Flora Force DensiMAXTM Package Insert
Scheduling status: C1
Proprietary name (and dosage form): Flora Force DensiMAX ™ Tablets
Composition: Each tablet contains:
Calcium from Aquamin®* (Lithothamnion calcareum) 450.0mg, Magnesium from Aquamin®* (Lithothamnion calcareum) 31.0mg, and 74 other trace minerals including boron, zinc, iron and selenium from Aquamin®* (Lithothamnion calcareum), Vitamin D3 (vegetarian) 6.0mcg
Pharmacological classification: Category D Western Herbal Medicine
Pharmacological action: 32.2 Other substances and agents, Others
Indications: Nutritional mineral supplement to prevent bone loss and support calcium remodelling of skeletal structures. Provides essential minerals and trace-elements for chemical pathways of body. Prevents and treats osteoporosis. Use as directed by healthcare practitioner.
Contra-indications: Any hypersensitivity or known allergy to seafood, seaweeds, and specific minerals, calcium, magnesium, boron, zinc and iron, or vitamin D.
In any condition that could lead to hypercalcaemia, hyper calciuria. In any parathyroid gland conditions, bone tumours, bone metastases and bone marrow disease.
Conditions involving the kidneys, kidney stones, kidney failure.
Any condition that can lead to increased Vitamin D
Precautions: DensiMAX is sourced from seaweed; a plant based multi-mineral origin safe for most persons, however it is important to note contra-indications, warnings and interactions with other medications.
Warnings: Please ensure that your condition has been diagnosed medically before taking DensiMAX
In case of elderly persons blood levels of calcium should be regularly monitored. This is of particular importance if any cardiac glycosides and diuretics are taken simultaneously.
Drug Interaction: Drugs taken prior or long term that have an influence on the levels of Calcium and other minerals on blood. Vitamin D containing supplements.
Any medication or supplements containing Calcium and minerals taken simultaneously.
Please discuss with your practitioner before taking DensiMax
Thiazide diuretics: could increase amount of calcium in blood.
Cardiac glycosides can have increased side effects.
Steroids: (oral) can reduce available calcium.
Tetracyclines, fluroquinolone anti-biotics, thyroid medication, iron, zinc, fluoride, affect levels of absorption.
Laxatives and obesity medication can reduce absorption of DensiMax
Pregnancy and lactation: DensiMAX can be taken during pregnancy under medical supervision and if contra-indications and warnings are observed.
The same applies to breastfeeding mothers as long as the baby does not receive other supplementations that include any DensiMAX constituents.
Dosage and directions for use: Take one tablet twice daily with meals or as prescribed by a healthcare practitioner.
Pregnant woman: Take one tablet daily.
DensiMAX is best taken with a glass of water (200ml).
Do not discontinue any prescribed medication without discussion with a practitioner.
If you are on a multi-drug regime take DensiMAX at least 4 hours away from other drugs.
Do remember: foods such as spinach contains oxalic acid and whole grains phytic acid which can reduce calcium absorption
Side-effects and special precautions: None documented to date. However please read contra- indications and warnings as well as drug interaction.
Known symptoms of over-dosage and particulars of its treatment: None known, but could include nausea, vomiting, weakness, fatigue, abdominal pain, constipation.
Contact a practitioner or local hospital poison centre for further advice and supportive treatment
Identification: 23mm oblong off-white tablet
Presentation: 60 Tablets packed in a 125ml amber glass bottle with a seal and mustard gold cap in a product box and information brochure.
Storage instructions: Store below 25ºC. KEEP OUT OF REACH OF CHILDREN.
Registration number: To be allocated.
Applicant: Flora Force Health Products (Pty) Ltd., PO Box 426, Rondebosch, 7701, Cape Town
Date of publication: 28/04/2015
*Aquamin® is a registered Trade mark of Marigot Ltd. Ireland