Mélatonine Sommeil VERDALIS
Integratore alimentare dichiarato in Francia, decisione del 10 novembre 2026
Mélatonine Sommeil VERDALIS è un integratore alimentare dichiarato in Francia. Stato: dichiarato in Francia, commercializzazione possibile. 1 punto della sua composizione richiede una verifica (sostanza vietata, dose o nuovo alimento).
- Marca
- non indicata
- Responsabile dell’immissione in commercio
- TGH VENTURES
- Stato
- Dichiarato in Francia, commercializzazione possibile: l’amministrazione non si è opposta alla dichiarazione (non è né un’autorizzazione né una valutazione della sicurezza)
- Forma
- Capsula
- Dose giornaliera
Traduzione non disponibile. Testo originale, lingua: francese.
2 gélules
- Modalità d’uso
Traduzione non disponibile. Testo originale, lingua: francese.
Prendre 2 gélules par jour, le soir, environ 30 minutes avant le coucher, avec un grand verre d’eau.
- Popolazioni destinatarie
- Uomini e donne dai 18 anni
- Sconsigliato (secondo il fabbricante)
- Adolescenti (sotto i 18 anni), Donne che allattano, Donne in gravidanza, In trattamento con anticoagulanti, In trattamento con antidepressivi, In trattamento antipertensivo, In trattamento farmacologico
- Obiettivi dichiarati dal fabbricante (non sono indicazioni autorizzate)
- Sonno
Notifica 381979, procedura Article 15. Compl’Alim, dichiarazioni di integratori alimentari, consultato il 15 novembre 2026.
Composizione dichiarata
Piante
| Pianta | Parte | Preparazione | Al giorno |
|---|---|---|---|
| Melissa officinalis L. | Feuille | Extrait sec aqueux | 400 mg |
| Griffonia simplicifolia (DC.) Baill. | Graine | Extrait sec hydroalcoolique | 100 mg |
Sostanze
| Nome | Al giorno |
|---|---|
| mélatonine | 1,2 mg |
Altri ingredienti attivi
| Nome | Al giorno |
|---|---|
| Fibres solubles d'acacia | non dichiarata |
Additivi
E464
Altri ingredienti
maltodextrine
Elenco della dichiarazione, decisione dell'amministrazione del (Compl’Alim, dichiarazioni di integratori alimentari).
Il prodotto è cambiato? Fotografi la confezione.
Avvertenze dell’etichetta
Traduzione non disponibile. Testo originale, lingua: francese.
Ceci n’est pas un médicament. Ce complément alimentaire ne se substitue pas à une alimentation variée et équilibrée et ne remplace pas un mode de vie sain. Ne pas dépasser la dose journalière recommandée. Réservé à l’adulte. Déconseillé aux femmes enceintes ou allaitantes, aux enfants et adolescents. Déconseillé aux personnes sous traitement médicamenteux, notamment antidépresseurs, somnifères, anxiolytiques, sédatifs, anticoagulants, antihypertenseurs ou immunosuppresseurs, sauf avis médical. Déconseillé aux personnes souffrant de troubles de l’humeur, d’épilepsie, d’asthme ou de maladies inflammatoires ou auto-immunes, sauf avis médical. Ne pas conduire ou utiliser de machines après consommation. Ne pas associer à d’autres produits contenant de la mélatonine ou du 5-HTP. Tenir hors de portée des jeunes enfants. À conserver dans un endroit frais et sec, à l’abri de la lumière, de la chaleur et de l’humidité, idéalement en dessous de 25 °C.Aspetti normativi
- Substance interdite
Griffonia simplicifolia (DC.) Baill.: pianta pericolosa vietata negli alimenti in Belgio (elenco 1).
Fonte: Belgio, regio decreto del 31 agosto 2021, elenchi di piante (allegato sostituito il 30 gennaio 2024), arrêté royal du 31 août 2021, annexe remplacée le 30 janvier 2024, liste 1, page PDF 73.
Queste informazioni riprendono la dichiarazione del fabbricante all’amministrazione (DGAL). Non dicono se il prodotto sia efficace e non sostituiscono il parere di un medico o farmacista, in particolare in gravidanza o durante un trattamento.
Avvertenze ufficiali (Health Canada)
Health Canada pubblica avvertenze su questi ingredienti:
- Melissa officinalis L.
Leggere l'avvertenza, quando si applica e gli studi citati
Testo originale ufficiale in inglese.
LEMON BALM -MELISSA OFFICINALIS
Via di somministrazione: Oral
Precauzioni e avvertenze
Ask a health care practitioner/health care provider/health care professional/doctor/physician before use if you are pregnant or breastfeeding (EMA 2014).
Fonti citate da Health Canada (1)
- EMA 2014. European Medicines Agency. Melissae folium.. London (UK): EMA Committee on Herbal Medicinal Products (HMPC), 16 June2014. [Accessed 2023 October 27]. Available at: https://www.ema.europa.eu/en/medicines/herbal/melissae-folium
When using this product exercise caution if you drive or use machinery as you may experience drowsiness (EMA 2014).
Fonti citate da Health Canada (1)
- EMA 2014. European Medicines Agency. Melissae folium.. London (UK): EMA Committee on Herbal Medicinal Products (HMPC), 16 June2014. [Accessed 2023 October 27]. Available at: https://www.ema.europa.eu/en/medicines/herbal/melissae-folium
Ask a health care practitioner/health care provider/health care professional/doctor/physician if symptoms persist or worsen.
- mélatonine
Leggere l'avvertenza, quando si applica e gli studi citati
Testo originale ufficiale in inglese.
MELATONIN - Oral
Precauzioni e avvertenze
Ask a health care practitioner/health care provider/health care professional/doctor/physician before use if you are taking medications for seizure, blood pressure, to suppress the immune system, to affect mental state or increase sedation, steroids or blood thinners (Wirtz et al. 2008; IOM 2004; Herxheimer and Petrie 2002; Lusardi et al. 2000; Maestroni 1993).
Fonti citate da Health Canada (5)
- Herxheimer A, Petrie KJ. Melatonin for the prevention and treatment of jet lag. Cochrane Database of Systematic Reviews 2002 Issue 2. Art. No.: CD001520. DOI: 10.1002/14651858.CD001520. [Accessed 2023 August 22]. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8958662/pdf/CD001520.pdf DOI
- IOM 2004: Institute of Medicine Committee on the Framework for Evaluating the Safety of Dietary Supplements. Prototype monograph on melatonin. Dietary Supplement Ingredient Prototype Monographs, Developed as Examples for the Report Dietary Supplements: A Framework for Evaluating Safety. Institute of Medicine and the National Research Council of the National Academies, Washington (DC): National Academies Press 2004: D1-D71.
- Lusardi P, Piazza E, Fogari R. Cardiovascular effects of melatonin in hypertensive patients well controlled by nifedipine: a 24-hour study. British Journal of Clinical Pharmacology 2000;49:423-427. PubMed Studio randomizzato
- Maestroni GJM. The immunoneuroendocrine role of melatonin. Journal of Pineal Research 1993;14(1):1-10. PubMed Articolo di revisione
- Wirtz PH, Spillmann M, Bärtschi C, Ehlert U, von Känel R. Oral melatonin reduces blood coagulation activity: a placebo-controlled study in healthy young men. Journal of Pineal Research 2008;44:127-133. PubMed Studio randomizzato
Ask a health care practitioner/health care provider/health care professional/doctor/physician before use if you have cardiovascular, immune, liver or kidney disease, seizure disorder, asthma or diabetes (Peschke and Mühlbauer 2010; Carrillo-Vico et al. 2005; IOM 2004; der Marderosian and Beuttlers 2003; Sutherland et al. 2003; Calvo et al. 2002; Herxheimer and Petrie 2002; Sutherland et al. 2002; Cagnacci et al. 2001a; Arangino et al. 1999; Sheldon 1998; Maestroni 1993).
Fonti citate da Health Canada (12)
- Arangino S, Cagnacci A, Angiolucci M, Vacca AMB, Longu G, Volpe A, Melis GB. Effects of melatonin on vascular reactivity, catecholamine levels, and blood pressure in healthy men. American Journal of Cardiology 1999; 83(9):1417-1419. PubMed Studio randomizzato
- Cagnacci A, Arangino S, Renzi A, Paoletti AM, Melis GB, Cagnacci P, Volpe A. Influence of melatonin administration on glucose tolerance and insulin sensitivity of postmenopausal women. Clinical Endocrinology (Oxford) 2001a;54(3):339-346. PubMed Studio randomizzato
- Calvo JR, Guerrero JM, Osuna C, Molinero P, Carrillo-Vico A. Melatonin triggers Crohn's disease symptoms. Journal of Pineal Research 2002;32(4):277-278. PubMed Caso clinico
- Carrillo-Vico A, Guerrero JM, Lardone PJ, Reiter RJ. A review of the multiple actions of melatonin on the immune system. Endocrine 2005;27:189-200. PubMed Articolo di revisione
- der Marderosian A, Beutler JA, editors. 2003. The Review of Natural Health Products, 3rd edition. St. Louis (MO): Facts and Comparisons®, a Wolters Kluwer Company.
- Herxheimer A, Petrie KJ. Melatonin for the prevention and treatment of jet lag. Cochrane Database of Systematic Reviews 2002 Issue 2. Art. No.: CD001520. DOI: 10.1002/14651858.CD001520. [Accessed 2023 August 22]. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8958662/pdf/CD001520.pdf DOI
- IOM 2004: Institute of Medicine Committee on the Framework for Evaluating the Safety of Dietary Supplements. Prototype monograph on melatonin. Dietary Supplement Ingredient Prototype Monographs, Developed as Examples for the Report Dietary Supplements: A Framework for Evaluating Safety. Institute of Medicine and the National Research Council of the National Academies, Washington (DC): National Academies Press 2004: D1-D71.
- Maestroni GJM. The immunoneuroendocrine role of melatonin. Journal of Pineal Research 1993;14(1):1-10. PubMed Articolo di revisione
- Peschke E, Mühlbauer E. New evidence for a role of melatonin in glucose regulation. Best practice & research. Clinical endocrinology & metabolism 2010;24(5):829-841. PubMed Articolo di revisione
- Sheldon SH. Pro-convulsant effects of oral melatonin in neurologically disabled children. Lancet 1998;351:1254. PubMed
- Sutherland ER, Martin RJ, Ellison MC, Kraft M. Immunomodulatory effects of melatonin in asthma. American Journal of respiratory and critical care medicine 2002;166:1055-1061. PubMed
- Sutherland ER, Ellison MC, Kraft M, Martin RJ. Elevated serum melatonin is associated with the nocturnal worsening of asthma. Journal of Allergy and Clinical Immunology 2003;112(3):513-517. PubMed
1 studio citato nel testo non ha un riferimento corrispondente nella monografia (vedi le anomalie nella pagina delle fonti).
When using this product avoid taking with alcohol or products that cause drowsiness (Herxheimer and Petrie 2002; Holliman and Chyka 1997).
Fonti citate da Health Canada (1)
- Herxheimer A, Petrie KJ. Melatonin for the prevention and treatment of jet lag. Cochrane Database of Systematic Reviews 2002 Issue 2. Art. No.: CD001520. DOI: 10.1002/14651858.CD001520. [Accessed 2023 August 22]. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8958662/pdf/CD001520.pdf DOI
1 studio citato nel testo non ha un riferimento corrispondente nella monografia (vedi le anomalie nella pagina delle fonti).
When using this product avoid driving or using machinery for 5 hours (Avery et al. 1998; Suhner et al. 1998b).
Fonti citate da Health Canada (2)
- Avery D, Lenz M, Landis C. Guidelines for prescribing melatonin. Annals of Medicine 1998;30(1):122-130. PubMed Articolo di revisione
- Suhner A, Schlagenhauf P, Tschopp A, Hauri-Bionda R, Friedrich-Koch A, Steffen R. Impact of melatonin on driving performance. Journal of Travel Medicine 1998b;5(1):7-13. PubMed Studio randomizzato
Ask a health care practitioner/health care provider/health care professional/doctor/physician if sleeplessness persists for more than 4 weeks (chronic insomnia) (Buscemi et al. 2004; IOM 2004; Dipiro et al. 2002).
Fonti citate da Health Canada (3)
- Buscemi N, Vandermeer B, Pandya R, Hooton N, Tjosvold L, Hartling L, Baker G, Vohra S, Klassen T 2004. Melatonin for treatment of sleep disorders. Evidence Report/Technology Assessment No. 108. AHRQ Publication No. 05-E002-2. Rockville (MD): U.S. Department of Health and Human Services, Agency for Healthcare Research and Quality. November, 2004.
- DiPiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey LM. Pharmacotherapy: A Pathophysiological Approach. 5th edition. New York (NY): McGraw-Hill Co. Inc.; 2002.
- IOM 2004: Institute of Medicine Committee on the Framework for Evaluating the Safety of Dietary Supplements. Prototype monograph on melatonin. Dietary Supplement Ingredient Prototype Monographs, Developed as Examples for the Report Dietary Supplements: A Framework for Evaluating Safety. Institute of Medicine and the National Research Council of the National Academies, Washington (DC): National Academies Press 2004: D1-D71.
Controindicazioni
Do not use if you are pregnant or breastfeeding (IOM 2004).
Fonti citate da Health Canada (1)
- IOM 2004: Institute of Medicine Committee on the Framework for Evaluating the Safety of Dietary Supplements. Prototype monograph on melatonin. Dietary Supplement Ingredient Prototype Monographs, Developed as Examples for the Report Dietary Supplements: A Framework for Evaluating Safety. Institute of Medicine and the National Research Council of the National Academies, Washington (DC): National Academies Press 2004: D1-D71.
Reazioni avverse note
Stop use if allergy occurs or if you experience headache, confusion, or nausea (Herxheimer and Petrie 2002).
Fonti citate da Health Canada (1)
- Herxheimer A, Petrie KJ. Melatonin for the prevention and treatment of jet lag. Cochrane Database of Systematic Reviews 2002 Issue 2. Art. No.: CD001520. DOI: 10.1002/14651858.CD001520. [Accessed 2023 August 22]. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8958662/pdf/CD001520.pdf DOI
Monografia di Health Canada del 19 dicembre 2025
MELATONIN - Sublingual
Precauzioni e avvertenze
Ask a health care practitioner/health care provider/health care professional/doctor/physician before use if you are taking medications for seizure, blood pressure, to suppress the immune system, to affect mental state or increase sedation, steroids or blood thinners (Wirtz et al. 2008; IOM 2004; Herxheimer and Petrie 2002; Lusardi et al. 2000; Maestroni 1993).
Fonti citate da Health Canada (5)
- Herxheimer A, Petrie KJ. Melatonin for the prevention and treatment of jet lag. Cochrane Database of Systematic Reviews Issue 2 2002. Art. No.: CD001520. DOI: 10.1002/14651858.CD001520. [Accessed 2023 August 22]. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8958662/pdf/CD001520.pdf DOI
- IOM 2004: Institute of Medicine Committee on the Framework for Evaluating the Safety of Dietary Supplements. Prototype monograph on melatonin. Dietary Supplement Ingredient Prototype Monographs, Developed as Examples for the Report Dietary Supplements: A Framework for Evaluating Safety. Institute of Medicine and the National Research Council of the National Academies, Washington (DC): National Academies Press 2004: D1-D71.
- Lusardi P, Piazza E, Fogari R. Cardiovascular effects of melatonin in hypertensive patients well controlled by nifedipine: a 24-hour study. British Journal of Clinical Pharmacology 2000;49:423427. PubMed Studio randomizzato
- Maestroni GJM. The immunoneuroendocrine role of melatonin. Journal of Pineal Research 1993;14(1):1-10. PubMed Articolo di revisione
- Wirtz PH, Spillmann M, Bärtschi C, Ehlert U, von Känel R. Oral melatonin reduces blood coagulation activity: a placebo-controlled study in healthy young men. Journal of Pineal Research 2008;44:127-133. PubMed Studio randomizzato
Ask a health care practitioner/health care provider/health care professional/doctor/physician before use if you have a cardiovascular, immune, liver or kidney disease, seizure disorder, asthma or diabetes (Peschke and Mühlbauer 2010; Carrillo-Vico et al. 2005; IOM 2004; der Marderosian and Beuttlers 2003; Sutherland et al. 2003; Calvo et al. 2002; Herxheimer and Petrie 2002; Sutherland et al. 2002; Cagnacci et al. 2001a; Arangino et al. 1999; Sheldon 1998; Maestroni 1993).
Fonti citate da Health Canada (12)
- Cagnacci A, Arangino S, Renzi A, Paoletti AM, Melis GB, Cagnacci P, Volpe A. Influence of melatonin administration on glucose tolerance and insulin sensitivity of postmenopausal women. Clinical Endocrinology (Oxford) 2001a;54(3):339-346. PubMed Studio randomizzato
- Calvo JR, Guerrero JM, Osuna C, Molinero P, Carrillo-Vico A. Melatonin triggers Crohn's disease symptoms. Journal of Pineal Research 2002;32(4):277-278. PubMed Caso clinico
- Carrillo-Vico A, Guerrero JM, Lardone PJ, Reiter RJ. A review of the multiple actions of melatonin on the immune system. Endocrine 2005;27:189-200. PubMed Articolo di revisione
- der Marderosian A, Beutters JA, editors. 2003. The Review of Natural Health Products, 3rd edition. St. Louis (MO): Facts and Comparisons®, a Wolters Kluwer Company.
- Herxheimer A, Petrie KJ. Melatonin for the prevention and treatment of jet lag. Cochrane Database of Systematic Reviews Issue 2 2002. Art. No.: CD001520. DOI: 10.1002/14651858.CD001520. [Accessed 2023 August 22]. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8958662/pdf/CD001520.pdf DOI
- IOM 2004: Institute of Medicine Committee on the Framework for Evaluating the Safety of Dietary Supplements. Prototype monograph on melatonin. Dietary Supplement Ingredient Prototype Monographs, Developed as Examples for the Report Dietary Supplements: A Framework for Evaluating Safety. Institute of Medicine and the National Research Council of the National Academies, Washington (DC): National Academies Press 2004: D1-D71.
- Maestroni GJM. The immunoneuroendocrine role of melatonin. Journal of Pineal Research 1993;14(1):1-10. PubMed Articolo di revisione
- Peschke E, Mühlbauer E. New evidence for a role of melatonin in glucose regulation. Best practice & research. Clinical endocrinology & metabolism 2010;24(5):829-841. PubMed Articolo di revisione
- Sheldon SH. Pro-convulsant effects of oral melatonin in neurologically disabled children. Lancet 1998;351:1254. PubMed
- Sutherland ER, Martin RJ, Ellison MC, Kraft M. Immunomodulatory effects of melatonin in asthma. American Journal of respiratory and critical care medicine 2002;166:1055-1061. PubMed
- Sutherland ER, Ellison MC, Kraft M, Martin RJ. Elevated serum melatonin is associated with the nocturnal worsening of asthma. Journal of Allergy and Clinical Immunology 2003;112(3):513517.
- Arangino S, Cagnacci A, Angiolucci M, Vacca AMB, Longu G, Volpe A, Melis GB. Effects of melatonin on vascular reactivity, catecholamine levels, and blood pressure in healthy men. American Journal of Cardiology 1999;83(9):1417-1419. PubMed Studio randomizzato
1 studio citato nel testo non ha un riferimento corrispondente nella monografia (vedi le anomalie nella pagina delle fonti).
When using this product avoid taking with alcohol or products that cause drowsiness (Herxheimer and Petrie 2002; Holliman and Chyka 1997).
Fonti citate da Health Canada (1)
- Herxheimer A, Petrie KJ. Melatonin for the prevention and treatment of jet lag. Cochrane Database of Systematic Reviews Issue 2 2002. Art. No.: CD001520. DOI: 10.1002/14651858.CD001520. [Accessed 2023 August 22]. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8958662/pdf/CD001520.pdf DOI
1 studio citato nel testo non ha un riferimento corrispondente nella monografia (vedi le anomalie nella pagina delle fonti).
When using this product avoid driving or using machinery for 5 hours (Avery et al. 1998; Suhner et al. 1998b).
Fonti citate da Health Canada (2)
- Avery D, Lenz M, Landis C. Guidelines for prescribing melatonin. Annals of Medicine 1998;30(1):122-130. PubMed Articolo di revisione
- Suhner A, Schlagenhauf P, Tschopp A, Hauri-Bionda R, Friedrich-Koch A, Steffen R. Impact of melatonin on driving performance. Journal of Travel Medicine 1998b;5(1):7-13. PubMed Studio randomizzato
Ask a health care practitioner/health care provider/health care professional/doctor/physician if sleeplessness persists for more than 4 weeks (chronic insomnia) (Buscemi et al. 2004; IOM 2004; Dipiro et al. 2002).
Fonti citate da Health Canada (3)
- Buscemi N, Vandermeer B, Pandya R, Hooton N, Tjosvold L, Hartling L, Baker G, Vohra S, Klassen T. Melatonin for treatment of sleep disorders. Evidence Report/Technology Assessment No. 108. AHRQ Publication No. 05-E002-2. Rockville (MD): U.S. Department of Health and Human Services, Agency for Healthcare Research and Quality. November, 2004.
- DiPiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey LM. Pharmacotherapy: A Pathophysiological Approach. 5th edition. New York (NY): McGraw-Hill Co. Inc.; 2002.
- IOM 2004: Institute of Medicine Committee on the Framework for Evaluating the Safety of Dietary Supplements. Prototype monograph on melatonin. Dietary Supplement Ingredient Prototype Monographs, Developed as Examples for the Report Dietary Supplements: A Framework for Evaluating Safety. Institute of Medicine and the National Research Council of the National Academies, Washington (DC): National Academies Press 2004: D1-D71.
Controindicazioni
Do not use if you are pregnant or breastfeeding (IOM 2004).
Fonti citate da Health Canada (1)
- IOM 2004: Institute of Medicine Committee on the Framework for Evaluating the Safety of Dietary Supplements. Prototype monograph on melatonin. Dietary Supplement Ingredient Prototype Monographs, Developed as Examples for the Report Dietary Supplements: A Framework for Evaluating Safety. Institute of Medicine and the National Research Council of the National Academies, Washington (DC): National Academies Press 2004: D1-D71.
Reazioni avverse note
Stop use if allergy occurs or if you experience headache, confusion, or nausea (Herxheimer and Petrie 2002).
Fonti citate da Health Canada (1)
- Herxheimer A, Petrie KJ. Melatonin for the prevention and treatment of jet lag. Cochrane Database of Systematic Reviews Issue 2 2002. Art. No.: CD001520. DOI: 10.1002/14651858.CD001520. [Accessed 2023 August 22]. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8958662/pdf/CD001520.pdf DOI
Riguardano l'ingrediente, non questo prodotto né la sua dose. Non sostituiscono il parere medico.
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