DIACOMIT 250 mg Hard Capsule

Содержание инструкции

1. Diacomit 100 mg hard capsules
   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. How to store Diacomit
   6. Contents of the pack and other information
2. Diacomit 250 mg hard capsules, 500 mg hard capsules
   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. How to store Diacomit
   6. Package contents and other information
3. Diacomit 250 mg Powder for oral suspension in sachets, 500 mg Powder for oral suspension in sachets
   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. How to store Diacomit
   6. Package contents and other information

Package leaflet included in the package: Information for the user

Diacomit 100 mg hard capsules

stiripentol

Read this leaflet carefully before the 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 pediatrician or pharmacist.
• This medicine has been prescribed only for your child. Never give it to others. In fact, this medicine could be dangerous to other individuals, even if their symptoms are the same as those of your child.
• If the child experiences any side effects, including those not listed in this leaflet, inform your pediatrician or pharmacist. See section 4.

Contents of this leaflet

• 1. What Diacomit is and what it is used for
• 2. What you need to know before the 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 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 together with clobazam and valproate (other antiepileptic medicines) for the treatment of
a particular form of epilepsy called severe myoclonic epilepsy of infancy (Dravet syndrome) which affects children. Your pediatrician has prescribed this medicine to help treat
the 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 any of the other ingredients of this medicine (listed in section 6).
• if they have had delirious crises (a mental state characterized by confusion, excitement, restlessness and hallucinations).

Warnings and precautions
Consult your pediatrician or pharmacist before giving Diacomit

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

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

• medicines containing:
• cisapride (used to treat symptoms of heartburn);
• pimozide (used to treat symptoms of Tourette's syndrome, for example, making meaningless sounds and involuntary, repetitive body movements);
• ergotamine (used to treat migraine);
• dihydroergotamine (used to relieve signs and symptoms of reduced mental capacity due to the aging process);
• halofantrine (antimalarial treatment);
• quinidine (used to treat heart arrhythmias);
• bepridil (used to relieve chest pain);
• cyclosporine, tacrolimus, sirolimus (all three are used to prevent rejection following liver, kidney and heart transplantation);
• statins (simvastatin and atorvastatin, both used to reduce cholesterol levels in the blood).
• anticonvulsant medicines containing: phenobarbital, primidone, phenytoin, carbamazepine, diazepam
• medicines containing: midazolam or triazolam (medicines that reduce anxiety and insomnia - in combination with Diacomit they significantly increase the child's drowsiness); chlorpromazine (used for mental illnesses such as psychoses).
• If your child is taking medicines containing: caffeine (a substance that helps keep the mind awake) or theophylline (a substance used for asthma). The combination with Diacomit should be avoided as it may increase the concentrations of these substances in the blood with resulting digestive disorders, accelerated heartbeat and insomnia.
• If your child takes medicines metabolized by certain liver enzymes:
• citalopram (used in the treatment of depressive episodes);
• omeprazole (used for stomach ulcers);
• HIV protease inhibitors (used in the treatment of HIV);
• astemizole, chlorpheniramine (antihistamines);
• calcium channel blockers (used in the treatment of angina and heart rhythm disturbances);
• oral contraceptives;
• propranolol, carvedilol, timolol (used in the treatment of high blood pressure);
• fluoxetine, paroxetine, sertraline, imipramine, clomipramine (antidepressants);
• haloperidol (antipsychotic);
• codeine, dextromethorphan, tramadol (used in the treatment of pain)

Diacomit with food and drink
Diacomit MUST NOT be taken with milk or its derivatives (yogurt, creamy fresh cheeses,
etc.), fruit juices, carbonated drinks or foods and drinks containing caffeine or theophylline (for example
cola, chocolate, coffee, tea and energy drinks).

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

Driving and operating machinery
This medicine causes significant drowsiness.
The child must not use tools, machinery, drive vehicles (e.g. bicycle) if they experience this
symptom. Ask your pediatrician.

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

3. How to take Diacomit

The child must take these capsules following the doctor's instructions exactly at all times. If you
have any doubts, consult your pediatrician or pharmacist.

Dosage
The dose is adjusted by the doctor based on the child's age, weight, and general condition,
usually 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, according to
the doctor's instructions, for example morning – noon – evening before bedtime, in order to
cover the day-night period.

Dose adjustment
Increases in dosage must be gradual and occur over several weeks, while the
dose of other antiepileptic drugs is reduced simultaneously. The doctor will inform you
about the dose of other antiepileptic drugs.
If you feel that the effect of this medicine is too strong or too weak, inform your
pediatrician or pharmacist. The doctor will adjust the dose based on the child's condition.
There is a slight difference between Diacomit capsules and Diacomit powder for oral suspension. Inform your doctor
if the child should have problems switching from taking the capsules to taking the
powder for oral suspension or vice versa. Any switch from capsules to powder and vice versa must
be carried out under strict control of the pediatrician.
In case of vomiting a few minutes after taking the medicine, it is assumed that the medicine has not been
absorbed, therefore another dose must be administered.
However, the situation is different if the episode of vomiting occurs more than an hour after
taking the medicine, as stiripentol is rapidly absorbed.
In this case, it is assumed that a significant part of the administered dose has been absorbed at
the systemic level by the digestive system. It is therefore not necessary to proceed with a new
administration or an integration of the next dose.

How to take Diacomit capsules
To ensure that the entire amount of powder is taken by the patient, it is preferable not to open the
capsule and swallow it as a single oral unit. The child must take
Diacomit with food, and must NOT take it on an empty stomach. For foods and beverages to avoid,
see the section above “Diacomit with food and beverages”.

If the child takes more Diacomit than they should
If you know or think that the child has ingested more medicine than they should have, contact your
pediatrician.

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 time for the next dose. In this case, the child should take the next dose as usual. The
child should not take a double dose to make up for a missed single dose.

If the child stops taking Diacomit
The child should not stop treatment unless instructed by the doctor. Suddenly stopping
treatment may lead to a sudden onset of seizures.
If you have any doubts about the use of this medicine, consult your pediatrician 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 taken with sodium valproate, a medicine for epilepsy);
• 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 levels of liver enzymes, especially if Diacomit is taken with the antiepileptic medicines carbamazepine and sodium valproate;
• aggressiveness, irritability, agitation, hyperexcitability (unusual state of excitement);
• sleep disorders;
• hyperkinesia (exaggeration of 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 if Diacomit is taken with the antiepileptic medicine carbamazepine
• sensitivity to light;
• skin rash and skin allergies, urticaria (pink, itchy swellings on the skin);
• fatigue (feeling tired).

Rare side effects(may affect up to 1 in 1000)

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

Not known(frequency cannot be estimated from available data)

• Pneumonia (lung infection)

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

Reporting of side effects
If your child gets any side effect, talk to your doctor 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 to 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 must 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.

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

6. Contents of the pack and other information

What Diacomit 100 mg contains

• The active ingredient 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 is composed of gelatin, titanium dioxide (E171), erythrosine (E127), indigotine (E132). The printing ink contains shellac (E904), black iron oxide (E172).

Description of the appearance of Diacomit 100 mg and contents of the pack
The hard capsule of Diacomit 100 mg is white/pink in colour with "Diacomit 100 mg" imprinted on it.
The hard capsules are contained in bottles of 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: [email protected]

Manufacturer
Biocodex, 1 avenue Blaise Pascal - F-60000 Beauvais - France
For further information about Diacomit, 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/ Ελλάδα/ France/ Francia/ Franciaország/ Frakkland/ Francija/ Franza/ Frankrijk/ Francja/
Frankrike
Tel/Tel/Тел/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 Bucarest
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 medicine is available on the website of the European
Medicines Agency http://www.ema.europa.eu. There are also links to other websites
on rare diseases and related therapeutic treatments.

Diacomit 250 mg hard capsules, 500 mg hard capsules

stiripentol

Read this leaflet carefully before the 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 pediatrician or pharmacist.
• This medicine has been prescribed only for your child. Never give it to others. In fact, this medicine could be dangerous to other individuals, even if their symptoms are the same as those of your child.
• If the child experiences any side effects, inform your pediatrician or pharmacist, even if you notice any side effects not listed in this leaflet. See section 4.

Contents of this leaflet

• 1. What Diacomit is and what it is used for
• 2. What you need to know before the 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 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 together with clobazam and valproate (other antiepileptic medicines) for the treatment of a
particular form of epilepsy called severe myoclonic epilepsy of infancy (Dravet syndrome) which
affects children. Your pediatrician has prescribed this medicine to help treat the 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 any of the other ingredients of this medicine (listed in section 6).
• if they have had delirious crises (a mental state characterized by confusion, excitement, restlessness and hallucinations). Warningsand precautionsConsult your pediatrician or pharmacist before giving Diacomit
• if your child has kidney or liver problems.
• Before starting therapy with Diacomit, your child's liver function must be assessed and checks must be repeated every 6 months.
• Before starting therapy with Diacomit, the blood cell count must be assessed and checks must be repeated every 6 months.
• Given the frequency of undesirable gastrointestinal effects during treatment with Diacomit, clobazam and valproate (anorexia, loss of appetite, nausea, vomiting), the child's growth rate must be monitored very carefully.

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

• medicines containing:
• cisapride (used to treat the symptoms of heartburn);
• pimozide (used to treat the symptoms of Tourette's syndrome, for example, producing meaningless sounds and involuntary, repetitive body movements);
• ergotamine (used for the treatment of migraine);
• dihydroergotamine (used to relieve the signs and symptoms of reduced mental capacity due to the aging process);
• halofantrine (antimalarial treatment);
• quinidine (used for the treatment of heart arrhythmias);
• bepridil (used to relieve chest pain);
• cyclosporine, tacrolimus, sirolimus (all three are 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 - in combination with Diacomit they significantly increase the child's drowsiness); chlorpromazine (used for mental illnesses such as psychoses).
• If the child is taking medicines containing: caffeine (a substance that helps keep the mind awake) or theophylline (a substance used for asthma). The combination with Diacomit should be avoided as it may increase the concentrations of these substances in the blood with resulting digestive system disorders, accelerated heartbeat and insomnia. If the child is taking medicines metabolized by certain liver enzymes:
• citalopram (used in the treatment of depressive episodes);
• omeprazole (used for stomach ulcers);
• HIV protease inhibitors (used in the treatment of HIV);
• astemizole, chlorpheniramine (antihistamines)
• calcium channel blockers (used in the treatment of angina and heart rhythm disturbances);
• oral contraceptives
• propranolol, carvedilol, timolol (used in the treatment of high blood pressure);
• fluoxetine, paroxetine, sertraline, imipramine, clomipramine (antidepressants);
• haloperidol (antipsychotic);
• codeine, dextromethorphan, tramadol (used in the treatment of pain)

Diacomit with food and drink
Diacomit MUST NOT be taken with milk or its derivatives (yogurt, creamy fresh cheeses, etc.),
fruit juices, carbonated drinks or foods and drinks containing caffeine or theophylline (for example cola,
chocolate, coffee, tea and energy drinks).

Pregnancy and breastfeeding
If your daughter is pregnant or breastfeeding, suspects she is pregnant or is planning a
pregnancy, ask your doctor for advice 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.
The child must not use tools, machinery, drive vehicles (e.g. bicycle) if they experience this symptom.
Ask your pediatrician for advice.

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 following the doctor's instructions exactly at all times. If you have any doubts
consult your pediatrician or pharmacist.

Dosage
The dose is adjusted by the doctor based on the child's age, weight and general condition, generally
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 instructed by the
doctor, for example morning – noon – evening before bedtime, in order to cover the
day-night period

Dose adjustment
Increases in dosage must be gradual and occur over several weeks, while the dose of
other antiepileptic drugs is reduced simultaneously. The doctor will inform you of the dose of
other antiepileptic drugs.
If you feel that the effect of this medicine is too strong or too weak, inform your pediatrician or
pharmacist. The doctor will adjust the dose based on the child's condition.
Inform your pediatrician if any of the undesirable effects occur, as the doctor
may need to adjust the dose of this medicine and other antiepileptic medicines.
There is a slight difference between Diacomit capsules and Diacomit powder for oral suspension. Inform the doctor
if the child should have problems switching from taking the capsules to taking the
powder for oral suspension or vice versa. Any switch from capsules to powder and vice versa must
be carried out under strict pediatric control.
In case of vomiting a few minutes after taking the medicine, it is assumed that the medicine has not been absorbed,
therefore another dose must be administered.
However, the situation is different if the episode of vomiting occurs more than an hour
after taking the medicine, as stiripentol is rapidly absorbed.
In this case, it is assumed that a significant portion of the administered dose has been absorbed at the
systemic level by the digestive system. Therefore, it is not necessary to proceed with a new administration or
an integration of the next dose.

How to take Diacomit capsules
To ensure that the entire amount of powder is taken by the patient, it is preferable not to open the
capsule and swallow it as a single oral unit of administration. The child must take
Diacomit with food, it should NOT be taken on an empty stomach. For foods and beverages to avoid, see the
section above “Diacomit with food and beverages”.

If the child takes more Diacomit than they should
If you know or think that the child has ingested more medicine than they should, contact your pediatrician.

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 time for the
next dose. In this case, the child should take the next dose as usual. The child should not
take a double dose to make up for a missed single dose.

If the child stops treatment with Diacomit
The child should not stop treatment unless instructed by the doctor. Suddenly stopping
treatment may lead to a sudden onset of seizures.
If you have any doubts about the use of this medicine, consult your pediatrician 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 taken with sodium valproate, an anti-epileptic 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 concentrations of liver enzymes, especially if Diacomit is taken with carbamazepine and sodium valproate anti-epileptic medicines;
• aggression, irritability, agitation, hyperexcitability (an unusual state of excitement);
• sleep disorders;
• hyperkinesia (exaggeration of 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 if Diacomit is taken with the anti-epileptic medicine carbamazepine;
• sensitivity to light;
• skin rash and skin allergies, urticaria (itchy, pink swellings on the skin);
• fatigue (feeling tired).

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

• Decrease in platelet levels in the blood
• Abnormal results in liver function tests

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

• Pneumonia (lung infection)

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

Reporting of side effects
If your child gets any side effects, talk to your pediatrician or pharmacist. You can also report side effects directly through the national reporting system detailed in Appendix 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 must 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 package, to keep the medicine protected from light.

Do not dispose of any medicine in 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 ingredient 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 is composed of gelatin, titanium dioxide (E171) erythrosine (E127), indigotine (E132).
• The printing ink contains shellac (E904) black iron oxide (E172).

What Diacomit 500 mg contains

• The active ingredient 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 is composed of gelatin, titanium dioxide (E171).
• The printing ink contains shellac (E904) black iron oxide (E172).

Description of the appearance of Diacomit 250 mg and package contents
The hard capsule of Diacomit 250 mg is pink in color with "Diacomit 250 mg" imprinted on it.
The hard capsules are contained in bottles of 30, 60 or 90 capsules, in cardboard boxes. Not all
pack sizes may be marketed.

Description of the appearance of Diacomit 500 mg and package contents
The hard capsule of Diacomit 500 mg is white in color with "Diacomit 500 mg" imprinted on it. The hard capsules
are contained in bottles of 30, 60 or 90 capsules, in cardboard boxes. Not all pack sizes
may 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: [email protected]

Manufacturer
Biocodex,
1 avenue Blaise Pascal - F-60000 Beauvais - France
For further information about Diacomit, 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 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
related therapeutic treatments.

Diacomit 250 mg Powder for oral suspension in sachets, 500 mg Powder for oral suspension in sachets

stiripentol

Read this leaflet carefully before the 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 doctor or pharmacist.
• This medicine has been prescribed only for your child. Never give it to others. In fact, this medicine may be dangerous for other individuals, even if their symptoms are the same as those of your child.
• If the child experiences any side effects, inform your doctor or pharmacist, even if you notice any side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

• 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 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 together with clobazam and valproate (other antiepileptic medicines) for the treatment of a
particular form of epilepsy called severe myoclonic epilepsy of infancy (Dravet syndrome) which
affects children. Your pediatrician 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 any of the other ingredients of this medicine (listed in section 6).
• if they have had delirious crises (a mental state characterized by confusion, excitement, restlessness and hallucinations).

Warnings and precautions
Consult your pediatrician or pharmacist before giving Diacomit

• if your child has kidney or liver problems.
• Before starting therapy with Diacomit, your child's liver function must be assessed and checks must be repeated every 6 months.
• Before starting therapy with Diacomit, the blood cell count must be assessed and checks must be repeated every 6 months.
• Given the frequency of undesirable gastrointestinal effects during treatment with Diacomit, clobazam and valproate (anorexia, loss of appetite, nausea, vomiting), your child's growth rate must be monitored very carefully.

If your child has problems with some ingredients of Diacomit (for example aspartame, glucose, sorbitol). In
this case, see below: “ Diacomit contains aspartame, glucose, sorbitol and sodium”.

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

• medicines containing:
• cisapride (used to treat the symptoms of heartburn at night);
• pimozide (used to treat the symptoms of Tourette's syndrome, for example making meaningless sounds and uncontrollable, repetitive movements of the body);
• ergotamine (used for the treatment of migraine);
• dihydroergotamine (used to relieve the signs and symptoms of reduced mental capacity due to the aging process);
• halofantrine (an antimalarial drug);
• quinidine (used for the treatment of heart arrhythmias);
• bepridil (used to calm chest pain);
• cyclosporine, tacrolimus, sirolimus (all three are 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 in association with Diacomit significantly increase the child's drowsiness); chlorpromazine (used for mental illnesses such as psychoses).
• if your child is taking medicines containing: caffeine (a substance that helps keep the mind awake) or theophylline (a substance used in case of asthma). The association with Diacomit should be avoided as it may increase the concentrations of these substances in the blood with resulting digestive disorders, accelerated heartbeat and insomnia. If your child is taking medicines metabolized by certain liver enzymes:
• citalopram (used in the treatment of depressive episodes);
• omeprazole (used for gastric ulcer);
• HIV protease inhibitors (used in the treatment of HIV);
• astemizole, chlorpheniramine (antihistamines)
• calcium antagonists (used in the treatment of angina and heart rhythm disorders);
• oral contraceptives
• propranolol, carvedilol, timolol (used in the treatment of high blood pressure);
• fluoxetine, paroxetine, sertraline, imipramine, clomipramine (antidepressants);
• haloperidol (antipsychotic);
• codeine, dextromethorphan, tramadol (used in the treatment of pain)

Diacomit with food and drink
Diacomit MUST NOT be taken with milk or its derivatives (yogurt, creamy fresh cheeses, etc.),
fruit juices, carbonated drinks or foods and drinks containing caffeine or theophylline (for example cola,
chocolate, coffee, tea and energy drinks).

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

Driving and operating machinery
This medicine causes significant drowsiness.
The child must not use tools, machinery, drive vehicles (e.g. bicycle) if they experience this symptom.
Ask your pediatrician for advice.

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
suffering from phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates as the
body is unable to eliminate it correctly.
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 told you that you suffer from 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, always following the doctor's instructions exactly. If you have any doubts, consult your pediatrician or pharmacist.

Dosage
The dose is adjusted by the doctor based on the child's age, weight and general condition, generally 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, according to the doctor's instructions, for example morning – noon – evening before bedtime, in order to cover the day-night period

Dose adjustment
Increases in dosage must be gradual and occur over several weeks, while the dose of other antiepileptic drugs is simultaneously reduced. The doctor will inform you about the dose of other antiepileptic drugs.
If you feel that the effect of this medicine is too strong or too weak, inform your pediatrician or pharmacist. The doctor will adjust the dose according to the child's condition.
Inform your pediatrician if any of the undesirable effects occur, as the doctor may need to adjust the dose of this medicine and other antiepileptic medicines.
There is a slight difference between Diacomit capsules and Diacomit powder for oral suspension. Inform the doctor if the child should have problems switching from taking capsules to taking powder for oral suspension or vice versa. Any switch from capsules to powder and vice versa must be carried out under strict control of the pediatrician.
In case of vomiting a few minutes after taking the medicine, it is assumed that the medicine has not been absorbed, therefore another dose must be administered.
However, the situation is different if the episode of vomiting occurs more than an hour after taking the medicine, as stiripentol is rapidly absorbed.
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In this case, it is assumed that a significant part of the administered dose has been absorbed systemically by the digestive system. It is therefore not necessary to proceed with a new administration or an integration of the next dose.

How to take Diacomit powder for oral suspension
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 beverages to be avoided, see the section above “Diacomit with food and beverages”.

If the child takes more Diacomit than they should
If you know or think that the child has ingested more medicine than they should, contact your pediatrician.

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 time for the next dose. In this case, they should take the next dose as usual. The child should 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. Suddenly stopping treatment can lead to a sudden onset of seizures.
If you have any doubts about the use of this medicine, consult your pediatrician 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 if Diacomit is taken with sodium valproate, a medicine for epilepsy);
• insomnia, drowsiness;
• ataxia (inability to coordinate muscle movements), hypotonia (decreased muscle strength), dystonia (involuntary muscle contractions).

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

• increased concentrations of enzymes in the liver, especially if Diacomit is taken with carbamazepine and sodium valproate, medicines for epilepsy;
• aggression, irritability, agitation, hyperexcitability (an unusual state of excitement);
• sleep disorders;
• hyperkinesia (exaggeration of movements);
• nausea, vomiting;
• decreased number of a type of white blood cells.

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

• double vision if Diacomit is taken with the antiepileptic drug carbamazepine;
• sensitivity to light;
• skin rash and skin allergies, urticaria (itchy, pinkish swellings on the skin);
• fatigue (feeling tired).

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

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

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

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

• Pneumonia (lung infection)

Reporting of side effects
If your child gets any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system detailed 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 package, to keep the medicine protected from light.

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

6. Package contents and other information

What Diacomit 250 mg contains

• The active ingredient 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 carboxymethylcellulose and hydroxyethylcellulose.

What Diacomit 500 mg contains

• The active ingredient 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 carboxymethylcellulose and hydroxyethylcellulose.

Description of the appearance of Diacomit 250 mg and package contents
This medicine is presented as a pink 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 package contents
This medicine is presented as a pink powder contained in sachets.
Each pack contains 30, 60 or 90 sachets. Not all pack sizes may be
marketed.
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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 - 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 about 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
Франция/ 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]
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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 medicine is available on the website of the European Medicines
Agency: http://www.ema.europa.eu. There are also links to other websites on rare diseases and
related therapeutic treatments.
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ANNEX IV
Scientific conclusions and justification for the variation of the terms of the authorisation(s)
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Scientific conclusions
In light of the assessment of the Pharmacovigilance and Risk Assessment Committee (PRAC) of the Periodic Safety Update Report (PSUR) for stiripentol, the PRAC’s scientific conclusions are as follows:
In light of the available data on risks from clinical studies and spontaneous reports, the PRAC considers that there is at least a reasonable possibility of a causal relationship between stiripentol and pneumonia. The PRAC concluded that the medicine information for products containing stiripentol should be amended accordingly.
Having reviewed the PRAC recommendation, the Committee for Human Medicinal Products (CHMP) agrees with the PRAC’s overall conclusions and with the justification for the recommendation.

Justification for the variation of the terms of the authorisation(s)
Based on the scientific conclusions on stiripentol, the CHMP considers that the benefit-risk ratio of the medicine(s) containing stiripentol remains unchanged, save for the proposed changes to the medicine information.
The CHMP recommends the variation of the terms of the authorisation(s).
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