Package Leaflet: Information for the User

Diacomit 250 mg 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 your child, as it may harm them.
• If your child experiences any side 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 additional 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 helptreat epilepsy.

Your child MUST NOT take Diacomit

• if your child isallergicto ethosuximide or to any of the other ingredientsof this medication (listed in 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 child haskidney or liver problems.
• Your child's liver function must be evaluated before starting treatment with Diacomit and checked every 6 months.
• Your child's blood count must be evaluated before 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 medicines and Diacomit

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

Notify your child's doctor if your child is takingany of the following medicines:

• medicines thatcontain:

• cisapride (used to treat heartburn symptoms);
• pimozide (used to treat symptoms of Tourette's syndrome: vocal tics and involuntary, repetitive body movements);
• ergotamine (used to treat migraines);
• 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 transplant rejection);
• statins (simvastatin and atorvastatin, both used to lower blood cholesterol levels).

• antiepileptic medicines that contain:

• phenobarbital, primidone, phenytoin, carbamazepine, diazepam.

• medicines that contain:

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

• If your child is taking medicines thatcontain:

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

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

• citalopram (used to treat depression episodes);
• omeprazole (used to treat stomach ulcers);
• protease inhibitors for HIV (used to treat HIV);
• astemizole, chlorpheniramine (antihistamines);
• calcium channel blockers (used to treat angina and 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, fizzy drinks, 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 medicine. During pregnancy, DO NOT stop an effective antiepileptic treatment.

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

Driving and operating machinery

This medicine may cause drowsiness in your child.

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

Diacomit contains sodium

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

Your child should take these capsules exactly as instructed by your child's doctor. If in 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 should 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, replaced over several weeks, the/s other/s antiepileptic medication/s, which will be reduced at the same time. Your child's doctor will inform you of the new dosage of the 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 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 switching between the capsule and oral suspension 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 should take Diacomit with food and should NOT take it on an empty stomach. To know the foods and beverages to be avoided, consult the previous section “Taking Diacomit with food and beverages”.

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 of the 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 each 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 instructs you to do so. 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 produce 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 disorders (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 need 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 about 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 diacomit 250 mg and contents of the pack

The hard capsule of Diacomit 250 mg is pink and has the imprint “Diacomit 250 mg”. The hard capsules are packed in plastic bottles containing 30, 60 or 90 capsules, in cardboard boxes. Only some pack sizes may be marketed.

Appearance of Diacomit 500 mg and contents of the pack

The hard capsules of diacomit 500 mg are white and have the imprint “Diacomit 500 mg”.

The hard capsules are packed in plastic bottles containing 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 for manufacturing

Biocodex

1 avenue Blaise Pascal - F-60000 Beauvais - France

You can request more information about this medicinal product 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

/ Greece/ France/ France/ Hungary/ Denmark/ Greece/ Spain/ France/ Croatia/ Hungary/ Ireland/ Iceland/ Italy/ Luxembourg/ Malta/ Netherlands/ Norway/ Poland/ Portugal/ Sweden/ Slovenia

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

e-mail:medi[email protected]

CZ

Desitin Pharma spol. s r.o

Opletalova 25

11121 Prague

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:in[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 update of this leaflet

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.There are also links to other websites on diseases and orphan treatments.