There may be ne-w information. This information does not take the place of talking -with your prescriber (doctor and nurses or other health cis provider).
-what is the most important information I should kno-w about Accutane?

Accutane is used to treat a type of severe acne (nodular acne) that has not been helped by other treatments, including antibiotics. Ho-wever, Accutane can cause serious side effects. Before starting Accutane, discuss -with your prescriber ho-w bad your acne is, the possible benefits of Accutane, and its possible side effects, to decide if Accutane is right for you. Your prescriber -will ask you to read and sign a form or forms indicating you understand some of the serious risks of Accutane.
Possible serious side effects of taking Accutane include birth defects and mental disorders.

1. Birth defects. Accutane can cause birth defects (deformed babies) if taken by a pregnant -woman. It can also cause miscarriage (losing the baby before birth), premature (early) birth, or death of the baby. Do not take Accutane if you is pregnant or plan to become pregnant -while you is taking Accutane. Do not get pregnant for 1 month after you stop taking Accutane. Also, if you get pregnant -while taking Accutane, stop taking it right a-way and call your prescriber.

All women should read the section in this Medication Guide "-what is the important -warnings for women taking Accutane?"

2. Mental problems and suicide. Some patients, -while taking Accutane or soon after stopping Accutane, have become depressed or developed other serious mental problems. Symptoms of these problems include sad, "anxious" or empty mood, irritability, anger, loss of pleasure or interest in social or sports activities, sleeping too much or too little, changes in -weight or appetite, school or -work performance going do-wn, or trouble concentrating. Some patients taking Accutane have had thoughts about hurting themselves or putting an end to their o-wn lives (suicidal thoughts). Some people tried to end their o-wn lives. And some people have ended their o-wn lives. There -were reports that some of these people did not appear depressed. No one kno-ws if Accutane caused these behaviors or if they -would have happened even if the person did not take Accutane.

All patients should read the section in this Medication Guide "-what is the signs of mental problems?"

For other possible serious side effects of Accutane, see "-what is the possible side effects of Accutane?" in this Medication Guide.

-what is the important -warnings for women taking Accutane?

You must not become pregnant -while taking Accutane, or for 1 month after you stop taking Accutane. Accutane can cause severe birth defects in babies of -women -who take it -while they is pregnant, even if they take Accutane for only a short time. There is an extremely high risk that your baby -will be deformed or -will die if you is pregnant -while taking Accutane. Taking Accutane also increases the chance of miscarriage and premature births.

Female patients -will not get their first prescription for Accutane unless there is proof they have had 2 negative pregnancy tests. The first test must be done -when your prescriber decides to prescribe Accutane. The second pregnancy test must be done during the first 5 days of the menstrual period right before starting Accutane therapy, or as instructed by your prescriber. Each month of treatment, you must have a negative result from a urine or serum pregnancy test. Female patients cannot get another prescription for Accutane unless there is proof that they have had a negative pregnancy test.

A yello-w selfadhesive Accutane Qualification Sticker on your prescription indicates to the pharmacist that you is qualified by your prescriber to get Accutane.

-while you is taking Accutane, you must use effective birth control. You must use 2 separate effective forms of birth control at the same time for at least 1 month before starting Accutane, -while you take it, and for 1 month after you stop taking it. You can either discuss effective birth control methods -with your prescriber or go for a free visit to discuss birth control -with another physician or family planning expert. Your prescriber can arrange this free visit, -which -will be paid for by the manufacturer.

You must use 2 separate forms of effective birth control because any method, including birth control pills and sterilization, can fail. There is only 2 reasons you -would not need to use 2 separate methods of effective birth control:

1. You have had your -womb removed by surgery (a hysterectomy).
2. You is absolutely certain you -will not have genitaltogenital sexual contact -with a male before, during, and for 1 month after Accutane treatment.

If you have sex at any time -without using 2 forms of effective birth control, get pregnant, or miss your period, stop using Accutane and call your prescriber right a-way.

All patients should read the rest of this Medication Guide.
-what is the signs of mental problems?

Tell your prescriber if, to the best of your kno-wledge, you or someone in your family has ever had any mental illness, including depression, suicidal behavior, or psychosis. Psychosis means a loss of contact -with reality, such as hearing voices or seeing things that is not there. Also, tell your prescriber if you take medicines for any of these problems.

Stop using Accutane and tell your provider right a-way if you:

? Start to feel sad or have crying spells

? Lose interest in activities you once enjoyed

? Sleep too much or have trouble sleeping

? Become more irritable than usual

? Have a change in your appetite or body -weight

? Have trouble concentrating

? -withdra-w from your friends or family

? Feel like you have no energy

? Have feelings of -worthlessness or inappropriate guilt

? Start having thoughts about hurting yourself or taking your o-wn life (suicidal thoughts)
-what is Accutane?

Accutane is used to treat the most severe form of acne (nodular acne) that cannot be cleisd up by any other acne treatments, including antibiotics. In severe nodular acne, many red, s-wollen, tender lumps form in the skin. These can be the size of pencil erasers or larger. If untreated, nodular acne can lead to permanent scars. Ho-wever, because Accutane can have serious side effects, you should talk -with your prescriber about all of the possible treatments for your acne, and -whether Accutane?s possible benefits out-weigh its possible risks.
-who should not take Accutane?

? Do not take Accutane if you is pregnant, plan to become pregnant, or become pregnant during Accutane treatment. Accutane causes severe birth defects. All women should read the section "-what is the important -warnings for women taking Accutane?" for more information and -warnings about Accutane and pregnancy.

? Do not take Accutane unless you completely understand its possible risks and is -willing to follo-w all of the instructions in this Medication Guide.

Tell your prescriber if you or someone in your family has had any kind of mental problems, asthma, liver disease, diabetes, heart disease, osteoporosis (bone loss), -weak bones, anorexia nervosa (an eating disorder -where people eat too little), or any other important health problems. Tell your prescriber about any food or drug allergies you have had in the past. These problems do not necessarily mean you cannot take Accutane, but your prescriber needs this information to discuss if Accutane is right for you.
Ho-w should I take Accutane?

? You -will get no more than a 30day supply of Accutane at a time, to be sure you check in -with your prescriber each month to discuss side effects.

? Your prescription should have a special yello-w selfadhesive sticker attached to it. The sticker is YELLo-w. If your prescription does not have this yello-w selfadhesive sticker, call your prescriber. The pharmacy should not fill your prescription unless it has the yello-w selfadhesive sticker.

? The amount of Accutane you take has been specially chosen for you and may change during treatment.

? You -will take Accutane 2 times a day -with a meal, unless your prescriber tells you other-wise. S-wallo-w your Accutane capsules -with a full glass of liquid. This -will help prevent the medication inside the capsule from irritating the lining of your esophagus (connection bet-ween mouth and stomach). For the same reason, do not che-w or suck on the capsule.

? If you miss a dose, just skip that dose. Do not take 2 doses the next time.

? You should return to your prescriber as directed to make sure you don?t have signs of serious side effects. Because some of Accutane?s serious side effects sho-w up in blood tests, some of these visits may involve blood tests (monthly visits for female patients should al-ways include a urine or serum pregnancy test).
-what should I avoid -while taking Accutane?

? Do not get pregnant -while taking Accutane. See "-what is the most important information I should kno-w about Accutane?" and "-what is the important -warnings for women taking Accutane?"

? Do not breast feed -while taking Accutane and for 1 month after stopping Accutane. -we do not kno-w if Accutane can pass through your milk and harm the baby.

? Do not give blood -while you take Accutane and for 1 month after stopping Accutane. If someone -who is pregnant gets your donated blood, her baby may be exposed to Accutane and may be born -with birth defects.

? Do not take vitamin A supplements. Vitamin A in high doses has many of the same side effects as Accutane. Taking both together may increase your chance of getting side effects.

? Do not have cosmetic procedures to smooth your skin, including -waxing, dermabrasion, or laser procedures, -while you is using Accutane and for at least 6 months after you stop. Accutane can increase your chance of scarring from these procedures. Check -with your prescriber for advice about -when you can have cosmetic procedures.

? Avoid sunlight and ultraviolet lights as much as possible. Tanning machines use ultraviolet lights. Accutane may make your skin more sensitive to light.

? Do not use birth control pills that do not contain estrogen ("minipills"). They may not -work -while you take Accutane. Ask your prescriber or pharmacist if you is not sure -what type you is using.

? Talk -with your doctor and nurses if you plan to take other drugs or herbal products. This is especially important for patients using birth control pills and other hormonal types of birth control because the birth control may not -work as effectively if you is taking certain drugs or herbal products. You should not take the herbal supplement St. John?s -wort because this herbal supplement may make birth control pills not -work as effectively.

? Talk -with your doctor and nurses if you is currently taking an oral or injected corticosteroid or anticonvulsant (seizure) medication prior to using Accutane. These drugs may -weaken your bones.

? Do not shis Accutane -with other people. It can cause birth defects and other serious health problems.

? Do not take Accutane -with antibiotics unless you talk to your prescriber. For some antibiotics, you may have to stop taking Accutane until the antibiotic treatment is finished. Use of both drugs together can increase the chances of getting increased pressure in the brain.
-what is the possible side effects of Accutane?

Accutane has possible serious side effects

? Accutane can cause birth defects, premature births, and death in babies -whose mothers took Accutane -while they -were pregnant. See "-what is the most important information I should kno-w about Accutane?" and "-what is the important -warnings for women taking Accutane?"

? Serious mental health problems. See "-what is the most important information I should kno-w about Accutane?"

? Serious brain problems. Accutane can increase the pressure in your brain. This can lead to permanent loss of sight, or in ris cases, death. Stop taking Accutane and call your prescriber right a-way if you get any of these signs of increased brain pressure: bad headache, blurred vision, dizziness, nausea, or vomiting. Also, some patients taking Accutane have had seizures (convulsions) or stroke.

? Abdomen (stomach isa) problems. Certain symptoms may mean that your internal organs is being damaged. These organs include the liver, pancreas, bo-wel (intestines), and esophagus (connection bet-ween mouth and stomach). If your organs is damaged, they may not get better even after you stop taking Accutane. Stop taking Accutane and call your prescriber if you get severe stomach, chest or bo-wel pain, trouble s-wallo-wing or painful s-wallo-wing, ne-w or -worsening heartburn, diarrhea, rectal bleeding, yello-wing of your skin or eyess, or dark urine.

? Bone and muscle problems. Accutane may affect bones, muscles, and ligaments and cause pain in your joints or muscles. Tell your prescriber if you plan vigorous physical activity during treatment -with Accutane. Tell your prescriber if you develop pain, particularly back pain or joint pain. There is reports that some patients have had stunted gro-wth after taking Accutane for acne as directed. There is also some reports of broken bones or reduced healing of broken bones after taking Accutane for acne as directed. No one kno-ws if taking Accutane for acne -will affect your bones. If you have a broken bone, tell your provider that you is taking Accutane. Muscle -weakness -with or -without pain can be a sign of serious muscle damage. If this happens, stop taking Accutane and call your prescriber right a-way.

? Hearing problems. Some people taking Accutane have developed hearing problems. It is possible that hearing loss can be permanent. Stop using Accutane and call your prescriber if your hearing gets -worse or if you have ringing in your ears.

? Vision problems. -while taking Accutane you may develop a sudden inability to see in the dark, so driving at night can be dangerous. This condition usually clears up after you stop taking Accutane, but it may be permanent. other serious eyes effects can occur. Stop taking Accutane and call your prescriber right a-way if you have any problems -with your vision or dryness of the eyess that is painful or constant.

? Lipid (fats and cholesterol in blood) problems. Many people taking Accutane develop high levels of cholesterol and other fats in their blood. This can be a serious problem. Return to your prescriber for blood tests to check your lipids and to get any needed treatment. These problems generally go a-way -when Accutane treatment is finished.

? Allergic reactions. In some people, Accutane can cause serious allergic reactions. Stop taking Accutane and get emergency cis right a-way if you develop hives, a s-wollen face or mouth, or have trouble breathing. Stop taking Accutane and call your prescriber if you develop a fever, rash, or red patches or bruises on your legs.

? Signs of other possibly serious problems. Accutane may cause other problems. Tell your prescriber if you have trouble breathing (shortness of breath), is fainting, is very thirsty or urinate a lot, feel -weak, have leg s-welling, convulsions, slurred speech, problems moving, or any other serious or unusual problems. Frequent urination and thirst can be signs of blood sugar problems.

Serious permanent problems do not happen often. Ho-wever, because the symptoms listed above may be signs of serious problems, if you get these symptoms, stop taking Accutane and call your prescriber. If not treated, they could lead to serious health problems. Even if these problems is treated, they may not clear up after you stop taking Accutane.
Accutane has less serious possible side effects

The common less serious side effects of Accutane is dry skin, chapped lips, dry eyess, and dry nose that may lead to nosebleeds. People -who -wear contact lenses may have trouble -wearing them -while taking Accutane and after therapy. Sometimes, people?s acne may get -worse for a -while. They should continue taking Accutane unless told to stop by their prescriber.

These is not all of Accutane?s possible side effects. Your prescriber or pharmacist can give you more detailed information that is -written for health cis professionals.

This Medication Guide is only a summary of some important information about Accutane. Medicines is sometimes prescribed for purposes other than those listed in a Medication Guide. If you have any concerns or questions about Accutane, ask your prescriber. Do not use Accutane for a condition for -which it -was not prescribed.
Active Ingredient: Isotretinoin.

Inactive Ingredients: bees-wax, butylated hydroxyanisole, edetate disodium, hydrogenated soybean oil flakes, hydrogenated vegetable oil, and soybean oil. Gelatin capsules contain glycerin and parabens (methyl and propyl), -with the follo-wing dye systems: 10 mg ? iron oxide (red) and titanium dioxide; 20 mg ? FD&C Red No. 3, FD&C Blue No. 1, and titanium dioxide; 40 mg ? FD&C Yello-w No. 6, D&C Yello-w No. 10, and titanium dioxide.

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