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ACITRETIN capsule


  1. What Should Males Know Before Taking Acitretin Capsules?
  2. Do Not Take Acitretin Capsules If You Take These Medicines:
  3. Stop Taking Acitretin Capsules And Call Your Prescriber Right Away If You Get The Following Signs Or Symptoms Of Possible Serious Side Effects:
  4. Call Your Prescriber Right Away If You Have Any Of The Following Symptoms:
  5. Manufactured By:
  6. Manufactured For:
  7. What Should Males Know Before Taking Acitretin?
  8. What Is Acitretin?
  9. Who Should Not Take Acitretin?
  10. Do Not Take Acitretin If You Take These Medicines:
  11. Stop Taking Acitretin And Call Your Prescriber Right Away If You Get The Following Signs Or Symptoms Of Possible Serious Side Effects:
  12. Following Symptoms:
  13. Active Ingredient:
  14. Inactive Ingredients:
  15. Acitretin Can Cause Serious Side Effects, Including:
  16. Note: If You Are A Female Who Can Become Pregnant:
  17. After You Start Taking Acitretin, You Must Have A Pregnancy Test Repeated Each Month That You Are Taking Acitretin. This Is To Be Sure That You Are Not Pregnant During Treatment Because Acitretin Can Cause Birth Defects. In Addition, Your Prescription Of Acitretin Will Be Limited To A Monthly Supply.for At Least 3 Years After Stopping Treatment With Acitretin, You Must Have A Pregnancy Test Repeated Every 3 Months To Make Sure That You Are Not Pregnant.discuss Effective Birth Control (contraception) With Your Prescriber. You Must Use 2 Effective Forms Of Birth Control (contraception) At The Same Time During All Of The Following:
  18. During Treatment With Acitretinfor At Least 3 Years After Stopping Treatment With Acitretinif You Are Sexually Active, You Must Use 2 Effective Forms Of Birth Control (contraception) At The Same Time Even If You Think You Cannot Become Pregnant, Unless 1 Of The Following Is True For You:
  19. The Following Are Considered Effective Forms Of Birth Control:primary Forms:
  20. Secondary Forms (use With A Primary Form):
  21. What Are The Important Warnings And Instructions For Females Taking Acitretin?
  22. Acitretin?
  23. Patient Information
  24. What Are The Important Warnings And Instructions For Females Taking Acitretin Capsules?
  25. Important: If You Are A Female Who Can Become Pregnant:
  26. Discuss Effective Birth Control (contraception) With Your Prescriber. You Must Use 2 Effective Forms Of Birth Control (contraception) At The Same Time During All Of The Following:
  27. If You Are Sexually Active, You Must Use 2 Effective Forms Of Birth Control (contraception) At The Same Time Even If You Think You Cannot Become Pregnant, Unless 1 Of The Following Is True For You:
  28. Primary Forms:
  29. What Are Acitretin Capsules?
  30. Who Should Not Take Acitretin Capsules?
  31. Acitretin Capsules Can Cause Serious Side Effects, Including:
  32. What Are The Ingredients In Acitretin Capsules?

What Should Males Know Before Taking Acitretin Capsules? 



Small amounts of acitretin are found in the semen of males taking acitretin capsules. Based upon available information, it appears that these small amounts of acitretin in semen pose little, if any, risk to an unborn child while a male patient is taking the drug or after it is discontinued. Discuss any concerns you have about this with your prescriber.

All patients should read the rest of this Medication Guide.

Do Not Take Acitretin Capsules If You Take These Medicines: 

  • methotrexate
  • tetracyclines

The use of these medicines with acitretin capsules may cause serious side effects.

  • Do NOT take acitretin capsules if you are allergic to acitretin,the active ingredient in acitretin capsules, to any of the other ingredients in acitretin capsules (

    • Take acitretin capsules with food.
    • Be sure to take your medicine as prescribed by your prescriber. The dose of acitretin capsules varies from patient to patient. The number of capsules you must take is chosen specially for you by your prescriber. This dose may change during treatment.
    • If you miss a dose, do not double the next dose. Skip the missed dose and resume your normal schedule.
    • If you take too much acitretin capsules (overdose), call your local poison control center or emergency room.

    You should have blood tests for liver function, cholesterol, and triglycerides before starting treatment and during treatment to check your body s response to acitretin capsules. Your prescriber may also do other tests.

    Once you stop taking acitretin capsules, your psoriasis may return. Do not treat this new psoriasis with leftover acitretin capsules. It is important to

    • Avoid pregnancy.

Stop Taking Acitretin Capsules And Call Your Prescriber Right Away If You Get The Following Signs Or Symptoms Of Possible Serious Side Effects: 

  • Bad headaches, nausea, vomiting, blurred vision.These symptoms can be signs of increased brain pressure that can lead to blindness or even death.
  • Vision problems. Decreased vision in the dark (night blindness).Since this can start suddenly, you should be very careful when driving at night. This problem usually goes away when treatment with acitretin capsules stops. Stop taking acitretin capsules and call your prescriber if you develop any vision problems or eye pain.
  • Depression.There have been some reports of patients developing mental problems including a depressed mood, aggressive feelings, or thoughts of ending their own life (suicide). These events, including suicidal behavior, have been reported in patients taking other drugs similar to acitretin capsules as well as patients taking acitretin capsules. Since other things may have contributed to these problems, it is not known if they are related to acitretin capsules.
  • Aches or pains in your bones, joints, muscles, or back, trouble moving, or loss of feeling in your hands or feet.These can be signs of abnormal changes to your bones or muscles.
  • Frequent urination, great thirst or hunger.Acitretin capsules can affect blood sugar control, even if you do not already have diabetes. These are some of the signs of high blood sugar.
  • Shortness of breath, dizziness, nausea, chest pain, weakness, trouble speaking, or swelling of a leg. These may be signs of a heart attack, blood clots, or stroke.Acitretin capsules can cause serious changes in blood fats (lipids). It is possible for these changes to cause blood vessel blockages that lead to heart attacks, strokes, or blood clots.
  • Blood vessel problems.Acitretin capsules can cause fluid to leak out of your blood vessels into your body tissues.

Call Your Prescriber Right Away If You Have Any Of The Following Symptoms: 

sudden swelling in one part of your body or all over your body, weight gain, fever, lightheadedness or feeling faint, or muscle aches. If this happens, your prescriber will tell you to stop taking acitretin capsules.
  • Serious allergic reactions.

    • Store acitretin capsules at 68 to 77 F (20 C to 25 C).

      Active ingredient: acitretin, USP

      Inactive ingredients: microcrystalline cellulose, sodium lauryl sulfate, maltodextrin, povidone and sodium ascorbate. The 10-mg, 17.5-mg, and 25-mg gelatin capsule shells contain gelatin, iron oxide (yellow), titanium dioxide, sodium lauryl sulfate and black imprinting ink. In addition, the 17.5-mg gelatin capsule shells also contain iron oxide (red).

      This Medication Guide has been approved by the U.S. Food and Drug Administration.

      All brand names listed are the registered trademarks of their respective owners and are not trademarks of AvKARE, Inc.

  • Manufactured By: 


    Sigmapharm Laboratories, LLC

    Bensalem, PA 19020 USA

    Manufactured For: 


    AvKARE, Inc.

    Pulaski, TN 38478



    OS083A-02 REV. 0418

    Revised 04/2018

    What Should Males Know Before Taking Acitretin? 



    Small amounts of acitretin are found in the semen of males taking acitretin. Based upon available information, it appears that these small amounts of acitretin in semen pose little, if any, risk to an unborn child while a male patient is taking the drug or after it is discontinued. Discuss any concerns you have about this with your prescriber.

    All patients should read the rest of this Medication Guide.

    What Is Acitretin? 



    Acitretin is a medicine used to treat severe forms of psoriasis in adults. Psoriasis is a skin disease that causes cells in the outer layer of the skin to grow faster than normal and pile up on the skin s surface. In the most common type of psoriasis, the skin becomes inflamed and produces red, thickened areas, often with silvery scales.

    Because acitretin can have serious side effects,
    you should talk with your prescriber about whether possible benefits of acitretin outweigh its possible risks. Acitretin may not work right away. You may have to wait 2 to 3 months before you get the full benefit of acitretin. Psoriasis gets worse for some patients when they first start treatment with acitretin.

    Acitretin has not been studied in children.

    Who Should Not Take Acitretin? 

    • Do NOT take acitretin if you can get pregnant.Do not take acitretin if you are pregnant or might get pregnant during treatment with acitretin or at any time forat least 3 yearsafter you stop treatment with acitretin ().
    • Do NOT take acitretin if you are breastfeeding.Acitretin can pass into your milk and may harm your baby. You will need to choose either to breastfeed or take acitretin, but not both.
    • Do NOT take acitretin if you have severe liver or kidney disease.
    • Do NOT take acitretin if you have repeated high blood lipids(fat in the blood).

    Do Not Take Acitretin If You Take These Medicines: 

    • methotrexate
    • tetracyclines

    The use of these medicines with acitretin may cause serious side effects.

    • Do NOT take acitretin if you are allergic to acitretin, the active ingredient in acitretin, to any of the other ingredients in acitretin (

      • Take acitretin with food.
      • Be sure to take your medicine as prescribed by your prescriber. The dose of acitretin varies from patient to patient. The number of capsules you must take is chosen specially for you by your prescriber. This dose may change during treatment.
      • If you miss a dose, do not double the next dose. Skip the missed dose and resume your normal schedule.
      • If you take too much acitretin (overdose), call your local poison control center or emergency room.

      You should have blood tests for liver function, cholesterol, and triglycerides before starting treatment and during treatment to check your body s response to acitretin. Your prescriber may also do other tests.

      Once you stop taking acitretin, your psoriasis may return. Do not treat this new psoriasis with leftover acitretin. It is important to

      • Avoid pregnancy.

    Stop Taking Acitretin And Call Your Prescriber Right Away If You Get The Following Signs Or Symptoms Of Possible Serious Side Effects: 


    • Bad headaches, nausea, vomiting, blurred vision.These symptoms can be signs of increased brain pressure that can lead to blindness or even death.
    • Vision problems. Decreased vision in the dark (night blindness).Since this can start suddenly, you should be very careful when driving at night. This problem usually goes away when treatment with acitretin stops. Stop taking acitretin and call your prescriber if you develop any vision problems or eye pain.
    • Depression.There have been some reports of patients developing mental problems including a depressed mood, aggressive feelings, or thoughts of ending their own life (suicide). These events, including suicidal behavior, have been reported in patients taking other drugs similar to acitretin as well as patients taking acitretin. Since other things may have contributed to these problems, it is not known if they are related to acitretin.
    • Aches or pains in your bones, joints, muscles, or back, trouble moving, or loss of feeling in your hands or feet.These can be signs of abnormal changes to your bones or muscles.
    • Frequent urination, great thirst or hunger.Acitretin can affect blood sugar control, even if you do not already have diabetes. These are some of the signs of high blood sugar.
    • Shortness of breath, dizziness, nausea, chest pain, weakness, trouble speaking, or swelling of a leg. These may be signs of a heart attack, blood clots, orstroke.Acitretin can cause serious changes in blood fats (lipids). It is possible for these changes to cause blood vessel blockages that lead to heart attacks, strokes, or blood clots.
    • Blood vessel problems.Acitretin can cause fluid to leak out of your blood vessels into your body tissues.Call your prescriber right away if you have any of the

    Following Symptoms: 

    sudden swelling in one part of your body or all over your body, weight gain, fever, lightheadedness or feeling faint, or muscle aches. If this happens, your prescriber will tell you to stop taking acitretin.
  • Serious allergic reactions.

    • STORE acitretin between 15 to 25 C (59 to 77 F)
    • Keep acitretin away from sunlight, high temperature, and humidity.

    Keep acitretin and all medicines out of the reach of children.

    General information about the safe and effective use of acitretin

    Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use acitretin for a condition for which it was not prescribed. Do not give acitretin to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about acitretin that is written for health professionals.

  • Active Ingredient: 

    acitretin.

    Inactive Ingredients: 

    microcrystalline cellulose, maltodextrin, sodium ascorbate, gelatin, black imprinting ink (the solid components are shellac glaze, propylene glycol and iron oxide black). Gelatin capsule shells contain gelatin, red ferric oxide (10 mg, 22.5 mg and 25 mg only), yellow ferric oxide (17.5 mg and 25 mg only), sodium lauryl sulfate, and titanium dioxide (10 mg, 17.5 mg and 25 mg only).

    For more information about acitretin call 1-877-835-5472 or go towww.acitretinEPPA.com.

    TEGISONis a registered trademark of Hoffmann-La Roche Inc.


    Manufactured by:
    Micro-Sphere SA
    Via Cantonale, 77
    6998 Monteggio, Switzerland

    Distributed by:
    Amneal Pharmaceuticals LLC

    Bridgewater, NJ 08807

    This Medication Guide has been approved by the U.S. Food and Drug Administration.

    Rev. 11-2018-00

    Acitretin Can Cause Serious Side Effects, Including: 

    1. Severe birth defects.If you are a female who can get pregnant, you should use acitretin only if you are not pregnant now, can avoid becoming pregnant for at least 3 years, and other medicines do not work for your severe psoriasis or you cannot use other psoriasis medicines. Information about effects on unborn babies and about how to avoid pregnancy is found in the next section: What are the important warnings and instructions for females taking acitretin?

    image-do not get pregnant

    2. Liver problems,including abnormal liver function tests and inflammation of your liver (hepatitis). Your prescriber should do blood tests to check how your liver is working before you start taking and during treatment with acitretin. Stop taking acitretin and call your prescriber right away if you have any of the following signs or symptoms of a serious liver problem:

    • yellowing of your skin or the whites of your eyes
    • nausea and vomiting
    • loss of appetite
    • dark urine

    What are the important warnings and instructions for females taking

    Note: If You Are A Female Who Can Become Pregnant: 

    You must not takeacitretin if you are pregnant or might become pregnant during treatment or at any timefor at least 3 yearsafter you stop treatment because acitretin can cause severe birth defects.
    Duringtreatment withacitretin and for 2 months after you stop treatment withacitretin, you must avoid drinks, foods, and all medicines that contain alcohol. This includes over-the-counter products that contain alcohol.Avoiding alcohol is very important, because alcohol changes acitretin into a drug that may take longer than 3 years to leave your body. The chance of birth defects may last longer than 3 years if you swallow any form of alcohol during treatment with acitretin and for 2 months after you stop taking acitretin.
    You and your prescriber must be sure you are not pregnant before you starttherapy withacitretin. You must have negative results from 2 pregnancy tests before you start treatment withacitretin.A negative result shows you are not pregnant. Because it takes a few days after pregnancy begins for a test to show that you are pregnant, the first negative test may not ensure you are not pregnant. Do not start acitretin until you have negative results from 2 pregnancy tests.
    Thefirst pregnancy test(urine or blood) will be done at the time you and your prescriber decide if acitretin might be right for you.
    Thesecond pregnancy testwill usually be done during the first 5 days of your menstrual period. You must start taking acitretin within 7 days of when the urine or blood for the second pregnancy test is collected.

    After You Start Taking Acitretin, You Must Have A Pregnancy Test Repeated Each Month That You Are Taking Acitretin. This Is To Be Sure That You Are Not Pregnant During Treatment Because Acitretin Can Cause Birth Defects. In Addition, Your Prescription Of Acitretin Will Be Limited To A Monthly Supply.for At Least 3 Years After Stopping Treatment With Acitretin, You Must Have A Pregnancy Test Repeated Every 3 Months To Make Sure That You Are Not Pregnant.discuss Effective Birth Control (contraception) With Your Prescriber. You Must Use 2 Effective Forms Of Birth Control (contraception) At The Same Time During All Of The Following: 

    for at least 1 month before beginning treatment with acitretin

    During Treatment With Acitretinfor At Least 3 Years After Stopping Treatment With Acitretinif You Are Sexually Active, You Must Use 2 Effective Forms Of Birth Control (contraception) At The Same Time Even If You Think You Cannot Become Pregnant, Unless 1 Of The Following Is True For You: 

    • You had your womb (uterus) removed during an operation (a hysterectomy).
    • Your prescriber said you have gone completely through menopause (the change of life ).

    You can get a free birth control counseling session and pregnancy testing from a prescriber or family planning expert. Your prescriber can give you aContraception Counseling Referral Form for this free session.

    The Following Are Considered Effective Forms Of Birth Control:primary Forms: 

    • having your tubes tied (tubal ligation)
    • partner's vasectomy
    • IUD (Intrauterine device)
    • Birth control pills that contain both estrogen and progestin (combination oral contraceptives); not progestin-only "minipills"
    • hormonal birth control products are injected, implanted, or inserted in your body
    • birth control patch

    Secondary Forms (use With A Primary Form): 

    • diaphragms with spermicide
    • condoms (with or without spermicide)
    • cervical caps with spermicide
    • vaginal sponge (contains spermicide)

    At least 1 of your 2 methods of birth control must be a primary form.
    If you have sex at any time without using 2 effective forms of birth control (contraception) at the same time, or if you get pregnant or miss your period, stop usingacitretin and call your prescriber right away.
    Consider Emergency Contraception (EC) if you have sex with a male without correctly using 2 effective forms of birth control (contraception) at the same time.EC is also called emergency birth control or the morning after pill. Contact your prescriberas soon as possibleif you have sex without using 2 effective forms of birth control (contraception) at the same time, because EC works best if it is used within 1 or 2 days after sex. EC is not a replacement for your usual 2 effective forms of birth control (contraception) because it is not as effective as regular birth control methods.
    You can get EC from private doctors or nurse practitioners, women s health centers, or hospital emergency rooms. You can get the name and phone number of EC providers nearest you by calling the free Emergency Contraception Hotline at 1-866-245-6020 or www.not-2-late.com.
    Stop takingacitretin right away and contact your prescriber if you get pregnant while taking acitretin or at any time for at least 3 years after treatment has stopped. You need to discuss the possible effects on the unborn baby with your prescriber.
    If you do become pregnant while takingacitretin or at any time for at least 3 years after stopping acitretin, you should report your pregnancy to Impax Generics Medical Information Call Center at 1-877-994-6729or directly to the Food and Drug Administration (FDA) MedWatch program at 1-800-FDA-1088.Your name will be kept in private (confidential). The information you share will help the FDA and the manufacturer evaluate the Pregnancy Prevention Program for acitretin.
    Do not takeacitretin if you are breastfeeding.Acitretin can pass into your milk and may harm your baby. You will need to choose either to breastfeed or take acitretin, but not both.

    What should males know before taking

    What Are The Important Warnings And Instructions For Females Taking Acitretin? 

    Stop taking acitretin and call your prescriber right away if you get the following signs or symptoms of possible serious side effects:
    Bad headaches, nausea, vomiting, blurred vision.These symptoms can be signs of increased brain pressure that can lead to blindness or even death.
    Vision problems.Decreased vision in the dark(night blindness).Since this can start suddenly, you should be very careful when driving at night. This problem usually goes away when treatment with acitretin stops. Stop taking acitretin and call your prescriber if you develop any vision problems or eye pain.
    Depression.There have been some reports of patients developing mental problems including a depressed mood, aggressive feelings, or thoughts of ending their own life (suicide). These events, including suicidal behavior, have been reported in patients taking other drugs similar to acitretin as well as patients taking acitretin. Since other things may have contributed to these problems, it is not known if they are related to acitretin.
    Aches or pains in your bones, joints, muscles, or back, trouble moving, or loss of feeling in your hands or feet.These can be signs of abnormal changes to your bones or muscles.
    Frequent urination, great thirst or hunger.Acitretin can affect blood sugar control, even if you do not already have diabetes. These are some of the signs of high blood sugar.
    Shortness of breath, dizziness, nausea, chest pain, weakness, trouble speaking, or swelling of a leg. These may be signs of a heart attack, blood clots, or stroke.Acitretin can cause serious changes in blood fats (lipids). It is possible for these changes to cause blood vessel blockages that lead to heart attacks, strokes, or blood clots.
    Blood vessel problems.Acitretin can cause fluid to leak out of your blood vessels into your body tissues.

    Acitretin? 

    Active ingredient: acitretin.
    Inactive ingredients: microcrystalline cellulose, maltodextrin, sodium ascorbate, gelatin, black imprinting ink (the solid components are shellac glaze, propylene glycol and iron oxide black). Gelatin capsule shells contain gelatin, red ferric oxide (10 mg, 22.5 mg and 25 mg only), yellow ferric oxide (17.5 mg and 25 mg only), sodium lauryl sulfate, and titanium dioxide (10 mg, 17.5 mg and 25 mg only).
    General information about the safe and effective use ofacitretin
    Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use acitretin for a condition for which it was not prescribed. Do not give acitretin to other people, even if they have the same symptoms that you have.
    This Medication Guide summarizes the most important information about acitretin. If you would like more information, talk with your prescriber. You can ask your pharmacist or prescriber for information about acitretin that is written for health professionals.
    For more information about acitretin call 1-877-994-6729 or go towww.acitretinEPPA.com.
    ThisMedication Guide has been approved by the U.S. Food and Drug Administration.
    TEGISONis a registered trademark of Hoffmann-La Roche Inc.

    Manufactured by:
    Micro-Sphere SA
    Via Cantonale
    CH-6996 Ponte Cremenaga
    Lugano
    Switzerland

    Distributed by:
    Impax Generics
    Hayward, California 94544

    Revised: November 2016
    LA-1788-02

    Patient Information 

    Acitretin Capsules, USP

    (a" si tre' tin)

    Read this Medication Guide carefully before you start taking acitretin capsules and read it each time you get more acitretin capsules. There may be new information.

    The first information in this Medication Guide is about birth defects and how to avoid pregnancy.After this section there is important safety information about possible effects for any patient taking acitretin capsules.All patientsshould read this entire Medication Guide carefully. This information does not take the place of talking with your prescriber about your medical condition or treatment.

    What Are The Important Warnings And Instructions For Females Taking Acitretin Capsules? 

    Medication Guide Prenancy Warning
    Liver problems,including abnormal liver function tests and inflammation of your liver (hepatitis). Your prescriber should do blood tests to check how your liver is working before you start taking and during treatment with acitretin capsules. Stop taking acitretin capsules and call your prescriber right away if you have any of the following signs or symptoms of a serious liver problem:
    o
    yellowing of your skin or the whites of your eyes
    o
    nausea and vomiting
    o
    loss of appetite
    o
    dark urine

    Important: If You Are A Female Who Can Become Pregnant: 

    You must not take acitretin capsules if you are pregnant or might become pregnant during treatment or at any time for at least 3 years after you stop treatment because acitretin capsules can cause severe birth defects.
    During treatment with acitretin capsules and for 2 months after you stop treatment with acitretin capsules, you must avoid drinks, foods, and all medicines that contain alcohol. This includes over-the-counter products that contain alcohol.Avoiding alcohol is very important, because alcohol changes acitretin into a drug that may take longer than 3 years to leave your body. The chance of birth defects may last longer than 3 years if you swallow any form of alcohol during treatment with acitretin capsules and for 2 months after you stop taking acitretin capsules.
    You and your prescriber must be sure you are not pregnant before you start therapy with acitretin capsules. You must have negative results from 2 pregnancy tests before you start treatment with acitretin capsules.A negative result shows you are not pregnant. Because it takes a few days after pregnancy begins for a test to show that you are pregnant, the first negative test may not ensure you are not pregnant. Do not start acitretin capsules until you have negative results from 2 pregnancy tests.
    o
    Thefirst pregnancy test(urine or blood)will be done at the time you and your prescriber decide if acitretin capsules might be right for you.
    o
    Thesecond pregnancy testwill usually be done during the first 5 days of your menstrual period. You must start taking acitretin capsules within 7 days of when the urine or blood for the second pregnancy test is collected.
    After you start taking acitretin capsules, you must have a pregnancy test repeated each month that you are taking acitretin capsules. This is to be sure that you are not pregnant during treatment because acitretin capsules can cause birth defects. In addition, your prescription of acitretin capsules will be limited to a monthly supply.
    For at least 3 years after stopping treatment with acitretin capsules, you must have a pregnancy test repeated every 3 months to make sure that you are not pregnant.

    Discuss Effective Birth Control (contraception) With Your Prescriber. You Must Use 2 Effective Forms Of Birth Control (contraception) At The Same Time During All Of The Following: 

    o
    for at least 1 month before beginning treatment with acitretin capsules
    o
    during treatment with acitretin capsules
    o
    for at least 3 years after stopping treatment with acitretin capsules

    If You Are Sexually Active, You Must Use 2 Effective Forms Of Birth Control (contraception) At The Same Time Even If You Think You Cannot Become Pregnant, Unless 1 Of The Following Is True For You: 

    o
    You had your womb (uterus) removed during an operation (a hysterectomy).
    o
    Your prescriber said you have gone completely through menopause (the change of life ).
    You can get a free birth control counseling session and pregnancy testing from a prescriber or family planning expert. Your prescriber can give you a Contraception Counseling Referral Form for this free session.

    Primary Forms: 

    having your tubes tied (tubal ligation)
    partner s vasectomy
    IUD (intrauterine device)
    birth control pills that contain both estrogen and progestin (combination oral contraceptives); not progestin-only minipills
    hormonal birth control products that are injected, implanted, or inserted in your body
    birth control patch

    What Are Acitretin Capsules? 

    Acitretin capsules are a medicine used to treat severe forms of psoriasis in adults. Psoriasis is a skin disease that causes cells in the outer layer of the skin to grow faster than normal and pile up on the skin s surface. In the most common type of psoriasis, the skin becomes inflamed and produces red, thickened areas, often with silvery scales.

    Because acitretin capsules can have serious side effects,you should talk with your prescriber about whether possible benefits of acitretin capsules outweigh its possible risks.

    Acitretin capsules may not work right away. You may have to wait 2 to 3 months before you get the full benefit of acitretin capsules. Psoriasis gets worse for some patients when they first start treatment with acitretin capsules.

    Acitretin capsules have not been studied in children.

    Who Should Not Take Acitretin Capsules? 

    Do NOT take acitretin capsules if you can get pregnant.Do not take acitretin capsules if you are pregnant or might get pregnant during treatment with acitretin capsules or at any time forat least 3 yearsafter you stop treatment with acitretin capsules (

    Take acitretin capsules with food.
    Be sure to take your medicine as prescribed by your prescriber. The dose of acitretin capsules varies from patient to patient. The number of capsules you must take is chosen specially for you by your prescriber. This dose may change during treatment.
    If you miss a dose, do not double the next dose. Skip the missed dose and resume your normal schedule.
    If you take too many acitretin capsules (overdose), call your local poison control center or emergency room.

    You should have blood tests for liver function, cholesterol, and triglycerides before starting treatment and during treatment to check your body s response to acitretin capsules. Your prescriber may also do other tests.

    Once you stop taking acitretin capsules, your psoriasis may return. Do not treat this new psoriasis with leftover acitretin capsules. It is important to

    Avoid pregnancy.

    Acitretin Capsules Can Cause Serious Side Effects, Including: 

    Store acitretin capsules between 20 to 25 C (68 to 77 F).
    Keep acitretin capsules away from sunlight, high temperature, and humidity.

    Keep acitretin capsules and all medicines out of the reach of children.

    General information about the safe and effective use of acitretin capsules

    Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use acitretin capsules for a condition for which it was not prescribed. Do not give acitretin capsules to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about acitretin capsules that is written for health professionals.

    What Are The Ingredients In Acitretin Capsules? 

    Active ingredient: acitretin

    Inactive ingredients: edetate disodium, gelatin, maltodextrin, microcrystalline cellulose, poloxamer 407, red iron oxide, sodium ascorbate and titanium dioxide. The 25 mg capsules also contain black iron oxide and yellow iron oxide.

    The black imprinting ink for the 10 mg capsules contains black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.

    The white imprinting ink for the 25 mg capsules contains povidone, propylene glycol, shellac, sodium hydroxide and titanium dioxide.

    Manufactured for: Mylan Pharmaceuticals Inc.,Morgantown, WV 26505 U.S.A.

    For more information, call Mylan at 1-877-446-3679 (1-877-4-INFO-RX).

    Revised: 5/2018
    USV:ACIT:R8



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