SONGHA NIGHT

ה/אפור

ה/דבכנ

03.2019

ה/דבכנ ת/חקור

Night

-

Songha

תרבח

Pharma Shalom

אפורל ןולע רושיא לע עידוהל תשקבמ שדח

.ןודנבש רישכתה לש ןכרצל ןולעב םינוכדע ןכו

:לארשיב רישכתה לש המושרה היוותהה

Sedative in states of tension, nervousness and insomnia

תרוצ

ה

ןתמ

רישכתה לש

:

COATED TABLETS

ביכרמ םי ליעפ םי

:

VALERIAN DRY EXTRACT 120 MG

MELISSA OFFICINALIS

80 MG

הרמחה הווהמה ןוכדע השענ םהב םיפיעס םיניוצמ וז העדוהב

שגדומ בוהצב ( הצוח וקב ןמוסמ קחמנש טסקט . טסקט

:ןכרצל ןולעב םינוכדע

:המדקה

.םייעובש רחאל םירפתשמ םניא וא םירימחמ )םימוטפמיס( הלחמה ינימסת םא אפורל תונפל ךילע

הפורתב שומישל תועגונה תודחוימ תורהזא

ליגל תחתמ םידליב הז רישכתב שמתשהל ןיא ,םיקפסמ םיינילק םינותנב רוסחמ בקע

.אפורה םע תוצעייתה אלל ,טיינ הגנוס םע דחי העגרהל וא הנישל םיפסונ םירישכת לוטיל ןיא

.וז הפורת הנורחאל תלטנש וא לטונ התאש ול רפסל רוכז ,רחא יאופר תווצ שיאל וא אפורל הנופ התא םא

דציכ ?הפורתב שמתשת

.אפורה לא תונפל שי ,לופיט םייעובש רחאל םירימחמ ףא וא ,םירבוע םניא םינימסתה םא

םידליב ןונימ

ליג לעמ םידלי

אפורה י"ע עבקי ןונימה

תופסונ יאוול תועפות

לש עודי אל רפסמב ושחרתה( ןטב יבאכו תוליחב לשמל ומכ ,לוכיעה תכרעמב תוערפה וחווד תופורת תעילב רחאל )םילפוטמ .ןאירלו תוליכמה

הרמחה םיווהמ םניאש םיפסונ םינוכדע םימייק םינולעב

וז העדוהל .םינכדועמה אפורל ןולעהו ןכרצל ןולעה םיפרוצמ

ולעה םינ

אפורל ןכרצלו סרופמ םי

לבקל ןתינו ,תואירבה דרשמ רתאבש תופורתה רגאמב

ם

ספדומ םי

לעבל הינפ ידי לע תרבח ,םושירה

Pharma-Shalom

,

הכאלמה בוחר

21

,ןיעה שאר היישעתה רוזיא ,

ןופלטב וא

03-9031424

.

,הכרבב

ןב יר

םולש

הנוממ חקור

1.

N

AME OF THE

M

EDICINAL

P

RODUCT

Songha Night, coated tablets

2.

ACTIVE INGREDIENTS

1 tablet contains:

120 mg dry extract of

Valeriana

root and 80 mg dry extract of

Melissa officinalis

leaves

Excipients: sucrose 111.4 mg, liquid spray-dried glucose 31.7 mg.

For a full list of excipients, see section 6.1

P

HARMACEUTICAL

F

ORM

Coated tablet.

Grey-blue, sugarcoated, biconvex tablet with a diameter of 10 mm.

C

LINICAL

P

ARTICULARS

Therapeutic indications

Sedative in states of tension, nervousness and insomnia

Posology and mode of administration

Oral use.

Dosage for adults, elderly and adolescence above 12 years:

Insomnia:

2-3 tablets ½ hour before bedtime.

Sedative in states of tension, nervousness:

2-3 tablets, three times a day

Consult with a doctor if symptoms persist or are aggravated after 2 weeks of treatment.

Due to insufficient data, Songha Night should not be used with children below 12 years of age).

Contraindications

Known hypersensitivity to valerian or melissa

or to any excipient of the product listed in section 6.1.

Special warnings and special precautions for use

The product contains sucrose and glucose. Patients with any of the following rare hereditary

conditions should therefore not use this medical product; fructose intolerance, glucose- or galactose

malabsorption or sucrose-isomaltase deficiency.

Due to insufficient data, Songha Night should not be used with children below 12 years of age

Interaction with other medicinal products and other forms of interaction

Valerian: Only limited data on pharmacological interaction with other medical products are available.

Clinically relevant data with medical products metabolized by CYP 2D6, CYP 3A4/5, CYP 1A2 or

CYP 2E1 has not been observed. Combination of synthetically sleeping medicines or tranquilizers

requires a medical diagnosis and supervision.

Melissa : Presently there are no known data on interactions.

4.6

Fertility, pregnancy and lactation

Due to lack of sufficient data, the use during pregnancy and lactation cannot be recommended.

The eventual effect of the medical product on fertility has not been studied.

Traffic warning

Songha Night have moderate impact on the ability to drive and use machinery. Patients who feel

influenced by Songha Night should not drive nor use machines.

Undesirable effects

Gastrointestinal symptoms (i.e. nausea, abdominal pain) may occur after intake of products containing

valerian root. The frequency is unknown.

Reporting suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It

allows continued monitoring of the benefit/risk balance of the medicinal product.

Any suspected adverse events should be reported to the Ministry of Health according to the National

Regulation by using an online form

(http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic@moh.g

ov.il).

Overdose

Valerian root: a dose of approximate 20 g valerian root caused benign symptoms (fatigue, abdominal

cramps, chest tightness, dizziness, tremor of hands and mydriasis), symptoms which resolved within

24 hours.

Melissa leaf: No cases of overdose have been reported.

P

HARMACOLOGICAL

P

ROPERTIES

5.1

Pharmacodynamic properties

Pharmacoterapeutic group: Sleeping medicines and sedatives, combinations excluding barbiturate,

ATC code N05CX.

Pharmacokinetic properties

Preclinical safety data

No mutagenic potential could be indicated in product specific Ames test on the extracts present in

Songha Night.

P

HARMACEUTICAL

P

ARTICULARS

6.1

List of excipients

Sucrose

Cellulose, microcrystalline

Talc

Liquid spray dried glucose

Acacia, spray-dried

Sodium starch glycolate (type A)

Silica colloidal anhydrous

Magnesium stearate

Titanium dioxide

Carnauba wax

Indigo Carmine

Macrogol 6000

6.2

Incompatibilities

Not relevant.

6.3

Shelf-life

The expiry date of the product is indicated on the packaging materials

6.4

Special precautions for storage

Store below 25°C.

6.5

Nature and content of container

30 coated tablets in blister (Alu/PVC/PVDC).

6.6

Special requirements for destruction

No special requirements.

7.

M

ARKETING

A

UTHORISATION

H

OLDER

Pharma Shalom,

21 Hamelacha st., Ind. Zone Rosh Ha’ayin

8. MANUFACTURER

Ginsana SA,

VIA MULINI, 6934, Bioggio, Switzerland

9.

M

ARKETING

A

UTHORIZATION

N

UMBER

134-16-29935

This leaflet format has been determined by the Ministry of Health and the content has been checked

and approved in 02.2019.