DORMINOL NIGHT

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

HOP CONES DRY EXTRACT; VALERIAN ROOT DRY EXTRACT

متاح من:

NEOPHARM (ISRAEL)1996 LTD

ATC رمز:

N05CM09

الشكل الصيدلاني:

FILM COATED TABLETS

تركيب:

HOP CONES DRY EXTRACT 42 MG; VALERIAN ROOT DRY EXTRACT 187.5 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Not required

المصنعة من قبل:

MAX ZELLER SOHNE AG, SWITZERLAND

المجموعة العلاجية:

VALERIAN

المجال العلاجي:

VALERIAN

الخصائص العلاجية:

Herbal medicinal product for problems falling asleep and staying asleep, as well as restless sleep.

تاريخ الترخيص:

2018-02-28

نشرة المعلومات

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS)
-
1986
The dispensing of this medicine does not require a physician’s
prescription
DORMINOL NIGHT
FILM COATED TABLETS
COMPOSITION:
Each tablet contains:
Valerian root dry extract 187.5 mg
Hop cones dry extract 42 mg
NON ACTIVE INGREDIENTS AND ALLERGENS: see paragraph 6:
“FURTHER INFORMATION”
.
READ THIS PACKAGE INSERT CAREFULLY IN ITS ENTIRETY BEFORE USING THIS
MEDICINE. This insert
is a synopsis of the product information. In case you have any
additional questions, please
ask a doctor or a pharmacist.
This medicine is intended for use in adolescents and adults over the
age of 12 years.
You should use the drug according to the instructions in the dosage
section of this leaflet.
Consult a pharmacist in case you need farther information. You should
refer to the physician
in case your sleeping disorder gets worse or do not get better
following a period of one
month.
1.
WHAT THIS MEDICINE IS USED FOR?
Inducing sleep in cases of problems falling asleep and staying asleep,
as well as in cases
of sleep disorders and restless sleep.
THERAPEUTIC GROUP:
Sleep-inducing substances.
2.
BEFORE USING THE MEDICINE
THIS MEDICINE SHOULD NOT BE USED IF:
SPECIAL WARNING RELATED TO THE MEDICINE USE:
Do not use this medicine without consulting a doctor before starting
treatment:
-
if you suffer from other illnesses
-
If you are sensitive to any type of food or medicine
-
if you take other medication
-
if you are pregnant or breast-feeding
DRUG-DRUG INTERACTIONS
IF YOU ARE TAKING OR WERE TAKING LATELY OTHER MEDICINES INCLUDING
MEDICINES THAT CAN BE
BOUGHT WITHOUT A PRESCRIPTION AND FOOD SUPPLEMENTS, TELL A DOCTOR OR A
PHARMACIST.
You should consult your doctor if you are taking other medications to
induce sleep.
PREGNANCY AND LACTATION:
There is not enough data available considering the use of the medicine
in pregnancy and
lactation, therefore it is recommended to avoid using this medicine.
If you are pregnant or
breast-feeding you should cons

خصائص المنتج

SUMMARY OF PRODCUT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Dorminol Night film coated tablet
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Fixed combination of _Valeriana officinalis _L., radix (Valerian Root
Dry Extract ) and
_Humulus lupulus _L., flos (Hop Cones Dry Extract ).
1 film coated tablet contains:
42 mg Hop Cones Dry Extract
187.5 mg Valerian Root Dry Extract
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film coated tablet
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Herbal medicinal product for problems falling asleep and staying
asleep, as well as
restless sleep
.
(
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
-1
2 film coated tablets should be taken half to one hour before bed
time.
_Adolescents over 12 years of age _
1 film coated tablet should be taken half to one hour before bed time
_Elderly _
Posology is the same as for adults.1- 2 film coated tablets should be
taken half to one
hour before bed time.
The use in children below the age of 12 years is not recommended (see
section 4.4).
Duration of use
Because of its gradual onset of efficacy Dorminol Night is not
suitable for acute
interventional treatment of mild nervous tension or sleep disorders.
To achieve
optimal treatment effect, the continued use over 4 weeks is
recommended.
If symptoms persist or worsen after 4 weeks of continued use, a doctor
should be
consulted.
Method of administration
Oral use.
Crushing of the tablets is permissible but it may be difficult to
crush the film
coating.
4.3 CONTRAINDICATION
Hypersensitivity to the active substance(s) or to any of the
excipients of Dorminol
Night.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The use of Dorminol Night is not recommended in children below the age
of 12
years, due to lack of adequate data.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Only limited data on pharmacological interactions with other medicinal
products are
available. Clinically relevant interaction with drugs metabolised by
the CY