BONDORMIN

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

BROTIZOLAM

Available from:

RAFA LABORATORIES LTD

ATC code:

N05CD09

Pharmaceutical form:

TABLETS

Composition:

BROTIZOLAM 0.25 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

RAFA LABORATORIES LTD, JERUSALEM

Therapeutic area:

BROTIZOLAM

Therapeutic indications:

Treatment of Insomnia.

Authorization date:

2020-10-31

Patient Information leaflet

Patient Package Insert in Accordance With the Pharmacists' Regulations
(Preparations) – 1986
This medicine is dispensed with a doctor's prescription only
Bondormin
Tablets
Active ingredient:
Each tablet contains Brotizolam 0.25 mg
For the list of the additional ingredients, see section 6.
See also 'Important information about some of the medicine's
ingredients' in section 2.
Read this entire leaflet carefully before using the medicine.
This leaflet contains concise information about the medicine. If you
have any further questions, please
refer to the doctor or pharmacist.
This medicine has been prescribed for treatment for you. Do not pass
it on to others under any
circumstance. It may harm them, even if you think their medical
condition is similar to yours.
Introduction to the patient leaflet for benzodiazepines
This medicine belongs to the benzodiazepine group which has special
properties requiring extreme
caution while using it.
Close medical monitoring is very important when taking this medicine.
When taking this medicine, be sure to contact the doctor after 2
weeks, since the treatment is intended
for short time periods only.
Prolonged use of the medicine may cause the effect of the medicine to
be lessened.
Prolonged use may cause a severe effect of dependence, making it
difficult for the patient to stop taking
the medicine and therefore you should stop taking the medicine
gradually, as instructed by the doctor.
Uncontrolled discontinuation of treatment may be accompanied by
withdrawal symptoms such as:
tension, irritability, confusion, tremor, insomnia, abdominal pain,
vomiting, nausea, sweating,
convulsions, muscle pains and spasms.
See 'If you stop taking the medicine' in section 3.
Sometimes, prolonged use of the medicine may cause changes in
behavioral patterns and disturbing
thoughts.
Particularly for elderly care is recommended when walking, since the
medicine impairs alertness and
sometimes coordination of body movements, therefore there is concern
of stumbling or falling.
1. What is the medicine i

Summary of Product characteristics

Page 1 of 10
Bondormin-DL-March 2023-02
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 _
Bondo