Roaccutane® (isotretinoin)
WHAT IS IT
ROACCUTANE contains the active ingredient isotretinoin. The retinoids work by reducing the amount of the oily substance (i.e. sebum) made by glands in your skin, reducing bacteria, reducing inflammation and opening clogged pores.
ROACCUTANE is used to treat severe acne. There are many different types of medicines used to treat acne. ROACCUTANE is used for more severe cases that are resistant to other treatments.Your doctor, however, may have prescribed ROACCUTANE for another purpose. Ask your doctor if you have any questions about why ROACCUTANE has been prescribed for you. This medicine is available only with a doctor's prescription.
BEFORE YOU TAKE IT
Do not take ROACCUTANE if:
you are pregnant, or you intend to become pregnant
If you fall pregnant while taking ROACCUTANE there is an extremely high risk of having a baby that is severely deformed. You must use effective birth control for one month before, during and one month after treatment.
you are breastfeeding:
Breastfeeding must stop before treatment begins. Do not breastfeed while taking ROACCUTANE.
you have had an allergic reaction to ROACCUTANE, Vitamin A, other retinoids or any ingredients listed here.
you have liver disease.
you have hypervitaminosis A (This is a condition caused by taking an excessive amount of Vitamin A in the diet either from foods, vitamin supplements and/or some medicines).
you have very high fat levels (cholesterol, triglycerides) in your blood.
the packaging is torn or shows signs of tampering
the expiry date printed on the pack has passed. If you take this medicine after the expiry date has passed, it may not work as well. If the pharmacist has repacked the medicine for you, there may not be an expiry date on the pack.
If you are not sure if you should start taking ROACCUTANE, contact your doctor.
You must tell your doctor if:
you have any allergies to any other substances, such as foods, preservatives or dyes
you have any other health problems or issues including:
diabetes, or a history of diabetes in your family.
a history of pancreatitis (inflamed pancreas).
kidney disease.
very high fat levels (cholesterol, triglycerides) in your blood.
depression or mental illness.
suicidal thoughts or tendencies.
you drink large amounts of alcohol
you are on the "mini-pill", a progestogen only oral contraceptive pill. These mini-pills may be an inadequate method of birth control during ROACCUTANE therapy.
you undertake regular vigorous exercise.
If you have not told your doctor about any of the above, tell your doctor before you start taking ROACCUTANE.
Taking other medicines:
Tell your doctor if you are taking any other medicines including any that you have bought from a pharmacy, supermarket or health food shop. Some medicines may interfere with ROACCUTANE. These include: tetracycline antibiotics (such as Vibra-Tab, Doryx, Doxine, Doxy-100, Doxy-50, Minotab-50, Minomycin, Panmycin), vitamin A, or preparations containing vitamin A, other medicines you are using to treat your acne. These medicines may be affected by ROACCUTANE, or may affect how well it works. You may need to take different amounts of your medicine, or you may need to take different medicines. Your doctor will advise you. Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking ROACCUTANE. Ask your doctor or pharmacist if you are not sure about this list of medicines.
HOW TO TAKE IT
How much to take:
Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in the product leaflet. Take ROACCUTANE exactly as your doctor has prescribed. Your doctor will tell you how many ROACCUTANE capsules to take each day.This dose will be calculated to suit your individual needs and your body weight. This dose may be adjusted during therapy when the doctor knows how you respond to ROACCUTANE. For most patients the dose ranges from 0.5 to 1.0mg/kg per day. Up to 2.0mg/kg per day may be required for more severe cases.
Way to take it:
Capsules should be swallowed whole with a glass of water or milk.Do not open the capsules and do not take any capsules that are damaged. Female patients should wait until the 2nd or 3rd day of the next normal menstrual period after having used effective birth control for at least one month before starting ROACCUTANE therapy. This helps ensure that you aren't pregnant before you start taking ROACCUTANE.
When to take it:
ROACCUTANE may be taken once or twice a day and must always be taken with a meal.
How long to take ROACCUTANE:
Continue taking ROACCUTANE for as long as your doctor prescribes. Acne treatment with ROACCUTANE will usually last 4 to 6 months. In the first few weeks of treatment your acne will probably get a little worse before it gets better.
At the end of treatment, your acne should have cleared up significantly. Most patients notice their skin condition continues to improve for up to two months after ROACCUTANE treatment is finished. However, some patients may need more than one course of treatment.
ROACCUTANE cannot improve scars or pitting that were present before treatment started, however it may help prevent such skin damage in the future.
If you forget to take ROACCUTANE:
Do not take an extra dose. Wait until the next dose and take your normal dose then.
Do not try to make up for the dose that you missed by taking more than one dose at a time. If you have missed several doses, please inform your doctor and follow the advice given to you.
In case of an overdose:
If you or another person have taken more than the recommended dose of ROACCUTANE, immediately telephone your doctor. Do this even if there are no signs of discomfort or poisoning .You may need urgent medical attention. Signs of overdose include transient headache, vomiting, facial flushing, reddened lips, stomach pain, dizziness and unsteady walking.
While you are taking ROACCUTANE:
Things you must do:
If you become pregnant while taking ROACCUTANE, stop taking it and tell your doctor immediately.ROACCUTANE causes severe birth defects in babies if the mother is taking ROACCUTANE. You must use strict birth control starting at least 1 month before you begin taking ROACCUTANE, for the whole time you are taking ROACCUTANE and for 1 month after you finish taking ROACCUTANE. Even if you are infertile or not sexually active effective birth control is recommended.
If you take further courses of ROACCUTANE after completing the initial treatment you must ensure that each time you take ROACCUTANE you use strict birth control at least one month before, for the whole time during and for 1 month after you have finished taking ROACCUTANE.
If you do become pregnant while taking ROACCUTANE, you should discuss with your doctor whether to continue with the pregnancy or have it terminated.
Tell your doctor if you notice any changes in your mood (feeling persistently sad or "down").
Tell all doctors, dentists and pharmacists who are treating you that you are taking ROACCUTANE.
Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed. Otherwise, your doctor may think that it was not effective and change your treatment unnecessarily.
Tell your doctor if you feel the capsules are not helping your condition.
Be sure to keep all of your appointments with your doctor so that your progress can be checked. Your doctor may ask you to have regular blood tests to monitor your liver function, blood sugar levels and blood fat levels. Your doctor may decide to monitor your bone growth and make-up, particularly if you are a child or young person.
If you are intending to do a lot of heavy exercise, tell your doctor.Your muscles and joints may be more prone to tenderness or stiffness if you do a lot of heavy exercise while taking ROACCUTANE.
Things you must not do:
Do not stop taking ROACCUTANE or change the dose without first checking with your doctor.
Do not let yourself run out of medicine over the weekend or on holidays.
Do not give ROACCUTANE to anyone else even if their symptoms seem similar to yours.
Do not use ROACCUTANE to treat other complaints unless your doctor says to.
Do not take any other medicines whether they require a prescription or not without first telling your doctor or consulting with a pharmacist.
Do not donate blood during treatment with ROACCUTANE or for at least 4 weeks after stopping treatment.
Things to be careful of:
Be careful driving or operating machinery until you know how ROACCUTANE affects you. Normally ROACCUTANE would not affect your ability to drive a car or operate machinery. However altered night vision and other visual disturbances may occur when taking ROACCUTANE. Make sure you know how you react to ROACCUTANE before you drive a car, operate machinery or do anything else that may be dangerous if your vision is affected.
Wearing contact lenses during treatment with ROACCUTANE may cause discomfort. ROACCUTANE may cause dry eyes. An eye lubricant or artificial tears, available from your pharmacist, should relieve this problem. Otherwise, you may temporarily need to wear your contact lenses for shorter periods or wear glasses instead.
Avoid excessive sun exposure and solariums. Apply a sunscreen while taking ROACCUTANE. Your skin may be more prone to sunburn while on ROACCUTANE.
Avoid hair removal using waxing and also dermabrasion (medical removal of layers of skin) while taking ROACCUTANE and for at least 6 months after stopping ROACCUTANE. Your skin may be more sensitive while on ROACCUTANE. Waxing may cause scarring or dermatitis and dermabrasion may cause scarring during and for at least 6 months after ROACCUTANE therapy.
Avoid using facial peels, electrolysis and some hair treatments. Your skin and hair may be more delicate during treatment and for a while after taking ROACCUTANE.
POSSIBLE SIDE EFFECTS
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking ROACCUTANE.
ROACCUTANE helps most people with acne but it may have unwanted side effects.All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects. Ask your doctor or pharmacist to answer any questions you may have. Tell your doctor if you notice any of the following and they worry you: dryness of the lips, mouth, throat, nose, eyes and skin. A moisturiser or petroleum jelly can be used to soften the lining of the nose, lips and the skin areas not affected by the acne, skin eruptions, rashes itching, inflammation, redness, sweating or colouration, nail inflammation, infection or altered appearance, nosebleeds, tenderness or stiffness in your bones, joints or muscles tiredness, headache, an increased susceptibility to sunburn, hair loss or increased growth feeling depressed. Your doctor can help you with these side effects.
Tell your doctor immediately or go to your nearest Accident or Emergency Centre if you notice any of the following:
nausea, vomiting, stomach pain
persistent headache, severe headache or seizure
blurred vision or visual disturbances, including decreased vision at night
severe stomach pain which passes straight through to your back (infected pancreas)
blood in your urine
difficulty in breathing.
These may be serious side effects. You may need urgent medical attention. Serious side effects are rare. This is not a complete list of all possible side effects. Others may occur in some people and there may be some side effects not yet known. Tell your doctor if you notice anything else that is making you feel unwell, even if it is not on this list. Ask your doctor or pharmacist if you don't understand anything in this list. Do not be alarmed by this list of possible side effects. You may not experience any of them.
STORING IT
Keep your capsules in the blister pack until it is time to take them. If you take the capsules out of the packaging they will not keep well. Keep the blister pack in a cool dry place where the temperature stays below 25 C. Do not store ROACCUTANE, or any other medicine, in a bathroom or near a sink. Do not leave it in the car or on window sills. Heat and dampness can destroy some medicines.
Keep ROACCUTANE where young children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Protect ROACCUTANE from light.
Disposal
If your doctor tells you to stop taking ROACCUTANE, or the capsules have passed their expiry date, ask your pharmacist what to do with any capsules that are left over.
FURTHER INFORMATION
For answers to specific healthcare questions or concerns, Roche recommends consulting your physician or professional healthcare provider.