Valproic Acid, Divalproex Sodium delayed release capsules

What is this medication?

VALPROIC ACID (val PROE ik AS id) is used to prevent seizures caused by some forms of epilepsy. It is also used to treat bipolar mania and to prevent migraine headaches.

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

COMMON BRAND NAME(S): Stavzor

What should I tell my care team before I take this medication?

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

• if you often drink alcohol
• kidney disease
• liver disease
• low platelet counts
• mitochondrial disease
• suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member
• urea cycle disorder (UCD)
• an unusual or allergic reaction to divalproex sodium, sodium valproate, valproic acid, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Do not cut, crush or chew this medicine. You can take it with or without food. If it upsets your stomach, take it with food. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 10 years 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 medication?

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

• sodium phenylbutyrate

This medicine may also interact with the following medications:

• aspirin
• certain antibiotics like ertapenem, imipenem, meropenem
• certain medicines for depression, anxiety, or psychotic disturbances
• certain medicines for seizures like carbamazepine, clonazepam, diazepam, ethosuximide, felbamate, lamotrigine, phenobarbital, phenytoin, primidone, rufinamide, topiramate
• certain medicines that treat or prevent blood clots like warfarin
• cholestyramine
• female hormones, like estrogens and birth control pills, patches, or rings
• propofol
• rifampin
• ritonavir
• tolbutamide
• zidovudine

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 medication?

Tell your doctor or health care provider if your symptoms do not get better or they start to get worse.

This medicine may cause serious skin reactions. They can happen weeks to months after starting the medicine. Contact your health care provider right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. Or, you might notice a red rash with swelling of the face, lips or lymph nodes in your neck or under your arms.

Wear a medical ID bracelet or chain, and carry a card that describes your disease and details of your medicine and dosage times.

You may get drowsy, dizzy, or have blurred vision. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. To reduce dizzy or fainting spells, do not sit or stand up quickly, especially if you are an older patient. Alcohol can increase drowsiness and dizziness. Avoid alcoholic drinks.

This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

Patients and their families should watch out for new or worsening depression or thoughts of suicide. Also watch out for sudden changes in feelings such as feeling anxious, agitated, panicky, irritable, hostile, aggressive, impulsive, severely restless, overly excited and hyperactive, or not being able to sleep. If this happens, especially at the beginning of treatment or after a change in dose, call your health care provider.

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. Talk to your health care provider or pharmacist for more information. Women who become pregnant while using this medicine may enroll in the North American Antiepileptic Drug Pregnancy Registry by calling 1-888-233-2334. This registry collects information about the safety of antiepileptic drug use during pregnancy.

This medicine may cause a decrease in folic acid and vitamin D. You should make sure that you get enough vitamins while you are taking this medicine. Discuss the foods you eat and the vitamins you take with your health care provider.

What side effects may I notice from receiving this medication?

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
• changes in vision
• rash, fever, and swollen lymph nodes
• redness, blistering, peeling or loosening of the skin, including inside the mouth
• signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin
• suicidal thoughts or other mood changes
• unusual bleeding or bruising

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

• constipation
• diarrhea
• dizziness
• hair loss
• headache
• loss of appetite
• weight gain

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 medication?

Keep out of reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Keep container tightly closed. 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.