RIVOTRIL

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

CLONAZEPAM

متاح من:

TZAMAL BIO-PHARMA LTD

ATC رمز:

N03AE01

الشكل الصيدلاني:

DROPS

تركيب:

CLONAZEPAM 2.5 MG/ML

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

CHEPLAPHARM ARZNEIMITTEL GMBH, GERMANY

المجموعة العلاجية:

CLONAZEPAM

المجال العلاجي:

CLONAZEPAM

الخصائص العلاجية:

Anti-epileptic. Panic disorder.

تاريخ الترخيص:

2023-08-31

نشرة المعلومات

2
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) – 1986
This medicine is dispensed with a doctor's prescription only
RIVOTRIL
®
2.5 MG/ML
Drops
COMPOSITION:
1 ml RIVOTRIL contains:
clonazepam 2.5 mg
* For information on inactive ingredients, see section 6 -
‘Additional information’.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet contains
concise information about this medicine. If you have any further
questions, consult your doctor or
pharmacist.
This medicine has been prescribed to treat your illness. 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 patient leaflet for benzodiazepines
This medicine belongs to a group of medicines called benzodiazepines,
which have special
properties, and require extreme caution when used. Close medical
follow-up is very important
when taking this medicine.
The following section relates only to short-term treatment with the
medicine:
When you take this medicine, be sure to contact your doctor after 2 to
4 weeks, as the treatment
is only intended for short periods of time.
Prolonged use of the medicine may cause it to become less effective.
Prolonged use may cause a serious side effect of dependence, where it
will be 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 pain,
vomiting, nausea, sweating,
spasms, cramps and muscle pain.
At times, prolonged use of medicine may cause changes in behavioral
patterns and intrusive
thoughts.
Particularly in the elderly, it is recommended to use caution when
walking, as the medicine
inhibits alertness and at times coordination of body movements, and
therefore there is a concern
of slips or falls.
Taking this medicine along with opioids, other central nervous system
depressants (including
drugs) or alcohol may cause a sense of

خصائص المنتج

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1
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RIVOTRIL
®
ρ
CLONAZEPAM
Drops
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE,
MISUSE, AND ADDICTION; AND DEPENDENCE AND WITHDRAWAL
REACTIONS
•
CONCOMITANT USE OF BENZODIAZEPINES AND OPIOIDS MAY RESULT IN PROFOUND
SEDATION, RESPIRATORY DEPRESSION, COMA, AND DEATH. RESERVE CONCOMITANT
PRESCRIBING OF THESE DRUGS FOR 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.
•
THE USE OF BENZODIAZEPINES, INCLUDING RIVOTRIL, EXPOSES USERS TO RISKS
OF ABUSE,
MISUSE, AND ADDICTION, WHICH CAN LEAD TO OVERDOSE OR DEATH. ABUSE AND
MISUSE
OF BENZODIAZEPINES COMMONLY INVOLVE CONCOMITANT USE OF OTHER
MEDICATIONS,
ALCOHOL, AND/OR ILLICIT SUBSTANCES, WHICH IS ASSOCIATED WITH AN
INCREASED
FREQUENCY OF SERIOUS ADVERSE OUTCOMES. BEFORE PRESCRIBING RIVOTRIL AND
THROUGHOUT TREATMENT, ASSESS EACH PATIENT’S RISK FOR ABUSE, MISUSE,
AND
ADDICTION_._
•
THE CONTINUED USE OF BENZODIAZEPINES, INCLUDING RIVOTRIL, MAY LEAD TO
CLINICALLY
SIGNIFICANT PHYSICAL DEPENDENCE. THE RISKS OF DEPENDENCE AND
WITHDRAWAL
INCREASE WITH LONGER TREATMENT DURATION AND HIGHER DAILY DOSE. ABRUPT
DISCONTINUATION OR RAPID DOSAGE REDUCTION OF RIVOTRIL AFTER CONTINUED
USE MAY
PRECIPITATE ACUTE WITHDRAWAL REACTIONS, WHICH CAN BE LIFE-THREATENING.
TO REDUCE
THE RISK OF WITHDRAWAL REACTIONS, USE A GRADUAL TAPER TO DISCONTINUE
RIVOTRIL OR
REDUCE THE DOSAGE_. _
1.
NAME OF THE MEDICINE
Rivotril
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Rivotril oral liquid contains 2.5 mg/mL clonazepam (one drop contains
0.1 mg clonazepam)
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Excipients with known effect
_Oral liquid _
Saccharin sodium
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Rivotril 2.5 mg/mL oral liquid is a clear, blue solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Anti-epileptic.
Panic Disorder.
4.2
DOSE AND METHOD OF ADMINISTRATION
WARNING: RIVOTRIL ORAL LIQUID
MEASURE THE