Land: Australia
Språk: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
stiripentol, Quantity: 250 mg
Chiesi Australia Pty Ltd
Capsule
Excipient Ingredients: sodium starch glycollate type A; magnesium stearate; povidone; Gelatin; titanium dioxide; erythrosine; indigo carmine; Shellac; iron oxide black
Oral
60 capsules
(S4) Prescription Only Medicine
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.
Visual Identification: opaque pink capsule of size 2 with self-locking closure, imprinted with Diacomit 250 mg; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Registered
2019-09-13
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 Les hele dokumentet
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 Les hele dokumentet