Diacomit

Country: Unjoni Ewropea

Lingwa: Ingliż

Sors: EMA (European Medicines Agency)

Ingredjent attiv:

stiripentol

Disponibbli minn:

Biocodex

Kodiċi ATC:

N03AX17

INN (Isem Internazzjonali):

stiripentol

Grupp terapewtiku:

Antiepileptics,

Żona terapewtika:

Myoclonic Epilepsy, Juvenile

Indikazzjonijiet terapewtiċi:

Diacomit is indicated for use in conjunction with clobazam and valproate as adjunctive therapy of refractory generalized tonic-clonic seizures in patients with severe myoclonic epilepsy in infancy (SMEI, Dravet's syndrome) whose seizures are not adequately controlled with clobazam and valproate.

Sommarju tal-prodott:

Revision: 18

L-istatus ta 'awtorizzazzjoni:

Authorised

Data ta 'l-awtorizzazzjoni:

2007-01-03

Fuljett ta 'informazzjoni

78
B. PACKAGE LEAFLET
79
PACKAGE LEAFLET: INFORMATION FOR THE USER
DIACOMIT 100 MG HARD CAPSULES
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 before your child takes Diacomit
3.
How to take Diacomit
4.
Possible side effects
5
How to store Diacomit
6.
Contents of the pack and other information
1.
WHAT DIACOMIT IS AND WHAT IT IS USED FOR
Stiripentol, the active ingredient 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

Karatteristiċi tal-prodott

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Diacomit 100 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 100 mg of stiripentol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule
Size 4, pink and white capsule, imprinted with “Diacomit 100 mg”,
length of 14 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Diacomit is indicated for use in conjunction with clobazam and
valproate as adjunctive therapy of
refractory generalized tonic-clonic seizures in patients with severe
myoclonic epilepsy in infancy
(SMEI, Dravet’s syndrome) whose seizures are not adequately
controlled with clobazam and
valproate.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Diacomit should only be administered under the supervision of a
paediatrician / paediatric neurologist
experienced in the diagnosis and management of epilepsy in infants and
children.
Posology
_Paediatric population_
The dose of stiripentol is calculated on a mg/kg body weight basis.
The daily dosage may be administered in 2 or 3 divided doses.
The initiation of adjunctive therapy with stiripentol should be
undertaken gradually using upwards
dose escalation to reach the recommended dose of 50 mg/kg/day
administered in conjunction with
clobazam and valproate.
Stiripentol dosage escalation should be gradual, starting with
20mg/kg/day for 1 week, then
30mg/kg/day for 1 week. Further dosage escalation is age dependent:
- children less than 6 years should receive an additional 20 mg/kg/day
in the third week, thus
achieving the recommended dose of 50 mg/kg/day in three weeks;
- children from 6 to less than 12 years should receive an additional
10 mg/kg/day each week, thus
achieving the recommended dose of 50 mg/kg/day in four weeks;
- children and adolescents 12 years and older should receive an
additional 5 mg/kg/day each week
until the optimum dose is reached based on clinical judgment.
The recommended dose of 50 mg/kg/day is based on the available
clinical study fin