Sandoz Valproic: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Sandoz Valproic has been prescribed to you to control your epilepsy. Please follow your doctor’s recommendations carefully.

What it does:

Sandoz Valproic 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:

Sandoz Valproic 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 valproic acid or any of the other

  ingredients in Sandoz Valproic

• patients with known urea cycle disorders (a genetic disorder)
• patients with known porphyria (a genetic disorder)

What the medicinal ingredient is:

Valproic acid

What the non-medicinal ingredients are:

Sandoz Valproic 250 mg capsules contain the following nonmedicinal ingredients: corn oil, gelatin, glycerin, methylparaben, propylparaben, titanium dioxide, FD&C yellow #6.

What dosage forms it comes in:

Sandoz Valproic is available as a capsule containing 250 mg of valproic acid.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

• Hepatotoxicity: liver failure resulting in death has occurred

  in patients receiving valproic acid. These incidents usually

  occurred during the first 6 months of treatment with valproic acid. 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.

  • Birth Defects: Sandoz Valproic can cause birth defects and problems with early development of the child if it is taken during pregnancy. Sandoz Valproic should not be used in female children, in female adolescents, in women of childbearing potential and pregnant women unless other treatments do not work or are not tolerated. If you are a female of childbearing age you should use an effective method of birth control while you are taking Sandoz Valproic. Tell your doctor right away if you become pregnant or think you might be pregnant.
  • Pancreatitis: cases of life threatening pancreas disorder have been reported in both children and adults receiving valproic acid. 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 Sandoz Valproic 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 Sandoz

  Valproic (including fever or rash).

• are a female child or female adolescent, a woman of childbearing potential, or pregnant.
• are breast-feeding (nursing); Sandoz Valproic passes into breast milk. You must discuss with your doctor whether you should breastfeed or take Sandoz Valproic. You cannot do both.

• are male and thinking about fathering a child. Sandoz

  Valproic 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 Sandoz Valproic:

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

• Since Sandoz Valproic 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 Sandoz Valproic. 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 Sandoz Valproic 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 Sandoz Valproic should talk to their healthcare providers about using other possible treatments instead of Sandoz Valproic. If you are a female capable of becoming pregnant you should only take Sandoz Valproic if nothing else works for you. If the decision is made to use Sandoz Valproic, 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 Sandoz Valproic.

• No longer getting your period, fluid filled sacs (cysts) on

  the ovaries and increased testosterone levels have been reported in women taking Sandoz Valproic.

• Before prescribing this medicine to you, your doctor will

  have explained what might happen to your baby if you become pregnant while taking Sandoz Valproic. 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 Sandoz Valproic use.

Pregnant Women

• Sandoz Valproic carries a risk if taken during pregnancy.

  The higher the dose, the higher the risks, though all doses carry a risk.

• If you take Sandoz Valproic 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 Sandoz Valproic 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 Sandoz Valproic during pregnancy are also more likely to have Autism spectrum disorders and more 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 Sandoz Valproic, 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

    Sandoz Valproic, 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 valproic acid alone or when taken with phenobarbital.

• Serious skin reactions (such as conditions called Stevens-

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

Drugs that may interact with Sandoz Valproic 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;

• Estrogen-containing products (including contraceptives that

  contain estrogen).

PROPER USE OF THIS MEDICATION

Sandoz Valproic treatment must only be started and supervised by a doctor specialised in the treatment of epilepsy. 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 Sandoz Valproic.

It is important to keep your appointments for medical checkups.

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

Do not stop taking Sandoz Valproic 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 Sandoz Valproic exactly as instructed by your doctor.

The recommended starting dose of Sandoz Valproic will be decided by your doctor based on your weight, your seizures 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.

Sandoz Valproic may be taken with or without food.

Overdose:

If you think you have taken too much Sandoz Valproic, 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 Sandoz Valproic.

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.

Uncommon

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

HOW TO STORE IT

Sandoz Valproic capsules 250 mg should be stored between 15 and 30°C, away from heat and humidity. Keep bottle tightly closed when not in use.

Keep out of reach and sight of children.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction

  Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or

• Calling toll-free at 1-866-234-2345.

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, plus the full product monograph prepared for health professionals, can be obtained by contacting the sponsor, Sandoz Canada Inc., at: 1-800-361-3062

or

by written request at:

110 Rue de Lauzon

Boucherville, (QC), Canada

J4B 1E6

or by e-mail at :

medinfo@sandoz.com