Teva-Divalproex: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

TEVA-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.

TEVA-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:

TEVA-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:

TEVA-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 divalproex sodium or any of the other ingredients in

  • TEVA-DIVALPROEX.
  • 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:

TEVA-DIVALPROEX 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.

TEVA-DIVALPROEX 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.

TEVA-DIVALPROEX 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:

TEVA-DIVALPROEX 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 TEVA-DIVALPROEX. These incidents usually occurred during the first 6 months of treatment with TEVA-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

BEFORE you use TEVA-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);
• have ever had an unusual or allergic reaction to TEVA-DIVALPROEX (including fever or rash);
• are pregnant or are planning to become pregnant;
• are breast-feeding (nursing); TEVA-DIVALPROEX passes into breast milk. You must discuss with your doctor whether you should breastfeed or take TEVA-DIVALPROEX. You cannot do both;
• are male and thinking about fathering a child. TEVA-DIVALPROEX can make you less fertile;
• are taking any other prescription or over the counter medicine;
• have kidney disease;
• have other medical conditions including a history of unexplained coma, intellectual disability or any type of brain dysfunction;

• have a psychiatric disorder or have thoughts of suicide;

  • consume alcohol on a regular basis.

Precautions while taking TEVA-DIVALPROEX:

• Your doctor will monitor your response to TEVA-DIVALPROEX on a regular basis. However, if your seizures get worse, you should tell your doctor immediately.

• Since TEVA-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 TEVA-DIVALPROEX. You should remember that this medicine was prescribed only for you; it should never be given to anyone else.
• As with other drugs used to treat epilepsy, some patients may experience an increase in the number of seizures and the severity (including status epilepticus), or the onset of new types of seizures with TEVA-DIVALPROEX instead of an improvement. If you start having more seizures, new types of seizures or your seizures get worse contact your doctor immediately.

Female children, female adolescents and women of childbearing potential

• All female children, female adolescents and women of childbearing age who are being treated with TEVA-DIVALPROEX should talk to their healthcare providers about using other possible treatments instead of TEVA-DIVALPROEX. If you are a female capable of becoming pregnant you should only take TEVA-DIVALPROEX if nothing else works for you.
• If the decision is made to use TEVA-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 TEVA-DIVALPROEX.
• No longer getting your period, fluid filled sacs (cysts) on the ovaries and increased testosterone levels have been reported in women taking TEVA-DIVALPROEX.
• Before prescribing this medicine to you, your doctor will have explained what might happen to your baby if you become pregnant while taking TEVA-DIVALPROEX. If you decide later you want to have a child, you should not stop taking your medicine until you have discussed this with your doctor and agreed on a plan for switching to another medication if this is possible.
• Ask your doctor about taking folic acid when trying to get pregnant. Folic acid can lower the general risk of birth defects in the spine (spina bifida) and early miscarriage that exists with all pregnancies. However, it is unlikely that folic acid will reduce the risk of birth defects associated with TEVA-DIVALPROEX use.

Pregnant women

• TEVA-DIVALPROEX carries a risk if taken during pregnancy. The higher the dose, the higher the risks, though all doses carry a risk.
• If you take TEVA-DIVALPROEX during pregnancy, your child has a serious risk of birth defects and problems with development which can be seriously debilitating such as lower IQ and problems with brain development. Birth defects which have been reported include spina bifida (where the bones of the spine are not properly developed); problems with the development of the bones of the face and skull; and problems with the development of the heart, kidney, urinary tract and sexual organs, arms and legs. These can begin early in the pregnancy, even before you know that you are pregnant.
• It is estimated that up to 30-40% of preschool children whose mothers took TEVA-DIVALPROEX during pregnancy may have problems with early childhood development. This means these children can be slow to walk and talk, have lower intelligence (lower IQ scores) than other children and have difficulty with language and memory.
• Children born to mothers who took TEVA-DIVALPROEX during pregnancy are also more likely to have Autism spectrum disorders and more often likely to develop symptoms of Attention Deficit Hyperactivity Disorder (ADHD).

• 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 TEVA-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 TEVA-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

Drugs that may interact with TEVA-DIVALPROEX include:

• anticonvulsants such as carbamazepine, lamotrigine, primidone, topiramate, felbamate, phenytoin, ethosuximide, phenobarbital, olanzapine, rufinamide;
• 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, ritonavir, lopinavir, lamivudine;
• 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;
• acetazolamide, a medicine used to treat glaucoma and epilepsy;
• cholestyramine, a medicine used to lower cholesterol;
• propofol, a drug used to relax you before and after surgery;
• nimodipine;
• antipsychotics

PROPER USE OF THIS MEDICATION

TEVA-DIVALPROEX treatment must only be started and supervised by a doctor specialised in the treatment of epilepsy or mania (bipolar disorders). 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 TEVA-DIVALPROEX.

It is important to keep your appointments for medical checkups.

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

Do not stop taking TEVA-DIVALPROEX suddenly as this can cause a serious increase in the number of seizures and their severity, including status epilepticus.

Usual dose:

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

The recommended starting dose of TEVA-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.

TEVA-DIVALPROEX may be taken with or without food.

TEVA-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 TEVA-DIVALPROEX, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose:

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 TEVA-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 an 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 TEVA-DIVALPROEX, contact your doctor or pharmacist.

HOW TO STORE IT

TEVA-DIVALPROEX tablets should be stored between 15 and 25°C. Tablets should be protected from light.

TEVA-DIVALPROEX should be kept out of reach of children.

REPORTING SIDE EFFECTS

MORE INFORMATION

This document plus the full Product Monograph prepared for health professionals can be found by contacting Teva Canada Limited by:

Phone: 1-800-268-4127 ext. 3;

Email: druginfo@tevacanada.com; or

Fax: 1-416-335-4472

Teva Canada Limited

30 Novopharm Court

Toronto, Ontario

Canada

M1B 2K9

www.tevacanada.com

Last revised: May 1, 2017