Consumer Information for: PMS-CARBAMAZEPINE

Serious Warnings and Precautions

Serious Warnings and Precautions

• Blood: Although infrequently reported and very rarely fatal, serious adverse effects affecting blood cell counts have been observed during the use of pms-CARBAMAZEPINE or pms-CARBAMAZEPINE-CR. Other side effects include: low white blood cell count, bone marrow depression, hepatitis and signs of liver failure such as jaundice (yellowing of the skin or eyes). Contact your doctor immediately if you are experiencing any of these symptoms. Close clinical and frequent laboratory supervision with your doctor should be maintained throughout treatment with pms-CARBAMAZEPINE or pms-CARBAMAZEPINE-CR in order to detect as early as possible any possible signs of a blood disorder. Your doctor should discontinue pms-CARBAMAZEPINE or pms-CARBAMAZEPINE-CR, if there is significant evidence of a bone marrow depression.


• Skin: Serious and sometimes fatal skin reactions known as Toxic Epidermal Necrolysis (TEN) and StevensJohnson Syndrome (SJS), have been reported with carbamazepine. Other serious skin reactions such as Drug Rash with Eosinophilia and Systemic Symptoms (DRESS), Acute Generalized Exanthematous Pustulosis (AGEP) and Maculopapular Rash have also been reported. Although very rare, serious forms of DRESS and AGEP may also lead to death. Some cases of these skin reactions have been genetically linked. Your doctor may recommend a blood test to determine if you belong to an at-risk population.


• Contact your doctor immediately if you are developing any combination of:
• a rash or any serious skin reactions such as red skin, blistering of the lips, eyes or mouth, and skin peeling accompanied by fever
• swollen lymph nodes
• joint pain
• enlargement of the liver and/or the spleen
• problems related to the lungs, kidneys, pancreas, heart, bone marrow, thymus, and colon

Your doctor will determine if it is indeed drugrelated, and discontinue pms-CARBAMAZEPINE or pms-CARBAMAZEPINE-CR in this case.

• Cancer: Long-term toxicity studies in rats have indicated a possible cancer risk associated with carbamazepine. Before taking pms-CARBAMAZEPINE or pms-CARBAMAZEPINECR discuss with your doctor the potential benefits and possible risks of this treatment for you.

BEFORE you use pms-CARBAMAZEPINE or pms-CARBAMAZEPINE-CR talk to your doctor or pharmacist if:

• About your medical conditions, especially if you have or have had any liver, kidney, heart or thyroid disease or blood disorders (including those caused by other drugs).
• If you have a history, or family history, of bone disease or have taken antiepileptics (such as phenobarbital, phenytoin, primidone, oxcarbazepine, lamotrignine, sodium valproate and/or carbamezepine) for a prolonged period of time.
• Of any allergies you may have, especially if you have ever shown any unusual sensitivity (rash or other signs of allergy) to oxcarbazepine or other drugs used to treat your condition. It is important to note that if you are allergic to pms-CARBAMAZEPINE or pms-CARBAMAZEPINE-CR (carbamazepine), there is an approximately 1 in 4 (25%) chance that you could also have an allergic reaction to oxcarbazepine (TRILEPTAL*).
• If you are pregnant. If you are planning on becoming pregnant, discuss the potential benefits against any potential hazards of pms-CARBAMAZEPINE or pms-CARBAMAZEPINE-CR with your doctor. This is especially important during the first three months of pregnancy. The risk to a fetus may be less if pms-CARBAMAZEPINE or pms-CARBAMAZEPINE-CR is:
• the only drug used to control seizures
• used at the lowest dose that still controls seizures
• Your doctor may recommend that you take folic acid before and during your pregnancy and vitamin K during the last weeks of pregnancy.
• The doctor may recommend that the newborn receive vitamin K and be observed for liver and gall bladder problems.
• If you are a women taking hormonal contraceptive (birth control medicine), pms-CARBAMAZEPINE or pms-CARBAMAZEPINE-CR may render this contraceptive ineffective. Therefore, you should use a different or additional non-hormonal method of contraception while you are taking pms-CARBAMAZEPINE or pms-CARBAMAZEPINE-CR. This should help to prevent an unwanted pregnancy. Tell your doctor at once if you get irregular vaginal bleeding or spotting. If you have any questions about this, ask your doctor or health professional.
• If you are breast-feeding. pms-CARBAMAZEPINE or pms-CARBAMAZEPINE-CR is known to pass into breast milk. You must discuss with your doctor the benefits of breastfeeding against any possible risks to the infant. If you decide to breastfeed, the baby must be observed for liver and gall bladder problems, drowsiness, and allergic skin reactions.
• pms-CARBAMAZEPINE and pms-CARBAMAZEPINECR may affect male fertility or cause abnormal sperm.
• Of any other medicines (prescription and nonprescription) you are taking.
• Of your usual alcohol consumption
• If you have increased pressure in the eye (glaucoma)
• If you have difficulty passing urine (urinary retention).
• If you were told by your physician that you suffer from mental problems, a mental disorder called psychosis that may be accompanied by confusion or agitation, or have thoughts about suicide.

If any of these apply to you, tell your doctor.

• If an allergic reaction happens such as fever with lymph nodes swelling, rash or skin blistering, tell your doctor immediately or go to the emergency department at your nearest hospital. (see Side effects and what to do about them).
• If you experience an increase in the number of seizures, tell your doctor immediately.
• If you experience any side effects such as drowsiness, headache, unsteadiness on the feet, double vision, dizziness, nausea or vomiting, consult your doctor.
• If, at any time, you have thoughts of harming or killing yourself. A small number of people being treated with antiepileptic drugs have reported having such thoughts or behavior. Should this happen to you, or to those in your care if you are a caregiver or guardian, talk to your doctor immediately. Close observation by a doctor is necessary in this situation. Do not discontinue your medication on your own.
• If you have kidney problems associated with low sodium blood level or if you have kidney problems and you are also taking certain medicines that lower sodium blood level (diuretics such as hydrochlorothiazide, furosemide).