DIACOMIT 100 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Diacomit100mg Hard 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. This includes any possible side effects 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. Storing Diacomit
6. Package Contents 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

Warnings and Precautions

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

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 heartburn);
• pimozide (used to treat symptoms of Tourette's syndrome: vocal and movement tics);
• ergotamine (used to treat migraine);
• dihydroergotamine (used to relieve signs and symptoms of reduced mental capacity due to the aging process);
• halofantrine (an antimalarial drug);
• quinidine (used to treat heart rhythm disorders);
• 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 (medicines used to reduce anxiety and insomnia — combined with Diacomit, they can cause significant drowsiness in your child);
• chlorpromazine (used for mental illnesses such as psychosis).

• 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 may increase their blood levels, leading to digestive disorders, increased heart rate, and insomnia.

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

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 is planning to have a baby, ask her doctor for advice 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 they are unsure, they should 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 directed by their doctor; for example, in the morning, at noon, and at bedtime to cover a day and a night.

Dose Adjustment

Dose increases should be gradual and over several weeks, while reducing the dose(s) of other antiepileptic medicines. Your child's doctor will inform you of the new dose of the other antiepileptic medicines.

If you think 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 capsule and oral suspension formulations of Diacomit. Please consult your doctor if your child experiences any problems when switching from capsules to oral suspension or vice versa. When 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, this changes if vomiting occurs more than an hour after taking the medicine, as stiripentol is rapidly absorbed.

In this case, it is considered that a significant fraction of the administered dose has been absorbed systemically in the gastrointestinal tract. Therefore, there will be no need to take 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 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

Consult your child's doctor if you know or think your child has taken more of the 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 they remember, unless it is time for the next dose. In that case, they should 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 suddenly can 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 number of a type of white blood cell.

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 prescribed medicines.

Reporting Side Effects

If your child experiences side effects, talk to your child's doctor or pharmacist. This includes any possible side effects 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. Storing Diacomit

• Keep this medicine out of the sight and reach of children.
• Your child should not use this medicine after the expiry date which is stated on the label after "EXP". The expiry date is the last day of the month shown.

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. Package Contents and Further Information

Composition of Diacomit 100 mg

• The active substance is stiripentol. Each hard capsule contains 100 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), black iron oxide (E172).

Appearance of Diacomit 100 mg and Package Contents

The Diacomit 100 mg hard capsule is white/pink and printed with "Diacomit 100 mg".

The hard capsules are packaged in plastic bottles with 100 capsules in cardboard boxes.

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 obtain further information on 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

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

Email: medinfo@biocodex.com

CZ

Desitin Pharma spol. s r.o

Opletalova 25

11121 Prague 1

Czech Republic

Tel: 00420-2-222 45 375

Email: desitin@desitin.cz

DE

Desitin Arzneimittel GmbH

Weg beim Jäger 214

D-22335 Hamburg

Germany

Tel: +49 (0)40 59101 525

Email: epi.info@desitin.de

EE

Biocodex OÜ

Väike-Paala 1

11415 Tallinn

Estonia

Tel: +372 605 6014

Email: info@biocodex.ee

FI

Biocodex Oy

Metsänneidonkuja 8

02130 Espoo

Finland

Tel: +358 9 329 59100

Email: info@biocodex.fi

LT

Biocodex UAB

Savanoriu av. 349

LT-51480 Kaunas

Lithuania

Tel: +370 37 408681

Email: info@biocodex.lt

LV

Biocodex SIA

Kalnini A, Marupes nov.,

Marupe, LV-2167

Latvia

Tel: +371 67 619365

Email: 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

Email: office@desitin.ro

SK

Desitin Pharma s.r.o.

Trojicné námestie 13

82106 Bratislava

Slovakia

Tel: 00421-2-5556 38 10

Email: 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 rare diseases and treatments.