PHL-Divalproex: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

phl-DIVALPROEX 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.

phl-DIVALPROEX 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:

phl-DIVALPROEX 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 gamma- aminobutyric acid (GABA).

When it should not be used:

phl-DIVALPROEX should not be taken by:

$ patients with liver disease or significant liver dysfunction $ patients who are allergic to the drug

$ patients with known urea cycle disorders (a genetic disorder)

What the medicinal ingredient is:

Divalproex sodium

What the nonmedicinal ingredients are:

carnauba wax, colloidal silicon dioxide, hydroxypropyl methylcellulose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl acetate phthalate, povidone, pregelatinized starch, purified stearic acid, sodium alginate, sodium bicarbonate, talc, titanium dioxide, triethyl citrate, and the following:

125 mg: D&C Red No.27, FD & C Blue No.2, FD & C Yellow

No.6, and FD&C Yellow No.10

250 mg: FD & C Blue No.2, FD & C Yellow No.6 500 mg: D & C Red No.30, FD & C Blue No.1, FD & C Red

No.40.

What dosage forms it comes in:

Enteric Coated Tablets: 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 phl-DIVALPROEX. These incidents usually occurred during the first 6 months of treatment with phl-DIVALPROEX. 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: phl-DIVALPROEX can produce birth defects to an unborn baby. Accordingly, the use of phl-DIVALPROEX 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 disorder have been reported in both children and adults receiving phl-DIVALPROEX Some cases have occurred shortly after first use as well as after several years of use. Abdominal pain, nausea, vomiting and/or anorexia can be symptoms of pancreatitis that require immediate medical evaluation.

BEFORE you use phl-DIVALPROEX 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 ever had an unusual or allergic reaction to phl-

DIVALPROEX (including fever or rash);

$ you are allergic to any component of phl-DIVALPROEX tablets;

$ you are pregnant or are planning to become pregnant; $ you are breast-feeding (nursing); phl-DIVALPROEX 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, mental retardation or 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 phl-DIVALPROEX:

• Your doctor will monitor your response to phl-

  DIVALPROEX on a regular basis. However, if your seizures get worse, you should tell your doctor immediately.

• Since phl-DIVALPROEX 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 phl-DIVALPROEX. You should remember that this medicine was prescribed only for you; it should never be given to anyone else.

INTERACTIONS WITH THIS MEDICATION

Serious Drug Interactions

• Rare cases of coma have been reported in patients

  receiving divalproex sodium alone or when taken with phenobarbital.

• Serious skin reactions (such as conditions called Stevens-

  Johnson syndrome and Toxic Epidermal Necrolysis) have been reported when divalproex sodium and lamotrigine were taken together.

Drugs that may interact with phl-DIVALPROEX 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 phl-DIVALPROEX.

It is important to keep your appointments for medical checkups.

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

Usual dose:

It is very important to take phl-DIVALPROEX exactly as instructed by your doctor.

The recommended starting dose of phl-DIVALPROEX 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.

phl-DIVALPROEX may be taken with or without food.

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

Overdose:

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Center immediately, even if there are no symptoms.

Missed Dose:

Do not abruptly 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 DO ABOUT THEM

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

Different side effects have been reported by patients taking phl-DIVALPROEX. The most commonly reported adverse reactions are nausea, vomiting and indigestion. 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.

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

HOW TO STORE IT

phl-DIVALPROEX tablets should be stored between 15°C and 30°C.

phl-DIVALPROEX 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 online 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, or

• Mail to: Canada Vigilance Program Health Canada

  Postal Locator 0701E

  Ottawa, Ontario

  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

This document plus the full product monograph, prepared for health professionals, can be obtained by contacting Pharmel Inc. at 1-888-550-6060.

Pharmel Inc.

Montreal Quebec

H4P 2T4

Last revised: February 22, 2013