Patient Medication Information: uses, side effects, how to take - ZDS-Lacosamide
What is ZDS-Lacosamide used for?
ZDS-Lacosamide is used in adults to treat partial-onset seizures and can be taken alone or with other seizure medicines.
How does ZDS-Lacosamide work?
ZDS-Lacosamide works in the brain to block the spread of seizure activity. The precise way that ZDS-Lacosamide works to treat partial-onset seizures is unknown.
What are the ingredients in ZDS-Lacosamide?
Medicinal ingredient: lacosamide
Non-medicinal ingredients:
Film-coated tablets: colloidal silicon dioxide, crospovidone, hydroxypropylcellulose, Lecithin, low substituted hydroxypropylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide and additional agents listed below:
50 mg tablets: iron oxide red, iron oxide black, FD&C Blue #2/indigo carmine aluminum lake
100 mg tablets: iron oxide yellow
150 mg tablets: iron oxide yellow, iron oxide red, iron oxide black
200 mg tablets: FD&C Blue #2/indigo carmine aluminum lake
ZDS-Lacosamide comes in the following dosage forms:
Film-coated tablets: 50 mg, 100 mg, 150 mg and 200 mg
Do not use ZDS-Lacosamide if you:
- are allergic to lacosamide or any of the other ingredients in ZDS-Lacosamide listed in the “nonmedicinal ingredients” section
- suffer or have suffered in the past from a certain type of heart rhythm disorder (second or third degree AV block)
To help avoid side effects and ensure proper use, talk to your healthcare professional before
you take ZDS-Lacosamide. Talk about any health conditions or problems you may have, including if you:
- have any health problems, including ones you have had in the past
- have kidney or liver disease
- suffer from a severe heart disease such as heart rhythm disorder, heart failure or heart attack
are pregnant or plan to become pregnant. It is not known if ZDS-Lacosamide may harm your unborn baby. You and your health care professional will have to decide if ZDS-Lacosamide is right for you while you are pregnant. If you use ZDS-Lacosamide while you are pregnant, ask your healthcare provider about joining the North American Antiepileptic Drug Pregnancy Registry by calling (888) 233-2334 (toll free). Women who are pregnant and planning to take ZDS-Lacosamide should call the pregnancy registry to enable collection of valuable data about ZDS-Lacosamide use in pregnancy. Information on the registry can also be found at the following website: http://www.aedpregnancyregistry.org/
- are breastfeeding. It is not known if ZDS-Lacosamide passes into breast milk and if it can harm your baby. You and your health care professional should decide whether you should take ZDS-Lacosamide or breastfeed, but not both
Other warnings you should know about:
Severe Skin Reactions: In rare cases, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), Stevens - Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), has been reported with ZDS-Lacosamide. These serious and life-threatening reactions have been reported in very rare cases with this type of medicine.
Driving and Using Machines: ZDS-Lacosamide may cause dizziness and poor coordination which could increase the risk of accidental injury or a fall. Therefore, you should be careful until you are used to the effects this medicine might have.
Do not
- drive,
- operate complex machinery, or
- engage in other hazardous activities
until you know how ZDS-Lacosamide affects you.
Ask your health care professional when it is okay to do these activities.
Visual trouble: ZDS-Lacosamide may cause double vision and blurred vision. If you experience visual disturbances while taking ZDS-Lacosamide, notify your health care professional.
Suicidal Thoughts and Behaviour Changes: A small number of people being treated with anti- epileptics such as ZDS-Lacosamide have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your health care professional.
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-Lacosamide:
- any medicines that make you sleepy or dizzy.
- any medications to treat a heart condition, such as certain types of irregular heartbeat or heart failure (beta-blockers, class I anti-arrhythmic drugs, etc.).
- any medications that may cause certain changes in heart electrical activity (carbamazepine, pregabalin, lamotrigine, eslicarbazepine, etc.).
How to take ZDS-Lacosamide:
ZDS-Lacosamide Film-coated tablets
ZDS-Lacosamide may be taken with or without food.
- Swallow the tablets whole with plenty of water. Do not chew or crush tablets.
Usual dose:
ZDS-Lacosamide must be taken twice a day, once in the morning and once in the evening, at about the same time each day.
When you take ZDS-Lacosamide on its own
The treatment with ZDS-Lacosamide usually starts with 100 mg in the morning and 100 mg in the evening (200 mg a day). After one week your dose may be increased. The daily maintenance dose is between 200 mg and 600 mg.
When you take ZDS-Lacosamide with other seizure medicines
The treatment with ZDS-Lacosamide usually starts with 50 mg in the morning and 50 mg in the evening (100 mg a day). After one week your dose may be increased. The daily maintenance dose is between 200 mg and 400 mg.
Your health care professional may use a different dose if you have problems with your kidneys or liver.
If your health care professional decides to stop your treatment with ZDS-Lacosamide, he/she will decrease the dose step by step. This is to prevent your symptoms from coming back again or becoming worse.
Do not stop taking ZDS-Lacosamide or any other seizure medicine unless your healthcare professional told you to. Stopping a seizure medicine is very serious and can cause seizures that will not stop (status epilepticus).
Tell your healthcare provider if your seizures get worse or if you have any new types of seizures.
Remember: This medicine has been prescribed for you. Do not give it to anybody else.
Overdose:
| If you think you, or a person you are caring for, have taken too much ZDS-Lacosamide, 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. |
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Missed Dose:
If you miss a dose by a few hours, take it as soon as you remember. If it is close to your next dose, take ZDS-Lacosamide at your next regular time. Do not take two doses at the same time to make up for the missed dose.
What are possible side effects from using ZDS-Lacosamide?
These are not all the possible side effects you may have when taking ZDS-Lacosamide. If you experience any side effects not listed here, tell your healthcare professional.
The most common side effects associated with the use of ZDS-Lacosamide are:
- dizziness
- poor coordination
- headache
- nausea, vomiting
- fatigue
- blurred vision, double vision
If you are elderly (older than 65), you may have a higher chance of the following side effects:
- falling
- diarrhea
- tremors/shaking
Tell your health care professional about any side effect that bothers you or that does not go away.
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 | ||
| UNCOMMON | |||
| Allergic reaction: swelling in the mouth, tongue, face and throat, itching, rash | √ | ||
| 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 | ||
Heart rhythm problems: irregular pulse, slow pulse, rapid pulse, palpitations, shortness of breath, feeling lightheaded, fainting | √ | ||
| Thoughts of suicide or hurting yourself | √ | ||
| RARE | |||
| Liver disorder or liver injury: itching, right upper belly pain, dark urine, yellow skin or eyes, unexplained flu-like symptoms | √ | ||
| Serious skin reaction: 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, urinating less often, less 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:
NOTE: Contact your health professional if you need information about how to manage your |
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| side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
•
- Store ZDS-Lacosamide at room temperature, 15°C to 30°C.
•
- Keep ZDS-Lacosamide and all medicines out of the reach and sight of children.
If you want more information about ZDS-Lacosamide:
•
- 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://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; or by calling 1-877-716-5599.
Zydus Pharmaceuticals (Canada) Inc.
ON L4W 5K4.