Roaccutane (Roaccutane 20mg capsules)

 

Overview

Information specific to: Roaccutane 20mg capsules when used in Acne.

Roaccutane (Roh-ak-you-tane) is a medicine which is used in treating acne. Roaccutane contains isotretinoin. It is supplied by Roche Products Limited.

The information in this Medicine Guide for roaccutane varies according to the condition being treated and the particular preparation used.

Your medicine

Roaccutane is used to treat acne. Roaccutane works by suppressing the activity of sebaceous glands in the skin. It reduces the amount of oil produced by these glands. Roaccutane also reduces the size of the sebaceous glands and the inflammation that occurs with acne. Roaccutane is given to people when their previous treatments for acne have not been successful.

Roaccutane may make the skin all over your body more fragile or sensitive. Your skin may be more easily damaged during treatment with Roaccutane and for some time after treatment has stopped. You should not wax your skin while you are taking Roaccutane and for at least six months after you have stopped taking it. Some types of dermabrasion or laser treatments should also be avoided while you are taking Roaccutane and for five to six months after stopping treatment. You should also be careful about using preparations on your skin while you are taking Roaccutane. Your skin may become irritated if you use certain skin preparations such as preparations that treat acne while you are taking Roaccutane. For more information about skin preparations to avoid during treatment with Roaccutane talk to your prescriber or read the Patient Information Leaflet that comes with this medicine.

Roaccutane can cause your skin to become more sensitive to all forms of UV light. While you are taking Roaccutane, you should try to avoid exposing your skin to intense sunlight or UV light. If you need to go out in the sun use a high protection sun screen. You should use a sun screen that has a minimum sun protection factor of 15. You should also avoid using tanning beds or lamps while you are taking Roaccutane.

Roaccutane may harm a baby if it is taken during pregnancy. It may also increase the chances of having a miscarriage. Women must not become pregnant while they are taking Roaccutane. For this reason women who could become pregnant are only prescribed Roaccutane if they are very careful about using contraception to prevent pregnancy. Women who are being treated with Roaccutane and who do not have a menstrual period or who are not currently sexually active must also use contraception.

If you are a woman and you are taking Roaccutane, you must not become pregnant during treatment and for at least one month after stopping treatment with Roaccutane. You must use one form, or preferably two forms, of effective contraception one month before you begin treatment with Roaccutane. You must continue to use this contraception while you are taking Roaccutane and for at least a month after you have stopped taking Roaccutane. During this time, if you become pregnant, or think you have become pregnant, you must immediately contact your prescriber. For more information about using contraception and what types of contraception should be used while taking Roaccutane talk to your prescriber or read the Patient Information Leaflet that comes with your medicine.

Treatment with Roaccutane can only be started in a woman once the prescriber is certain that the woman is not pregnant. Women will need to have a pregnancy test before, during and five weeks after stopping treatment with Roaccutane. For more information about pregnancy tests during treatment with Roaccutane, talk to your prescriber.

It is very important that you do not share your medicine with other people as it may not be suitable for them and could cause them harm. It is also important that you do not give blood while you are taking Roaccutane and for one month after you have stopped taking it. Roaccutane may be in your blood and if your blood is given to a pregnant woman during a blood transfusion Roaccutane may harm the baby.

Other information about Roaccutane:

  • you may need to take Roaccutane for several weeks before you can expect to see any benefits from taking this medicine. Treatment with Roaccutane is stopped once the acne has resolved but it may be started again if the acne returns. For more information about when you would expect to see the benefits of taking Roaccutane and how long your treatment will last for, talk to your prescriber.
  • your prescriber may vary the dose of your medicine to find what is best for you

Do not share your medicine with other people. It may not be suitable for them and may harm them.

The pharmacy label on your medicine tells you how much medicine you should take. It also tells you how often you should take your medicine. This is the dose that you and your prescriber have agreed you should take. You should not change the dose of your medicine unless you are told to do so by your prescriber.

If you feel that the medicine is making you unwell or you do not think it is working, then talk to your prescriber.

Whether this medicine is suitable for you

Roaccutane is not suitable for everyone and some people should never use it. Other people should only use it with special care. It is important that the person prescribing this medicine knows your full medical history.

Your prescriber may only prescribe this medicine with special care or may not prescribe it at all if you:

  • are a woman who could become pregnant
  • are allergic or sensitive to or have had a reaction to any of the ingredients in the medicine
  • are allergic or sensitive to or have had a reaction to peanut or soya in the past
  • are an alcoholic
  • are breast-feeding
  • are doing intensive physical activity or exercise
  • are obese
  • are pregnant
  • have asthma
  • have diabetes
  • have fructose intolerance
  • have hyperlipidaemia
  • have kidney problems
  • have liver problems
  • have metabolic problems
  • have or have had depression
  • have or have had thoughts of committing suicide
  • have vitamin A poisoning
  • wear contact lenses

Furthermore the prescriber may only prescribe this medicine with special care or may not prescribe it at all for child under 12 years of age.

As part of the process of assessing suitability to take this medicine a prescriber may also arrange tests:

  • to determine whether or not the medicine is suitable and whether it must be prescribed with extra care
  • to check that this medicine is not having any undesired effects

Over time it is possible that Roaccutane can become unsuitable for some people, or they may become unsuitable for it. If at any time it appears that Roaccutane has become unsuitable, it is important that the prescriber is contacted immediately.

Alcohol

Alcohol can interact with certain medicines.

In the case of Roaccutane:

  • there are no known interactions between alcohol and Roaccutane

Diet

Medicines can interact with certain foods. In some cases, this may be harmful and your prescriber may advise you to avoid certain foods.

In the case of Roaccutane:

  • there are no specific foods that you must exclude from your diet when taking Roaccutane

Driving and operating machinery

When taking any medicine you should be aware that it might interfere with your ability to drive or operate machinery safely.

In the case of Roaccutane:

  • this medicine could affect your ability to drive or operate machinery

You should see how this medicine affects you before you judge whether you are safe to drive or operate machinery. Some people who take this medicine may have drowsiness, dizziness or reduced night vision. Reduced night vision may occur suddenly. You must not drive unless your vision has returned to normal or if you feel drowsy or dizzy while taking Roaccutane. If you are in any doubt about whether you should drive or operate machinery, talk to your prescriber.

Family planning and pregnancy

Most medicines, in some way, can affect the development of a baby in the womb. The effect on the baby differs between medicines and also depends on the stage of pregnancy that you have reached when you take the medicine.

In the case of Roaccutane:

  • Roaccutane is a medicine which has implications for pregnancy as it may harm a baby. You must not become pregnant while you are taking it, and for at least one month after you stop taking this medicine
  • if you could become pregnant, you must use one form, or preferably two forms, of effective contraception one month before starting Roaccutane, during treatment with Roaccutane and for at least one month after stopping treatment. During this time, if you become pregnant, or think you have become pregnant, you must immediately contact your prescriber
  • your prescriber will only start your treatment with Roaccutane once they are certain that you are not pregnant. You will need to have a pregnancy test before starting treatment with Roaccutane, during treatment and five weeks after treatment has stopped. For more information talk to your prescriber

This medicine is not suitable during pregnancy. It is very important that you seek urgent medical advice if you become pregnant or think you have become pregnant while taking this medicine.

If you are planning to become pregnant, you should discuss your personal circumstances with your doctor so that together you can make a decision about what treatment you may need during your pregnancy.

Breast-feeding

Certain medicines can pass into breast milk and may reach your baby through breast-feeding.

In the case of Roaccutane:

  • women who are breast-feeding must not take this medicine

Before you have your baby you should discuss breast-feeding with your doctor or midwife. If you wish to breast-feed you should discuss with your prescriber whether there are any other medicines you could take which would also allow you to breast-feed.

Taking other medicines

If you are taking more than one medicine they may interact with each other. At times your prescriber may decide to use medicines that interact, in other cases this may not be appropriate.

The decision to use medicines that interact depends on your specific circumstances. Your prescriber may decide to use medicines that interact, if it is believed that the benefits of taking the medicines together outweigh the risks. In such cases, it may be necessary to alter your dose or monitor you more closely.

Tell your prescriber the names of all the medicines that you are taking so that they can consider all possible interactions. This includes all the medicines which have been prescribed by your GP, hospital doctor, dentist, nurse, health visitor, midwife or pharmacist. You must also tell your prescriber about medicines which you have bought over the counter without prescriptions.

The following medicines may interact with Roaccutane:

  • vitamin A

The following types of medicine may interact with Roaccutane:

  • exfoliants
  • keratolytics
  • tetracyclines

If you are taking Roaccutane and one of the above medicines or types of medicines, make sure your prescriber knows about it.

Complementary preparations and vitamins

Medicines can interact with complementary preparations and vitamins.

Make sure you tell your prescriber the names of all the complementary preparations and vitamins that you are taking or are planning to take.

Your prescriber can then decide whether it is appropriate for you to take combinations that are known to interact.

In the case of Roaccutane:

  • this medicine may interact with vitamin A

If you have been prescribed Roaccutane you should only take something on the above list on the specific advice of your prescriber or pharmacist.

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