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FLUDARA ORAL 10 MG FILM-COATED TABLETS

Active substance(s): FLUDARABINE PHOSPHATE

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Package leaflet: Information for the user

oral 10 mg film-coated tablets
Fludarabine phosphate

3. How to take Fludara oral
4. Possible side effects
5. How to store Fludara oral
6. Contents of the pack and other information
1. What Fludara oral is and what it is used for

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505015

FLUDARA PO 10MG Leaflet

Genzyme UK (Suffolk)

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3. How to take Fludara oral
Always take this medicine exactly as your doctor has
told you. Check with your doctor or pharmacist if you
are not sure.
How many tablets to take
The dose you should take depends on your body
surface area. This is measured in square metres (m2)
and is worked out by the doctor from your height
and weight.
The recommended dose is 40 mg fludarabine
phosphate/m2 body surface area, once a day.
The usual dose is between 3 to 10 tablets once
a day. The exact number of tablets you should take
is calculated by your doctor.

Pharma
Code

Do not take Fludara oral:
왘 if you are allergic to fludarabine phosphate
or any of the other ingredients of this medicine
(listed in section 6).
왘 if you have an intolerance to lactose
monohydrate (see sub-section “Fludara oral
contains lactose monohydrate”).
왘 if you are breast-feeding.
왘 if you have severe kidney problems.
왘 if your red blood cell count is low, because of
a type of anaemia (decompensated haemolytic
anaemia). Your doctor will have told you if you
have this condition.
Tell your doctor, before taking Fludara oral if you
think any of these may apply to you.
Warnings and precautions
Talk to your doctor before taking Fludara oral.
Take special care with Fludara oral:
왘 if your bone marrow is not working properly
or if you have a poorly functioning or depressed
immune system or a history
of serious infections.
컄 Your doctor may decide to not give you this
medicine, or may take precautions.
왘 if you feel very unwell, notice any unusual
bruising, more bleeding than usual after injury,
or if you seem to be catching a lot of infections.
왘 if during treatment you have a red to
brownish urine, or have a rash or any blisters
on your skin.
컄 Tell your doctor immediately.

609326

2. What you need to know before you take
Fludara oral

Artwork No.

Fludara oral contains the active substance
fludarabine phosphate which stops the growth
of new cancer cells. All cells of the body produce
new cells like themselves by dividing. Fludara oral
is taken up by the cancer cells and stops them
dividing.
In cancers of the white blood cells (such as chronic
lymphocytic leukaemia) , the body produces many
abnormal white blood cells (lymphocytes) and
lymph nodes start to grow in various parts of the
body. The abnormal white blood cells cannot carry
out the normal disease fighting functions and may
push aside healthy blood cells. This can result in
infections, a decrease in number of red blood cells
(anaemia), bruising, severe bleeding or even organ
failure.
Fludara is used in the treatment of B-cell chronic
lymphocytic leukaemia (B-CLL) in patients with
sufficient healthy blood cell production.
First treatment for chronic lymphocytic leukaemia
with Fludara oral should only be started in patients
with advanced disease having disease-related
symptoms or evidence of disease progression.

artwork.leicester@multipkg.com

2. What you need to know before you take
Fludara oral

Clearly mark any amendments on one proof and return to MPS

1. What Fludara oral is and what it is used for

Warning! We cannot accept responsibility for any errors
in this proof after approval. Whilst we take extreme care
DWDOOWLPHVWRHQVXUHDFFXUDF\WRRXUFOLHQW·VEULHI
the final responsibility must be taken by our client.

What is in this leaflet

왘 if you consider or are breastfeeding you
should not start it or continue while on treatment
with Fludara.
왘 if you need a vaccination, check with your
doctor, because live vaccinations should
be avoided during and after treatment with
Fludara oral.
왘 if you have kidney problems or if you are
over 65, you will have regular blood and/or
laboratory tests to check your kidney function.
If your kidney problems are severe, you will not
be prescribed this medicine at all (see sections
2 and 3).
왘 Fludara oral tablets may cause more
vomiting and nausea (being or feeling sick)
than Fludara given intravenously. If this is a
problem, your doctor will consider switching your
treatment to the intravenous Fludara.
Children and adolescents
The safety and effectiveness of Fludara oral
in children below the age of 18 years has not
been established. Therefore, Fludara oral is not
recommended for use in children.
Older patients and Fludara:
People over 65 will have regular tests for kidney
function (see section 3. How to take Fludara oral).
People over 75 will be monitored especially closely.
Other medicines and Fludara oral
Tell your doctor if you are taking, have recently
taken or might take any other medicines, including
medicines obtained without a prescription.
It is especially important to tell your doctor about:
왘 pentostatin (deoxycoformycin), also used to
treat B-CLL. Taking these two drugs together can
lead to severe lung problems.
왘 dipyridamole, used to prevent excessive blood
clotting or other similar drugs. They may reduce
the effectiveness of Fludara oral.
왘 cytarabine (Ara-C) used to treat chronic
lymphatic leukaemia. If Fludara oral is combined
with cytarabine, levels of the active form of
Fludara in leukaemic cells may rise. However, the
overall levels in the blood and its elimination from
the blood were not shown to have changed.
Pregnancy, breast-feeding and fertility
Pregnancy
Fludara oral should not be given to women who are
pregnant because animal studies and very limited
experience in humans have shown a possible risk
of abnormalities in the unborn baby as well as early
pregnancy loss or premature delivery.
If you are pregnant or you think you may be
pregnant, tell your doctor immediately. Your doctor
will carefully weigh the benefit of your treatment
against a possible risk for an unborn child and,
if you are pregnant, will only prescribe Fludara
if clearly necessary.
Breast-feeding:
You must not start or continue breast feeding during
your treatment with Fludara, as this medicine may
interfere with the growth and development of
your baby.
Fertility
Men and women, who are fertile, must use effective
contraception during treatment and for at least
6 months afterwards.
Driving and using machines
Some people get tired, feel weak, have disturbed
vision, become confused, or agitated or have
seizures while they are treated with Fludara oral.
Do not try to drive or operate machines until you are
sure that you are not affected.
Fludara oral contains lactose monohydrate
This medicine contains lactose monohydrate (a type
of sugar). If you have been told by your doctor that
you cannot tolerate certain sugars, contact your
doctor before taking this medicine.

IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING
FULL APPROVAL OF DESIGN AND TEXT.

Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
왘 Keep this leaflet. You may need to read it again.
왘 If you have any further questions, ask your
doctor or pharmacist.
왘 This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
왘 If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.

These may be signs of a reduction in the number
of your blood cells, which may be caused either by
the disease itself or the treatment. It can last for
up to a year, independent of whether or not you
had treatment with Fludara oral before. During
treatment with Fludara oral also your immune system
may attack different parts of your body, or your red
blood cells (called ‘autoimmune disorders’). These
conditions can be life-threatening.
If this occurs your doctor will stop your treatment
and you may receive further medication such as
transfusion of irradiated blood (see below) and
adrenocorticoids.
You will have regular blood tests during treatment
and you will be closely monitored while you are being
treated with Fludara oral.
왘 if you notice any unusual symptoms of your
nervous system such as disturbed vision,
headache, confusion, seizures.
If Fludara oral is used for a long time, its effects on
the central nervous system are not known. However,
patients treated with the recommended dose for up
to 26 courses of treatment were able to tolerate it.
When Fludara is used at the recommended dose,
following the treatment with some other medications
or at the same time as some other medications,
the following adverse events have been reported:
neurological disorders manifested by headache,
feeling sick (nausea) and vomiting, seizures, visual
disturbances including vision loss, changes in
mental status (thinking abnormal, confusion, altered
consciousness) and occasionally neuromuscular
disorders manifested by muscle weakness in your
limbs (including irreversible partial or complete
paralysis) (symptoms of leukoencephalopathy,
acute toxic leukoencephalopathy or posterior
reversible leukoencephalopathy syndrome (RPLS)).
In patients on doses four times greater than
recommended blindness, coma and death have
been reported. Some of these symptoms appeared
delayed around 60 days or more after treatment
had been stopped. In some patients receiving
Fludara doses higher than the recommended
dose, leukoencephalopathy (LE), acute toxic
leukoencephalopathy (ATL) or posterior reversible
leukoencephalopathy syndrome (RPLS) have also
been reported. Same symptoms of LE, ATL or RPLS
as above described could occur. LE, ATL, and RPLS
may be irreversible, life-threatening, or fatal.
Whenever LE, ATL or RPLS is suspected, your
treatment will Fludara will be stopped for further
investigations. If the diagnosis of LE, ATL, or RPLS
is confirmed, you doctor will permanently
discontinue your treatment with Fludara.
왘 if you notice any pain in your side, blood in
your urine or reduced amount of urine.
When your disease is very severe, your body may
not be able to clear all the waste products from the
cells destroyed by Fludara oral. This is called tumour
lysis syndrome and can cause kidney failure and
heart problems from the first week of treatment. Your
doctor will be aware of this and may give you other
medicines to help prevent it. He/she may decide that
you should start your treatment in hospital.
왘 if you need to have stem cells collected
and you are being treated with Fludara oral
(or have been).
왘 if you need a blood transfusion and you
are being treated with Fludara oral
(or have been).
In case you need a blood transfusion your doctor
will ensure that you only receive blood that has
been treated by irradiation. There have been severe
complications and even death, from transfusions
of non-irradiated blood.
왘 if you notice any changes to your skin either
while you are receiving this medicine or after
you have finished the treatment.
왘 if you have or have had skin cancer it may
worsen or flare up again while you take Fludara
oral or afterwards. You may develop skin cancer
during or after Fludara oral treatment.
Other things to consider, when taking
Fludara oral:
왘 Men and women, who are fertile, must use
effective contraception during treatment and
for at least 6 months afterwards. It cannot be
ruled out that Fludara oral may harm an unborn
baby. Your doctor will carefully weigh the benefit
of your treatment against a possible risk for an
unborn child and, if you are pregnant, will only
treat you with Fludara if clearly necessary.

By reporting side effects you can help provide more
information on the safety of this medicine.

artwork.leicester@multipkg.com

Proof By

Language

Market

Min. Point Size

Size

Profile

Item Code

Description

Customer

5

louise.heel

English

UK

7pt

201x259mm

GI201259

505015

FLUDARA PO 10MG Leaflet

Genzyme UK (Suffolk)

Pharma
Code

Folded: 101x27mm

Proof No.

09/11/2015

Measure bar should be 150mm at 100% scale

Clearly mark any amendments on one proof and return to MPS

Date

609326

50 gsm

N/A

Process Black + 25% + 15% tint

Colours Used

Pantone 2592 C

Keyline (does not print)

6. Contents of the pack and other information
What Fludara oral contains
왘 The active substance is fludarabine phosphate.
Each film-coated tablet of Fludara oral contains
10 mg fludarabine phosphate.
왘 The other ingredients are
– in the tablet core: cellulose (microcrystalline),
lactose (monohydrate), silica (colloidal
anhydrous), croscarmellose sodium,
magnesium stearate;
– in the film-coat: hypromellose, talc, titanium
dioxide (E171), ferric oxide pigment (yellow
(E172)), ferric oxide pigment (red (E172)).
What Fludara oral looks like and contents
of the pack
Fludara oral are salmon-pink, capsule-shaped
film-coated tablets, marked with ‘LN’ in a regular
hexagon on one side.
The tablets are provided in blisters of 5 tablets each.
The blisters are of polyamide/aluminium/
poly-propylene thermoformable foil with a lidding
foil of aluminium. The blisters are packed
in a polyethylene tablet container with
a child-resistent polypropylene screw cap.
Fludara oral is available in packs containing:
왘 15 tablets in 3 blisters in a child-resistant bottle.
왘 20 tablets in 4 blisters in a child-resistant bottle.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Genzyme Europe B.V.
Gooimeer 10
1411 DD Naarden
The Netherlands
Manufacturer
Genzyme Ltd, 37 Hollands Road, Haverhill, Suffolk,
CB9 8PU, UK
This medicinal product is authorised in the
Member States of the EEA under the following
names:
Italy Fludara
Austria Fludara
Luxembourg Fludara
Denmark Fludara
The Netherlands Fludara
Finland Fludara
Norway Fludara
France Fludara
Spain Beneflur
Greece Fludara
Sweden Fludara
Iceland Fludara
UK Fludara
Ireland Fludara
This leaflet was last revised in November 2015
Local representative:
Sanofi
One Onslow Street, Guildford, Surrey,
GU1 4YS, UK
Tel: 0845 372 7101
email: uk-medicalinformation@sanofi.com
-------------------------------------------------------The following information is intended for healthcare
professionals only:
Handling and disposal
Fludara should not be handled by pregnant staff.
Procedures for proper handling should be followed
according to local requirements for cytotoxic drugs.
Waste material may be disposed of by incineration.
Any unused medicinal product or waste material
should be disposed of in accordance with local
requirements for cytotoxic drugs.
505015

Warning! We cannot accept responsibility for any errors
in this proof after approval. Whilst we take extreme care
DWDOOWLPHVWRHQVXUHDFFXUDF\WRRXUFOLHQW·VEULHI
the final responsibility must be taken by our client.

5. How to store Fludara oral
Keep this medicine out of the sight and reach
of children.
Do not use this medicine after the expiry date which
is stated on the bottle label and blister foil after
“EXP”. The expiry date refers to the last day of
that month.
Fludara oral is a cytotoxic drug. It should always
be stored in the original, child resistant container.
This medicine does not require any special
temperature storage conditions. Store in the original
package to protect from moisture.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help to protect the environment.
Return any unused or waste tablets to your doctor
or pharmacist. They will take care that Fludara oral
is disposed of according to local requirements for
cytotoxic drugs.

Artwork No.

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them. If you
are not sure what the side effects below are, ask
your doctor to explain them to you.
Some side effects can be life-threatening. Tell your
doctor immediately:
왘 if you have difficulty breathing, have a cough,
or have chest pain with or without fever. These
may be signs of an infection of the lungs.
왘 if you notice any unusual bruising, more
bleeding than usual after injury or if you seem
to be catching a lot of infections. These may
be caused by a reduced number of blood cells.
This may also lead to an increased risk
of (serious) infections, caused by organisms,
that usually do not cause disease in healthy
persons (opportunistic infections) including
a late reactivation of viruses, for example
herpes zoster.
왘 if you notice any pain in your side, blood in your
urine, or reduced amount of urine. These may be
signs of tumour lysis syndrome (see section 2).
왘 if you notice any skin and / or mucous coat
reaction with redness, inflammation, blistering
and tissue break down. These may be signs of
a severe allergic reaction (Lyell’s syndrome,
Stevens-Johnson syndrome).
왘 if you have palpitations (if you suddenly become
aware of your heart beat) or chest pain. These
may be signs of heart problems.

Below are possible side effects by how common
they are, as known from Fludara for intravenous
use. Very common side effects (may affect more
than 1 in 10 people)
– infections (some serious)
– infections due to depressed immune system
(opportunistic infections)
– infection of the lungs (pneumonia) with possible
symptoms like breathing difficulties and / or
cough with or without fever
– reduction in the number of blood platelets
(thrombocytopenia) with the possibility of
bruising and bleeding
– lowered white blood cell count (neutropenia)
– lowered red blood cell count (anaemia)
– cough
– vomiting, diarrhea, feeling sick (nausea)
– fever
– feeling tired (fatigue)
– weakness
Common side effects (may affect up to
1 in 10 people)
– other blood related cancers (myelodysplastic
syndrome, acute myeloid leukaemia).
Most patients with these conditions were
previously, or at the same time or later treated
with other cancer drugs (alkylating agents,
topoisomerase inhibitors) or radiation therapy
– bone marrow depression (myelosuppression)
– severe loss of appetite leading to weight loss
(anorexia)
– numbness or weakness in limbs (peripheral
neuropathy)
– disturbed vision
– inflammation of the inside of the mouth
(stomatitis)
– skin rash
– swelling due to excessive fluid retention
(oedema)
– inflammation of the mucous coat of the digestive
system from the mouth to the anus (mucositis)
– chills
– generally feeling unwell
Uncommon side effects (may affect up to
1 in 100 people)
– autoimmune disorder (see section 2)
– tumour lysis syndrome (see section 2)
– confusion
– lung toxicity, scarring throughout the lungs
(pulmonary fibrosis), inflammation of the lungs
(pneumonitis), shortness of breath (dyspnoea)
– bleeding in the stomach or intestines
– abnormal levels of the liver or pancreas enzymes
Rare side effects (may affect up to
1 in 1,000 people)
– disorders of the lymph system due to a viral
infection (EBV-associated lymphoproliferative
disorder)
– coma
– seizures
– agitation
– blindness
– inflammation or damage of the nerve of the eyes
(optic neuritis; optic neuropathy)
– heart failure
– irregular heart beat (arrhythmia)
– skin cancer
– skin and/or mucous coat reaction with redness,
inflammation, blistering and tissue break down
(Lyell’s syndrome, Stevens-Johnson syndrome)
Not known (frequency cannot be estimated from
available data)
– bleeding in the brain
– neurological disorders manifested by
headache, feeling sick (nausea) and vomiting,
seizures, visual disturbances including vision
loss, changes in mental status (thinking
abnormal, confusion, altered consciousness),
and occasionally neuromuscular disorders
manifested by muscle weakness in your limbs
(including irreversible partial or complete
paralysis) (symptoms of leukoencephalopathy,
acute toxic leukoencephalopathy or posterior
reversible leukoencephalopathy syndrome
(RPLS)).
– bleeding in the lungs
– inflammation of the bladder, which can cause
pain when passing urine, and can lead to blood
in the urine (haemorrhagic cystitis)
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report
side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard

IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING
FULL APPROVAL OF DESIGN AND TEXT.

How to take Fludara oral tablets
Swallow the tablet whole with water. Do not break
or chew the tablets. You can take Fludara oral either
on an empty stomach or together with food.
How long you should take Fludara oral
Take the dose worked out by your doctor once a day
for 5 consecutive days.
This 5-day-course of treatment will be repeated
every 28 days until your doctor has decided that
the best effect has been achieved (usually after
6 courses).
How long the treatment lasts depends on how
successful your treatment is and how well you
tolerate Fludara oral. The repeat course may be
delayed if side effects are a problem.
You will have blood tests after every treatment.
Your individual dose will be carefully adjusted
according to the number of your blood cells and
your response to the treatment. If the number of
your blood cells is too low, your next treatment
cycle may be postponed for up to two weeks or your
dose may be decreased. The dosage may also be
decreased if side effects are a problem.
If you have been treated for two courses and
you did not respond to the treatment but you
also showed few symptoms of a reduced blood
cell count, your doctor may decide to increase
your dose.
If you have kidney problems or if you are over
the age of 65, you will have regular tests to check
your kidney function. If your kidneys do not work
properly your doctor may prescribe a lower dose.
If your kidney function is severely reduced you
will not be prescribed this medicine at all
(see section 2).
If you take more Fludara oral than you should
Tell your doctor immediately if you took too many
Fludara oral tablets
High doses can lead to a severely reduced number
of blood cells.
For Fludara given intravenously it has been reported,
that overdose can cause delayed blindness, coma
and even death.
If you forget to take Fludara oral
Talk to your doctor as soon as possible if you
think you may have missed a dose or vomit after
tablet taking.
Do not take a double dose to make up for the
forgotten tablets.
If you stop taking Fludara oral
Do not stop taking Fludara oral without advice from
your doctor.
You and your doctor may decide to stop your
treatment with Fludara oral, if the side effects are
becoming too severe.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

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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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