Phytofacile Confort menstruel
Integratore alimentare dichiarato in Francia, notifica n. 2024-2-1137, decisione del 19 febbraio 2024
Phytofacile Confort menstruel è un integratore alimentare dichiarato in Francia. Stato: dichiarato in Francia, commercializzazione possibile. 2 norme d’uso si applicano ai suoi ingredienti (limiti e avvertenze).
- Marca
- non indicata
- Responsabile dell’immissione in commercio
- LABORATOIRE D'AROMATHERAPIE DE PHYTOTHERAPIE ET D'HERBORISTERIE TRADITIONNELLE - PHYTOFRANCE (LAPHT PHYTOFRANCE) (L.A.P.H.T. PHYTOFRAN)
- 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
- Flacone
- Dose giornaliera
Traduzione non disponibile. Testo originale, lingua: francese.
6 pipettes
- Modalità d’uso
Traduzione non disponibile. Testo originale, lingua: francese.
3 pipettes doseuses, 2 fois par jour, pendant 3 semaines
- Popolazioni destinatarie
- Donne
- Sconsigliato (secondo il fabbricante)
- Adolescenti (sotto i 18 anni), Donne che allattano, Pregresso tumore al seno, Bambini (sotto i 12 anni), Bambini piccoli (da 1 a 3 anni), Donne in gravidanza, Insufficienza renale, Malattia renale, Lattanti (sotto 1 anno), Problemi cardiaci, Problemi al fegato, In trattamento con anticoagulanti, In trattamento farmacologico
- Obiettivi dichiarati dal fabbricante (non sono indicazioni autorizzate)
- Cicli mestruali
Notifica 139277, procedura Article 15. Compl’Alim, dichiarazioni di integratori alimentari, consultato il 15 novembre 2026.
Composizione dichiarata
Piante
| Pianta | Parte | Preparazione | Al giorno |
|---|---|---|---|
| Aesculus hippocastanum L. | Fruit | Teinture | 26 mg |
| Artemisia vulgaris L. | Parties aériennes | Teinture | 26 mg |
| Vitex agnus-castus L. | Fruit | Teinture | 26 mg |
| Hamamelis virginiana L. | Feuille | Teinture | 26 mg |
| Matricaria chamomilla L. | Parties aériennes | Teinture | 26 mg |
| Ribes nigrum L. | Feuille (bourgeon) | Autre macérât | 2,97 mg |
| Rubus idaeus L. | Jeune pousse | Autre macérât | 2,97 mg |
| Malus domestica Borkh | Bourgeon | Autre macérât | 2,97 mg |
| Rosmarinus officinalis L. | Jeune pousse | Autre macérât | 2,97 mg |
Additivi
E422, E150a
Altri ingredienti
Eau déminéralisée, Alcool
Elenco della dichiarazione, decisione dell'amministrazione del (Compl’Alim, dichiarazioni di integratori alimentari).
Avvertenze dell’etichetta
Traduzione non disponibile. Testo originale, lingua: francese.
Déconseillé aux enfants, femmes enceintes, allaitantes, aux personnes ayant des antécédents personnels ou familiaux de cancer du sein ou sous traitement anticoagulant. Déconseillé en cas d’allergies aux Astéracées, d’insuffisance cardiaque ou rénale œdémateuse, de cancer hormono-dépendant (ou d’antécédents de tels cancers), de tumeur hypophysaire à prolactine, d’antécédents de troubles hypophysaires, d’obstructions biliaires ou autres troubles de la fonction biliaire. En cas de traitement médicamenteux, demander conseil à un professionnel de santé. Réservé à l’adulte.Aspetti normativi
- Conditions légales
Artemisia vulgaris L.: L'huile essentielle de cette plante est interdite.
Fonte: Decreti francesi del 9 maggio 2006 (nutrienti), del 24 giugno 2014 (piante) e del 26 settembre 2016 (altre sostanze), raccolta LEGI consolidata, arrêté du 24 juin 2014, annexe I.
- Conditions légales
Vitex agnus-castus L.: L'étiquetage doit comporter un avertissement déconseillant l'usage chez les femmes ayant des antécédents personnels ou familiaux de cancer du sein.
Fonte: Decreti francesi del 9 maggio 2006 (nutrienti), del 24 giugno 2014 (piante) e del 26 settembre 2016 (altre sostanze), raccolta LEGI consolidata, arrêté du 24 juin 2014, annexe I.
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:
- Aesculus hippocastanum L.
Leggere l'avvertenza, quando si applica e gli studi citati
Testo originale ufficiale in inglese.
Horse Chestnut - Aesculus Hippocastanum
Via di somministrazione: Oral (Bradley 2006; ESCOP 2003)
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 or breastfeeding (Brinker 2010; Mills and Bone 2005).
Fonti citate da Health Canada (2)
- Brinker F. Herb Contraindications and Drug Interactions, 4th edition. Sandy (OR): Eclectic Medical Publications; 2010.
- Mills S, Bone K. The Essential Guide to Herbal Safety. St. Louis (MO): Elsevier Churchill Livingstone; 2005.
Reazioni avverse note
When using this product you may experience headache, dizziness, gastric irritation, or itchiness (Bradley 2006; Mills and Bone 2005; ESCOP 2003).
Fonti citate da Health Canada (3)
- Bradley PR, editor. British Herbal Compendium: A Handbook of Scientific Information on Widely Used Plant Drugs, Volume 2. Bournemouth (UK): British Herbal Medicine Association; 2006.
- ESCOP 2003: ESCOP Monographs: The Scientific Foundation for Herbal Medicinal Products, 2nd edition. Exeter (UK): European Scientific Cooperative on Phytotherapy and Thieme; 2003.
- Mills S, Bone K. The Essential Guide to Herbal Safety. St. Louis (MO): Elsevier Churchill Livingstone; 2005.
- Artemisia vulgaris L.
Leggere l'avvertenza, quando si applica e gli studi citati
Testo originale ufficiale in inglese.
MUGWORT - ARTEMISIA VULGARIS
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.
Controindicazioni
Do not use if you are pregnant or breastfeeding (Brinker 2010; Blumenthal et al. 1998; Williamson et al. 1988).
Fonti citate da Health Canada (3)
- Blumenthal M, Busse W, Goldberg A, Gruenwald J, Hall T, Riggins C, Rister R, editors. The Complete German Commission E Monographs: Therapeutic Guide to Herbal Medicines. Austin (TX): American Botanical Council; 1998.
- Brinker F. Herb Contraindications and Drug Interactions, 4th edition. Sandy (OR): Eclectic Medical Publications; 2010.
- Williamson EM, Evans FJ, Wren RC. Potter's New Cyclopaedia of Botanical Drugs and Preparations. Saffron Walden (UK): C.W. Daniel Company Limited; 1988.
Reazioni avverse note
Stop use if hypersensitivity/allergy occurs (Brinker 2010; Wichtl 2004; Hoffmann 2003).
Fonti citate da Health Canada (3)
- Brinker F. Herb Contraindications and Drug Interactions, 4th edition. Sandy (OR): Eclectic Medical Publications; 2010.
- Hoffmann D. Medical Herbalism. Rochester (VT): Healing Arts Press; 2003.
- Wichtl M, editor. Herbal Drugs and Phytopharmaceuticals: A Handbook for Practice on a Scientific Basis, 3rd edition. Stuttgart (D): Medpharm GmbH Scientific Publishers; 2004.
- Vitex agnus-castus L.
Leggere l'avvertenza, quando si applica e gli studi citati
Testo originale ufficiale in inglese.
CHASTE TREE - VITEX AGNUS-CASTUS
Via di somministrazione: Oral (WHO 2009; Bradley 2006; Mills and Bone 2000)
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 taking hormone-containing medications such as progesterone preparations, oral contraceptives or hormone replacement therapy (Brinker 2010; WHO 2009; Bradley 2006).
Fonti citate da Health Canada (4)
- Bradley PR, editor. 2006. British Herbal Compendium: A Handbook of Scientific Information on Widely Used Plant Drugs, Volume 2. Bournemouth (GB): British Herbal Medicine Association.
- Brinker F. Herb Contraindications and Drug Interactions, 4th edition. Sandy (OR): Eclectic Medical Publications; 2010.
- WHO 2009: World Health Organization. WHO Monographs on Selected Medicinal Plants, Volume 4. Geneva (CH): World Health Organization.
- OMS 2009: Organisation mondiale de la santé. WHO Monographs on Selected Medicinal Plants, Volume 4. Genève (CH): Organisation mondiale de la santé.
Controindicazioni
Do not use if you are pregnant, breastfeeding or attempting to conceive unless you have consulted with a health care practitioner/health care provider/health care professional/doctor/physician (EMA 2018; Najib et al. 2022; Brinker 2010; WHO 2009; Dugoua et al. 2008; ESCOP 2003; Blumenthal 2000; Mills and Bone 2000).
Fonti citate da Health Canada (9)
- Blumenthal M, Goldberg A, Brinkmann J, editors. 2000. Herbal Medicine: Expanded Commission E Monographs. Boston (MA): Integrative Medicine Communications.
- Brinker F. Herb Contraindications and Drug Interactions, 4th edition. Sandy (OR): Eclectic Medical Publications; 2010.
- Dugoua JJ, Seely D, Pern D, Koren G, Mills E. Safety and efficacy of chastetree (Vitex Agnus-Castus) during pregnancy and lactation. Can J. Clin Pharmacol 2008;15(1);e74-e79.
- EMA 2018. European Medicines Agency. European Union herbal monograph on Vitex agnus-castus L., fructus. London (GB): EMA Committee on Herbal Medicinal Products (HMPC); 27 March 2018. [Accessed 2024 February 29] Available from: https://www.ema.europa.eu/en/documents/herbal-monograph/final-european-union-herbal-monograph-vitex-agnus-castus-l-fructus-revision-1_en.pdf
- ESCOP 2003: European Scientific Cooperative on Phytotherapy Scientific Committee. ESCOP Monographs: The Scientific Foundation for Herbal Medicinal Products, 2nd edition. Exeter (GB): European Scientific Cooperative on Phytotherapy in collaboration with Thieme.
- Mills S, Bone K. 2000. Principles and Practice of Phytotherapy. Toronto (ON): Churchill Livingstone.
- Najib FS, Poordast T, Mahmudi MS, Shiravani Z, Namazi N, Omrani GR. Does Vitex Agnus-Castus L. Have Deleterious Effect on Fertility and Pregnancy Outcome? An Experimental Study on Rats for Prediction of Its Safety. J. Pharmacopuncture 2022;25(2):106-113. PubMed
- WHO 2009: World Health Organization. WHO Monographs on Selected Medicinal Plants, Volume 4. Geneva (CH): World Health Organization.
- OMS 2009: Organisation mondiale de la santé. WHO Monographs on Selected Medicinal Plants, Volume 4. Genève (CH): Organisation mondiale de la santé.
- Hamamelis virginiana L.
Leggere l'avvertenza, quando si applica e gli studi citati
Testo originale ufficiale in inglese.
WITCH HAZEL - HAMAMELIS VIRGINIANA Buccal and Oromucosal
Via di somministrazione: Buccal Oromucosal
Precauzioni e avvertenze
Ask a health care practitioner/health care provider/health care professional/doctor/physician if symptoms persist or worsen.
Monografia di Health Canada del 27 febbraio 2026
WITCH HAZEL - HAMAMELIS VIRGINIANA Ophthalmic
Precauzioni e avvertenze
Ask a health care practitioner/health care provider/health care professional/doctor/physician if symptoms worsen or persist (for) more than 2 days (EMA 2009).
Fonti citate da Health Canada (1)
- EMA 2009: European Medicines Agency. Committee on Herbal Medicinal Products. Community Herbal Monograph on Hamamelis virginiana L., folium et cortex aut ramunculus destillatium. [Accessed 2026 February 3]. Available from: https://www.ema.europa.eu/en/documents/herbal-monograph/final-community-herbal-monograph-hamamelis-virginiana-l-folium-cortex-aut-ramunculus-destillatum_en.pdf
Stop use and ask a health care practitioner/health care provider/health care professional/doctor/physician if you experience eye pain, changes in vision, continued redness, or irritation of the eye (EMA 2009).
Fonti citate da Health Canada (1)
- EMA 2009: European Medicines Agency. Committee on Herbal Medicinal Products. Community Herbal Monograph on Hamamelis virginiana L., folium et cortex aut ramunculus destillatium. [Accessed 2026 February 3]. Available from: https://www.ema.europa.eu/en/documents/herbal-monograph/final-community-herbal-monograph-hamamelis-virginiana-l-folium-cortex-aut-ramunculus-destillatum_en.pdf
Monografia di Health Canada del 27 febbraio 2026
WITCH HAZEL -HAMAMELIS VIRGINIANA 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 or breastfeeding (Barnes et al. 2007; ESCOP 2003).
Fonti citate da Health Canada (2)
- Barnes J, Anderson LA, Philipson JD. 2007. Herbal Medicines, 3rd edition. London (GB): The Pharmaceutical Press.
- ESCOP 2003: European Scientific Cooperative on Phytotherapy Scientific Committee. 2003. ESCOP Monographs: The Scientific Foundation for Herbal Medicinal Products, 2nd edition. Exeter (GB): European Scientific Cooperative on Phytotherapy and Thieme.
Reazioni avverse note
When using this product you may experience gastrointestinal discomfort/disturbances (Gardner and McGuffin 2013; ESCOP 2003; Berardi et al. 2002; Mills and Bone 2000).
Fonti citate da Health Canada (4)
- Berardi RR, DeSimone EM, Newton GD, Oszko MA, Popovich NG, Rollins CJ, Shimp LA, Tietze KJ, editors. 2002. Handbook of Nonprescription Drugs: An Interactive Approach to Self-Care, 13th edition. Washington (DC): American Pharmaceutical Association.
- ESCOP 2003: European Scientific Cooperative on Phytotherapy Scientific Committee. 2003. ESCOP Monographs: The Scientific Foundation for Herbal Medicinal Products, 2nd edition. Exeter (GB): European Scientific Cooperative on Phytotherapy and Thieme.
- Gardner Z, McGuffin M, editors. American Herbal Products Association's Botanical Safety Handbook. Second Edition. Boca Raton (FL): Taylor and Francis Group; 2013.
- Mills S, Bone K. 2000. Principles and Practice of Phytotherapy. Toronto (ON): Churchill Livingstone.
Monografia di Health Canada del 27 febbraio 2026
WITCH HAZEL - HAMAMELIS VIRGINIANA Topical
Precauzioni e avvertenze
Condizione di applicazione: All products.
For external use only.
When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.
Keep out of reach of children. If swallowed, call a poison control centre or get medical help right away.
Si applica ai prodotti: for use on minor wounds/burns/bruises/irritations/inflammations or on hemorrhoids.
Stop use and ask a health care practitioner/health care provider/health care professional/doctor/physician if symptoms worsen, last (for) more than 7 days.
Si applica ai prodotti: for use on varicose veins.
Ask a health care practitioner/health care provider/health care professional/doctor/physician if symptoms persist or worsen.
Controindicazioni
Si applica ai prodotti: for use on minor wounds/burns/bruises/irritations/inflammations.
Do not use on deep or puncture wounds, animal bites or serious burns.
Reazioni avverse note
Condizione di applicazione: All products.
Stop use if a skin rash occurs (ESCOP 2003; Berardi et al. 2002; Mills and Bone 2000).
Fonti citate da Health Canada (3)
- Berardi RR, DeSimone EM, Newton GD, Oszko MA, Popovich NG, Rollins CJ, Shimp LA, Tietze KJ, editors. Handbook of Nonprescription Drugs: An Interactive Approach to Self-Care, 13th edition. Washington (DC): American Pharmaceutical Association; 2002.
- ESCOP 2003: European Scientific Cooperative on Phytotherapy Scientific Committee. ESCOP Monographs: The Scientific Foundation for Herbal Medicinal Products, 2nd edition. Exeter (GB): European Scientific Cooperative on Phytotherapy and Thieme; 2003.
- Mills S, Bone K. Principles and Practice of Phytotherapy. Toronto (ON): Churchill Livingstone; 2000.
Si applica ai prodotti: for use on hemorrhoids.
Stop use and ask a health care practitioner/health care provider/health care professional/doctor/physician if you experience bleeding.
- Matricaria chamomilla L.
Leggere l'avvertenza, quando si applica e gli studi citati
Testo originale ufficiale in inglese.
GERMAN CHAMOMILE - MATRICARIA CHAMOMILLA Oral
Via di somministrazione: Oral (ESCOP 2003; Blumenthal et al. 2000; WHO 1999; Bradley 1992).
Precauzioni e avvertenze
When using this product exercise caution if you drive or use machinery as you may experience drowsiness.
Ask a health care practitioner/health care provider/health care professional/doctor/physician if symptoms persist or worsen.
Reazioni avverse note
Stop use if hypersensitivity/allergy occurs (ESCOP 2003; Bradley 1992).
Fonti citate da Health Canada (2)
- Bradley PR, editor. British Herbal Compendium, Volume 1. Bournemouth (GB): British Herbal Medicine Association; 1992.
- ESCOP 2003: European Scientific Cooperative on Phytotherapy Scientific Committee. 2003. ESCOP Monographs: The Scientific Foundation for Herbal Medicinal Products, 2nd edition. Exeter (GB): European Scientific Cooperative on Phytotherapy and Thieme.
Monografia di Health Canada del 19 dicembre 2025
German Chamomile - Matricaria Chamomilla Topical
Precauzioni e avvertenze
Ask a health care practitioner/health care provider/health care professional/doctor/physician if symptoms persist or worsen.
Reazioni avverse note
Stop use if hypersensitivity/allergy occurs (ESCOP 2003; Bradley 1992).
Fonti citate da Health Canada (2)
- Bradley PR, editor. British Herbal Compendium, Volume 1. Bournemouth (GB): British Herbal Medicine Association; 1992.
- ESCOP 2003: European Scientific Cooperative on Phytotherapy Scientific Committee. ESCOP Monographs: The Scientific Foundation for Herbal Medicinal Products, 2nd edition. Exeter (GB): European Scientific Cooperative on Phytotherapy and Thieme; 2003.
Monografia di Health Canada del 31 gennaio 2025
GERMAN CHAMOMILE - MATRICARIA CHAMOMILLA Buccal
Via di somministrazione: Buccal (ESCOP 2003; Blumenthal et al. 2000; Bradley 1992)
Precauzioni e avvertenze
Ask a healthcare practitioner/health care provider/health care professional/doctor/physician if symptoms persist or worsen.
Reazioni avverse note
Stop use if hypersensitivity/allergy occurs (ESCOP 2003; Bradley 1992).
Fonti citate da Health Canada (2)
- Bradley PR, editor. British Herbal Compendium, Volume 1. Bournemouth (GB): British Herbal Medicine Association; 1992.
- ESCOP 2003: European Scientific Cooperative on Phytotherapy Scientific Committee. ESCOP Monographs: The Scientific Foundation for Herbal Medicinal Products, 2nd edition. Exeter (GB): European Scientific Cooperative on Phytotherapy and Thieme; 2003.
- Rosmarinus officinalis L.
Leggere l'avvertenza, quando si applica e gli studi citati
Testo originale ufficiale in inglese.
ROSEMARY – ROSMARINUS OFFICINALIS Oral
Via di somministrazione: Oral (ESCOP 2003)
Precauzioni e avvertenze
Ask a health care practitioner/health care provider/health care professional/doctor/physician if symptoms persist or worsen.
Controindicazioni
Do not use if you are pregnant or breastfeeding (Gardner and McGuffin 2013; Brinker 2010; Barnes et al. 2007; Blumenthal et al. 2000).
Fonti citate da Health Canada (4)
- Barnes J, Anderson LA, Philipson JD. Herbal Medicines, 3rd edition. London (UK): The Pharmaceutical Press; 2007.
- Blumenthal M, Goldberg A, Brinkmann J, editors. Herbal Medicine: Expanded Commission E Monographs. Boston (MA): Integrative Medicine Communications; 2000.
- Brinker F. Herb Contraindications and Drug Interactions, 4th edition. Sandy (OR): Eclectic Medical Publications; 2010.
- Gardner Z, McGuffin M, editors. American Herbal Products Association’s Botanical Safety Handbook. 2nd edition. Boca Ration (FL): Taylor and Francis Group; 2013.
Monografia di Health Canada del 29 maggio 2026
ROSEMARY - ROSMARINUS OFFICINALIS Topical
Via di somministrazione: Topical (ESCOP 2003)
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 or breastfeeding (Gardner and McGuffin 2013; Brinker 2010; Barnes et al. 2007; Blumenthal et al. 2000).
Fonti citate da Health Canada (4)
- Barnes J, Anderson LA, Philipson JD. Herbal Medicines, 3rd edition. London (UK): The Pharmaceutical Press; 2007.
- Blumenthal M, Goldberg A, Brinkmann J, editors. Herbal Medicine: Expanded Commission E Monographs. Boston (MA): Integrative Medicine Communications; 2000.
- Brinker F. Herb Contraindications and Drug Interactions, 4th edition. Sandy (OR): Eclectic Medical Publications; 2010.
- Gardner Z, McGuffin M, editors. American Herbal Products Association’s Botanical Safety Handbook. 2nd edition. Boca Ration (FL): Taylor and Francis Group; 2013.
Ask a health care practitioner/health care provider/health care professional/doctor/physician before use if you have large open wounds, skin lesions, feverish conditions, acute inflammation, severe circulatory disorders or hypertension (ESCOP 2003).
Fonti citate da Health Canada (1)
- ESCOP 2003: ESCOP Monographs: The Scientific Foundation for Herbal Medicinal Products, 2nd edition. Exeter (UK): European Scientific Cooperative on Phytotherapy and Thieme; 2003.
Reazioni avverse note
Stop use if hypersensitivity/allergy occurs (Barnes et al. 2007; ESCOP 2003).
Fonti citate da Health Canada (2)
- Barnes J, Anderson LA, Philipson JD. Herbal Medicines, 3rd edition. London (UK): The Pharmaceutical Press; 2007.
- ESCOP 2003: ESCOP Monographs: The Scientific Foundation for Herbal Medicinal Products, 2nd edition. Exeter (UK): European Scientific Cooperative on Phytotherapy and Thieme; 2003.
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