Professional Information for Medicines for Human Use

SCHEDULING STATUS:

PROPRIETARY NAME AND DOSAGE FORM:
Slow-Mag® Tablets

COMPOSITION:
Enteric coated tablets containing Magnesium Chloride 535 mg, equivalent to 64 mg elemental magnesium.
Other ingredients are: Calcium carbonate, magnesium stearate, povidone K25 and talc.
Preservative free
Sugar free

CATEGORY AND CLASS:
A 24 Mineral substitutes, electrolytes and trace elements

PHARMACOLOGICAL ACTION:
Magnesium supplement in the treatment of hypomagnesemia and magnesium deficiencies.

INDICATIONS:
For prophylactic and therapeutic treatment of disorders arising from imbalance and deficiency of magnesium.

CONTRAINDICATIONS:
Renal impairment; acute dehydration and gastric lesions and disorders.

WARNINGS AND SPECIAL PRECAUTIONS:
See CONTRAINDICATIONS and SIDE EFFECTS

DOSAGE AND DIRECTIONS FOR USE:
According to the individual needs of the patient.
Prophylactic dose: 2 or 4 tablets daily in divided doses.
Therapeutic dose: 2 - 6 tablets daily in divided doses

SIDE EFFECTS:
Mild forms of diarrhoea and bowel discomfort may occur. Occasionally nausea is reported.
Slow-Mag® is generally well tolerated.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Gastrointestinal discomfort in mild cases may be treated by discontinuing Slow-Mag® and increasing fluid intake. Unusual overdoses by the oral route are not recorded but could give rise to renal failure, reduced tendon reflexes and respiratory paralysis. This situation could be countered by intravenous fluid therapy using K, Na, and Ca electrolyte replacement solutions and monitoring the situation clinically. Where the magnesium is still present in the gastro-intestinal tract, suitable ion exchange therapy may be instituted.
IDENTIFICATION: Red, biconvex, round, enteric coated tablets.

PRESENTATION:
Slow-Mag® is supplied in amber glass bottles of 30, 60 and 100 tablets.

STORAGE INSTRUCTIONS:
Store at or below 25 °C in a dry place, away from sunlight and heat.
Keep out of reach of children.

REGISTRATION NUMBER:
H/24/89

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION:
P&G South African Trading (Pty) Ltd.
10th Floor, Alice Lane Towers, 15 Alice Lane
Sandton, 2196
South Africa

1 = Company Registration Number: 1970/004059/07
® = Registered Trademark

DATE OF PUBLICATION OF THE PROFESSIONAL INFORMATION:
Date of Registration: 12 November 1975

Complementary Medicine (Health Supplement).
This unregistered medicine has not been evaluated by the SAHPRA for its quality, safety or intended use.

SCHEDULING STATUS:

1. NAME OF THE MEDICINE:
Slow Mag® Performance Orange Fizzies

2. QUALITATIVE & QUANTITATIVE COMPOSITION
Each effervescent tablet contains: Magnesium (as magnesium carbonate) 200 mg, pantothenic acid (vitamin B5) (as calcium pantothenate) 30 mg, panax quinquefolius L. (american ginseng) 100 mg [root, 3:1 extract providing 300 mg of root equivalent].
Contains sweetener: Sucralose 23 mg per effervescent tablet.
No added preservatives. No artificial flavours. Suitable for vegetarians.
Suitable for vegans.

For full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM
Tablets.
Large, round, flat, uncoated pale purple speckled tablets with red, purple & orange specks.

4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Slow Mag® Performance Orange Fizzies: • Helps enhance mental performance. • Supports physical performance.

Magnesium:
• Contributes to a reduction of tiredness and fatigue.

Pantothenic acid (Vitamin B5):
• Contributes to normal mental performance.

Ginseng:

• Helps Maintain low stress levels.
Slow Mag® Performance Orange Fizzies is indicated in adults.

4.2 Posology and method of administration
Posology: Adults: Take 1 tablet daily, dissolved in a glass of water, or as directed by your healthcare professional.

Special populations: Refer to section 4.4

Paediatric population: Slow Mag® Performance Orange Fizzies is not suitable for children.

Method of administration: Oral

4.3 Contraindications
Do not take Slow Mag® Performance Orange Fizzies if you are hypersensitive (allergic) to magnesium (as magnesium carbonate) 200 mg, pantothenic acid (vitamin B5) (as calcium pantothenate) 30 mg, panax quinquefolius L. (american ginseng) 100 mg [root, 3:1 extract providing 300 mg of root equivalent], or any of the ingredients of Slow Mag® Performance Orange Fizzies (listed in section 6.1).

4.4 Special warnings and precautions for use
Special care should be taken, and a doctor or healthcare provider consulted before using Slow Mag® Performance Orange Fizzies if you are taking blood-thinning medications or under medical supervision.

Do not use if pregnant or breastfeeding.
Product is not to be used as a substitute for a varied diet.

4.5 Interaction with other medicines and other forms of interaction
No interaction studies for this medicine have been conducted. It may influence the effect of other medications or products.

4.6 Fertility, pregnancy, and lactation_
Do not use if you are pregnant or breastfeeding.

4.7 Effects on ability to drive and use machines
Your ability to drive and operate machines should not be affected by Slow Mag® Performance Orange Fizzies.

4.8 Undesirable effects
Side effects are not expected from use of Slow Mag® Performance Orange Fizzies. However, if you experience any untoward effects while taking Slow Mag® Performance Orange Fizzies, please consult your doctor, pharmacist, or other health care provider for advice.

Reporting of suspected adverse reactions.

Health care providers are asked to report any suspected adverse reactions to SAHPRA via the “6.04 Adverse Drug Reactions 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.

5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Category D: 34.12 Multiple substance formulation.

5.2 Pharmacokinetic properties
N/A

6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Citric Acid, sodium hydrogen carbonate, flavour orange, red beet powder (red beet juice conc. (beta vulgaris L.), maltodextrin, citric acid (E330)), sucralose, Beta carotin 1% (maltodextrin, starch sodium octenyl succinate, vegetable oil, sodium ascorbate, tocopherol, beta carotene, vitamin B2 (riboflavin-5-phosphate).

6.2 Incompatibilities
Not applicable.

6.3 Shelf life
24 months.

6.4 Special precautions for storage
Store at or below 25 °C. Store tube tightly closed in a cool, dry place. Do not store in a bathroom. Do not use after the expiry date stated on the label.

6.5 Nature and contents of container
Polypropylene tube with LDPE tamper evident push down caps in a cardboard carton containing pack sizes of 15s and 30s. Not all pack sizes may be marketed.

6.6 Special precautions for disposal
Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets).

7 HOLDER OF CERTIFICATE OF REGISTRATION
P&G South African Trading (Pty) Ltd. 10th Floor, Alice Lane Towers, 15 Alice Lane, Sandton, 2196, South Africa

8 REGISTRATION NUMBER(S)
Not Applicable

9 AUTHORISATION/RENEWAL OF THE AUTHORISATION
Not Applicable

10 DATE OF REVISION OF THE TEXT
Dec 2022

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

SCHEDULING STATUS:

1. NAME OF THE MEDICINE:
Slow-Mag Multivitamin Effervescent Tablets

2. QUALITATIVE & QUANTITATIVE COMPOSITION
Each effervescent tablet contains:
Magnesium carbonate 408,16 mg providing Magnesium (elemental) 99,18 mg;
Magnesium oxide 120,85 mg providing Magnesium (elemental) 72,87 mg;
Providing total Magnesium (elemental) 172,05 mg;
Ascorbic acid (Vitamin C) 80,02 mg;
Nicotinamide (Vitamin B3) 16 mg;
DL- alpha tocopheryl acetate 17,88 mg providing Tocopherol (Vitamin E) 12 mg;
Ferrous gluconate 83,33 mg providing Iron (elemental) 10 mg;
Zinc sulphate monohydrate 27.4 mg providing Zinc (elemental) 10 mg;
Calcium pantothenate 6,66 mg providing Pantothenic acid (Vitamin B5) 6 mg;
Riboflavin sodium phosphate 1,99 mg providing Riboflavin (Vitamin B2) 1,40 mg;
Pyridoxine hydrochloride 1,71 mg, providing Pyridoxine (Vitamin B6) 1,40 mg;
Thiamine Nitrate 1,36 mg providing Thiamine (Vitamin B1) 1,10 mg;
Folic acid 200 mcg;
Biotin (Vitamin H) 50 mcg;
Cholecalciferol (Vitamin D3) 5 mcg (200 IU);
Cyanocobalamin (Vitamin B12) 2,50 mcg.
Contains sugar: Isomalt (E953) 97,18 mg, dextrose 72,77 mg
Contains sweeteners: Sorbitol (E420) 599,87 mg, acesulfam potassium (E 950) 29,25 mg and sodium saccharin (E954) 17.55 mg

3. PHARMACEUTICAL FORM
Effervescent Tablets

__4. CLINICAL PARTICULARS __
4.1 Therapeutic indications
Multivitamin and multimineral supplement to support optimum nutrition, general health and well-being.
Magnesium helps with the reduction of tiredness and fatigue, contributes to energy production and normal muscle function.
Vitamin B12, iron and folic acid help to form red blood cells,iron helps in their proper function.
Vitamins B1 and B3 contribute to normal growth.
Vitamins B2, B5 and B6 contribute to tissue formation.
Vitamins B1, B2, B3, B5, B6, B12, biotin and zinc help to metabolise carbohydrates, fats and proteins.
Vitamin C helps to metabolise fats and proteins.
Folic acid helps to metabolise proteins.
Vitamins C and D help in the development and maintenance of bones and teeth.
Vitamins C and E are antioxidants for the maintenance of good health.
Vitamins C and Zinc help in connective tissue formation. Zinc helps maintain healthy skin.

4.2 Posology and method of administration
Posology: Adults: Take 1 tablet daily, dissolved in a glass of water after food, or as directed by your healthcare professional. Do not exceed the recommended daily dose.
Special populations: Refer to section 4.4
Paediatric population: Slow Mag Multivitamin Effervescent tablet is not suitable for children.
Method of administration: Oral

4.3 Contraindications
Do not take Slow-Mag Multivitamin Effervescent Tablets if you are hypersensitive to Magnesium carbonate providing Magnesium (elemental); Magnesium oxide providing Magnesium (elemental) ; Ascorbic acid (Vitamin C); Nicotinamide (Vitamin B3); DL- alpha tocopheryl acetate providing Tocopherol (Vitamin E); Ferrous gluconate providing Iron (elemental) ; Zinc sulphate monohydrate providing Zinc (elemental); Calcium pantothenate providing Pantothenic acid (Vitamin B5); Riboflavin sodium phosphate providing Riboflavin (Vitamin B2); Pyridoxine hydrochloride, providing Pyridoxine (Vitamin B6); Thiamine Nitrate providing Thiamine (Vitamin B1); Folic acid; Biotin (Vitamin H); Cholecalciferol (Vitamin D3); Cyanocobalamin (Vitamin B12) or any of the ingredients of Slow-Mag Multivitamin Effervescent Tablets (listed in section 6.1).

4.4 Special warnings and precautions for use
The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account. The content of sorbitol in medicinal products for oral use may affect the bioavailability of other medicinal products for oral use administered concomitantly.
Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Patients with rare glucose-galactose malabsorption should not take this medicine.
Excessive consumption of sorbitol may produce laxative effects.
This medicinal product contains 380 mg sodium per tablet, equivalent to 19% of the WHO recommended maximum daily intake for sodium.

Slow-Mag Multivitamin Effervescent Tablets is considered high in sodium. This should be particularly taken into account for those on a low salt diet.

4.5 Interaction with other medicines and other forms of interaction
Magnesium, iron, and zinc may influence the absorption of certain medicines (e.g. tetracyclines, fluoroquinolones) taken concomitantly, and vice versa. Administration of this product and such medicines should generally be separated by 2 to 3 hours.

4.6 Fertility, pregnancy and lactation
This product may be administered during pregnancy and lactation at the recommendation of the physician.

4.7 Effects on ability to drive and use machines
None known.

4.8 Undesirable effects
Immune system disorders: Frequency not known - Hypersensitivity reaction (e.g., rash)
Gastrointestinal disorders: Frequency not known - Diarrhea, bowel discomfort, and nausea.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are requested to report any suspected adverse reactions to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website.

4.9 Overdose
In the event of overdose, treatment should be discontinued.

5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties

Category D: 34.12 Multiple substance formulation.

5.2 Pharmacokinetic properties
Not Applicable

5.3 Preclinical safety data
Not applicable

6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Citric acid(E330), sodium hydrogen carbonate, starch, sorbitol, maltodextrin, isomalt, dextrose, strawberry flavor, acesulfame potassium, forest strawberry flavor, sodium saccharin, karmoisin, propylene glycol, lemon oil.

6.2 Incompatibilities
Not Applicable

6.3 Shelf life
24 months

6.4 Special precautions for storage
Store at or below 25 °C
Store tube tightly closed in a cool, dry place.
Do not use if tamper-evident seal on tube is broken or missing.
KEEP OUT OF REACH OF CHILDREN

6.5 Nature and contents of container
Large, round, flat, uncoated off-white tablet with white and brown speckles packed in polypropylene tube with LDPE tamper evident push down caps in a cardboard carton containing pack sizes of 10s and 30s (10s x 3 tube). Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling
Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets).

7. HOLDER OF CERTIFICATE OF REGISTRATION P&G South African Trading (Pty) Ltd
15 Alice Lane Tower
Alice Lane
Sandton, Johannesburg
2196, South Africa

8. REGISTRATION NUMBER(S)
To be allocated

9. DATE OF FIRST AUTHORISATION
To be allocated

10. DATE OF REVISION OF THE TEXT
To be allocated