Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Diacomit (Stiripentol). If you are concerned about side effects, discuss the risks and benefits of Diacomit (Stiripentol) with your doctor.

The following side effects have been reported by at least 1% of people taking Diacomit (Stiripentol). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• confusion
• decreased muscle coordination and tone
• difficulty concentrating
• difficulty sleeping
• dizziness
• dry, itchy skin
• increased production of saliva
• loss of appetite
• nausea
• nightmares
• speech difficulties
• tiredness
• vomiting
• unusual, increased muscle contractions

weight loss Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• behaviour changes (e.g., agitation, nervousness, aggression)
• movement disorders
• signs of bleeding (e.g., bloody nose, blood in urine, coughing blood, bleeding gums, cuts that don't stop bleeding)
• signs of infection (symptoms may include Fever or chills, severe Diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
• signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
• thoughts of hurting oneself or others

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Diacomit (Stiripentol).

250 mg
Each size 2 pink gelatin capsule contains 250 mg Diacomit (Stiripentol). Nonmedicinal ingredients: erythrosine, gelatin, indigotine, magnesium stearate, povidone, sodium starch glycolate, titanium dioxide.

500 mg
Each size 0 white gelatin capsule contains 500 mg Diacomit (Stiripentol). Nonmedicinal ingredients:gelatin, magnesium stearate, povidone, sodium starch, glycolate, titanium dioxide.

Powder for suspension

250 mg
Each packet of tutti frutti flavoured powder for suspension contains 250 mg Diacomit (Stiripentol). Nonmedicianl ingredients: aspartame, carmellose sodium, erythrosine, glucose, hydroxyethylcellulose, povidone, sodium starch glycolate, sorbitol, titanium dioxide, tutti frutti flavour.

500 mg
Each packet of tutti frutti flavoured powder for suspension contains 500 mg Diacomit (Stiripentol). Nonmedicianl ingredients: aspartame, carmellose sodium, erythrosine, glucose, hydroxyethylcellulose, povidone, sodium starch glycolate, sorbitol, titanium dioxide, tutti frutti flavour.

Do not take Diacomit (Stiripentol) if you are allergic to Diacomit (Stiripentol) or any ingredients of the medication.

There may be an interaction between Diacomit (Stiripentol) and any of the following:

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Diacomit (Stiripentol). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Diacomit (Stiripentol).

Caffeine: Diacomit (Stiripentol) interacts with caffeine and other similar substances. People who take stiripenol should avoid colas, chocolate, coffee, tea and energy drinks.

Delirium and hallucinations: Rarely, Diacomit (Stiripentol) has been linked to delirium or hallucinations when taken by adults. If you have a history of psychoses or delirium, discuss with your doctor how Diacomit (Stiripentol) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Diacomit (Stiripentol), and whether any special monitoring is needed.

Drowsiness/Reduced Alertness: Diacomit (Stiripentol) may cause drowsiness or dizziness, affecting your ability to drive or operate machinery. Avoid these and other hazardous tasks until you have determined how Diacomit (Stiripentol) affects you.

Growth Problems: Diacomit (Stiripentol) can cause appetite loss and stomach upset which may result in loss of weight. For children this can result in growth problems. Your child's growth rate should be monitored by your doctor while taking Diacomit (Stiripentol). Talk to your doctor if your child is experiencing significant loss of appetite and weight loss.

Infection: Diacomit (Stiripentol) can reduce the number of cells that fight infection in the body (white blood cells). Tell your doctor immediately if you notice signs of an infection, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness. Your doctor will do blood tests regularly to monitor the number of specific types of blood cells in your blood.

Kidney function: Reduced kidney function may cause Diacomit (Stiripentol) to build up in the body and cause side effects. If you have kidney problems, discuss with your doctor how Diacomit (Stiripentol) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Diacomit (Stiripentol), and whether any special monitoring is needed. Your doctor may want to test your kidney function regularly with blood tests while you are taking Diacomit (Stiripentol).

Liver function: The effect of reduced liver function on how the body uses Diacomit (Stiripentol) has not been studied. Diacomit (Stiripentol) may reduce liver function and can cause liver problems. If you have liver problems, discuss with your doctor how Diacomit (Stiripentol) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Diacomit (Stiripentol), and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking Diacomit (Stiripentol).

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately

Other medications for seizures: It is important to avoid taking Carbamazepine, Phenytoin or Phenobarbital when using Diacomit (Stiripentol). If you or your child are using any of these medications, discuss with your doctor the appropriate way to change medications.

Suicidal or agitated behaviour: People taking Diacomit (Stiripentol) may feel agitated (restless, anxious, aggressive, emotional, and feeling not like themselves), or they may want to hurt themselves or others. These symptoms may occur within several weeks after starting Diacomit (Stiripentol). If you experience these side effects or notice them in a family member who is taking Diacomit (Stiripentol), contact your doctor immediately. You should be closely monitored by your doctor for emotional and behaviour changes while taking Diacomit (Stiripentol).

Pregnancy: Although there is no information on the effect that Diacomit (Stiripentol) can have on the developing baby if it is taken by the mother during pregnancy, many medications that are used to treat seizures cause harm to the unborn baby. Diacomit (Stiripentol) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Diacomit (Stiripentol), contact your doctor immediately.

Breast-feeding: Diacomit (Stiripentol) may pass into breast milk. If you are a breast-feeding mother and are taking Diacomit (Stiripentol), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Seniors: There is no information regarding the safe and effective use of Diacomit (Stiripentol) by older adults. Seniors may be more likely to experience side effects because of liver and kidney impairment.