SmartHerbals Healthy Gut (3 variants)
PROFESSIONAL INFORMATION
COMPLEMENTARY MEDICINE: COMBINATION PRODUCT (WESTERN HERBAL MEDICINE / HEALTH SUPPLEMENT)
This unregistered medicine has not been evaluated by SAHPRA for its quality, safety or intended use.
SCHEDULING STATUS [S0]
1 NAME OF THE MEDICINE
SMARTHERBALS HEALTHY GUT powder.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each scoop (10 g) contains:
Aloe ferox Mill. (Aloe) [leaf powder] 832,5 mg per 10-g dose
Montmorillonite (Bentonite clay) [powder] 417,5 mg per 10-g dose
Contains sugar:
Each 10 g contains 174,8 mg dextrose, 524,4 mg maltose and 786,6 mg maltotriose.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder.
Fine, light brown powder.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
SMARTHERBALS HEALTHY GUT is a complementary medicine that promotes gastrointestinal health. SMARTHERBALS HEALTHY GUT may assist with relieving abdominal pain and discomfort by supporting the stomach’s function. SMARTHERBALS HEALTHY GUT may assist with the maintenance of symptoms associated with IBS, diarrhoea and constipation.
4.2 Posology and method of administration
Adults:
1 scoop or sachet (10 g) daily mixed in a glass of water or juice.
Consult a healthcare provider for use beyond 7 days.
A healthcare provider should be consulted if symptoms persist or worsen.
Do not exceed the recommended daily dose.
Children:
Not suitable for children under the age of 12 years.
4.3 Contraindications
Hypersensitivity to any of the active or inactive ingredients listed in sections 2 and 6.1.
Pregnancy or breastfeeding (see section 4.6).
Abnormal constrictions of the gastrointestinal tract, potential or existing intestinal obstruction, faecal impaction, atonic bowel, appendicitis, inflammatory colon disease such as Crohn's disease or ulcerative colitis, abdominal pain of unknown origin, undiagnosed rectal bleeding, nausea, vomiting, diarrhoea and fever (see section 4.4).
Severe dehydration with depleted water or electrolytes.
4.4 Special warnings and precautions for use
Surgery:
SMARTHERBALS HEALTHY GUT has antiplatelet and hypoglycaemic effects which may cause excessive bleeding (especially in patients with bleeding disorders) or interfere with blood glucose control. SMARTHERBALS HEALTHY GUT should be discontinued two weeks prior to surgery.
Renal disease:
Caution is advised with SMARTHERBALS HEALTHY GUT in patients with kidney disease. Prior consultation with a healthcare provider is advised.
Gastrointestinal disorders:
A healthcare provider should be consulted prior to use of SMARTHERBALS HEALTHY GUT in patients with faecal impaction or symptoms such as abdominal pain, nausea, vomiting and fever. SMARTHERBALS HEALTHY GUT should be stopped, or the dose should be reduced if patients experience abdominal pain, cramps, spasms and/or diarrhoea (see section 4.3).
Anaemia:
SMARTHERBALS HEALTHY GUT may interfere with iron absorption and may worsen anaemia in patients who are already iron deficient.
Hypokalaemia:
SMARTHERBALS HEALTHY GUT possesses potassium-binding capacity and may reduce potassium levels and may worsen hypokalaemia in patients who are already potassium deficient (see section 4.5).
Contains sugar:
Each 10 g contains 174,8 mg dextrose, 524,4 mg maltose and 786,6 mg maltotriose. Patients with rare glucose-galactose malabsorption should not take SMARTHERBALS HEALTHY GUT.
Paediatric population:
SMARTHERBALS HEALTHY GUT is not suitable for children under the age of 12 years.
4.5 Interaction with other medicines and other forms of interaction
Anticoagulant/antiplatelet medicines:
SMARTHERBALS HEALTHY GUT may enhance the effects of anticoagulant/antiplatelet medicines or herbal supplements. Concomitant use may increase the risk of bruising and bleeding (see section 4.4).
Cardiac medicines:
Caution is advised against the concomitant use of SMARTHERBALS HEALTHY GUT with cardiac medicines such as digoxin or cardiac glycoside-containing herbal supplements.
Antidiabetic medicines:
Concomitant use of SMARTHERBALS HEALTHY GUT antidiabetic medicines or herbal supplements with hypoglycaemic potential might increase the risk of hypoglycaemia. Caution is advised.
Diuretics and medicines influencing electrolyte balance:
Caution is advised for the concomitant use of SMARTHERBALS HEALTHY GUT with thiazide diuretics, coricosteroids, stimulant laxatives, horsetail, liquorice root, or other medicines or health supplements which may aggravate electrolyte imbalance. There is an increased risk of hyperkalemia when taken with potassium-sparing diuretics.
Mineral supplements:
SMARTHERBALS HEALTHY GUT can interfere with absorption of iron and zinc and may decrease the effects of these minerals. SMARTHERBALS HEALTHY GUT also has potassium-binding capacity, which may decrease the effects of potassium and cause hypokalaemia (see section 4.4).
4.6 Fertility, pregnancy and lactation
SMARTHERBALS HEALTHY GUT should not be taken during pregnancy and lactation (see section 4.3).
4.7 Effects on ability to drive and use machines
SMARTHERBALS HEALTHY GUT is unlikely to affect the ability to drive a vehicle and use machines (see section 4.8). Nevertheless, caution is advised before driving a vehicle or operating machinery until the effects of SMARTHERBALS HEALTHY GUT are known.
4.8 Undesirable effects
SMARTHERBALS HEALTHY GUT is generally well tolerated.
Immune system disorders:
Frequency unknown: hypersensitivity and/or allergic reactions.
Gastrointestinal disorders:
Frequency unknown: abdominal cramps, constipation, vomiting, and diarrhoea.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of SMARTHERBALS HEALTHY GUT is important. It allows continued monitoring of the benefit/risk balance of SMARTHERBALS HEALTHY GUT. Healthcare 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: http://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
Category and class:
D 33.7 Combination product.
Mechanism of action:
SMARTHERBALS HEALTHY GUT contains aloe and bentonite clay which promotes gastrointestinal health by supporting the stomach’s function.
Aloe is commonly used for inflammatory bowel diseases and ulcers. In colorectal mucosa in vitro aloe gel has an antioxidant effect, decreasing levels of colorectal prostaglandin E2 and interleukin 8. Anthraquinones contain a tricyclic anthracene nucleus and are cleaved to form anthrones in the colon which are responsible for potent laxative effects. Anthrones irritate mucous membranes, causing increased mucous secretion and peristalsis. They also increase fluid and electrolyte secretion into the lumen, causing a feeling of distention. The cathartic effects occur within 10 hours. Water and electrolyte reabsorption are inhibited. Aloe latex causes a loss of potassium from cells paralysing the intestinal muscles.
Bentonite clay is commonly used for various gastrointestinal issues. Montmorillonite clay possibly binds to the mucosal glycoproteins and covers the mucosa. Other possible mechanisms related to gastrointestinal health include reduced inflammation of the intestinal barrier and adsorptive properties.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Unidri 20 (enzyme converted, demineralised maltodextrin powder providing 2 % dextrose, 6 % maltose and 9 % maltotriose).
Silicon dioxide.
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
3 years.
6.4 Special precautions for storage
Store at or below 25 °C.
Store in the original packaging.
6.5 Nature and contents of container
280 g of powder packed in a white plastic tub with a green screw-on lid and a measuring scoop.
100 g of powder packed in a white plastic tub with a green screw-on lid and a measuring scoop.
10 x 10 g of powder packed in individual sachets.
6.6 Special precautions for disposal
No special requirements.
7. HOLDER OF CERTIFICATE OF REGISTRATION:
Smart Biotech (Pty) Ltd
Building 4, Albury Park, 1 Magalieszight Avenue
Dunkeld West, Johannesburg
Tel: 011 593 3199
8. REGISTRATION NUMBER
Will be allocated by SAHPRA upon registration.
9. DATE OF FIRST AUTHORISATION
Will be allocated by SAHPRA upon registration.
10. DATE OF REVISION OF THE TEXT
This leaflet was last revised in June 2024.