- ABSORICA can cause birth defects (deformed babies), loss of a baby before birth (miscarriage), death of the baby, and early (premature) births.
- Females who are pregnant or who plan to become pregnant must not take ABSORICA.
- Females must not get pregnant for 1 month before starting ABSORICA, while taking ABSORICA, and for 1 month after stopping ABSORICA. Females who can get pregnant must agree to use two separate forms of effective birth control at the same during this period.
- If you have sex at any time without using two forms of effective birth control, get pregnant, or miss your expected period, stop using ABSORICA and call your doctor right away.
Read the Medication Guide that comes with ABSORICA before you start taking it and each time you get a prescription. There may be new information.
What is the most important information I should know about ABSORICA?
- Because ABSORICA can cause birth defects, ABSORICA is only for patients who can understand and agree to carry out all of the instructions in the iPLEDGE® program.
- ABSORICA may cause serious mental health problems.
Serious Mental Health Problems
- ABSORICA may cause depression, psychosis (seeing or hearing things that are not real) and suicide.
- Some patients taking ABSORICA have had thoughts about hurting themselves or putting an end to their own lives (suicidal thoughts). Some people tried to end their own lives and some people have ended their own lives.
- Stop ABSORICA and call your doctor right away if you or a family member notices that you have any of the following signs and symptoms of depression: start to feel sad or have crying spells, lose interest in activities you once enjoyed, sleep too much or have trouble sleeping, become more irritable, angry or aggressive than usual (e.g., temper outbursts, thoughts of violence), have a change in your appetite or body weight, have trouble concentrating, withdraw from your friends or family, feel like you have no energy, have feelings of worthlessness or guilt, start having thoughts about hurting yourself or taking your own life (suicidal thoughts), start acting on dangerous impulses, start seeing or hearing things that are not real. After stopping ABSORICA, you may also need follow-up mental health care if you had any of these symptoms.
Who should NOT take ABSORICA?
- Do not take ABSORICA if you are pregnant, plan to become pregnant, or become pregnant during ABSORICA treatment. See “What is the most important information I should know about ABSORICA?”
- Do not take ABSORICA if you are allergic to anything in it.
What should I tell my doctor before taking ABSORICA?
- Tell your doctor if you or a family member has any of the following health conditions: mental problems, asthma, liver disease, diabetes, heart disease, bone loss (osteoporosis) or weak bones, an eating problem called anorexia nervosa (where people eat too little), or food or medicine allergies.
- Tell your doctor if you are pregnant or breastfeeding. ABSORICA must not be used by females who are pregnant or breastfeeding.
- Tell your doctor about all the medicines you take including prescription and over-the-counter medicines, vitamins and herbal supplements. ABSORICA and certain other medicines can interact with each other, sometimes causing serious side effects. Especially tell your doctor if you take: Vitamin A supplements, tetracycline antibiotics, progestin-only birth control pills (mini-pills), Dilantin® (phenytoin), corticosteroid medicines, or St. John’s Wort. These medicines should not be used with ABSORICA unless your doctor tells you it is okay.
What should I avoid while taking ABSORICA?
- While taking ABSORICA and for one month after stopping ABSORICA:
- Do not get pregnant. See “What is the most important information I should know about ABSORICA?”
- Do not breastfeed. It is not known if ABSORICA can pass through your milk and harm your baby.
- Do not give blood. If someone who is pregnant gets your donated blood, her baby may be exposed to ABSORICA and may be born with birth defects.
- Do not take other medicines or herbal products with ABSORICA unless you talk to your doctor.
- Do not drive at night until you know if ABSORICA has affected your vision. ABSORICA may decrease your ability to see in the dark.
- Do not have cosmetic procedures to smooth your skin, including waxing, dermabrasion, or laser procedures, while you are using ABSORICA and for at least 6 months after you stop. ABSORICA can increase your chance of scarring from these procedures. Check with your doctor for advice about when you can have cosmetic procedures.
- Avoid sunlight and ultraviolet lights (e.g., tanning machines) as much as possible. ABSORICA may make your skin more sensitive to light.
What are the possible side effects of ABSORICA?
- ABSORICA can cause birth defects and serious mental health problems. See “What is the most important information I should know about ABSORICA?”
- Serious brain problems. ABSORICA can increase the pressure in your brain which can lead to permanent loss of eyesight and, in rare cases, death. Stop taking ABSORICA and call your doctor right away if you get any of these signs of increased brain pressure: bad headache, blurred vision, dizziness, nausea or vomiting, seizures (convulsions) or stroke.
- Skin problems. Skin rash can occur in patients taking ABSORICA. In some patients a rash can be serious. Stop taking ABSORICA and call your doctor right away if you develop conjunctivitis (red or inflamed eyes, like “pink eye”), a rash with a fever, blisters on legs, arms or face and/or sores in your mouth, throat, nose, eyes, or if your skin begins to peel.
- Stomach area (abdomen) problems. Certain symptoms may mean that your internal organs are being damaged. These organs include the liver, pancreas, bowel (intestines), and esophagus (connection between mouth and stomach). If your organs are damaged, they may not get better even after you stop taking ABSORICA. Stop taking ABSORICA and call your doctor if you get: severe stomach, chest or bowel pain, trouble swallowing or painful swallowing, new or worsening heartburn, diarrhea, rectal bleeding, yellowing of your skin or eyes, dark urine.
- Bone and muscle problems. ABSORICA may affect bones, muscles, and ligaments and cause pain in your joints or muscles. Tell your doctor if you plan hard physical activity during treatment. Tell your doctor if you get back or joint pain. If you break a bone, tell all healthcare providers that you take ABSORICA. ABSORICA may stop long bone growth in teenagers who are still growing.
- Hearing problems. Stop using ABSORICA and call your doctor if your hearing gets worse or if you have ringing in your ears. Your hearing loss may be permanent.
- Vision problems. ABSORICA may affect your ability to see in the dark. This condition usually clears up after you stop taking ABSORICA, but may be permanent. Other serious eye effects can occur. Stop taking ABSORICA if you have any problems with your vision or dryness of the eyes that is painful or constant. If you wear contact lenses, you may have trouble wearing them while taking ABSORICA and after treatment.
- Lipid (fats and cholesterol in blood) problems. ABSORICA can raise the level of fats and cholesterol in your blood. This can be a serious problem. Return to your doctor for blood tests to check your lipids and to get any needed treatment. These problems usually go away when ABSORICA treatment is finished.
- Serious allergic reactions. Stop taking ABSORICA and get emergency care right away if you develop hives, a swollen face or mouth, or have trouble breathing. Stop taking ABSORICA and call your doctor if you get a fever, rash, or red patches or bruises on your legs.
- Blood sugar problems. ABSORICA may cause blood sugar problems including diabetes. Tell your doctor if you are very thirsty or urinate a lot.
- Decreased red and white blood cells. Call your doctor if you have trouble breathing, faint, or feel weak.
- The common, less serious side effects of ABSORICA are dry skin, chapped lips, dry eyes, and dry nose that may lead to nosebleeds.
- ABSORICA contains the color additive FD&C Yellow No. 5 (tartrazine) which may cause allergic type reactions, including asthma, in some people. The overall occurrence of allergic reaction is low and is most often seen in people who also have an allergy to aspirin.
- You are encouraged to report all side effects or Adverse Drug Events (ADEs) of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088. You are also encouraged to report side effects or ADEs to our Drug Safety Department at 1-800-406-7984 or drug.safetyUSA@sunpharma.com (preferred) with as much information as available.