What is Roaccutane ?
Roaccutane 20mg Product Genuine on Roche Turkey
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 conditions of the Pregnancy Prevention
Programme 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, and the prescription will only
be valid for seven days. 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.
* 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.
* This medicine may
rarely cause depression, anxiety, aggression and mood changes and very
rarely psychotic symptoms (eg delusions or hallucinations) and thoughts
of suicide or suicide attempts. For this reason, if you start to feel
depressed, or experience any other changes in your mood or behaviour
during treatment, it is very important to talk to your doctor straight
away.
* 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 and triglycerides) 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.
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 all the criteria described in the warning section above are met.
* Acne that has developed before reaching puberty (prepubertal acne).
* Decreased liver function.
* People with high levels of fats (lipids) such as cholesterol and triglycerides in their blood (hyperlipidaemia).
* A condition resulting from the excessive consumption of vitamin A (hypervitaminosis A).
* People taking tetracycline-type antibiotics.
* Soya allergy (Roaccutane capsules contain soya oil).
* Rare hereditary problems of fructose intolerance (Roaccutane capsules contain sorbitol).
* This medicine is not recommended for children under 12 years of age.
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 conditions of the Pregnancy
Prevention Programme listed in the warning section 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.