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Complementary medicine Category D33.6 (western herbal)
This unregistered medicine has not been evaluated by SAHPRA for its quality, safety or intended use.
SCHEDULING STATUS: S0
1. NAME OF MEDICINE
LILIA 7-HMR LIGNANS MENOPAUSE (Capsules) 72 mg 7-hydroxy matairesinol
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
LILIA 7-HMR LIGNANS MENOPAUSE capsules: each capsule contains:
7-hydroxy matairesinol (Picea Abies L.) [wood knots] 72 mg in the aglycone form, co-crystalized with potassium acetate.
For full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Capsule, clear vege-capsule (free from animal derivatives)
4. CLINICAL PARTICULARS
4.1. Therapeutic indications:
· LILIA 7-HMR LIGNANS MENOPAUSE is an effective Anti-Oxidant
· LILIA 7-HMR LIGNANS MENOPAUSE helps reduce severe and frequent hot flashes in menopausal women.
· LILIA 7-HMR LIGNANS NENOPAUSE helps to reduce metabolic imbalances, typical of metabolic syndrome& obesity.
· LILIA 7-HMR LIGNANS MENOPAUSE helps to stimulate Hyaluronic Acid / Collagen & Elastin production
4.2. Posology and method of administration
Posology
Take one capsule daily after evening meal.
Method of administration
Oral use.
Swallow the capsule whole with water, after evening meal.
4.3. Contraindications
Known hypersensitivity to LILIA 7-HMR LIGNANS MENOPAUSE or any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
· Consult a healthcare practitioner if your currently are taking any medication for chronic conditions.
· Consult a healthcare practitioner if you have a bleeding disorder or are taking blood thinning medication.
· Consult a healthcare practitioner if symptoms worsen.
4.5. Interaction with other medicines and other forms of interactions
No interaction studies have been performed.
4.6. Fertility, pregnancy and lactation
Not recommended for use in pregnant or breastfeeding women.
4.7. Effects on ability to drive and use machines.
LILIA 7-HMR LIGNANS MENOPAUSE is not likely to impair your ability to drive vehicles or operate machinery. However, do take care if you take LILIA 7-HMR LIGNANS MENOPAUSE until you know how it will affect you.
4.8. Undesirable effects
No side-effects have been reported with the recommended dosage.
If other adverse reactions not mentioned above occur, a healthcare professional should be consulted.
Reporting of suspected adverse reactions.
Reporting suspected adverse reactions after authorization of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are asked to report any suspected adverse reactions to:
SAHPRA via the “6.04 Adverse Drug Reactions Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8
4.9. Overdose
No cases of overdose were reported. Treatment for overdose should be symptomatic and supportive.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties
Lignans have a chemical structure similar to the body's own oestrogen and are found in many types of food, such as legumes, whole grains, oil seeds and fruit and vegetables. However, the quantity of lignans in food is quite low, making extraction inefficient. In addition to being quite costly to the environment. As a result, normal dietary intake is often insufficient, especially considering modern diets that tend to be lacking in fibre.
7-Hydroxy matairesinol is a patented lignans, & once digested, are metabolized by the gut microflora into ENTEROLACTONE, which have the biological effect in the body. Being in the AGLYCONE form, ENTEROLCTONE from 7-hydroxymatairsinol, shows high absorption, creating a prolonged effect.
The enterolactone’s chemical structure resembles the body's own oestrogen structure and “Mimick” the effects of the body’s own oestrogen.
5.2. Pharmacokinetic properties
No data available.
5.3. Preclinical safety data
No data available.
6. PHARMACEUTICAL PARTICULARS
6.1. List of excipients
Di calcium phosphate; silicon dioxide and magnesium stearate
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
24 months
6.4. Special precautions for storage
Store at or below 25 °C in a dry place away from direct sunlight.
KEEP OUT OF REACH AND SIGHT OF CHILDREN.
6.5. Nature and contents of container
The capsules are packed into blisters consisting of transparent PVC/Aluminium three-ply foil blisters. Pack sizes of 30 capsules. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
No special requirements.
7. HOLDER OF CERTIFICATE OF REGISTRATION
WELLHOUSE Healthcare (Pty) Ltd
1st Floor Quayside Office Park Unit 6
Cnr Gordon & Hedge Streets
Knysna, 6570
Email: willemsnr@wellhousehealthacare.co.za
Telephone: +27 (0) 44 382 0382
Fax: +27 (0) 44 382 0383
Mobile: 082 450 2062
8. REGISTRATION NUMBER
To be allocated
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
To be allocated.
10. DATE OF REVISION OF THE TEXT
20th February 2023