BONDORMIN

Land: Israel

Språk: engelsk

Kilde: Ministry of Health

Aktiv ingrediens:

BROTIZOLAM

Tilgjengelig fra:

RAFA LABORATORIES LTD

ATC-kode:

N05CD09

Legemiddelform:

TABLETS

Sammensetning:

BROTIZOLAM 0.25 MG

Administreringsrute:

PER OS

Resept typen:

Required

Produsert av:

RAFA LABORATORIES LTD, JERUSALEM

Terapeutisk gruppe:

BROTIZOLAM

Terapeutisk område:

BROTIZOLAM

Indikasjoner:

Treatment of Insomnia.

Autorisasjon dato:

2010-10-31

Informasjon til brukeren

1
PATIENT LEAFLET ACCORDING TO THE PHARMACISTS' REGULATIONS
(PREPARATIONS) -
1986
This medicine is sold with a doctor's prescription only
BONDORMIN
TABLETS
ACTIVE INGREDIENT:
Each tablet contains 0.25 mg brotizolam.
For a list of the other ingredients, please see section 6.
See also 'Important information about some of the medicine's
ingredients' in section 2.
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE.
This leaflet contains concise information about the medicine. If you
have any further
questions, please refer to your doctor or pharmacist.
This medicine has been prescribed for your treatment. Do not pass it
on to others. It may
harm them, even if it seems to you that their medical condition is
similar to yours.
INTRODUCTION TO THE PATIENT LEAFLET FOR BENZODIAZEPINES
This medicine belongs to the group of benzodiazepines, which has
special properties
requiring the utmost caution while using it.
Close medical follow-up is very important while taking this medicine.
When taking this medicine, make sure to refer to your doctor after two
weeks, since
treatment is intended for short periods of time only.
Prolonged use of this medicine may cause a reduction in its effect.
Prolonged use may cause a severe effect of dependence, making it
difficult for the
patient to discontinue taking the medicine and therefore,
discontinuation of the medicine
should be done gradually, according to the doctor's instructions.
Uncontrolled discontinuation of treatment is accompanied by withdrawal
symptoms, such
as: tension, nervousness, confusion, tremor, insomnia, abdominal
pains, vomiting,
nausea, sweating, spasms, cramps and muscle pain.
Sometimes prolonged use of the medicine may cause changes in
behavioral patterns
and nagging thoughts.
Especially in the elderly, caution is recommended when walking, since
the medicine
impairs alertness and sometimes coordination of body movements, thus
raising concern
about stumbles or falls.
Taking this medicine along with medicines from the opioid group, other
medicines
which depres

Preparatomtale

Page 1 of 10
Bondormin-DL-April 2017-01
Doctor leaflet
1.
NAME OF THE MEDICINAL PRODUCT
BONDORMIN
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Bondormin tablet contains 0.25 mg brotizolam.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets.
The tablet can be divided into 2 equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of Insomnia.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Unless otherwise prescribed, the usual dose is ½ - 1 tablet a day
(equivalent to 0.125 - 0.25 mg
brotizolam).
Treatment should be started with ½ a tablet a day (equivalent to
0.125 mg brotizolam). Depending on
individual response, ½ a tablet a day (equivalent to 0.125 mg
brotizolam) may be sufficient. The
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS

Concomitant use of benzodiazepines and opioids may result in profound
sedation, respiratory depression,
coma, and death.

Reserve concomitant prescribing of these drugs for use in patients for
whom alternative treatment options
are inadequate.

Limit dosages and durations to the minimum required.

Follow patients for signs and symptoms of respiratory depression and
sedation.
Page 2 of 10
maximum dose of 1 tablet a day (equivalent to 0.25 mg brotizolam)
should not be exceeded because of
the increased risk of adverse CNS effects.
In isolated cases (e.g. pre-operative sleep disturbances) the dose may
be increased to 2 tablets.
Special populations:
A reduction in dosage to ½ a tablet a day should be considered in the
following populations (see
section 4.4):
- patients with impaired liver function (see section 4.3 and section
5.2)
- elderly and debilitated patients (see section 5.2)
- patients with chronic respiratory insufficiency with hypercapnia due
to the risk of respiratory
depression, especially at night (see section 4.3)
The tablets can be divided into equal halves for this purpose.
No dosage adjustment is normally necessary in patients with impaired
renal function (see 5.2).
_Paediatric population _
Bondor