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Last Updated 15 Mar 2012

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Roaccutane 20mg capsules

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.

There are 2 preparations of Roaccutane available. If Roaccutane 20mg capsules is not the preparation you are looking for, please select from the drop down list below.

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Roaccutane 20mg capsules

Information specific to Roaccutane 20mg capsules when used in treating acne

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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.

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When to take your medicine

Some medicines work best if they are taken at a specific time of day. Getting the most from your medicine can also be affected by what you eat, when you eat and the times at which you take other medicines. Make sure you follow any specific instructions given to you by your prescriber or that are in the Patient Information Leaflet that comes with this medicine.

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How to take your medicine

Some medicines have specific instructions about how to take them. This is because they work better when taken correctly. These instructions can include getting the right dose and special instructions for preparing the medicine.

In the case of Roaccutane:

If you are having problems taking this form of Roaccutane, you should talk to your prescriber or pharmacist. They may be able to give you advice on other ways to take your medicine or other preparations that are easier for you to take.

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Taking too much of your medicine

Taking extra doses of some medicines can be harmful. In some cases even one extra dose can cause you problems. If you take extra doses of your medicine, you must get medical advice immediately. You may need a test to assess the effect of taking extra doses. This is because the effects of taking too much medicine are very complex so it is very important that you seek medical advice.

Contact your prescriber, pharmacist, specialist clinic or NHS Direct on 0845 46 47 for advice.

Make sure you take all of your medicine containers with you if you are advised to go to hospital.

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Stopping your medicine

Suddenly stopping your medicine may cause your original condition to return. This is why you must speak to your prescriber if you are having any problems taking your medicine.

If you are not having any problems taking this medicine then do not stop taking it, even if you feel better, unless advised to do so by your prescriber.

If you are in any doubt, contact your prescriber, pharmacist, specialist clinic or NHS Direct on 0845 46 47.

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Looking after your medicine

The instructions on how you should keep your medicine are on the pharmacy label. You should keep your medicine in the original container. This will help to keep your medicine in the best condition and also allow you to check the instructions. Do not take the medicine if the packaging appears to have been tampered with or if the medicine shows any signs of damage. Make sure that the medicine is out of the sight and reach of children.

In the case of Roaccutane:

  • store the medicine in the original package to protect it from moisture and light
  • if your medicine comes in a plastic and metal-foil blister pack, do not store it in temperatures above 25°C

You must not take the medicine after the expiry date shown on the packaging. If you have any unused medicine, return it to your pharmacist who will dispose of it safely.

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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:

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.

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Side-effects

A medicine is only made available to the public if the clinical trials have shown that the benefits of taking the medicine outweigh the risks.

Once a medicine has been licensed, information on the medicine's effects, both intended and unintended, is continuously recorded and updated.

Some side-effects may be serious while others may only be a mild inconvenience.

Everyone's reaction to a medicine is different. It is difficult to predict which side-effects you will have from taking a particular medicine, or whether you will have any side-effects at all. The important thing is to tell your prescriber or pharmacist if you are having problems with your medicine.

Very common: More than 1 in 10 people who take Roaccutane:

  • abnormal laboratory test results
  • back pain
  • blood problems
  • dermatitis
  • dry eye - seek medical advice if you get dry eyes. You may need to use an eye drop or an eye ointment to stop your eyes from becoming dry while you are taking Roaccutane
  • dry skin - you should use a moisturising cream or ointment while you are taking Roaccutane
  • fragile skin - skin may be damaged more easily
  • high levels of lipids in the blood
  • inflammation and cracking of the skin of the lips or dry lips - you should use a lip balm while you are taking Roaccutane
  • irritation or inflammation of the eye or eyelid
  • itching
  • joint pain
  • muscle pain or tenderness
  • skin exfoliation
  • skin rash or rashes

Common: More than 1 in 100 people who take Roaccutane:

  • blood in the urine
  • dryness in the nose
  • headaches
  • high levels of cholesterol in the blood
  • increased blood sugar levels
  • inflammation of the nose and throat
  • nose bleed
  • proteinuria

Rare: More than 1 in 10,000 people who take Roaccutane:

  • allergic reactions - seek medical advice if you have an allergic reaction
  • anaphylactic reactions
  • hair loss
  • hypersensitivity reactions
  • skin hypersensitivity reactions
  • thoughts of committing suicide, behavioural problems or worsening of behavioural problems including: aggression, feeling anxious, mood changes, depression or psychosis or psychotic-like behaviour - you or your carer must seek medical advice if you become depressed or if your depression worsens

Very rare: Fewer than 1 in 10,000 people who take Roaccutane:

  • arthritis
  • blood in diarrhoea - stop taking Roaccutane and seek immediate medical advice if you have blood in diarrhoea
  • blurred vision
  • bone problems
  • bronchospasm
  • cataracts
  • convulsions
  • diabetes
  • dry throat
  • eye or eyesight problems - seek medical advice if you have problems with your eyesight
  • facial erythema
  • feeling dizzy
  • feeling drowsy
  • gastrointestinal problems including inflammation or bleeding
  • general feeling of being unwell
  • hair overgrowth
  • hair problems
  • hearing problems
  • hoarse voice
  • infections including infections around the finger or toenails
  • inflammatory bowel disease
  • intolerance to contact lenses - if you usually wear contact lenses you may need to wear glasses instead of contact lenses while you are taking Roaccutane
  • kidney problems
  • liver problems
  • lowering of bone mineral density
  • lymphadenopathy
  • metabolic problems
  • nail problems
  • nausea
  • night vision reduced - this may occur suddenly
  • over-sensitivity or fear of light
  • pancreatitis - this may be fatal
  • photosensitivity skin reaction
  • premature epiphyseal closure
  • problems with colour vision
  • raised intracranial pressure - stop taking Roaccutane and seek immediate medical advice if you vomit
  • skin colour changes
  • skin problems such as erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis - seek medical advice if you develop any signs or symptoms of skin reactions while taking Roaccutane
  • sweating
  • tendon or ligament problems
  • vasculitis - this may occur with easy bruising of the skin or mucous membrane
  • worsening of acne

The frequency of these side-effects is unknown:

If you feel unwell or if you have concerns about a side-effect, you will need to seek advice. If you feel very ill, get medical help straight away. Contact your prescriber, pharmacist, nurse or call NHS Direct on 0845 46 47.

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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:

The following types of medicine may interact with Roaccutane:

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

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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:

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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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.

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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
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Alcohol

Alcohol can interact with certain medicines.

In the case of Roaccutane:

  • there are no known interactions between alcohol and Roaccutane
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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.

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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.

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Ingredients of your medicine

Medicines contain active ingredients. They may also contain other, additional ingredients that help ensure the stability, safety and effectiveness of the medicine. They are also added to improve the medicine's taste and appearance and to make it easier to take. Some may be used to prolong the life of the medicine.

You should check that you are able to take the ingredients in your medicine, especially if you have any allergies.

Roaccutane contains:

  • beeswax, yellow
  • black iron oxide (E172)
  • glycerol 85%
  • karion 83 containing sorbitol, mannitol, hydrogenated hydrolysed starch
  • propylene glycol
  • red iron oxide (E172)
  • shellac, modified
  • sorbitol (E420)
  • soya-bean oil, hydrogenated
  • soya-bean oil, partially hydrogenated
  • soya-bean oil, refined
  • titanium dioxide (E171)

If you are not able to take any of the ingredients in your medicine, talk to your prescriber or pharmacist to see if they can suggest an alternative medicine. If you have reacted badly to Roaccutane before, do not take Roaccutane. Talk to your prescriber, pharmacist or nurse as soon as possible.

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Roaccutane, Version 6, last updated 15 Mar 2012