LASEA

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

LAVENDER OIL

Available from:

DR.SAMUELOV IMPORTING & MARKETING LTD, ISRAEL

Pharmaceutical form:

CAPSULES SOFT

Composition:

LAVENDER OIL 80 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

DR. WILLMAR SCHWABE GMBH &CO. KG, GERMANY

Therapeutic indications:

Treatment of anxiety in adults.

Authorization date:

2020-12-31

Patient Information leaflet

PATIENT PACKAGE INSERT ACCORDING TO PHARMACISTS' REGULATION
(PREPARATIONS)-
1986
This medicine can be sold with a physician’s prescription only.
LASEA
®
Soft capsules
NAME OF THE MEDICINE, ITS FORM AND STRENGTH
NAME OF THE MEDICINE: Lasea
®
FORM: Soft capsules
THE ACTIVE INGREDIENT AND ITS QUANTITY IN A DOSAGE UNIT:
Each soft capsule contains Lavender oil (Silexan
®
) 80 mg.
For list of excipients and allergens in the medicine - see section 6.
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE.
This leaflet contains concise information about the medicine. If you
have any further
questions, ask the physician or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm
them, even if you think that their medical condition is similar.
The medicine is intended for adults above 18 years of age.
1. WHAT IS THE MEDICINE INTENDED FOR?
The medicine Lasea
®
is intended for adults, for treatment of anxiety.
THERAPEUTIC GROUP: Anxiolytics.
2. BEFORE USING THIS MEDICINE:
DO NOT USE THE MEDICINE:
•
If you suffer from liver dysfunction (liver failure).
•
If you are hypersensitive (allergic) to lavender or to any of the
other ingredients this
medicine contains. The active ingredient appears in section 1 and the
other
ingredients are listed in section 6.
•
If you have previously developed hypersensitivity (an allergic
reaction) to Lasea®
•
Under 18 years of age.
SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE:
DRUG INTERACTIONS: IF YOU ARE TAKING OR HAVE RECENTLY TAKEN ANY OTHER
MEDICINES,
INCLUDING NON-PRESCRIPTION DRUGS AND NUTRITION SUPPLEMENTS, TELL YOUR
PHYSICIAN OR PHARMACIST.
As of now there are no known interactions between Lasea
®
and other medicines.
CHILDREN AND ADOLESCENTS:
Do not use Lasea
® in children and adolescents under 18 years of age since there is
not enough information regarding use of the medicine in this age
group.
PREGNANCY AND BREAST-FEEDING:
In experimental studies, no fetal toxicity has been observed as a
result of using the
active in

Summary of Product characteristics

- 1 -
PHYSICIANS PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
LASEA®
80 mg / soft capsule
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 soft capsule contains:
Active substance: 80 mg lavender oil (Silexan
®
)
Contains 12 mg sorbitol. For a full list of excipients, see section
6.1
3.
PHARMACEUTICAL FORM
Soft capsule
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Treatment of Anxiety, in adults
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Adults from 18 years of age take one soft capsule once daily
(corresponding to 80 mg
lavender oil per day).
The soft capsules are to be taken in whole, unchewed with sufficient
liquid (preferably a
glass of water). The soft capsule should not be cut or emptied.
Lasea® should not be
taken in a lying position.
_CHILDREN AND ADOLESCENTS_
Lasea® is contraindicated for persons under the age of 18 years as
there are no
adequate data available concerning the application of this
pharmaceutical product in this
age group.
_MODE OF APPLICATION_
If the symptoms persist unchanged or deteriorate after two weeks of
treatment, you
should consult your doctor.
- 2 -
4.3.
CONTRAINDICATIONS
Lasea® is not to be taken:
•
In case of liver dysfunction (hepatic failure)
•
Hypersensitivity to lavender oil or one of the other constituents of
the
pharmaceutical product.
•
In case a hypersensitivity reaction was developed to Lasea in previous
use.
•
By children and adolescents under 18 years of age.
4.4.
SPECIALS WARNINGS AND PRECAUTIONS FOR USE
Please take note to 4.3 and 4.6
4.5.
INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None known
4.6.
PREGNANCY AND LACTATION
No impairment of fertility and embryo-foetal development due to
Lasea® was shown
in reproductive toxicity studies in rats and rabbits (see section
5.3). Clinical data on
the use of lavender oil during pregnancy are not available. Lasea®
should therefore
not be used during pregnancy.
The safety of the use of Lasea® during lactation has not yet been
investigated. It is
not known whether con