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NAVELBINE 20MG SOFT CAPSULE

Active substance: VINORELBINE TARTRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

NAVELBINE 20mg soft capsule
NAVELBINE 30mg soft capsule
NAVELBINE 80mg soft capsule
Vinorelbine as tartrate
Read all of this leaflet carefully before you start taking this
medicine.
•  eep this leaflet. You may need to read it again.
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• f you have further questions, ask your doctor or your
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pharmacist.
•  his medicine has been prescribed for you. Do not pass it
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on to others. It may harm them, even if their symptoms are
the same as yours.
• f any of the side effects gets serious, or if you notice any
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side effects not listed in this leaflet, please tell your doctor
or pharmacist.

In this leaflet:
1. What Navelbine soft capsule is and what it is used for
2. Before you take Navelbine soft capsule

3. How to take Navelbine soft capsule
4. Possible side effects
5. Storing Navelbine soft capsule
6. Further information.

1. What Navelbine soft capsule is and what it is used for

Navelbine belongs to a family of medicines used to treat cancer
called the vinca-alkaloid family.
Navelbine is used to treat:
• Non-small cell lung cancer.
•  dvanced breast cancer that has not responded to other
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medicines.
It is not recommended for use by children under 18 years old.

2. Before you take Navelbine soft capsule

Do not take Navelbine soft capsule
• f you are allergic (hypersensitive) to the active ingredient,
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vinorelbine, or any of the related family of cancer drugs called
the vinca alkaloids.
• f you are allergic to any of the other ingredients in Navelbine
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capsules (refer to section 6 of this leaflet).
• f you are pregnant or think that you might be pregnant.
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• If you are breast feeding.
• If you have a severe liver disease.
• f you have had an operation on your stomach or small bowel,
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or if you have gut disorder which affects how you absorb food.
These may affect how your body absorbs Navelbine.

• f you have a low white blood cell count (neutrophils, leucocytes)
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or a severe infection current or recent within two weeks.
• If you have a low blood platelet cell count (thrombocytopenia).
• f you plan to have a yellow fever vaccination or have just had one.
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• f you require long-term oxygen therapy.
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If in doubt, ask your doctor or pharmacist.

Take special care with Navelbine soft capsule
Please inform your doctor if:
•  ou have a history of heart attack or severe chest pain.
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•  our ability to carry out activities of daily living is strongly reduced.
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•  ou have problems with your liver or you have received
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radiotherapy where the treatment field included the liver.
• f you have been told by your doctor that you have an intolerance
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to some sugars, contact your doctor before taking this medicinal
product.
•  ou have symptoms of infection (such as fever, chills, joint pain,
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cough).
•  ou take, or have recently taken, any other medicines including
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medicines obtained without a prescription.
•  ou plan to have a vaccination or have just had one.
Y
Before and during your treatment with Navelbine blood cell counts
are performed to check that it is safe for you to receive treatment.
If the results of this analysis are not satisfactory, your treatment
may be delayed and further checks made until these values return
to normal.

Taking other medicines
Please inform your doctor or pharmacist if you are taking, or have
recently taken, any other medicines, including medicines obtained
without a prescription.
If you are given Navelbine as well as medicines that affect your
bone marrow it may make some of the side effects worse.
Your doctor should take special attention if you are taking the
following medicines:
•  edicines used to thin your blood (anticoagulants),
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•  n anti-epileptic medicine called phenytoin,
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•  ntifungal medicines such as itraconazole and ketaconazole,
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•  n anti-cancer medicine called mitomycin C,
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•  edicines that impair your immune system such as ciclosporin
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and tacrolimus.

Male fertility
Men being treated with Navelbine are advised not to father a
child during and up to 3 months after the last capsule. You should
discuss sperm banking with your doctor before starting treatment
with Navelbine.

However, some of the possible side effects of Navelbine could affect
your ability to drive or perform skilled tasks: see section 4; Possible
side effects below for details. Therefore, it is recommended that
you should not drive if you feel unwell or if your doctor has advised
you not to drive.

Women of child bearing age
Women of child-bearing age must use effective contraception (birth
control) during treatment and up to 3 months after treatment.

Important information about some of the ingredients
This medicine contains sorbitol. If you have been told by your doctor
that you have an intolerance to some sugars, contact your doctor
before taking this medicinal product.
This medicinal product contains small amounts of ethanol (alcohol),
less than 100mg per dose, you will not be affected by this small
quantity.

Pregnancy
Do not take Navelbine if you are pregnant, or think that you might
be pregnant. If you have to start treatment with Navelbine and you
are pregnant, or if pregnancy occurs during your treatment with
Navelbine, do not stop taking Navelbine. Immediately ask your
doctor about the potential risks for the unborn child.

Many vaccines (live attenuated vaccines) are not recommended
during treatment with Navelbine. Please inform your doctor if you
require any vaccinations.

Breast-feeding
Do not take Navelbine if you are breast feeding.
Breast feeding must be discontinued if treatment with Navelbine
is necessary.

Taking Navelbine soft capsule with food and drink
The soft capsule of Navelbine should be swallowed whole with
water without chewing or sucking the capsule.
It is preferable to take Navelbine with a light meal.
Navelbine should not be taken with a hot drink as it will dissolve
the capsule too quickly.

Ask your doctor or pharmacist for advice before taking any
medicine.
Driving and using machines
It is unlikely that Navelbine will affect your ability to drive or operate
machinery.

3. How to take Navelbine soft capsule

Navelbine should be given under the supervision of a qualified
doctor who is experienced in the use of cancer treatments.
Navelbine must be taken by mouth.
Navelbine is used in patients over 18 years old.
It is not recommended for use by children under 18 years old.
Always take Navelbine exactly as your doctor has told you.
You should check with your doctor or pharmacist
if you are not sure.

Dosage
Before and during your treatment with Navelbine your doctor will
check your blood cell count to determine when you receive your
treatment and which dose is suitable for you. Your doctor will tell
you the number and strength of capsules which you should take.
This will depend on your body weight and body height.

If you take an anti-sickness medicine
Vomiting can occur with Navelbine: see section 4. Possible side
effects. If your doctor has prescribed an anti-sickness medication,
always take it exactly as the doctor has told you.

Your doctor will calculate your body surface area in square meters
(m2). The usual weekly dose, taken in a single dose, is 60 mg/m2 of
body surface area for the first 3 doses. After the third dose, your
doctor will decide if the dose will be increased to 80mg/m2 of
body surface area. In any case, your doctor may adjust the dose of
Navelbine.

Method of administration
Before opening the blisters containing Navelbine, make sure that
there are no damaged capsules because the liquid inside is an
irritant and may be harmful if it comes into contact with your skin,
eyes or mucosa. If it happens, wash the affected area immediately
and thoroughly with water.

If you are receiving the capsules with another medicine to treat
your cancer/condition, your doctor will decide on an appropriate
dose for you.

Do not swallow any damaged capsules;
return them to your doctor or pharmacist.

The total dose should never exceed 160 mg per week.
You should never take Navelbine more than once a week.

Opening the “peel-push” blister:
1. Cut the blister along the black dotted line with a pair of scissors.
2. Peel the soft plastic foil off.
3. Push the capsule through the aluminium foil.

Frequency of administration
Normally Navelbine treatment is scheduled once a week.
The frequency will be determined by your doctor.
Duration of treatment
The duration of your treatment is decided by your doctor.

Take Navelbine during a light meal; this will help to reduce
the feeling of sickness.

Taking Navelbine soft capsule:
•  wallow Navelbine whole with water,
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preferably with a light meal. It should not
be taken with a hot drink as it will dissolve
the capsule too quickly.

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•  o not chew or suck the capsules.
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• f you chew or suck a capsule by mistake, rinse your mouth
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thoroughly with water and tell your doctor immediately.
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• f you vomit within a few hours after taking your Navelbine,
contact your doctor; do not repeat the dose.
If you take more Navelbine soft capsule than you should
If you may have taken more Navelbine than the prescribed dose,
contact a doctor immediately.
Your dose of Navelbine is carefully monitored and checked by your
doctor and pharmacist. However, although you will have received
the correct amount of chemotherapy your body may sometimes
react giving severe symptoms.
Some of these symptoms may develop as signs of an infection
(such as fever, chills, cough, joint pain). You may also become
severely constipated. You must immediately contact your doctor if
any of these severe symptoms occur.
If you forget to take Navelbine soft capsule
Do not take a double dose to make up a forgotten dose.
Contact your doctor who will take the decision about rescheduling
your dose.
If you stop using Navelbine soft capsule
Your doctor will decide when you should stop your treatment.
However, if you want to stop your treatment
earlier, you should discuss other options with
your doctor.

If you have any further questions on the use of this product,
ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Navelbine can have side effects although not
everybody gets them.
While taking Navelbine, if you develop any of the following
symptoms you should contact your doctor immediately:
• signs of a major infection such as cough, fever and chills
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•  evere constipation with abdominal pain when your bowels
have not been open for several days,
• severe dizziness, light-headedness when you stand up
• severe chest pain which is not normal for you
• signs of allergy such as itching, shortness of breath.
Very common side effects
(can occur in more than 1 in 10 patients treated)

• Feeling sick (nausea)
• Vomiting

What should you do?
Immediately
contact your doctor
if this becomes
uncontrollable.
These side effects
may be controlled
with standard therapy.
Do not repeat the dose
if you vomit within a few
hours after taking your
Navelbine.

•  fall in some white blood cells which makes you
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more vulnerable to infection. This can commonly
cause bacterial, viral or fungal infections in
your body (respiratory, urinary, gastro-intestinal
systems and possibly others).
•  fall in red blood cells (anaemia) which can
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make the skin pale and cause weakness or
breathlessness.
•  fall in blood platelets (thrombocytopenia) which
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can increase the risk of bleeding or bruising.
•  oss of some reflex reactions, occasionally
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difference in the perception of touch.

Immediately contact
your doctor, especially
if your temperature
reaches 38°C or higher.

Immediately contact
your doctor for
treatment, should these
symptoms become
severe.

• nflammation or sores in the mouth or throat
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(stomatitis).
Immediately contact
•  iarrhoea.
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•  onstipation. If you have abdominal pain or if you your doctor.
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do not have a bowel movement for several days.
•  astric disorders.
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H
•  air loss (alopecia).
•  iredness (fatigue).
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•  alaise.
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•  ever.
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•  eight loss.
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•  oss of appetite (anorexia).

Ask your doctor for
advice if the symptoms
persist.
These are possible
symptoms when
receiving chemotherapy.

Common side effects
(can occur in less than 1 in 10 patients treated)

What should you do?

Uncommon side effects
(can occur in more than 1 in 100 patients treated)

What should you do?

Effects on your nervous system:
•  alance disorders (ataxia).
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•  ifficulty in sleeping.
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•  eadache.
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•  izziness.
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•  difference in your taste of the flavours.
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• nflammation of the throat and gullet
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(oesophagitis).
•  ifficulty when swallowing food or liquids.
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•  kin reactions.
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•  oint pain (arthralgia).
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•  aw pain.
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•  uscle pain (myalgia).
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•  ain at different sites in your body and
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pain where your tumour is.
•  hills.
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•  eight gain.
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Ask your doctor for
advice if the symptoms
persist.

•  euromotor disorders.
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•  ifferences in your eyesight.
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•  igh blood pressure with symptoms such as a
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headache.
•  ow blood pressure with symptoms such as
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dizziness or feeling faint.
•  hortness of breath.
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•  ough
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•  bnormal liver test.
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•  ain, burning and difficulty in passing urine.
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Immediately contact
your doctor for
treatment, should any
of these symptoms
become severe.

Immediately contact
Effects on your gastrointestinal system:
•  evere constipation with abdominal pain when your doctor.
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your bowels have not been open for several days
(paralytic ileus).
The list below specifies side effects also reported with Navelbine soft capsule,
with frequency not known:
Side effects with frequency not known

What should you do?

Effects on your blood:
•  ow blood sodium (severe hyponatraemia) which
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can cause symptoms of tiredness, confusion,
muscle twitching and coma.
•  eneralised infection (sepsis) due to severe fall
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Immediately contact
of white blood cells.
your doctor.
Effects on your gastrointestinal system:
•  astrointestinal bleeding.
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Effects on your breathing:
•  evere difficulties in breathing.
S

Effects on your heart and blood vessels:
•  eart attack (myocardial infarction in patients
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with cardiac medical history or cardiac risk
factors).

Immediately contact
your doctor.

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

5. Storing Navelbine

Keep out of the reach and sight of children
Do not use Navelbine after the expiry date which is stated on
the blister and box (after Exp). The expiry date refers to the last day
of that month.
Store in a refrigerator (2°C - 8°C). Do not freeze.
Store in the original package in order to protect from light.
Medicines should not be disposed of via wastewater or household
waste. For safety reasons any unused capsules must be returned to
your doctor or pharmacist for destruction. These measures will help
to protect the environment.

6. FURTHER INFORMATION

What Navelbine soft capsule contains
The active substance is: Vinorelbine (as tartrate) 20, 30 or 80 mg.

The other ingredients are:
•  he solution contains: ethanol anhydrous; purified water; glycerol;
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macrogol 400.
•  he capsule shell contains: gelatin; glycerol 85 %; sorbitol/
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sorbitan (anidrisorb 85/70); triglycerides, medium chain and
PHOSAL 53 MCT (phosphatidylcholine; glycerides; ethanol
anhydrous) and colouring agents (E171-titanium dioxide and
E172 red and/or yellow iron oxide depending on the strength).
•  he edible printing ink contains: cochineal extract (E120),
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hypromellose, propylene glycol.
What Navelbine soft capsule looks like and contents of the
pack
Navelbine 20 mg soft capsules are light brown coloured, printed
with «N20».
Navelbine 30 mg soft capsules are pink coloured, printed with
«N30».
Navelbine 80 mg soft capsules are pale yellow coloured, printed
with «N80».
Soft capsules of 20, 30 and 80 mg are available as packs of
1 blister of 1 soft capsule.
Marketing Authorisation Holder
Pierre Fabre Ltd,
Hyde Abbey House, 23 Hyde Street
Winchester Hampshire S023 7DR, United Kingdom.

Manufacturer
Pierre Fabre Médicament Production
Avenue du Béarn
64320 Idron - France.
For any information on this product please contact Pierre Fabre Ltd;
Phone: 01962 874400
Other formats:
To listen to or request a copy of this leaflet in Braille,
large print or audio please call, free of charge:
0800 198 5000 (UK Only).
Please be ready to give the following information:
Product Name
Navelbine 20 mg soft capsule:
Navelbine 30 mg soft capsule:
Navelbine 80 mg soft capsule:

Reference Number
PL 00603/0029
PL 00603/0030
PL 00603/0032

This is a service provided by the Royal National Institute of the Blind.
This leaflet was last approved in 04/2011
NAVELBINE®: a registered trademark of PIERRE FABRE MEDICAMENT

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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