GEMMOCAPS PERIMENOPAUSE
Food supplement declared in France, declaration No 2024-6-1529, decision dated 27 June 2024
GEMMOCAPS PERIMENOPAUSE (HERBALGEM) is a food supplement declared in France. Status: declared in France, may be marketed. 1 rule of use applies to its ingredients (limits and warnings).
- Brand
- HERBALGEM
- Food business operator placing the product on the market
- Herbalgem S.A.
- Status
- Declared in France, may be marketed: the authorities did not object to the declaration (this is neither an authorisation nor a safety assessment)
- Form
- Capsule
- Daily dose
- 1 capsule par jour
- Not recommended (according to the manufacturer)
- Adolescents (under 18), Breastfeeding women, Pregnant women, Liver problems
- Objectives stated by the manufacturer (these are not authorised claims)
- Menopause
Declaration 143225, procedure Article 15. Compl'Alim, food supplement declarations (France), retrieved 15 November 2026.
Declared composition
Plants
| Plant | Part | Preparation | Per day |
|---|---|---|---|
| Malus domestica Borkh | Bourgeon | Macérât hydroglycériné | 49.1 mg |
| Vitis vinifera L. | Feuille (bourgeon) | Macérât hydroglycériné | 35.7 mg |
| Actaea racemosa L. | Rhizome | Extrait sec hydroalcoolique | 30 mg |
| Rubus idaeus L. | Jeune pousse | Macérât hydroglycériné | 11.1 mg |
Additives
E422, E464
Other ingredients
Eau purifiée
List from the declaration, administrative decision dated (Compl'Alim, food supplement declarations (France)).
Label warnings
Tenir hors de portée des jeunes enfants. Ne pas dépasser la dose conseillée. Ne se substitue pas à une alimentation variée etéquilibrée et à un mode de vie sain. Prendre l’attache d’un professionnel de la santé. Ne pas utiliser pendant la grossesse etl’allaitement, chez les personnes de moins de 18 ans. Déconseillé en cas de de cancer hormono-dépendant, d’affection biliaireou hépatique. Conserver à l’abri de toute source de chaleur et de la lumière. Ce produit contient un déshydratant qui absorbel’humidité, ne pas le jeter, ni le consommer.
Regulatory points
- Conditions légales
Actaea racemosa L.: Seuls les extraits aqueux et hydro-alcooliques de titre faible (30 %) sont admis. La portion journalière recommandée ne doit pas conduire à une ingestion de glycosides de triterpène (calculés comme 27-déoxyactéine) supérieure à 3 mg.
Source: French orders of 9 May 2006 (nutrients), 24 June 2014 (plants) and 26 September 2016 (other substances), consolidated LEGI collection, arrêté du 24 juin 2014, annexe I.
This information reproduces the manufacturer's declaration to the administration (DGAL). It does not say whether the product is effective and does not replace advice from a doctor or pharmacist, particularly during pregnancy or when taking medication.
Official warnings (Health Canada)
Health Canada publishes warnings on these ingredients:
- Actaea racemosa L.
Read the warning, when it applies and the studies cited
Black Cohosh - Actaea Racemosa
Route of administration: Oral
Cautions and warnings
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 breastfeeding.
Ask a health care practitioner/health care provider/health care professional/doctor/physician before use if you have a liver disorder or develop symptoms of liver trouble (EMA 2018, 2007; Lynch et al. 2006; Mills et al. 2006; Cohen et al. 2004; NIH 2004).
Sources cited by Health Canada (6)
- Cohen SM, O'Connor AM, Hart J, Merel NH, Te HS. Autoimmune hepatitis associated with the use of black cohosh: a case study. Menopause: the Journal of the North American Menopause Society 2004;11(5):575-577. PubMed Case report
- EMA 2018: European Medicines Agency. Committee on Herbal Medicinal Products (HMPC). European Union Herbal monograph on Cimicifuga racemosa (L.) Nutt., rhizome. March 2018. [Accessed 2025 January 3]. Available from: https://www.ema.europa.eu/en/documents/herbal-monograph/final-european-union-herbal-monograph-cimicifuga-racemosa-l-nutt-rhizome-revision-1_en.pdf
- EMA 2007: European Medicines Agency. Committee on Herbal Medicinal Products (HMPC) Annex 1. Assessment of case reports connected to herbal medicinal products containing Cimicifugae racemosae rhizoma (Black cohosh, root). London (UK): European Medicines Agency; May 20027. [Accessed 2025 January 3]. Available from: https://www.ema.europa.eu/en/documents/herbal-report/assessment-case-reports-connected-herbal-medicinal-products-containing-cimicifugae-racemosae-rhizoma-black-cohosh-root_en.pdf
- Lynch CR, Folkers ME, Hutson WR. Fulminant hepatic failure associated with the use of black cohosh: a case report. Liver Transplantation 2006;12(6):989-992. PubMed Case report
- Mills E, Duguoa J, Perri D, Koren G. Herbal Medicines in Pregnancy and Lactation. New York (NY): Taylor and Francis; 2006.
- NIH 2004: National Institutes of Health. Workshop on the Safety of Black Cohosh in Clinical Studies. Bethesda (MD): National Institutes of Health, Department of Health and Human Services; November 22, 2004. [Accessed 2024 December 3]. Available from: https://files.nccih.nih.gov/s3fs-public/news/blackcohosh_mtngsumm.pdf
Contraindications
Do not use if you are pregnant (Brinker 2010; Hoffmann 2003; Tilgner 1999).
Sources cited by 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.
- Tilgner S. Herbal Medicine from the Heart of the Earth Creswell (OR): Wise Acre Press; 1999.
They concern the ingredient, not this product or its dose. They do not replace medical advice.
Brand : HERBALGEM
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