Consumer medicine information

Gemcitabine Ebewe

gemcitabine hydrochloride concentrated injection

Consumer Medicine Information

WHAT IS IN THIS LEAFLET

This leaflet answers some common questions about Gemcitabine Ebewe.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet. You may need to read it again.

WHAT GEMCITABINE EBEWE IS USED FOR

This medicine is used to treat patients with

  • lung cancer
  • pancreatic cancer
  • bladder cancer
  • breast cancer
  • ovarian cancer.

It contains the active ingredient gemcitabine hydrochloride. Gemcitabine hydrochloride belongs to a group of medicines called antineoplastic or cytotoxic medicines. You may also hear of these being called chemotherapy medicines.

It works by killing cancer cells and preventing cancer cells from growing and multiplying.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.

Gemcitabine Ebewe may be used in combination with other cytotoxic medicines to treat cancer.

This medicine is not addictive.

BEFORE YOU ARE GIVEN GEMCITABINE EBEWE

When you must not be given it

You must not be given this medicine if you have an allergy to:

  • gemcitabine hydrochloride, the active ingredient, or to any of the other ingredients listed at the end of this leaflet under Product Description.
  • any other similar medicines.

Some of the symptoms of an allergic reaction may include:

  • shortness of breath
  • wheezing or difficulty breathing
  • swelling of the face, lips, tongue or other parts of the body
  • rash, itching or hives on the skin.

You must not be given this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your doctor, nurse or pharmacist for disposal.

If you are not sure whether you should be given this medicine, talk to your doctor.

Before you are given it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have or have had any of the following medical conditions:

  • any kidney or liver disease including hepatitis.

Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding. Like most anticancer agents, Gemcitabine Ebewe should not be given during pregnancy. It is recommended that you do not breast-feed while you are receiving Gemcitabine Ebewe, as it is not known whether it passes into breast milk.

Tell your doctor if you are planning to father a child. Men being treated with gemcitabine are advised not to father a child during and up to six months after treatment and to seek further advice regarding cryoconservation of sperm prior to treatment because of the possibility of infertility due to therapy with gemcitabine

If you have not told your doctor about any of the above, tell him/her before you are given Gemcitabine Ebewe.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and Gemcitabine Ebewe may interfere with each other. These include:

  • radiotherapy
  • live vaccinations.

These medicines may be affected by Gemcitabine Ebewe or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while being given this medicine.

HOW GEMCITABINE EBEWE IS GIVEN

Gemcitabine Ebewe is given as an infusion (drip) into your veins over a 30 minute period. Your doctor or nurse will inject it for you.

Never inject this medicine yourself. Always let your doctor or nurse administer it.

Your doctor will decide the dosage of Gemcitabine Ebewe to be given to you. The dosage you receive is based on your weight and height. Your doctor may use this medicine differently to the way it is described in this leaflet. If you have any queries on the dosage of your medicine or on how often it will be given to you, please ask your doctor.

How often it will be given

For Lung Cancer
Gemcitabine Ebewe can be given once a week for three consecutive weeks, followed by one week without treatment or once a week for two consecutive weeks, followed by one week without treatment. Your doctor will decide how many of these cycles you will need.

For Pancreatic Cancer
Initially, Gemcitabine Ebewe is given once a week for up to seven weeks followed by a week without treatment. Subsequent cycles of Gemcitabine Ebewe are given once a week for three consecutive weeks followed by a week without treatment. Your doctor will decide how many of these cycles you will need.

For Bladder Cancer
Gemcitabine Ebewe is given once a week for three consecutive weeks, followed by one week without treatment. Your doctor will decide how many of these cycles you will need.

For Breast Cancer
Gemcitabine Ebewe is given once a week for two consecutive weeks, followed by one week without treatment. Your doctor will decide how many of these cycles you will need.

For Ovarian Cancer
Gemcitabine Ebewe can be given once a week for two consecutive weeks, followed by one week without treatment. Your doctor will decide how many of these cycles you will need.

In Case of Overdose

As Gemcitabine Ebewe is given to you under the supervision of your doctor, it is very unlikely that you will receive too much. However, if you experience any side effects after being given Gemcitabine Ebewe, tell your doctor immediately.

WHILE YOU ARE RECEIVING GEMCITABINE EBEWE

Things your doctor should do

  • your doctor should do blood counts before each dose of Gemcitabine Ebewe
  • your doctor should do periodic checks of your liver and kidney function.

Things you must do

Follow all directions given to you by your doctor carefully.

Keep all of your doctor’s appointments so that your progress can be checked. Your doctor may do some blood tests and other tests, from time to time to make sure the medicine is working and to prevent any side effects.

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are being given Gemcitabine Ebewe.

Tell any other doctors, dentists, pharmacists and health care professionals who treat you that you are being given this medicine.

If you become pregnant while being given this medicine, tell your doctor immediately.

Things to be careful of

Be careful driving or operating machinery until you know how Gemcitabine Ebewe affects you. This medicine may cause sleepiness in some people. If you have this symptom, do not drive, operate machinery or do anything else that could be dangerous.

Be careful when drinking alcohol while you are being given this medicine. If you drink alcohol, drowsiness may be worse.

The breakdown products may be excreted in body fluids and waste, including blood, urine, faeces, vomitus and semen.

In general, precautions to protect other people should be taken while you are receiving Gemcitabine Ebewe by:

  • flushing the toilet twice (with the toilet lid down) to dispose of any body fluids and waste
  • wearing gloves to clean any spill of body fluid or waste. Use paper towels or old rags, a strong solution of non-bleaching detergent and large amounts of water to mop up the spill. Discard the towels or rags into a separate waste bag and dispose of fluids in the toilet
  • washing linen or clothing that is heavily contaminated by body fluids or waste separately from other items. Use a strong solution of non-bleaching detergent and large amounts of water
  • placing soiled disposable nappies and other pads in a plastic bag, seal and dispose into the garbage
  • for sexual intercourse, use a barrier method such as a condom.

SIDE EFFECTS

Tell your doctor or health care professional as soon as possible if you do not feel well while you are being given Gemcitabine Ebewe. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Ask your doctor or health care professional to answer any questions you may have.

Tell your doctor or health care professional if you notice any of the following and they worry you:

  • tiredness, sleepiness, drowsiness
  • skin rash and itching
  • swelling of the hands, feet or face
  • unusual hair loss or thinning
  • soreness in the mouth, ulceration of the mouth
  • scaling, ulceration, sore formation on the skin
  • pain at the site of injection
  • insomnia
  • weakness
  • difficulty in breathing
  • dizziness, light-headedness.

Stomach or bowel problems such as:

  • feeling sick
  • nausea
  • vomiting
  • diarrhoea
  • constipation.

Influenza-like symptoms such as:

  • fever
  • headache
  • back-pain
  • cold shivers
  • cough
  • sweating
  • muscle pain
  • unusual tiredness or weakness
  • loss of appetite
  • generally feeling unwell
  • inability to sleep
  • runny or blocked nose, sneezing.

These are the more common side effects of Gemcitabine Ebewe.

Tell your doctor as soon as possible if you notice any of the following:

  • frequent infections such as fever, severe chills, sore throat or ulcers
  • sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips or tongue or other parts of the body, shortness of breath, wheezing or trouble breathing
  • difficulty in breathing; wheezing or coughing
  • shortness of breath
  • bruising or bleeding more easily than normal
  • tiredness, headaches, being short of breath when exercising, dizziness and looking pale.

Skin reactions such as:

  • skin lesions
  • small, solid, raised areas of skin
  • raised bumps on the skin that contain fluid (blisters)
  • open sores on the skin (ulcers)
  • peeling of skin.

The above list includes serious side effects that may require medical attention.

Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you notice any of the following even if they occur several weeks after stopping treatment with Gemcitabine Ebewe:

  • breathlessness, which may be severe and usually worsens on lying down
  • quick shallow breathing followed by shortness of breath and difficulty in breathing
  • shortness of breath
  • swelling of the face, lips, mouth or throat which may cause difficulty in swallowing or breathing
  • slightly bluish, greyish or dark purple discolouration of the skin
  • cold extremities, discolouration or loss of sensation in the extremities
  • severe skin reactions including desquamation and bullous skin eruptions, painful red areas which may bleed
  • tiredness, headaches and bruising or bleeding more easily than normal
  • yellowing of the skin and/or eyes; passing less urine than is normal
  • chest pain, changes in the rhythm or rate of the heart beat
  • collapse, numbness or weakness of the arms or legs, confusion, visual disturbance, difficulty swallowing, slurred and loss of speech
  • abdominal pain and/or bloody diarrhoea.

The above list includes serious side effects. You may need urgent medical attention or hospitalisation. These side effects are rare.

Tell your doctor or health care professional if you notice anything else that is making you feel unwell. Other side effects not listed above may also occur in some people.

The benefits and side effects may take some time to occur. Therefore, even after you have finished your Gemcitabine Ebewe treatment, you should tell your doctor or health care professional immediately if you notice any of the side effects listed in this section.

STORAGE

Gemcitabine Ebewe will be stored appropriately at the pharmacy or on the ward.

10mg/mL strengths:
Gemcitabine Ebewe 200mg/20mL
Gemcitabine Ebewe 500mg/50mL
Gemcitabine Ebewe 1000mg/100mL
Keep the medicine in a cool dry place where the temperature stays below 25ºC. Do not refrigerate or freeze.

40mg/mL strengths:
Gemcitabine Ebewe 200mg/5mL
Gemcitabine Ebewe 1000mg/25mL
Gemcitabine Ebewe 2000mg/50mL
Store at 2ºC to 8ºC. Do not freeze.

PRODUCT DESCRIPTION

What it looks like

Gemcitabine Ebewe concentrated injection is a clear, colourless to pale yellow concentrate for solution for infusion.
Gemcitabine Ebewe is available in glass vial containers with a rubber stopper.
Gemcitabine Ebewe comes in two concentrations.

10mg/mL strengths:
Gemcitabine Ebewe 200mg/20mL
Gemcitabine Ebewe 500mg/50mL
Gemcitabine Ebewe 1000mg/100mL

40mg/mL strengths:
Gemcitabine Ebewe 200mg/5mL
Gemcitabine Ebewe 1000mg/25mL
Gemcitabine Ebewe 2000mg/50mL

Ingredients

10mg/mL strengths:
Active ingredients:

  • Gemcitabine Ebewe 200mg/20mL – 200mg gemcitabine as hydrochloride.
  • Gemcitabine Ebewe 500mg/50mL – 500mg gemcitabine as hydrochloride.
  • Gemcitabine Ebewe 1000mg/100mL – 1000mg gemcitabine as hydrochloride.

Inactive Ingredients:

  • Sodium acetate
  • Sodium hydroxide
  • Water for injections

40mg/mL strengths:
Active ingredients:

  • Gemcitabine Ebewe 200mg/5mL – 200mg gemcitabine as hydrochloride.
  • Gemcitabine Ebewe 1000mg/25mL – 1000mg gemcitabine as hydrochloride.
  • Gemcitabine Ebewe 2000mg/50mL – 2000mg gemcitabine as hydrochloride.

Inactive Ingredients:

  • Water for injections
  • Dilute hydrochloric acid.

Supplier

Sandoz Pty Ltd
ABN 60 075 449 553
19 Harris St
Pyrmont NSW 2009
Australia
Tel: 1800 634 500

Novartis New Zealand Ltd
Private Bag 65904 Mairangi Bay
Auckland 0754
New Zealand
Tel: 0800 354 335

This leaflet was prepared in June 2011.

Australian Register Numbers

10mg/mL strengths:
Gemcitabine Ebewe 200mg/20mL concentrated injection: AUST R 146760
Gemcitabine Ebewe 500mg/50mL concentrated injection: AUST R 146762
Gemcitabine Ebewe 1000mg/100mL concentrated injection: AUST R 146761

40mg/mL strengths:
Gemcitabine Ebewe 200mg/5mL concentrated injection: AUST R 169042
Gemcitabine Ebewe 1000mg/25mL concentrated injection: AUST R 169041
Gemcitabine Ebewe 2000mg/50mL concentrated injection: AUST R 169043

Published by MIMS November 2011