VALERIANE TINCTURA FLORIS

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

VALERIAN DRY EXTRACT

Available from:

BEN SHIMON FLORIS LTD, ISRAEL

ATC code:

N05CM09

Pharmaceutical form:

DROPS

Composition:

VALERIAN DRY EXTRACT 2.5 G / 100 ML

Administration route:

PER OS

Prescription type:

Not required

Manufactured by:

BEN SHIMON FLORIS LTD, ISRAEL

Therapeutic group:

VALERIAN

Therapeutic area:

VALERIAN

Therapeutic indications:

Tranquilizer.

Authorization date:

2021-06-30

Patient Information leaflet

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Summary of Product characteristics

Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
VALERIANE TINCTURA FLORIS
1. NAME OF THE MEDICINAL PRODUCT:
VALERIANE TINCTURA FLORIS
2. QUALITATIVE AND QUANTITATIVE COMPOSITION :
1 ml solution contains 25 mg valerian dry extract
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM:
Drops.
Per os.
Almost clear, with some insoluble matter brown liquid, odor and taste
of valerian and alcohol.
4. CLINICAL PARTICULARS:
4.1 THERAPEUTIC INDICATIONS:
VALERIANE TINCTURA FLORIS is indicated for relief of anxiety, stress
and nervousness.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION:
Posology: per os.
For adults and children over the age of 12 years: 20-50 drops in a
glass of water as required.
(see Section 4.4 Special warnings and precautions for use). Do not
exceed the recommended
dosage.
4.3 CONTRAINDICATIONS:
Known hypersensitivity to the active substance or to any of the
additional ingredients contained in the medicine. For the list of the
inactive substances - see
Section 6.1 "
List of excipients ".
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE:
• Do not drink wine or alcoholic beverages during the treatment with
the medicine.
• If you are sensitive to any food or medicine, inform your
physician before using this medicine.
• Do not use this medicine frequently,
or for a long period, without consulting a physician.
The use of this medicine may impair alertness. Therefore, caution must
be exercised when
driving a vehicle or operating dangerous machinery and in any activity
that requires alertness.
If you are taking, or recently took, other medicines, including over
the counter medicines and
dietary supplements, inform your doctor or pharmacist.
Pregnancy and Breast-feeding: If you are pregnant, planning to become
pregnant or if you are
breast-feeding, consult your doctor or pharmacist before using the
medicine, since there is
insufficient data on the safety of the medication in these conditions.
Important information about some of the ingredients of the medicine:
contains alcohol,
flammable substanc