Dosage form:

• Extended release tablet (333 mg sodium valproate + 145 mg valproic acid)

What is this drug used for?

• It is used to treat seizures.
• It is used to prevent migraine headaches.
• It is used to treat bipolar problems.

What do I need to tell my doctor BEFORE I take this drug?

• If you are allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have any of these health problems: Liver disease or a urea cycle disorder.
• Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take this drug?

• Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert or have clear eyesight until you see how this drug affects you.
• Have blood work checked as you have been told by the doctor.
• This drug may affect certain lab tests. Tell all of your health care providers and lab workers that you take this drug.
• If you are not able to eat or drink like normal, talk with your doctor. This includes if you are sick, fasting, or you are having certain procedures or surgery.
• You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush.
• High blood levels of ammonia have happened with this drug. This can lead to certain brain problems. In some people, this has been deadly. Sometimes, these brain problems have gone back to normal after this drug was stopped. However, sometimes they have not fully gone back to normal. Talk with the doctor.
• A severe and sometimes deadly reaction has happened. Most of the time, this reaction has signs like fever, rash, or swollen glands with problems in body organs like the liver, kidney, blood, heart, muscles and joints, or lungs.
• If you are 65 or older, use this drug with care. You could have more side effects.
• This drug may affect being able to father a child.
• This drug may cause harm to an unborn baby. Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Constipation, diarrhea, stomach pain, throwing up.
• Hungrier.
• Feeling dizzy, sleepy, tired, or weak.
• Trouble sleeping.
• Weight gain or loss.
• Hair loss.
• Feeling nervous and excitable.
• Flu-like signs.

Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Signs of high ammonia levels like a heartbeat that does not feel normal, breathing that is not normal, feeling confused, pale skin, slow heartbeat, seizures, sweating, throwing up, or twitching.
• Chest pain.
• Swelling in the arms or legs.
• Change in eyesight.
• Memory problems or loss.
• Change in balance and trouble walking.
• Any unexplained bruising or bleeding.
• Purple spots or redness of the skin.
• Not able to pass urine or change in how much urine is passed.
• Swollen gland.
• Muscle pain or weakness, joint pain or swelling.
• Shakiness.
• Not able to control eye movements.
• Ringing in ears.
• Feeling cold.
• Like other drugs that may be used for seizures, this drug may rarely raise the risk of suicidal thoughts or actions. The risk may be higher in people who have had suicidal thoughts or actions in the past. Call the doctor right away about any new or worse signs like depression; feeling nervous, restless, or grouchy; panic attacks; or other changes in mood or behavior. Call the doctor right away if any suicidal thoughts or actions occur.

How is this drug best taken?

Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food. Take with food if it causes an upset stomach.
• Keep taking this drug as you have been told by your doctor or other health care provider.
• Do not stop taking this drug all of a sudden without calling your doctor. You may have a greater risk of seizures.
• If you take cholestyramine, you may need to take it at some other time than this drug. Talk with your pharmacist.
• Swallow whole. Do not chew, break, or crush. Take with a full glass of water.
• If you have trouble swallowing, talk with your doctor.
• If you see parts of this drug in your stool, call your doctor.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

How do I store and/or throw out Sodium Valproate + Valproic acid?

• Store in the original container at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.