ORZAX CHARDON-MARIE PLUS
Integratore alimentare dichiarato in Francia, notifica n. 2023-12-110, decisione del 4 dicembre 2023
ORZAX CHARDON-MARIE PLUS è un integratore alimentare dichiarato in Francia. Stato: dichiarato in Francia, commercializzazione possibile. Nessuna delle regole che verifichiamo rileva punti sulla composizione dichiarata.
- Marca
- non indicata
- Responsabile dell’immissione in commercio
- ORZAX EU OÜ
- 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.
1 gelule par jour
- Sconsigliato (secondo il fabbricante)
- Adolescenti (sotto i 18 anni), Donne che allattano, Donne in gravidanza
Notifica 329556, procedura Article 15. Compl’Alim, dichiarazioni di integratori alimentari, consultato il 15 novembre 2026.
Composizione dichiarata
Piante
| Pianta | Parte | Preparazione | Al giorno |
|---|---|---|---|
| Silybum marianum (L.) Gaertn. | Graine | Poudre (de plantes séchées ou broyées) | 250 mg |
| Cynara scolymus L. | Feuille | Poudre (de plantes séchées ou broyées) | 150 mg |
| Taraxacum campylodes G.E.Haglund | Plante entière | Poudre (de plantes séchées ou broyées) | 50 mg |
Additivi
E464, E460, E551, E470b
Elenco della dichiarazione, decisione dell'amministrazione del (Compl’Alim, dichiarazioni di integratori alimentari).
Aspetti normativi
Nessuna delle norme che verifichiamo si applica agli ingredienti notificati.
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:
- Silybum marianum (L.) Gaertn.
Leggere l'avvertenza, quando si applica e gli studi citati
Testo originale ufficiale in inglese.
MILK THISTLE - SILYBUM MARIANUM
Via di somministrazione: Oral
Precauzioni e avvertenze
Ask a health care practitioner/health care provider/health care professional/doctor/physician if symptoms persist or worsen.
Ask a health care practitioner/health care provider/health care professional/doctor/physician before use if you are pregnant (Brinker 2010; Mills et al. 2006).
Fonti citate da Health Canada (2)
- Brinker F. Herb Contraindications and Drug Interactions, 4th edition. Sandy (OR): Eclectic Medical Publications; 2010.
- Mills E, Dugoua J, Perri D, Koren G. Herbal Medicines in Pregnancy and Lactation : An Evidence-Based Approach. London (UK): Taylor and Francis Medical; 2006.
Reazioni avverse note
Stop use if hypersensitivity/allergy occurs (Geier et al. 1990; Mironets et al. 1990).
Fonti citate da Health Canada (2)
- Geier J, Fuchs Th, Wahl R. [Anaphylactic shock due to an extract of Silybum marianum in a patient with immediate-type allergy to Kiwi fruit]. Anaphylaktischer Schock durch einen Mariendistel-Extrakt bei Soforttyp-Allergie auf Kiwi. Allergologie 1990;13(10):387-388 (in German).
- Mironets VI, Krasovskaia EA, Polischuk II. [A case of urticaria during carsil treatment]. Vrachebnoe Delo 1990;(7):86-87 (in Russian).
- Taraxacum campylodes G.E.Haglund
Leggere l'avvertenza, quando si applica e gli studi citati
Testo originale ufficiale in inglese.
DANDELION - TARAXACUM OFFICINALE
Via di somministrazione: Oral
Precauzioni e avvertenze
Condizione di applicazione: All products.
Ask a health care practitioner/health care provider/health care professional/doctor/physician before use if you have a liver or biliary disorder or an intestinal obstruction (Brinker 2010; Godfrey et al. 2010; ESCOP 2003; Bradley 1992).
Fonti citate da Health Canada (5)
- Bradley PR, editor. 1992. British Herbal Compendium, Volume 1. Bournemouth (GB): British Herbal Medicine Association.
- Brinker F. Herb Contraindications and Drug Interactions, 4th edition. Sandy (OR): Eclectic Medical Publications; 2010.
- ESCOP 2003: ESCOP Monographs: The Scientific Foundation for Herbal Medicinal Products. 2nd edition. Exeter (GB): European Scientific Cooperative on Phytotherapy and Thieme; 2003.
- Godfrey A, Saunders P, Barlow K, Gowan M. Principles and Practices of Naturopathic Botanical Medicine: Volume 1: Botanical Medicine Monographs, 1st edition. Toronto (ON): CCNM Press Inc.; 2010.
- EMA 2009: European Medicines Agency, Science Medicines Health. 12 November 2009. EMA/HMPC/212895/2008. Committee on Herbal Medicinal Products (HMPC) Community herbal monograph on Taraxacum officinale Weber ex Wigg., radix cum herba. Final. [Consulté le 14 mars 2024]. Disponible à : https://www.ema.europa.eu/en/documents/herbal-monograph/final-community-herbal-monograph-taraxacum-officinale-weber-ex-wigg-radix-cum-herba_en.pdf
Condizione di applicazione: Constipation, Flushing of the urinary tract, Indigestion, and Loss of appetite.
Ask a health care practitioner/health care provider/health care professional/doctor/physician if symptoms persist or worsen.
Controindicazioni
Si applica ai prodotti: providing 10 g or more of dried leaf or dried root or dried whole plant, per day or 10 mL or more of juice, per day.
Do not use if you have diabetes or a blood pressure, kidney or cardiovascular disorder (Goksu et al. 2010; EMA 2009; Hunt et al. 2005; Green et al. 2002; Mujais and Katz 2000; Carlsen et al. 1990; Kuller et al. 1986; Artz et al. 1966).
Fonti citate da Health Canada (8)
- Artz SA, Paes IC, Faloon WW. Hypokalemia-induced hepatic coma in cirrhosis. Occurrence despite neomycin therapy. Gastroenterology 1966;51(6):1046-1053. PubMed
- Carlsen JE, Køber L, Torp-Pedersen C, Johansen P. Relation between dose of bendrofluazide, antihypertensive effect, and adverse biochemical effects. British Medical Journal 1990;300(6730):975-978. PubMed Studio randomizzato
- EMA 2009: European Medicines Agency, Science Medicines Health. 12 November 2009. EMA/HMPC/212895/2008. Committee on Herbal Medicinal Products (HMPC) Community herbal monograph on Taraxacum officinale Weber ex Wigg., radix cum herba. Final. [Accessed 2024 March 14]. Available from: https://www.ema.europa.eu/en/documents/herbal-monograph/final-community-herbal-monograph-taraxacum-officinale-weber-ex-wigg-radix-cum-herba_en.pdf
- Goksu E, Eken C, Karadeniz O, Kucukyilmaz O, Firt report of hypoglycemia secondary to dandelion (Taraxacum officinale) ingestion. The American Journal of Emergency Medicine 2010;28:111.e1-111.e2
- Green DM, Ropper AH, Kronmal RA, Psaty BM, Burke GL. Serum potassium level and dietary potassium intake as risk factors for stroke. Neurology 2002;59(3):314-320. PubMed
- Hunt SA, Abraham WT, Chin MH, Feldman AM, Francis GS, Ganiats TG, Jessup M, Konstam MA, Mancini DM, Michl K, Oates JA, Rahko PS, Silver MA, Stevenson LW, Yancy CW, Antman EM, Smith Jr. SC, Adams CD, Anderson JL, Faxon DP, Fuster V, Halperin JL, Hiratzka LF, Jacobs AK, Nishimura R, Ornato JP, Page RL, Riegel B. American College of Cardiology, American Heart Association Task Force on Practice Guidelines, American College of Chest Physicians, International Society for Heart and Lung Transplantation, Heart Rhythm Society. ACC/AHA 2005 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Update the 2001 Guidelines for the Evaluation and Management of Heart Failure): developed in collaboration with the American College of Chest Physicians and the International Society for Heart and Lung Transplantation: endorsed by the Heart Rhythm Society. Circulation 2005;112(12):e154-235.
- Kuller LH, Hulley SB, Cohen JD, Neaton J. Unexpected effects of treating hypertension in men with electrocardiographic abnormalities: a critical analysis. Circulation 1986;73(1):114-123. PubMed
- Mujais SK, Katz AL. Potassium deficiency. In: Seldin & Giebisch's The Kidney: Physiology and Pathophysiology. Lippincott Williams and Wilkins; 2000. p1615.
Do not use if you are taking heart medications or other products containing diuretics (Goksu et al. 2010; EMA 2009; Hunt et al. 2005; Green et al. 2002; Mujais and Katz 2000; Carlsen et al. 1990; Kuller et al. 1986; Artz et al. 1966).
Fonti citate da Health Canada (8)
- Artz SA, Paes IC, Faloon WW. Hypokalemia-induced hepatic coma in cirrhosis. Occurrence despite neomycin therapy. Gastroenterology 1966;51(6):1046-1053. PubMed
- Carlsen JE, Køber L, Torp-Pedersen C, Johansen P. Relation between dose of bendrofluazide, antihypertensive effect, and adverse biochemical effects. British Medical Journal 1990;300(6730):975-978. PubMed Studio randomizzato
- EMA 2009: European Medicines Agency, Science Medicines Health. 12 November 2009. EMA/HMPC/212895/2008. Committee on Herbal Medicinal Products (HMPC) Community herbal monograph on Taraxacum officinale Weber ex Wigg., radix cum herba. Final. [Accessed 2024 March 14]. Available from: https://www.ema.europa.eu/en/documents/herbal-monograph/final-community-herbal-monograph-taraxacum-officinale-weber-ex-wigg-radix-cum-herba_en.pdf
- Goksu E, Eken C, Karadeniz O, Kucukyilmaz O, Firt report of hypoglycemia secondary to dandelion (Taraxacum officinale) ingestion. The American Journal of Emergency Medicine 2010;28:111.e1-111.e2
- Green DM, Ropper AH, Kronmal RA, Psaty BM, Burke GL. Serum potassium level and dietary potassium intake as risk factors for stroke. Neurology 2002;59(3):314-320. PubMed
- Hunt SA, Abraham WT, Chin MH, Feldman AM, Francis GS, Ganiats TG, Jessup M, Konstam MA, Mancini DM, Michl K, Oates JA, Rahko PS, Silver MA, Stevenson LW, Yancy CW, Antman EM, Smith Jr. SC, Adams CD, Anderson JL, Faxon DP, Fuster V, Halperin JL, Hiratzka LF, Jacobs AK, Nishimura R, Ornato JP, Page RL, Riegel B. American College of Cardiology, American Heart Association Task Force on Practice Guidelines, American College of Chest Physicians, International Society for Heart and Lung Transplantation, Heart Rhythm Society. ACC/AHA 2005 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Update the 2001 Guidelines for the Evaluation and Management of Heart Failure): developed in collaboration with the American College of Chest Physicians and the International Society for Heart and Lung Transplantation: endorsed by the Heart Rhythm Society. Circulation 2005;112(12):e154-235.
- Kuller LH, Hulley SB, Cohen JD, Neaton J. Unexpected effects of treating hypertension in men with electrocardiographic abnormalities: a critical analysis. Circulation 1986;73(1):114-123. PubMed
- Mujais SK, Katz AL. Potassium deficiency. In: Seldin & Giebisch's The Kidney: Physiology and Pathophysiology. Lippincott Williams and Wilkins; 2000. p1615.
Riguardano l'ingrediente, non questo prodotto né la sua dose. Non sostituiscono il parere medico.
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