STILNOX 10 MG TABLETS

מדינה: ישראל

שפה: אנגלית

מקור: Ministry of Health

מרכיב פעיל:

ZOLPIDEM TARTRATE

זמין מ:

SANOFI ISRAEL LTD

קוד ATC:

N05CF02

טופס פרצבטיות:

FILM COATED TABLETS

הרכב:

ZOLPIDEM TARTRATE 10 MG

מסלול נתינה (של תרופות):

PER OS

סוג מרשם:

Required

תוצרת:

SANOFI WINTHROP INDUSTRIE, FRANCE

קבוצה תרפויטית:

ZOLPIDEM

איזור תרפויטי:

ZOLPIDEM

סממני תרפויטית:

Indications are limited to treatment of severe sleep disorders in the following cases: - Occasional insomnia - Transient insomnia.

תאריך אישור:

2017-06-30

עלון מידע

1
*816921*
816921
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only
STILNOX 10 MG TABLETS
ACTIVE INGREDIENT AND ITS QUANTITY:
Each tablet contains: Zolpidem Tartrate 10 mg
INACTIVE AND ALLERGENIC INGREDIENTS IN THE PREPARATION – SEE SECTION
2 “IMPORTANT
INFORMATION ABOUT SOME OF THE INGREDIENTS OF THE MEDICINE” AND
SECTION 6
“FURTHER INFORMATION”.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE 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
to treat you.
Do not pass it on to others. It may harm them even if it seems to you
that their
medical condition is similar.
This medicine is not intended for children and adolescents under the
age of 18.
1. WHAT IS THE MEDICINE INTENDED FOR?
For the treatment of insomnia.
THERAPEUTIC GROUP: Hypnotic and sedative substances.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
∙ You have ever experienced complex sleep behavior (such as driving
a car, making
and eating food, talking on the phone or having sex while not being
fully awake)
after taking Stilnox (see “Special warnings regarding use of the
medicine”).
∙ You are sensitive (allergic) to the active ingredient (zolpidem)
or to any of the
additional ingredients contained in the medicine (see section 6).
∙ You have suffered in the past from an allergic reaction to
zolpidem-containing
medicines. Symptoms of severe allergic reaction to zolpidem may
include:
swelling of your face, lips and throat that may cause difficulty in
breathing or
swallowing.
∙ You are suffering from severe liver failure.
∙ You drank alcohol in the evening or before bedtime.
∙ You will not be able to get a full night's sleep after taking the
medicine
(7-8 hours) before you need to be active again.
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE:
∙ DO NOT TAKE MORE STILNOX THAN PRE

מאפייני מוצר

1
_STIL-SPC-10MG-21.0 _
_ _
STILNOX 10MG TABLETS
PRESCRIBING INFORMATION
WARNING: COMPLEX SLEEP BEHAVIORS
COMPLEX SLEEP BEHAVIORS INCLUDING SLEEP-WALKING, SLEEP-DRIVING, AND
ENGAGING IN OTHER
ACTIVITIES WHILE NOT FULLY AWAKE MAY OCCUR FOLLOWING USE OF STILNOX.
SOME OF THESE EVENTS
MAY RESULT IN SERIOUS INJURIES, INCLUDING DEATH. DISCONTINUE STILNOX
IMMEDIATELY IF A
PATIENT EXPERIENCES A COMPLEX SLEEP BEHAVIOR _[SEE CONTRAINDICATIONS
(4) AND WARNINGS _
_AND PRECAUTIONS (8.1)]._
1
NAME OF THE MEDICINAL PRODUCT STILNOX 10MG TABLETS
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains zolpidem tartrate 10 mg
Excipients with known effect:
Each Stilnox tablet contains 90.4 mg lactose monohydrate
3
PHARMACEUTICAL FORM
Stilnox tablets are white to off-white film coated oblong tablets
4
THERAPUTIC INDICATIONS AND USAGE
Indications are limited to treatment of severe sleep disorders in the
following cases:
- Occasional insomnia
- Transient insomnia.
The short-term treatment of insomnia in situations where the insomnia
is debilitating or is
causing severe distress to the patient. As with all hypnotics long
term use is not
recommended and a course of treatment should not exceed 4 weeks.
Hypnotics should generally be limited to 7 to10 days of use, and
reevaluation of the patient is
recommended if they are to be taken for more than 2 to 3 weeks.
5
DOSAGE AND ADMINISTRATION
5.1
DOSAGE IN ADULTS
Use the lowest effective dose for the patient. The recommended initial
dose is 5 mg for
women and either 5 or 10 mg for men, taken only once per night
immediately before bedtime
with at least 7-8 hours remaining before the planned time of
awakening. If the 5 mg dose is
2
not effective, the dose can be increased to 10 mg. In some patients,
the higher morning blood
levels following use of the 10 mg dose increase the risk of next day
impairment of driving
and other activities that require full alertness [see Warnings and
Precautions (8.2)]. The total
dose of Stilnox should not exceed 10 mg once daily immediately before
bedtime.
St