HYPNODORM

국가: 이스라엘

언어: 영어

출처: Ministry of Health

유효 성분:

FLUNITRAZEPAM

제공처:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

ATC 코드:

N05CD03

약제 형태:

TABLETS

구성:

FLUNITRAZEPAM 2 MG

관리 경로:

PER OS

처방전 유형:

Required

Manufactured by:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

치료 그룹:

FLUNITRAZEPAM

치료 영역:

FLUNITRAZEPAM

치료 징후:

Insomnia of various etiology.

승인 날짜:

2013-06-30

환자 정보 전단

THIS LEAFLET FORMAT HAS BEEN
DETERMINED BY THE MINISTRY OF
HEALTH AND THE CONTENT THEREOF HAS
BEEN CHECKED AND APPROVED
PATIENT PACKAGE INSERT
IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a
doctor’s prescription only
HYPNODORM
®
TABLETS
COMPOSITION
Each tablet contains:
Flunitrazepam 2 mg.
For a list of the inactive ingredients,
see section 6 in this leaflet.
READ THIS LEAFLET CAREFULLY IN ITS
ENTIRETY BEFORE USING THIS MEDICINE.
This leaflet contains concise information
about the medicine. If you have further
questions, refer to the doctor or
pharmacist.
This medicine has been prescribed
for the treatment of your ailment. Do
not pass it on to others. It may harm
them even if it seems to you that their
medical condition is similar.
INTRODUCTION
This
medicine
belongs
to
the
benzodiazepine group, which has
special characteristics that demand
great caution when used. Medicines
from this group impair the quality of
sleep, suppress deep refreshing sleep
and therefore cause ineffective and
superficial sleep.
• Close medical monitoring is
very important when taking this
medicine. Therefore, when you
are taking this medicine, be sure
to refer to a doctor after 7-10 days
of treatment, as the treatment is
intended for a short period of time
only.
• Prolonged use of this medicine may
lead to a diminution in the efficacy
of the medication. Such use may
also cause severe dependence, in
which the patient will find it difficult
to discontinue the intake of this
medicine. Sometimes, prolonged
use of this medicine may cause
changes in behavior patterns
as well as bring on troublesome
thoughts.
• Uncontrolled discontinuation of
treatment may be accompanied
by withdrawal symptoms such as:
tension, nervousness, confusion,
trembling, recurrence of insomnia,
abdominal pain, nausea, vomiting,
sweating, seizures.
• Elderly: Be careful to lean on
something when standing up
from a lying or sitting position, as
this medicine impairs alertness
and sometimes body movement

제품 특성 요약

HYPNODORM 1 6 2013, RH
"
ע עבקנ הז ןולע טמרופ
"
רשואו קדבנ ונכותו תואירבה דרשמ י
."
רשואמ ןולע
:
יאמ
2013
“This leaflet format has been determined by the Ministry of Health
and the content thereof has been
checked and approved.” Date of approval: May 2013
HYPNODORM

TABLETS
COMPOSITION
Each tablet contains:
_ Active Ingredient _
Flunitrazepam
2 mg
_ Other Ingredients _
Microcrystalline cellulose, lactose, talc, magnesium stearate
_ _
_Lactrose content: 63.8 mg per tablet. _
ACTION
Hypnodorm contains flunitrazepam, a benzodiazepine hypnotic.
Hypnodorm induces sleep within 15-20 minutes, which lasts for 6-8
hours.
Hypnodorm enjoys a wide therapeutic margin, is well tolerated and
during prolonged use,
tolerance has practically not been observed.
INDICATIONS
Insomnia of various etiology.
CONTRAINDICATIONS
Known hypersensitivity to benzodiazepines or to any other ingredient
of the preparation.
First trimester of pregnancy and in breastfeeding.
Acute pulmonary insufficiency; respiratory depression, chronic
psychoses, phobic or
obsessional states.
Acute narrow-angle glaucoma because of atropine-like side effects.
Benzodiazepines may
be used in patients with open-angle glaucoma who are receiving
appropriate therapy).
Myasthenia gravis.
Severe hepatic insufficiency
Sleep apnea syndrome.
Use in children.
WARNINGS
(See also Precautions)
_Effect on Ability to Drive and/or Operate Machinery _
Complex behaviours such as “sleep -driving” (i.e.driving while not
fully awake after
taking a sedative-hypnotic, with amnesia for the event) have been
reported with
sedative hypnotics. These events can occur in sedative-hypnotic naive
as well as in
sedative-hypnotic
experienced
persons.
These
events
can
occur
at
normal
therapeutic doses, and the risk appears to be increased when
sedative-hypnotics are
combined with alcohol or other CNS depressants or used at doses
exceeding the
maximum recommended dose. Due to the risk to the patient and the
community,
discontinuation of s