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What are the aims of this leaflet?
This leaflet has been written to help you understand more about accutane. It
tells you what it is, how it works, how it is used and where you can find out
more about it.

What is accutane and how does it work?
accutane (brand name Roaccutane) belongs to a group of drugs called
retinoids, which are closely related to vitamin A. It works in a variety of ways,
targeting different factors that cause acne including the production of sebum
(an oily substance produced by the skin) and the production of keratin (outer
scales of skin) that block the pores of the hair follicle.

What skin conditions are treated with accutane?
accutane is licensed to treat severe acne, often where there is risk of
scarring. Your dermatologist may occasionally use accutane to treat other
skin conditions such as hidradenitis suppurativa and rosacea. In the United
Kingdom, accutane may only be prescribed if you are under the care of a
consultant dermatologist.

Will accutane cure my acne?
A large proportion of patients (about 9 out of 10) see a significant
improvement in their acne with a single course of accutane, although during
the first few weeks of treatment the acne may worsen before it starts to
improve.
A small number of patients continue to have milder (although improved) acne
following accutane that can be controlled with conventional therapies, such
as antibiotics. Others may relapse after stopping treatment with accutane,
and occasionally, a prolonged or further course of treatment is required.

What dose should I take and for how long?
Your dermatologist will calculate the amount of accutane you need
according to your body weight and decide on an appropriate starting dose. At
future appointments the dose of accutane may be changed depending on
side effects and your response to the medication. Most patients take between
20 mg and 80 mg of accutane each day, and a course commonly lasts
between 16 and 24 weeks. With doses in the lower end of this range, which
are often better tolerated, a course may last longer than 24 weeks. Your acne
may continue to improve for up to 8 weeks after treatment. The benefits of
accutane may continue in the skin for several years after treatment.

How should I take accutane?

As accutane is better absorbed into the body with food containing some fat,
it is best to take the medication after a meal. The capsules need to be
swallowed whole and should not be crushed or split open. Keep the capsules
in a cool (5 to 25°C) dark place away from children.
Caution for patients of child-bearing potential
Patients must not take accutane in pregnancy. If a person becomes
pregnant whilst taking accutane or 4 weeks after they finish the course,
there is a high risk that the baby will be harmed with severe and serious
defects (such as abnormal appearance or intellectual disability) and an
increased risk of miscarriage.

If you do become pregnant, or suspect that you may be pregnant, you must
stop the medication immediately and contact your doctor, so you may be
referred to a specialist pregnancy clinic. A termination of pregnancy will be
recommended. You should not breast feed while taking accutane and for a
month after completing treatment.
Please see below for more information on the Pregnancy Prevention
Programme.

What is the Pregnancy Prevention Programme?
All women with child-bearing potential should be entered into the Pregnancy
Prevention Programme whilst taking their course of accutane, in order to
minimise the risk of pregnancy. There are rules that the government body, the
Medicines and Healthcare products Regulatory Agency, has produced which
doctors and pharmacists must follow:

• Before starting accutane you must use at least one, and preferably
two, forms of effective contraception for at least one month before
starting treatment. It is necessary to discuss general aspects of
contraception with your doctor or nurse.
• Combined contraceptive pills are considered to be effective. Certain
antibiotics (e.g. amoxicillin) and herbal products (e.g. St John’s Wort)
can interfere with hormonal contraceptives (‘The Pill’) making them less
effective.
• However, oral progestogen-only contraceptives (“the mini pill”) are
NOT considered effective on their own as a contraceptive, but can be
used in conjunction with other contraceptive methods.
• Barrier methods, such as condoms and caps, should not be used
alone, but can be used in conjunction with other contraceptive
methods.
• You will be given your first prescription for accutane after having a
negative pregnancy test at the clinic.
• Ideally you should start treatment on day 2 or 3 of your menstrual
cycle.
• Each month you will attend the clinic for a pregnancy test and you will
have a final pregnancy test 5 weeks after finishing treatment.
• You will only be supplied with 30 days of treatment on each visit
following a negative pregnancy test.
• You must collect your prescription for accutane from the pharmacy
within 7 days of it being signed by your doctor.
• Contraception needs to be continued after treatment is stopped, for a
further month.

Do all women have to enter the Pregnancy Prevention Programme?
Women who are unable to become pregnant due to medical reasons, or have
been sterilised, or had a hysterectomy, or had both ovaries surgically
removed, or postmenopausal (defined as more than a year since last
menstrual period) may be excluded from the Pregnancy Prevention
Programme. In exceptional circumstances, females capable of becoming
pregnant but who are not sexually active may be exempted from the
Pregnancy Prevention Programme.

Will accutane affect future pregnancies?
accutane does not affect fertility. One month after finishing a course of
accutane, you may get pregnant with no additional risk to the unborn baby.
There has been no known adverse effect on the pregnancy if a man taking
accutane fathers a child even though small amounts of accutane is found
in semen.

Peanut or soya allergy
accutane contains soya oil. Occasionally, patients with soya allergy might
react to the trace levels of soya proteins in soya oil. Extremely rarely, patients
with peanut allergy might also have a reaction to the soya proteins in soya oil.
You should inform your doctor and pharmacist if you think you may have an
allergy to soya or peanut.

What are the common side effects of accutane?
In general, dryness of the skin, lips, and eyes is the most common side effect.
Using a non-comedogenic moisturiser (one that does not block the skin pores)
and lip balm regularly will help. In more severe cases, this can turn into
eczema and may require additional treatment. Nosebleeds may occur if the
inside of the nose becomes very dry. Dry eyes may make the wearing of
contact lenses a little uncomfortable and may be helped by using artificial
tears eye drops available over the counter.

As a result of the skin becoming dry and cracked, the risk of skin infection is
increased. Wounds may also take longer to heal and the skin may feel fragile
and peel with friction. Whilst taking accutane, and for six months afterwards,
your skin will be more delicate than usual; hair removal using waxing,
epilation, dermabrasion, or laser treatment, as well as tattoos and piercings
should be avoided. Shaving is normally tolerated, but use of a moisturiser
afterwards is advisable.

accutane may increase your skin’s sensitivity to the sun. You should
therefore avoid direct sun exposure whilst taking this medication. Where
necessary a sun-protection product with a high protection factor of at least
SPF 30 should be used. You should also avoid the use of sun beds.
Muscles and joints may ache especially after exercise. Temporary hair
thinning may occasionally occur.

accutane can rarely affect your vision, in particular the ability to see at night
(less than 1 in 10,000 chance). If you develop difficulties seeing at night or in
dark situations you should avoid driving and/or operating heavy machinery.
Patients whose jobs may be impacted by this, such as drivers, airline pilots,
people in the military, and those who operate heavy machinery, are advised to
discuss this with their employer before starting the medication, and check with
current Civil Aviation guidelines. These night vision changes may be
permanent in extremely rare circumstances.
accutane may sometimes cause an increase in the levels of fats in your
blood (which can lead to inflammation of the pancreas), or inflammation of the
liver. Blood tests will be requested during treatment to monitor any potential
side-effects.

What are the rare side effects of accutane?
A number of more serious side effects may occur although these are rare.
accutane can lead to changes in mood and/or behaviour (between 1 in
1,000 and 1 in 10,000 chance) and less commonly, unusual experiences
including thoughts of self-harm and suicide. There have also been reports of
patients attempting suicide (less than 1 in 10,000 chance). If you have ever
had low mood, suicidal ideas or any other mental health problem, please
discuss this with your dermatologist before starting treatment. If you have a
history of depression your dermatologist may ask a psychiatrist to see you
before starting accutane to determine if it is safe for you to take. If you or
your friends/relatives feel that your mood or behaviour is changing, or if
you start having thoughts of self-harm whilst taking accutane, please
inform your doctor and stop taking it immediately. Your dermatologist
will then discuss it with you and advise if it is safe to take in the future.

A very rare side effect is raised pressure in the brain (less than 1 in 10,000
chance), this causes severe headache, nausea, vomiting and blurred vision.
Sexual side effects, such as erectile dysfunction, vaginal dryness, and
decreased libido, may also occur; these are understood to be rare but may
persist despite completing the course of treatment.

There have been few rare cases of patients developing inflammatory bowel
disease such as, Crohn’s disease and ulcerative colitis, during or after
treatment with accutane. Although it has not been proved that accutane
causes this, please stop taking your medication immediately if you develop
bloody diarrhoea and see your GP on the same day or attend the nearest

Accident and Emergency department depending on the severity of your
symptoms and how you feel.
This is not a complete list of side effects, and if you do develop any new
problems while taking accutane please inform your doctor or nurse.

Are there any other precautions whilst taking accutane?
You must never share your tablets with other people. You cannot donate
blood when taking accutane and for at least one month after stopping the
medication in case the blood is given to a pregnant woman.

Can I drink alcohol whilst taking accutane?
Yes, but not to excess as alcohol can also cause inflammation of the liver.
You should not exceed the government recommended guidelines for alcohol
consumption (no more than 14 units per week).

Can I take other medications at the same time as accutane?
Most drugs can be taken safely with accutane but some medications may
interact. It is important that you tell your doctor and pharmacist what you are
currently taking before taking any new prescription or over-the-counter
medications (including herbal remedies).
Medications to avoid while taking accutane include:
• Tetracycline antibiotics
• Methotrexate
• Vitamin A supplements (including multi-vitamins containing vitamin A)
This is not a complete list and it is important that you always inform your
doctor and pharmacist that you are taking accutane and read the in-pack
leaflet.

Where can I find out more about accutane?
If you would like any further information about accutane, or if you have any
concerns about your treatment, you should discuss this with your doctor or
pharmacist. This information sheet does not list all the side effects this drug
can cause. For full details, please see the drug information leaflet that comes
with your medicine. Your doctor will assess your medical circumstances and
draw your attention to side effects that may be relevant in your particular
case.