Flora Force Milk Thistle Capsules Package Insert
Scheduling status: C0
Proprietary name (and dosage form): Flora Force Milk Thistle Capsules 400mg.
Composition: Each capsule contains Silybum marianum powder 400mg.
Pharmacological classification: Category D Western Herbal Medicine
Pharmacological action: 11 Medicines acting on gastro-intestinal tract. 11.10 Others.
Indications: Herbal medicine for supporting of the liver function, assisting the kidney function, adrenal system, immune system and assists in the treatment of inflammatory bowel disease and psoriasis.
Contra-indications: For persons with an allergy to plants in the Compositae family.
Not to be taken during pregnancy or lactation.
In persons with hormone related conditions.
Milk Thistle is contra-indicated in hormone related cancers: breast, uterine, prostate,
Warnings: See contra-indications and Interactions.
Drug interaction: Possible interactions may occur, discuss with a practitioner before taking Milk Thistle
Diabetic drugs: Milk Thistle may lower blood sugar in persons with diabetes. A dose adjustment might be required.
Glipizide (Glucotrol), Tolbutamide (Tolinase),
Anti-hypertensive drugs: Irbesartan (Avapro), losartan (Cozaar),
Birth control and Hormone replacement therapy.
Anti-psychotic drugs: Haloperidol, phenothiazines, phenytoin (Dilantin) (for seizures), halothane (anaesthetics)
Drugs metabolised by liver enzymes, (Cytochrome P450…):
Cholesterol drugs: Atorvastatin (Lipitor), fluvastatin (Lescol), lovastatin (Mevacor), rosuvastatin (Crestor)
Anxiolytic drugs: Diazepam (Valium), Lorazapam (Ativan), oxazepam (Serax),
Anti-depressants: Amitriptyline (Elavil),
Parkinsons: Entacapone (Comtan)
Asthma drugs: Zileuton (Zyflo),
Arthritis and anti-inflammatory drugs: Celecoxib (Celebrex), diclofenac (Voltaren), ibuprofen (Advil, Motrin), piroxicam (Feldene),
Anti- platelet, anti-coagulant drugs: Plavix, Warfarin
Some cancer drugs: Irinotecan (Camptosar), Tamoxifen (Nolvadex)
Pregnancy and lactation: Not to be taken during pregnancy and breast feeding
Dosage and directions for use: Take one to two capsules twice daily or as prescribed.
Please discuss your condition with a practitioner before using Milk Thistle. For the treatment of inflammatory bowel disease or psoriasis, please ensure that the condition has been
diagnosed by a practitioner. Should inflammatory bowel symptoms not improve within 4 weeks, and psoriasis within 3 months, please consult your practitioner.
Side-effects and special precautions: Milk Thistle is generally regarded as safe; side effects are mild and may be stomach upset and diarrhoea. Reduce dosage and discuss with practitioner.
Known symptoms of over dosage and particulars of its treatment: None known.
Identification: Clear size 0 all vegetable capsule containing pale green herbal powder.
Presentation: 60 Capsules packed into 125ml amber glass bottle with light green screw cap and safety seal insert, 500 Capsules packed into a 109x117mm securitainer with tamper evident seal.
Storage instructions: Store below 25ºC. KEEP OUT OF REACH OF CHILDREN.
Applicant: Flora Force Health Products (Pty) Ltd., PO Box 426, Rondebosch, 7701, Cape Town
Registration number: To be allocated.
Date of Publication: 09/07/2015