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