Package leaflet: Information for the user

Diacomit 100 mg hard capsules

stiripentol
Please read this leaflet carefully before your child takes this medicine, as it
contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your paediatrician or pharmacist.
This medicine has been prescribed for your child only. Never give it to others. It may be harmful to other people, even if their symptoms are the same as your child's.
If your child experiences any side effects, including those not listed in this leaflet, inform your paediatrician or pharmacist. See section 4.

Contents of this leaflet

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

1. What Diacomit is and what it is used for

Stiripentol, the active substance in Diacomit, belongs to a group of medicines called antiepileptics.
It is used in combination with clobazam and valproate (other antiepileptic medicines) for the treatment of a particular form of epilepsy known as severe myoclonic epilepsy in infancy (Dravet syndrome), which affects children. Your paediatrician has prescribed this medicine to help treat your child's epilepsy.

2. What you should know before your child takes Diacomit

Your child must NOT take Diacomit

if they are allergic to stiripentol or to any of the other ingredients of this medicine (listed in section 6).
if they have experienced delirious episodes (a mental state characterized by confusion, excitement, restlessness, and hallucinations).

Warnings and precautions
Talk to your paediatrician or pharmacist before giving Diacomit to your child

if your child has kidney or liver problems.
before starting treatment with Diacomit, the child's liver function should be assessed, and checks should be repeated every 6 months.
before starting treatment with Diacomit, blood cell count should be evaluated, and checks should be repeated every 6 months.
due to the frequent occurrence of gastrointestinal side effects during treatment with Diacomit, clobazam, and valproate (anorexia, loss of appetite, nausea, vomiting), the child's growth rate must be monitored very closely.

Other medicines and Diacomit
Inform the paediatrician or pharmacist if your child is taking, has recently taken, or might take any other medicine.
Talk to the 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, such as meaningless sounds and uncontrollable, repetitive body movements);
- ergotamine (used to treat migraine);
- dihydroergotamine (used to relieve signs and symptoms of mental decline due to aging);
- halofantrine (an antimalarial treatment);
- quinidine (used to treat cardiac arrhythmias);
- bepridil (used to relieve chest pain);
- ciclosporin, tacrolimus, sirolimus (all three used to prevent rejection after liver, kidney, and heart transplants);
- statins (simvastatin and atorvastatin, both used to reduce cholesterol levels in the blood).
- antiepileptic medicines containing: phenobarbital, primidone, phenytoin, carbamazepine, diazepam
- medicines containing: midazolam or triazolam (medicines that reduce anxiety and insomnia – when used with Diacomit, they significantly increase drowsiness in the child); chlorpromazine (used for mental illnesses such as psychosis).
- If your child is taking medicines containing: caffeine (a substance that helps keep the mind awake) or theophylline (a substance used in asthma). The combination with Diacomit should be avoided as it could increase blood levels of these substances, leading to gastrointestinal disturbances, rapid heartbeat, and insomnia.
If your child is taking medicines metabolized by certain liver enzymes:
- citalopram (used to treat depressive episodes);
- omeprazole (used for gastric ulcer);
- HIV protease inhibitors (used in the treatment of HIV);
- astemizole, chlorpheniramine (antihistamines);
- calcium antagonists (used to treat angina and cardiac rhythm disorders);
- oral contraceptives;
- propranolol, carvedilol, timolol (used to treat high blood pressure);
- fluoxetine, paroxetine, sertraline, imipramine, clomipramine (antidepressants);
- haloperidol (an antipsychotic);
- codeine, dextromethorphan, tramadol (used to treat pain)

Diacomit with food and drink
Diacomit must NOT be taken with milk or dairy products (yoghurt, creamy fresh cheeses, etc.), fruit juices, carbonated drinks, or foods and beverages containing caffeine or theophylline (e.g. cola, chocolate, coffee, tea, and energy drinks).

Pregnancy and breastfeeding
If your daughter is pregnant, breastfeeding, thinks she may be pregnant, or is planning a pregnancy, consult your doctor before taking this medicine.
Effective antiepileptic therapy must NOT be stopped during pregnancy.
Breastfeeding is not recommended during treatment.

Driving and using machines
This medicine causes significant drowsiness.
Your child should not use tools, machinery, or drive vehicles (e.g. bicycles) if they experience this symptom. Consult your paediatrician.

DIACOMIT contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule and is therefore essentially ‘sodium-free’.

3. How to take Diacomit

The child must take these capsules exactly as directed by the doctor. If you
have any doubts, consult the paediatrician or pharmacist.
Dosage
The doctor will adjust the dose according to the child's age, body weight and general condition,
usually 50 mg per kg of body weight per day.
When to take Diacomit
The child should take this medicine two or three times a day, at regular intervals, as directed by the
doctor, for example morning – midday – evening before going to bed, in order to cover the 24-hour
period.
Dose adjustment
Dose increases should be gradual and take place over several weeks, while the dose of other
antiepileptic medicines is simultaneously reduced. The doctor will inform you about the dose of
other antiepileptic medicines.
If you feel that the effect of this medicine is too strong or too weak, inform the paediatrician or
pharmacist. The doctor will adjust the dose according to the child's condition.
There is a slight difference between Diacomit capsules and Diacomit oral suspension powder. Inform the doctor
if the child experiences any problems when switching from capsules to oral suspension powder or vice versa.
Any switch from capsules to powder or vice versa must be carried out under close supervision of the paediatrician.
If vomiting occurs a few minutes after administration, it is assumed that the medicine has not been
absorbed and another dose should be administered.
However, the situation is different if vomiting occurs more than one hour after administration, since
stiripentol is rapidly absorbed.
In this case, it is assumed that a significant portion of the administered dose has already been
systemically absorbed through the gastrointestinal tract. Therefore, there is no need to administer
another dose or to supplement the next dose.
How to take Diacomit capsules
To ensure that the full amount of powder is taken by the patient, it is preferable not to open the
capsule and to swallow it whole as a single oral dosage unit. The child must take Diacomit with food; it must
NOT be taken on an empty stomach. For foods and drinks to avoid, see the section above “Diacomit with food and drink”.
If the child takes more Diacomit than prescribed
If you know or suspect that the child has taken more medicine than prescribed, contact the
paediatrician immediately.
If the child forgets to take Diacomit
It is important that the child takes this medicine regularly every day at the same time. If the child
forgets to take a dose, it should be taken as soon as you remember, unless it is almost time for the
next dose. In that case, the child should take the next dose at the usual time. The child must not take a double
dose to make up for a forgotten single dose.
If the child stops taking Diacomit
The child must not stop treatment unless instructed by the doctor. Stopping treatment suddenly may
lead to a sudden recurrence of seizures.
If you have any doubts about how to use this medicine, consult the paediatrician or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause unwanted side effects, although not everyone experiences them.
Very common side effects (may affect more than 1 in 10 people):

loss of appetite, weight loss (particularly when Diacomit is used in combination with sodium valproate, an antiepileptic medicine);
insomnia, drowsiness;
ataxia (inability to coordinate muscle movements), hypotonia (reduced muscle strength), dystonia (involuntary muscle contractions).

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

increased liver enzyme levels, especially when Diacomit is used in combination with the antiepileptic medicines carbamazepine and sodium valproate;
aggression, irritability, agitation, hyperexcitability (unusual state of excitement);
sleep disturbances;
hyperkinesia (exaggerated movements);
nausea, vomiting;
reduced number of a type of white blood cells.

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

double vision when Diacomit is used in combination with the antiepileptic medicine carbamazepine;
light sensitivity;
skin rash and skin allergies, urticaria (itchy, pink, swollen areas on the skin);
fatigue (feeling of tiredness).

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

decreased platelet count in the blood;
abnormal results in liver function tests.

Not known (frequency cannot be estimated from available data):

Pneumonia (lung infection).

To eliminate these unwanted side effects, the paediatrician may need to adjust the dosage of Diacomit or of any other prescribed medicine.
Reporting of side effects
If your child experiences any side effect, including those not listed in this leaflet, please contact your paediatrician or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Diacomit

Keep this medicine out of the sight and reach of children.
Do not give this medicine to the child after the expiry date stated on the label after "Exp.". The expiry date refers to the last day of that month.

Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Diacomit 100 mg contains

The active substance is stiripentol. Each hard capsule contains 100 mg of stiripentol.
The excipients contained in the capsule are: povidone, sodium starch glycolate, and magnesium stearate (E470b).
The capsule coating consists of gelatin, titanium dioxide (E171), erythrosine (E127), and indigo carmine (E132). The printing ink contains shellac (E904) and black iron oxide (E172).

Description of the appearance of Diacomit 100 mg and package contents
The hard capsule of Diacomit 100 mg is white/pink in colour with "Diacomit 100 mg" printed on it.
The hard capsules are contained in bottles of 100 capsules, packed in cardboard boxes.

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 further information on Diacomit, 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
France/ Γαλλία/ France/ Francia/ Franciaország/ Frakkland/ Francija/ Franza/ Frankrijk/ Francja/
Frankrike
Tél/Tel/Teл/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 4
02130 Espoo
Finland
Tel: +358 9 329 59100
e-mail: [email protected]

LT
Biocodex UAB
Savanorių av. 349
LT-51480 Kaunas
Lithuania
Tel: +370 37 408681
e-mail: [email protected]

LV
Biocodex SIA
Kalniņi A, Mārupes nov.,
Mārupe, 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]

This leaflet was last updated on

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu. Links to other websites on rare diseases and their therapeutic treatments are also provided.

Package leaflet: Information for the user

Diacomit 250 mg hard capsules, 500 mg hard capsules

stiripentol
Please read this entire leaflet carefully before your child takes this medicine, as it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, consult your child's paediatrician or pharmacist.
This medicine has been prescribed for your child only. Never give it to anyone else. It could be dangerous for other individuals, even if their symptoms are the same as your child's.
If your child experiences any side effects, inform the paediatrician or pharmacist, even if the side effects are not listed in this leaflet. See section 4.

Contents of this leaflet

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

1. What Diacomit is and what it is used for

Stiripentol, the active substance in Diacomit, belongs to a group of medicines called antiepileptics.
It is used in combination with clobazam and valproate (other antiepileptic medicines) for the treatment of a
specific form of epilepsy known as severe myoclonic epilepsy in infancy (Dravet syndrome), which affects children.
Your paediatrician has prescribed this medicine to help treat your child's epilepsy.

2. What you should know before your child takes Diacomit

Your child MUST NOT take Diacomit

if he/she is allergic to stiripentol or to any of the other ingredients of this medicine (listed in section 6).
if he/she has experienced delirious seizures (a mental state characterized by confusion, excitement, restlessness, and hallucinations).

Warnings and precautions
Talk to your paediatrician or pharmacist before giving Diacomit to your child:

if your child has kidney or liver problems.
Before starting treatment with Diacomit, your child's liver function must be assessed, and checks must be repeated every 6 months.
Before starting treatment with Diacomit, blood cell count must be evaluated, and checks must be repeated every 6 months.
Due to the frequent occurrence of gastrointestinal side effects during treatment with Diacomit, clobazam, and valproate (such as anorexia, loss of appetite, nausea, vomiting), your child's growth rate must be monitored very closely.

Other medicines and Diacomit
Tell your paediatrician or pharmacist if your child is taking, has recently taken, or might take any other medicines.
Talk to your doctor if your child is taking any of the following medicines:

medicines containing:
- cisapride (used to treat symptoms of nighttime heartburn);
- pimozide (used to treat symptoms of Tourette’s syndrome, such as producing meaningless sounds and uncontrollable, repetitive body movements);
- ergotamine (used to treat migraine);
- dihydroergotamine (used to relieve signs and symptoms of impaired mental function due to aging);
- halofantrine (an antimalarial treatment);
- quinidine (used to treat cardiac arrhythmias);
- bepridil (used to relieve chest pain);
- ciclosporin, tacrolimus, sirolimus (all three used to prevent rejection following liver, kidney, and heart transplantation);
- statins (simvastatin and atorvastatin, both used to reduce cholesterol levels in the blood).
- antiepileptic medicines containing: phenobarbital, primidone, phenytoin, carbamazepine, diazepam.
- medicines containing: midazolam or triazolam (medicines that reduce anxiety and insomnia – when used in combination with Diacomit, they significantly increase drowsiness in the child); chlorpromazine (used for mental illnesses such as psychosis).
- If your child takes medicines containing: caffeine (a substance that helps keep the mind awake) or theophylline (a substance used in case of asthma). The combination with Diacomit should be avoided, as it may increase blood concentrations of these substances, leading to gastrointestinal disturbances, increased heart rate, and insomnia. If your child takes medicines metabolized by certain liver enzymes:
- citalopram (used to treat depressive episodes);
- omeprazole (used for gastric ulcer);
- HIV protease inhibitors (used in the treatment of HIV);
- astemizole, chlorpheniramine (antihistamines);
- calcium antagonists (used to treat angina and cardiac rhythm disorders);
- oral contraceptives;
- propranolol, carvedilol, timolol (used to treat high blood pressure);
- fluoxetine, paroxetine, sertraline, imipramine, clomipramine (antidepressants);
- haloperidol (an antipsychotic);
- codeine, dextromethorphan, tramadol (used to treat pain).

Diacomit with food and drinks
Diacomit MUST NOT be taken with milk or dairy products (yoghurt, creamy fresh cheeses, etc.), fruit juices, carbonated drinks, or foods and beverages containing caffeine or theophylline (e.g. cola, chocolate, coffee, tea, and energy drinks).

Pregnancy and breastfeeding
If your daughter is pregnant, breastfeeding, thinks she may be pregnant, or is planning a pregnancy, consult your doctor before taking this medicine.
Effective antiepileptic therapy MUST NOT be discontinued during pregnancy.
Breastfeeding is not recommended during treatment.

Driving and using machines
This medicine causes significant drowsiness.
Your child must not use tools, machinery, or drive vehicles (e.g. bicycle) if experiencing this symptom.
Consult your paediatrician.

DIACOMIT contains sodium.
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially 'sodium-free'.

3. How to take Diacomit

The child must take these capsules exactly as instructed by the doctor. If you have any doubts, consult your paediatrician or pharmacist.
Dosage
The doctor will adjust the dose according to the child's age, body weight and general condition. The usual dose is 50 mg per kg of body weight per day.
When to take Diacomit
The child must take this medicine two or three times a day, at regular intervals, as directed by the doctor, for example in the morning – at midday – in the evening before going to bed, in order to cover the 24-hour period.
Dose adjustment
Dosage increases should be gradual and take place over several weeks, while the dose of other antiepileptic medicines is simultaneously reduced. Your doctor will inform you about the dose of other antiepileptic medicines.
If you feel that the effect of this medicine is too strong or too weak, inform your paediatrician or pharmacist. The doctor will adjust the dose according to the child's condition.
Inform your paediatrician if any adverse reactions occur, as the doctor may need to adjust the dose of this medicine and of other antiepileptic medicines.
There is a slight difference between Diacomit capsules and Diacomit oral suspension powder. Inform your doctor if the child experiences any problems when switching from capsules to oral suspension powder or vice versa. Any switch between capsules and powder must be carried out under close supervision of the paediatrician.
In case of vomiting within a few minutes after administration, the medicine is presumed not to have been absorbed, and another dose should be administered.
However, the situation is different if vomiting occurs more than one hour after administration, as stiripentol is rapidly absorbed.
In this case, a significant portion of the administered dose is presumed to have been systemically absorbed through the gastrointestinal tract. Therefore, re-administration is not required, nor is supplementation of the next dose.
How to take Diacomit capsules
To ensure that the full amount of powder is taken by the patient, it is preferable not to open the capsule and to swallow it whole as a single oral dosage unit. The child must take Diacomit with food; it must NOT be taken on an empty stomach. For information on foods and drinks to avoid, see the section above “Diacomit with food and drink”.
If the child takes more Diacomit than prescribed
If you know or suspect that the child has taken more medicine than prescribed, contact your paediatrician immediately.
If the child forgets to take Diacomit
It is important that the child takes this medicine regularly every day at the same time. If the child forgets to take a dose, give it as soon as you remember, unless it is almost time for the next dose. In that case, the child should take the next dose at the usual time. The child must not take a double dose to make up for a missed single dose.
If the child stops taking Diacomit
The child must not stop treatment unless instructed by the doctor. Abruptly stopping treatment may lead to a sudden recurrence of seizures.
If you have any doubts about how to use this medicine, consult your paediatrician 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 (particularly if Diacomit is combined with sodium valproate, an antiepileptic medicine);
insomnia, drowsiness;
ataxia (lack of coordination of muscle movements), hypotonia (reduced muscle strength), dystonia (involuntary muscle contractions).

Common side effects (may affect less than 1 in 10 people but more than 1 in 100):

increased liver enzyme concentrations, especially if Diacomit is combined with the antiepileptic medicines carbamazepine and sodium valproate;
aggression, irritability, agitation, hyperexcitability (state of unusual excitement);
sleep disorders;
hyperkinesia (excessive movement);
nausea, vomiting;
reduced number of a type of white blood cells.

Uncommon side effects (may affect less than 1 in 100 people but more than 1 in 1,000):

double vision if Diacomit is combined with the antiepileptic medicine carbamazepine;
light sensitivity;
skin rash and skin allergies, urticaria (itchy, pink, swollen areas on the skin);
fatigue (feeling of tiredness).

Rare side effects (may affect less than 1 in 1,000 people but more than 1 in 10,000):

Decreased level of platelets in the blood
Abnormal results in liver function tests

Not known (frequency cannot be estimated from available data)

Pneumonia (infection of the lungs)

To eliminate these side effects, the paediatrician may need to adjust the dosage of Diacomit or of any other prescribed medicines.

Reporting of side effects

If your child experiences any side effects, including those not listed in this leaflet, please contact your paediatrician or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Diacomit

Keep this medicine out of the sight and reach of children.
The child should not take this medicine after the expiry date stated on the label after "EXP.". The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.

Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Diacomit 250 mg Contains

The active substance is stiripentol. Each hard capsule contains 250 mg of stiripentol.
The excipients contained in the capsule are: povidone, sodium starch glycolate, and magnesium stearate (E470b).
The capsule coating consists of gelatin, titanium dioxide (E171), erythrosine (E127), and indigotine (E132).
The printing ink contains shellac (E904) and black iron oxide (E172).

What Diacomit 500 mg Contains

The active substance is stiripentol. Each hard capsule contains 500 mg of stiripentol.
The excipients contained in the capsule are: povidone K29/32, sodium starch glycolate, and magnesium stearate (E470b).
The capsule coating consists of gelatin and titanium dioxide (E171).
The printing ink contains shellac (E904) and black iron oxide (E172).

Description of the Appearance of Diacomit 250 mg and Contents of the Package
The Diacomit 250 mg hard capsule is pink in colour with "Diacomit 250 mg" printed on it.
The hard capsules are packed in bottles containing 30, 60, or 90 capsules, with cardboard outer boxes. Not all pack sizes may be marketed.

Description of the Appearance of Diacomit 500 mg and Contents of the Package
The Diacomit 500 mg hard capsule is white in colour with "Diacomit 500 mg" printed on it. The hard capsules are packed in bottles containing 30, 60, or 90 capsules, with cardboard outer boxes. Not all pack sizes may be marketed.

Diacomit is also available as an oral suspension powder in sachets containing 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 further information on Diacomit, 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
France/ Γαλλία/ France/ Francia/ Franciaország/ Frakkland/ Francija/ Franza/ Frankrijk/ Francja/ Frankrike
Tél/Tel/Teл/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: 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 4
02130 Espoo
Finland
Tel: +358 9 329 59100
e-mail: [email protected]

LT
Biocodex UAB
Savanorių av. 349
LT-51480 Kaunas
Lithuania
Tel: +370 37 408681
e-mail: [email protected]

LV
Biocodex SIA
Kalniņi A, Mārupes nov.,
Mārupe, 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]

This leaflet was last updated on
Other Sources of Information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu. Links to other websites on rare diseases and their therapeutic treatments are also provided.

Patient Information Leaflet: Information for the User

Diacomit 250 mg Oral Suspension Powder in Sachets, 500 mg Oral Suspension Powder in Sachets

stiripentol
Please read this leaflet carefully before your child takes this medicine, as it contains
important information for you.
.

Keep this leaflet. You may need to read it again.
If you have any questions, consult your child's paediatrician or pharmacist.
This medicine has been prescribed for your child only. Never give it to others. This medicine could be dangerous for other people, even if their symptoms are the same as your child's.
If your child experiences any side effects, inform the paediatrician or pharmacist, even if you notice side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

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

1. What Diacomit is and what it is used for

Stiripentol, the active substance of Diacomit, belongs to a group of medicines called antiepileptics.
It is used in combination with clobazam and valproate (other antiepileptic medicines) for the treatment of a
specific form of epilepsy known as severe myoclonic epilepsy in infancy (Dravet syndrome), which affects children.
Your child's paediatrician 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 they are allergic to stiripentol or to any of the other ingredients of this medicine (listed in section 6).
if they have experienced delirious seizures (a mental state characterized by confusion, excitement, restlessness, and hallucinations).

Warnings and precautions
Talk to your pediatrician or pharmacist before administering Diacomit

if your child has kidney or liver problems.
Before starting treatment with Diacomit, your child's liver function should be assessed, and checks should be repeated every 6 months.
Before starting treatment with Diacomit, blood cell count should be evaluated and monitored every 6 months.
Due to the frequent occurrence of gastrointestinal side effects during treatment with Diacomit, clobazam, and valproate (such as loss of appetite, nausea, vomiting), your child's growth rate must be closely monitored.

If your child has problems with certain ingredients in Diacomit (e.g. aspartame, glucose, sorbitol), see below: "Diacomit contains aspartame, glucose, sorbitol, and sodium".

Other medicines and Diacomit
Inform your pediatrician or pharmacist if your child is taking, has recently taken, or might take any other medicines.
Talk to your doctor if your child is taking any of the following medicines:

Medicines containing:
- cisapride (used to treat symptoms of nighttime heartburn);
- pimozide (used to treat symptoms of Tourette syndrome, such as meaningless sounds and uncontrollable, repetitive body movements);
- ergotamine (used to treat migraine);
- dihydroergotamine (used to relieve signs and symptoms of reduced mental capacity due to aging);
- halofantrine (an antimalarial drug);
- quinidine (used to treat cardiac arrhythmias);
- bepridil (used to relieve chest pain);
- ciclosporin, tacrolimus, sirolimus (all three used to prevent rejection following liver, kidney, or heart transplantation);
- statins (simvastatin and atorvastatin, both used to reduce cholesterol levels in the blood);
- antiepileptic medicines containing: phenobarbital, primidone, phenytoin, carbamazepine, diazepam;
- medicines containing: midazolam or triazolam (medicines that reduce anxiety and insomnia; when used with Diacomit, they significantly increase drowsiness in the child); chlorpromazine (used for mental illnesses such as psychosis);
- if your child is taking medicines containing: caffeine (a substance that helps keep the mind alert) or theophylline (a substance used in asthma). The combination with Diacomit should be avoided, as it may increase blood levels of these substances, leading to gastrointestinal disturbances, increased heart rate, and insomnia.
- If your child takes medicines metabolized by certain liver enzymes:
  - citalopram (used to treat depressive episodes);
  - omeprazole (used for gastric ulcer);
  - HIV protease inhibitors (used in the treatment of HIV);
  - astemizole, chlorpheniramine (antihistamines);
  - calcium antagonists (used to treat angina and cardiac rhythm disorders);
  - oral contraceptives;
  - propranolol, carvedilol, timolol (used to treat high blood pressure);
  - fluoxetine, paroxetine, sertraline, imipramine, clomipramine (antidepressants);
  - haloperidol (an antipsychotic);
  - codeine, dextromethorphan, tramadol (used to treat pain).

Diacomit with food and drinks
Diacomit MUST NOT be taken with milk or dairy products (yogurt, creamy fresh cheeses, etc.), fruit juices, carbonated drinks, or foods and beverages containing caffeine or theophylline (e.g. cola, chocolate, coffee, tea, and energy drinks).

Pregnancy and breastfeeding
If your daughter is pregnant, breastfeeding, suspects she may be pregnant, or is planning a pregnancy, consult your doctor before taking this medicine.
Antiepileptic therapy must NOT be discontinued during pregnancy.
Breastfeeding is not recommended during treatment.

Diacomit contains aspartame, glucose, sorbitol, and sodium
This medicine contains 2.5 mg of aspartame per 250 mg sachet and 5 mg of aspartame per 500 mg sachet. Aspartame is a source of phenylalanine. Therefore, it may be harmful in patients with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.
This medicine contains sorbitol: 2.4 mg per 250 mg sachet and 4.8 mg per 500 mg sachet.
Glucose may be harmful to teeth. If your doctor has informed you of an intolerance to certain sugars, contact them before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per sachet, i.e., essentially 'sodium-free'.

3. How to take Diacomit

The child must take the contents of each sachet exactly as directed by the doctor. If you have any doubts, consult your paediatrician or pharmacist.
Dosage
The dose will be adjusted by the doctor according to the child's age, body weight, and general condition, usually 50 mg per kg of body weight per day.
When to take Diacomit
The child should take this medicine two or three times a day, at regular intervals, as directed by the doctor, for example, morning – midday – evening before bedtime, in order to cover the day-night period.
Dosage adjustment
Dosage increases should be gradual and occur over several weeks, while the dose of other antiepileptic medicines is simultaneously reduced. Your doctor will inform you about the dosage of other antiepileptic medicines.
If you feel that the effect of this medicine is too strong or too weak, inform your paediatrician or pharmacist. The doctor will adjust the dose according to the child's condition.
Inform your paediatrician if any adverse effects occur, as the doctor may need to adjust the dose of this medicine and of other antiepileptic medicines.
There is a slight difference between Diacomit capsules and Diacomit oral suspension powder. Inform the doctor if the child experiences any problems when switching from capsules to oral suspension powder or vice versa. Any switch between capsules and powder must be carried out under close supervision by the paediatrician.
In case of vomiting within a few minutes after administration, it is assumed that the medicine has not been absorbed; therefore, another dose should be administered.
However, the situation is different if vomiting occurs more than one hour after administration, as stiripentol is rapidly absorbed.
In this case, it is assumed that a significant portion of the administered dose has already been systemically absorbed through the gastrointestinal tract. Therefore, there is no need to administer another dose or to supplement the next dose.
How to take Diacomit oral suspension powder
The powder must be dissolved in a glass of water and taken immediately during meals. The child must take Diacomit with food; it must NOT be taken on an empty stomach. For foods and drinks to avoid, see the section above “Diacomit with food and drink”.
If the child takes more Diacomit than they should
If you know or suspect that the child has taken more medicine than they should, contact your paediatrician immediately.
If the child forgets to take Diacomit
It is important that the child takes this medicine regularly every day at the same time. If the child forgets to take a dose, they should take it as soon as they remember, unless it is almost time for the next dose. In that case, they should take the next dose at the usual time. The child must NOT take a double dose to make up for the missed dose.
If the child stops taking Diacomit
The child must NOT stop treatment unless instructed by the doctor. Stopping treatment suddenly may lead to a sudden recurrence of seizures.
If you have any questions about the use of this medicine, consult your paediatrician or pharmacist.

4. Possible side effects

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

Very common side effects (may occur in more than 1 out of 10 people):

loss of appetite, weight loss (especially if Diacomit is taken together with sodium valproate, an antiepileptic medicine);
insomnia, drowsiness;
ataxia (inability to coordinate muscle movements), hypotonia (reduced muscle strength), dystonia (involuntary muscle contractions).

Common side effects (may occur in less than 1 out of 10 but more than 1 out of 100 people):

increased liver enzyme levels, especially if Diacomit is taken together with the antiepileptic medicines carbamazepine and sodium valproate;
aggression, irritability, agitation, hyperexcitability (state of unusual excitement);
sleep disturbances;
hyperkinesia (excessive movement);
nausea, vomiting;
reduced number of a type of white blood cells.

Uncommon side effects (may occur in less than 1 out of 100 but more than 1 out of 1,000 people):

double vision, if Diacomit is taken together with the antiepileptic medicine carbamazepine;
light sensitivity;
skin rash and skin allergies, urticaria (itchy, pink, swollen patches on the skin);
fatigue (feeling of tiredness).

Rare side effects (may occur in less than 1 out of 1,000 but more than 1 out of 10,000 people):

decreased level of platelets in the blood;
abnormal results in liver function tests.

To eliminate these side effects, the paediatrician may need to adjust the dosage of Diacomit or of one of the other prescribed medicines.

Not known (frequency cannot be estimated from available data):

Pneumonia (infection of the lungs)

Reporting of side effects
If the child experiences any side effects, including those not listed in this leaflet, please consult the paediatrician or pharmacist. You may also report side effects directly through the national reporting system listed in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Diacomit

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

The child should not take this medicine after the expiry date which is stated on the label after "EXP.". The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.

Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What Diacomit 250 mg contains

The active substance is stiripentol. Each sachet contains 250 mg of stiripentol.
The excipients contained in the sachet are: povidone, sodium starch glycolate, liquid glucose (spray-dried), erythrosine (E127), titanium dioxide (E171), aspartame (E951), mixed fruit flavouring (contains sorbitol), sodium carmellose and hydroxyethylcellulose.

What Diacomit 500 mg contains

The active substance is stiripentol. Each sachet contains 500 mg of stiripentol.
The excipients contained in the sachet are: povidone, sodium starch glycolate, liquid glucose (spray-dried), erythrosine (E127), titanium dioxide (E171), aspartame (E951), mixed fruit flavouring (contains sorbitol), sodium carmellose and hydroxyethylcellulose.

Description of the appearance of Diacomit 250 mg and contents of the pack
This medicine is a pink-coloured powder contained in sachets.
Each pack contains 30, 60 or 90 sachets. Not all pack sizes may be marketed.
Description of the appearance of Diacomit 500 mg and contents of the pack
This medicine is a pink-coloured powder contained in sachets.
Each pack contains 30, 60 or 90 sachets. Not all pack sizes may be marketed.
Diacomit is also available as an oral suspension powder in sachets of 250 mg and 500 mg.

MARKETING AUTHORISATION HOLDER

Biocodex,
22 rue des Aqueducs - 94250 – F -Gentilly - France
Tel: + 33 1 41 24 30 00 - e-mail: [email protected]

Manufacturer

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

For further information on DIACOMIT, please contact the local representative of the marketing authorisation holder: