PACKAGE INSERT SALUSA 45 SCHEDULING STATUS Complementary Medicine Category 7. Nutritional Substance PROPRIETARY NAME (and dosage form) SALUSA 45 caplets COMPOSITION Each caplet contains: %NRV’s (1) Vitamin A 800mcg 100% Betacarotene 100mcg Vitamin D 15mcg 100% Vitamin E 15mg 100% Vitamin C 90mg 100% Thiamine (Vitamin B1) 1,8mg 150% Riboflavin (Vitamin B2) 2mg 154% Nicotinamide (Vitamin B3) 16mg 100% Pantothenic Acid (Vitamin B5) 5mg 100% Pyridoxine (Vitamin B6) 2,6mg 150% Cyanocobalamine (Vitamin B12) 3,6mcg 150% Biotin 90mcg 300% Folic Acid 500mcg 200% Boron 1mg -(2) Calcium 195mg 15% Chromium 50mcg 143% Copper 1mg 111% Iodine 150mcg 100% Iron 9mg 50% Magnesium 100mg 24% Manganese 1mg 44% Molybdenum 25mcg 56% Phosphorus 125mg 10% Potassium 40mg -(2) Selenium 55mcg 100% Zinc 11mg 100% -(2) Luteine 5mg -(2) Green Tea Extract 95% 25mg 1) Nutrient Reference Values (NRV’s) based on the SA RDA for adults and persons over 4 years (R642 Act 54 of 1972) 2) No SA NRV’s established PHARMACOLOGICAL CLASSIFICATION A22.1 Multivitamins with minerals PHARMACOLOGICAL ACTION (Pharmacokinetics, pharmacodynamics and summary of clinical studies, where applicable) Multivitamin and mineral dietary supplement. INDICATIONS A multivitamin and mineral supplement is indicated to assist in supplementing vitamin and mineral deficiencies, where the dietary intake is known to be insufficient. SALUSA 45 caplets should be taken in addition to a healthy, balanced diet and should not be regarded as a replacement for a healthy diet. CONTRAINDICATIONS If there is a known hypersensitivity or allergy to any of the ingredients in SALUSA 45. WARNINGS SALUSA 45 is a comprehensive and well balanced vitamin and mineral supplement and should not be regarded as a replacement for a healthy balanced diet. The recommended dosage should not be exceeded, unless on the advise of your medical practitioner. If you are suffering from a medical condition, or if taking any other medication, do not commence treatment with SALUSA 45, without prior consultation with and approval from your medical practitioner. Do not commence treatment with SALUSA 45 if you are allergic to any of the ingredients INTERACTIONS No known interactions, if taken as prescribed. Please consult with your medical practitioner before using SALUSA 45, if you are currently being treated for any medical condition or if you are taking any other medication. DOSAGE AND DIRECTIONS FOR USE Take one caplet daily in the mornings after breakfast, with a glass of water. In the case of severe nutritional deficiency, the dosage may be increased by a medical practitioner. SIDE EFFECTS AND SPECIAL PRECAUTIONS When taken as prescribed, there have been no reported cases of severe adverse events and side effects associated with any of the ingredients in SALUSA 45. Isolated cases of nausea and vomiting have been reported and this can be minimized by taking SALUSA 45 after a meal. KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT In cases of suspected overdosage, dosage with the product should be stopped immediately and withdrawal of the product is recommended. Treatment of the patient is symptomatic and supportive. IDENTIFICATION SALUSA 45 caplets are light orange in colour. PRESENTATION SALUSA 45 caplets are packed in white plastic bottles of 30 or 90 caplets. STORAGE INSTRUCTIONS Store in a cool, dry place, below 25 C, out of direct sunlight. Keep the container well closed at all times. KEEP OUT OF REACH OF CHILDREN GRACE PHARMACEUTICALS PTY LTD, 1 VICKI AVE, GLENASHLEY, 4022, Tel: 0861 114 788 BIOSENTA (PTY) LTD. Unit 5 College House, Village Walk, Parklands, 7440. Tel: 021 556 3516 EMAIL: info@biosenta.co.za