MYL-Divalproex: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

ICION

What the medication is used for:

Myl-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.

Myl-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:

Myl-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 gammaaminobutyric acid (GABA).

When it should not be used:

Myl-Divalproex 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:

Myl-Divalproex tablets contain: pregelatinized starch, povidone, colloidal silicon dioxide, talc, hydrogenated castor oil, lactose monohydrate, hydroxypropyl methylcellulose, titanium dioxide, glycerol triacetate, methacrylic acid, ethyl acrylate, sodium lauryl sulphate, polyethylene sorbitan

monooleate, methyl methacrylate, triethyl citrate, and vanilla flavour.

In addition, individual tablets contain:

125 mg tablets: FD&C Red No. 40

250 mg tablets: FD&C Yellow No. 6

500 mg tablets: FD&C Red No. 30 and FD&C Blue No. 2 Opacode Black: Shellac, Ethanol, Isopropyl Alcohol, Iron Oxide, N-Butyl Alcohol, Propylene Glycol, Ammonium Hydroxide 28%

What dosage forms it comes in:

Myl-Divalproex is available as Delayed-Release 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 Divalproex Sodium. These incidents usually occurred during the first 6 months of treatment with 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: Divalproex Sodium can produce birth defects to an unborn baby. Accordingly, the use of Divalproex Sodium 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 Divalproex Sodium. 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 Myl-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 have ever had an unusual or allergic reaction to Myl-

  Divalproex (including fever or rash);

• you are allergic to any component of Myl-Divalproex tablets;
• you are pregnant or are planning to become pregnant; • you are breast-feeding (nursing); Divalproex Sodium 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 disability 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 Myl-Divalproex:

• Your doctor will monitor your response to Myl-

  Divalproex on a regular basis. However, if your seizures get worse, you should tell your doctor immediately. • Since Myl-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 Myl-Divalproex. 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

  Myl-Divalproex should talk to their healthcare providers about using other possible treatments instead of Myl-Divalproex. If the decision is made to use Myl-Divalproex 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 Myl-Divalproex.

Pregnant Women

• If you take Myl-Divalproex 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 Myl-Divalproex 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

  Myl-Divalproex 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 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 Myl-Divalproex and lamotrigine were taken together.

Drugs that may interact with Myl-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 Myl-Divalproex.

It is important to keep your appointments for medical checkups.

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

Usual dose:

It is very important to take Myl-Divalproex exactly as instructed by your doctor.

The recommended starting dose of Myl-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.

Myl-Divalproex may be taken with or without food. Tablets should not be crushed, chewed or divided but must be swallowed whole.

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

Overdose:

If you think you have taken too much Myl-Divalproex, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

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 DO ABOUT THEM

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

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.

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

HOW TO STORE IT

Myl-Divalproex tablets should be stored between 15°C and 30^°C. Tablets should be protected from light and moisture.

Myl-Divalproex should be kept out of reach and sight of children.

REPORTING SIDE EFFECTS

You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.

3 ways to report:

• Online at MedEffect (http://hc-sc.gc.ca/dhp-mps/medeff/index-eng.php);

• By calling 1-866-234-2345 (toll-free); • By completing a Consumer Side Effect Reporting

  Form and sending it by:

  • Fax to 1-866-678-6789 (toll-free), or

  • Mail to: Canada Vigilance Program

    Health Canada

    Postal Locator 0701E

    Ottawa, Ontario

    K1A 0K9

Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect (http://hc-sc.gc.ca/dhp-mps/medeff/index-eng.php).

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

This document can be found at: www.mylan.ca.

The full Product Monograph prepared for health professionals can be obtained by contacting the sponsor, Mylan Pharmaceuticals ULC at: 1-800-575-1379

Etobicoke, Ontario M8Z 2S6

Date of revision: September 08, 2016

Mylan Pharmaceuticals ULC

Etobicoke, ON M8Z 2S6

1-800-575-1379

www.mylan.ca