Patient Medication Information: uses, side effects, how to take - ZDS-Brivaracetam
What is ZDS-Brivaracetam used for?
ZDS-Brivaracetam is used in adults, adolescents and children ≥4 years of age with epilepsy to treat partial-onset seizures when taken together with other anti-seizure medicines.
How does ZDS-Brivaracetam work?
ZDS-Brivaracetam works in the brain to block the spread of seizure activity. The precise way that ZDS-Brivaracetam works to treat partial-onset seizures is unknown.
What are the ingredients in ZDS-Brivaracetam?
Medicinal ingredients: brivaracetam
Non-medicinal ingredients:
Croscarmellose sodium, FD&C blue #1, FD&C yellow #5, ferric oxide yellow, GMDCC (glyceryl mono and dicaprylocaprate), GMCC Type 1 (glyceryl monocaprylocaprate), Glycerol of FA (glycerol esters of fatty acids), lactose anhydrous, lactose monohydrate, magnesium stearate, polyvinyl alcohol, sodium lauryl sulfate, talc, titanium dioxide.
ZDS-Brivaracetam comes in the following dosage forms:
- Tablets: 25 mg, 50 mg, 75 mg and 100 mg
Do not use ZDS-Brivaracetam if:
- you are allergic to brivaracetam or any of the other ingredients of this medicine (listed in section What are the ingredients in ZDS-Brivaracetam?)
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take ZDS-Brivaracetam. Talk about any health conditions or problems you may have, including if you:
- have ever had a rash or unusual reaction while taking ZDS-Brivaracetam or any other anti-epileptic drug
- have or have had depression, mood problems or suicidal thoughts or behaviour
- have liver problems. Your healthcare professional may need to adjust the dose.
- have kidney problems
- are allergic to lactose. ZDS-Brivaracetam tablets contain lactose.
are pregnant or planning to become pregnant. You must only take ZDS-Brivaracetam during pregnancy if your healthcare professional tells you to.
- If you become pregnant while you are taking ZDS-Brivaracetam, ask your healthcare professional about joining the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of anti-epileptic medicine during pregnancy. You can enroll in this registry by calling (888) 233-2334 (toll free). Information on the registry can also be found at: http://www.aedpregnancyregistry.org/;
- are breastfeeding or planning to breastfeed. brivaracetam passes into breast milk. You and your healthcare professional should decide whether you should take ZDS-Brivaracetam or breastfeed, but not both.
Other warnings you should know about:
- New or Worsened Emotional Problems: A small number of people being treated with anti- epileptic medicines such as ZDS-Brivaracetam have had thoughts of harming or killing themselves. If you have any of these thoughts at any time, talk to your healthcare professional immediately.
- Serious Skin Reactions: Serious allergic skin reactions can be caused by anti-epileptic medicines. Get immediate medical help if you develop a rash together with a fever at any point during treatment. This includes skin peeling, itching, redness, and blisters of the lips, eyes, mouth, nasal passages or genitals along with other symptoms such as sore throat, swollen glands, joint pain or any problems related to the liver, kidneys, heart, lungs or other organs.
Driving and Using Machines: ZDS-Brivaracetam may make you feel dizzy, drowsy and affect your coordination. Do not drive, operate machinery, or engage in other hazardous activities until you know how ZDS-Brivaracetam affects you.
- Serious Allergic Reaction: Taking ZDS-Brivaracetam may affect your skin or other parts of your body such as your liver, kidneys, heart, or blood cells. These allergic reactions can be life-threatening and can cause death. Get immediate medical help if you have: fever, severe rash, hives, swollen lymph glands, swelling of your face, flu-like feeling, yellow skin or eyes, shortness of breath, swelling of the legs, dry cough, chest pain or discomfort, urinating less often, less urine or dark urine.
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 ZDS-Brivaracetam:
- Rifampin, an antibiotic used to treat infections
- Other anti-epileptic medicines including carbamazepine, phenytoin and phenobarbital
- Alcohol. You should not drink alcohol while you are taking ZDS-Brivaracetam. ZDS-Brivaracetam can make the effects of alcohol worse.
How to take ZDS-Brivaracetam:
- Always take ZDS-Brivaracetam exactly as your healthcare professional has told you. Check with your healthcare professional if you are not sure.
- Do not stop taking ZDS-Brivaracetam without talking to your healthcare professional. Stopping ZDS-Brivaracetam suddenly can cause serious problems, including seizures that will not stop. Your healthcare professional will decide how long you should take ZDS-Brivaracetam.
Swallow ZDS-Brivaracetam tablets whole with a glass of water. Do not crush or chew the tablets. ZDS-Brivaracetam tablets can be taken with or without food.
Usual dose:
Note: ZDS-Brivaracetam is only available as 25 mg, 50 mg, 75 mg, and 100 mg tablet strengths.
Usual dose for adults, and adolescents and children (aged 4 years and older) weighing 50 kg or more:
- The recommended starting dose for adults is 50 mg twice a day (100 mg/day).
- The recommended starting dose for adolescents and children weighing 50 kg or more is 25 mg twice a day (50 mg/day).
- The dose may be adjusted to between 25 mg twice a day (50 mg/day) and 100 mg twice a day (200 mg/day), to be taken once in the morning and once in the evening at about the same time each day.
- The maximum dose is 100 mg twice a day (200 mg/day).
Usual dose for children and adolescents (aged 4 years and older) weighing less than 50 kg:
- Your healthcare professional will decide on the right dose for your child, depending on their weight.
Overdose: You may experience dizziness and sleepiness.
If you think you, or a person you are caring for, have taken too much ZDS-Brivaracetam, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada's toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
Missed Dose:
If you miss a dose, take it as soon as you remember. Take your next dose at the time you would normally take it. If you are not sure what to do, ask your healthcare professional.
What are possible side effects from using ZDS-Brivaracetam?
These are not all the possible side effects you may have when taking ZDS-Brivaracetam. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- Sleepiness/drowsiness
- Feeling tired/fatigue
- Headache
- Dizziness
- Poor coordination
- Nausea, vomiting
- Irritability
Serious side effects and what to do about them
| Serious side effects and what to do about them | |||||
|---|---|---|---|---|---|
| Symptom / effect | Talk to your healthcare professional | Get immediate medical help | |||
| Symptom / effect | Talk to your healthcare professional | Get immediate medical help | |||
| Only if severe | In all cases | ||||
| Only if severe | In all cases | ||||
UNCOMMON New or Worsened Emotional Problems: thoughts of suicide or hurting yourself; psychotic symptoms such as hallucinations (seeing or hearing things that are really not there), delusions (false or strange thoughts or beliefs), and unusual behaviour | ✓ | ✓ | |||
RARE Allergic Reaction: swelling in the mouth, tongue, face and throat, itching, rash | ✓ | ||||
RARE Bronchospasm and Angioedema: severe allergic reactions involving swelling of the face, eyes, or tongue, difficulty swallowing, wheezing, hives and generalized itching, rash, fever, abdominal cramps, chest discomfort or tightness, difficulty breathing, unconsciousness | ✓ | ||||
UNKNOWN Serious Allergic Skin Reactions: any combination of itchy skin rash, redness, blistering and peeling of the skin and/or inside of the lips, eyes, mouth, nasal passages or genitals, accompanied by fever, chills, headache, cough, body aches or swollen glands, joint pain, yellowing of the skin or eyes, dark urine, chest pain | ✓ | ||||
UNKNOWN Allergic Reactions known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) (serious skin reaction that may affect more than one organ): fever, severe rash, hives, swollen lymph glands, swelling of your face, flu-like feeling, yellow skin or eyes, shortness of breath, swelling of the legs, dry cough, chest pain or discomfort, urinating less often, less urine or dark urine. | ✓ | ||||
If you 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:
- Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
Store ZDS-Brivaracetam at room temperature, 15 to 30°C.
Keep out of reach and sight of children.
If you want more information about ZDS-Brivaracetam:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); or by calling 1-877-716-5599.
Manufacturer :
Zydus Lifesciences Ltd.
Moraiya, Ahmedabad-382210, India.
Importer / Distributor :
Zydus Pharmaceuticals (Canada) Inc.
ON L4W 5K4.