Description
How does it work?
Roaccutane capsules contain the active
ingredient isotretinoin. (NB. Isotretinoin capsules are also available
without a brand name, ie as the generic medicine.) Isotretinoin belongs
to a group of medicines known as retinoids, which are derivatives of
vitamin A. Isotretinoin taken by mouth works by reducing the production
of the skin’s natural oil (sebum).
Acne occurs due to an excessive production of sebum from over-active
sebaceous glands in the skin. The sebum blocks the sebaceous glands,
which prevents the oil from flowing freely out and causes an
accumulation of sebum under the skin. The bacteria associated with acne
thrive in these conditions. They feed on the sebum, and produce waste
products and fatty acids that irritate the sebaceous glands, making
them inflamed and causing spots.
Isotretinoin decreases the size and activity of the sebaceous glands in
the skin, which reduces the amount of sebum that is produced. This
stops the glands becoming blocked, and means bacteria are less likely
to thrive. It also reduces the inflammation in the skin.
Isotretinoin can have serious side effects and its use must be
supervised by a dermatologist. It is reserved for the treatment of
severe acne (such as nodular or conglobate acne or acne at risk of
permanent scarring) that has not improved with standard treatment
involving oral antibiotics and topical medicines.
Your acne may worsen at the start of treatment, but this usually
subsides within 7 to 10 days of continued treatment. In most cases,
complete or near-complete clearing of acne is achieved with a 12 to 16
week course of treatment, and you are likely to remain free of acne for
a long time. Repeat courses are not normally recommended, unless a
definite relapse is seen after treatment is stopped. Repeat courses
should not be started until at least eight weeks after stopping
treatment, as your acne may still improve in this time.
What is it used for?
Severe acne that has not responded to standard treatment with oral antibiotics and topical medicines
Warning!
Isotretinoin causes major birth defects (serious malformations
of a developing foetus) if taken during pregnancy. For this reason your
doctor will not prescribe the treatment to women who could get
pregnant, unless the following criteria are met: At least one, but
preferably two (for example the pill and condoms), effective methods of contraception
must be used at all times to prevent pregnancy. Contraception must
start at least four weeks before starting treatment, be used at all
times during treatment and for at least four weeks after stopping
treatment, even if you don't have a period. Your doctor cannot
prescribe isotretinoin until you have been using effective
contraception for at least a month and have had a negative pregnancy
test. Your doctor is only allowed to prescribe 30 days supply of
isotretinoin at a time. You will need to have a follow-up visit every
month, at which you will have to have a negative pregnancy test before
a new prescription can be issued. Five weeks after stopping treatment
you should have a final pregnancy test to make sure you have not fallen
pregnant. If you think there is a chance you could be pregnant, either
during treatment, or in the first month after stopping treatment, you
must consult your doctor immediately.
There is no evidence to suggest that children fathered by men who
are taking isotretinoin will be affected by the medicine, but men
should remember not to give this medicine to anyone, particularly
females.
You should never give this medicine to another person and you
should return any unused medicine to your pharmacist at the end of
treatment.
People taking this medicine must not donate blood during treatment,
and for at least four weeks after stopping treatment. This is due to
the potential risk of the medicine to an unborn child if the blood
transfusion was received by a pregnant woman.
This medicine may cause depression, anxiety, mood changes,
psychotic symptoms and rarely suicide attempts. For this reason, if you
start to feel depressed, or experience any other mood changes during
treatment, it is important to talk to your doctor.
You should avoid exposing your skin to intense sunlight or UV light
while taking this medicine. You should use a sunscreen of at least SPF
15 when necessary.
Isotretinoin is likely to make your skin and lips very dry, so it
is recommended that you use a moisturiser and lip balm from the start
of treatment.
You should avoid waxing any part of your body while taking
isotretinoin, and for at least six months after stopping treatment, as
this could cause stripping of the top layer of skin. Chemical
dermabrasion and cutaneous laser treatment should also be avoided
during treatment with isotretinoin and for five to six months after
stopping treatment, as this could cause scarring.
Isotretinoin can make your eyes dry. This can be relieved with
artificial tear drops. Ask your doctor or pharmacist for advice. If you
wear contact lenses you may find that they become uncomfortable during
treatment and you have to wear glasses instead. Decreased night vision
may also occur during treatment and after treatment has been stopped,
and can occur suddenly. For this reason you are advised to be cautious
when driving or operating any vehicle at night. If you experience any
visual difficulties, inform your doctor so that your vision can be
monitored. It may sometimes be necessary to stop treatment.
You will need to have a blood test to monitor your liver function
before you start treatment with this medicine, one month after starting
and then at further three-monthly intervals.
The amount of lipids (fats such as cholesterol) in your blood
should also be monitored before treatment, one month after starting
treatment and at three-monthly intervals. If your blood level of
triglycerides becomes too high, your isotretinoin dose may need to be
reduced and you may have to go on a low fat diet. If your triglycerides
cannot be controlled, you may have to stop treatment with isotretinoin.
This medicine may increase your blood sugar level. People with
diabetes may need to monitor their blood sugar more frequently during
treatment with this medicine. Ask your doctor for advice.
If you experience severe bloody diarrhoea during treatment with
this medicine you should stop taking it and consult your doctor
immediately.
This medicine is not recommended for children under 12 years of age.
Use with caution in
Women who could get pregnant
History of depression
Decreased kidney function
Alcoholism
Diabetes
Obesity
Lipid metabolism disorders
Not to be used in
Pregnancy
Breastfeeding
Woman who could get pregnant, unless the criteria described in warnings above are met
Acne that has developed before reaching puberty (prepubertal acne)
Decreased liver function
High levels of fats
A condition resulting from the excessive consumption of vitamin A (hypervitaminosis A)
People taking tetracycline-type antibiotics
Peanut or soya allergy (Roaccutane capsules contain arachis oil and soya oil)
Rare hereditary problems of fructose intolerance (Roaccutane capsules contain fructose)
This medicine should not be used if you are allergic to one or any of
its ingredients. Please inform your doctor or pharmacist if you have
previously experienced such an allergy.
If you feel you have experienced an allergic reaction, stop
using this medicine and inform your doctor or pharmacist immediately.
Pregnancy and Breastfeeding
Certain medicines should not be used during pregnancy or breastfeeding.
However, other medicines may be safely used in pregnancy or
breastfeeding providing the benefits to the mother outweigh the risks
to the unborn baby. Always inform your doctor if you are pregnant or
planning a pregnancy, before using any medicine.
Isotretinoin MUST NOT be used during pregnancy as it causes
major birth defects and serious malformations of the foetus. Women who
could get pregnant will only be prescribed this medicine if all the
criteria listed in warnings above are met. At least one and preferably
two effective methods of contraception must be used to prevent
pregnancy for at least one month before starting treatment, during
treatment and for at least one month after finishing treatment. If you
think you could be pregnant at any point during treatment or in the
month after stopping treatment you must consult your doctor immediately.
This medicine must not be used by breastfeeding mothers, as it
passes into breast milk and could have adverse effects on the nursing
infant. Seek medical advice from your doctor.
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