DANAZOL CAPSULES 200MG

Active substance: DANAZOL

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danazol
capsules
#200 mg
200
mg

Danazol
capsules

danazol
capsules
#200 mg

56 capsules

Each capsule contains: Danazol 200 mg.
Also contains: lactose.
Dosage: For oral use as directed by a doctor.
Read the enclosed leaflet. Keep out of the sight
and reach of children. Protect from light. Store
below 25°C. Keep the container tightly closed in
order to protect from light and moisture.
PL 04569/0137   POM 333735 LL0441AH
Mylan, Potters Bar,
Herts, EN6 1TL, U.K.

TBC
30

200
mg

5. How to store Danazol

Danazol
capsules

Keep this medicine out of the sight and reach
of children.
Store below 25°C.

56 capsules

Blister packs: Store in the original package in order to
protect from light and moisture.

Each capsule contains: Danazol 200 mg.
Also contains: lactose.
Dosage: For oral use as directed by a doctor.
Read the enclosed leaflet. Keep out of the sight
and reach of children. Protect from light. Store
below 25°C. Keep the container tightly closed in
order to protect from light and moisture.

Containers: Keep the container tightly closed in
order to protect from light and moisture.
Do not use this medicine after the expiry date
which is stated on the carton after EXP. The expiry
date refers to the last day of that month.

PL 04569/0137   POM 333735 LL0441AH
Mylan, Potters Bar,
Herts, EN6 1TL, U.K.

01

Do not use this medicine if you notice Danazol
capsules look damaged in any way.

TBC

02

danazol

This leaflet was last revised in 02/2014.

•  f you get any side effects, talk to your doctor
I
or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet:
1.  hat Danazol is and what it is used for.
W
2.  hat you need to know before you take Danazol.
W
3.  ow to take Danazol.
H
4.  ossible side effects.
P
5.  ow to store Danazol.
H
6.  ontents of the pack and other information.
C
1.  hat Danazol is and what it is used for
W

03

Danazol belongs to a group of medicines called
antigonadotropins. Danazol lowers the amount of
some hormones (gonadotrophins) in your body. It is
used to treat:

Capsule shell contains: gelatin, titanium dioxide
(E171); and for 100 mg only: iron oxide black (E172);
and for 200 mg only: iron oxide red (E172), iron oxide
yellow (E172), erythrosine (E127).
What Danazol looks like and the contents of
the pack
Danazol capsules 100 mg are capsules with a light
grey body and a dark grey cap marked in black 'DL
100' and 'G'
Danazol capsules 200 mg are capsules with a white
body and an orange cap marked in black 'DL 200'
and 'G'

27

Do not take Danazol if you:
•  allergic to danazol or any of the other
are
ingredients of this medicine (listed in section
6). Signs of an allergic reaction include: a rash,
swallowing or breathing problems, swelling of your
lips, face, throat or tongue
•  pregnant, might become pregnant or think you
are
may be pregnant or are breastfeeding (see section
'Pregnancy and breast-feeding')
• 
have severe kidney, liver or heart disease
•  a member of your family have porphyria (a
or
disorder of metabolism)
• 
have blood clots in your circulation or have a
history of such events (thromboembolic disease)
05

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

Warnings and precautions
If any of the following conditions applies to you, or if
you have had any of them in the past, you must talk
to your doctor or pharmacist before taking Danazol.
•  you have taken Danazol or a similar medicine
if
before and had side effects such as water retention,
voice changes, growth of facial hair or muscle
development
•  you have any liver or kidney problems
if

Your doctor may take regular blood samples to check
your blood and to check that your liver and thyroid
are working properly.
If you are going to have a blood test, it is important
to tell your doctor you are taking Danazol.

24

• 
changes in the level of fat (lipid) in your blood
•  increase in liver enzymes (which are used to
an
check how the liver is working)

28

•  DPE containers with polyethylene
H
snap closures.

These changes do not usually cause symptoms and
return to normal when you stop taking Danazol.
Reporting side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any 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
By reporting side effects you can help provide more
information on the safety of this medicine.
19

Rare side effects:
• 
sensitivity of the skin to sunlight.
Some rare side effects that may occur if Danazol
is taken for a long time: if you have hereditary
angioedema (an inherited condition causing swelling
of the skin, lungs and digestive system) you may get
blood in your urine.

Pack sizes of 28, 30, 50, 56, 60, 84, 90, 100, 112 and
250 capsules are available in all pack types.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom

Changes in blood tests
During treatment with Danazol, if you have blood
tests, your doctor may notice:
• 
changes in the number of red blood cells or
platelets in your blood. You may also notice that
you bruise or bleed easily or unexpectedly
•  increase in certain types of white blood cells
an
• 
raised levels of an enzyme (creatine phosphokinase),
which maybe an indicator of muscle damage

Manufacturer
Generics [UK] Limited, Potters Bar, Hertfordshire,
EN6 1TL, United Kingdom
Gerard Laboratories, 35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13, Ireland

08

Children and adolescents
Danazol should not be given to children
and adolescents.

04

•  tatins such as simvastatin, atorvastatin and
S
lovastatin. Danazol may increase the risk of muscle
weakness or rapid breakdown of muscle.
Danazol may increase the effect of the
following medicines:
• 
medicine to treat epilepsy, fits or convulsions such
as carbamazepine, phenytoin, phenobarbital (anticonvulsants)
• 
anticoagulants such as warfarin (to thin the blood)
as your dosage will need to be adjusted
• 
anaesthetics (see 'Operations or tests'
section below)
• 
medicines used to prevent rejection of organ
transplants such as ciclosporin, tacrolimus. Danazol
can increase the levels of these medicines in your
blood and may damage your kidneys

26

6.  ontents of the pack and other information
C
What Danazol contains
The active substance is danazol. Each 100 mg capsule
contains 100 mg danazol. Each 200 mg capsule
contains 200 mg danazol.
The other ingredients are: lactose monohydrate
(see section 2 'Danazol contains lactose'), cellulose
microcrystalline, silica colloidal anhydrous, povidone
K30, lactose anhydrous, sodium starch glycolate,
sodium laurilsulfate and magnesium stearate.

Danazol with alcohol
Do not drink alcohol during treatment. This is
because drinking alcohol whilst taking Danazol can
make you feel sick or short of breath.

4. Possible side effects

Other medicines and Danazol
Tell your doctor or pharmacist if you are
taking, have recently taken or might take any
other medicines.

Danazol contains lactose. If you have been told by
your doctor that you have an intolerance to some
sugars, contact your doctor before taking
this medicine.

In particular, tell your doctor if you are taking any of
the following:
• 
steroids such as testosterone, oestrogen,
progesterone (including 'the pill' or hormone
replacement therapy – known as HRT)

12

Pregnancy and breast-feeding
Do not take Danazol if you are pregnant, think you may
be pregnant or are planning to have a baby. Danazol
may harm your unborn child. If you are of child-bearing
age you must use reliable contraception during
treatment, but not the contraceptive pill. If you think
you may have become pregnant, stop taking Danazol
immediately and tell your doctor.
Do not take Danazol if you are breast-feeding.
Danazol may reach your baby through the breast
milk. If you are planning to breastfeed, talk to your
doctor or pharmacist.

18

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
If any of the following happen, stop taking Danazol
and tell your doctor immediately or go to your
nearest hospital emergency department:
• 
allergic reactions which may include signs such as
skin rash, sudden swelling of the face, lips, tongue
and/or throat which may cause difficulty breathing
or swallowing
• 
skin rashes, which may be severe and occur with
fever and/or swelling of the face
•  increase in the pressure of the fluid which
an
surrounds the brain, which can lead to changes in
eye sight such as blurred vision

13

09

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.

Other side effects include:
• 
weight gain, acne or greasy skin, hair loss (similar to
male baldness)

• 
numbness or weakness of the face or limbs, these
may be signs of a stroke
• 
numbness/pain in the arms or legs, which may be
caused by a blood clot
• 
pain or tightness in the chest, jaw or arm, these
may be signs of a heart attack
•  reduction in the number of white blood cells
a
which help fight infection. This may be seen in
blood tests or you may notice an increase in the
number of infections such as sore throat, mouth
ulcers and fever that you get
• 
voice changes such as hoarseness or a sore throat,
growth of facial or body hair, muscle development,
or enlarged clitoris (part of the female sex organs)
• 
liver problems which may cause yellowing of your
skin or whites of the eyes, dark urine, pale stools
(jaundice), tumours and blood-filled cysts in
the liver

Driving and using machines
Danazol is not known to affect your ability to drive
or use machines. However, some side effects such as
dizziness, a spinning feeling, and changes in eyesight
may occasionally occur. If affected, you should not
drive or use machines.

Elderly patients
Danazol should not be given to the elderly.

23

• 
endometriosis (where the tissue that normally lines
your womb and is shed during your
period grows outside your womb). You may
also be given Danazol before or after surgery
for endometriosis
• 
painful or heavy periods (menorrhagia)
• 
painful breast disease, but not malignant. This may
be connected with your periods or caused by cysts
(lumps) in the breast. Danazol is used where other
treatments have not worked or when they cannot
be taken
• 
enlarged breasts (in both men and women).

20

These are serious side effects. You may need
medical attention.

Ask your doctor or pharmacist for advice before
taking any medicine if you are pregnant or
breast-feeding.

Danazol may also affect the results of certain tests
for thyroid function and specific tests which show
activity relating to the production of red blood cells.

07

Danazol Capsules are available in either:
• polypropylene containers with
polyethylene caps
•  lastic/aluminium foil blister strips
p

2.  hat you need to know before you take Danazol
W

If you have to take Danazol for more than six months
your doctor will arrange for an ultrasound test to
check your liver.

• 
liver injury that may cause pain in the liver or liver
failure that may cause a swollen abdomen, mental
disorientation and confusion
• 
blood-filled cysts in the spleen, which may rupture
and cause bleeding
•  inflamed pancreas causing abdominal pain
an
with sickness
•  (epilepsy) may get worse if you suffer from fits,
fits
or you may develop epilepsy if you are prone to
developing the condition.

11

•  you have high blood pressure or heart disease
if
•  you have diabetes mellitus (high blood sugar)
if
•  you have a blood problem with increased amount
if
of red blood cells, where the blood gets thicker
(polycythaemia)
•  you have fits (epilepsy)
if
•  you have problems with fat metabolism
if
(lipid disorders)
•  you have a history of blood clots
if
•  you get migraines
if
•  you are having treatment to remove a tumour
if
•  you may have breast cancer
if
•  you have an illness which could be made worse
if
by fluid retention.

Danazol Capsules 100 mg
Danazol Capsules 200 mg

If you are having tests, tell your doctor. This is
because Danazol treatment may interfere with
laboratory tests of male sex hormone (testosterone),
fats (lipids), sugars and plasma proteins.

Do not take this medicine if any of the above apply
to you. If you are not sure, talk to your doctor or
pharmacist before taking Danazol.

25

Package leaflet: Information for the patient

29

06

• 
have a type of tumour (called an androgen
dependent tumour) that is affected by steroids
• 
have unexpected bleeding from your vagina which
has not been checked by a doctor.

• 
visual disturbances which may take the form of
blurring or difficulty in focusing and in wearing
contact lenses
• 
menstrual changes such as irregular periods,
spotting or loss of periods. Your periods will usually
return to normal 60 to 90 days after treatment, but
sometimes you may have persistent loss of periods
• 
you may also have flushing, vaginal dryness or
irritation, reduction in breast size and, in men,
lowering of sperm count during treatment
• 
dizziness, a spinning feeling (vertigo)
• 
headaches which may be severe (migraine)
• 
feeling sick (nausea)
• 
changes in skin colour (pigmentation), flaking,
peeling, red skin, unusual bruising or bleeding
under the skin which may be seen as
purple spots

22

17
10

• 
alpha calcidol (a form of vitamin D) used for vitamin
D deficiency and illnesses where there is not
enough calcium in the blood.

Endometriosis: the recommended dose is 200 mg to
800 mg daily for three to six months. Normally you
will need to take Danazol for 6 months, but you may
have to take it for up to 9 months.
15

Description Danazol 200mg 56
Pharma Code TBC
SAP No. N/A
Vendor Job No. 220028

TrackWise PR No. 333735

Proof No. 3

Packing Site/Printer N/A
Supplier Code LL0441AH
Sign-offs

Time: 15:01
Page Count 1/1

No. of colours 4

Superceded Affiliate Item Code 10005387

MA No. 04569/0137

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

Adults: The recommended dose is 200 mg to 800 mg
each day in up to four divided doses. DO NOT TAKE
more than 8 of the 100 mg capsules or 4 of the
200 mg capsules in one day. Your dose will depend
on your needs and medical condition:

Operations or tests
If you are due to have an operation, tell your doctor
you are taking Danazol. This is because Danazol can
increase the effect of some anaesthetics.

Client Market UK
Keyline/Drawing No. N/A
Barcode Info 5016695560281

Colours
Non-Print
Colours

Black

PMS
306

Keyline

PMS
712

Braille

PMS
Reflex Blue

Equate CMYK
with
Main Font Myriad Pro
Dimensions 52 x 101mm

14

Take this medicine by mouth.
Swallow Danazol capsules whole with a glass
of water.
Before starting your course of treatment, your doctor
will check if you are pregnant. If you are of child
bearing age, you should start treatment on the first
day of your period to avoid exposing a pregnancy
to its possible effects. Use reliable contraception
(such as an Intra Uterine Device or barrier method
in conjunction with contraceptive foam or jelly).
The contraceptive pill should not be used until your
treatment with Danazol has finished.

You must take Danazol as a continuous course. Your
doctor may adjust your dose according to your
response. Once your condition has improved, they
may advise you to take a lower dose.
If you feel the effect of your medicine is too weak or
too strong, do not change the dose yourself, but ask
your doctor.

Danazol may lower the effect of the
following medicines:
• 
anti-diabetic medication including insulin
• 
medicines used to lower blood pressure
(anti-hypertensives)
• 
medicines for migraine.

Date: 12 Mar 2014

Affiliate Item Code 333735

3. How to take Danazol

If you stop taking Danazol
Do not stop or change your treatment before talking
to your doctor. Do not stop taking Danazol just
because you feel better. If you stop, your illness may
get worse.

21

Component Type Label Leaflet

If you take more Danazol than you should
If you accidentally take too many capsules, contact
your doctor or nearest hospital emergency department
immediately for advice. Take the medicine pack with
you. This is so the doctor knows what you have taken.
If you forget to take Danazol
Unless it is nearly time for your next dose, take it as
soon as you remember. Do not take a double dose to
make up for a forgotten dose.

• 
back ache, pain in the arms and legs, severe muscle
cramps, muscle tremors or twitches, muscle or joint
pain or swelling
• 
racing or irregular heart beat
•  you have high blood pressure it may get worse
if
•  you are diabetic, your blood sugar levels may be
if
affected. Even if you are not diabetic you may get
low blood sugar
• 
feeling tired, mood changes
• 
changes in sex drive (libido)
• 
increased appetite, anxiety, nervousness, depression
• 
breathlessness, swelling or inflammation of the
lungs (interstitial pneumonitis)
• 
chest or stomach pain
• 
water retention or bloating, which may occasionally
lead to a feeling of tingling or numbness in
the hands, sometimes known as carpal
tunnel syndrome.

Body Text Size 7 pt

Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.

If your endometriosis is severe, or if your bleeding
continues after 2 months of treatment, your doctor
may give you a higher dose.
Before an operation for endometriosis, the
recommended dose is 400 mg to 800 mg daily for
3 to 6 weeks.
Menorrhagia: the recommended dose is 200 mg
daily for 3 months.
Breast disease: the recommended dose is 200 mg to
300 mg daily for 3 to 6 months. To treat breast cysts
the usual dose is 300 mg daily for 3 to 6 months.
Enlarged breasts: the recommended dose is 400 mg
daily for 6 months. If you are a young adult, the
starting dose may be 200 mg daily. If your condition
does not improve in the first two months, your doctor
may increase the dose to 400 mg daily.

16

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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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