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    Lavender Oil

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    ddandan_2
    The document provides prescribing information for the soft capsule Lasea, containing 80 mg of lavender oil. Lasea is indicated for the treatment of anxiety in adults and is contraindicated for those under 18, with liver dysfunction, or hypersensitivity to lavender oil. Common side effects include gastrointestinal complaints and allergic skin reactions.

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    Lavender Oil

    Uploaded by

    ddandan_2
    73 views4 pages
    The document provides prescribing information for the soft capsule Lasea, containing 80 mg of lavender oil. Lasea is indicated for the treatment of anxiety in adults and is contraindicated for those under 18, with liver dysfunction, or hypersensitivity to lavender oil. Common side effects include gastrointestinal complaints and allergic skin reactions.

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    The document provides prescribing information for the soft capsule Lasea, containing 80 mg of lavender oil. Lasea is indicated for the treatment of anxiety in adults and is contraindicated for those under 18, with liver dysfunction, or hypersensitivity to lavender oil. Common side effects include gastrointestinal complaints and allergic skin reactions.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    73 views4 pages

    Lavender Oil

    Uploaded by

    ddandan_2
    The document provides prescribing information for the soft capsule Lasea, containing 80 mg of lavender oil. Lasea is indicated for the treatment of anxiety in adults and is contraindicated for those under 18, with liver dysfunction, or hypersensitivity to lavender oil. Common side effects include gastrointestinal complaints and allergic skin reactions.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
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    2017 ‫פורמט עלון זה נקבע ע"י משרד הבריאות ותוכנו נבדק ואושר על ידו ביולי‬

    Physicians Prescribing Information

    1. NAME OF THE MEDICINAL PRODUCT


    Lasea®

    80 mg / soft capsule

    2. QUALITATIVE AND QUANTITATIVE COMPOSITION


    1 soft capsule contains:
    Pharmaceutically active constituents: 80 mg lavender oil (Silexan®)

    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.

    Duration of application
    If the symptoms persist unchanged or deteriorate after two weeks of treatment, you
    should consult your doctor.

    -1-
    4.3. Contraindications
    Lasea® is not to be taken:
    • In case of liver dysfunction (liver insufficiency).
    • Hypersensitivity to lavender oil or one of the other constituents of the
    pharmaceutical product.
    • By children and adolescents under 18 years of age.

    4.4. Specials warnings and precautions for use

    Patients with rare hereditary fructose intolerance should not take Lasea®.

    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 by Lasea® could be 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 application during lactation has not yet been investigated. It is not
    known whether constituents of lavender oil or their metabolites are excreted in breast
    milk. Nursing women should therefore not take Lasea®.

    4.7. Effects on ability to drive and use machines


    None known

    4.8. Undesirable effects


    The evaluation of adverse reactions is based on the following information on frequency:

    Very common more than 1 out of 10 treated persons


    Common less than 1 out of 10 but more than 1 out of 100 treated persons
    Uncommon less than 1 out of 100 but more than 1 out of 1000 treated persons
    Rare less than 1 out of 1000 but more than 1 out of 10 000 treated persons
    Very rare less than 1 out of 10 000 treated persons, including single cases

    When taking Lasea®, gastro-intestinal complaints (mainly eructation) and allergic skin
    reactions may occur commonly

    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=AdversEffectM
    edic@moh.gov.il

    4.9. Overdose
    No cases of overdose have become known up to now.

    -2-
    5. PHARMACOLOGICAL PROPERTIES
    5.1. Pharmacodynamic properties
    In animal experiments carried out with lavender oil (Silexan®) contained in Lasea®,
    anxiolytic, antidepressive and sedative properties could be demonstrated after oral
    application. With regards to the mechanism of action of lavender oil, in vitro
    investigations indicated an effect on the GABAA receptors via potentiation of the
    response of GABAA receptors to GABA.
    Spasmolytic effects of lavender oil could be demonstrated in vitro.

    5.2. Pharmacokinetic properties


    Published investigations on pharmacokinetics of lavender oil after oral application are
    not available.

    5.3. Preclinical safety data


    In mice, no symptoms of systemic toxicity were found after oral administration of
    Lavender oil (Silexan®) at single doses of up to 2000 mg/kg; doses of 2700 mg/kg up to
    4000 mg/kg of Lavender oil (Silexan®) by oral route, led, in a dose-dependent manner,
    to a mild to moderate inhibition of motility, ataxia and dyspnea.
    In safety-pharmacological investigations, no effect of Lavender oil (Silexan®) on
    cardiovascular parameters (NOEL* ≥ 450 mg/kg orally, dog), behaviour and body
    temperature (NOEL* ≥ 450 mg/kg orally, rat) was observed; in rats, a dose of 450 mg/kg
    orally led to a short-term respiration-stimulating effect (NOEL* 150 mg/kg orally).
    Chronic toxicity was investigated in rats and dogs (30, 100 or 300 mg/kg Lavender oil
    (Silexan®) by oral route) for a duration of 26 weeks (rat) and 39 weeks (dog). In both
    studies, the NOAEL** was 300 mg/kg BW.

    Studies on reproductive toxicity were carried out in rats (combined segment I and
    segment II study, segment III study) and in rabbits (segment II) with doses ranging from
    30 to 100 and 300 mg/kg Lavender oil (Silexan®) by oral route. In rabbits, complete
    foetal resorption in the early postimplantation phase was observed in one animal of the
    low dose group (N=21) and in respectively two animals of the medium (N=22) and high
    dose group (N=21). No embryotoxic effects were found in rats. NOEL test was above
    300 mg/kg/day.
    Mutagenicity tests with Lavender oil (Silexan®) (Ames test, test with cultivated human
    lymphocytes, micronucleus test) did not provide indications of mutagenic properties of
    Lavender oil (Silexan®). Investigations on cancerogenicity are not available.

    * NOEL = No observed effect level


    ** NOAEL = No observed adverse effect level

    6. PHARMACEUTICAL PARTICULARS
    6.1. List of excipients
    Gelatin succinylated; glycerol 85%; refined rapeseed oil; sorbitol solution 70%; carmine
    lacquer (E 120); patent blue V; aluminium lacquer (E 131); titanium dioxide (E 171).

    6.2. Incompatibilities
    None known

    6.3. Shelf-life
    The expiry date is printed on both pack and container (blister strip). The shelf life of
    Lasea® is 5 years. Lasea® should not be used after expiry of shelf life.

    -3-
    6.4. Special precautions for storage
    Do not store at temperatures above 30 °C.

    6.5. Nature and contents of container


    The container (blister strip) is made of PVC/PVDC foil and
    aluminium foil. Each blister pack contains 14 soft capsules.

    6.6. Special precautions for disposal / handling of the product


    No special requirements

    7. PHARMACEUTICAL COMPANY AND MANUFACTURER


    Dr. Willmar Schwabe GmbH & Co. KG
    Willmar-Schwabe-Strasse 4
    76227 Karlsruhe / Germany

    8. ISRAELI MARKETING AUTHORIZATION HOLDER


    Dr. Samuelov Importing & Marketing Ltd
    13 Hasadna st, POB 2486
    Ra'anana 4365007, Israel
    Phone: 09 7483769

    9. MARKETING AUTHORIZATION NUMBER


    155-33-34385-00

    10. DATE OF FIRST AUTHORIZATION/RENEWAL OF AUTHORIZATION


    01/2016

    11. DATE OF REVISION OF THE TEXT


    20/07/2017

    LASEA-SPC-07/2017

    -4-

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