Professional information 

Scheduling status S0

1. Name of medicine
   

   Tala Health & Wellness
   Tala Volcano C

2. Qualitative and Quantitative Composition 
   Each 5-gram serving contains:
   

   Ascorbic acid (Vitamin C)	1000 mg
   Contains non-nutritive sweetener sucralose	35 mg per 5 gram serving

   
   See 6.1 for full list of ingredients 
3. Pharmaceutical form 
   Effervescent powder 
4. Clinical Particulars
   1. Therapeutic Indications 
      Taking Vitamin C:
      
      

      • Helps to metabolise fats, and proteins 

      • Contributes to iron absorption from food

      • Contributes to cell protection from free radical damage

      • Contributes to the protection cells from oxidative stress 

      • Contributes to normal collagen formation for the normal function of blood vessels, bones, cartilage, skin, gums, and teeth

      • Helps in connective tissue formation 

      • Contributes to wound healing

      • Contributes to the normal function of the immune system

      • Contributes to maintain the normal function of the immune system during and after intense physical stress

      • Contributes to the reduction of tiredness and fatigue

      • An antioxidant for the maintenance of good health

      • A factor in the maintenance of good health

   2. Posology and method of administration 
      Adults and children over 9 years old: Take one 5 gram serving dissolved in water daily
      
      Elderly populations
      No studies have been performed in elderly populations, but no dose adjustment is expected to be required.
      
      

      Paediatric populations: 

      Children 1 – 3 years: ¼ to ½ of a 5-gram (scoop) serving daily dissolved in water

      Children 4 – 8 years: ½ to ¾ of a 5-gram (scoop) serving daily dissolved in water

   3. Contraindications: 

      Do not take Tala Volcano C effervescent power if you have ever had an allergic reaction to a vitamin C supplement 
      
      

      Special warnings and precautions for use

      Supplementation with Vitamin C, especially when taken in large doses can cause kidney stones in some people. 

      Interactions with other medicines and other forms of interaction. 

      Taking vitamin C with antacids containing aluminium can increase the absorption of aluminium.

      Taking vitamin C with oral contraceptives or hormone replacement therapy might increase your oestrogen levels. 

      The use of antioxidants, such as vitamin C, during chemotherapy might reduce the effect of chemotherapy drugs. 

      Taking vitamin C with protease inhibitors, niacin and statins might reduce their effect. 

      High doses of vitamin C might reduce your response to warfarin.

      
      Fertility, pregnancy, and lactation

      Safety of VOLCANO C in pregnancy and lactation has not been established. 

      Consult a physician prior to use if you are pregnant or breastfeeding.

       

      Undesirable effects

      Vitamin C is considered safe at normal doses. Too much vitamin C can cause side effects such as nausea, vomiting, and diarrhea, heartburn, stomach cramps or bloating. Other side effects include fatigue, sleepiness, insomnia, headache, and skin flushing.
      
      

      Overdose

      Taking too much vitamin C can cause nausea, vomiting, and diarrhea, heartburn, stomach cramps or bloating as well as fatigue and sleepiness or sometimes insomnia, headache, and skin flushing.

5. Pharmacological properties

   Vitamin C is an antioxidant. Antioxidants help protect the body against free radicals, which play a role in heart disease, cancer, and other diseases. 

   Vitamin C helps in iron absorption. 

   Vitamin C a nutrient essential in the formation of blood vessels, cartilage, muscles, and bones. 

   Vitamin C is essential to the body’s healing process.

6. Pharmaceutical properties

   1. List of excipients 

      Anhydrous citric acid, inulin, sodium bicarbonate, citrus flavourant, beetroot power, aerosol, beta carotene. Contains non-nutritive sweetener sucralose.

   2. Incompatibilities 

      Consult your physician before taking VOLCANO C with other medicines.

      See “interactions with other medicines and other forms of interaction”.

   3. Shelf Life

      24 months

   4. Special precautions for storage

      Keep out of reach of children.

      Store at or below 25 ֯c

   5. Presentation 

      White HDPE container of 150g Volcano C effervescent powder with a screw off cap.

      White HDPE container of 500g Volcano C effervescent powder with a screw off cap.

      Box of ten sachets, each sachet contains 5 g Volcano C effervescent powder.

7. Applicant

   Johannes J Snyman CC

   454 Koedoesnek Street, 

   Waterkloof Ridge

   Pretoria. 

8. Date of revision of the text

   February 2024

Reference:

SAHPRA Guideline 7.04_CM_SE_Health_Supplements_Mar22_v4_3 Pg 32 & 34