FRISIUM

Țară: Israel

Limbă: engleză

Sursă: Ministry of Health

Ingredient activ:

CLOBAZAM

Disponibil de la:

SANOFI ISRAEL LTD

Codul ATC:

N05BA09

Forma farmaceutică:

TABLETS

Compoziție:

CLOBAZAM 10 MG

Calea de administrare:

PER OS

Tip de prescriptie medicala:

Required

Produs de:

SANOFI WINTHROP INDUSTRIE, FRANCE

Grupul Terapeutică:

CLOBAZAM

Zonă Terapeutică:

CLOBAZAM

Indicații terapeutice:

Frisium is a 1,5-benzodiazepine indicated for the short-term relief (2 – 4 weeks) only of anxiety in adult patients that is severe, disabling or subjecting the individual to unacceptable distress, occurring alone or in association with insomnia or short term psychosomatic, organic or psychotic illness.The use of Frisium to treat short-term “mild” anxiety is inappropriate and unsuitable.

Data de autorizare:

2022-06-30

Prospect

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
This medicine is dispensed with a doctor’s prescription only
FRISIUM
Tablets, 10 mg
ACTIVE INGREDIENT:
Each tablet contains:
Clobazam 10 mg
Inactive ingredients: See section 2 – ‘Important information about
some
of the ingredients of the medicine’ and section 6 – ‘Further
Information’.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THIS
MEDICINE.
This leaflet contains concise information about the medicine. If you
have
further questions, refer to the doctor or pharmacist.
This medicine has been prescribed to treat you. Do not pass it on to
others. It may harm them even if it seems to you that their medical
condition is similar.
INTRODUCTION TO THE PATIENT LEAFLET FOR BENZODIAZEPINES
-
This medicine belongs to the benzodiazepine group, which has special
characteristics which require a lot of caution during use.
-
It is very important to be under close medical supervision when taking
this medicine.
-
When you are taking this medicine, be sure to refer to a doctor after
2-4
weeks, as the treatment is meant for short periods only.
-
Prolonged use of the medicine may reduce the effect of the medicine.
-
Such use may cause a severe dependence effect, which will make it hard
for the patient to stop taking the medicine.
- Unregulated discontinuation of treatment is accompanied with
withdrawal effects, such as: tension, irritability, confusion, tremor,
insomnia, abdominal pains, vomiting, nausea, sweating, spasms.
- Sometimes, prolonged use of the medicine may cause behavioral
changes and bothersome thoughts.
-
It is recommended, especially for the elderly, to be careful when
walking,
as the medicine impairs alertness and sometimes body movement
coordination, and there is therefore danger of tripping or falling.
Taking this medicine with opioids, other medicines that suppress the
central nervous system (including drugs) or alcohol, may cause deep
sleepiness, breathing difficulties (respiratory depressio

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