Produced under strict pharmaceutical conditions, Femarelle® is a standardized substance from plant origin. Each capsule contains 322 mg fermented soybean extract (DT56a) & 108 mg of flaxseed (excipient).
Femarelle® is encapsulated in transparent gelatin capsules, size 0. The contents are beige with brown specks. Disintegration time is within one hour after swallowing.
Femarelle® is intended for menopausal and postmenopausal women. The therapeutic indication is the relief of menopausal symptoms and to support bone health.
The recommended intake of Femarelle® is one capsule taken twice daily (morning and evening), with or without food.
Femarelle® has been available in the worldwide market since the year 2000. It is well tolerated, and no serious adverse events have been reported to date. Femarelle® was introduced to the Canadian market in November 2014.
The manufacturing procedure of Femarelle® provides this unique proprietary compound. The manufacturing follows the industry standards for drugs; comprehensive microbiological and biochemical testing are rigorously performed throughout the process. The pharmacological efficacy and the shelf life of the product are constantly monitored, and state-of-the-art technology is used to maintain the long-term stability of the active ingredient in the product.
The manufacturing procedure is subject to the strictest quality control standards with ISO 9001-2008, HAACP, cGMP and BVQI certificates as well as the environmental ISO 14001.
Se-cure Pharmaceuticals Ltd. is committed to ensuring that each capsule produced is characterized by identical therapeutic features according to the accepted standards of the pharmaceutical industry.
Femarelle's Mechanicsm of Action (SERM)
The uniqueness of Femarelle® derives from its origin as a plant-based SERM (Selective Estrogen Receptor Modulator) that targets specific tissue sites, while having no effect on others.
Femarelle® relieves menopausal symptoms both in the short and long term and increases bone mineral density, while having no effect on the uterus or on breast tissue (Figure 2). This tissue-selective mechanism of activity has been demonstrated and confirmed in clinical and pre-clinical studies (see next section).
Femarelle® represents the new generation of treatment for menopause management, providing a safe and effective solution for the relief of vasomotor symptoms and to support bone health.