Berberine

Additional information

Weight	0.3 kg
Dimensions	5 × 5 × 12 cm

Benefits

• Reduces blood sugar
• Improves markers of cholesterol
• Promotes heart health
• Regulates metabolism

Supplement Facts

Serving Size:	3 Capsules
Servings per Bottle:	30 Servings
Active Ingredient per Serving:	Berberine HCL (Berberis Wilsoniae Hemsl. Extract)
Inactive Ingredients:	Microcrystalline Cellulose (MCC) (Filler), HPMC Hypromellose (Vegan Capsules)

 

• A serving equals a daily dose.
• Take one capsule, three times daily, preferably 30 minutes before food.
• Discontinue use if any adverse effects are experienced.

Patient Information Leaflet

 

PIL Genologix Berberine V1.0 

SCHEDULING STATUS

S0

 

GENOLOGIX BERBERINE- hard capsule

Active Pharmaceutical Ingredient	Quantity per capsule	Quantity per serving
Berberis aristata	333 mg	1000 mg
[root, 40:1 extract standardised to Berberine HCL 97% DHE]	13320 mg	39960 mg

Sugar free

COMPLEMENTARY MEDICINE: Health Supplement – Carotenoids

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.

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

• Keep this leaflet. You may need to read it again.
• Do not share GENOLOGIX BERBERINE with any other person.
• Ask your health care provider or pharmacist if you need more information or advice.

 

What is in this leaflet

1. What GENOLOGIX BERBERINE is and what it is used for.
2. What you need to know before you take GENOLOGIX BERBERINE.
3. How to take GENOLOGIX BERBERINE.
4. Possible side effects.
5. How to store GENOLOGIX BERBERINE.
6. Contents of the pack and other information.

 

1. What is GENOLOGIX BERBERINE used for

GENOLOGIX BERBERINE is a plant alkaloid and a source of antioxidants which support and maintain a healthy immune system. It may also aid in regulating metabolism, blood sugar and cholesterol levels.

 

2. What you need to know before you take GENOLOGIX BERBERINE

Do not take GENOLOGIX BERBERINE

• If you are hypersensitive (allergic) to Berberis aristata or any of the other ingredients of GENOLOGIX BERBERINE (listed in section 6).
• If you are suffering from hyperbilirubinemia (a condition in which there is too much bilirubin in your blood).
• If you are taking cyclosporine.

 

Warnings and precautions

Take special care with GENOLOGIX BERBERINE:

• If you are having any surgical procedure done. You should stop taking GENOLOGIX BERBERINE at least two weeks before an operation.

  

Children

Not intended for children younger than 18 years.

 

Other medicines and GENOLOGIX BERBERINE

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

Tell your doctor or pharmacist if you are currently taking:

• Antihypertensive medicines (used to treat high blood pressure) or supplements with a blood pressure-lowering effect.
• Medication that is changed by the liver. Berberine, as in GENOLOGIX BERBERINE might change how quickly the liver breaks down these medications. This could change the effects and side effects of these medications.
• Anticoagulant/ Anti-platelets (medicines that slows blood clotting). Berberine might slow blood clotting. Taking Berberine, as in GENOLOGIX BERBERINE, along with medications that also slow blood clotting might increase the risk of bruising and bleeding.
• Antidiabetic medicines (used to treat high blood sugar levels), or supplements which can influence blood sugar levels. Berberine, as in GENOLOGIX BERBERINE, might lower blood sugar. Taking it with other supplements with similar effects might lower blood sugar too much.
• Sedative medications (CNS depressants) or supplements that also have a sedative effect; Berberine might cause sleepiness and slowed breathing. Some medications, called sedatives, can also cause sleepiness and slowed breathing. Taking Berberine, GENOLOGIX BERBERINE, with sedative medications might cause breathing problems and or/ too much sleepiness.
• Tacrolimus; tacrolimus is removed from the body by the liver. Berberine, as in GENOLOGIX BERBERINE, might slow down the body’s ability to remove tacrolimus. This might increase the effects and side effects of tacrolimus.
• Probiotics; Berberine, as in GENOLOGIX BERBERINE, might kill certain probiotics. If taken together, Berberine, as in GENOLOGIX BERBERINE, might reduce how well probiotic supplements work.

 

Pregnancy, breastfeeding and fertility

Safety in fertility, pregnancy and lactation has not been established.

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before taking this medicine.

 

Driving and using machines

Berberine may cause drowsiness. Exercise caution if operating heavy machinery, driving a motor vehicle or involved in activities requiring mental alertness.

 

3. How to take GENOLOGIX BERBERINE.

Do not share your medicines with any other person.

Always take GENOLOGIX BERBERINE 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.

Adults: The usual dose is 3 capsules daily.

Children: Not intended for children younger than 18 years.

A varied diet is the most effective and safe way to achieve good nutrition, health, body composition as well as mental and physical performance.

If you take more GENOLOGIX BERBERINE 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 GENOLOGIX BERBERINE

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

4. Possible side effects

GENOLOGIX BERBERINE can have side effects.

Not all side effects reported for GENOLOGIX BERBERINE are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking GENOLOGIX BERBERINE, please consult your health care provider for advice.

 

If any of the following happens, stop taking GENOLOGIX BERBERINE and tell your doctor immediately or go to the casualty department at your nearest hospital.

• swelling of the hands, feet, ankles, face, lips and 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 reaction to GENOLOGIX BERBERINE. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following:

Frequent side effects:

• stomach pain,
• diarrhoea (loose, watery stools),
• nausea (feeling sick),
• vomiting (being sick).
• abdominal distension or bloating.

Side effect with unknown frequency:

• headache,
• increase in liver enzyme transaminase,
• muscle fatigue or muscle pain.

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

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 Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8.

By reporting side effects, you can help provide more information on the safety of GENOLOGIX BERBERINE.

 

5. How to store GENOLOGIX BERBERINE.

Store all medicines out of reach of children.

Store at or below 25 °C in a dry place.

Protect from moisture and light.

 

6. Contents of the pack and other information.

The active substance is Berberis aristata [root, 40:1 extract standardised to Berberine HCL 97% DHE]. There other ingredients are the hypromellose capsules and microcrystalline cellulose.

 

What GENOLOGIX BERBERINE looks like and contents of the pack

Clear capsules containing a yellow to orange powder.

90 capsules, packed in an appropriately labelled blue glass bottle with a metal lid.

 

Holder of Certificate of Registration

Genologix Distributors (Pty) Ltd

Unit 16 & 17 Acacia business park

73 Nguni Way

Waterfall

3610

Email: [email protected]

Tel: +27 60 532 8317

This leaflet was revised in

November 2022.

Registration

To be allocated by SAHPRA.

 

 

 

 

 

 

Important Information

SAFETY INFORMATION:

• Do not exceed recommended dose.
• Do not use if pregnant or nursing.
• Do not use if under 18 years of age as safety in children has not been established.
• If you have a known medical condition, consult your doctor before using this or any other health supplement.

WHAT’S IN THE BOX:

• 90 vegan hard capsules (Halal & Kosher) each containing 333mg of Berberine HCL (Berberis Wilsoniae Hemsl. Extract) = 30 servings of 1000mg Berberine HCL (Berberis Wilsoniae Hemsl. Extract)
• Store in a cool, dark, dry place.
• Product packaging may differ slightly from the advertised image, based on packaging availability.

DISCLAIMER:

This health supplement has not been evaluated by the SAHPRA for its quality, safety or intended use. Health supplements are intended to complement health or supplement the diet. They are not intended to be used as a treatment to cure illnesses.