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AZAFALK 75MG FILM-COATED TABLETS

Active substance(s): AZATHIOPRINE

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Azafalk 75mg film-coated tablets, UK/H/2846/02/DC, Dr. Falk Pharma GmbH



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Package leaflet:
Information for the user

1. What Azafalk® 75mg tablets are
and what they are used for

Azafalk® 75mg
film-coated tablets

Azafalk® 75mg tablets contain the active
ingredient azathioprine, which belongs
to a group of medicines called immunosuppressives. Immunosuppressives reduce the
strength of your immune system.

Read all of this leaflet carefully before
you start taking this medicine because it
contains important information for you.
– Keep this leaflet. You may need to read it
again.
– If you have any further questions, ask
your doctor or pharmacist.
– This medicine has been prescribed for you
only. Do not pass it on to others. It may
harm them, even if their signs of illness
are the same as yours.
– 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.

Your doctor has prescribed Azafalk® 75mg
tablets for one of the following conditions:
– To help your body accept an organ
transplant.
– To control some diseases where your
immune system is reacting against your
own body.

Azathioprine

What is in this leaflet

1. What Azafalk® 75mg tablets are and what
they are used for
2. What you need to know before you take
Azafalk® 75mg tablets
3. How to take Azafalk® 75mg tablets
4. Possible side effects
5. How to store Azafalk® 75mg tablets
6. Contents of the pack and other information

Azafalk® 75mg tablets can also be used
alone or in combination with other medicines to treat:
– severe rheumatoid arthritis
– severe inflammation of the gut
(Crohn’s disease or ulcerative colitis)
or to treat:
– s ome diseases where your immune
system is reacting against your own
body (autoimmune diseases) including
severe inflammatory diseases of the
skin, liver, artery and some blood
disorders.

2. What you need to know before
you take Azafalk® 75mg tablets
Do not take Azafalk® 75mg tablets
if you:

– are allergic to azathioprine, mercaptopurine, or any of the other ingredients of this
medicine (listed in section 6). An allergic
reaction may include rash, itching, difficulty



of breathing or swelling of the face, lips,
throat or tongue.
– have a severe infection
– have a severe liver or bone marrow
disorder
– have pancreatitis (inflammation of the
pancreas)
– have recently had a vaccination with a
live vaccine such as smallpox or yellow
fever
– are pregnant (unless your doctor tells you)
– are breast-feeding

Warnings and precautions

Talk to your doctor before taking Azafalk
75mg tablets.
You will not be given Azafalk® 75mg tablets
unless you can be monitored for side effects.
You should tell your doctor straight away
if you develop ulcers of the throat, fever,
infections, bruising, or bleeding.
®

Talk to your doctor before taking Azafalk®
75mg tablets
– if you are going to have a vaccination while
you are taking Azafalk® 75mg tablets
– if you have a condition where your body
produces too little of a natural chemical
called thiopurine methyltransferase (TPMT)
– if you suffer from a condition known as
Lesch-Nyhan syndrome.
If you are receiving immunosuppressive
therapy, taking Azafalk® 75mg tablets could
put you at greater risk of:
– tumours, including skin cancer. Therefore,
when taking Azafalk® 75mg tablets, avoid
excessive exposure to sunlight, wear
protective clothing and use protective
sunscreen with a high protection factor.
– lymphoproliferative disorders

– treatment with Azafalk® 75mg tablets
increases your risk of getting a type of
cancer called lymphoproliferative disorder. With treatment regimen containing
multiple immunosuppressants (including
thiopurines), this may lead to death.
– A combination of multiple immunosuppressants, given concomitantly increases the
risk of disorders of the lymph system due
to a viral infection (Epstein-Barr virus (EBV)associated lymphoproliferative disorders).
Taking Azafalk® 75mg tablets could put you
at greater risk of:
– developing a serious condition called Macrophage Activation Syndrome (excessive
activation of white blood cells associated
with inflammation), which usually occurs in
people who have certain types of arthritis.

Blood tests

You will need a blood test once a week
during the first 8 weeks of treatment. You
may need blood
tests more often if you:
– are elderly
– are taking a high dose
– have a liver or kidney disorder
– have a bone marrow disorder
– have an overactive spleen
It is important that you use effective contraception (such as condoms) as Azafalk®
75mg tablets may cause birth defects when
taken by either the man or woman.

Other medicines and Azafalk® 75mg
tablets

Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines, e.g.:

– Allopurinol, oxipurinol or thiopurinol
(treatments for gout)
– Muscle relaxants such as curare, d-tubocurarine, pancuronium, or succinylcholine
– Other immunosuppressants such as
cyclosporin or tacrolimus
– Infliximab (a treatment for Crohn’s disease)
– Olsalazine, mesalazine or sulfasalazine
(treatments for ulcerative colitis)
– Warfarin or phenprocoumon (blood
thinners)
– ACE-inhibitors (treatments for high blood
pressure or heart failure)
– Trimethoprim and sulphamethoxazole
(antibiotics)
– Cimetidine (a treatment for ulcers of the
digestive tract)
– Indomethacin (a treatment for rheumatoid arthritis)
– Cancer treatments or treatments that slow
or stop the production of new blood cells
– Furosemide (a water tablet for heart failure)
– Vaccines such as hepatitis B
– any “live” vaccine

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think
you may be pregnant or are planning to have
a baby, ask your doctor or pharmacist for
advice before taking this medicine.
You must not take Azafalk® 75mg tablets if you
are pregnant unless your doctor tells you to.
Tell your doctor if you are or believe you
might be pregnant. Both male and female
patients of reproductive age should use a
contraceptive other than an interuterine
device (e.g. coil, Copper T).
You should continue to use a contraceptive
for three months after treatment with
Azafalk® 75mg tablets has stopped.

You must not breast-feed during treatment
with Azafalk® 75mg, as metabolic products
produced in the body pass into the breast
milk and can damage your child.

Driving and using machines

You are safe to drive or operate machinery
when taking Azafalk® 75mg tablets unless
you experience dizziness. Dizziness maybe
made worse by alcohol and you should not
drive or operate machinery if you have been
drinking alcohol.
Azafalk® 75mg tablets contain lactose
Azafalk® 75mg tablets contain lactose. If you
have been told by your doctor that you have
an intolerance to some sugars, contact
your doctor before taking this medicine.

3. How to take Azafalk® 75mg tablets
Always take this medicine exactly as your
doctor or pharmacist has told you. Check
with your doctor or pharmacist if you are not
sure.
The tablets should be taken during meals
with a glass of liquid.

Dosage

Patients who have had a transplant:
The recommended first day dose is up to
5 mg/kg of body weight per day. The recommended dose is then 1-4 mg/kg of body
weight per day.
Other conditions:
The recommended dosage is 1-3 mg/kg of
body weight per day.

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Azafalk 75mg film-coated tablets, UK/H/2846/02/DC, Dr. Falk Pharma GmbH

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Use in children and adolescents
Azafalk® 75mg is not recommended for use
in children below 18 years due to insufficient
data for the treatment of juvenile chronic
arthritis, systemic lupus erythematosus,
dermatomyositis and polyarteritis nodosa.
For all other indications, the given dose
recommendations apply for children and
adolescents as well as for adults.
Elderly:
The elderly may need a reduced dose.
Patients with a liver or kidney disorder may
need a reduced dose.
Patients with severe liver disorder must not
take Azafalk® tablets.
The duration of treatment with Azafalk®
75mg is determined by your doctor.
Please ask your doctor if you think that the
effect of Azafalk® 75mg is too strong or too
weak.

If you take more Azafalk 75mg
tablets than you should
®

Contact your doctor, pharmacist or nearest
hospital immediately.

If you forget to take Azafalk® 75mg
tablets
Do not take a double dose to make up for a
forgotten dose.

If you stop taking Azafalk® 75mg
tablets

Any withdrawal of Azafalk 75mg tablets
should be performed under close monitoring. Please ask your doctor.
®

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

Common: may affect up to 1 in 10 people
– low blood platelet level, which may cause
you to bruise or bleed easily.

4. Possible side effects

Uncommon: may affect up to 1 in 100 people
– infections caused by a virus, fungus or
bacteria in all patients except transplant
patients
– low red blood cell level, which may cause
you to be tired, get headaches, be short
of breath when exercising, feel dizzy and
look pale
– hypersensitivity reactions, which may lead
to general discomfort, dizziness, feeling
sick, vomiting, diarrhoea, fever, shivering,
skin reactions like exanthema and rash,
inflammation of the blood vessels, muscle
and joint pain, low blood pressure, kidney
or liver disorders and problems with your
bowel
– inflammation of the pancreas, which may
cause you severe upper stomach pain,
with feeling sick (nausea) and being sick
(vomiting)
– liver problems, which may cause pale
stools, dark urine, itchiness and yellowing
of your skin and eyes, and abnormalities
in the results of liver function tests.

Like all medicines, this medicine can cause side
effects, although not everybody gets them.

Serious side effects

Tell your doctor straight away if you
get any sudden wheeziness, difficulty in
breathing, swelling of the eyelids, face or
lips, rash or itching (especially affecting
your whole body).
If you develop any of the following side
effects, contact your doctor immediately:
– Severe sickness
– Diarrhoea
– Fever, chills
– Muscle or bone pain, muscle stiffness
– Tiredness, dizziness
– Inflammation of the blood vessels
– Kidney disorders (symptoms may include
changes in the amount of urine passed
and changes in its colour)
The following side effects have also been
reported:
Very common: may affect more than
1 in 10 people
– infections caused by a virus, fungus or
bacteria in transplant patients
– reduction in your bone marrow function
– low white blood cell level in your blood
tests, which may cause an infection.
– feeling sick (nausea) and being sick
(vomiting), loss of appetite (anorexia).

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Rare: may affect up to 1 in 1,000 people
– problems with your blood and bone marrow which may cause weakness, tiredness, paleness, headaches, sore tongue,
breathlessness, bruising or infections
– problems with your bowel leading to diarrhoea, abdominal pain, constipation, feeling sick (nausea) and being sick (vomiting)
– severe liver damage which can be life
threatening
– hair loss which may get better even though
you continue to take Azafalk® tablets

– various types of cancers including blood,
lymph and skin cancers.
Very rare: may affect up to 1 in 10,000 people
– life-threatening allergic reactions leading
to severe conditions affecting the skin
(Stevens-Johnson syndrome and toxic
epidermal necrolysis)
– inflammation of your lungs causing
breathlessness, cough and a fever.

Reporting of side effects

If you get any side effects, talk to your
doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly
via the national reporting system listed in
Appendix V*. By reporting side effects you
can help provide more information on the
safety of this medicine.
[*For the printed material, please refer to the
guidance of the annotated QRD template.]

5. How to store Azafalk® 75mg tablets
Keep this medicine out of the sight and
reach of children.
Store in the original package to protect from
light.
Do not use Azafalk® 75mg tablets after the
expiry date which is stated on the carton
and blister after “EXP”. The expiry date
refers to the last day of that month.
Do not use Azafalk® 75mg tablets if you
notice any visible signs of deterioration.
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 protect the environment.

Marketing Authorisation Holder
and Manufacturer

6. Contents of the pack and
other information
What Azafalk® 75mg tablets contain:

The active substance is azathioprine.
Each Azafalk® 75mg film-coated tablet
contains 75 mg azathioprine.

The other ingredients are:
Tablet core: croscarmellose sodium, colloidal
anhydrous silica, lactose monohydrate, microcrystalline cellulose, sodium stearyl fumarate,
starch pregelatinized, povidone K25
Tablet coat: Macrogol 3350, Polysorbate 80,
Poly(vinyl alcohol), Talc

What Azafalk® 75mg tablets look like
and contents of the pack

Azafalk® 75mg film-coated tablets are yellow,
round, biconvex tablets of 10.0 mm marked
“75” on one side.
Crushing of the tablets should be avoided.
If the film-coating of a tablet is damaged or
the tablet is completely crushed, avoid skin
contamination and inhalation of tablet particles. For appropriate long-term dosing other
medicinal products containing 25 mg should
be used, if necessary.

Packaging:
The film-coated tablets are packed in PVC/
aluminium blisters in a carton box.
Azafalk® 75mg tablets are available in packs of:
20, 30, 50, 60, 90 or 100 film-coated tablets
Not all packs sizes may be marketed.

This medicinal product is authorised
in the Member States of the EEA
under the following names:

Austria, Germany, Lithuania, The Netherlands,
Portugal, Slovenia, United Kingdom: Azafalk®.
Spain: Immufalk®.
This leaflet was last revised in {MM/YYYY}.
The following information is intended for
medical or healthcare professionals only:

Azafalk® 75mg film-coated tablets
Instructions for use and handling
and disposal

There are no risks associated with handling
tablets with intact coating. In that case no
special safety precautions are necessary.
However, Azafalk® film-coated tablets should
be handled in strict accordance with guidance for handling cytotoxic agents when
people have crushed the film-coated tablets.
Surplus medical products as well as contaminated appliances should be temporarily stored
in clearly labelled containers. Any unused
product or waste material should be disposed
of in accordance with local requirements.
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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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