VIMPAT 100 MG

Country: Iżrael

Lingwa: Ingliż

Sors: Ministry of Health

Ingredjent attiv:

LACOSAMIDE

Disponibbli minn:

NEOPHARM LTD, ISRAEL

Kodiċi ATC:

N03AX18

Għamla farmaċewtika:

FILM COATED TABLETS

Kompożizzjoni:

LACOSAMIDE 100 MG

Rotta amministrattiva:

PER OS

Tip ta 'preskrizzjoni:

Required

Manifatturat minn:

UCB PHARMA S.A., BELGIUM

Grupp terapewtiku:

LACOSAMIDE

Żona terapewtika:

LACOSAMIDE

Indikazzjonijiet terapewtiċi:

Vimpat is indicated as monotherapy and adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.שינוי משטר מינון: 10/5/20204.2 Posology and method of administrationPosologyLacosamide must be taken twice a day (usually once in the morning and once in the evening).Lacosamide may be taken with or without food.If a dose is missed, the patient should be instructed to take the missed dose immediately, and then to take the next dose of lacosamide at the regularly scheduled time. If the patient notices the missed dose within 6 hours of the next one, he/she should be instructed to wait to take the next dose of lacosamide at the regularly scheduled time. Patients should not take a double dose.Adolescents and children weighing 50 kg or more, and adultsThe following table summarises the recommended posology for adolescents and children weighing 50 kg or more, and for adults. More details are provided in the table below. Monotherapy Adjunctive therapyStarting dose 100 mg/day or 200 mg/day 100 mg/daySingle loading dose (if applicable) 200 mg 200 mgTitration (incremental steps) 50 mg twice a day (100 mg/day) at weekly intervals 50 mg twice a day (100 mg/day) at weekly intervalsMaximum recommended dose up to 600 mg/day up to 400 mg/dayMonotherapy The recommended starting dose is 50 mg twice a day which should be increased to an initial therapeutic dose of 100 mg twice a day after one week.Lacosamide can also be initiated at the dose of 100 mg twice a day based on the physician's assessment of required seizure reduction versus potential side effects.Depending on response and tolerability, the maintenance dose can be further increased at weekly intervals by 50 mg twice a day (100 mg/day), up to a maximum recommended daily dose of 300 mg twice a day (600 mg/day). In patients having reached a dose greater than 400 mg/day and who need an additional antiepileptic medicinal product, the posology that is recommended for adjunctive therapy below should be followed.Adjunctive therapy The recommended starting dose is 50 mg twice a day which should be increased to an initial therapeutic dose of 100 mg twice a day after one week. Depending on response and tolerability, the maintenance dose can be further increased at weekly intervals by 50 mg twice a day (100 mg/day), up to a maximum recommended daily dose of 400 mg (200 mg twice a day). Initiation of lacosamide treatment with a loading dose Lacosamide treatment may also be initiated with a single loading dose of 200 mg, followed approximately 12 hours later by a 100 mg twice a day (200 mg/day) maintenance dose regimen. Subsequent dose adjustments should be performed according to individual response and tolerability as described above. A loading dose may be initiated in patients in situations when the physician determines that rapid attainment of lacosamide steady state plasma concentration and therapeutic effect is warranted. It should be administered under medical supervision with consideration of the potential for increased incidence of serious cardiac arrhythmia and central nervous system adverse reactions (see section 4.8). Administration of a loading dose has not been studied in acute conditions such as status epilepticus.DiscontinuationIn accordance with current clinical practice, if lacosamide has to be discontinued, it is recommended this be done gradually (e.g. taper the daily dose by 200 mg/week).In patients who develop serious

Data ta 'l-awtorizzazzjoni:

2017-12-31

Fuljett ta 'informazzjoni

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) - 1986
The medicine is to be supplied upon a physician’s prescription only
VIMPAT
® 50 MG
film-coated tablets
VIMPAT
® 100 MG
film-coated tablets
VIMPAT
® 150 MG
film-coated tablets
VIMPAT
® 200 MG
film-coated tablets
Each film-coated Vimpat tablet contains Lacosamide 50 mg, 100 mg, 150
mg or 200 mg.
For information regarding the excipients see section 6
"Additional information".
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This
leaflet contains concise
information about the medicine. If you have any further questions,
refer to the physician or the
pharmacist.
This medicine has been prescribed for the treatment of your illness.
Do not pass it on to others.
It may harm them even if it seems to you that their illness is
similar.
Epilepsy is an illness characterized by repeated fits (seizures).
Vimpat is administered when
the state of epilepsy in which the fits are initially partial
(affecting only one side of the brain),
but may develop into generalised fits (affecting larger areas on both
sides of the brain).
Treatment with Vimpat is long-term. Do not stop treatment without an
explicit instruction from
the physician. Discontinuation of treatment may cause a recurrence or
worsening of the illness’
symptoms. See section "IF YOU STOP TAKING THE MEDICINE".
1. WHAT IS THE MEDICINE INTENDED FOR?
•
Vimpat is used in adults, adolescents and children aged 4 years and
older.
•
Vimpat is indicated for the treatment of a certain type of epilepsy
characterised by the
occurrence of "partial-onset seizure with or without secondary
generalisation".
•
Vimpat may be used on its own or with other antiepileptic medicines.
Vimpat contains lacosamide. This belongs to a group of medicines
called "antiepileptic
medicines". These medicines are used to treat epilepsy.
THERAPEUTIC GROUP: Anticonvulsant.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
- You are sensitive (allergic) to the active ingredient, or to any of
th

Karatteristiċi tal-prodott

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
VIMPAT
®
50
MG
VIMPAT
®
100
MG
VIMPAT
®
150
MG
VIMPAT
®
200
MG
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Vimpat 50 mg:
Each film-coated tablet contains 50 mg lacosamide.
Vimpat 100 mg:
Each film-coated tablet contains 100 mg lacosamide.
Vimpat 150 mg:
Each film-coated tablet contains 150 mg lacosamide.
Vimpat 200 mg:
Each film-coated tablet contains 200 mg lacosamide.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Vimpat 50 mg film-coated tablets
Pinkish, oval film-coated tablets with approximate dimensions of 10.4
mm x 4.9 mm, and debossed with
‘SP’ on one side and ‘50’ on the other side.
Vimpat 100 mg film-coated tablets
Dark yellow, oval film-coated tablets with approximate dimensions of
13.2 mm x 6.1 mm, and debossed
with ‘SP’ on one side and ‘100’ on the other side.
Vimpat 150 mg film-coated tablets
Salmon, oval film-coated tablets with approximate dimensions of 15.1
mm x 7.0 mm, and debossed with
‘SP’ on one side and ‘150’ on the other side.
Vimpat 200 mg film-coated tablets
Blue, oval film-coated tablets with approximate dimensions of 16.6 mm
x 7.8 mm, and debossed with
‘SP’ on one side and ‘200’ on the other side.
2
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Vimpat is indicated as monotherapy and adjunctive therapy in the
treatment of partial-onset seizures
with or without secondary generalisation in adults, adolescents and
children from 4 years of age with
epilepsy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Lacosamide must be taken twice a day (usually once in the morning and
once in the evening).
_ _
Lacosamide may be taken with or without food.
If a dose is missed, the patient should be instructed to take the
missed dose immediately, and then to
take the next dose of lacosamide at the regularly scheduled time. If
the patient notices the missed dose
within 6
hours of the next one, he/she should be instructed to wait to take the
next do