What Epival is used for and how to use it
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Epival - Consumer Medicine Information

Manufacture: Abbott Laboratories
Country: Canada
Condition: Epilepsy
Class: Anticonvulsants
Form: Tablets
Ingredients: sodium alginate, microcrystalline cellulose, povidone, magnesium stearate, hypromellose, macrogol 400, macrogol 6000, talc, titanium dioxide (171), iron oxide red, glycol butylene glycol montanate

About This Medication

What the Medication is Used For

EPIVAL has been prescribed to you to either:

  • control your epilepsy
  • treat symptoms of mania associated with bipolar disorder, such as aggressiveness, agitation, impulsive behaviour or excessively elevated mood.

EPIVAL is not indicated for the treatment of the symptoms of mania in patients under 18 years of age.

Please follow your doctor’s recommendations carefully.

What it Does

EPIVAL has anticonvulsant properties. The mechanism of action has not yet been established. It has been suggested that its activity in epilepsy is related to increased brain concentrations of gammaaminobutyric acid (GABA).

When it Should Not be Used

EPIVAL should not be taken by:

  • patients with liver disease or significant liver dysfunction
  • patients with mitochondrial diseases (e.g., Alpers or Alpers-Huttenlocher disease)
  • patients who are allergic to the drug
  • patients with known urea cycle disorders (a genetic disorder)
  • patients with known porphyria (a genetic disorder)

What the Medicinal Ingredient Is

divalproex sodium

What the Non-Medicinal Ingredients Are

EPIVAL 125 mg tablets also contain diacetylated monoglycerides, FD&C Red No. 40, hydroxypropylmethyl cellulose phthalate, povidone, pregelatinized starch (contains corn starch), silicon dioxide, talc, titanium dioxide, and vanillin.

EPIVAL 250 mg tablets also contain diacetylated monoglycerides, FD&C Yellow No. 6, hydroxypropylmethyl cellulose phthalate, povidone, pregelatinized starch (contains corn starch), silicon dioxide, talc, titanium dioxide, and vanillin.

EPIVAL 500 mg tablets also contain diacetylated monoglycerides, D&C Red No. 30, FD&C Blue No. 2, hydroxypropylmethyl cellulose phthalate, povidone, pregelatinized starch (contains corn starch), silicon dioxide, talc, titanium dioxide, and vanillin.

What Dosage Forms it Comes In

EPIVAL is available as enteric-coated tablets in the following strengths: 125 mg, 250 mg, and 500 mg.

Warnings and Precautions

Serious Warnings and Precautions

  • Hepatotoxicity: liver failure resulting in death has occurred in patients receiving EPIVAL. These incidents usually occurred during the first 6 months of treatment with EPIVAL. Patients taking several anticonvulsant drugs, children, those with a history of liver disease, metabolic disorders, severe seizure disorders accompanied by mental retardation, and those with brain disease may be at particular risk. Experience has indicated that children under the age of 2 years are at a considerably increased risk of developing fatal hepatotoxicity, especially those on multiple anticonvulsants.
  • Teratogenicity: EPIVAL can produce birth defects to an unborn baby. Accordingly, the use of EPIVAL in women of childbearing potential requires that the benefits of its use be weighed against the risk of injury to the fetus.
  • Pancreatitis: cases of life threatening pancreas disorderhave been reported in both children and adults receivingEPIVAL. Some cases have occurred shortly after first useas well as after several years of use. Abdominal pain,nausea, vomiting and/or anorexia can be symptoms ofpancreatitis that require immediate medical evaluation.

BEFORE you use EPIVAL talk to your doctor or pharmacist if:

  • you have a history of, or suffer from a liver disease, such as jaundice (yellowing of the skin and eyes);
  • you have ever had an unusual or allergic reaction to EPIVAL (including fever or rash);
  • you are allergic to any component of EPIVAL tablets;
  • you are pregnant or are planning to become pregnant;
  • you are breast-feeding (nursing); EPIVAL passes into breast milk;
  • you are taking any other prescription or over the counter medicine;
  • you have kidney disease;
  • you have other medical conditions including a history of unexplained coma, intellectual disabilityor any type of brain dysfunction;
  • you have a psychiatric disorder or have thoughts of suicide;
  • you consume alcohol on a regular basis.

Precautions While Taking EPIVAL

  • Your doctor will monitor your response to EPIVAL on a regular basis. However, if your seizures get worse, you should tell your doctor immediately
  • Since EPIVAL may cause poor coordination and/or drowsiness, you should not engage in hazardous activities, such as driving and operating machinery, until you know that you don’t become drowsy from the drug.
  • You should not stop taking your medication unless directed by your doctor. You should always check that you have an adequate supply of EPIVAL. You should remember that this medicine was prescribed only for you; it should never be given to anyone else.

Women of Childbearing Potential

  • All women of childbearing age who are being treated with EPIVAL should talk to their healthcare providers about using other possible treatments instead of EPIVAL. If the decision is made to use EPIVAL, you must use an effective method of birth control (contraception). You should talk to your doctor about the best kind of birth control to use while you are taking EPIVAL.

Pregnant Women

  • If you take EPIVAL during pregnancy, your child has a higher risk for birth defects and adverse effects on IQ and brain development, which can begin early in the pregnancy, even before you know that you are pregnant.
  • There may be other medications to treat your condition that have a lower chance of birth defects.
  • If you are planning to become pregnant, or if you become pregnant while taking EPIVAL, you should promptly inform your doctor. Do not suddenly stop taking the drug. Appropriate treatment options will need to be discussed with your physician to ensure the benefits outweigh the risks.
  • Pregnancy Registry: If you become pregnant while taking EPIVAL, talk to your doctor about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of antiepileptic medicines during pregnancy. Information on the registry can also be found at the following website: http://www.aedpregnancyregistry.org/.

Interactions With This Medication

Serious Drug Interactions

  • Rare cases of coma have been reported in patients receiving EPIVAL alone or when taken with phenobarbital.
  • Serious skin reactions (such as conditions called Stevens-Johnson syndrome and Toxic Epidermal Necrolysis) have been reported when EPIVAL and lamotrigine were taken together.

Drugs That May Interact With EPIVAL Include

  • anticonvulsants such as carbamazepine, lamotrigine, primidone, topiramate, felbamate, phenytoin, ethosuximide, phenobarbital;
  • anticoagulants such as acetylsalicylic acid, warfarin, dicumarol;
  • benzodiazepines such as diazepam, lorazepam, clonazepam;
  • some medicines used to treat infections such as rifampin;
  • some medicines used to treat diabetes such as tolbutamide;
  • some HIV-antiviral medication such as zidovudine;
  • any of the group of antibiotics in the carbapenem class such as doripenem, ertapenem, imipenem, meropenem;
  • some medicines used to treat heartburn and peptic ulcers such as cimetidine;
  • medicines used to treat depression such as Selective Serotonin Re-Uptake Inhibitors (SSRIs), Monoamine Oxidase Inhibitors (MAOIs), Tricyclic antidepressants such as amitriptyline, nortriptyline;
  • antipsychotics.

Proper Use of This Medication

Please consult your doctor before taking any other medication, including over-the-counter medicines. Some drugs can produce various side effects when they are used in combination with EPIVAL.

It is important to keep your appointments for medical checkups.

The doctor may need to take blood tests to measure the amount of EPIVAL in your blood when adjusting your medications.

Usual Dose

It is very important to take EPIVAL exactly as instructed by your doctor.

The recommended starting dose of EPIVAL will be decided by your doctor based on your weight, your seizures or manic episodes and your concomitant medications. Be sure to tell your doctor all the prescription and over the counter medications that you are currently taking. Your doctor will gradually increase the dosage until your condition is well controlled without experiencing side effects. You should carefully follow the instructions that were given to you and not change your dose without consulting with your doctor.

EPIVAL may be taken with or without food.

EPIVAL is not indicated for the treatment of the symptoms of mania in patients under 18 years of age.

Overdose

If you accidentally take an overdose of EPIVAL, you should contact your doctor or nearest hospital emergency, or your Regional Poison Control Centre, even though you may not feel sick.

Missed Dose

Do not suddenly stop taking your medicine because of the risk of increasing your epileptic seizures.

If you miss a dose, you should not try to make up for it by doubling up on your next dose. You should take your next regularly scheduled dose and try not to miss any more doses.

Side Effects and What To About Them

You should check with your doctor or pharmacist right away if you notice any bothersome or unusual effects while taking EPIVAL.

The most commonly reported adverse reactions include nausea, vomiting indigestion, sleepiness, headache, diarrhea, weakness, tremor and dizziness. Changes in hair are also reported, such as hair loss or in increase in hair on face, chest and back. If any of these affect you severely, contact your doctor or pharmacist.

You should know that this does not mean that you will experience such effects, because people can react in different ways to the same medicine.

Serious Side Effects, How Often They Happen and What to do About Them

Symptom / effect Talk with your doctor or pharmacist right away Seek emergency medical attention
Only if severe In all cases
Common Hallucinations: seeing or hearing something that is not there T
Uncommon Brain dysfunction from high ammonia levels in the(tiredness, vomiting, abnormal walking, extreme irritability*, combative/bizarre behaviour**, refusal to eat meat or high protein products**) T
Decreased number of platelets in the blood(may result in easy bruising and bleeding from the skin or other areas) T
Liver disorder (weakness, tiredness, abdominal pain, diarrhea, facial swelling, loss of appetite, yellowing of the skin or eyes, dark urine, nausea, and vomiting) T
Pancreas disorder (abdominal pain, nausea, vomiting, and/or loss of appetite) T
Thoughts of suicide or hurting yourself,symptoms of depression or unusual changes in mood or behaviour T
Rare Muscle disorder (unexplained muscle pain or tenderness, with a fever or “teacoloured” urine, or reduced urination) T
* In young children ** In older children or adults

This is not a complete list of side effects. For any unexpected effects while taking EPIVAL, contact your doctor or pharmacist.

How to Store It

EPIVAL tablets should be stored between 15 and 25°C. Tablets should be protected from light.

EPIVAL should be kept out of reach of children.

Reporting Suspected Side Effects

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

  • Report on line at: www.healthcanada.gc.ca/medeffect
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789
    • Mail to: Canada Vigilance Program Health Canada Postal Locator 0701D Ottawa, ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect Canada Web site at www.healthcanada.gc.ca/medeffect

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

More Information

The most recent version of this document plus the full Product Monograph, prepared for health professionals can be found at

www.abbott.ca

or by contacting the sponsor, BGP Pharma ULC, Saint-Laurent,

Qc H4S 1Z1 at:

1-800-699-9948