References


Applicant’s address and contact details

Gulf Drug Company (Pty) Ltd. 22 Burnside Drive, Old Mill Industrial Park, Mount Edgecombe, 4300. Reg. No.: 1984/005793/07.

For full prescribing details refer to the approved patient information leaflet. Further information is available from Gulf Drug Company (Pty) Ltd. info@gulfdrug.co.za

Product composition:

Gastrointestinal / Digestive wellbeing

  • De Witts Antacid Powder 100 g, 200 g. S0. Each 2,5 g contains: Sodium bicarbonate 1,2125 g, Calcium carbonate 0,5 g, Magnesium carbonate light 0,25 g, Magnesium trisilicate 0,25 g, Aluminium hydroxide gel 0,05 g. Reg. nr: E/11.4.1/731.

     

  • Magasil 100 mL, 200 Ml. S0. Each 10 mL contains: Magnesium carbonate light 500,0 mg, Magnesium trisilicate 500,0 mg, Sodium bicarbonate 500 mg. Ref. nr: E1402 (Act 101/1965).

     

  • Pectikon Suspension 100 mL. S0. Each 30 mL contains: Kaolin light 6 g, Apple pectin 450 mg. Ref. nr: E1413 (Act 101/1965)

     

  • Fybalax 10s, 30s. S0. Each sachet contains: Ispaghula husk 95 % powder 3,69 g providing Ispaghula husk 3,5 g. Category D Medicine: A33.8 Discipline specific: Other
    This unregistered medicine has not been evaluated by the SAHPRA for its quality, safety or intended use.

Pain, Fever & Inflammation

  • Painblok 10s, 24s, 48 x 2s, 100s, 1000s. S0. S1. Each tablet contains: Paracetamol 500 mg. Reg. nr: 27/2.7/0138. CONTAINS PARACETAMOL.

     

  • Painblok syrup 50 mL, 100 mL (plastic/glass). S0. Each 5 mL contains: Paracetamol 120,0 mg. Ref. nr: B1454 (Act 101/1965). CONTAINS PARACETAMOL.

     

  • Painblok Alcohol & Sugar Free syrup (50 mL, 100 mL). S0. Each 5 mL contains: Paracetamol 120,0 mg. Reg. nr:  29/2.7/0208. CONTAINS PARACETAMOL.

     

  • Solarub 25 g, 500 g. S0. Each 100 g ointment contains: 10 g Gaultheria Procumbens (Wintergreen oil). Category D medicine: Discipline Specific. D33.6 Western Herbal Medicine. This unregistered medicine has not been evaluated by the SAHPRA for its quality, safety or intended use.

Renal & Diuretics

  • De Witts K&B Pills 16s, 24s, 100s. S0. Each tablet contains: Dry Buchu Extract 27,5 mg, Extract Uva Ursi 55,0 mg. Ref. nr: H1642 (Act 101/1965)

Vitamins, Minerals & Supplements

  • Zyora Zymag 10s and 30s. S0. Each effervescent tablet contains: Magnesium carbonate 1 090 mg providing Magnesium (elemental) 250 mg, Ascorbic acid (Vitamin C) 200 mg, MecobalActive® as methylcobalamin (Vitamin B12) 50 μg. Category D Medicine: Health Supplement. This unregistered medicine has not been evaluated by the SAHPRA for its quality, safety or intended use.

     

  • Zyora Zyzinc Effervescent tablets 20s. S0. Each tablet contains the following active materials: Zinc lactate 46,5 mg (providing Zinc 10 mg), Ascorbic Acid 1000 mg (providing Vitamin C 1000 mg) and Vitamin D 1000 IU. Category D Medicine: Health Supplement This unregistered medicine has not been evaluated by the SAHPRA for its quality, safety or intended use.

     

  • Zyora Zyzinc capsules 60s. S0. Each capsule contains: L-methionine Zinc complex 62,5 mg yielding elemental Zinc 12,5 mg, Vitamin C (calcium ascorbate) 500 mg, Cholecalciferol (Vitamin D3) 500 IU. Category D Medicine: Health Supplement.
    This unregistered medicine has not been evaluated by the SAHPRA for its quality, safety or intended use.

     

  • Zyora Zyboost Effervescent tablets 10s and 30s. S0. Each effervescent tablet contains: Paullinia cupana Kunth (Guarana) 200 mg [seed, extract standardised to 20 % (40 mg) caffeine], Ascorbic acid (Vitamin C) 500 mg, Calcium carbonate 277,8 mg providing Calcium (elemental) 100 mg, Magnesium oxide 169,5 mg providing Magnesium (elemental) 100 mg, Niacinamide (Vitamin B3) 20 mg, Zinc oxide 13,7 mg providing Zinc (elemental) 11 mg, Calcium D-pantothenate 10,9 mg providing Pantothenic acid (Vitamin B5) 10 mg, Pyridoxine HCl 12,3 mg providing Pyridoxine (Vitamin B6) 10 mg, Riboflavin 5-phosphate sodium 6,7 mg providing Riboflavin (Vitamin B2) 5 mg, Thiamine HCl 5,7 mg providing Thiamine (Vitamin B1) 5 mg, Folic acid 200 μg, D-Biotin (Vitamin H) 100 μg, MecobalActive® as methylcobalamin (Vitamin B12) 50 μg. Category D Medicine: Discipline-Specific Traditional Claims. This unregistered medicine has not been evaluated by the SAHPRA for its quality, safety or intended use.

  • Zyora ZyB capsules 60 capsules. S0. Each delayed release capsule contains: Niacinamide ascorbate 48,5 mg providing Niacin (Vitamin B3) 20 mg, Calcium D-pantothenate 43,5 mg providing Pantothenic acid (Vitamin B5) 20 mg, Riboflavin 5-phosphate sodium 31,8 mg providing Riboflavin (Vitamin B2) 25 mg, Thiamine HCl 31,8 mg providing Thiamine (Vitamin B1) 25 mg, Pyridoxine HCl 24,3 mg, providing Pyridoxine (Vitamin B6) 20 mg, D-alpha-tocopherol (Vitamin E) 5 mg, ExtraFolate-S® (as Methyltetrahydrofolic acid) 400 μg, providing Folate 327 μg, MecobalActive® Methylcobalamin (Vitamin B12) 100 μg, Biotin (Vitamin H) 50 μg. Category D Medicines: Health Supplement. This unregistered medicine has not been evaluated by the SAHPRA for its quality, safety or intended use.

  • Zyora Zycalm capsules 30s. S0. Each capsule contains: Valerian extract 100mg, L-theanine 150mg. Category D Medicine: Discipline-Specific Traditional Claims. This unregistered medicine has not been evaluated by the SAHPRA for its quality, safety or intended use.

  • Zyora Zykrill® 30’s and 60’s. S0. Each capsule contains: Krill oil 90 mg providing Phospholipids 330 mg, astaxanthin 50 μg, choline 41 mg, Total Omega-3 159 mg, EPA 89 mg and DHA 41 mg. Category D Medicine: Health Supplement. This unregistered medicine has not been evaluated by the SAHPRA for its quality, safety or intended use.

Women’s health

  • Sinopol Sachets 30’s. S0. Each sachet contains: Alpha-lipoic acid 400 mg, Myo-inositol 1000 mg, Folic acid 200 ug. Category D Medicine: Health Supplement. This unregistered medicine has not been evaluated by the SAHPRA for its quality, safety or intended use.

     

  • Sinopol Tablets 30’s. S0. Each tablet contains:  Alpha-lipoic acid 400 mg, Myo-inositol 500 mg, Betaine 50 mg, Riboflavin 0,85 mg providing Vitamin B2 0,85 mg, Pyridoxine 0,95 mg providing Vitamin B6 0,95 mg, Folic acid 200 ug, Cyanocobalamin 1,3 ug providing Vitamin B12 1,3 ug. Category D Medicine: Health Supplement. This unregistered medicine has not been evaluated by the SAHPRA for its quality, safety or intended use.

Marketing references

A.        Magasil 100mL and 200mL

  1. Magasil professional information and patient information leaflet.

 

B.        Painblok (Painblok 10s, 24s, 48 x 2s, 100s, 1000’)

  1. Painblok tablets approved professional information.

  2. https://www.mayoclinic.org/diseases-conditions/migraine-headache/expert-answers/migraine-headache/faq-20058505.

 

C.       Painblok (Painblok syrup 50mL & 100ml; Painblok Alcohol sugar free syrup 50mL &100mL)

  1. Painblok syrup and alcohol-free syrup approved professional information.

  2. https://www.mayoclinic.org/diseases-conditions/migraine-headache/expert-answers/migraine-headache/faq-20058505.

 

D.       Sinopol sachets 30s and Sinopol tablets 30s:

  1. Sinopol® approved professional information, February 2024.

  2. Genazzani AD, Prati A, Marchini F, Petrillo T, Napolitano A, Simoncini T. Differential insulin response to oral glucose tolerance test (OGTT) in overweight/obese polycystic ovary syndrome patients undergoing to myo-inositol (MYO), alpha lipoic acid (ALA), or combination of both. Gynecological Endocrinology 2019. Doi: 10.1080/09513590.2019.1640200.

  3. Keen MA, Shah IH, Sheikh G. Cutaneous Manifestations of Polycystic Ovary Syndrome: A Cross-Sectional Clinical Study. Indian Dermatol Online J. 2017;8(2):104–110. doi

  4. Bellver J, Rodríguez-Tabernero L, Robles A, Muñoz E, Martínez F, Landeras J. et al. Polycystic ovary syndrome throughout a woman’s life. J Assist Reprod Genet 2018;35:25–39. Doi:10.1007/s10815-017-1047-7.

  5. Genazzani AD, Despini G, Santagni S, Prati A, Rattighieri E, Chierchia E, et al. Effects of a Combination of Alpha Lipoic Acid and Myo-Inositol on Insulin Dynamics in Overweight/Obese Patients with PCOS. Endocrinol Metab Synd 2014,3(3). DOI: 10.4172/2161-1017.1000140.   

  6. Genazzani AD, Shefer K, Della Casa D, Prati A, Napolitano A, Manzo A, et al. Modulatory effects of alpha-lipoic acid (ALA) administration on insulin sensitivity in obese PCOS patients. J Endocrinol Invest 2018;41:583–590.      

  7. Derosa G, D’Angelo A, Romano D, Maffiolo P. A Clinical Trial about a Food Supplement Containing α-Lipoic Acid on Oxidative Stress Markers in Type 2 Diabetic Patients. Int J Mol Sci 2016;17:1802. doi:10.3390/ijms17111802.

  8. Rago R, Marcucci I, Leto G, Caponecchia L, Salacone P, Bonanni P, et al. Effect of myo-inositol and alpha-lipoic acid on oocyte quality in polycystic ovary syndrome non-obese women undergoing in vitro fertilization: a pilot study. J Biol Regulators Homeostatic Agents 2015;29(4):1-11.

  9. Sirmans SM, Pate KA. Epidemiology, diagnosis, and management of polycystic ovary syndrome. Clin Epidemiol 2014:6 1–13.

  10. Teede HJ, Misso ML, Deeks AA, Moran LJ, Stuckey BGA, Wong JLA, et al. Assessment and Management of polycystic ovary syndrome; summary of an evidence-based guideline. Med J Aust 2011;195(6):S65-S112

  11. Carbonelli MG, Di Renzo L, Bigioni M, et al. α-Lipoic Acid Supplementation: A Tool for Obesity Therapy.? Curr Pharmaceut Design 2010;16:840-846.                                                                                                                                                                                              

  12. Cappelli V, Musacchio MC, Bulfoni A, Morgante G, De Leo V. Natural molecules for the therapy of hyperandrogenism and metabolic disorders in PCOS. Eur Rev Med Pharmacol Sci 2017; 21(2Suppl):15-29.

  13. Günalan E, Yaba A, Yılmaz B. The effect of nutrient supplementation in the management of polycystic ovary syndrome-associated metabolic dysfunctions: A critical review. J TurkGer Gynecol Assoc 2018;19:220-32. Doi: 10.4274/jtgga.2018.0077. 20.

  14. Iezzi ML, Varriale G, Rorge N, Lasorella S, Zagaroli L, Verrotti A. Polycystic ovary syndrome in adolescence: new therapeutic approach with inositol and alphalipoic acid. Int J Curr Res 2017;9(7):54006-54011

  15. De Cicco S, Immediata V, Romualdi D, et al. Myoinositol combined with alpha-lipoic acid may improve the clinical and endocrine features of polycystic ovary syndrome through an insulin-independent action. Gynecol Endocrinol 2017;33(9):698–701."

  16. Mohamaddi M. Oxidative Stress and Polycystic Ovary Syndrome: A Brief Review. Int J Prev Med 2019;10:86. Doi: 10.4103/ijpvm.IJPVM_576_17.

  17. Constantino D, Minozzi G, Minozzi F, et al. Metabolic and hormonal effects of myo-inositol in women with polycystic ovary syndrome: a double-blind trial. Eur Rev Med Pharmacol Sci 2009;13:105-110

  18. Haghighian HK, Haidari F, Mohammadi-asl J, Dadfar M. Randomized, triple-blind, placebo-controlled clinical trial examining the effects of alpha-lipoic acid supplement on the spermatogram and seminal oxidative stress in infertile men. Fertil Steril 2015;104:318-24.

 

E.        Zyora zyboost™ effervescent tablets 10s and 30s:

  1. Zyora zyboost™ approved professional information.

  2. D.O. Kennedy , C.F. Haskell , B. Robertson , J. Reay , C. Brewster-Maund , J. Luedemann , S. Maggini , M. Ruf , A. Zangara, A.B. Scholey. Improved cognitive performance and mental fatigue following a multi-vitamin and mineral supplement with added guaraná (Paullinia cupana). Volume 50, Issues 2–3 March–May 2008, Pages 506-513

  3. Mecobalactive brochure – literature on hand.

  4. Thakkar, K and Billa, G 2014. Treatment of vitamin B12 deficiency–Methylcobalamine? Cyancobalamine? Hydroxocobalamin?—clearing the confusion. European Journal of Clinical Nutrition volume 69, pages1–2 (2015)

  5. Ji, Xintonga., Li, Chenxiaa., | Zhu, Xiaozhenga., Yu, Wenleia., Cai, Yanyua., Zhu, Xinyia., Lu, Linjiea., Qian, Qiweia., Hu, Yua., Zhu, Xuanc., Wang, Huanhuana. 2022. Methylcobalamin Alleviates Neuronal Apoptosis and Cognitive Decline Induced by PM2.5 Exposure in Mice. Journal of Alzheimer's Disease, vol. 86, no. 4, pp. 1783-1796, 2022

  6. MecobalActive Provides Sustainable Solution for Vitamin B12 Supplements to Reduce Pollution Impact on Earth. https://www.globenewswire.com/news-release/2019/12/09/1958087/0/en/MecobalActive-Provides-Sustainable-Solution-for-Vitamin-B12-Supplements-to-Reduce-Pollution-Impact-on-Earth.html Date of access: 04/10/2024.

 

F.         Zyora zymag™ effervescent tablets 10s and 30s:

  1. Zymag approved professional information.

  2. Tarsitano, M.G., Quinzi, F., Folino, K., Greco, F., Pio Oranges, F., Cerulli, C., and Emerenziani, G.P. Effects of magnesium supplementation on muscle soreness in different types* of physical activities: a systematic review. Journal of Translational Medicine (2024) 22:629.

  3. Reno AM, Green M, Killen LG, O’Neal EK, Pritchett K, et al. Effects of magnesium supplementation on muscle soreness and performance.

  4. Strength Cond Res. 2022;36(8):2198–203. https:// doi. org/ 10. 1519/ JSC.

  5. Steward CJ, Zhou Y, Keane G, Cook MD, Liu Y, et al. One week of magnesium supplementation lowers IL-6, muscle soreness and increases post-exercise blood glucose in response to downhill running. Eur J Appl Physiol. 2019;119(11–12):2617–27. https:// doi. org/ 10. 1007/ s00421- 019- 04238-y.

  6. MecobalActive Provides Sustainable Solution for Vitamin B12 Supplements to Reduce Pollution Impact on Earth. https://www.globenewswire.com/news-release/2019/12/09/1958087/0/en/MecobalActive-Provides-Sustainable-Solution-for-Vitamin-B12-Supplements-to-Reduce-Pollution-Impact-on-Earth.html Date of access: 04/10/2024

 

G.       Zyora zyzinc™ capsules 60s:

  1. Zyora zyzinc™ capsules approved professional information.

  2. Read, A.R et al. The Role of Zinc in Antiviral Immunity. Adv Nutr 2019; 10:696 - 710.

  3. Chien, X.X., Zafra-Stone, S., Bagchi, M., Debasis, B. 2006. Bioavailability, antioxidant and immune-enhancing properties of zinc methionine. BioFactors, vol. 27, no. 1-4, pp. 231-244, 2006.

 

H.       Zyora zyzinc™ effervescent tablets 20s:

  1. Zyora zyzinc™ effervescent tablet approved professional information.

  2. Read, A.R et al. The Role of Zinc in Antiviral Immunity. Adv Nutr 2019; 10:696 - 710.

  3. Chien, X.X., Zafra-Stone, S., Bagchi, M., Debasis, B. 2006. Bioavailability, antioxidant and immune-enhancing properties of zinc methionine. BioFactors, vol. 27, no. 1-4, pp. 231-244, 2006.

 

I.           Zyora zycalm™ 30 capsules

  1. Zyora zycalm™ approved professional information.

  2. Baba, Y., Inagaki, S., Nakagawa, S., Kaneko, T., Kobayashi, M.  and Takihara, T. 2021. Effects of l-Theanine on Cognitive Function in Middle-Aged and Older Subjects: A Randomized Placebo-Controlled Study. J Med Food. April 2021; 24(4): 333–341.

  3. Hidese, S., Ogawa, S., Ota, M., Ishida, I., Yasukawa, Z., Ozeki, M., and Kunugi, H. 2019. Effects of L-Theanine Administration on Stress-Related Symptoms and Cognitive Functions in Healthy Adults: A Randomized Controlled Trial. Nutrients. 2019 Oct; 11(10): 2362.

  4. Roh, D., Jung, J.H., Yoon, K.H., Lee, C.H., Kang, L.Y., Lee, S., Shin, K., Kim, D.H. 2019. Valerian extract alters functional brain connectivity: A randomized double-blind placebo-controlled trial.  Phytotherapy research: Volume33, Issue 4, April 2019 Pages 939-948.