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 headache that doesn't go away, nausea, vomiting, or vision changes (such as blurred vision).
Before taking alitretinoin, 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 (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. 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.
Alitretinoin 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.
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 right away. See also Warning section.
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.
It is unknown if this medication passes into breast milk. However, similar drugs pass into breast milk. Breastfeeding is not recommended while using this medication. Consult your doctor before breastfeeding.
Headache, flushing, dry eyes, or dry lips/skin may occur. If any of these effects last or get worse, 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 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: mental/mood changes (such as depression, anxiety, thoughts of suicide), back/joint/muscle pain.
Stop taking alitretinoin and tell your doctor right away if you have any very serious side effects, including: headache that is severe or doesn't go away, nausea/vomiting that doesn't stop, abdominal pain, bloody/severe diarrhea, bleeding from the rectum, vision changes (such as blurred/double vision, decreased vision).
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 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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