Diacomit – Package Leaflet: InfoCons – Consumer Protection presents, in an accessible format, the official package leaflet of the medicine Diacomit, as authorised in the European Union and published in the Union Register of medicinal products.
Before anything else
Read all of this leaflet carefully before your child starts taking this medicine because it contains important information for you .
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your child’s doctor or pharmacist.
- This medicine has been prescribed for your child only. Do not pass it on to others. It may harm them, even if their symptoms are the same as your child’s.
- If your child gets any side effects , talk to your child’s doctor or pharmacist . This includes any possible side effects not listed in this leaflet. See Section 4.
What is i n this leaflet 1. What Diacomit is and what it is used for 2. What you need to know b efore your child takes Diacomit 3. How to take Diacomit 4. Possible side effects 5 How to store Diacomit 6. Contents of the pack and o ther information 1. What Diacomit is and what it is used for Stiripentol, the active ingredient of Diacomit, belongs to a group of medicines called antiepileptics.
It is used in conjunction with clobazam and valproate (other antiepileptic medicines ) to treat a certain form of epilepsy called severe myoclonic epilepsy in infancy (Dravet’s syndrome), which affects children. Your child’s doctor has prescribed this medicine to help treat your child’s epilepsy.
2. What you need to know before your child takes Diacomit Your child must NOT take Diacomit
- if your child is allergic to stiripentol or to any of the other ingredients of this medicine (listed in section 6) .
- if your child has ever experienced attacks of delirium (a mental state with confusion, excitement, restlessness and hallucinations) .
Warnings and precautions
Talk to your child’s doctor or pharmacist before taking Diacomit
- if your child has kidney or liver problems.
- Your child’s liver function should be assessed prior to starting Diacomit and checked every 6 months.
- Your child’s blood count should be assessed prior to starting Diacomit and checked every 6 months.
- Because the frequency of gastrointestinal side effect with Diacomit, clobazam and valproate, such as anorexia, loss of appetite, vomiting, your child’s growth rate should be carefully monitored.
Other medicines and Diacomit
Tell your child’s doctor or pharmacist if your child is using , has recently used or might use any other medicines.
Tell your doctor if your child is taking any of the following medicine s:
- medicines containing:
- cisapride (used to treat symptoms of night -time heartburn);
- pimozide (used to treat the symptoms of Tourette’s syndrome e.g. vocal outbursts and uncontrolled, repeated movements of the body);
- ergotamine (used to treat migraine);
- dihydroergotamine (used to relieve the signs and symptoms of decreased mental capacity due to the aging process);
- halofantrine (an antimalarial treatment );
- quinidine (used to treat abnormal heart rhythms);
- bepridil (used to control chest pain);
- cyclosporine, tacrolimus, sirolimus (all three used to prevent rejections of liver, kidney and heart transplants);
- statins (simvastatin and atorvastatin, both used to reduce the amount of cholesterol in blood).
- antiepileptic medicines containing: phenobarbital, primidone, phenytoin, carbamazepine, diazepam.
- medicines containing: midazolam or triazolam ( medicines used to reduce anxiety and sleeplessness – in combination with Diacomit they may make your child very sleepy); chlorpromazine (used for mental illness such as psychosis).
- If your child takes m edicines containing: caffeine (th is substance help s restore mental alertness) or theophylline (th is substance is used in case of asthma ). The combination with Diacomit should be avoided as it may increase their blood levels, leading to digestive disorders, racing heart and insomnia.
- If your child takes medicines metabolized by certain liver enzymes :
- citalopram (used in the treatment of depressive episod es);
- omeprazole (used in case of gastric ulcer) ;
- HIV protease inhibitors (used in the treatment of HIV) ;
- astemizole, chlorpheniramine (antihistamines) ;
- calcium channel blockers (used in the treatment of ang or or troubles of heart rhythm) ;
- oral contraceptives ;
- propranolol, carvedilol, timolol ( used in the treatment of high blood pressure );
- fluoxetine, paroxetine, sertraline, imipramine, clomipramine (antidepressants) ;
- haloperidol (antipsychotics) ;
- codeine, dextromethorphan, tramadol ( used in the treatment of pain ).
Diacomit with food and drink Do NOT take Diacomit with milk or dairy products (yoghurt, soft cream cheeses, etc), fruit juice, fizzy drinks or food and drinks that contain caffeine or theophylline (for example cola, chocolate, coffee, tea and energy drinks).
Pregnancy and breast -feeding If you r child is pregnant or breast -feeding, think she may be pregnant or is planning to have a baby, ask your doctor for advice before taking this medicine.
During pregnancy, effective antiepileptic treatment must NOT be stopped.
Breast -feeding is not recommended during treatment with this medicine.
Driving and using machines
This medicine may make your child feel sleepy.
Your child should not use any tools, machines, ride or drive if affected in this way. Check with your child’s doctor.
Diacomit contains sodium
82 This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium -free’ .
3. How to take Diacomit Your child should always take these capsules exactly as your child’s doctor has told you. You should check with your child’s doctor or pharmacist if you are not sure.
Dosage The dose is adjusted by the doctor according to your child’s age, weight and condition, generally 50 mg per kg bodyweight and per day.
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 morning – noon – bedtime to cover the night -and-day period.
Dose adjustment Dose increases should be gradual , taking place over a few weeks while the dose (s) of the other antiepileptic medicine(s) is (are) reduced at the same time. Your child’s doctor will tell you the new dose of the other antiepileptic medicine(s).
If you have the impression that the effect of this medicine is too strong or too weak, talk to your child’s doctor or pharmacist . The dose will be adjusted by the doctor according to your child’s condition.
There are slight differences between the Diacomit capsules and powder for oral suspension. If your child experiences any problems when switching from taking the capsules to the powder for oral suspension or vice versa please inform your doctor. In case of switch between capsule and powder formulations it should be done under the close supervision of your child’s doctor.
In case of vomiting within the first few minutes of intake it is assumed that no medicine has been absorbed and a new dose should be given.
However, the situation is different if the vomiting occurs more than one hour after medicine intake because stiripentol is quickly absorbed.
In such a case, it is assumed that a significant fraction of the administered dose has been absorbed syste mically from the digestive tract. Thus, there would be no need for a new intake or for an adjustment of the next dose.
How to take the Diacomit capsules To ensure that the whole amount of powder is taken by the patient, it is preferable not to open the capsule and to swallow it as a single oral administration unit form. Your child should take Diacomit with food, it should NOT be taken on an empty stomach . For food and drinks to be avoided, see the section “Diacomit with food and drink” above.
If your child takes more Diacomit than he or she should Contact your child’s doctor if you know or think your child has taken more medicine than he or she should have.
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, he or she should take it as soon as you remember unless it is time for the next dose. In that case carry on with the next dose as normal. Your child should not take a double dose to make up for a forgotten individual dose.
83 If your child stops taking Diacomit Your child must not stop taking this medicine unless the doctor tells you to. Stopping treatment suddenly can lead to an outbreak of seizures.
If you have any further questions on the use of this medicine , ask your child’s doctor or pharmacist.
4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common side effects (may affect more than one in 10 people )
- loss of appetite, weight loss (especially when combined with the antiepileptic medicine sodium valproate);
- insomnia (sleeplessness), drowsiness;
- ataxia (inability to coordinate muscle movements), hypotonia (low muscle strength), dystonia (involuntary muscle contractions ).
Common side effects (may affect up to 1 in 10 people )
- raised levels of liver enzymes, especially when given with either of the antiepileptic medicines carbamazepine and sodium valproate;
- aggressiveness, irritability, agitation, hyperexcitability (state of being unusually excitable);
- sleep disorders (abnormal sleeping);
- hyperkinesis (exaggerated movements);
- nausea, vomiting;
- a low number of a type of white blood cells.
Uncommon side effects (may affect up to 1 in 100 people )
- double vision when used in combination with the antiepileptic medicine carbamazepine;
- sensitivity to light;
- rash, skin allergy, urticaria (pinkish, itchy swellings on the skin);
- fatigue (tiredness).
Rare side effects (may affect up to 1 in 1,000 people)
- decrease of platelet level in the blood ;
- abnormal liver function test.
Not known (frequency cannot be estimated from the available data)
- Pneumonia (infection of the lungs) To eliminate these side effects, your child’s doctor may have to change the dose of Diacomit or one of the other medicines prescribed for your child .
Reporting of side effects
If you r child gets any side effects, talk to your child’s doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed 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.
- Your child should not take Diacomit after the expiry date, which is stated on the label after “EXP” . The expiry date refers to the last day of that month.
84 Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Diacomit 100 mg contains
- The active substance is stiripentol. Each hard capsule contains 100 mg of stiripentol.
- The other ingredients of the capsule are povidone, sodium starch glycolate and magnesium stearate (E470b ).
- The capsule shell is made of gelatin, titanium dioxide (E171), erythrosine (E127), indigotin (E132).
The printing ink contains shellac (E904), black iron oxide (E172) .
What Diacomit 100 mg looks like and contents of the pack
Diacomit 100 mg hard capsule is white/ pink and imprinted with “Diacomit 100 mg” .
The hard capsules are supplied in plastic bottles containing 100 capsules in cardboard cartons.
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 any information about this medicine, 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/Te л/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 Repu blic 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 Latvi a 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 revised in
Other sources of information Detailed information on this medicine is available on the European Medicine Agency website: http://www.ema.europa.eu. There are also links to other websites about rare diseases and treatments.
87 Package leaflet : Information for the user Diacomit 250 mg hard capsule Diacomit 500 mg hard c apsule stiripentol Read all of this leaflet carefully before your child starts taking this medicine because it contains important information for you .
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your child’s doctor or pharmacist.
- This medicine has been prescribed for your child only. Do not pass it on to others. It may harm them, even if their symptoms are the same as your child’s.
- If your child gets any side effects , talk to your child’s doctor or pharmacist . This includes any possible side effects not listed in this leaflet. See Section 4.
What is i n this leaflet 1. What Diacomit is and what it is used for 2. What you need to know b efore your child takes Diacomit 3. How to take Diacomit 4. Possible side effects 5 How to store Diacomit 6. Contents of the pack and o ther information
ℹ️ 1. What Diacomit is and what it is used for
Stiripentol , the active ingredient of Diacomit, belongs to a group of medicines called antiepileptics.
It is used in conjunction with clobazam and valproate (other antiepileptic medicines ) to treat a certain form of epilepsy called severe myoclonic epilepsy in infancy (Dravet’s syndrome), which affects children. Your child’s doctor has prescribed this medicine to help treat your child’s epilepsy.
⚠️ 2. What you need to know before your child takes Diacomit
Your child must NOT take Diacomit
- if your child is allergic to stiripentol or to any of the other ingredients of this medicine (listed in section 6) .
- if your child has ever experienced attacks of delirium (a mental state with confusion, excitement, restlessness and hallucinations) .
Warnings and precautions
Talk to your child’s doctor or pharmacist before taking Diacomit
- if your child has kidney or liver problems.
- Your child’s liver function should be assessed prior to starting Diacomit and checked every 6 months .
- Your child’s blood count should be assessed prior to starting Diacomit and checked every 6 months .
- Because the frequency of gastrointestinal side effect with Diacomit, clobazam and valproate, such as anorexia, loss of appetite, vomiting, your child’s growth rate should be carefully monitored.
Other medicines and Diacomit
Tell your child’s doctor or pharmacist if your child is using , has recently used or might use any other medicines.
Tell your doctor if your child is taking any of the following medicine s:
- medicines containing:
- cisapride (used to treat symptoms of night time heartburn);
- pimozide (used to treat the symptoms of Tourette’s syndrome e.g. vocal outbursts and uncontrolled, repeated movements of the body);
- ergotamine (used to treat migraine);
- dihydroergotamine (used to relieve the signs and symptoms of decreased mental capacity due to the aging process);
- halofantrine (an antimalarial treatment );
- quinidine (used to treat abnormal heart rhythms);
- bepridil (used to control chest pain);
- cyclosporine, tacrolimus, sirolimus (all three used to prevent rejections of liver, kidney and heart transplants);
- statins (simvastatin and atorvastatin, both used to reduce the amount of cholesterol in blood).
- antiepileptic medicines containing: phenobarbital, primidone, phenytoin, carbamazepine, diazepam.
- medicines containing: midazolam or triazolam ( medicines used to reduce anxiety and sleeplessness – in combination with Diacomit they may make your child very sleepy); chlorpromazine (used for mental illness such as psychosis).
- If your child takes m edicines containing: caffeine (this substance help s restore mental alertness) or theophylline (th is substance is used in case of asthma ). The combination with Diacomit should be avoided as it may increase their blood levels, leading to digestive disorders, racing heart and insomnia.
- If your child takes medicines metabolized by certain liver enzymes :
- citalopram (used in the treatment of depressive episod es);
- omeprazole (used in case of gastric ulcer) ;
- HIV protease inhibitors (used in the treatment of HIV) ;
- astemizole, chlorpheniramine (antihistamines) ;
- calcium channel blockers (used in the treatment of ang or or troubles of heart rhythm) ;
- oral contraceptives ;
- propranolol, carvedilol, timolol ( used in the treatment of high blood pressure );
- fluoxetine, paroxetine, sertraline, imipramine, clomipramine (antidepressants) ;
- haloperidol (antipsychotics) ;
- codeine, dextromethorphan, tramadol ( used in the treatment of pain ).
Diacomit with food and drink Do NOT take Diacomit with milk or dairy products (yoghurt, soft cream cheeses, etc), fruit juice, fizzy drinks or food and drinks that contain caffeine or theophylline (for example cola, chocolate, coffee, tea and energy drinks).
Pregnancy and breast -feeding If you r child is pregnant or breast -feeding, think she may be pregnant or is planning to have a baby, ask your doctor for advice before taking this medicine.
During pregnancy, effective antiepileptic treatment must NOT be stopped.
Breast -feeding is not recommended during treatment with this medicine.
Driving and using machines
This medicine may make your child feel sleepy.
Your child should not use any tools, machines, ride or drive if affected in this way. Check with your child’s doctor.
Diacomit contains sodium
89 This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium -free’ .
💊 3. How to take Diacomit
Your child should always take these capsules exactly as your child’s doctor has told you. You should check with your child’s doctor or pharmacist if you are not sure.
Dosage The dose is adjusted by the doctor according to your child’s age, weight and condition, generally 50 mg per kg bodyweight and per day.
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 morning – noon – bed-time to cover the night -and-day period.
Dose adjustment Dose increases should be gradual , taking place over a few weeks while the dose (s) of the other antiepileptic medicine(s) is (are) reduced at the same time. Your child’s doctor will tell you the new dose of the other antiepileptic medicine(s).
If you have the impression that the effect of this medicine is too strong or too weak, talk to your child’s doctor or pharmacist . The dose will be adjusted by the doctor according to your child’s condition.
Please consult your child’s doctor in the event of any side effects as the doctor may have to adjust the dose of this medicine and the other antiepileptic medicine(s).
There are slight differences between the Diacomit capsules and powder for oral suspension. If your child experiences any problems when switching from taking the capsules to the powder for oral suspension or vice versa please inform your doctor. In case of switch between capsule and powder formulations it should be done under the close supervision of your child’s doctor.
In case of vomiting within the first few minutes of intake it is assumed that no medicine has been absorbed and a new dose should be given.
However, the situation is different if the vomiting occurs more than one hour after medicine intake because stiripentol is quickly absorbed.
In such a case, it is assumed that a significant fraction of the administered dose has been absorbed syste mically from the digestive tract. Thus, there would be no need for a new intake or for an adjustment of the next dose.
How to take the Diacomit capsules To ensure that the whole amount of powder is taken by the patient, it is preferable not to open the capsule and to swallow it as a single oral administration unit form.
Your child should take Diacomit with food, it should NOT be taken on an empty stomach . For food and drinks to be avoided, see the section “Diacomit with food and drink” above.
If your child takes more Diacomit than he or she should Contact your child’s doctor if you know or think your child has taken more medicine than he or she should have.
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, he or she should take it as soon as you remember unless it is time for the next dose. In that case carry on with the next dose as normal. Your child should not take a double dose to make up for a forgotten individual dose.
90 If your child stops taking Diacomit Your child must not stop taking this medicine unless the doctor tells you to. Stopping treatment suddenly can lead to an outbreak of seizures.
If you have any further questions on the use of this medicine , ask your child’s doctor or pharmacist.
❗ 4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common side effects (may affect more than one in 10 people )
- loss of appetite, weight loss (especially when combined with the antiepileptic medicine sodium valproate);
- insomnia (sleeplessness), drowsiness;
- ataxia (inability to coordinate muscle movements), hypotonia (low muscle strength), dystonia (involuntary muscle contractions ).
Common side effects (may affect up to 1 in 10 people )
- raised levels of liver enzymes, especially when given with either of the antiepileptic medicines carbamazepine and sodium valproate;
- aggressiveness, irritability, agitation, hyperexcitability (state of being unusually excitable);
- sleep disorders (abnormal sleeping);
- hyperkinesis (exaggerated movements);
- nausea, vomiting;
- a low number of a type of white blood cells.
Uncommon side effects (may affect up to 1 in 100 people )
- double vision when used in combination with the antiepileptic medicine carbamazepine;
- sensitivity to light;
- rash, skin allergy, urticaria (pinkish, itchy swellings on the skin);
- fatigue (tiredness).
Rare side effects (may affect up to 1 in 1,000 people)
- decrease of platelet level in the blood ;
- abnormal liver function test.
Not known (frequency cannot be estimated from the available data)
- Pneumonia (infection of the lungs) To eliminate these side effects, your child’s doctor may have to change the dose of Diacomit or one of the other medicines prescribed for your child .
Reporting of side effects
If you r child gets any side effects, talk to your child’s doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed 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.
- Your child should not take Diacomit 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 in order to protect from light.
91 Do not throw away any medicines via wastewater or household waste . Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
📦 6. Contents of the pack and other information
What Diacomit 250 mg contains
- The active substance is stiripentol. Each hard capsule contains 250 mg of stiripentol.
- The other ingredients of the capsule are povidone, sodium starch glycolate and magnesium stearate (E470b) .
- The capsule shell is made of gelatin, titanium dioxide (E171), erythrosine (E127), indigotin (E132).
- The printing ink contains shellac (E904), black iron oxide (E172) .
What Diacomit 500 mg contains
- The active substance is stiripentol. Each hard capsule contains 500 mg of stiripentol.
- The other ingredients of the capsule are povidone, sodium starch glycolate and magnesium stearate (E470b) .
- The capsule shell is made of gelatin, titanium dioxide (E171).
- The printing ink contains shellac (E904), black iron oxide (E172) .
What Diacomit 250 mg looks like and contents of the pack
Diacomit 250 mg hard capsule is pink and printed with “Diacomit 250 mg” .
The hard capsules are supplied in plastic bottles containing 30, 60 or 90 capsules in cardboard cartons.
Not all pack sizes may be marketed.
What Diacomit 500 mg looks like and contents of the pack
Diacomit 500 mg hard capsule is white and printed with “Diacomit 500 mg” .
The hard capsules are supplied in plastic bottles containing 30, 60 or 90 capsules in cardboard cartons.
Not all pack sizes may be marketed.
Diacomit is also available as 250 mg and 500 mg powder for oral suspension in sachets.
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 any information about this medicine, 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 / Franciaors zág/ 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 Repub lic 92 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 93 e-mail: [email protected]
This leaflet was last revised in
Other sources of information Detailed information on this medicine is available on the European Medicine Agency website: http://www.ema.europa.eu. There are also links to other websites about rare diseases and treatments.
94 Package leaflet : information for the user Diacomit 250 mg powder for oral suspension in sachet Diacomit 500 mg powder for oral suspension in sachet stiripentol Read all of this leaflet carefully before your child starts taking this medicine because it contains important information for you .
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your child’s doctor or pharmacist.
- This medicine has been prescribed for your child only. Do not pass it on to others. It may harm them, even if their symptoms are the same as your child’s.
- If your child gets any side effects , talk to your child’s doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See Section 4.
What is in this leaflet:
1. What Diacomit is and what it is used for 2. What you need to know b efore your child takes Diacomit 3. How to take Diacomit 4. Possible side effects 5 How to store Diacomit 6. Contents of the pack and o ther information 1. What Diacomit is and what it is used for Stiripentol , the active ingredient of Diacomit, belongs to a group of medicines called antiepileptics.
It is used in conjunction with clobazam and valproate (other antiepileptic medicines) to treat a certain form of epilepsy called severe myoclonic epilepsy in infancy (Dravet’s syndrome), which affects children. Your child’s doctor has prescribed this medicine to help treat your child’s epilepsy.
2. What you need to know before your child takes Diacomit Your child must NOT take Diacomit
- if your child is allergic to stiripentol or to any of the other ingredients of this medicine (listed in section 6) .
- if your child has ever experienced attacks of delirium (a mental state with confusion, excitement, restlessness and hallucinations) .
Warnings and precautions
Talk to your child’s doctor or pharmacist before taking Diacomit
- if your child has kidney or liver problems.
- Your child’s liver function should be assessed prior to starting Diacomit and checked every 6 months .
- Your child’s blood count should be assessed prior to starting Diacomit and checked every 6 months .
- Because of the frequency of gastrointestinal side effects with Diacomit, clobazam and valproate, such as anorexia, loss of appetite, vomiting, your child’s growth rate should be carefully monitored.
If your child has problems with certain ingredients of Diacomit (e.g. aspartame, glucose, sorbitol ). In this case, please see below: “Important information about some of the ingredients of Diacomit” .
95 Other medicines and Diacomit Tell your child’s doctor or pharmacist if your child is using , has recently used or might use any other medicines.
Tell your doctor if your child is taking any of the following medicine s:
- medicines containing:
- cisapride (used to treat symptoms of night time heartburn);
- pimozide (used to treat the symptoms of Tourette’s syndrome e.g. vocal outbursts and uncontrolled, repeated movements of the body);
- ergotamine (used to treat migraine);
- dihydroergotamine (used to relieve the signs and symptoms of decreased mental capacity due to the aging process);
- halofantrine (an antimalarial treatment );
- quinidine (used to treat abnormal heart rhythms);
- bepridil (used to control chest pain);
- cyclosporine, tacrolimus, sirolimus (all three used to prevent rejections of liver, kidney and heart transplants);
- statins (simvastatin and atorvastatin, both used to reduce the amount of cholesterol in blood).
- antiepileptic medicines containing: phenobarbital, primidone, phenytoin, carbamazepine, diazepam.
- medicines containing: midazolam or triazolam ( medicines used to reduce anxiety and sleeplessness – in combination with Diacomit they may make your child very sleepy); chlorpromazine (used for mental illness such as psychosis).
- If your child takes medicines containing :
Caffeine (this substance help s restore mental alertness) or theophylline ( this substance is used in case of asthma ). The combination with Diacomit should be avoided as it may increase their blood levels, leading to digestive disorders, racing heart and insomnia.
- If your child takes medicines metabolized by certain liver enzymes :
- citalopram (used in the treatment of depressive episod es);
- omeprazole (used in case of gastric ulcer) ;
- HIV protease inhibitors (used in the treatment of HIV) ;
- astemizole, chlorpheniramine (antihistamines) ;
- calcium channel blockers (used in the treatment of ang or or troubles of heart rhythm) ;
- oral contraceptives ;
- propranolol, carvedilol, timolol ( used in the treatment of high blood pressure );
- fluoxetine, paroxetine, sertraline, imipramine, clomipramine (antidepressants) ;
- haloperidol (antipsychotics) ;
- codeine, dextromethorphan, tramadol ( used in the treatment of pain ).
Diacomit with food and drink Do NOT take Diacomit with milk or dairy products (yoghurt, soft cream cheeses, etc), fruit juice, fizzy drinks or food and drinks that contain caffeine or theophylline (for example cola, chocolate, coffee, tea and energy drinks).
Pregnancy and b reast -feeding If you r child is pregnant or breast -feeding, think she may be pregnant or is planning to have a baby, ask your doctor for advice before taking this medicine.
During pregnancy, effective antiepileptic treatment must NOT be stopped.
Breast -feeding is not recommended during treatment with this medicine.
Driving and using machines
This medicine may make your child feel sleepy.
Your child should not use any tools, machines, ride or drive if affected in this way. Check with your child’s doctor.
Diacomit contains aspartame, glucose, sorbitol and sodium
This medicine contains 2.5 mg aspartame in each 250mg -sachet and 5 mg each 500mg -sachet .
Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
This medicine contains sorbitol : 2.4 mg in each 250mg -sachet and 4.8 mg in each 500mg -sachet.
Glucose m ay be harmful to the teeth .
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
This medicine contains less than 1 mmol sodium (23 mg) per sachet , that is to say essentially ‘sodium – free’ .
3. How to take Diacomit Your child should always take the contents of each sachet exactly as your child’s doctor has told you.
You should check with your child’s doctor or pharmacist if you are not sure.
Dosage The dose is adjusted by the doctor according to your child’s age, weight and condition, generally 50 mg per kg bodyweight and per day.
When to take Diacomit Your child should take this medicine two or three times a day at regular intervals as d irected by your child’s doctor: for example morning – noon – bed-time to cover the night -and-day period.
Dose adjustment Dose increases should be gradual , taking place over a few weeks while the dose (s) of the other antiepileptic medicine(s) is (are) reduced at the same time. Your child’s doctor will tell you the new dose of the other antiepileptic medicine(s).
If you have the impression that the effect of this medicine is too strong or too weak, talk to your child’s doctor or pharmacist . The dose will be adjusted by the doctor according to your child’s condition.
Please consult your child’s doctor in the event of any side effects as the doctor may have to adjust the dose of this medicine and the other antiepileptic medicine(s).
There are slight differences between the Diacomit capsules and powder for oral suspension. If your child experiences any problems when switching from taking the capsules to the powder for oral suspension or vice versa please inform your doctor. In case of switch between capsule and powder formulation it should be done under the close supervision of your child’s doctor.
In case of vomiting within the first few minutes of intake it is assumed that no medicine has been absorbed and a new dose should be given.
However, the situation is different if the vomiting occurs more than one hour after medicine intake because stiripentol is quickly absorbed . In such a case, it is assumed that a significant fraction of the administered dose has been absorbed systemically from the digestive tract. Thus, there would be no need for a new intake or for an adjustment of the nex t dose.
How to take the Diacomit powder for oral suspension The powder should be mixed in a glass of water and should be taken immediately after mixing during the meal. Your child should take Diacomit with food, it should NOT be taken on an empty stomach.
For food and drinks to be avoided, see the section “ Diacomit with food and drink ” above.
If your child takes more Diacomit than he or she should Contact your child’s doctor if you know or think your child has taken more medicine than he or she should have.
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, he or she should take it as soon as you remember unless it is time for the next dose. In that case carry on with the next dose as normal. Your child should not take a double dose to make up for a forgotten individual dose.
If your child stops taking Diacomit Your child must not stop taking this medicine unless the doctor tells you to. Stopping treatment suddenly can lead to an outbreak of seizures.
If you have any further questions on the use of this medicine , ask your child’s doctor or pharmacist.
4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common side effects (may affect more than one in 10 people )
- loss of appetite, weight loss (especially when combined with the antiepileptic medicine sodium valproate);
- insomnia (sleeplessness), drowsiness;
- ataxia (inability to coordinate muscle movements), hypotonia (low muscle strength), dystonia (involuntary muscle contractions ).
Common side effects (may affect up to1 in 10 people )
- raised levels of liver enzymes, especially when given with either of the antiepileptic medicines carbamazepine and sodium valproate;
- aggressiveness, irritability, agitation, hyperexcitability (state of being unusually excitable);
- sleep disorders (abnormal sleeping);
- hyperkinesis (exaggerated movements);
- nausea, vomiting;
- a low number of a type of white blood cells.
Uncommon side effects (may affect up to 1 in 100 people )
- double vision when used in combination with the antiepileptic medicine carbamazepine;
- sensitivity to light;
- rash, skin allergy, urticaria (pinkish, itchy swellings on the skin);
- fatigue (tiredness).
Rare side effects (may affect up to 1 in 1,000 people)
- decrease of platelet level in the blood ;
- abnormal liver function test
Not known (frequency cannot be estimated from the available data)
- Pneumonia (infection of the lungs) To eliminate these side effects, your child’s doctor may have to change the dose of Diacomit or one of the other medicines prescribed for your child .
Reporting of side effects
If you r child gets any side effects, talk to your child’s doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V .
By reporting side effects you can help provide more information on the safety of this medicine.
98 5. How to store Diacomit
- Keep this medicine out of the sight and reach of children.
- Your child should not take Diacomit 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 in order to protect from light.
Do not throw away any medicines via wastewater or household waste . Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Diacomit 250 mg contains
- The active substance is stiripentol. Each sachet contains 250 mg of stiripentol.
- The other ingredients of the sachet are povidone, sodium starch glycolate, glucose liquid (spray dried), erythrosine (E127), titanium dioxide (E171), aspartame (E951), tutti frutti flavour (contains sorbitol), carmellose sodium, hydroxyethylcellulose.
What Diacomit 500 mg contains
- The active substance is stiripentol. Each sachet contains 500 mg of stiripentol.
- The other ingredients of the sachet are povidone, sodium starch glycolate, glucose liquid (spray dried), erythrosine (E127), titanium dioxide (E171), aspartame (E951), tutti frutti flavour (contains sorbitol), carmellose sodium, hydroxyethylcellulose.
What Diacomit 250 mg looks like and contents of the pack
This medicine is a pale pink powder supplied in sachets.
Cartons contain either 30, 60 or 90 sachets. Not all pack sizes may be marketed.
What Diacomit 500 mg looks like and contents of the pack
This medicine is a pale pink powder supplied in sachets.
Cartons contain either 30, 60 or 90 sachets. Not all pack sizes may be marketed.
Diacomit is also available as 250 mg and 500 mg capsules for oral use
Marketing Authorisation Holder
Biocodex ,22 rue des Aqueducs – F-94250 Gentilly – France Tel: + 33 1 41 24 30 00 – e-mail: medinfo @biocodex.com
Manufacturer
Biocodex , 1 avenue Blaise Pascal – F-60000 Beauvais – France For any information about this medicine, 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] 99 CZ Desitin Pharma spol. s r.o Opletalova 25 11121 Prague 1 Czech Repu blic 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: epi.info@desitin .de 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 Latvi a 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] 100 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 revised in
Other sources of information Detailed information on this medicine is available on the European Medicine Agency website: http://www.ema.europa.eu. There are also links to other websites about rare diseases and treatments.
📄 Package Leaflet – official source
This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Diacomit (PDF, ec.europa.eu).
You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/06/367).
⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.