LACOSAMIDE - lacosamide solution
Novitium Pharma LLC
|Lacosamide (la-KOE-sa-mide) Oral Solution, USP CV|
|Read this Medication Guide before you start taking lacosamide oral solution and each time you get a refill. There may be new information. This Medication Guide describes important safety information about lacosamide oral solution. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.|
| What is the most important information I should know about lacosamide? Do not stop taking lacosamide without first talking to your healthcare provider. Stopping Lacosamide suddenly can cause serious problems. Stopping seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus).
Lacosamide can cause serious side effects, including:
How can I watch for early symptoms of suicidal thoughts and actions?
2. Lacosamide may cause you to feel dizzy, have double vision, feel sleepy, or have problems with coordination and walking. Do not drive, operate heavy machinery, or do other dangerous activities until you know how lacosamide affects you.
3. Lacosamide may cause you to have an irregular heartbeat or may cause you to faint. In rare cases, cardiac arrest has been reported. Call your healthcare provider right away if you:
If you have fainted or feel like you are going to faint you should lay down with your legs raised.
4.Lacosamide is a federally controlled substance (CV) because it can be abused or lead to drug dependence. Keep your lacosamide in a safe place, to protect it from theft. Never give your lacosamide to anyone else, because it may harm them. Selling or giving away this medicine is against the law.
|What is lacosamide?
Lacosamide is a prescription medicine used:
It is not known if lacosamide is safe and effective for partial-onset seizures in children under 1 month of age.
| What should I tell my healthcare provider before taking Lacosamide?
Before you take Lacosamide, tell your healthcare provider about all of your medical conditions, including if you:
Taking lacosamide with certain other medicines may cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider. Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist each time you get a new medicine.
|How should I take lacosamide?
|What should I avoid while taking lacosamide?
Do not drive, operate heavy machinery, or do other dangerous activities until you know how lacosamide affects you. Lacosamide may cause you to feel dizzy, have double vision, feel sleepy, or have problems with coordination and walking.
|What are the possible side effects of lacosamide?
A serious allergic reaction that may affect your skin or other parts of your body such as your liver or blood cells. Call your healthcare provider right away if you have:
The most common side effects of lacosamide include:
These are not all of the possible side effects of lacosamide. For more information ask your healthcare provider or pharmacist. Tell your healthcare provider about any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
|How should I store lacosamide oral solution?
|General Information about the safe and effective use of lacosamide.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use lacosamide for a condition for which it was not prescribed. Do not give lacosamide to other people, even if they have the same symptoms that you have. It may harm them.
This Medication Guide summarizes the most important information about lacosamide. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about lacosamide that is written for health professionals.
|What are the ingredients in lacosamide oral solution?
Active ingredient: Lacosamide, USP
Oral solution inactive ingredients: purified water, methyl paraben, polyethylene glycol, non-crystallizing sorbitol solution, glycerin, sodium carboxymethyl cellulose, acesulfame potassium, anhydrous citric acid, sodium chloride, artificial cherry flavour (including flavors and alcohol).
Additional pediatric use information is approved for UCB, Inc.’s VIMPAT® (lacosamide) oral solution. However, due to UCB, Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
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For more information, go to www.novitiumpharma.com or call 1-855-204-1431.
Novitium Pharma LLC
70 Lake Drive, East Windsor,
New Jersey 08520