DBL Gemcitabine Injection

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NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.

Gemcitabine Hydrochloride

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about DBL™ Gemcitabine Injection (gemcitabine). 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 gemcitabine 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 with the medicine.

You may need to read it again.

What gemcitabine is used for

This medicine is used to treat the following types of cancer:

lung cancer

pancreatic cancer

bladder cancer

breast cancer

ovarian cancer.

This medicine belongs to a group of medicines called antineoplastic or cytotoxic medicines. You may also hear of these being called chemotherapy medicines.

This medicine works by killing cancer cells and stopping 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 may be used alone or in combination with other medicines to treat cancer.

This medicine is not addictive.

This medicine is available only with a doctor's prescription.

Before are given gemcitabine

When you must not be given it

Do not take gemcitabine if you have an allergy to:

any medicine containing gemcitabine hydrochloride

any of the ingredients listed at the end of this leaflet.

if the packaging is torn or shows sign of tampering.

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

Tell your doctor or pharmacist if you are pregnant or intend to become pregnant.

Like most cytotoxic medicines, gemcitabine is not recommended for use during pregnancy. If there is any need to consider gemcitabine during your pregnancy, your doctor or pharmacist will discuss with you the benefits and risks of using it.

Gemcitabine may cause birth defects if either the male or female is using it at the time of conception. It is recommended that you use some kind of birth control while you are being treated with gemcitabine.

Tell your doctor or pharmacist if you are breast-feeding while being treated with this medicine.

Gemcitabine may pass into breast milk and there is a possibility that your baby may be affected.

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 pharmacist for disposal.

If you are not sure whether you should start taking 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 medical conditions, especially the following:

liver problems

kidney problems.

Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding.

Your doctor can discuss with you the risks and benefits involved.

Tell your doctor if you are going to be vaccinated (have an injection to prevent a certain disease).

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

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 may interfere with each other.

These medicines may be affected by gemcitabine 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 taking this medicine.

How gemcitabine is given

How much is given

Your doctor will decide what dose you will receive. This depends on your condition and other factors, such as your weight, liver function, kidney function and other chemotherapy medicines you are being given.

Gemcitabine may be given alone or in combination with other drugs.

Several courses of gemcitabine therapy may be needed depending on your response to treatment.

Additional treatment may not be repeated until your blood cell numbers return to acceptable levels and any uncontrolled effects have been controlled.

Ask your doctor if you want to know more about the dose of Gemcitabine you receive.

How it is given

Gemcitabine must only be given by a doctor or nurse.

This medicine is usually given as a slow injection into a vein over 30 minutes.

How often it is given

For Lung Cancer

Gemcitabine 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 is given once a week for up to seven weeks followed by a week without treatment. Subsequent cycles of gemcitabine 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 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 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 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.

If you are given too much (overdose)

As gemcitabine 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 severe side effects after being given gemcitabine, tell your doctor immediately or go to Accident and Emergency at the nearest hospital.

In case of overdose, immediately contact the Poisons Information Centre for advice (telephone 13 11 26 in Australia).

You may need urgent medical attention.

While you are being treated with gemcitabine

Things you must do

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

Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.

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

Keep all of your doctor's appointments so that your progress can be checked.

Your doctor may want to check your blood pressure and do some blood and other tests from time to time to check on your progress and to detect any unwanted side effects.

Things to be careful of

Be careful driving or operating machinery until you know how gemcitabine affects you.

This medicine may cause sleepiness or drowsiness in some people. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are being treated with gemcitabine.

Like other medicines that treat cancer, gemcitabine may have unwanted side effects, some of which may be serious. You may need medical treatment 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 pharmacist to answer any questions you may have.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

sleepiness, drowsiness

itchy rash

swelling of the hands, feet or face

unusual hair loss or thinning

soreness, swelling or ulcers in the mouth

scaling, ulceration, sore formation on the skin

redness, warmth or pain in an area of skin that may be leaking clear fluid or pus.

pain at the site of injection

itching.

Stomach or bowel problems such as:

feeling sick

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.

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

wheezing or coughing

bruising or bleeding more easily than normal

tiredness, dizziness, headaches, being short of breath when exercising.

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

If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

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

rapid laboured breathing; extreme shortness of breath; slightly bluish, greyish or dark purple discolouration of the skin; cold extremities

quick shallow breathing followed by shortness of breath and difficulty in breathing

bruising or bleeding more easily than normal; yellowing of the skin and/or eyes; passing less urine than is normal; swollen legs

confusion

visual disturbance

seizures, fits or convulsions

chest pain, changes in the rhythm or rate of the heart beat.

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

Tell your doctor or pharmacist if you notice anything that is making you feel unwell.

Other side effects not listed above may also occur in some people. Some of these side effects can only be found when your doctor does tests from time to time to check your progress.

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

After using gemcitabine

Storage

DBL Gemcitabine Injection (Solution for Injection) will be stored in the pharmacy or on the ward. The solution should be stored in the fridge, between 2-8°C.