Mylan-Valproic: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

S MEDICATION

What the medication is used for:

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

What it does:

Mylan-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:

Mylan-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 the drug
• 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:

Mylan-Valproic 250 mg capsules contain the following non- medicinal ingredients: Corn Oil, D&C Yellow' No. 10, FD&C Red No. 40, Gelatin, Glycerine, Purified Water and Titanium Dioxide.

What dosage forms it comes in:

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

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

BEFORE you use Mylan-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);
• you have ever had an unusual or allergic reaction to valproic acid (including fever or rash);
• you are allergic to any component of Mylan-Valproic capsules;
• you are pregnant or are planning to become pregnant;
• you are breast-feeding (nursing); valproic acid 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 Mylan-Valproic:

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

• Since Mylan-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 Mylan-Valproic. 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 Mylan-Valproic should talk to their healthcare providers about using other possible treatments instead of Mylan-Valproic. If the decision is made to use Mylan-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 Mylan-Valproic.

Pregnant Women

• If you take Mylan-Valproic 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 Mylan-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 Mylan-Valproic, talk to your doctor about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enrol 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

INTERACTIONS WITH THIS MEDICATION

Drugs that may interact with Mylan-Valproic 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.

P

PROPER USE OF THIS MEDICATION

ROPER 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 Mylan-Valproic.

It is important to keep your appointments for medical checkups.

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

Usual dose:

It is very important to take Mylan-Valproic exactly as instructed by your doctor.

The recommended starting dose of Mylan-Valproic 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.

Mylan-Valproic may be taken with or without food.

Overdose:

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

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 Mylan-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.

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

HOW TO STORE IT

Mylan-Valproic should be stored between 15°C and 30°C.

Mylan-Valproic 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 requested by contacting the sponsor, Mylan Pharmaceuticals ULC at:

1-800-575-1379

Last revised: May 7, 2015

Mylan Pharmaceuticals ULC

85 Advance Road

Etobicoke, Ontario

M8Z 2S6

MORE INFORMATION