SugarBear Legal

 

Professional Information for SUGARBEARHAIR® HAIR VITAMINS

COMPLEMENTARY MEDICINE: HEALTH SUPPLEMENT

This unregistered medicine has not been evaluated by the SAHPRA for its quality, safety or intended use.

 

SCHEDULING STATUS

S0

 

  1. NAME OF THE MEDICINE

SUGARBEARHAIR® HAIR VITAMINS chewable gummies

 

  1. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active ingredients

Per gummy

(2,5 g)

Per 2-gummy dose (5 g)

Ascorbic acid (Vitamin C)                  

10 mg

20 mg

Sodium

5 mg

10 mg

Calcium D-pantothenate                    

5,7 mg

11,4 mg

            providing Pantothenic acid (Vitamin B5)

2,6 mg

5,2 mg

DL-alpha tocopheryl acetate (Vitamin E)

3,7 mg

7,4 mg

Zinc citrate

11,9 mg

23,8 mg

            providing elemental Zinc

1,35 mg

2,7 mg

Pyridoxine hydrochloride (Vitamin B6)

1 mg

2 mg

Folate

217,5 µg

435 µg

            providing Folic acid    

130 µg

260 µg

Vitamin H (Biotin)

125 µg

250 µg

Retinyl palmitate (Vitamin A) 

31,5 µg RAE

63 µg RAE

Inositol

20 µg

40 µg

Ergocalciferol (Vitamin D2)

10 µg

20 µg

Cyanocobalamin (Vitamin B12)

3 µg

6 µg

 

Excipients with known effects:

Contains sugar (1,5 g sucrose per gummy).

Contains preservatives:

Pectin                                      47, 5 % m/m

Citric acid (E330)                    17,5 % m/m

Sodium citrate (E331)             15 % m/m

 

For the full list of excipients, see section 6.1.

 

  1. PHARMACEUTICAL form

Chewable gummies.

Light blue, berry flavour, soft chewable vegan gummy bear.

 

  1. Clinical particulars

4.1     Therapeutic indications

SUGARBEARHAIR® HAIR VITAMINS is a health supplement that contains a unique combination of more than 13 vitamins and minerals that is used by adults to promote and support hair and nail growth.

Suitable for all hair types and genders.

 

4.2       Posology and method of administration

Adults and children over the age of 12 years:

Chew 2 SUGARBEARHAIR® HAIR VITAMINS daily after breakfast or as directed by your health care provider.

Chew thoroughly before swallowing.

Take 2 hours before or after taking any other medication.

Do not exceed the recommended dosage.

 

Children:

Not suitable for children under the age of 12 years.

 

4.3     Contraindications

  • Hypersensitivity to any of the active ingredients or to any of the excipients listed in section 2 or 6.1.
  • Pregnancy and lactation (see section 4.6).
  • Concomitant administration with other hair or nail supplements or medicines.

 

4.4     Special warnings and precautions for use

Patients should take special care with SUGARBEARHAIR® HAIR VITAMINS if they are currently taking any medication or if they are suffering from a medical condition.

 

Sugar intolerance:

SUGARBEARHAIR® HAIR VITAMINS contains sugar (sucrose). Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take SUGARBEARHAIR® HAIR VITAMINS.

 

4.5       Interaction with other medicines and other forms of interaction

Antibiotics:

SUGARBEARHAIR® HAIR VITAMINS may decrease the absorption of antibiotics. Doses should be separated by at least 2 hours prior, or 4 to 6 hours after taking SUGARBEARHAIR® HAIR VITAMINS.

 

4.6     Fertility, pregnancy and lactation

SUGARBEARHAIR® HAIR VITAMINS is contraindicated during pregnancy or lactation (see section 4.3).

 

4.7     Effects on ability to drive and use machines

 

  • Undesirable effects

SUGARBEARHAIR® HAIR VITAMINS is generally well tolerated.

 

Gastrointestinal disorders:

Less frequent:                nausea, diarrhoea, constipation, dyspepsia, bloating, flatulence.

 

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of SUGARBEARHAIR® HAIR VITAMINS is important. It allows continued monitoring of the benefit/risk balance of SUGARBEARHAIR® HAIR VITAMINS. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8 .

 

4.9     Overdose

In overdose, side effects can be precipitated and/or be of increased severity (see section 4.8).

In the event of overdose, treatment should be symptomatic and supportive.  

 

  1. PHARMACOLOGICAL PROPERTIES

5.1     Pharmacodynamic properties

Category and class: D 34.12 Multiple substance formulation.

 

Mechanism of action:

Zinc helps to maintain immune function and is a factor in the maintenance of good health.

Biotin and folic acid plays a role in the maintenance of good health.

Inositol is an essential component of cell membrane phospholipids, with weak lipotropic activity, and can move fat out of liver and intestine cells.

Vitamin A is a fat-soluble vitamin that contributes to the maintenance of skin, membranes and immune function.

Vitamin B5 and B6 plays a role in the maintenance of good health and contributes to tissue formation.

Vitamin B12 is a water-soluble vitamin that plays a factor in the maintenance of good health.

Vitamin C is a water-soluble vitamin that provides antioxidants for the maintenance of good health and helps in connective tissue formation.

Vitamin D is a factor in the maintenance of good health and helps in the absorption and use of calcium.

Vitamin E provides antioxidants for the maintenance of good health.

 

5.2     Pharmacokinetic properties

Zinc is absorbed in the small intestines, distributed in the body in skeletal muscle and bone and mainly excreted through the faeces.

Biotin is completely absorbed and reaches peak concentrations after 1 – 2 hours. Biotin metabolites are formed by beta-oxidation, sulfur oxidation, or both. About half of the biotin dose is excreted within 24 hours in the urine.

Inositol is almost completely absorbed and is metabolised by myo-inositol oxidase, and excreted via urine.

Folate is the general term that refers to a variety of chemical forms of folic acid. Folate in food is about 20 % to 50 % less bioavailable than synthetic folic acid, which is almost 100 % bioavailable. After folic acid is absorbed, it is reduced to tetrahydrofolate and then enters a methylation cycle, where it is further converted to L-methylfolate. Folic acid is excreted mainly in the urine.

Vitamin A is a fat-soluble vitamin. Ingested vitamin A is mainly stored in the liver. Elimination is mainly through urine, with smaller amounts through the breath and faeces.

Pantothenic acid (Vitamin B5) is the precursor of coenzyme A (CoA) and is excreted in the urine.

Pyridoxine (Vitamin B6) is passively absorbed from the upper gastrointestinal tract, converted in the liver to coenzyme pyridoxal phosphate and excreted in the urine.

Vitamin B12 is an essential water-soluble vitamin. It is absorbed in the terminal ileum and has a half-life of about 25 to 30 hours.

Vitamin C is well abosrbed at lower doses and excreted via urine.

Vitamin D is a fat-soluble vitamin. It is well absorbed and requires hydroxylation in the body to form the active metabolite, calcitriol.

Vitamin E is mostly absorbed in the small intestines by passive diffusion and is excreted mainly unchanged via the faeces.

 

  1. PHARMACEUTICAL PARTICULARS

6.1       List of excipients

Carnauba wax

Citric acid (E330)

Coconut oil

FD & C Blue 1 (E133) (colourant)

Flavourants

Organic tapioca syrup

Pectin

Raw cane sugar

Sodium citrate (E331)

Titanium dioxide (E171)

Water.

 

6.2     Incompatibilities

Not applicable.

 

6.3     Shelf life

2 years.

Store at or below 25 °C.

 

  • Special precautions for storage

Store in a dry place away from direct sunlight.

Store in the original container until required for use.

 

  • Nature and contents of container

The gummy bears are packed in a translucent plastic bottle sealed with a white screw plug and encased with plastic.

Pack size: 60 gummies.

 

6.6     Special precautions for disposal and other handling

No special requirements.

 

  1. HOLDER OF CERTIFICATE OF REGISTRATION

LeBasi Pharmaceuticals (Pty) Ltd

San Domenico Building, Ground Floor, Unit 6

10 Church Street

Durbanville 7551

South Africa

 

  1. REGISTRATION NUMBER

Will be allocated by SAHPRA upon registration.

 

  1. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Will be allocated by SAHPRA upon registration.

 

  1. DATE OF REVISION OF THE TEXT

October 2021.

 

Professional Information for SUGARBEAR® WOMEN’S MULTI

COMPLEMENTARY MEDICINE: HEALTH SUPPLEMENT

This unregistered medicine has not been evaluated by the SAHPRA for its quality, safety or intended use.

 

SCHEDULING STATUS

S0

 

  1. NAME OF THE MEDICINE

SUGARBEAR® WOMEN’S MULTI chewable gummies

 

  1. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active ingredients

Per gummy

(2,5 g)

Per 2-gummy dose (5 g)

Vegan collagen booster blend:

50 mg

100 mg

            providing Glycine

0,0025 mg

0,005 mg

                            Glutamic acid

0,03 mg

0,06 mg

                            L-Glutathione

50 mg

100 mg

Ascorbic acid (Vitamin C)                  

10 mg

20 mg

Calcium D-pantothenate                    

2,2 mg

4,4 mg

            providing Pantothenic acid             (Vitamin B5)

1 mg

2 mg

Omega-3 Fatty Acids (from Salvia hispanica L. (Chia) seed extract)

0,5 mg

1 mg

DL-alpha tocopheryl acetate (Vitamin E)

2,25 mg

4,5 mg

Riboflavin (Vitamin B2)

0,2 mg

0,4 mg

Zinc citrate

13,2 mg

26,4 mg

            providing elemental Zinc

1,5 mg

3 mg

Pyridoxine hydrochloride (Vitamin B6)

1 mg

2 mg

Folate

50 µg

100 µg

            providing Folic acid    

30 µg

60 µg

Vitamin H (Biotin)

90 µg

180 µg

Inositol

20 µg

40 µg

Ergocalciferol (Vitamin D2)

12,5 µg

25 µg

Methylcobalamin (Vitamin B12)

4 µg

8 µg

 

Excipients with known effects:

Contains sugar (1,5 g sucrose per gummy).

Contains preservatives:

Pectin                                      47, 5 % m/m

Citric acid (E330)                    17,5 % m/m

Sodium citrate (E331)             15 % m/m

 

For the full list of excipients, see section 6.1.

 

  1. PHARMACEUTICAL form

Chewable gummies.

Light pink, berry flavour, soft chewable vegan gummy bear.

 

  1. Clinical particulars

4.1     Therapeutic indications

SUGARBEAR® WOMEN’S MULTI is a health supplement that contains a unique combination of micronutrients, multivitamins and minerals formulated for woman for the maintenance of good health.

Suitable for all women.

 

4.2       Posology and method of administration

Adults and children over the age of 12 years:

Chew 2 SUGARBEAR® WOMEN’S MULTI daily after breakfast or as directed by your health care provider.

Chew thoroughly before swallowing.

Take 2 hours before or after taking any other medication.

Do not exceed the recommended dosage.

 

Children:

Not suitable for children under the age of 12 years.

 

4.3     Contraindications

  • Hypersensitivity to any of the active ingredients or to any of the excipients listed in section 2 or 6.1.
  • Pregnancy and lactation (see section 4.6).
  • Concomitant administration with any other woman’s multivitamins, supplements or medicines.

 

4.4     Special warnings and precautions for use

Patients should take special care with SUGARBEAR® WOMEN’S MULTI if they are currently taking any medication or if they are suffering from a medical condition.

 

Sugar intolerance:

SUGARBEAR® WOMEN’S MULTI contains sugar (sucrose). Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take SUGARBEAR® WOMEN’S MULTI.

 

4.5       Interaction with other medicines and other forms of interaction

SUGARBEAR® WOMEN’S MULTI may decrease the absorption of antibiotics. Doses should be separated by at least 2 hours prior, or 4 to 6 hours after taking SUGARBEAR® WOMEN’S MULTI.

 

4.6     Fertility, pregnancy and lactation

SUGARBEAR® WOMEN’S MULTI is contraindicated during pregnancy or lactation (see section 4.3).

 

4.7     Effects on ability to drive and use machines

 

  • Undesirable effects

SUGARBEAR® WOMEN’S MULTI is generally well tolerated.

 

Gastrointestinal disorders:

Less frequent:                nausea, diarrhoea, constipation, dyspepsia, bloating, flatulence.

 

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of SUGARBEAR® WOMEN’S MULTI is important. It allows continued monitoring of the benefit/risk balance of SUGARBEAR® WOMEN’S MULTI. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8 .

 

4.9     Overdose

In overdose, side effects can be precipitated and/or be of increased severity (see section 4.8).

In the event of overdose, treatment should be symptomatic and supportive.  

 

  1. PHARMACOLOGICAL PROPERTIES

5.1     Pharmacodynamic properties

Category and class: D 34.12 Multiple substance formulation.

 

Mechanism of action:

Zinc helps to maintain immune function and is a factor in the maintenance of good health.

Biotin, folic acid and omega-3 fatty acids plays a role in the maintenance of good health.

Inositol is an essential component of cell membrane phospholipids, with weak lipotropic activity, and can move fat out of liver and intestine cells.

Vitamin B2, B5 and B6 plays a role in the maintenance of good health and contributes to tissue formation.

Vitamin B12 is a water-soluble vitamin that plays a factor in the maintenance of good health.

Vitamin C is a water-soluble vitamin that provides antioxidants for the maintenance of good health and helps in connective tissue formation.

Vitamin D is a factor in the maintenance of good health and helps in the absorption and use of calcium.

Vitamin E and L-Glutathione provides antioxidants for the maintenance of good health.

Glycine and glutamic acid provides a source of amino acids involved in muscle protein synthesis.

 

5.2     Pharmacokinetic properties

Zinc is absorbed in the small intestines, distributed in the body in skeletal muscle and bone and mainly excreted through the faeces.

Biotin is completely absorbed and reaches peak concentrations after 1 – 2 hours. Biotin metabolites are formed by beta-oxidation, sulfur oxidation, or both. About half of the biotin dose is excreted within 24 hours in the urine.

Inositol is almost completely absorbed and is metabolised by myo-inositol oxidase, and excreted via urine.

Folate is the general term that refers to a variety of chemical forms of folic acid. Folate in food is about 20 % to 50 % less bioavailable than synthetic folic acid, which is almost 100 % bioavailable. After folic acid is absorbed, it is reduced to tetrahydrofolate and then enters a methylation cycle, where it is further converted to L-methylfolate. Folic acid is excreted mainly in the urine.

Omega 3 fatty acids are well absorbed in the body and increases levels of omega-3 fatty acids in most cells of the body.

Riboflavin (Vitamin B2) is a water-soluble vitamin that is converted in the body to the cofactors flavin mononucleotide (FMN) and flavin-adenine dinucleotide (FAD). Following supplementation, riboflavin levels are increased in the blood and excretion is in the urine.

Pantothenic acid (Vitamin B5) is the precursor of coenzyme A (CoA) and is excreted in the urine.

Pyridoxine (Vitamin B6) is passively absorbed from the upper gastrointestinal tract, converted in the liver to coenzyme pyridoxal phosphate and excreted in the urine.

Vitamin B12 is an essential water-soluble vitamin. It is absorbed in the terminal ileum and has a half-life of about 25 to 30 hours.

Vitamin C is well absorbed at lower doses and excreted via urine.

Vitamin D is a fat-soluble vitamin. It is well absorbed and requires hydroxylation in the body to form the active metabolite, calcitriol.

Vitamin E is mostly absorbed in the small intestines by passive diffusion and is excreted mainly unchanged via the faeces.

Glycine is absorbed rapidly in the blood with maximal levels approximately 40 minutes after ingestion. Glycine passively diffuse across the blood-brain barrier and is eliminated within hours after ingestion.

Glutamic acid is absorbed in the jejunum, with a terminal half-life of 1 hour. It is eliminated in the urine but is almost fully reabsorbed by the renal tubules.

Glutathione is a tripeptide made from the amino acids glycine, cysteine and glutamic acid. In the body it is primarily synthesised in the liver.

 

  1. PHARMACEUTICAL PARTICULARS

6.1       List of excipients

Beta carotene (colourant)

Carnauba wax

Citric acid (E330)

Coconut oil

Flavourants

Magnesium dioxide

Organic tapioca syrup

Pectin

Raw cane sugar

Sodium citrate (E331)

Water.

 

6.2     Incompatibilities

Not applicable.

 

6.3     Shelf life

2 years.

Store at or below 25 °C.

 

  • pecial precautions for storage

Store in a dry place away from direct sunlight.

Store in the original container until required for use.

 

  • Nature and contents of container

The gummy bears are packed in a translucent plastic bottle sealed with a white screw plug and encased with plastic.

Pack size: 60 gummies.

 

6.6     Special precautions for disposal and other handling

No special requirements.

 

  1. HOLDER OF CERTIFICATE OF REGISTRATION

LeBasi Pharmaceuticals (Pty) Ltd

San Domenico Building, Ground Floor, Unit 6

10 Church Street

Durbanville 7551

South Africa

 

  1. REGISTRATION NUMBER

Will be allocated by SAHPRA upon registration.

 

  1. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Will be allocated by SAHPRA upon registration.

 

  1. DATE OF REVISION OF THE TEXT

October 2021.

 

Professional Information for SUGARBEAR® PROCOLLAGEN

COMPLEMENTARY MEDICINE: HEALTH SUPPLEMENT

This unregistered medicine has not been evaluated by the SAHPRA for its quality, safety or intended use.

 

SCHEDULING STATUS

S0

 

  1. NAME OF THE MEDICINE

SUGARBEAR® PROCOLLAGEN chewable gummies

 

  1. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active ingredients

Per gummy

(2,5 g)

Per 2-gummy dose (5 g)

Vegan collagen booster blend:

50 mg

100 mg

            providing Glycine

0,0025 mg

0,005 mg

                            Glutamic acid

0,03 mg

0,06 mg

                            L-Glutathione

50 mg

100 mg

Ascorbic acid (Vitamin C)                  

10 mg

20 mg

Calcium D-pantothenate                    

2,2 mg

4,4 mg

            providing Pantothenic acid             (Vitamin B5)

1 mg

2 mg

DL-alpha tocopheryl acetate (Vitamin E)

2,25 mg

4,5 mg

Riboflavin (Vitamin B2)

0,2 mg

0,4 mg

Zinc citrate

13,2 mg

26,4 mg

            providing elemental Zinc

1,5 mg

3 mg

Pyridoxine hydrochloride (Vitamin B6)

1 mg

2 mg

Folate

50 µg

100 µg

            providing Folic acid    

30 µg

60 µg

Vitamin H (Biotin)

90 µg

180 µg

Ergocalciferol (Vitamin D2)

12,5 µg

25 µg

Methylcobalamin (Vitamin B12)

4 µg

8 µg

 

Excipients with known effects:

Contains sugar (1,5 g sucrose per gummy).

Contains preservatives:

Pectin                                      47, 5 % m/m

Citric acid (E330)                    17,5 % m/m

Sodium citrate (E331)             15 % m/m

 

For the full list of excipients, see section 6.1.

 

  1. PHARMACEUTICAL form

Chewable gummies.

Light pink, berry flavour, soft chewable vegan gummy bear.

 

  1. Clinical particulars

4.1     Therapeutic indications

SUGARBEAR® PROCOLLAGEN is a health supplement that contains a unique combination of micronutrients, multivitamins and minerals formulated for woman for the maintenance of healthy skin and good health.

Suitable for all women.

 

4.2       Posology and method of administration

Adults and children over the age of 12 years:

Chew 2 SUGARBEAR® PROCOLLAGEN gummies daily after breakfast or as directed by your health care provider.

Chew thoroughly before swallowing.

Take 2 hours before or after taking any other medication.

Do not exceed the recommended dosage.

 

Children:

Not suitable for children under the age of 12 years.

 

4.3     Contraindications

  • Hypersensitivity to any of the active ingredients or to any of the excipients listed in section 2 or 6.1.
  • Pregnancy and lactation (see section 4.6).
  • Concomitant administration with any other woman’s multivitamins, supplements or medicines.

 

4.4     Special warnings and precautions for use

Patients should take special care with SUGARBEAR® PROCOLLAGEN if they are currently taking any medication or if they are suffering from a medical condition.

 

Sugar intolerance:

SUGARBEAR® PROCOLLAGEN contains sugar (sucrose). Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take SUGARBEAR® PROCOLLAGEN.

 

4.5       Interaction with other medicines and other forms of interaction

SUGARBEAR® PROCOLLAGEN may decrease the absorption of antibiotics. Doses should be separated by at least 2 hours prior to, or 4 to 6 hours after taking SUGARBEAR® PROCOLLAGEN.

 

4.6     Fertility, pregnancy and lactation

SUGARBEAR® PROCOLLAGEN is contraindicated during pregnancy or lactation (see section 4.3).

 

4.7     Effects on ability to drive and use machines

 

  • Undesirable effects

SUGARBEAR® PROCOLLAGEN is generally well tolerated.

 

Gastrointestinal disorders:

Less frequent:                nausea, diarrhoea, constipation, dyspepsia, bloating, flatulence.

 

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of SUGARBEAR® PROCOLLAGEN is important. It allows continued monitoring of the benefit/risk balance of SUGARBEAR® PROCOLLAGEN. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8 .

 

4.9     Overdose

In overdose, side effects can be precipitated and/or be of increased severity (see section 4.8).

In the event of overdose, treatment should be symptomatic and supportive. 

 

  1. PHARMACOLOGICAL PROPERTIES

5.1     Pharmacodynamic properties

Category and class: D 34.12 Multiple substance formulation.

 

Mechanism of action:

Zinc helps to maintain immune function and is a factor in the maintenance of good health.

Biotin and folic acid play a role in the maintenance of good health.

Vitamin B2, B5 and B6 play a role in the maintenance of good health and contribute to tissue formation.

Vitamin B12 is a water-soluble vitamin that plays a factor in the maintenance of good health.

Vitamin C is a water-soluble vitamin that provides antioxidants for the maintenance of good health and helps in connective tissue formation.

Vitamin D is a factor in the maintenance of good health and helps in the absorption and use of calcium.

Vitamin E and L-Glutathione provide antioxidants for the maintenance of good health.

Glycine and glutamic acid provide a source of amino acids involved in muscle protein synthesis.

 

5.2     Pharmacokinetic properties

Zinc is absorbed in the small intestines, distributed in the body in skeletal muscle and bone and mainly excreted through the faeces.

Biotin is completely absorbed and reaches peak concentrations after 1 – 2 hours. Biotin metabolites are formed by beta-oxidation, sulfur oxidation, or both. About half of the biotin dose is excreted within 24 hours in the urine.

Folate is the general term that refers to a variety of chemical forms of folic acid. Folate in food is about 20 % to 50 % less bioavailable than synthetic folic acid, which is almost 100 % bioavailable. After folic acid is absorbed, it is reduced to tetrahydrofolate and then enters a methylation cycle, where it is further converted to L-methylfolate. Folic acid is excreted mainly in the urine.

Riboflavin (Vitamin B2) is a water-soluble vitamin that is converted in the body to the cofactors flavin mononucleotide (FMN) and flavin-adenine dinucleotide (FAD). Following supplementation, riboflavin levels are increased in the blood and excretion is in the urine.

Pantothenic acid (Vitamin B5) is the precursor of coenzyme A (CoA) and is excreted in the urine.

Pyridoxine (Vitamin B6) is passively absorbed from the upper gastrointestinal tract, converted in the liver to coenzyme pyridoxal phosphate and excreted in the urine.

Vitamin B12 is an essential water-soluble vitamin. It is absorbed in the terminal ileum and has a half-life of about 25 to 30 hours.

Vitamin C is well absorbed at lower doses and excreted via urine.

Vitamin D is a fat-soluble vitamin. It is well absorbed and requires hydroxylation in the body to form the active metabolite, calcitriol.

Vitamin E is mostly absorbed in the small intestines by passive diffusion and is excreted mainly unchanged via the faeces.

Glycine is absorbed rapidly in the blood with maximal levels approximately 40 minutes after ingestion. Glycine passively diffuse across the blood-brain barrier and is eliminated within hours after ingestion.

Glutamic acid is absorbed in the jejunum, with a terminal half-life of 1 hour. It is eliminated in the urine but is almost fully reabsorbed by the renal tubules.

Glutathione is a tripeptide made from the amino acids glycine, cysteine and glutamic acid. In the body it is primarily synthesised in the liver.

 

  1. PHARMACEUTICAL PARTICULARS

6.1       List of excipients

Beta carotene (colourant)

Carnauba wax

Citric acid (E330)

Coconut oil

Fruit and vegetable juice (colourant)

Fruit flavours

Magnesium dioxide

Organic tapioca syrup

Pectin

Raw cane sugar

Sodium citrate (E331)

Titanium dioxide (E171)

Water.

 

6.2     Incompatibilities

Not applicable.

 

6.3     Shelf life

2 years.

Store at or below 25 °C.

 

  • Special precautions for storage

Store in a dry place away from direct sunlight.

Store in the original container until required for use.

 

  • Nature and contents of container

The gummy bears are packed in a translucent plastic bottle sealed with a white screw plug and encased with plastic.

Pack size: 60 gummies.

 

6.6     Special precautions for disposal and other handling

No special requirements.

 

  1. HOLDER OF CERTIFICATE OF REGISTRATION

LeBasi Pharmaceuticals (Pty) Ltd

San Domenico Building, Ground Floor, Unit 6

10 Church Street

Durbanville 7551

South Africa

 

  1. REGISTRATION NUMBER

Will be allocated by SAHPRA upon registration.

 

  1. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Will be allocated by SAHPRA upon registration.

 

  1. DATE OF REVISION OF THE TEXT

June 2022.