Professional information 

Scheduling status S0

1. Name of medicine
   Tala Health & Wellness
   VITAMIN D3 + K2
2. Qualitative and Quantitative Composition
   

   EACH CAPSULE CONTAINS:	QUANTITY
   Cholecalciferol (Vitamin D3)	10 mg
   Providing Cholecalciferol
   (elemental)	1000 IU|25 µg
   Menaquinon-7 (Vitamin K2)	1 mg
   providing Menaquinone-7
   (elemental)	2 µg

3. Pharmaceutical form
   White capsules
4. Clinical Particulars
   
   1. Therapeutic Indications
      The vitamin in VITAMIN D3 + K2 capsules are known to:
       Contribute to the development and maintenance of strong bones and teeth
       Help in the absorption and use of calcium and phosphorous
       Contribute to the maintenance of normal muscle function
       Contribute to the normal function of the immune system
   2. Posology and method of administration
      Take one capsule daily with food
      
      Elderly populations
      No studies have been performed in elderly populations, but no dose
      adjustment is expected to be required.
      
      Paediatric populations:
      The quantity of Vitamin D3 and Vitamin K2 in VITAMIN D3 + K2 is suitable for
      children from one year. However, do not give VITAMIN D3 + K2 capsules to
      young children due to the choking hazard.
   3. Contraindications:
      Do not take VITAMIN D3 + K2 if you are allergic to either of the active
      substances or other ingredients.
      
      Special warnings and precautions for use
      Taking very high doses of vitamin D3 of 4000 IU and above for long periods of
      time may cause high levels of calcium in the blood. 
      
      Interactions with other medicines and other forms for interaction
       Do not take VITAMIN D3 + K2 capsules with antacids as vitamin D can
      increase the absorption of aluminium.
      Take VITAMIN D3 + K2 capsules two hours before or 4 hours after antacids.
       Anticonvulsants Phenobarbital and Phenytoin increase the breakdown of
      vitamin D and reduce calcium absorption.
       Taking Atorvastatin with vitamin D might affect the way your body
      processes this cholesterol drug.
       If you take vitamin D with the cholesterol-lowering drug, Cholestyramine,
      this can result in a reduced absorption of vitamin D.
       Don’t take vitamin D with the psoriasis drug Calcipotriene (Dovonex). The
      combination might increase the risk of too much calcium in the blood
      (hypercalcemia).
       Use vitamin D cautiously if you’re taking drugs processed in the body by
      the Cytochrome P-450 enzymes.
       Avoid taking high doses of vitamin D with the heart medication, Digoxin.
      High doses of vitamin D can cause hypercalcemia, which increases the risk
      of fatal heart problems with digoxin.
       High doses of vitamin D can cause hypercalcemia, which might reduce the
      effectiveness of diltiazem. Avoid taking high doses of vitamin D with blood
      pressure medicine.
       The weight-loss drug, Orlistat (Xenical), can reduce your absorption of
      vitamin D.
       Taking thiazide diuretics with vitamin D increases your risk of
      hypercalcemia.
       Taking corticosteroid mediations such as Prednisone can reduce calcium
      absorption and impair your body’s processing of vitamin D.
       Long-term use of high doses of stimulant laxatives can reduce vitamin D
      and calcium absorption.
       Taking high doses of vitamin D with of verapamil, a blood pressure
      medicine can cause hypercalcemia, and might also reduce the effectiveness
      of verapamil.
      
      Fertility, pregnancy, and lactation
      Safety of VITAMIN D3 + K2 in pregnancy and lactation has not been
      established.
      Consult a physician prior to use if you are pregnant or breastfeeding.
      
      Undesirable effects
      VITAMIN D3 + K2 is likely safe when taken at the recommended dose.
      Most people will not experience side effects with VITAMIN D3 + K2, unless too
      much is taken.
      Some side effects of taking too much VITAMIN D3 + K2 include weakness, dry
      mouth, nausea, vomiting, and others.
      
      Overdose
      The following symptoms have been reported when too much VITAMIN D3 + K2
      is taken – nausea and vomiting, poor appetite and weight loss, constipation,
      weakness, confusion and disorientation, heart rhythm problems, kidney stones
      and kidney damage.
5. Pharmacological properties
   Both vitamin D3 and Vitamin K2 contributes to the maintenance of normal
   bones. Vitamin K2 plays an essential role in bone metabolism. Vitamin D3 helps
   the body absorb calcium and phosphorus.
   VITAMIN D3 + K2, therefore, plays an essential role in the maintenance of good
   health.
   
   

   Pharmaceutical properties
   List of excipients
   Filler, magnesium stearate
   
   Incompatibilities
   In the absence of studies VITAMIN D3 + K2 should not be given with other
   medicines.
   Please refer to Interactions

   
   Shelf Life
   24 months
   Special precautions for storage
   Keep out of reach of children.

   Store at or below 25 *C

   Presentation
   Amber glass bottle containing 60 capsules

6. Applicant
   454 Koedoesnek Avenue
   Waterkloof Ridge
   Pretoria, RSA
   021 347 8497
7. Date of revision of the text
   February 2024
   
   References:
   SAHPRA Guideline 7.04_CM_SE_Health_Supplements_Mar22_v4_3 Pg 32 & 34