Package Leaflet: Information for the User

Diacomit250mg Hard Capsules

Diacomit 500 mg Hard Capsules

estiripentol

Read this leaflet carefully before your child starts taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your child's doctor or pharmacist.
• This medicine has been prescribed for your child only. Do not give it to other people,even if they have the same symptoms,as it may harm them.
• If your child experiencesany adverse effects,consult your child's doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

6. Contents of the pack and other information

Estiripentol, the active ingredient in Diacomit, belongs to a group of medications called antiepileptics.

It is used in combination with clobazam and valproate (other antiepileptic medications) to treat a specific form of epilepsy called severe myoclonic epilepsy of infancy (Dravet syndrome), which affects children. Your child's doctor has prescribed this medication to help treat the epilepsy.

Your child MUST NOT take Diacomit

• if your child isallergicto estiripentol or to any of the other componentsof this medication (including in the section 6).
• if your child has ever haddelirium attacks(a mental state with confusion, emotion, restlessness, and hallucinations).

Warnings and precautions

Consult with your child's doctor or pharmacist before your child starts taking Diacomit

• if your childhaskidney or liver problems.
• Your child's liver function must be evaluatedbefore starting treatment with Diacomit and checked every 6 months.
• Your child's blood count must be evaluatedbefore starting treatment with Diacomit and checked every 6 months.
• Your child's growth rate must be closely monitored due to the gastrointestinal side effects of Diacomit, clobazam, and valproate, such as anorexia, loss of appetite, and vomiting.

Other medications and Diacomit

Inform your child's doctor or pharmacist if your child is taking, has taken recently, or may need to take any other medication.

Notify your child's doctor if your child is taking any of the following medications:

• medications thatcontain:

• cisapride (used to treat symptoms of nocturnal heartburn);
• pimozide (used to treat symptoms of Tourette's syndrome: vocal tics and involuntary, repetitive body movements);
• ergotamine (used to treat migraine);
• dihydroergotamine (used to alleviate symptoms of reduced mental capacity due to aging);
• halofantrine (antimalarial medication);
• quinidine (used to treat cardiac arrhythmias);
• bepridil (used to control chest pain);
• ciclosporin, tacrolimus, sirolimus (all used to prevent organ rejection in liver, kidney, and heart transplants);
• statins (simvastatin and atorvastatin, both used to reduce blood cholesterol levels).

• antiepileptic medications that contain:

• phenobarbital, primidone, phenytoin, carbamazepine, diazepam.

• medications thatcontain:

• midazolam or triazolam (medications used to reduce anxiety and insomnia — combined with Diacomit cause excessive drowsiness in your child);
• chlorpromazine (used to treat mental illnesses such as psychosis).

• If your child is taking medications thatcontain:

• caffeine (this substance helps to regain mental alertness) or theophylline (this substance is used to treat asthma). Avoid combining these with Diacomit, as it may increase their blood levels, leading to gastrointestinal disturbances, increased heart rate, and insomnia.

• If your child is taking medications metabolized by certain liver enzymes:

• citalopram (used to treat episodes of depression);
• omeprazole (used to treat stomach ulcers);
• HIV protease inhibitors (used to treat HIV);
• astemizole, chlorpheniramine (antihistamines);
• calcium channel blockers (used to treat angina or cardiac arrhythmias);
• oral contraceptives;
• propranolol, carvedilol, timolol (used to treat high blood pressure);
• fluoxetine, paroxetine, sertraline, imipramine, clomipramine (antidepressants);
• haloperidol (antipsychotics);
• codeine, dextromethorphan, tramadol (analgesics).

Taking Diacomit with food and drinks

Do not take Diacomit with milk or dairy products (yogurt, creamy cheeses, etc.), fruit juices, carbonated beverages, or foods and drinks containing caffeine or theophylline (such as cola, chocolate, coffee, tea, or energy drinks).

Pregnancy and breastfeeding

If your daughter is pregnant or breastfeeding, or if you think she might be pregnant or plans to become pregnant, consult your child's doctor before taking this medication. During pregnancy, DO NOT interrupt an effective antiepileptic treatment.

It is not recommended to breastfeed during treatment with this medication.

Driving and operating machinery

This medication may cause drowsiness in your child.

Your child should not operate tools or machines or drive if affected in this way. Consult your child's doctor.

Diacomit contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per capsule; it is essentially "sodium-free".

Your child must take these capsules exactly as instructed by your child's doctor. In case of doubt, consult with your child's doctor or pharmacist again.

Dosage

Your child's doctor will adjust the dosage according to your child's age, weight, and condition, usually 50 mg per day per kg of weight.

When to take Diacomit

Your child must take this medication two or three times a day at regular intervals as indicated by your child's doctor, for example, in the morning, at noon, and at bedtime to cover the night and daytime periods.

Dose adjustment

Dose increases should be gradual, replacing, over several weeks, the doses of other/s antiepileptic medication/s, which will be reduced at the same time.The doctor will inform you of the new dosage of other/s antiepileptic medication/s.

If you feel that the effect of this medication is too strong or too weak, consult with your child's doctor or pharmacist. The doctor will adjust the dosage based on your child's condition.

In case of adverse effects, consult with your child's doctor, as it may be necessary to adjust the dosage of this medication and other antiepileptic medications.

There are slight differences between the capsules and the powder for oral suspension of Diacomit. Please consult your doctor if your child experiences any problem when switching from capsules to oral suspension powder, or vice versa.If switching between the capsule and powder formulations, it should be done under the strict supervision of your child's doctor.

In case of vomiting in the first minutes after taking, it is considered that the medication has not been absorbed and a new dose should be administered.

However, the situation changes if vomiting occurs more than an hour after taking the medication, as stiripentol is rapidly absorbed.

If this is the case, it will be considered that a significant fraction of the administered dose has been systematically absorbed in the digestive tract.Therefore, there will be no need to administer a new dose or adjust the next dose.

How to take Diacomit capsules

To ensure that the patient takes the complete amount of powder, it is recommended not to open the capsule and have your child swallow it as a single dose orally.Your child must take Diacomit with food and NOT take it on an empty stomach.Please consult the previous section “Taking Diacomit with food and drinks” to know the foods and beverages to avoid.

If your child takes more Diacomit than they should

Consult with your child's doctor if you know or believe that your child has taken more medication than they should.

If your child forgets to take Diacomit

It is essential that your child takes this medication regularly at the same time every day.If your child forgets to take a dose, they should take it as soon as you remember, unless it is time for the next dose.In that case, continue with the next dose as usual.Your child should not take a double dose to compensate for the missed doses.

If your child interrupts the treatment with Diacomit

Your child should not stop taking this medication unless the doctor tells you to.The interruption of treatment may cause a seizure crisis.

If you have any other doubts about the use of this medication, ask your child's doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Frequent Adverse Effects(may affect more than one in 10 people):

• loss of appetite, weight loss (especially in combination with the antiepileptic medication valproate sodium);
• insomnia, drowsiness;

• ataxia (inability to coordinate muscle movements), hypotonia (poor muscle strength), dystonia (involuntary muscle contractions).

Common Adverse Effects(may affect up to one in 10 people):

• elevation of liver enzyme levels, especially when administered with the antiepileptic medications carbamazepine or valproate sodium;
• aggressiveness, irritability, agitation, hyperexcitability (unusual excitability);
• sleep disturbances (abnormalities of sleep);
• hyperkinesia (exaggerated movements);
• nausea, vomiting;
• low count of a type of white blood cell.

Uncommon Adverse Effects(may affect up to one in 100 people):

• double vision when used with the antiepileptic medication carbamazepine; sensitivity to light;
• eruption, skin allergy, urticaria (inflammation of the skin with a pinkish tone and accompanied by itching);
• fatigue (tiredness).

Rare Adverse Effects(may affect up to one in 1,000 people):

• decrease in platelet count in the blood;

• abnormal liver function test.

To eliminate these adverse effects, the child's doctor may have to adjust the dose of Diacomit or one of the other medications prescribed to the child.

Reporting Adverse Effects

If your child experiences any type of adverse effect, consult the child's doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can alsoreport them directly through thenational notification system included in theAppendix V. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

• Keep this medication out of the sight and reach of children.

• Your child should not use this medication after the expiration date that appears on the label after “EXP.”The expiration date is the last day of the month indicated.

• Store in the original packaging to protect it from light.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

Composition of Diacomit250mg

• The active ingredient isthestiripentol. Each hard capsule contains250mg of stiripentol.
• The other components of the capsule are povidone, sodium starch glycolate and magnesium stearate (E470b).
• The capsule is made of gelatin, titanium dioxide (E171), erythrosine (E127) and indigotin (E132).
• The printing ink contains shellac (E904), iron oxide black (E172).

Composition of Diacomit500mg

• The active ingredient isthestiripentol. Each hard capsule contains500mg of stiripentol.
• The other components of the capsule are povidone, sodium starch glycolate and magnesium stearate (E470b).
• The capsule is made of gelatin, dioxide of titanium (E171).
• The printing ink contains shellac (E904), iron oxide black (E172).

Appearance of Diacomit250mg and contents of the pack

The hard capsule of Diacomit250 mg is pink and has the imprint “Diacomit250mg”.

The hard capsules are packed in plastic bottlesthat contain 30, 60 or 90 capsules,in cardboard boxes.Only some pack sizes may be marketed.

Appearance of Diacomit500mg and contents of the pack

The hard capsule of Diacomit500 mg is whiteand has the imprint “Diacomit500mg”.

The hard capsules are packed in plastic bottlesthat contain 30, 60 or 90 capsules,in cardboard boxes.Only some pack sizes may be marketed.

Diacomit is also available in powder for oral suspension in sachets of 250 mg and 500 mg.

Marketing Authorisation Holder

Biocodex,22 rue des Aqueducs – F-94250 Gentilly - France

Tel: + 33 1 41 24 30 00 - e-mail:[email protected]

Responsible Person

Biocodex

1 avenue Blaise Pascal - F-60000 Beauvais - France

Further information on this medicinal product can be obtained by contacting the local representative of the marketing authorisation holder:

AT/BE/BG/CY/DK/EL/ES/FR/HR/HU/IE/IS/IT/LU/MT/NL/NO/PL/PT/SE/SI

Biocodex

22 rue des Aqueducs – F-94250 Gentilly

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