Agnucaston Tablets (Vitex Agni Casti): Indications, Dosing, and Official Patient Leaflet

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Reviewed by Dr. Ahmad Abdel-Baqi in accordance with our Editorial Policy, based strictly on the manufacturer's approved prescribing leaflet.

Executive Clinical Summary

Agnucaston® film-coated tablets contain standardized dry extract of the fruit of the chaste tree (Vitex agni casti). It is authorized for women suffering from menstrual cycle irregularities, cyclic breast pain (mastodynia/mastalgia), and premenstrual syndrome (PMS). Dosing is continuous over several months, including during menstrual periods, but the medication is strictly contraindicated during pregnancy and breastfeeding.

Composition & Active Substance

  • Active Ingredient: Dry extract of the fruit of the chaste tree (Agni casti fructus).
  • Strength per Tablet: Each 125.0 mg film-coated tablet contains 20.00 mg of Extr. Vitex Agni casti e fruct. spir. sicc. (drug-to-extract ratio 2:1).
  • Tablet Core Composition: Standardized with 16–24% native extract and 84–76% polyvidone as technical standardizing agent.
  • Excipients: Povidone, lactose 1 H2O, magnesium stearate, macrogol, talc, ammonium methacrylate copolymer, titanium (IV) oxide (E 171), yellow iron oxide (E 172), indigotine lacquer (E 132).

Approved Therapeutic Indications

Agnucaston® is indicated for the treatment of women in cases of:

  • Menstrual disorders (cycle irregularities).
  • Mastodynia, frequently in connection with pain (mastalgia).
  • Premenstrual syndrome (PMS).

Dosage and Method of Administration

  • Daily Dose: Unless otherwise prescribed by an attending physician, take 1 film-coated tablet once daily in the morning.
  • Mode of Administration: Tablets must be swallowed whole with liquid.
  • Continuity: Agnucaston® is taken without interruption, including during days of menstrual bleeding.
  • Treatment Duration: Intake should continue for several months, persisting even after symptoms have improved or completely subsided.
  • Recurrence: If symptoms reappear upon discontinuation, consultation with the attending physician is required before resuming therapy.

Side Effects & Interactions

  • Adverse Reactions: Allergic skin reactions are rare. Severe forms of cutaneous hypersensitivity have been reported in isolated cases.
  • Drug Interactions: No drug or agent interactions are known to date.

Contraindications & Safety Warnings

  • General Contraindications: None known up to now.
  • Pregnancy: Agnucaston® must NOT be taken during pregnancy.
  • Lactation: The preparation must NOT be taken during the lactation period.
  • Storage: Store in a dry place at room temperature. Keep out of reach of children. Do not use after the stated expiry date.

Official Patient Information Leaflet (Document Viewer)

Authoritative Medical References:
  1. Bionorica AG. Agnucaston® Film-coated tablets: Patient Information Leaflet. Reference: RF 1334202 EG. Neumarkt, Germany.
  2. European Medicines Agency (EMA) / Committee on Herbal Medicinal Products (HMPC). Community herbal monograph on Vitex agnus-castus L., fructus.
  3. World Health Organization (WHO). Fructus Agni Casti. In: WHO Monographs on Selected Medicinal Plants, Volume 2.
Medical Disclaimer: This document is published exclusively for academic, informational, and educational purposes. It does not constitute individual medical diagnosis, therapeutic advice, or clinical endorsement. Always seek the advice of your physician or qualified health provider regarding any medical condition. Review our complete Medical Disclaimer.
 
   
     

About the Author

     

Dr. Ahmad Baker, PharmD

     

He is a senior pharmacist and health educator with extensive experience in the Middle East and North Africa region. Through his writing, Dr. Ahmad aims to empower communities by providing reliable, evidence-based health information. With expertise in clinical pharmacy and regulatory affairs, he strives to offer unique insights into healthcare and simplify complex medical concepts, making them accessible to everyone.

   
   
      Dr. Ahmad Baker    
 
      
   

Legal Disclaimer

   

The information provided in this blog is for educational purposes only and is not a substitute for professional medical advice. We do not guarantee the accuracy or completeness of information regarding medications or medical products, and official sources should be verified before making any decisions. By using this blog, you agree to assume personal responsibility for relying on the information provided.

 

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