Tretinoin Oral capsule

What is this medicine?

TRETINOIN (TRET i noe in) is a medicine belonging to a class called the retinoids. It is similar to vitamin A. It is used to treat certain leukemias, such as acute promyelocytic leukemia (APL).

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• high cholesterol
• liver disease
• an unusual or allergic reaction to tretinoin, vitamin A, parabens, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• other retinoids
• vitamin A supplements

This medicine may also interact with the following medications:

• aminocaproic acid
• aprotinin
• cimetidine
• cyclosporine
• diltiazem
• erythromycin
• medicines for fungal infections like ketoconazole, itraconazole, and voriconazole
• medicines that increase your sensitivity to sunlight such as tetracyclines or sulfa drugs
• methotrexate
• orlistat
• phenobarbital
• rifampin
• steroid medicines like prednisone or cortisone
• tranexamic acid
• verapamil

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. You will need to have regular blood checks.

This drug may make you feel generally unwell. This is not uncommon, as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your doctor tells you to stop.

Call your doctor or health care professional for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick.

This medicine may increase your risk to bruise or bleed. Call your doctor or health care professional if you notice any unusual bleeding.

Be careful brushing and flossing your teeth or using a toothpick because you may get an infection or bleed more easily. If you have any dental work done, tell your dentist you are receiving this medicine.

Avoid taking products that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your doctor. These medicines may hide a fever.

Do not become pregnant while taking this medicine. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. You should have a pregnancy test within 1 week before starting this medicine. Use 2 kinds of birth control and take monthly pregnancy tests while you are taking this medicine and for 1 month after stopping this medicine. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• low blood counts - this medicine may decrease the number of white blood cells, red blood cells and platelets. You may be at increased risk for infections and bleeding.
• signs of infection - fever or chills, cough, sore throat, pain or difficulty passing urine
• signs of decreased platelets or bleeding - bruising, pinpoint red spots on the skin, black, tarry stools, blood in the urine
• signs of decreased red blood cells - unusually weak or tired, fainting spells, lightheadedness
• breathing problems
• changes in blood pressure
• changes in emotions or moods
• changes in hearing
• changes in vision
• chest pain
• confusion
• depressed mood
• hallucination, loss of contact with reality
• mouth sores
• nausea, vomiting
• pain, tingling, numbness in the hands or feet
• problems with balance, talking, walking
• seizures
• stomach pain
• swelling of the ankles, feet, hands
• trouble passing urine or change in the amount of urine
• water or weight gain
• yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• bone pain
• changes in skin color
• dry skin
• hair loss
• headache
• increased sweating
• loss of appetite
• stomach upset
• trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at 15 to 30 degrees C (59 to 86 degrees F). Protect from light. Throw away any unused medicine after the expiration date.

NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.