Country: Israel
Language: English
Source: Ministry of Health
HYPERICI HERBA EXTRACTUM SICCUM
RAFA LABORATORIES LTD
FILM COATED TABLETS
HYPERICI HERBA EXTRACTUM SICCUM 250 MG
PER OS
Required
MAX ZELLER SOHNE AG, SWITZERLAND
Symptoms of mild to moderate depression including: dejected mood, mood lability, inner restlessness, anxiety, states of tension and the difficulty in falling asleep and sleeping through the night which is associated with these conditions. Treatment is recommended for up to 24 weeks.
2015-07-07
Remotiv-SPC-November 2023 1. REMOTIV ® 250 REMOTIV ® 500 Film coated tablets Herbal medicinal product 2. COMPOSITION Composition Active substance of Remotiv 250 mg: St. John's wort (Hypericum perforatum), dry extract. One film-coated tablet contains 250mg of the standardized dry extract (Ze 117), standardized to 0.5mg total hypericin. The unique patented extraction process (extraction solvent: ethanol 50% w/w; drug-extract ratio: 4-7:1) guarantees a consistently high-quality product, which has a very low hyperforin content (see below “Drug interactions”). Active substance of Remotiv 500mg: St. John's wort (Hypericum perforatum), dry extract. One film-coated tablet contains 500mg of the standardized dry extract (Ze 117), standardized to 1mg total hypericin. The unique patented extraction process (extraction solvent: ethanol 50% w/w; drug-extract ratio: 4-7:1) guarantees a consistently high-quality product, which has a very low hyperforin content (see below “Drug interactions”). For list of excipients: see section 6.1 This medicine contains approx. 120 mg digestible carbohydrates per single dose. The medicine is suitable for diabetics. 3. PHARMACEUTICAL FORM GALENIC FORM AND ACTIVE SUBSTANCE PER UNIT Film coated tablets. Herbal medicinal product Remotiv 250: 1 film coated tablet contains 250 mg of the quantified dry extract from St. John’s wort (corresponding to 0.25 - 0.75 mg total hypericins (calculated as hypericin) and maximum 0.5 mg hyperforin. Remotiv 500: 1 film coated tablet contains 500 mg of the quantified dry extract from St. John’s wort (corresponding to 0.5 - 1.5 mg total hypericins (calculated as hypericin) and maximum 1 mg hyperforin. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS For the treatment of symptoms of mild to moderate depression including dejected mood, mood lability, anxiety, inner restlessness, states of tension, and difficulty in falling asleep and sleeping through the night which is associated with these conditions. Treatment is recommended for up to 24 weeks. 4.2 Read the complete document