Patient Medication Information: uses, side effects, how to take - Depakene (BGP Pharma, Capsule)
Serious Warnings and Precautions
These can begin early in the pregnancy, even before you know that you are pregnant. DEPAKENE® should not be used in female children, in women of childbearing potential or in pregnant women unless your doctor decides that you should. If you are taking DEPAKENE® and are of childbearing potential, you should use an effective method of birth control. If you become pregnant, or think you may be pregnant while taking DEPAKENE®, tell your doctor right away.
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What is DEPAKENE® used for?
- DEPAKENE® is used in adults and children to control epilepsy (a disorder of the brain that causes seizures. Please follow your doctor’s instructions carefully.
How does DEPAKENE® work?
DEPAKENE® is thought to work by increasing the amount of an amino acid in the brain called “gamma-aminobutyric acid" (GABA). By changing the amount of GABA in the brain, DEPAKENE® is able to help control epilepsy.
What are the ingredients in DEPAKENE®?
Medicinal ingredients: valproic acid
Non-medicinal ingredients: artificial cherry flavor, FD&C Red No. 40, glycerin, methylparaben*, propylparaben*, purified water, sorbitol, sucrose, vanillin, and hydrochloric acid and sodium hydroxide for pH adjustment.
* methylparaben and propylparaben may cause an immediate or delayed allergic reaction.
DEPAKENE® comes in the following dosage forms:
Oral solution; 250 mg of valproic acid for every 5 mL.
Do not use DEPAKENE® if:
- you are allergic to valproic acid or to any other ingredient in DEPAKENE®
- you are pregnant, think you are pregnant or are planning to become pregnant, unless you and your doctor have decided you should
- you are a woman of childbearing potential, unless you meet all conditions of the Pregnancy Prevention Program, your doctor will talk to you about this
- you have liver disease or severe liver problems
you have a mitochondrial disorder such as Alpers-Huttenlocher Syndrome. Children under 2 years of age who may have a mitochondrial disorder should not take DEPAKENE®
- you have or have a family history of a urea cycle disorder (a condition that affects how your body removes waste)
- you have porphyria (a condition that affects the nervous system and skin)
- you or any of your close relatives have a history of severe hepatitis, especially when caused by medicines
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To help avoid side effects and ensure proper use, talk to your healthcare professional before you take DEPAKENE®. Talk about any health conditions or problems you may have, including if you:
- have or have a history of liver disease or liver problems;
- are breastfeeding or planning to breastfeed. You must discuss with your doctor whether to breastfeed or take DEPAKENE®, you cannot do both. Do not breastfeed for one month after stopping DEPAKENE®;
- have kidney disease or kidney problems;
- have diabetes;
have any of the following rare conditions, DEPAKENE® contains sucrose:
- fructose intolerance
- glucose-galactose malabsorption
- sucrose-isomaltase insufficiency
- have Human Immunodeficiency Virus (HIV) or Cytomegalovirus (CMV);
- have a history of muscular disorders (including carnitine palmitoyl transferase type II deficiency);
- have other medical conditions including a history of unexplained coma, intellectual disability or any type of brain dysfunction;
- drink alcohol on a regular basis;
- are elderly (65 years of age or older).
Other warnings you should know about:
Pregnancy: DEPAKENE® may harm your unborn baby. Your doctor may require you to do a pregnancy test before you start treatment with DEPAKENE® to make sure that you are not pregnant. You must use effective methods of birth control. It is recommended that you use a form of birth control that does not depend on you to remember to use or take it, such as an intrauterine device (IUD) or 2 forms of birth control, such as the pill and a condom. You should use birth control:
- for at least one month before starting DEPAKENE®;
- while you are taking DEPAKENE®;
- for at least one month after stopping DEPAKENE®.
Talk to your doctor about the best form of birth control for you. Some hormonal birth controls that contain estrogen may affect how well DEPAKENE® works.
Before prescribing DEPAKENE®, your doctor should have explained to you what might happen to your baby if you become pregnant while taking DEPAKENE® (see the Serious warnings and precautions box above). If you are a parent or caring for a female child taking DEPAKENE®, tell the doctor as soon as your child has her first period. If you have any questions about what may happen if you become pregnant, talk to a healthcare professional. If you become pregnant, or think you are pregnant while taking DEPAKENE®, tell your doctor right away.
When you are prescribed DEPAKENE®:
- your doctor will give you a patient guide;
- you should receive a patient card every time you get DEPAKENE® from the pharmacy.
Make sure you understand these documents.
Pregnancy Registry: If you become pregnant while taking DEPAKENE®, 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/.
Pregnancy Prevention Program: Information on the Pregnancy Prevention Program including educational resources, as well as to report suspected embryo-fetal exposure to valproate, can be found at the following website: www.depakene.ca.
Fertility:
Use in Women: If you are female and taking DEPAKENE® you may no longer get your period. You may also develop cysts (fluid filled sacs) on the ovaries and your testosterone levels may increase.
Use in Men: DEPAKENE® may affect male fertility during treatment. DEPAKENE® can make you less fertile or infertile. This may or may not be reversible if your dose is decreased or if you stop taking DEPAKENE®.
If you have interest in starting a family, talk to your doctor. Do not stop taking DEPAKENE® unless your doctor has told you to do so.
Monitoring and Blood Tests: Your doctor should do blood tests before starting treatment with DEPAKENE® and while you are taking it. These tests will monitor:
- platelet (a type of blood cell) count and your blood’s ability to clot
- liver function
- the amount of valproate (the active ingredient in DEPAKENE®) in the body
- the amount of any other medications you are taking in your body
Your doctor will monitor your response to DEPAKENE® on a regular basis. If you start to have more seizures or your seizures get worse, tell your doctor immediately.
Suicidal Thoughts and Behaviour Changes: If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital right away. DEPAKENE® may also cause behavioural changes in you or you child such as aggression, agitation, change in attention span and learning disorders.
Driving and Using Machines: DEPAKENE® may cause you to become drowsy or light-headed. Avoid driving, using machinery, or doing dangerous activities until you know how DEPAKENE® affects you.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with DEPAKENE®:
- phenobarbital and lamotrigine, which are anticonvulsants (drugs used to treat seizures). These might cause serious life-threatening effects when mixed with DEPAKENE®;
- other anticonvulsants such as carbamazepine, primidone, topiramate, felbamate, phenytoin, ethosuximide, rufinamide;
- anticoagulants (drugs used to thin blood) 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 medicines such as zidovudine, ritonavir, lopinavir, lamivudine;
- 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 drug used to treat glaucoma and epilepsy;
- cholestyramine, a drug used to lower cholesterol;
- propofol, a drug used to relax you before and after surgery;
- nimodipine, a drug used to prevent brain damage;
- antipsychotics (drugs used to manage psychosis) such as olanzapine, chlorpromazine, quetiapine;
- estrogen-containing products (including contraceptives that contain estrogen);
- alcohol.
How to take DEPAKENE®:
- DEPAKENE® treatment must only be started and supervised by a doctor specialised in the treatment of epilepsy.
- It is important to keep your appointments for medical checkups.
- Take DEPAKENE® exactly as your doctor prescribes, do not change your dose unless your doctor tells you to.
- Do not stop taking DEPAKENE® suddenly as this can increase the number of seizures you have and their severity, including status epilepticus.
DEPAKENE® can be taken with or without food.
Usual dose:
Your doctor will decide the dose of DEPAKENE® for you. The dose is based on your weight, your seizures and the other medicines you or your child take. Your doctor will slowly increase the dosage until your or your child’s condition is well controlled, without side effects.
Overdose:
| If you think you, or a person you are caring for, have taken too much DEPAKENE®, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
Missed Dose:
If you or your child misses a dose, do not try to make up for it by doubling the next dose. Take or give the next regularly scheduled dose and try not to miss any more doses.
What are possible side effects from using DEPAKENE®?
These are not all the possible side effects you or your child may have when taking DEPAKENE®. If you or your child experience any side effects not listed here, tell your healthcare professional.
- headache
- nausea or vomiting
- indigestion
- diarrhea
- tremors (involuntary shaking)
- feeling tired
- feeling weak or dizzy
- hair loss or hair growth on the face, chest or back
- increased appetite that may lead to weight gain
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| COMMON | |||
| Allergic reaction: difficulty swallowing or breathing, wheezing; drop in blood pressure; feeling sick to your stomach and throwing up; hives or rash; swelling of the face, lips, tongue or throat. | X | ||
| Hallucinations (seeing or hearing things that are not there) | X | ||
| Urinary incontinence (involuntary loss of urine) | X | ||
| UNCOMMON | |||
| Aggravated convulsions (an increase in the number of seizures you have or having new types of seizures) | X | ||
| Depression (sad mood that won’t go away): difficulty sleeping or sleeping too much, changes in appetite or weight, feelings of worthlessness, guilt, regret, helplessness or hopelessness, withdrawal from social situations, family, gatherings and activities with friends, reduced libido (sex drive) and thoughts of death. If you have a history of depression, your depression may become | X | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Get immediate medical help |
|---|
| Only if severe | In all cases | ||
|---|---|---|---|
| worse | |||
| Hyperammonemia (high ammonia levels in the blood): tiredness, vomiting, abnormal walking, extreme irritability, combative/bizarre behaviour, not wanting to eat meat or high protein products | X | ||
| Hypothermia (low body temperature): shivering, slurred speech or mumbling, slow, shallow breathing, weak pulse, very low energy, confusion or memory loss | X | ||
| Kidney problems: nausea, vomiting, fever, swelling of extremities, fatigue, thirst, dry skin, irritability, dark urine, increased or decreased urine output, blood in the urine, rash, weight gain (from retaining fluid), loss of appetite, abnormal blood test results, mental status changes (drowsiness, confusion, coma) | X | ||
| Liver injury: yellowing of the skin or eyes, itchy skin, dark urine and pale stools, abdominal pain, nausea, vomiting, loss of appetite | X | ||
| Pancreatitis (inflammation of the pancreas): upper abdominal pain, fever, rapid heart beat, nausea, vomiting, tenderness when touching the abdomen | X | ||
| Serious skin reactions when taken with lamotrigine: fever, severe rash, swollen lymph glands, flu-like feeling, blisters and peeling skin that may start in and around the mouth, nose, eyes and genitals and spread to other areas of the body, yellow skin or eyes, shortness of breath, dry cough, chest pain or discomfort, feeling thirsty, | X | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Get immediate medical help |
|---|
| Only if severe | In all cases | ||
|---|---|---|---|
| urinating less often, less urine | |||
| Thoughts of suicide or hurting yourself | X | ||
| Thrombocytopenia (low blood platelets): bruising or bleeding for longer than usual if you hurt yourself, fatigue and weakness | X | ||
| RARE | |||
| Brain atrophy (loss of brain cells): memory loss, seizures, loss of motor skills, difficulty speaking, reading or understanding. | X | ||
| Coagulation abnormalities (problems with how your blood clots): abnormal bleeding, bruising easily, won’t stop bleeding when you are injured, sudden nosebleeds, fatigue, headache | X | ||
| Rhabdomyolysis (breakdown of damaged muscle): muscle tenderness, weakness, red-brown (tea-coloured) urine | X | ||
If you or your child have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
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. |
Storage:
Store DEPAKENE® oral solution between 15 and 30°C.
Keep out of reach and sight of children.
If you want more information about DEPAKENE®:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp); the manufacturer’s website www.mylan.ca, or by calling 1-844-596-9526.