capsules, for oral use
powder, for oral suspension
|Read this Medication Guide before you start taking DIACOMIT and each time you get a refill. There may be new information.
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 DIACOMIT?
DIACOMIT can cause serious side effects, including:
Call your healthcare provider between visits as needed, especially if you are worried about symptoms.
- Sleepiness and drowsiness. Sleepiness and drowsiness are serious and common side effects. DIACOMIT can make you sleepy or dizzy, and slow your thinking. Your healthcare provider may decrease your dose of clobazam or other seizure medicines.
- Do not drive, operate heavy machinery, or do other dangerous activities until you know how DIACOMIT affects you.
- Do not drink alcohol or take other medicines that may make you sleepy or dizzy while taking DIACOMIT until you talk to your healthcare provider.
- DIACOMIT, when taken with alcohol or medicines that cause sleepiness or dizziness, may make your sleepiness or dizziness worse.
- Loss of appetite and weight loss. Loss of appetite and weight loss are serious and common side effects. DIACOMIT can cause frequent nausea and loss of appetite that can cause weight loss.
- Your weight should be checked frequently during DIACOMIT treatment.
- Children who take DIACOMIT should have their weight and growth checked often.
- Low white blood cell counts (neutropenia) and low platelet counts (thrombocytopenia). Low white blood cell counts may occur during treatment with DIACOMIT and may cause serious infections. Low platelet counts may cause serious bleeding problems. Your healthcare provider should check your white blood cell count and platelet count before and during treatment.
- Do not stop taking DIACOMIT without first talking to your healthcare provider. Stopping a seizure medicine such as DIACOMIT should be done slowly to avoid having seizures more often, or seizures that do not stop (status epilepticus).
- Like other antiepileptic drugs, DIACOMIT may cause suicidal thoughts or actions in a very small number of people (about 1 in 500).
Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:
How can I watch for early symptoms of suicidal thoughts and actions?
- thoughts about suicide or dying
- attempts to commit suicide
- new or worse depression
- new or worse anxiety
- feeling agitated or restless
- panic attacks
- trouble sleeping (insomnia)
- new or worse irritability
- acting aggressive, being angry, or violent
- acting on dangerous impulses
- an extreme increase in activity and talking (mania)
- other unusual changes in behavior or mood
- Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
- Keep all follow-up visits with your healthcare provider as scheduled.
Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.
Call your healthcare provider right away if you have any of the above side effects while taking DIACOMIT.
|What is DIACOMIT?
DIACOMIT is a prescription medicine used along with clobazam to treat seizures in people 2 years or older with Dravet syndrome.
DIACOMIT has not been shown to be able to treat seizures associated with Dravet syndrome without the use of clobazam.
It is not known if DIACOMIT is safe and effective in children under 2 years of age. There is limited information on safety in patients 6 months and older in non-pivotal trials.
|Before you take DIACOMIT, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
- have liver or kidney problems.
- have phenylkentonuria (PKU). DIACOMIT powder for oral suspension contains aspartame. The artificial sweetener may be harmful to people with PKU.
- have or have had depression, mood problems, suicidal thoughts or behavior.
- drink alcohol.
- are pregnant or plan to become pregnant. It is not known if DIACOMIT may harm your unborn baby.
- Tell your healthcare provider right away if you become pregnant while taking DIACOMIT. You and your healthcare provider will decide if you should take DIACOMIT while you are pregnant.
Pregnancy Registry: If you become pregnant while taking DIACOMIT, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can register by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of antiepileptic medicines, including DIACOMIT, during pregnancy. Information about the registry can be found at the website, http://www.aedpregnancyregistry.org/.
- are breastfeeding, or plan to breastfeed. It is not known if DIACOMIT passes into breast milk. Talk to your healthcare provider about the best way to feed your baby while taking DIACOMIT.
Taking DIACOMIT with certain other medicines can cause side effects or affect how well DIACOMIT or the other medicines 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 when you get a new medicine.
|How should I take DIACOMIT?
- Take DIACOMIT exactly as your healthcare provider tells you to take it.
- Your healthcare provider will tell you how much DIACOMIT to take and when to take it.
- DIACOMIT capsules should be swallowed whole with a glass of water during a meal. Do not break or open capsules.
- DIACOMIT powder for oral suspension should be mixed in a glass of water (100 mL) and should be taken right away after mixing during a meal. To be sure there is no medicine left in the glass, add a small amount of water (25 mL) to the drinking cup and drink all of the mixture. See the complete Instructions for Use on the right way to use DIACOMIT powder for oral suspension.
- Your healthcare provider may change your dose if needed. Do not change your dose of DIACOMIT without talking to your healthcare provider.
- If you miss a dose of DIACOMIT, take it as soon as you remember. If it is almost time for the next scheduled dose, skip the missed dose and take your next dose at your regular time. Do not take 2 doses of DIACOMIT at the same time.
- If you take too much DIACOMIT, call your healthcare provider or go to the nearest hospital emergency room right away.
|What should I avoid while taking DIACOMIT?
- Do not drive, operate heavy machinery, or do other dangerous activities that need you to be alert until you know how DIACOMIT affects you.
- Do not drink alcohol or take other medicines that may make you sleepy or dizzy while taking DIACOMIT without first talking to your healthcare provider.
|What are the possible side effects of DIACOMIT?
DIACOMIT may cause serious side effects, including:
The most common side effects of DIACOMIT include:
See “What is the most important information I should know about DIACOMIT?”
These are not all the possible side effects of DIACOMIT. For more information, ask your healthcare provider or pharmacist.
- loss of control of body movements (ataxia)
- low muscle tone or muscle weakness (hypotonia)
- trouble saying words clearly (dysarthria)
- trouble sleeping (insomnia)
Tell your healthcare provider if you have 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 DIACOMIT?
Keep DIACOMIT and all medicines out of the reach of children.
- Store DIACOMIT at room temperature between 68°F to 77°F (20°C to 25°C).
- Store in a dry place in the original package.
- Protect from light.
|General information about the safe and effective use of DIACOMIT.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use DIACOMIT for a condition for which it was not prescribed. Do not give DIACOMIT to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about DIACOMIT that is written for health professionals.
|What are the ingredients in DIACOMIT?
Active ingredient: stiripentol
Capsule inactive ingredients: erythrosine (250 mg capsule only), gelatin, indigotine (250 mg capsule only), magnesium stearate, povidone, sodium starch glycolate, titanium dioxide.
Powder for oral suspension inactive ingredients: aspartame, carmellose sodium, erythrosine, glucose, hydroxyethylcellulose, povidone, sodium starch glycolate, sorbitol, titanium dioxide, tutti frutti flavor.
BIOCODEX, 1 avenue Blaise Pascal, 60000 BEAUVAIS – France
For more information about DIACOMIT, go to www.biocodex.com or call BIOCODEX at 1-866-330-3050