DIACOMIT 250 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Diacomit 250 mgHard Capsules

Diacomit 500 mgHard Capsules

Stiripentol

Read all of 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 further questions, ask your child's doctor or pharmacist.
• This medicine has been prescribed for your child only. Do not give it to others, as it may harm them.
• If your child experiences any side effects, talk to your child's doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Diacomit and what is it used for
2. What you need to know before your child takes Diacomit
3. How to take Diacomit
4. Possible side effects
5. Storage of Diacomit

1. Contents of the pack and further information

1. What is Diacomit and what is it used for

Stiripentol, the active ingredient of Diacomit, belongs to a group of medicines called antiepileptics.

It is used in combination with clobazam and valproate (other antiepileptic medicines) 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 medicine to help treat the epilepsy.

2. What you need to know before your child takes Diacomit

Your child MUST NOT take Diacomit

• if your child is allergic to stiripentol or any of the other ingredients of this medicine (listed in section 6).
• if your child has ever suffered from delirium (a mental state with confusion, emotion, restlessness, and hallucinations).

Warnings and precautions

Talk to your child's doctor or pharmacist before your child starts taking Diacomit

• if your child has kidney 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 carefully monitored due to gastrointestinal side effects with Diacomit, clobazam, and valproate, such as anorexia, loss of appetite, and vomiting.

Other medicines and Diacomit

Tell your child's doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines.

Tell your doctor if your child is taking any of the following medicines:

• medicines that contain:

• cisapride (used to treat symptoms of nocturnal heartburn);
• pimozide (used to treat symptoms of Tourette's syndrome: vocal tics and repeated, uncontrolled body movements);
• ergotamine (used to treat migraines);
• dihydroergotamine (used to relieve signs and symptoms of reduced mental capacity due to the aging process);
• halofantrine (an antimalarial medicine);
• quinidine (used to treat heart rhythm disorders);
• 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 medicines that contain:

• phenobarbital, primidone, phenytoin, carbamazepine, diazepam.

• medicines that contain:

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

• If your child is taking medicines that contain:

• caffeine (these substances help to restore mental alertness) or theophylline (this substance is used in case of asthma). Their combination with Diacomit should be avoided, as it may increase their blood levels, leading to digestive disorders, increased heart rate, and insomnia.

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

• citalopram (used to treat depressive episodes);
• omeprazole (used for stomach ulcers);
• HIV protease inhibitors (used to treat HIV);
• astemizole, chlorphenamine (antihistamines);
• calcium channel blockers (used to treat angina or heart rhythm problems);
• oral contraceptives;
• propranolol, carvedilol, timolol (used to treat high blood pressure);
• fluoxetine, paroxetine, sertraline, imipramine, clomipramine (antidepressants);
• haloperidol (antipsychotics);
• codeine, dextromethorphan, tramadol (painkillers).

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 that contain caffeine or theophylline (e.g., cola, chocolate, coffee, tea, or energy drinks).

Pregnancy and breastfeeding

If your daughter is pregnant or breastfeeding, thinks she may be pregnant, or plans to become pregnant, consult her doctor before taking this medicine. During pregnancy, DO NOT stop effective antiepileptic treatment.

Breastfeeding is not recommended during treatment with this medicine.

Driving and using machines

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".

3. How to take Diacomit

Your child should take these capsules exactly as their doctor has told them. If in doubt, consult your child's doctor or pharmacist again

Dose

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

When to take Diacomit

Your child should take this medicine two or three times a day at regular intervals as indicated by their doctor: for example, in the mornings, at noon, and at bedtime to cover the night and daytime periods.

Dose adjustment

Dose increases should be gradual, replacing, over several weeks, the dose(s) of the other antiepileptic medicine(s), which will be reduced at the same time. Your child's doctor will tell you the new dose of the other antiepileptic medicine(s).

If you think the effect of this medicine is too strong or too weak, talk to your child's doctor or pharmacist. The doctor will adjust the dose according to your child's condition.

If your child experiences side effects, talk to their doctor, as they may need to adjust the dose of this medicine and other antiepileptic medicines.

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

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

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

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

How to take the Diacomit capsules

To ensure that the patient takes the complete amount of powder, it is preferable not to open the capsule and to swallow it as a single oral dose. Your child should take Diacomit with food and NOT on an empty stomach. To know which foods and drinks to avoid, see the previous section "Taking Diacomit with food and drinks".

If your child takes more Diacomit than they should

Talk to your child's doctor if you know or think your child has taken more medicine than they should.

If your child forgets to take Diacomit

It is important that your child takes this medicine 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 make up for forgotten doses.

If your child stops taking Diacomit

Your child should not stop taking this medicine unless their doctor tells them to. Stopping treatment may cause a seizure crisis.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common side effects(may affect more than 1 in 10 people):

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

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

Common side effects(may affect up to 1 in 10 people):

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

Uncommon side effects(may affect up to 1 in 100 people):

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

Rare side effects(may affect up to 1 in 1,000 people):

• Decrease in platelet count in the blood;

• Abnormal liver function test.

To eliminate these side effects, your child's doctor may need to adjust the dose of Diacomit or one of the other prescribed medicines.

Reporting side effects

If your child experiences any side effects, talk to their doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Diacomit

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

• Your child should not use this medicine after the expiry date stated on the label after "EXP". The expiry date is the last day of the month stated.

• Store in the original package to protect from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Diacomit 250 mg

• The active ingredient is stiripentol. Each hard capsule contains 250 mg of stiripentol.
• The other ingredients of the capsule are povidone, sodium starch glycolate, and magnesium stearate (E470b).
• The capsule is made of gelatin, titanium dioxide (E171), erythrosine (E127), and indigo carmine (E132).
• The printing ink contains shellac (E904), iron oxide black (E172).

Composition of Diacomit 500 mg

• The active ingredient is stiripentol. Each hard capsule contains 500 mg of stiripentol.
• The other ingredients of the capsule are povidone, sodium starch glycolate, and magnesium stearate (E470b).
• The capsule is made of gelatin, titanium dioxide (E171),
• The printing ink contains shellac (E904), iron oxide black (E172).

Appearance of Diacomit 250 mg and pack contents

The Diacomit 250 mg hard capsule is pink and printed with "Diacomit 250 mg". The hard capsules are packed in plastic bottles containing 30, 60, or 90 capsules, in cardboard boxes. Some pack sizes may not be marketed.

Appearance of Diacomit 500 mg and pack contents

The Diacomit 500 mg hard capsules are white and printed with "Diacomit 500 mg".

The hard capsules are packed in plastic bottles containing 30, 60, or 90 capsules, in cardboard boxes. Some pack sizes may not be marketed.

Diacomit is also available as a 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: medinfo@biocodex.com

Manufacturer

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 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

/ Γaλλία/ France/ Francia/ Franciaország/ Frakkland/ Francija/ Franza/ Frankrijk/ Francja/ Frankrike

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

e-mail: medinfo@biocodex.com

CZ

Desitin Pharma spol. s r.o

Opletalova 25

11121 Pragua 1

Czech Republic

Tel: 00420-2-222 45 375

e-mail: desitin@desitin.cz

DE

Desitin Arzneimittel GmbH

Weg beim Jäger 214

D-22335 Hamburg

Germany

Tel: +49 (0)40 59101 525

e-mail: epi.info@desitin.de

EE

Biocodex OÜ

Väike-Paala 1

11415 Tallinn

Estonia

Tel: +372 605 6014

e-mail: info@biocodex.ee

FI

Biocodex Oy

Metsänneidonkuja 8

02130 Espoo

Finland

Tel: +358 9 329 59100

e-mail: info@biocodex.fi

LT

Biocodex UAB

Savanoriu av. 349

LT-51480 Kaunas

Lithuania

Tel: +370 37 408681

e-mail: info@biocodex.lt

LV

Biocodex SIA

Kalnini A, Marupes nov.,

Marupe, LV-2167

Latvia

Tel: +371 67 619365

e-mail: info@biocodex.lv

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: office@desitin.ro

SK

Desitin Pharma s.r.o.

Trojicné námestie 13

82106 Bratislava

Slovakia

Tel: 00421-2-5556 38 10

e-mail: desitin@desitin.sk

Date of last revision of this leaflet

Other sources of information

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