NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.
NAVELBINE ORAL
Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.
Why am I using Navelbine Oral?
Navelbine Oral contains the active ingredient vinorelbine tartrate. Navelbine Oral is used to treat lung cancer and advanced breast cancer. For more information, see Section 1. Why am I using Navelbine Oral? in the full CMI.
What should I know before I use Navelbine Oral?
Do not use if you have ever had an allergic reaction to or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before I use Navelbine Oral? in the full CMI.
What if I am taking other medicines?
Some medicines may interfere with Navelbine Oral and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
How do I use Navelbine Oral?
Navelbine Oral is given as a capsule. Swallow your Navelbine Oral capsule whole with a full glass of water, without chewing or sucking the capsule.
More instructions can be found in Section 4. How do I use Navelbine Oral? in the full CMI.
What should I know while using Navelbine Oral?
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Things you should do
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Keep all appointments with your doctor to check on your progress and monitor side effects.
If you become pregnant while taking Navelbine Oral, tell your doctor immediately.
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Things you should not do
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You should not breast-feed while you are being treated with Navelbine Oral.
Men being treated with Navelbine Oral are advised not to father a child during and up to a minimum of 3 months after treatment.
Do not use if you have or have had an infection or high temperature in the last 2 weeks
Do not use if you are currently receiving radiation therapy.
Do not use if you have recently had a yellow fever vaccination or plan to have one.
Do not use if you have severe liver problems, if you have a reduced number of platelets of red blood cells, if you have stomach or intestinal disorders or if you have any condition requiring long-term oxygen therapy
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Driving or using machines
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Be careful driving or operating machinery until you know how Navelbine Oral affects you.
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Drinking alcohol
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Fatigue and Dizziness are common side effects of Navelbine Oral. Drinking alcohol may make these symptoms worse.
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Looking after your medicine
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Store Navelbine Oral in the refrigerator (2 to 8°C). Do not freeze it.
Keep away from light and where children cannot reach.
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For more information, see Section 5. What should I know while using Navelbine Oral? in the full CMI.
Are there any side effects?
Common side effects include nausea, vomiting, diarrhoea, loss of appetite, unusual tiredness, weakness, sleepiness, drowsiness or lack of energy, unusual hair loss, constipation, aching muscles, skin reactions, fever, jaw pain, painful swollen joints, weight loss, weight gain and high or low blood pressure. Serious side effects include difficulty breathing, chest pain, fast or irregular heartbeat, rash, itching or hives on the skin, swelling of the feet and ankles, face, lips, tongue or other parts of the body.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.
Active ingredient(s): vinorelbine tartrate
Consumer Medicine Information (CMI)
This leaflet provides important information about using Navelbine Oral. You should also speak to your doctor or pharmacist if you would like further informationor if you have any concerns or questions about using Navelbine Oral.
Where to find information in this leaflet:
1. Why am I using Navelbine Oral?
2. What should I know before I use Navelbine Oral?
3. What if I am taking other medicines?
4. How do I use Navelbine Oral?
5. What should I know while using Navelbine Oral?
6. Are there any side effects?
7. Product details
Why am I using Navelbine Oral?
Navelbine Oral contains the active ingredient vinorelbine tartrate. Vinorelbine belongs to a family of medicines called vinca alkaloids.
Navelbine Oral belongs to a group of medicines called antineoplastic or cytotoxic medicines.You may also hear of these medicines being called chemotherapy.
Navelbine Oral is used treat lung cancer and advanced breast cancer.
Navelbine Oral may be used on its own or in combination with other medicines to treat cancer. Navelbine Oral works by stopping cancer cells from growing and multiplying causing the cells to die.
Navelbine Oral is not recommended for use in children and adolescents aged less than 18 years as there is no information on its effects in these age groups.
What should I know before I use Navelbine Oral?
Warnings
Do not use Navelbine Oral if:
you are allergic to vinorelbine; or to the other vinca alkaloids, (vinblastine, vincristine, vindesine, vinflunine); or to any of the ingredients listed at the end of this leaflet.
Symptoms of an allergic reaction to Navelbine Oral may include:
shortness of breath
wheezing, difficulty breathing or a tight feeling in your chest
swelling of the face, lips, tongue or other parts of the body
rash, itching, hives or flushed, red skin
if you have or have had (within the last two weeks), a severe infection. Your doctor may decide to delay your treatment until the infection has gone.
if you plan to have a yellow fever vaccine or have just had one.
if you are currently receiving radiation therapy to your liver.
if you have or have had any of the following medical conditions:
severe liver problems
a low white blood cell and/or platelet count which you may notice as signs of frequentinfections such as fever, severe chills, sore throat or mouth ulcers
surgery on your stomach or small bowel
stomach or intestinal disorders
any condition requiring long-term oxygen therapy
Always check the ingredients to make sure you can use this medicine.
Do not take Navelbine Oral if you are pregnant or intend to become pregnant.
Like most medicines used to treat cancer, Navelbine Oral is not recommended for use in pregnancy. Navelbine Oral may affect your developing baby if you take it during pregnancy. If there is a need to consider Navelbine Oral during your pregnancy, your doctor will discuss with you the benefits and risks of using it.
Do not breastfeed while being treated with Navelbine Oral.
Navelbine Oral may pass into breast milk and therefore there is a possibility that the breast-fed baby may be affected.
Check with your doctor if you:
have or have had a severe infection in the last 2 weeks. Your doctor may decide to delay your treatment until the infection has gone.
have allergies to:
any other medicines
any other substances, such as foods, preservatives or dyes
if you have, or have had, any of the following medical conditions:
heart problems (including chest pain and heart attack)
liver problems
a low white blood cell and/or platelet count which you may notice as signs of frequentinfections such as fever, severe chills, sore throat or mouth ulcers
stomach problems (including surgery on your stomach)
lung problems, including asthma
the rare hereditary problem of fructose intolerance (due to the presence of sorbitol).
take any medicines for any other condition or treatments for cancer, including radiation therapy.
Navelbine Oral must not be taken if you are currently receiving radiation therapy to your liver.
if you plan to have a vaccination. Having a live attenuated vaccine (eg: measles, mumps, rubella vaccine) is not recommended while taking Navelbine Oral as they may increase the risk of life-threatening vaccine disease.
if your ability to carry out activities of daily living is strongly reduced.
Navelbine Oral is a potent cytotoxic drug that results in a decrease in blood cells. Your blood count will be carefully monitored before and during your treatment.
During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Like most medicines used to treat cancer, Navelbine Oral is not recommended for use in pregnancy.Navelbine Oral may affect your developing baby if you take it during pregnancy.
If you are a fertile man or woman, you should use an effective method of contraception during your treatment with Navelbine Oral and for three months after your last dose of Navelbine Oral.
Men being treated with Navelbine Oral are advised not to father a child during and up to a minimum of 3 months after treatment.Prior to treatment, advice should be sought for conserving sperm due to the chance of irreversible infertility as a consequence of treatment with Navelbine Oral.
If there is a need to consider Navelbine Oral during your pregnancy, your doctor will discuss with you the benefits and risks of using it.
Talk to your doctor if you are breastfeeding or intend to breastfeed. You must stop breast-feeding before starting treatment with Navelbine Oral.
What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines may interfere with Navelbine Oral and affect how it works. These include:
mitomycin and lapatinib, medicines used to treat cancer;
warfarin, phenindione and other medicines used to prevent blood clots;
other medicines used to treat cancer such as cisplatin;
ketoconazole and itraconazole, medicines used to treat fungal infections;
retonavir, a medicine used to treat HIV and AIDS;
rifampicin, a medicine used to treat tuberculosis or meningitis;
cyclosporin and tacrolimus, drugs which reduce the body’s ability to fight illness/disease (known as immunosuppressants).
phenytoin, a medicine used to treat epilepsy or fits.
These medicines may be affected by Navelbine Oral or may affect how well it works. You may need to take different amounts of your medicine, or you may need to take different medicines.Your doctor or pharmacist will advise you.
Your doctor and pharmacist may have more information on medicines to be careful with or to avoid while having Navelbine Oral.
If you have not told your doctor about any of the above, do so before you begin treatment with Navelbine Oral.
Check with your doctor or pharmacist if you are not sure about what medicines, vitaminsor supplements you are taking and if these affect Navelbine Oral.
How do I use Navelbine Oral?
How much to take
Your doctor will decide what dose you will receive.This depends on your body surface area, your condition and factors such as your liver function and whether you are receiving any other chemotherapy medicines. Your doctor may adjust your dose during treatment.
Navelbine Oral may be given alone or in combination with other drugs.
Several courses of Navelbine Oral therapy may be needed depending on your response to treatment.
Navelbine Oral reduces the number of white blood cells in the body.Your doctor will check these levels regularly.Further doses of Navelbine Oral may be delayed until your blood cell numbers return to acceptable levels.
How to take
Navelbine Oral is given as a capsule.
Swallow your Navelbine Oral capsule whole with a full glass of water, without chewing or sucking the capsule.The liquid inside Navelbine Oral is an irritant and may cause damage if it comes in contact with your skin, mucosa or eyes.
Damaged capsules should not be swallowed.
If contact with the contents of the capsule does occur, wash the affected area thoroughly with water or a normal saline solution.
Navelbine Oral should be taken with food.
If vomiting occurs within a few hours of taking Navelbine Oral, the dose of Navelbine Oral should not be repeated.Your doctor may prescribe a medication to help with vomiting if it is a problem.
To open the child resistant packaging:
Cut the blister along the black dotted line;
Peel off the soft plastic foil;
Push the capsule through the aluminium foil.
How long it is given
Navelbine Oral is usually given every week, but it may be given less often if you are also having other medicines to treat cancer. Your doctor will decide how many doses you will need.
If you forget to use Navelbine Oral
Tell your doctor as soon as possible if you realise that you have missed your dose of Navelbine Oral.
If you have problems remembering when your next dose is due, use a diary or calendar or ask a friend to remind you.Please also refer to your Navelbine Oral ‘Patient Booklet’.
If you use too much Navelbine Oral
If you think that you have used too much Navelbine Oral you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling 13 11 26), or
(by calling 13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
What should I know while using Navelbine Oral?
Things you should do
Keep all appointments with your doctor. Your doctor may want to do some blood and other tests from time to time to check on your progress and monitor any unwanted side effects.
If you are about to be started on any new medicine, tell your doctor, dentist or pharmacist that you are having treatment with Navelbine Oral.
If you become pregnant while taking Navelbine Oral, tell your doctor immediately. Navelbine Oral can lower the number of white blood cells and platelets in your blood. This means that you have an increased chance of getting an infection or bleeding.
Take the following precautions to reduce your risk of infection or bleeding:
Check with your doctor immediately if you think you may be getting an infection, orif you get a fever, chills, cough, hoarse throat, lower back or side pain or findit painful or difficult to urinate;
Avoid people who have infections.
Be careful when using a toothbrush, toothpick or dental floss.Your doctor, dentist,nurse or pharmacist may recommend other ways to clean your teeth and gums.Checkwith your doctor before having any dental work.
Be careful not to cut yourself when you are using sharp objects such as a razor ornail cutters.
Avoid contact sports or other situations where you may bruise or get injured.
Call your doctor straight away if you
are feeling unwell after taking Navelbine Oral.
Remind any doctor, dentist or pharmacist you visit that you are having treatment with Navelbine Oral.
Things you should not do
You should not breast-feed while you are being treated with Navelbine Oral.Breastfeeding must be discontinued before starting treatment with Navelbine Oral.
Men being treated with Navelbine Oral are advised not to father a child during and up to a minimum of 3 months after treatment. Prior to treatment, advice should be sought for conserving sperm due to the chance of irreversible infertility as a consequence of treatment with Navelbine Oral.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how NavelbineOral affects you.
If you experience symptoms that affect your ability to concentrate and react, do not drive a car or operate machinery.Dizziness and fatigue are common side effects of Navelbine Oral.Make sure you know how Navelbine Oral affects you before you drive a car, operate machinery or do anything else that could be dangerous if you are feeling tired or dizzy.
Drinking alcohol
Tell your doctor if you drink alcohol.
Drinking alcohol may make the tiredness and dizziness worse.
Looking after your medicine
If you are storing Navelbine Oral at home:
Store Navelbine Oral in the refrigerator (2 to 8°C) in the original packaging. Do not freeze it.
Protect Navelbine Oral from light.
Do not store Navelbine Oral or any other medicine in the bathroom or near a sink.Do not leave it on a windowsill or in the car
Heat and dampness will destroy the medicine.
Follow the instructions in the carton on how to take care of your medicine properly.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If your doctor stops your treatment with Navelbine Oral, or it has passed its expiry date, return any leftover capsules to your pharmacist. Do not dispose of Navelbine Oral via wastewater or household waste.This will help to protect the environment.
Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.
Less serious side effects
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Less serious side effects
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What to do
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Pain Related
aching muscles, muscle tenderness or weakness, not caused by exercise
pain, including pain at the tumour site
jaw pain
painful swollen joints
Problems with skin and hair
skin reactions
unusual hair loss or thinning
Head and neurology related
unusual tiredness, weakness, sleepiness, drowsiness or lack of energy
trouble sleeping
dizziness
headache
Gastrointestinal upset
Nausea
vomiting
diarrhoea
constipation
upset stomach
loss of appetite
indigestion
weight loss
weight gain
Respiratory related
coughing
change in or loss of taste
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Speak to your doctor if you have any of these less serious side effects and they worryyou.
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Serious Side effects
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Serious side effects
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What to do
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Breathing problems:
difficulty breathing, short of breath
Infection related:
frequent infections or signs of infection such as fever, severe chills, sore throat or mouth ulcers (symptoms of a lack of white blood cells)
sore mouth
mouth ulcers and cold sores
viral, bacterial or fungal infections
blood infections (sepsis) symptoms such as high fever and deterioration in general health.
Head and neurology related
tiredness, headaches, dizziness and looking pale (symptoms of a decreased number of red blood cells)
Lack of muscle control may be associated with abnormal gait, speech changes and abnormalities in eyes movement
Bleeding related:
bleeding or bruising more easily than normal or nosebleeds (symptoms of a low blood platelet count)
Eye problems:
changes in your vision
Gastrointestinal problems:
stomach pain
Throat related:
difficulty swallowing
Urinary related:
pain or burning feeling when passing urine or other urinary problems.
Heart related:
chest pain
palpitations, fast or irregular heart beat
high blood pressure
low blood pressure
Allergy related:
rash, itching or hives on the skin
swelling of the feet and ankles, face, lips, tongue or other parts of the body
Liver related
liver disorders (abnormal liver test).
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Call your doctor straight away, or go straight to the Emergency Department at yournearest hospital if you notice any of these serious side effects.
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Tell your doctor or pharmacist if you notice anything else that may be making youfeel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stoptaking any of your medicines.
Product details
This medicine is only available with a doctor’s prescription.
What Navelbine Oral contains
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Active ingredient
(main ingredient)
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vinorelbine tartrate
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Other ingredients
(inactive ingredients)
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ethanol
purified water
glycerol
macrogol 400
gelatin
anidrisorb 85/70
phosal 53 MCT
medium-chain triglycerides
edible ink red
titanium dioxide
iron oxide yellow
iron oxide red
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Potential allergens
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No
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Do not take this medicine if you are allergic to any of these ingredients.
What Navelbine Oral looks like
Navelbine Oral soft capsules are available in four strengths: 20 mg, 30 mg, 40 mg* and 80 mg*.
Navelbine Oral 20 mg soft capsules are light brown and printed N20.
Navelbine Oral 30 mg soft capsules are pink and printed N30.
Navelbine Oral 40 mg soft capsules are brown and printed N40.
Navelbine Oral 80 mg soft capsules are pale yellow and printed N80.
Navelbine Oral comes in blister packs of 1 tablet.
*These pack sizes are not available in Australia.
Australian Registration Number:
20 mg: AUST R 99498
30 mg: AUST R 99558
40 mg: AUST R 99561
80 mg: AUST R 99564
Who distributes Navelbine Oral
Pierre Fabre Australia Pty Limited
Suite 901, 1 Elizabeth Plaza
North Sydney NSW 2060
This leaflet was prepared in August 2020
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