for the effective treatment of acne

for the
effective
treatment
of acne
for the
effective
treatment
of acne
What is acne?
Acne is a common skin condition
that is prevalent mainly in teenagers,
although it can affect some people
into their 40’s. Most people at some
point in their lives suffer from some
form of acne.
Acne is a condition that affects
the skin’s oil glands (sebaceous
glands). It is most common on the
face but can also occur on the
shoulders, back, chest, arms
and bottom.
Isotane works by reducing
the amount of sebum (an oily
substance produced by the
sebaceous glands in your
skin), reducing bacteria,
reducing inflammation and
opening clogged pores
There are two main types of acne:
mild or non-inflammatory; and
severe or inflammatory.
Mild acne is defined by closed
comedones (whiteheads) or
open comedones (blackheads).
Comedones are hair follicles that
have become plugged with fatty
material. This fatty material consists
of sebum (an oily substance
secreted by the sebaceous glands)
and keratin (dead skin cells).
Severe acne is defined by the
following: papules (small pink
bumps), pustules (small round red
lesions that contain visible pus),
and nodules (red hard painful
lumps under the skin). Severe or
inflammatory acne can penetrate
into the deeper layers of the skin
and result in permanent scarring.
What causes acne?
There are several contributing
factors to acne: hormones, bacteria,
increased sebum production, and
changes within the hair follicle.
During puberty or adolescence
there is an increase in the
production of sex hormones
(mainly androgens and testosterone).
This causes the sebaceous glands
to produce increased amounts of
sebum. Also during puberty, the
skin cells lining the hair follicle shed
at a faster rate, increasing the
probability that the sebum and
skin cells present will stick together
and result in blockage of the hair
follicle. The number of bacteria
on the skin surface also increases
during puberty. Young men are
more likely to have severe, longer
lasting acne than women due to
higher levels of testosterone. Young
women are prone to cycles of acne
due to hormonal changes that
occur during their menstrual cycle.
Other factors that may contribute
to acne include: use of greasy or
oily cosmetics; a family history
of acne; use of certain medicines
such as glucocorticoids, iodides,
lithium, bromides or anticonvulsants;
abrasion caused by over-vigorous
scrubbing; frequent shaving or
other manipulation to the skin;
exposure to airborne pollutants;
and exposure to high heat and
humidity.
Acne treatment
It is best to talk to your doctor
or dermatologist (skin specialist
doctor) about the correct treatment
for your acne. Some of the
treatment options they may give
you are mentioned below:
Topical treatment
For treatment of mild to moderate
acne, topical treatment may be
given. The most common topical
treatment is benzoyl peroxide. This
can be bought from your pharmacy
with or without a prescription, or
your supermarket. Other topical
treatments include prescription
medicines such as antibiotic
lotions. These topical treatments
are often sufficient to reduce
inflammation and unblock pores.
Treatment periods will vary between
patients but normally last between
2-4 weeks.
Oral treatment
For treatment of moderate to
severe acne, oral treatment may
be given. Isotretinoin, the active
ingredient in Isotane, is an oral
treatment commonly prescribed
by doctors and dermatologists.
Isotretinoin belongs to a group of
medicines called retinoids which
are Vitamin A derivatives. It works
by reducing the amount of sebum
(an oily substance produced by the
sebaceous glands in your skin),
reducing bacteria, reducing
inflammation and opening
clogged pores.
Other oral treatments for
moderate to severe acne include
oral antibiotics and hormonal
contraceptive pills. Oral antibiotics
(eg. doxycycline, minocycline) work
by reducing the amount of
bacteria on your skin. Hormonal
contraceptive pills help in the
regulation of hormones such as
the androgens during puberty.
Skin care
The most commonly experienced
side effects while taking isotretinoin
are skin side effects. Most patients
will notice side effects such as dry
lips and dry skin. Dry eyes and a
dry nose may also occur. The good
news is that these side effects
can be controlled and relieved by
following a good skin care routine.
Below are some guidelines that
may help in alleviating the
symptoms of dry skin.
General Care
• Limit shower time to minimise
exposure of your skin to water
• Avoid harsh soaps
• Use lukewarm water when
washing your face
• Regularly moisturise your face
and body
• Refrain from picking or squeezing
pimples
• Avoid waxing (as a means of hair
removal), dermabrasion (medical
removal of layers of skin), facial
peels and electrolysis while
taking Isotane and for at
least six months after stopping
Isotane. Your skin may be more
sensitive and fragile during this
time. These treatments may
cause scarring or dermatitis
(inflammation of the skin).
Sun Sensitivity
• Do not expose your skin to
sunlight for long periods
• Use a sunscreen, 30+ and oil-free
is the best option
• Cover up, such as wearing a hat
and a long sleeved t-shirt
• Do not sun bathe.
Dry Eyes
• If you wear contact lenses you
may experience dry eyes. It is
recommended that you wear
your lenses for shorter periods of
time, clean your lenses regularly
or wear glasses instead.
• Using artificial tears or an eye
lubricant can help with this.
Dry Lips
• Dry lips are a common side effect
of Isotane.
• Regularly applying a lip balm or
cream, that contains a sunscreen,
can help with this.
Isotretinoin
10 mg and 20 mg
Capsules
Dry Nose
• This is usually mild but can cause
nosebleeds in some patients.
• Applying petroleum jelly with a
cotton bud can help keep the
nose and nasal cavity moist.
• If you are experiencing frequent
nosebleeds, please see your
doctor or dermatologist for
further advice.
Dry Vagina
• This can cause discomfort during
sexual intercourse.
• A lubricant can help with this.
Dry Anus
• Some patients experience
irritation and dryness around
this area.
• Petroleum jelly can help with this.
Dry Hair
• You may find that your hair and
scalp are dryer than normal.
Using an anti-dandruff shampoo
during this period should help in
controlling this.
• Avoid using hair colouring or
perming products while taking
Isotane, as your hair and scalp
may be more sensitive during
this period.
Consumer medicine
information
Before you
take Isotane
What is in this leaflet
Do not take
Isotane if you:
This leaflet answers some
common questions about Isotane.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist. All medicines have
risks and benefits. Your doctor has
weighed the risks of you taking
Isotane against the benefits they
expect it will have for you. If you
have any concerns about taking
this medicine, ask your doctor or
pharmacist. Keep this leaflet with
the medicine. You may need to
read it again.
What Isotane is
used for
Isotane contains the active
ingredient, isotretinoin. Isotretinoin
belongs to a group of medicines
called retinoids which are vitamin
A derivatives. It works by reducing
the amount of sebum (an oily
substance produced by the
sebaceous glands in your skin),
reducing bacteria, reducing
inflammation and opening clogged
pores. There are many different
types of medicines used to treat
acne. Isotane is used for more
severe cases that are resistant to
other forms of treatment.
It is available only with a
doctor’s prescription and is usually
prescribed by dermatologists
(skin specialist doctors). Ask your
doctor if you have any questions
about why this medicine has been
prescribed for you. Your doctor
may have prescribed it for
another reason.
• are pregnant
• are breast-feeding
• have kidney or liver disease
• have an excessive amount of
vitamin A in the diet,
(hypervitaminosis A)
• are taking tetracycline antibiotics
• have very high levels of fat
(triglycerides, cholesterol) in
your blood
• have an allergy to any medicine
containing isotretinoin
• have an allergy to any other
retinoids, including Vitamin A or
any of the ingredients listed at the
end of this leaflet
• are a child under 13 years.
Do not take this medicine after the
expiry date printed on the pack or
if the packaging is torn or shows
signs of tampering.
If it has expired or is damaged,
return it to your pharmacist for
disposal.
If you are not sure whether you
should start taking this medicine,
talk to your doctor.
Advice for male
patients
Do not share your medication with
anyone, particularly not females.
Isotretinoin treatment does not
appear to damage sperm. Although
isotretinoin and its metabolites are
present in very low levels in your
semen, these levels are considered
too low to harm the unborn baby of
your female partner. No specific
contraceptive precautions are
necessary for men.
Advice for female
patients
• Do not take this medicine if you
are pregnant. If you become
pregnant while taking Isotane, there
is an extremely high risk that your
baby will be severely deformed.
Effective birth control must be used.
• Do not breast-feed if you are
taking this medicine. The active
ingredient in Isotane passes into
breast milk and there is a possibility
that your baby may be affected.
• Pregnancy testing should
be performed before, during
(every month is strongly
recommended) and for a month
after treatment has finished.
• If you become pregnant
while taking Isotane, stop
taking it and tell your doctor
immediately.
• You must use effective birth
control starting at least one month
before you begin taking Isotane, for
the whole time you are taking Isotane
and for one month after you finish
taking Isotane. Even if you are
infertile or not sexually active,
effective birth control is
recommended.
• If you take further courses of
Isotane after completing the initial
treatment, you must ensure that
each time you take Isotane you use
effective birth control starting at least
one month before treatment, for the
whole time during treatment and for
one month after you have finished
taking Isotane.
Before you start to take it
Tell your doctor if you:
• are depressed (have feelings of
deep sadness and unworthiness or
feel “down”), or have felt this way in
the past
• have abnormal thoughts or
behaviour or a mental illness, or have
had them in the past
• have thoughts about harming
yourself (suicidal thoughts or
tendencies), or have had them
in the past
• drink large amounts of alcohol
• are taking the mini-pill, a
progesterone-only oral
contraceptive pill
• intend to undertake regular
vigorous exercise
• have allergies to any other
medicines, foods, preservatives
or dyes
• have any other health problems,
especially the following: you are
considerably overweight; have
diabetes, or a history of diabetes
in your family; or a history of
pancreatitis (inflamed pancreas).
If you have not told your
doctor about any of the above,
tell him/her before you start
taking Isotane.
Taking other medicines
Tell your doctor or pharmacist
if you are taking any other
medicines, including any that
you get without a prescription
from your pharmacy, supermarket
or health food shop.
Some medicines and Isotane may
interfere with each other.
These include:
• tetracycline antibiotics medicines
used to treat bacterial infections,
including doxycycline and
minocycline
• vitamin A or preparations
containing vitamin A
• other medicines used for acne.
These medicines may be affected
by Isotane or may affect how well
it works. You may need different
amounts of your medicines, or
you may need to take different
medicines. Your doctor and
pharmacist have more information
on medicines to be careful with or
avoid while taking this medicine.
and your individual needs. Your
doctor may adjust your dose during
therapy, depending on how you
respond to Isotane.
How to take it
Swallow the capsules whole with
a full glass of water. Do not open
the capsules and do not take any
capsules that are damaged.
Isotane should always be taken
with a meal.
When to take it
Take your medicine at about the
same time each day.
Taking it at the same time each day
will have the best effect. It will also
help you remember when to take it.
Female patients should wait
until the 2nd or 3rd day of the
next normal menstrual period,
after having used effective birth
control for at least one month,
before starting Isotane therapy.
This helps ensure that you are
not pregnant before you start
taking Isotane.
How long to take it
Continue taking your medicine for
as long as your doctor tells you.
Treatment with Isotane will usually
last 16 to 24 weeks. During the first
few weeks of treatment your acne
may get a little worse before it
gets better.
How to take Isotane
Follow all directions given to you by
your doctor or pharmacist carefully.
They may differ from the information
contained in this leaflet. If you do
not understand the instructions
on the box, ask your doctor or
pharmacist for help.
How much to take
Take Isotane exactly as your doctor
has prescribed.
Your doctor will tell you how many
Isotane capsules to take and when
to take them each day. Your dose
will be based on your body weight
Most patients notice their skin
condition continues to improve
for up to two months after Isotane
treatment has finished. Some
patients, however, may need more
than one course of treatment to
notice significant improvement in
their acne.
Please note that Isotane cannot
improve scars or pitting that were
present before treatment started
but it will help prevent such skin
damage in the future.
If you forget to take it
Do not take a double dose to make
up for the dose that you missed.
This may increase the chance of
you getting an unwanted
side effect.
If you are not sure what to do,
ask your doctor or pharmacist.
If you have trouble remembering
to take your medicine, ask your
pharmacist for some hints.
If you take too much
(overdose)
Immediately telephone your doctor
or the National Poisons Information
Centre (0800 POISON or 0800 764
766) for advice, or go to Accident
and Emergency at the nearest
hospital, if you think that you or
anyone else may have taken too
much Isotane. Do this even if
there are no signs of discomfort or
poisoning. You may need urgent
medical attention.
Symptoms of an overdose may
include headache, nausea,
vomiting, dizziness, sleepiness,
blurred vision, itching, redness of
the skin and peeling skin.
While you are
taking Isotane
Things you must do
Tell your doctor if:
• you do become pregnant while
taking Isotane or in the month
following treatment, you should
discuss with your doctor whether
to continue with the pregnancy or
have the pregnancy terminated
• you or your friends or family
notice any changes in your mood
or behaviour (such as feelings of
deep sadness and
unworthiness or feeling “down”),
or if you start to have suicidal
thoughts or tendencies
• you notice any changes in your
vision or if your eyes start to feel dry
• you intend to do a lot of heavy
exercise. Your muscles and joints
may become tender, feel weak or
sore, if you do a lot of heavy
exercise while taking Isotane
• you have not taken your medicine
exactly as prescribed. Otherwise,
your doctor may think that it was
not effective and change your
treatment unnecessarily
• you feel Isotane is not helping
your condition.
If you are about to be started on
any new medicine, remind your
doctor and pharmacist that you are
taking Isotane.
Tell all doctors, dentists and
pharmacists who are treating you
that you are taking Isotane.
Be sure to keep all your
appointments with your doctor so
that your progress can be checked.
Regular follow-up appointments
with your doctor on a monthly basis
may be necessary. If you have any
questions about your follow-up
appointments, including how often
these will be, you should discuss
this with your doctor.
While you are taking Isotane your
doctor may decide to monitor your
bone growth and bone structure,
particularly if you are a child or
young person.
While you are taking Isotane your
doctor may ask you to have regular
blood tests to monitor your liver
function, blood sugar levels and
blood fat levels.
Things you must not do
Do not stop taking Isotane or
change the dose without first
checking with your doctor.
Do not let yourself run out of
medicine over the weekend or on
holidays.
Do not donate blood during
treatment with Isotane or for at
least four weeks after treatment has
finished.
Do not give Isotane to anyone else
even if they have the same
condition as you.
Do not use Isotane to treat other
complaints unless your doctor
advises you to do so.
Do not take any other medicines
whether they require a prescription
or not without first consulting your
doctor or pharmacist.
Take care when driving
Side effects
Be careful driving or operating
machinery until you know how
Isotane affects you.
Tell your doctor or pharmacist as
soon as possible if you do not feel
well while you are taking Isotane.
Normally Isotane would not affect
your ability to drive a car or operate
machinery. However, altered night
vision and other visual disturbances
may occur when taking Isotane.
This medicine helps most people
with severe acne, but it may have
unwanted side effects in a few
people. All medicines can have
side effects. Sometimes they are
serious, most of the time they are
not. You may need medical
attention if you get some of the
side effects.
Make sure you know how you
react to Isotane before you drive
a car, operate machinery or do
anything else that may be
dangerous if your vision is impaired.
Things to be careful of
Wearing contact lenses during
treatment with Isotane may cause
discomfort. Isotane may cause dry
eyes. An eye lubricant or artificial
tears, available from your pharmacy,
should relieve this problem.
Otherwise, you may temporarily
need to wear your contact lenses
for shorter periods or wear glasses
instead.
Avoid excessive sun exposure and
sun beds. Apply a sunscreen while
taking Isotane. Your skin may be
more prone to sunburn while
taking Isotane.
Avoid waxing (as a means of hair
removal), dermabrasion (medical
removal of layers of skin), facial
peels and electrolysis while taking
Isotane and for at least six months
after stopping Isotane. Your skin
may be more sensitive while taking
Isotane. These treatments may
cause scarring or dermatitis
(inflammation of the skin).
Avoid using hair colouring or
perming products. Your skin and
hair may be more sensitive during
treatment with Isotane and for
sometime after treatment has
stopped.
Do not be alarmed by the following
lists of side effects. You may not
experience any of them.
Ask your doctor or pharmacist to
answer any questions you may
have.
If any of the following happen,
tell your doctor IMMEDIATELY
or go to Accident and Emergency
at your nearest hospital:
• you feel depressed (have feelings
of deep sadness and unworthiness
or feel “down”)
• changes in your normal behaviour
• nausea, vomiting, diarrhoea with
blood and mucous, stomach pain
or fever
• persistent headache, severe
headache or seizure
• blurred vision or visual
disturbances, including decreased
vision at night
• severe stomach pain which
passes straight through to your
back (infected pancreas)
• blood in your urine
• tiredness, signs of bruising or
bleeding easily
• signs of infection such as
swelling, tenderness, redness and
increased temperature
• sudden signs of allergy such
as a skin rash, itching or hives;
swelling of the face, lips, tongue or
other parts of the body; shortness
of breath, wheezing or trouble
breathing.
The above list includes very serious
side effects. You may need urgent
medical attention or hospitalisation.
Tell your doctor or pharmacist if you
notice any of the following and they
worry you:
• dryness of the lips, mouth, throat,
nose, eyes, genitals or skin
• skin eruptions, rashes, itching,
inflammation, redness, sweating or
changes in skin colour
• nail inflammation, infection or
altered appearance
• nosebleeds
• tenderness, soreness or stiffness
in your bones, joints or muscles
• impaired hearing
• headache
• an increased sensitivity to sunlight
• hair loss, thinning or increased
growth.
The above side effects are usually
mild and short-lived.
This is not a complete list of all
possible side effects. Others may
occur in some people and there
may be some side effects not
yet known.
If you should suffer from any of
these side effects or any other
undesired effect, please tell your
doctor or pharmacist.
Further Information
Storage
Always keep your Isotane
capsules in the original blister pack
until it is time to take them.
If you take the capsules out of the
pack they may not keep well.
Keep your capsules in a cool dry
place where the temperature stays
below 25°C and protect from light.
Keep it where children cannot
reach it.
A locked cupboard at least oneand-a half metres above the ground
is a good place to store medicines.
Disposal
If your doctor tells you to stop
taking this medicine or the expiry
date has passed, ask your
pharmacist what to do with any
medicine that is left over.
What it looks like
10mg Capsule:
Oval capsule with a yellow paste
fill and a reddish brown opaque
gelatin shell bearing the logo
“I10” in black ink.
20mg Capsule:
Oval capsule with a yellow paste fill
and a bicoloured reddish brown/
cream opaque gelatin shell bearing
the logo “I20” in black ink.
Ingredients
Isotane 10 mg capsules contain
10mg of the active ingredient,
isotretinoin. Each capsule also
contains soybean oil, yellow
beeswax, hydrogenated vegetable
oil, gelatin, glycerol, red iron oxide
(E172), lecithin, medium chain
triglycerides, purified water and
black ink.
Isotane 20 mg capsules contain
20mg of the active ingredient,
isotretinoin. Each capsule also
contains soybean oil, yellow
beeswax, hydrogenated vegetable
oil, gelatin, glycerol, red iron oxide
(E172), yellow iron oxide (E172),
titanium dioxide (E171), lecithin,
medium chain triglycerides, purified
water and black ink.
This medicine does not contain
lactose, sucrose or gluten.
If you want to
know more
Should you have any questions
regarding this product, please
contact your pharmacist or doctor.
Who supplies this
medicine
Distributed in New Zealand by:
Mylan New Zealand Limited
PO Box 11183
Ellerslie
Auckland
Telephone: (09) 579 2792 or
Freephone: 0508 Isotane
Isotane (isotretinoin) 10 mg, 20mg Capsules are a Prescription Medicine
used to treat severe forms of acne that are resistant to other treatments.
WARNING: This medication can cause birth defects. Do not use
if you are pregnant or plan to become pregnant. Effective birth
control must be used one month before starting Isotane
treatment, during treatment and for at least one month after
treatment has finished. Do not take if you have an allergy to
isotretinoin, other retinoids including vitamin A or any of the excipients;
are pregnant or intend to become pregnant; are breastfeeding; have
kidney or liver disease; have an excessive amount of vitamin A in your diet;
are taking tetracycline antibiotics; have very high levels of fat (triglycerides,
cholesterol) in your blood. Tell your doctor if you are depressed or
have felt this way in the past; if you have thoughts about harming
yourself; drink large amounts of alcohol; are taking the mini-pill; intend to
undertake regular vigorous exercise or have any other health problems.
Side effects include dryness of the lips, mouth, throat, nose, eyes,
genitals or skin; skin eruptions, rashes, redness, sweating; nail
inflammation, infection or altered appearance; nosebleeds; tenderness,
soreness or stiffness in your bones, joints or muscles; impaired hearing;
headache; increased sensitivity to sunlight; hair loss, thinning or increased
growth; changes in normal behaviour; blurred vision, decreased night
vision; nausea, vomiting, diarrhoea. Medicines have benefits and some
may have risks.
Consult your doctor to see if Isotane is right for you. Always
read the label carefully and use strictly as directed. If symptoms
persist or you have side effects, see your health professional.
Full Consumer Medicine Information (CMI) is available at www.
medsafe.govt.nz. Isotane is fully funded on special authority.
Normal doctor’s fees & pharmacy charges apply.
Mylan NZ Ltd., Auckland. TAPS NA7864.