gemcitabine hydrochloride
Consumer Medicine Information
What is in this leaflet
This leaflet is designed to provide you with answers to some common questions about this medicine. It does not contain all the available information and does not take the place of talking with your doctor.
All medicines have risks and benefits.
Your doctor has more information about this medicine than is contained in this leaflet. Also, your doctor has had the benefit of taking a full and detailed history from you and is in the best position to make an expert judgement to meet your individual needs.
If you have any concerns about being given this medicine, talk to your doctor or health care professional.
Keep this leaflet with this medicine. You may need to read it again.
What GEMZAR is used for
GEMZAR is used to treat patients with:
lung cancer
cancer of the pancreas
bladder cancer
breast cancer
ovarian cancer.
GEMZAR works by killing cancer cells and preventing cancer cells from growing and multiplying.
GEMZAR belongs to a group of medicines called antineoplastic or cytotoxic medicines. You may also hear of these being called chemotherapy medicines.
Your doctor may have prescribed GEMZAR for another reason.
Ask your doctor or health care professional if you have any questions about why GEMZAR has been prescribed for you.
GEMZAR may be used in combination with other cytotoxic medicines to treat cancer.
Before you are given GEMZAR
Tell your doctor or health care professional if you have any of the following conditions or if you have ever experienced any of these conditions.
When you must not be given GEMZAR
You must not be given GEMZAR if you have had an allergic reaction to GEMZAR or to any of the ingredients listed at the end of this leaflet (see 'Product Description').
You must not be given GEMZAR if the packaging is torn or shows signs of tampering.
You must not be given GEMZAR after the expiry date printed on the pack.
Before you are given GEMZAR
Tell your doctor if you have allergies to:
any other medicines
any other substances such as 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 intend to become pregnant.
Like most medicines used to treat cancer, GEMZAR is not recommended to be given during pregnancy. If there is a need to consider GEMZAR during your pregnancy, your doctor will discuss with you the benefits and risks involved.
Tell your doctor if you are breast-feeding or plan to breast-feed.
It is recommended that you do not breast-feed while you are receiving GEMZAR, as it is not known whether GEMZAR passes into breast milk.
Tell your doctor or health care professional about these things before you are given GEMZAR.
Taking other medicines
Tell your doctor or health care professional if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines may be affected by GEMZAR or may affect how it works. Your doctor and health care professional may have more information on medicines to be careful with or avoid while being given GEMZAR.
How GEMZAR is given
GEMZAR is given as an infusion (drip) into your veins over a 30 minute period.
Your doctor or nurse will inject GEMZAR for you.
Never inject GEMZAR yourself. Always let your doctor or nurse do this.
How much GEMZAR will be given
Your doctor will decide what dose you will receive. This depends on your condition and other factors, such as your weight.
How often will GEMZAR be given
For Lung Cancer
GEMZAR 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, GEMZAR is given once a week for up to seven weeks followed by a week without treatment. Subsequent cycles of GEMZAR 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
GEMZAR 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
GEMZAR 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
GEMZAR 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.
Overdose
As GEMZAR 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 GEMZAR, tell your doctor immediately.
While you are receiving GEMZAR
Things you must do
Be sure to keep all your appointments with your doctor so your progress can be checked.
Your doctor may do some blood tests and other tests from time to time to check on your progress and detect any unwanted side effects.
Tell all doctors and health care professionals who are treating you that you are being given GEMZAR.
If you are about to be started on any new medicine, tell your doctor or health care professional that you are being given GEMZAR.
Tell your doctor if you become pregnant while you are being given GEMZAR.
Things to be careful of
Do not drive or operate machinery after receiving GEMZAR until you know how GEMZAR affects you.
GEMZAR may cause sleepiness in some people.
Side effects
Tell your doctor or health care professional as soon as possible if you do not feel well while you are being given GEMZAR.
Like other medicines that treat cancer, GEMZAR may have unwanted side effects, some of which may be serious. You may need medical treatment if you experience some of the side effects.
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 side effects and they worry you:
sleepiness, drowsiness
itchy rash
swelling of the hands, feet or face
unusual hair loss or thinning
soreness in the mouth
scaling, ulceration, sore formation on the skin
pain at the site of injection
dizziness, light-headedness
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 side effects:
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.
These may be serious side effects. You may need medical attention.
Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if any of the following happen:
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
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
discolouration or loss of sensation in the extremities.
These are very serious side effects. You may need urgent medical attention or hospitalisation.
Other side effects not listed above may occur in some patients. Tell your doctor or health care professional if you notice anything that is making you feel unwell.
Do not be alarmed by this list of possible side effects.
You may not experience any of them.
The benefits and side effects of GEMZAR may take some time to occur. Therefore, even after you have finished your GEMZAR treatment, you should tell your doctor or health care professional immediately if you notice any of the side effects listed in this section.
Storage
GEMZAR will be stored in the pharmacy or on the ward. The injection is kept in a cool dry place where the temperature stays below 30 degrees C.
Product Description
What it looks like
GEMZAR is a white to off white powder and is available in a glass vial container with a rubber stopper.
Ingredients
GEMZAR is available in two strengths.
GEMZAR 200 mg contains the active ingredient, gemcitabine hydrochloride, equivalent to 200 mg of gemcitabine.
GEMZAR 1 g contains the active ingredient, gemcitabine hydrochloride, equivalent to 1 g of gemcitabine.
Both strengths of GEMZAR also contain the inactive ingredients mannitol and sodium acetate.
