How does it work?

Isotretinoin belongs to a group of medicines known as retinoids, which are derivatives of vitamin A. It 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 that has not improved with a course of oral antibiotics, and for acne with cyst formation. 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.

What is it used for?

Cystic acne

Severe acne that has not responded to treatment with oral antibiotics

Warning!

People taking this medicine should not donate blood during treatment, and for at least four weeks after stopping treatment.

People with diabetes should monitor their blood sugar carefully during treatment with this medicine.

Avoid waxing any part of the body during therapy with isotretinoin, and for up to six months after stopping therapy, due to risk of inflammation of the skin (dermatitis) and scarring.

Surgical procedures involving the controlled scraping away of the top layers of the skin to smoothen the skin and remove small scars, wrinkles and tattoos, should be avoided during treatment with isotretinoin and for up to six months after stopping therapy, due to risk of enhanced scarring.

Decreased night vision may occur during therapy and after therapy has been stopped, and can occur suddenly. Patients are advised to be cautious when driving or operating any vehicle at night.

Isotretinoin causes major birth defects, and women of child bearing potential must not take isotretinoin unless the following criteria are met: A pregnancy test must be taken before starting treatment and must be negative. Treatment should be started on the second or third day of your menstrual period. Effective contraception must be used for at least four weeks before starting treatment, during treatment and for at least four weeks after stopping treatment. If you think you may be pregnant either during treatment, or in the first month after treatment, consult your doctor immediately.

You should have the amount of lipids (fats) in your blood monitored before treatment, one month after starting treatment and at the end of treatment. If your blood level of triglycerides becomes too high, you may need to reduce isotretinoin dose and go on a low fat diet. If it cannot be controlled, you may have to stop treatment with isotretinoin.

This medicine may cause depression, psychotic symptoms and rarely suicide attempts. If you feel depressed or experience any other mood changes during treatment, talk to your doctor.

You should have blood tests to monitor your liver function before you start treatment with this medicine, one month after starting and then at further three-monthly intervals.

If you experience any visual difficulties, inform your doctor so that your vision can be monitored. It may sometimes be necessary to stop treatment.

If you experience severe diarrhoea during treatment with this medicine you should consult your doctor immediately. It may be necessary for you to stop treatment.

Use with caution in

Alcoholism

Diabetes

Elderly people

History of depression

Lipid metabolism disorder

Obesity

Women of child-bearing potential

Not to be used in

A condition resulting from the excessive consumption of vitamin A (hypervitaminosis A)

Acne developing in the peroid before puberty

Breastfeeding

Decreased kidney function

Decreased liver function

High levels of fats

Pregnancy

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.

This medicine must not be used during pregnancy as it causes major birth defects. Women of child-bearing potential can only take this medicine if they use effective contraception for one month before, during and for one month after finishing treatment. Treatment must only be started on the second or third day of your menstrual period, and only after a negative pregnancy test.

This medicine should not be used by breastfeeding mothers. Discuss this with your doctor.

Label warnings

Follow the printed instructions you have been given with this medication.

Take this medication with or after food.

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