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.
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 on the second or third day of the next normal menstrual period; 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: yellowing eyes/skin, dark urine, persistent nausea/vomiting/loss of appetite, severe stomach/abdominal pain, unusual tiredness, persistent/severe headache, or vision changes (such as blurred/double vision, decreased vision).Who should not take acitretin?
Read the Medication Guide provided by your pharmacist before you start using acitretin and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist.
Read and complete the Patient Agreement and Informed Consent document before taking this drug.
Take this medication by mouth exactly as prescribed, usually once a day with your main meal.
The dosage is based on your medical condition and response to therapy. Do not take this more often or increase your dose without consulting your doctor. Your condition will not improve any faster but the risk of side effects may increase.
It may take 2 to 3 months before the full benefit of this medication is seen.
Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time each day.
See also Warning section.
You may experience more redness, itching, skin scaling, peeling and dry skin the first several weeks as your body adjusts to the medication. Dry eyes, eye irritation, crusting of the eye lids, increased sensitivity to sunlight, dry mouth, peeling of the skin of fingertips, palms or soles of feet, chapped lips, runny nose, thirst, taste changes and hair loss may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Contact lens wearers may be uncomfortable while taking this drug because it causes dry eyes.
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 you have any serious side effects, including: decreased night vision, fever, chills, aches and pain in the bones or joints, difficulty moving, swelling, sudden weight gain.
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.
Before taking acitretin, tell your doctor or pharmacist if you are allergic to it; or to other retinoids; 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.
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.
Acitretin 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.
Avoid drinking alcohol while taking this medication and for 2 months after stopping it.
This drug must not be used during pregnancy. If you become pregnant or think you may be pregnant, inform your doctor immediately. This drug should not be used if you are planning to become pregnant during treatment or within 3 years after use has stopped.
Use 2 effective forms of birth control starting 1 month before and during treatment and at least 3 years after use has stopped. If you are unsure which types of birth control are effective, consult your doctor, pharmacist, or Medication Guide.
Semen may pose a risk to a pregnant woman if a male is using this drug. Consult your doctor.
It is not known if this drug is excreted into breast milk. Breast-feeding is not recommended while using this medication and for at least three years after the medication has been stopped.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include severe headache, nausea, vomiting, drowsiness, irritability, loss of balance, and itching.
See also Warning section.
Do not share this medication with others.
Laboratory tests (such as liver function tests, X-rays, and cholesterol tests) should be performed before you start treatment, periodically to monitor your progress, or to check for side effects. Consult your doctor for more details.
If you miss a dose, use it as soon as you remember. If it is near the time of your next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
Store this medication at room temperature away from heat and light. Do not store in the bathroom. Keep this and all medications out of the reach of children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised May 2014. Copyright(c) 2014 First Databank, Inc.
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