DIACOMIT 250 mg POWDER FOR ORAL SUSPENSION

Introduction

Package Leaflet: Information for the User

Diacomit250mgPowder for Oral Suspension in Sachet

Diacomit 500 mg Powder for Oral Suspension in Sachet

stiripentol

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

• Keep this leaflet. 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, even if their symptoms are the same.
• If your child experiences side effects, contact 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 in 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 in infancy (Dravet syndrome), which affects children. Your child's doctor has prescribed this medicine to help treat your child's 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

Consult 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.

If your child has problems with any of the ingredients of Diacomit (e.g., aspartame, glucose, sorbitol), consult your doctor. See "Diacomit contains aspartame, glucose, sorbitol, and sodium" below.

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.

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

• medicines containing:

• cisapride (used to treat symptoms of nocturnal pyrosis);
• pimozide (used to treat symptoms of Tourette's syndrome: vocal and motor tics);
• ergotamine (used to treat migraine);
• dihydroergotamine (used to relieve signs and symptoms of decreased mental capacity due to the aging process);
• halofantrine (an antimalarial drug);
• quinidine (used to treat cardiac arrhythmias);
• bepridil (used to control chest pain);
• cyclosporin, 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 containing:

• phenobarbital, primidone, phenytoin, carbamazepine, diazepam.

• medicines containing:

• midazolam or triazolam (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 containing:

• caffeine (this substance helps to restore mental alertness) or theophylline (this substance is used in case of asthma). Their combination with Diacomit should be avoided, as it can 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 gastric ulcers);
• HIV protease inhibitors (used to treat HIV);
• astemizole, chlorphenamine (antihistamines);
• calcium channel blockers (used to treat angina or cardiac arrhythmia 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 containing caffeine or theophylline (e.g., cola, chocolate, coffee, tea, or energy drinks).

Pregnancy and Breastfeeding

If your daughter is pregnant or breastfeeding, or 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 ContainsAspartame, Glucose, Sorbitol, andSodium

This medicine contains 2.5 mg of aspartame per 250 mg sachet and 5 mg per 500 mg sachet. Aspartame is a source of phenylalanine, which may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

This medicine contains 2.4 mg of sorbitol per 250 mg sachet and 4.8 mg per 500 mg sachet.

Glucose may be harmful to teeth.

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

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

3. How to Take Diacomit

Your child should take these sachets exactly as their doctor has told them. If in doubt, consult their 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 inform you of the new dose of the other antiepileptic medicine(s).

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

There are slight differences between the capsules and the powder for oral suspension of Diacomit. Please consult your doctor if your child experiences any problems when switching from the capsules to the powder for oral suspension or vice versa. If the formulation is changed between capsules and powder, it should be done under the strict 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 systemically absorbed in the gastrointestinal tract. Therefore, there will be no need to take a new dose to adjust the next dose.

How to TakeDiacomit Powder for Oral Suspension

The powder should be dissolved in a glass of water and taken immediately after dissolution during a meal. 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

Consult your child's doctor if you know or think that 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 anomalies);

• 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;
• photosensitivity;
• 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 blood platelet count;
• 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 medicines prescribed to your child.

Reporting Side Effects

If your child experiences any side effects, contact 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 shown.
• 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 Diacomit250mg

• The active ingredient is stiripentol. Each sachet contains 250 mg of stiripentol.
• The other ingredients in the sachet are povidone, sodium starch glycolate, spray-dried glucose liquid, erythrosine (E127), titanium dioxide (E171), aspartame (E951), tutti-frutti flavor (contains sorbitol), sodium carmellose, hydroxyethylcellulose.

Composition of Diacomit500mg

• The active ingredient is stiripentol. Each sachet contains 500 mg of stiripentol.
• The other ingredients in the sachet are povidone, sodium starch glycolate, spray-dried glucose liquid, erythrosine (E127), titanium dioxide (E171), aspartame (E951), tutti-frutti flavor (contains sorbitol), sodium carmellose, hydroxyethylcellulose.

Appearance of Diacomit 250 mg and Contents of the Pack

This medicine is a light pink powder packaged in sachets.

The boxes contain 30, 60, or 90 sachets. Some pack sizes may not be marketed.

Appearance of Diacomit 500 mg and Contents of the Pack

This medicine is a light pink powder packaged in sachets.

The boxes contain 30, 60, or 90 sachets. Some pack sizes may not be marketed.

Diacomit is also available in oral capsule form, 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 from 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

Tel: + 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.