radiation toxicity - scarring of the air sacs of the lung associated with radiation therapy

• Radiation recall - (a skin rash like severe sunburn) which can occur on skin that has previously been exposed to radiotherapy

Very rare side effects

• Increased platelet count

• Anaphylactic reaction (severe hypersensitivity/ allergic reaction)

• 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.

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

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

5. HOW TO STORE GEMCITABINE

Keep out of the reach and sight of children.

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

Unopened vial: Store below 30°C.

Reconstituted solution: The product should be used immediately. The doctor or nurse responsible for giving you the drip will ensure that it has been stored and reconstituted correctly before giving it to you. The infusion will have been stored at room temperature (below 25°C) before use and will be given to you within 24 hours of it being mixed and diluted for use. Once Gemcitabine has been prepared for use it should be stored below 30°C. It should NOT be kept in a fridge.

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 mg or 1000 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 mg or 1000 mg of gemcitabine. Each pack of Gemcitabine contains 1 vial.

Marketing Authorisation Holder and Manufacturer

Dr. Reddy’s Laboratories (UK) Ltd., 6 Riverview Road, Beverley, East Yorkshire, HU17 OLD, United Kingdom.

This leaflet was last revised in 11/2011

PL numbers: 08553/0421 (200 mg) and 08553/0422 (1000 mg).

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