Lifepak®+ Treatment
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Vitamin B1 (as Thiamin mononitrate) 0,275 mg 4 coated tablets are packed into polypropylene film sachets and 60 Manganese (as Manganese Bisglycinate) 0,25 mg 4.5 Interaction with other medicines and other forms of sachets are packed into a carton. Zeaxanthin 0,125 mg interaction Copper (as Copper Bisglycinate) 0,125 mg • Contraindications of concomitant use (cross-refer to section 6.6 Special precautions for disposal Folate (as Pteroylmonoglutamic acid) 50 μg 4.3) are when the patient is under thyroid treatment, or under No special requirements. Vitamin A (Palmitate) 581 I.U treatment with an anticoagulant or if the patient is a tobacco smoker. 7. HOLDER OF CERTIFICATE OF REGISTRATION Retinyl Palmitate 248 I.U • Concomitant use is not recommended (cross-refer to section 4.4) Nu Skin Enterprises South Africa (Pty) Ltd. Beta-carotene 100 μg RE for diabetics, patients who are hypoglycemic or under medical Techno Link 63, LifePak®+ treatment. Regency Drive, Selenium (as Sodium selenate, Sodium selenite) 12,5 μg Biotin (as D-biotin) 11,25 μg LifePak®+contains β-carotene. β-carotene might decrease Route 21 Corporate Park, Iodine (as Potassium iodide) 11,25 μg effectiveness of statins used to lower cholesterol. Nellmapius Drive, No interaction studies have been performed for LifePak®+. Irene, 0157, Molybdenum (as Sodium molybdate) 11,25 μg South Africa Chromium (as Chrome (III) Chloride) 6,25 μg Paediatric population Vitamin K (as Phytonadione) 6,25 μg LifePak®+ is not recommended for children under the age of 18 8. REGISTRATION NUMBER(S) Vitamin D (as Cholecalciferol) 1,25 μg years. To be allocated. Vitamin B12 (as Cyanocobalamin) 0,6 μg 4.6 Fertility, pregnancy and lactation 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE Contains sugar: Dextrose 0,96 mg per tablet Not recommended for women who are pregnant, planning to AUTHORISATION PROFESSIONAL INFORMATION For full list of excipients, see section 6.1 become pregnant or breastfeeding. To be allocated. COMPLEMENTARY MEDICINES: HEALTH SUPPLEMENT 3. PHARMACEUTICAL FORM 4.7 Effects on ability to drive and use machines 10. DATE OF REVISION OF THE TEXT This unregistered medicine has not been evaluated by the LifePak®+tablets are yellow oval coated tablets, 19 mm length, 6 mm LifePak®+ should not have an effect on the ability to drive and use To be allocated. SAHPRA for its quality, safety or intended use. thick, with dark and red speckles. machines. SCHEDULING STATUS: S0 4. CLINICAL PARTICULARS 4.8 Undesirable effects 4.1 Therapeutic indications No undesirable effects have been reported for LifePak®+. 1. NAME OF THE MEDICINE LifePak®+is a Health Supplement which assists with general Report any suspected adverse reactions to SAHPRA via the “6.04 Name: LIFEPAK®+ Coated tablets well-being. A varied and balanced diet and a healthy lifestyle are of Adverse Drug Reactions Reporting Form”, found online under Strength: Each coated tablet contains 147 mg of LifePak®+ blend general importance. SAHPRA’s publications: https://www.sahpra.org.za/Publications/ Pharmaceutical form: Coated tablets LifePak®+is indicated for adults aged 18 years or older. Index/8 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 4.2 Posology and method of administration 4.9 Overdose Posology In overdose, side effects can be precipitated and/or be of increased Qualitative declaration: Take the contents of one (1) LifePak®+sachet: Four (4) coated tablets severity. Beta-carotene palmitate, calcium-L-ascorbate, cholecalciferol, at the same time once a day. D-alpha-tocopherol succinate, phytonadione, thiamin DO NOT EXCEED THE RECOMMENDED DAILY DOSE. 5 PHARMACOLOGICAL PROPERTIES mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, 5.1 Pharmacodynamic properties pteroylmonoglutamic acid, cyanocobalamin, D-biotin, D- Paediatric population Health Supplement calciumpantothenate, calcium carbonate, calcium citrate, potassium LifePak®+is not suitable for children under the age of 18 years. iodide, magnesium citrate, zinc bisglycinate, sodium selenate, 5.2 Pharmacokinetic properties sodium selenite, copper bisglycinate, manganese bisglycinate, Method of administration Not applicable. chrome (III) chloride, sodium molybdate, Citrus limon (L.) Burm, Swallow the tablets together with 250 ml of liquid with a meal. Citrus sinensis (L.) Osbeck, Citrus reticulata Blanco, Citrus x paradisi 5.3 Preclinical safety data Macfad, Vitis vinifera L. extract, lycopene, lutein, Allium cepa L 4.3 Contraindications Not applicable. extract, zeaxanthin. Do not take LifePak®+: • if you are hypersensitive (allergic) to iodine or any of the other 6. PHARMACEUTICAL PARTICULARS ingredients of LifePak®+ 6.1 List of excipients Quantitative composition: • if you have been diagnosed or suspected to suffer with prostate Tablet core: Croscarmellose sodium (E466), dicalcium phosphate cancer. dihydrate (E341), magnesium stearate (E470b), microcrystalline Calcium (as Calcium carbonate, Calcium citrate) 51.5 mg • if you are pregnant, planning to become pregnant or are cellulose (E460), silicon dioxide (E551), stearic acid (E570), Magnesium (as Magnesium citrate) 31,25 mg breastfeeding Coating: Dextrin, dextrose monohydrate, sodium carboxyl methyl Allium cepa L. extract 21,25 mg • if you have been diagnosed with thyroid disorders cellulose (E466), sodium citrate dihydrate (E331ii), soy lecithin Vitamin C (as Calcium-L-ascorbate) 20 mg • if you are being treated with anticoagulants (E322) Citrus fruit extract: 6,25 mg • if you are menopausal Citrus limon (L.) Burm. f. 1,25 mg • if you are a tobacco smoker. 6.2 Incompatibilities Citrus sinensis (L.) Osbeck 3,75 mg Not applicable. Citrus reticulata Blanco 0,625 mg Paediatric population Citrus x paradisi Macfad. 0,625 mg LifePak®+ is not recommended for children under the age of 18 6.3 Shelf life Niacin (as Niacinamide) 4 mg years. 24 Months. Vitis vinifera L. extract 3,125 mg Vitamin E (as D-alpha-tocopherol succinate) 4,45 I.U. 4.4 Special warnings and precautions for use 6.4 Special precautions for storage Zinc (as Zinc Bisglycinate) 1,875 mg Consult a doctor before using this product: Store between 15 °C and 25 °C. Panthothenic acid (as D-calcium-pantothenate) 1,25 mg • if you are diabetic Protect from light and moisture. Lycopene 0,875 mg • if you are hypoglycemic Keep in the original sachet and box until ready for use. Lutein 0,5 mg • if you are undergoing medical treatment. Vitamin B6 (as Pyridoxine hydrochloride) 0,35 mg Taking multiple supplements may cause a cumulative intake of 6.5 Nature and contents of container Vitamin B2 (as Riboflavin) 0,325 mg certain nutrients/substances. It is therefore recommended that you LifePak®+tablets are yellow oval coated tablets, 19 mm length, 6 mm consult your healthcare practitioner prior to use. thick, with dark and red speckles. 48 003742 94512124/1 .