PATIENT INFORMATION LEAFLET

SCHEDULING STATUS [S0]

SMARTHERBALS: HEALTHY GUT powder.

Aloe and bentonite clay.

Contains sugar. Each 10 g contains 174,8 mg dextrose, 524,4 mg maltose and 786,6 mg maltotriose.

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.

Read all of this leaflet carefully because it contains important information for you

SMARTHERBALS: HEALTHY GUT is available without a doctor’s prescription, for you to maintain your health. Nevertheless, you still need to use SMARTHERBALS: HEALTHY GUT carefully to get the best results from it.

Do not share SMARTHERBALS: HEALTHY GUT with any other person.
Ask your healthcare provider or pharmacist if you need more information or advice.
You must see a doctor if your symptoms worsen or do not improve after 7 days.

What is in this leaflet

1. What SMARTHERBALS: HEALTHY GUT is and what it is used for.

2. What you need to know before you take SMARTHERBALS: HEALTHY GUT.

3. How to take SMARTHERBALS: HEALTHY GUT.

4. Possible side effects.

5. How to store SMARTHERBALS: HEALTHY GUT.

6. Contents of the pack and other information.

1. What SMARTHERBALS: HEALTHY GUT is and what it is used for

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.

2. What you need to know before you take SMARTHERBALS: HEALTHY GUT

Do not take SMARTHERBALS: HEALTHY GUT:
If you are hypersensitive (allergic) to any of the active or other ingredients of SMARTHERBALS: HEALTHY GUT (listed in section 6).
If you are pregnant or breastfeeding (see Pregnancy and breastfeeding)
If you have abnormal narrowing of the gastrointestinal tract, potential or existing intestinal blockage, faecal impaction (a large, hard mass of stool that gets stuck in your colon), lack of normal muscle tone in the bowel, inflammation of the appendix, inflammatory colon disease such as Crohn's disease or ulcerative colitis, abdominal pain of unknown origin, undiagnosed rectal bleeding, nausea, vomiting, diarrhoea, or fever.
If you are severely dehydrated.

Warnings and precautions

Take special care with SMARTHERBALS: HEALTHY GUT:

SMARTHERBALS: HEALTHY GUT should be discontinued at least 2 weeks before surgical procedures, especially if you have a bleeding disorder.

If you have any kidney problems.
If you have problems with your stomach.
If you have low levels of iron in your blood (determined by a blood test).
If you have low potassium levels in your blood (determined by a blood test).

Children and adolescents

SMARTHERBALS: HEALTHY GUT is not suitable for children under the age of 12 years.

Other medicines and SMARTHERBALS: HEALTHY GUT

Always tell your healthcare provider if you are taking any other medicine. (This includes all complementary or traditional medicines.)

Tell your doctor or pharmacist if you are currently taking:

Anticoagulant/antiplatelet medicines (used to thin your blood), or herbal supplements with blood thinning effects.
Heart medicines.
Antidiabetic medicines (used to treat diabetes / high blood sugar) or herbal supplements that lower blood sugar levels.
Medicines or supplements that may cause or worsen electrolyte imbalance, such as water tablets, corticosteroids (used to treat inflammation), liquorice root or laxatives.
Mineral supplements containing iron and zinc.

Pregnancy and breastfeeding

Do not take SMARTHERBALS: HEALTHY GUT if you are pregnant or breastfeeding (see Do not take SMARTHERBALS: HEALTHY GUT)

Driving and using machines

SMARTHERBALS: HEALTHY GUT is unlikely to affect your ability to drive a vehicle and use machines. However, it is not always possible to predict to what extent SMARTHERBALS: HEALTHY GUT may interfere with your daily activities. Do not drive or operate machinery until you know how SMARTHERBALS: HEALTHY GUT affects you.

SMART HERBALS: HEALTHY GUT contains sugar

Each 10 g contains 174,8 mg dextrose, 524,4 mg maltose and 786,6 mg maltotriose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking SMARTHERBALS: HEALTHY GUT.

3. How to take SMARTHERBALS: HEALTHY GUT

Always take SMARTHERBALS: HEALTHY GUT exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

1 scoop or sachet (10 g) daily mixed in a glass of water or juice.

Consult your healthcare provider for use longer than 7 days.

Consult your healthcare provider if your symptoms persist or worsen.

Do not exceed the recommended daily dose.

If you take more SMARTHERBALS: HEALTHY GUT than you should

In the event of an overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to take SMARTHERBALS: HEALTHY GUT

Take your next dose at the normal time.

Do not take a double dose to make up for individual forgotten doses.

4. Possible side effects

SMARTHERBALS: HEALTHY GUT can have side effects.

Not all side effects reported for SMARTHERBALS: HEALTHY GUT are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking SMARTHERBALS: HEALTHY GUT, please consult your healthcare provider for advice.

If any of the following happens, stop taking SMARTHERBALS: HEALTHY GUT and tell your doctor immediately or go to the casualty department at your nearest hospital:

Swelling of your hands, feet, ankles, face, lips, mouth, or throat, which may cause difficulty in swallowing or breathing.
Rash or itching.
Fainting.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to SMARTHERBALS: HEALTHY GUT. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following:

Frequency unknown:

Stomach cramps, constipation (inability to pass stools), vomiting (being sick) and diarrhoea (loose stools).

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist. You can also report side effects 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.

By reporting side effects, you can help provide more information on the safety of SMARTHERBALS: HEALTHY GUT.

5. How to store SMARTHERBALS: HEALTHY GUT

Store at or below 25 °C.
Store in the original packaging.
KEEP OUT OF REACH OF CHILDREN.
Do not use after the expiry date printed on the container.
Return all unused medicine to your pharmacist.
Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).

6. Contents of the pack and other information

What SMARTHERBALS: HEALTHY GUT contains

Each 10 g contains:

Aloe ferox Mill. (Aloe) [leaf powder] 832,5 mg

Montmorillonite (Bentonite clay) [powder] 417,5 mg

The other ingredients are Unidri 20 (enzyme converted, demineralised maltodextrin powder providing 2 % dextrose, 6 % maltose and 9 % maltotriose), aerosil and magnesium stereate.

What SMARTHERBALS: HEALTHY GUT looks like and contents of the pack

Fine, light brown powder.

280-g/100-g tub: 280 or 100 g of powder packed in a white plastic tub with a green screw-on lid and a measuring scoop.

100-g pouch: 100 g of powder packed in a resealable pouch with a clear window

10x 10-g sachets: 10 g of powder packed in a sachet, packed in a paper box

Holder of Certificate of Registration:

Smart Biotech (Pty) Ltd

Building 4, Albury Park, 1 Magalieszight Avenue

Dunkeld West, Johannesburg

Tel: 011 593 3199

This leaflet was last revised in

June 2024

Registration number

Will be allocated by SAHPRA upon registration.

Access to the corresponding Professional Information