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Alitretinoin

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Warning

Women who are pregnant must not use alitretinoin. Women must avoid becoming pregnant while taking this medication and for one month after stopping treatment. It can cause serious (even fatal) birth defects, miscarriage, or premature birth of the baby. Talk with your doctor about the risks and benefits of taking this medication and your birth control options. Read and sign the Patient Informed Consent Form provided by your doctor.

Women who are able to have children must use two reliable forms of birth control for 1 month before starting alitretinoin, during use, and for at least 1 month 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.

Women who are able to have children must also meet the following requirements: test negative on 2 pregnancy tests before starting treatment; start treatment on the second or third day of the next normal menstrual period; have monthly pregnancy tests during treatment and for one month after stopping treatment.

Alitretinoin has been rarely linked to increased pressure in the brain (benign intracranial hypertension). Stop taking alitretinoin and tell your doctor right away if you develop persistent headache, nausea, vomiting, or vision changes (such as blurred vision).

Precautions

Before taking alitretinoin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as soy), 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: diabetes, high cholesterol/triglycerides, high levels of vitamin A, kidney disease, liver disease, mental/mood problems (such as depression), thyroid disease.

Do not donate blood while taking this drug and for at least 1 month after stopping treatment. This will lessen the chance of your blood being given to a pregnant woman.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths or sunlamps. Use a sunscreen and wear protective clothing when outdoors.

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

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This drug must not be used during pregnancy. It may harm an unborn baby. Females must use two reliable forms of birth control for 1 month before starting alitretinoin, during use, and for at least 1 month after treatment has stopped. If you become pregnant or think you may be pregnant, tell your doctor immediately. See also Warning section.

It is unknown if this drug passes into breast milk. However, similar drugs pass into breast milk. Breast-feeding while using this medication is not recommended. Consult your doctor before breast-feeding.

Side Effects

Headache, flushing, dry eyes, or dry lips/skin may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To relieve dry eyes, you may use a lubricating eye ointment or tear replacement eye drops. Ask your pharmacist for details. If you wear contact lenses and get dry eyes, you may need to wear glasses while using this medication.

Remember that your doctor has prescribed this medication because he or she 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 any of these serious side effects occur: mental/mood changes (such as depression, anxiety, thoughts of suicide), back/joint/muscle pain.

Stop taking alitretinoin and tell your doctor right away if any of these serious side effects occur: abdominal pain, bloody/severe diarrhea, bleeding from the rectum, persistent/severe headache, vision changes (such as blurred/double vision, decreased vision), persistent nausea/vomiting.

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), 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.

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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Drug information is selected from data included with permission and copyrighted by First DataBank, Inc. This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your healthcare professional. Always seek the advice of your healthcare professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your healthcare professional. This information does not contain any assurances that this product is safe, effective or appropriate for you.

This information is intended only for residents of the United States. Products sold under the same brand names in other countries may contain different ingredients.

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Information expires June 2015.