OSPOLOT

Страна: Ізраїль

мова: англійська

Джерело: Ministry of Health

Активний інгредієнт:

SULTHIAME

Доступна з:

MEGAPHARM LTD

Код атс:

N03AX03

Фармацевтична форма:

FILM COATED TABLETS

Склад:

SULTHIAME 200 MG

Адміністрація маршрут:

PER OS

Тип рецепту:

Required

Виробник:

DESITIN ARZNEIMITTEL GMBH, GERMANY

Терапевтична група:

SULTIAME

Терапевтична области:

SULTIAME

Терапевтичні свідчення:

Treatment of epilepsy in adults and in treatment of the so called focal benign epilepsy of children, when other medication was not adequate.

Дата Авторизація:

2014-12-31

інформаційний буклет

2
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS'
REGULATIONS (PREPARATIONS) - 1986
This medicine is to be supplied by physician’s prescription only
OSPOLOT
FILM-COATED TABLETS
ACTIVE INGREDIENT:
Each tablet contains:
sulthiame 200 mg
Each tablet contains 50 mg lactose monohydrate.
Inactive ingredients and allergens in the medicine: see section
"Important information about some of this medicine’s
ingredients" and section 6 "Additional information".
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet contains concise information
about this medicine. If you have any further questions, contact the
physician or pharmacist.
_ _
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may harm them, even if it seems
to you that their illness is similar.
1. WHAT IS THIS MEDICINE INTENDED FOR?
OSPOLOT is indicated for the treatment of epilepsy in adults and in
treatment of the so called focal benign epilepsy of
children, when other medication was not adequate.
THERAPEUTIC GROUP: Carbonic anhydrase inhibitors.
2. BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
-
You are sensitive (allergic) to the active ingredient sulthiame, or to
medicines from the sulpha group_,_ and/or to
any of the other ingredients of this medicine (please see section 6).
-
You suffer from hyperthyroidism.
-
You suffer or have previously suffered from congenital or acquired
acute porphyria, which affects the
production of hemoglobin_ _in your body._ _
-
You suffer from high blood pressure._ _
_ _
SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE
PRIOR TO COMMENCING TREATMENT WITH OSPOLOT, TELL THE PHYSICIAN IF:

you suffer or have previously suffered from impaired renal function

you suffer or have previously suffered from psychiatric disorders
CONTACT THE ATTENDING PHYSICIAN IMMEDIATELY IF ANY ONE OR MORE OF THE
FOLLOWING APPEAR:

Fever, sore throat, allergic skin reaction accompanied by lymph node
swelling and/or occurrence of flu-like
symptoms during treat

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS (SPC)
1. NAME OF THE MEDICINAL PRODUCT
Ospolot

200 mg, film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
_Ospolot_

_ 200 mg_
1 film-coated tablet contains 200 mg sulthiame.
_EXCIPIENT(S) WITH KNOWN EFFECT: ONE TABLET CONTAINS 50.0 MG LACTOSE
MONOHYDRATE _
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet
_Ospolot_

_ 200 mg _
White, round, slightly domed film-coated tablet with a dividing groove
on one side and
marked “200” on the other side. The tablet can be divided into
equal doses.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of epilepsy in adults and in treatment of the so called
focal benign epilepsy of
children, when other medication was not adequate
.
Note:
Treatment with _Ospolot_
_®_
should only be conducted by a paediatric neurologist with
sufficient experience in treating epilepsy.
Efficacy and safety of _Ospolot_
_®_
in the above-mentioned indication have not been
investigated in controlled studies. Prior to starting treatment with
sulthiame, a thorough
differential diagnostic procedure regarding other types of childhood
epilepsies is indicated.
Rolandic epilepsies demonstrate a high percentage of spontaneous
remissions – even
without drug treatment – and usually show a favourable course of
disease and a good
prognosis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dosage must be established and monitored by the doctor on an
individual basis. The
maintenance dose is about 5 to 10 mg/kg body weight/day. It should be
built up step-wise
(tapered in) over a one-week period._ Ospolot_

_ _
_200 mg_ film-coated tablets have a dividing
groove.
Due to the short half-life of sulthiame, the daily dose should as far
as possible be spread
over three single doses. If the daily dose is spread over the day in
this way, constant
plasma levels are to be expected after five to six days. Therapeutic
plasma concentrations
of sulthiame have not yet been determined.
_METHOD OF ADMINI