TRANXAL 5 MG

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

POTASSIUM CLORAZEPATE

متاح من:

CTS CHEMICAL INDUSTRIES LTD, ISRAEL

ATC رمز:

N05BA05

الشكل الصيدلاني:

CAPSULES

تركيب:

POTASSIUM CLORAZEPATE 5 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

CTS CHEMICAL INDUSTRIES LTD, ISRAEL

المجموعة العلاجية:

POTASSIUM CLORAZEPATE

المجال العلاجي:

POTASSIUM CLORAZEPATE

الخصائص العلاجية:

For the management and relief of anxiety, symptomatic relief of acute alcohol withdrawal, adjunctive therapy in the management of partial seizures.

تاريخ الترخيص:

2022-12-31

نشرة المعلومات

PATIENT LEAFLET IN ACCORDANCE
WITH THE PHARMACISTS’ REGULATIONS
)PREPARATIONS( – 1986
The medicine is dispensed with a doctor's
prescription only
TRANXAL 5 MG CAPSULES
TRANXAL 15 MG CAPSULES
THE ACTIVE INGREDIENT AND ITS QUANTITY:
Tranxal 5 mg: Each capsule contains Potassium
Clorazepate 5 mg
Tranxal 15 mg: Each capsule contains
Potassium Clorazepate 15 mg
Inactive ingredients and allergens in the
preparation – see section 6 “Additional
information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING
THE MEDICINE. This leaflet contains concise
information about the medicine. If you have
any other questions, refer to the doctor or the
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.
INTRODUCTION
The introduction is intended for users taking
this medicine for the indication of anxiety and
tension only.
This medicine belongs to the benzodiazepine
group, which has special characteristics that
require extra care during use.
·
It is highly important to be under close
medical supervision when taking this
medicine.
·
When taking this medicine, be sure to refer to
your doctor after 2-4 weeks, as the treatment
is intended for short time periods only.
·
Prolonged use of this medicine may cause
the effect of the medicine to decrease.
·
Prolonged use may cause severe
dependency, which will make it difficult for the
patient to stop taking the medicine.
·
Uncontrolled discontinuation of the treatment
may be accompanied by withdrawal effects,
such as: stress, nervousness, confusion,
tremor, insomnia, abdominal pain, vomiting,
nausea, sweating, spasms, cramps and
muscle pain.
·
Prolonged use of this medicine may
sometimes cause changes in behavioral
patterns and obsessive thoughts.
·
Care should be taken when walking,
especially in the elderly, since the medicine
impairs alertness and sometimes the
coordination of body movements, which may
lead to tripping or falling down.
Taking this medici

خصائص المنتج

1
SUMMARY OF THE PRODUCT CHARACTERISTICS
1.
TRADE NAME OF THE MEDICINAL PRODUCT
TRANXAL 5 MG, HARD CAPSULES
TRANXAL 15 MG, HARD CAPSULES
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance:
Tranxal 5 mg-
Clorazepate dipotassium 5mg
Tranxal 15 mg-
Clorazepate dipotassium 15mg
3.
PHARMACEUTICAL FORM
Capsules WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS
•
Concomitant use of benzodiazepines and opioids may result in profound
sedation,
respiratory depression, coma, and death _[_see _chapter _DRUG
INTERACTIONS_]_.
•
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.
CLINICAL PARTICULARS
4.1
Therapeutic indications
For the management and relief of anxiety, symptomatic relief of acute
alcohol
withdrawal, adjunctive therapy in the management of partial seizures.
4.2
Posology and route of administration
Duration:
Treatment should be as of a short duration as possible and reassessed
on a
regular basis, particularly if the patient has no symptoms. The
overall duration
of treatment should not exceed 8 to 12 weeks in most of patients,
including the
period of dosage tapering (see sections WARNINGS and PRECAUTIONS).
In some cases, it may be necessary to prolong treatment beyond the
recommended period. Prolonged treatment requires careful and repeated
assessments of the patient's status.
2
Prevention and treatment of delirium tremens and other symptoms of
alcohol
withdrawal: short-term treatment of about 8 to 10 days.
Pediatric population
Tranxal is not indicated for the management of partial seizures in
pediatric
patients under 9 years old.
Tranxal is not indicated for the management and relief of anxiety and
symptomatic relief of acute alcohol withdrawal in pediatric patients
under 6
years old.
Dose:
In all cases, treatment must be initiated at the lowest effective
dose, and the
maximum dose of 90 mg