VABEN TABLETS

Quốc gia: Israel

Ngôn ngữ: Tiếng Anh

Nguồn: Ministry of Health

Thành phần hoạt chất:

OXAZEPAM

Sẵn có từ:

RAFA LABORATORIES LTD

Mã ATC:

N05BA

Dạng dược phẩm:

TABLETS

Thành phần:

OXAZEPAM 10 MG

Tuyến hành chính:

PER OS

Loại thuốc theo toa:

Required

Sản xuất bởi:

RAFA LABORATORIES LTD, JERUSALEM

Nhóm trị liệu:

BENZODIAZEPINE DERIVATIVES

Chỉ dẫn điều trị:

Anxiolytic.

Ngày ủy quyền:

2022-02-28

Tờ rơi thông tin

1
PATIENT LEAFLET ACCORDING TO THE PHARMACISTS' REGULATIONS
(PREPARATIONS) – 1986
This medicine is sold with a doctor's prescription only
VABEN TABLETS
ACTIVE INGREDIENT:
Each tablet contains 10 mg Oxazepam.
For the list of other 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 your doctor or pharmacist.
This medicine has been prescribed for treatment for you. Do not pass
it on to others. 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
great caution while using it.
Close medical monitoring is extremely important when taking this
medicine.
When taking this medicine, be sure to contact the doctor after 2 to 4
weeks, since the treatment
is intended for short periods only.
Prolonged use of the medicine may cause the effect of the medicine to
decrease.
Prolonged use may cause a severe effect of dependence, which will make
it difficult for the
patient to stop taking the medicine.
Uncontrolled discontinuation of treatment may be accompanied by
withdrawal symptoms, such
as: tension, nervousness , confusion, tremor, insomnia, abdominal
pains, vomiting, nausea,
sweating, convulsions, spasms, cramps and muscle pains. 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 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 concomitantly with medicines from the opioid
group, other
medicines that depress the central nervous system (including drugs) o

Đặc tính sản phẩm

Vaben-SPC-January- 2024-03
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
VABEN TABLETS
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10mg Oxazepam.
Excipient with known effect:
Each tablet contains 68.83mg lactose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
White tablets.
4. CLINICAL PARTICULARS
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.
4.1 THERAPEUTIC INDICATIONS
Anxiolytic.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_ _
_Posology_
All patients taking oxazepam should be carefully monitored and routine
repeat prescriptions be
avoided. Patients who have received benzodiazepines for a long time
may require an extended
withdrawal period. Long-term chronic use is not recommended.
As an anxiolytic, the lowest effective dose should be employed, for
the shortest time possible;
dosage regimes should not exceed beyond 4 weeks and treatment should
always be gradually
withdrawn.
_Adults:_
_Anxiety _10-30mg three or four times a day.
Elderly patients and those who are particularly sensitive to
benzodiazepines: 10 mg three times
daily.
_Children: _Not recommended for children.
2
_Method of Administration_
For oral administration.
4.3 CONTRAINDICATIONS
Known hypersensitivity to benzodiazepines or any other ingredient in
the tablet; phobic or
obsessional states; chronic psychosis; respiratory depression, acute
pulmonary insufficiency;
myasthenia gravis; sleep apnoea syndrome; severe hepatic
insufficiency.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Patients should be advised that since their tolerance for alcohol and
other CNS depressants will
be diminished in the pre