ACITRETIN- acitretin capsule 
Sigmapharm Laboratories, LLC

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MEDICATION GUIDE

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 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 serious side effects, including:

birth defects

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

Important: If you are a female who can become pregnant:

The following are considered effective forms of birth control:

Primary Forms:

Secondary Forms (use with a Primary Form):

At least 1 of your 2 methods of birth control must be a primary form.

Contact your prescriber, women’s health centers, pharmacies, or hospital emergency rooms for information on how to get emergency contraception. A 24-hour, toll-free number (1-855-273-0150) is also available for patients to receive automated birth control and emergency contraception information.

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 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?

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

Before taking acitretin capsules, tell your prescriber about all your medical conditions, including if you have or have had:

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 over-the-counter 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 other medicines work. Be especially sure to tell your prescriber if you are taking the following medicines:

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?

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?

What are the possible side effects of acitretin capsules?

Acitretin capsules can cause serious side effects, including:

Stop taking acitretin capsules and call your prescriber right away if you get the following signs or symptoms of possible serious side effects:

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 dose of acitretin capsules is reduced or acitretin capsules are stopped.

Psoriasis gets worse for some patients when they first start treatment with acitretin capsules.
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.

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

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

How should I store acitretin?

Keep acitretin capsules 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 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.

For more information about acitretin capsules call 1-855-273-0150 or go to www.sigmapharm.com/PPET.

What are the ingredients in acitretin?
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 Sigmapharm Laboratories, LLC.


Sigmapharm Laboratories, LLC
Bensalem, PA 19020 USA

OS083-06 REV.1017

Revised 10/2017

Revised: 12/2017
Sigmapharm Laboratories, LLC