Acitretin

Warning

Do not use this medication if you are pregnant or planning to become pregnant within 3 years of stopping this drug because it has caused serious birth defects.

Use 2 effective birth control methods starting 1 month before taking this medication and at least 3 years after treatment has stopped. Do not use "minipills" (non-estrogen-containing pills) for birth control because they may not work as well with this drug. Consult your doctor for more details.

Females who are able to have children must not use this medication unless the following requirements are met: test negative on 2 pregnancy tests (they should be taken 1 week before starting this drug or at least 11 days after the last act of unprotected sexual intercourse); start therapy within 7 days of taking the second pregnancy test; present severe psoriasis and other treatments cannot be used; receive oral and written information on using 2 methods of birth control while taking this drug and for 3 years after stopping it; aware of the dangers of birth control failure and use during pregnancy; understand and correctly follow all birth control requirements and instructions including monthly pregnancy tests during treatment and every 3 months for 3 years after treatment has stopped.

Do not drink alcohol while using acitretin and for 2 months after stopping it because alcohol causes this drug to stay in the body longer.

It is not known if traces of this drug found in semen of male patients pose a risk to the unborn baby during use or after treatment has stopped.

Acitretin may rarely cause serious (possibly fatal) liver disease (hepatitis) and increased fluid pressure on the brain (pseudotumor cerebri). If you notice any of the following unlikely but serious side effects, get medical help right away: headache that is severe or doesn't go away, nausea/vomiting that doesn't stop, loss of appetite, yellowing eyes/skin, dark urine, severe stomach/abdominal pain, unusual tiredness, or vision changes (such as blurred/double vision, decreased vision).

Acitretin has also been linked to pancreatitis (inflammation of the pancreas). Tell your doctor right away if you develop lower abdominal pain that doesn't go away.

Rarely, acitretin may cause serious mental/mood changes, even after stopping the medication. Get medical help right away if you have symptoms such as depression, irritability, aggressive or violent behavior, or thoughts of suicide.

Precautions

See also Warning section.

Before taking acitretin, tell your doctor or pharmacist if you are allergic to it; or to vitamin A-related drugs (other retinoids such as isotretinoin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, heart disease, diabetes, personal/family history of mental/mood problems (such as depression).

Do not donate blood while taking this drug and for at least 3 years after stopping therapy. This will prevent the possibility of your blood being given to a pregnant woman.

This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness. Your doctor may direct you to limit or avoid phototherapy while you use this product. Ask your doctor for details.

Acitretin may cause vision changes, including decreased night vision. Do not drive, use machinery, or do anything that needs clear vision (especially at night) until you are sure you can perform such activities safely.

Avoid drinking alcohol while taking this medication and for 2 months after stopping it.

This drug must not be used during pregnancy. It may harm an unborn baby. If you become pregnant or think you may be pregnant, tell your doctor right away. This drug should not be used if you are planning to become pregnant during treatment or within 3 years after use has stopped.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the capsules.

Semen may pose a risk to a pregnant woman if a male is using this drug. Consult your doctor.

This medication passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this medication and for at least three years after the last dose. Consult your doctor before breastfeeding.

Side Effects

See also Warning section.

You may experience more redness, itching, skin scaling, peeling and dry skin during the first few weeks as your body adjusts to the medication. Dry eyes, eye irritation, crusting of the eye lids, dry mouth, skin peeling on the fingertips/palms/soles of feet, chapped lips, runny nose, thirst, taste changes and hair loss may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Contact lens wearers may be uncomfortable while taking this drug because it causes dry eyes.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: decreased night vision, fever, chills, dizziness, bone/joint pain, muscle pain/tenderness/weakness, difficulty moving, swelling, sudden weight gain, signs of kidney problems (such as change in the amount of urine).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

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