देश: इसराइल
भाषा: अंग्रेज़ी
स्रोत: Ministry of Health
LAVENDER OIL
DR.SAMUELOV IMPORTING & MARKETING LTD, ISRAEL
CAPSULES SOFT
LAVENDER OIL 80 MG
PER OS
Required
DR. WILLMAR SCHWABE GMBH &CO. KG, GERMANY
Treatment of anxiety in adults.
2020-12-31
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 पूरा दस्तावेज़ पढ़ें
- 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 पूरा दस्तावेज़ पढ़ें