MEDICATION GUIDE FOR PATIENTS

ACITRETIN (A si TRE tin) CAPSULESUSP

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 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 patients should 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 is the most important information I should know about acitretin capsules?

Acitretin capsules can cause severe birth defects. If you are a female who can get pregnant, you should use acitretin capsules 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 capsules?”.

What are the important warnings and instructions for females taking acitretin capsules?

• Before you receive your acitretin capsule prescription, you should have discussed and signed a Patient Information/Consent form with your prescriber. This is to help make sure you understand the risk of birth defects and how to avoid getting pregnant. If you did not talk to your prescriber about this and sign the form, contact your prescriber.
• 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 acitretin capsule treatment and for 2 months after you stop acitretin capsule treatment, 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 capsules 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 acitretin capsule therapy and for 2 months after you stop taking acitretin capsules.
• You and your prescriber must be sure you are not pregnant before you start acitretin capsules therapy. You must have negative results from 2 pregnancy tests before you start acitretin capsule treatment. 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.
  • The first pregnancy test will be done at the time you and your prescriber decide if acitretin capsules might be right for you.
  • The second pregnancy test will usually be done during the first 5 days of your menstrual period, right before you plan to start acitretin capsules. Your prescriber may suggest another time.
• After you start acitretin capsule therapy, 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.
• For at least 3 years after stopping acitretin capsule treatment, you must have a pregnancy test repeated every three 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 acitretin capsule treatment
  • during treatment with acitretin capsules
  • for at least 3 years after stopping acitretin capsule treatment
• 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:
  • 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 a Acitretin Capsules Patient Referral Form for this free session.
• You must use 2 effective forms of birth control (contraception) at the same time while you are on acitretin capsule treatment. You must use birth control for at least 1 month before you start acitretin capsules, during treatment, and at least 3 years after you stop acitretin capsule treatment.

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)
• hormonal birth control products that are injected, implanted, or inserted in your body
• birth control patch

Secondary Forms (use with a Primary Form):

• diaphragms with spermicide
• latex condoms (with or without spermicide)
• cervical caps with 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 using acitretin capsules 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 prescriber as soon as possible if 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 1-888-NOT-2-LATE (1-888-668-2528).
• Stop taking acitretin capsules right away and contact your prescriber if you get pregnant while taking acitretin capsules 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 taking acitretin capsules or at any time for at least 3 years after stopping acitretin capsules, you should report your pregnancy to TEVA USA, PHARMACOVIGILANCE at 1-888-838-2872, X6351 or directly to the Food and Drug Administration (FDA) MedWatch program (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 capsules.
• Do not take acitretin capsules if you are breast feeding. Acitretin can pass into your milk and may harm your baby. You will need to choose either to breast feed or take acitretin capsules, but not both.

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.

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 haveserious side effects, you should talk with your prescriber about whether acitretin capsules’ possible benefits outweigh their 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 acitretin capsule treatment.

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 acitretin capsule treatment or at any time for at least 3 years after you stop acitretin capsule treatment (see “What are the important warnings and instructions for females taking acitretin capsules?”).
• Do NOT take acitretin capsules if you are breastfeeding. Acitretin can pass into your milk and may harm your baby. You will need to choose either to breast feed or take acitretin capsules, but not both.
• Do NOT take acitretin capsules if you have severe liver or kidney disease.
• Do NOT take acitretin capsules if you have repeated high blood lipids (fat in the blood).
• 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 (see the end of this Medication Guide for a list of all the ingredients in acitretin capsules), or to any similar drugs (ask your prescriber or pharmacist whether any drugs you are allergic to are related to acitretin capsules).

Tell your prescriber if you have or ever had:

• diabetes or high blood sugar
• liver problems
• kidney problems
• high cholesterol or high triglycerides (fat in the blood)
• heart disease
• depression
• alcoholism
• an allergic reaction to a medication

Your prescriber needs this information to decide if acitretin capsules are right for you and to know what dose is best for you.

Tell your prescriber about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicines can cause serious side effects if taken while you also take acitretin capsules. Some medicines may affect how acitretin capsules work, or acitretin capsules may affect how your other medicines work. Be especially sure totell your prescriber if you are taking the following medicines:

• methotrexate
• tetracyclines
• phenytoin
• vitamin A supplements
• progestin-only oral contraceptives (“minipills”)
• Tegison® or Tigason (etretinate). Tell your prescriber if you have ever taken this medicine in the past.
• St. John’s Wort herbal supplement

Tell your prescriber if you are getting phototherapy treatment. Your doses of phototherapy may need to be changed to prevent a burn.

How should I take 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 see your prescriber again for treatment recommendations because your situation may have changed.

What should I avoid while taking acitretin capsules?

• Avoid pregnancy. See “What is the most important information I should know about acitretin capsules?”, and “What are the important warnings and instructions for females taking acitretin capsules?”.
• Avoid breastfeeding. See “What are the important warnings and instructions for females taking acitretin capsules?”.
• Avoid alcohol. Females must avoid drinks, foods, medicines, and over-the-counter products that contain alcohol. The risk of birth defects may continue for longer than 3 years if you swallow any form of alcohol during acitretin capsule treatment and for 2 months after stopping acitretin capsules (see “What are the important warnings and instructions for females taking acitretin capsules?”).
• Avoid giving blood. Do not donate blood while you are taking acitretin capsules and for at least 3 years after stopping acitretin capsule treatment. Acitretin in your blood can harm an unborn baby if your blood is given to a pregnant woman. Acitretin capsules do not affect your ability to receive a blood transfusion.
• Avoid progestin-only birth control pills (“minipills”). This type of birth control pill may not work while you take acitretin capsules. Ask your prescriber if you are not sure what type of pills you are using.
• Avoid night driving if you develop any sudden vision problems. Stop taking acitretin capsules and call your prescriber if this occurs (see “Serious side effects”).
• Avoid non-medical ultraviolet (UV) light. Acitretin capsules can make your skin more sensitive to UV light. Do not use sunlamps, and avoid sunlight as much as possible. If you are taking light treatment (phototherapy), your prescriber may need to change your light dosages to avoid burns.
• Avoid dietary supplements containing vitamin A. Acitretin is related to vitamin A. Therefore, do not take supplements containing vitamin A, because they may add to the unwanted effects of acitretin capsules. Check with your prescriber or pharmacist if you have any questions about vitamin supplements.
• DO NOT SHARE acitretin capsules with anyone else, even if they have the same symptoms. Your medicine may harm them or their unborn child.

What are the possible side effects of acitretin capsules?

• Acitretin capsules can cause birth defects. See “What is the most important information I should know about acitretin capsules?” and “What are the important warnings and instructions for females taking acitretin capsules?”
• Psoriasis gets worse for some patients when they first start acitretin capsule treatment. Some patients have more redness or itching. If this happens, tell your prescriber. These symptoms usually get better as treatment continues, but your prescriber may need to change the amount of your medicine.

Serious side effects.These do not happen often, but they can lead to permanent harm, or rarely, to death. Stop taking acitretin capsules and call your prescriber right away if you get the following signs or symptoms:

• Bad headaches, nausea, vomiting, blurred vision. These symptoms can be signs of increased brain pressure that can lead to blindness or even death.
• 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 acitretin capsule treatment stops. If you develop any vision problems or eye pain stop taking acitretin capsules and call your prescriber.
• 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. It is very important to stop taking acitretin capsules and call your prescriber right away if you develop such problems.
• Yellowing of your skin or the whites of your eyes, nausea and vomiting, loss of appetite, or dark urine. These can be signs of serious liver damage.
• Aches or pains in your bones, joints, muscles, or back; trouble moving; 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.

Common side effects.If you develop any of these side effects or any unusual reaction, check with your prescriber to find out if you need to change the amount of acitretin capsules you take. These side effects usually get better if the acitretin capsules dose is reduced or acitretin capsules are stopped.

• Chapped lips; peeling fingertips, palms, and soles; itching; scaly skin all over; weak nails; sticky or fragile (weak) skin; runny or dry nose, or nosebleeds. Your prescriber or pharmacist can recommend a lotion or cream to help treat drying or chapping.
• Dry mouth
• Joint pain
• Tight muscles
• Hair loss. Most patients have some hair loss, but this condition varies among patients. No one can tell if you will lose hair, how much hair you may lose or if and when it may grow back.
• Dry eyes. Acitretin capsules may dry your eyes. Wearing contact lenses may be uncomfortable during and after treatment with acitretin capsules because of the dry feeling in your eyes. If this happens, remove your contact lenses and call your prescriber. Also read the section about vision under “Serious side effects”.
• Rise in blood fats (lipids). Acitretin capsules can cause your blood fats (lipids) to rise. Most of the time this is not serious. But sometimes the increase can become a serious problem (see information under “Serious side effects”). You should have blood tests as directed by your prescriber.

These are not all the possible side effects of acitretin capsules. For more information, ask your prescriber or pharmacist.

How should I store acitretin capsules?

Keep acitretin capsules away from sunlight, high temperature, and humidity. Keep acitretin capsules away from children.

What are the ingredients in acitretin capsules?

Active ingredient: acitretin, USP (micronized)

Inactive ingredients: crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, gelatin, iron oxide black, microcrystalline cellulose, poloxamer, povidone, red iron oxide, shellac glaze, sodium ascorbate, sodium lauryl sulfate, titanium dioxide, and yellow iron oxide. The imprinting ink may also contain propylene glycol.

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 they were not prescribed. Do not give acitretin capsules to other people, even if they have the same symptoms that you have.

This Medication Guide summarizes the most important information about acitretin capsules. If you would like more information, talk with your prescriber. You can ask your pharmacist or prescriber for information about acitretin capsules that is written for health professionals.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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 Teva Pharmaceuticals USA.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

TEVA PHARMACEUTICALS USA

Sellersville, PA 18960

Iss. 6/2012