Diacomit 500 mg hard capsules

Patient Information Leaflet

Introduction

Package leaflet: Information for the user

Diacomit 250 mg hard capsules

Diacomit 500 mg hard capsules

stiripentol

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

Leaflet contents

1. What Diacomit is and what it is used for
2. What you need to know before your child takes Diacomit
3. How to take Diacomit
4. Possible side effects
5. How to store Diacomit
6. Contents of the pack and other information

1. What Diacomit is and what it is 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 drugs) to treat a specific form of epilepsy known as severe myoclonic epilepsy in infancy (Dravet syndrome), which affects children. Your child's doctor has prescribed this medicine to help manage 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 to any of the other ingredients of this medicine (listed in section 6).
• if your child has ever experienced delirium attacks (a mental state involving confusion, agitation, 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 monitored every 6 months.
• Your child’s blood count should be evaluated before starting treatment with Diacomit and monitored every 6 months.
• Your child’s growth rate should be carefully monitored due to gastrointestinal side effects associated with 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 recently taken, or might need to take any other medicines.

Tell 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 tics and repetitive, uncontrollable body movements);

• ergotamine (used to treat migraine);

• dihydroergotamine (used to relieve signs and symptoms of mental decline due to aging);

• halofantrine (an antimalarial drug);

• quinidine (used to treat heart rhythm disorders);

• bepridil (used to control chest pain);

• cyclosporine, tacrolimus, sirolimus (all three used to prevent rejection in liver, kidney, and heart transplants);

• statins (simvastatin and atorvastatin, both used to lower blood cholesterol levels).

• antiepileptic medicines containing:

• phenobarbital, primidone, phenytoin, carbamazepine, diazepam.

• medicines containing:

• midazolam or triazolam (drugs used to reduce anxiety and insomnia — when combined with Diacomit, they may cause excessive drowsiness in your child);

• chlorpromazine (used for mental illnesses such as psychosis).

• If your child is taking medicines containing:

• caffeine (a substance that helps restore mental alertness) or theophylline (a substance used in asthma). Their combination with Diacomit should be avoided, as it may increase their blood levels, leading to gastrointestinal disturbances, 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 in the treatment of HIV);

• astemizole, chlorphenamine (antihistamines);

• calcium channel blockers (used to treat angina or 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, carbonated drinks, or foods and beverages containing caffeine or theophylline (e.g., cola, chocolate, coffee, tea, or energy drinks).

Pregnancy and breastfeeding

If your daughter is pregnant or breastfeeding, thinks she might be pregnant, or plans to become pregnant, consult her doctor before taking this medicine. Effective antiepileptic treatment must not be interrupted during pregnancy.

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 machinery or drive if 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; therefore, it is essentially “sodium-free”.

3. How to take Diacomit

Your child must take these capsules exactly as directed by your child's doctor. If in doubt, please consult your child's doctor or pharmacist again.

Dosage

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 your child's doctor: for example, in the morning, at midday, and at bedtime to cover both daytime and nighttime 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 simultaneously. Your child's doctor will inform you about 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.

If adverse effects occur, consult your child's doctor, as it may be necessary to adjust the dose of this medicine and of other antiepileptic medicines.

There are slight differences between Diacomit capsules and the oral suspension powder. Please consult your doctor if your child experiences any problems when switching from capsules to oral suspension powder, or vice versa. Any switch between capsule and powder formulations must be carried out under the strict supervision of your child's doctor.

If vomiting occurs within the first few minutes after taking the medicine, the medicine is considered not to have been absorbed, and a new dose should be administered.

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

In such a case, a significant fraction of the administered dose is considered to have been systematically absorbed in the gastrointestinal tract. Therefore, there will be no need to administer another dose or to adjust the next scheduled dose.

How to take Diacomit capsules

To ensure the patient receives the full amount of powder, it is preferable not to open the capsule and to swallow it whole orally as a single dose. Your child should take Diacomit with food and must NOT take it on an empty stomach. For information about foods and drinks to avoid, please refer to the previous section “Taking Diacomit with food and drinks”.

If your child takes more Diacomit than they should

Contact your child's doctor if you know or suspect that 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 each day. If your child forgets to take a dose, they should take it as soon as you remember, unless it is almost time for the next dose. In that case, skip the missed dose and continue with the regular dosing schedule. Your child must NOT take a double dose to make up for a missed dose.

If your child stops taking Diacomit

Your child must not stop taking this medicine unless instructed by the doctor. Stopping treatment may trigger a seizure episode.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

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

• insomnia, somnolence;

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

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

• increased levels of liver enzymes, especially when administered with the antiepileptic medicines carbamazepine or sodium valproate;
• aggression, irritability, agitation, hyperexcitability (state of unusual excitability);
• sleep disorders (abnormalities in sleep);
• hyperkinesia (exaggerated movements);
• nausea, vomiting;
• low number of a type of white blood cells.

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

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

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

• decrease in blood platelet levels;

• abnormal liver function test.

To eliminate these adverse effects, your child’s doctor may need to adjust the dose of Diacomit or of any other medicines prescribed to your child.

Reporting of adverse effects

If your child experiences any type of adverse effect, consult your child’s doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse 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 must not use this medicine after the expiry date stated on the label after “EXP”. The expiry date refers to the last day of the month indicated.

• Store in the original packaging to protect it from light.

Medicines should not be disposed of via wastewater drains or household waste. Ask your pharmacist how to properly dispose of any unused medicine and its packaging. This helps protect the environment.

6. Package contents and other information

Composition of Diacomit 250 mg

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

Composition of Diacomit 500 mg

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

Appearance of Diacomit 250 mg and contents of the pack

The Diacomit 250 mg hard capsule is pink in colour and printed with “Diacomit 250 mg”.

The hard capsules are packed in plastic bottles containing 30, 60 or 90 capsules, presented in cardboard boxes. Only some pack sizes may be marketed.

Appearance of Diacomit 500 mg and contents of the pack

The Diacomit 500 mg hard capsule is white in colour and printed with “Diacomit 500 mg”.

The hard capsules are packed in plastic bottles containing 30, 60 or 90 capsules, presented in cardboard boxes. Only some pack sizes may be marketed.

Diacomit is also available as 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]

Manufacturer

Biocodex
1 avenue Blaise Pascal – F-60000 Beauvais – France

For more information about this medicinal product, please contact 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
/ Γaλλía/ France/ Francia/ Franciaország/ Frakkland/ Francija/ Franza/ Frankrijk/ Francja, Frankrike
Tél/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 Prague 1
Czech Republic
Tel: +420-2-222 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: +4021-252-3481
e-mail: [email protected]

SK

Desitin Pharma s.r.o.
Trojicné námestie 13
82106 Bratislava
Slovakia
Tel: +421-2-5556 38 10
e-mail: [email protected]

Date of latest revision of this leaflet

Other sources of information

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