DIACOMIT stiripentol 250 mg powder for oral suspension sachet

Země: Austrálie

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktivní složka:

stiripentol, Quantity: 250 mg

Dostupné s:

Chiesi Australia Pty Ltd

Léková forma:

Powder, oral

Složení:

Excipient Ingredients: sodium starch glycollate type A; povidone; spray-dried liquid glucose; erythrosine; titanium dioxide; aspartame; carmellose; hyetellose; Flavour

Podání:

Oral

Jednotky v balení:

60 sachets

Druh předpisu:

(S4) Prescription Only Medicine

Terapeutické indikace:

DIACOMIT is indicated for adjunctive treatment of generalised tonic-clonic and clonic seizures associated with severe myoclonic epilepsy in infancy (SMEI, also known as Dravet syndrome) in patients whose seizures are not adequately controlled with a benzodiazepine (usually clobazam) and valproate.

Přehled produktů:

Visual Identification: Pale pink powder packaged in paper/Al/PE film composite; Container Type: Sachet; Container Material: Other composite material; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Stav Autorizace:

Registered

Datum autorizace:

2019-09-13

Informace pro uživatele

DIACOMIT Consumer Medicine Information
DIACOMIT CMI Ver 3.0
1
▼
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects your
child may get. You can report
side effects to your child’s doctor, or directly at
www.tga.gov.au/reporting-problems.
DIACOMIT
®
_Stiripentol _
_250 mg and 500 mg capsule and powder for suspension _
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about DIACOMIT. As this
leaflet does not contain all the
available information, it is important that you talk to your doctor or
pharmacist. All medicines have risks
and benefits. Your doctor has weighed the risks of you receiving
DIACOMIT against the benefits this
medicine is expected to have for you.
If you have any concerns about taking this medicine, ask your doctor
or pharmacist.
KEEP THIS LEAFLET. YOU MAY NEED TO READ IT AGAIN.
WHAT DIACOMIT IS USED FOR
Stiripentol, the active ingredient of DIACOMIT, belongs to a group of
medicines called antiepileptics. It
is used in conjunction with other antiepileptic medicines to treat a
certain form of epilepsy called severe
myoclonic epilepsy in infancy (Dravet syndrome), which affects infants
and children. Your child’s doctor
has prescribed this medicine to help treat your child’s epilepsy. It
should always be taken in combination
with other prescribed antiepileptic medicines under the direction of a
doctor.
BEFORE YOUR CHILD TAKES DIACOMIT
_WHEN YOUR CHILD MUST NOT TAKE IT: _
_ _
Your child must NOT take DIACOMIT if he/she:

is allergic to stiripentol or to any of the other ingredients of
DIACOMIT (listed at the end of this
leaflet - (See "DIACOMIT description"). Signs of allergic reaction may
include a skin rash,
itching, shortness of breath or swelling of the face, lips or tongue.

has ever experienced attacks of delirium (a mental state with
confusion, excitement, restlessness
and hallucinations).
_BEFORE YOUR CHILD TAKES IT: _
Befor

Charakteristika produktu

DIACOMIT Product Information
DIACOMIT PI Ver 3.0
1
This medicinal product is subject to additional monitoring in
Australia. This will allow
quick identification of new safety information. Healthcare
professionals are asked to report any
suspected adverse events at www.tga.gov.au/reporting-problems.
AUSTRALIAN PRODUCT INFORMATION - DIACOMIT
®
(STIRIPENTOL)
1
NAME OF THE MEDICINE
DIACOMIT (stiripentol)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Stiripentol 250 mg and 500 mg capsule
Stiripentol 250 mg and 500 mg powder for oral suspension
Each capsule contains either 250 mg or 500 mg stiripentol as the
active ingredient.
Each sachet contains either 250 mg or 500 mg stiripentol as the active
ingredient.
Excipients with a known effect in powders for oral suspensions:
aspartame and sugars.
Capsules contain no excipients with a known effect.
For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
DIACOMIT 250 mg capsule appears as an opaque pink capsule of size 2
with self-locking
closure, imprinted with “Diacomit 250 mg”.
DIACOMIT 500 mg capsule appears as a white capsule of size 0 with
self-locking closure,
imprinted with “Diacomit 500 mg”.
DIACOMIT 250 mg and 500 mg powder for oral suspension is a pale pink
powder filled in a
single dose sachet.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
DIACOMIT is indicated for adjunctive treatment of generalised
tonic-clonic and clonic
seizures associated with severe myoclonic epilepsy in infancy (SMEI,
also known as Dravet
syndrome) in patients whose seizures are not adequately controlled
with a benzodiazepine
(usually clobazam) and valproate.
4.2
DOSE AND METHOD OF ADMINISTRATION
_DOSAGE _
Prescriptions and treatment should be initiated by neurologists
experienced in the diagnosis
and management of epilepsy, with continuation of patient management by
general
paediatricians and practitioners when the initiating neurologist is
unavailable.
▼

DIACOMIT Product Information
DIACOMIT PI Ver 3.0
2
GENERAL
The dose of stiripentol