Package Leaflet: Information for the User

Diacomit 250 mg Powder for Oral Suspension in a sachet

Diacomit 500 mg Powder for Oral Suspension in a sachet

estiripentol

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, 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 experiencessideeffects,consult your child's doctor orpharmacist, even if they do not appear in this leaflet. See section 4.

6. Contents of the pack and additional information

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

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 your child's epilepsy.

Your child MUST NOT take Diacomit

• if your child isallergicto estiripentol or to any of the othercomponentsof this medication (including in section 6).
• if your child has ever hadseizures with delirium(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 child haskidney or liver problems
• Your child's liver function should be evaluated before starting treatment with Diacomit and checked every 6 months.
• Your child's blood count should be evaluated before starting treatment with Diacomit and checked every 6 months.
• Your child's growth rate should be closely monitored due to the gastrointestinal side effects of Diacomit, clobazam, and valproate, such as anorexia, loss of appetite, and vomiting.

If your child has problems with any of the components of Diacomit (e.g. aspartame, glucose, sorbitol). In that case, see later: “Diacomit contains aspartame, glucose, sorbitol, and sodium”.

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

• medications thatcontain:

• cisapride (used to treat the symptoms of nocturnal heartburn);
• pimozide (used to treat the symptoms of Tourette's syndrome: vocal tics and involuntary, repetitive movements of the body);
• ergotamine (used to treat migraines);
• dihydroergotamine (used to alleviate the symptoms of reduced mental capacity due to the aging process);
• halofantrine (a medication for antimalarial treatment);
• quinidine (used to treat cardiac arrhythmias);
• bepridil (used to control chest pain);
• ciclosporin, tacrolimus, sirolimus (all used to prevent 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 that contain:

• 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 recover mental alertness) or theophylline (this substance is used in cases of asthma). Avoid combining it with Diacomit, as it may increase blood levels, leading to gastrointestinal disturbances, increased heart rate, and insomnia.

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

• citalopram (used in the treatment of depression episodes);
• omeprazole (used for gastric ulcers);
• HIV protease inhibitors (used in HIV treatment);
• astemizole, chlorpheniramine (antihistamines);
• calcium channel blockers (used in the treatment of angina or cardiac arrhythmias);
• oral contraceptives;
• propranolol, carvedilol, timolol (used in the treatment of 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 (e.g. cola, chocolate, coffee, tea, or energy drinks).

Pregnancy and breastfeeding

If your daughter ispregnant or breastfeeding, or if you think she might be pregnant or intends to become pregnant, consult your doctor before takingthis 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 they areaffectedin this way. Consult your child's doctor.

Diacomit contains aspartame, glucose, sorbitol, and sodium

This medication contains 2.5 mg of aspartame per 250 mg tablet and 5 mg per 500 mg tablet. Aspartame is a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

This medication contains 2.4 mg of sorbitol per 250 mg tablet and 4.8 mg per 500 mg tablet.

Glucose may harm teeth.

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

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

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

Dose

Your child's doctor will determine the dose based on your child's age, weight, and condition, usually 50 mg per day per kilogram of weight.

When to take Diacomit

Your child must take this medication two or three times a day at regular intervals, as instructed 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 antiepileptic medications, which will be reduced at the same time. Your child's doctor will inform you of the new dose of other antiepileptic medications.

If you think the effect of this medication is too strong or too weak, consult with your child's doctor or pharmacist. Your child's doctor will adjust the dose based on your child's condition.

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

In case of vomiting in the first few 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 portion of the administered dose has been systemically absorbed in the digestive tract. Therefore, there will be no need to administer a new dose to adjust the next dose.

How to take Diacomit oral suspension powder

The powder must be dissolved in a glass of water and taken immediately after dissolution during a meal. Your child must take Diacomit with food and MUST NOT take it on an empty stomach.To know the foods and beverages to avoid, consult the previous section “Diacomit intake with foods and beverages”..

If your child takes more Diacomit than they should

Consult with your child's doctor if you know or suspect 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 treatment with Diacomit

Your child should not stop taking this medication unless the doctor tells you to. Stopping 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 have adverse effects, although not everyone will experience them.

Very Common 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 (excessive 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;
• light sensitivity;
• eruption, skin allergy, urticaria (inflammation of the skin with a pink 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 need to adjust the dose of Diacomit or one of the other prescribed medications for 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 also report them directly through thenational notification system included in theAppendix V.* By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

• Your child should not use this medication after the expiration date shown 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 Diacomit 250 mg

• The active ingredient is stiripentol. Each pack contains 250 mg of stiripentol.
• The other components of the pack are povidone, sodium starch glycolate, liquid glucose (dried by spray drying), erythrosine (E127), titanium dioxide (E171), aspartame (E951), tutti frutti flavor (contains sorbitol), sodium caramel, hydroxyethylcellulose.

Composition of Diacomit 500 mg

• The active ingredient is stiripentol. Each pack contains 500 mg of stiripentol.
• The other components of the pack are povidone, sodium starch glycolate, liquid glucose (dried by spray drying), erythrosine (E127), titanium dioxide (E171), aspartame (E951), tutti frutti flavor (contains sorbitol), sodium caramel, hydroxyethylcellulose.

Appearance of Diacomit 250 mg and packaging

This medicine is a light pink powder packaged in sachets.

The boxes contain 30, 60, or 90 sachets. Some packaging sizes may only be marketed.

Appearance of Diacomit 500 mg and packaging

This medicine is a light pink powder packaged in sachets.

The boxes contain 30, 60, or 90 sachets. Some packaging sizes may only be marketed.

Diacomit is also available in oral capsule form for 250 mg and 500 mg.

Marketing Authorization Holder

Biocodex

22 rue des Aqueducs – F-94250 Gentilly - France

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

Responsible Person for Manufacturing

Biocodex

1 avenue Blaise Pascal - F-60000 Beauvais - France

You can request more information about this medicine by contacting the local representative of the marketing authorization 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

/ Greece/ France/ France/ Hungary/ Norway/ France/ France/ Netherlands/ France/ Poland/ Portugal/ Sweden/ Slovenia

Tel/Tel/Teπ/Τηλ/Sími: + 33 (0)1 41 24 30 00

e-mail:[email protected]

CZ

Desitin Pharma spol. s r.o

Opletalova 25

11121 Prague1

Czech Republic

Tel: 00420-2-222 45 375

e-mail:[email protected]

DE

Desitin Arzneimittel GmbH

Weg beim Jäger 214

D-22335 Hamburg

Germany

Tel: +49 (0)40 59101 525

e-mail:[email protected]

EE

Biocodex OÜ

Väike-Paala 1

11415 Tallinn

Estonia

Tel: +372 605 6014

e-mail:[email protected]

FI

Biocodex Oy

Metsänneidonkuja 8

02130 Espoo

Finland

Tel: +358 9 329 59100

e-mail:[email protected]

LT

Biocodex UAB

Savanoriu av. 349

LT-51480 Kaunas

Lithuania

Tel: +370 37 408681

e-mail:[email protected]

LV

Biocodex SIA

Kalnini A, Marupes nov.,

Marupe, LV-2167

Latvia

Tel: +371 67 619365

e-mail:[email protected]

RO

Desitin Pharma s.r.l

Sevastopol street, no 13-17

Diplomat Business Centre, office 102

Sector 1, 010991 Bucharest

Romania

Tel: 004021-252-3481

e-mail:[email protected]

SK

Desitin Pharma s.r.o.

Trojicné námestie 13

82106 Bratislava

Slovakia

Tel: 00421-2-5556 38 10

e-mail:[email protected]

Last review date of this leaflet

Other sources of information

Detailed information about this medicine is available on the European Medicines Agency website:http://www.ema.europa.eu.There are also links to other websites about orphan diseases and treatments.