Each 5 ml contains Sambucus nigra (Elderberry Juice) 1.9 g
Contains sugar.

• Complementary medicine Category D – Discipline specific
• 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.

SAMBUCOL is available without a doctor’s prescription, for you to maintain your health. Never the less you still need to use SAMBUCOL carefully to get the best results from it.

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

WHAT IS IN THIS LEAFLET:

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

1. WHAT SAMBUCOL IS AND WHAT IT IS USED FOR:
   Sambucus nigra has been used to help relieve the symptoms of
   colds and flu and to help relieve nasal congestion associated
   with sinusitis and hayfever. Sambucus nigra is commonly used
   as an antioxidant that helps protect cells and reduce the
   oxidative effect of oxidative cell damage caused by free
   radicals.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SAMBUCOL:
   Do not take SAMBUCOL:

• If you are allergic (hypersensitive) to Sambucus nigra
  (Black Elderberry) or any other ingredients of SAMBUCOL
  (listed in section 6)

Warnings and precautions:
Take special care with SAMBUCOL:
Do not exceed the recommended dose.
Contains sugar which may have an effect on the glycaemic control of patients with diabetes mellitus.
Children and adolescents:
SAMBUCOL is not intended for use in children under the age of 3 years old.

Other medicines and SAMBUCOL:
Be watchful when taking Elderberry with Cytochrome P450 3
A4 (CYP3A4) substrates.
Be cautious with the combination of Elderberry & Immunosuppressants.
Elderberry seems to stimulate production of cytokines
including interleukin and tumor necrosis factor.
Theoretically, elderberry might exacerbate autoimmune disease by stimulating disease activity. Advise patients with autoimmune diseases such as multiple sclerosis, systemic
lupus erythematosus (SLE), rheumatoid arthritis (RA), or others to avoid taking elderberry.
Always tell your healthcare professional if you are taking any other medicine.

Pregnancy and Breastfeeding:
Safety during pregnancy and breastfeeding 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 health care provider for advice before taking this medicine.

Driving and using machines:
It is not always possible to predict to what extent SAMBUCOL may interfere with the daily activities of a patient. Patients should ensure that they do not engage in the above activities until they are aware of the measure to which SAMBUCOL affects them.

3. HOW TO TAKE SAMBUCOL:
   Do not share medicines prescribed for you with any other person.
   Always take SAMBUCOL 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.
   Shake well before use. SAMBUCOL can be used throughout the year when needed.
   RECOMMENDED DAILY DOSE:
   ADULTS and CHILDREN over 12 years of age: 10ml daily
   CHILDREN from 3 to 12 years old: 5ml daily
   INCREASED DOSE FOR EXTRA SUPPORT:
   ADULTS and CHILDREN over 12 years of age:
   10ml up to four times daily
   CHILDREN 3-12 YEARS:
   5ml up to four times daily
4. POSSIBLE SIDE EFFECTS:
   No known side effects have been reported. If you experience any side effects or sensitivity towards SAMBUCOL contact your doctor or pharmacist immediately.
   If symptoms or cough persists contact your doctor or pharmacist immediately.
   Reporting of suspected adverse reactions
   If you get side effects, talk to your 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 SAMBUCOL.
5. HOW TO STORE SAMBUCOL:
   Store all medicines out of reach of children.

• Store at or below 25°C.
• Store in the original container.
• Do not use after the expiry date stated 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 SAMBUCOL contains:

• The active substances are:
  Sambucus nigra (Elderberry Juice) 1.9 g [Fruit, equivalent to 2.2 g elderberry fruit]
  The other ingredients are Glucose Syrup, Black Elderberry (Sambucus nigra) Juice, Acidity Regulator: Citric Acid,
  Preservative: Potassium Sorbate. No added: lactose, yeast, dairy or artificial colours.
  
• What SAMBUCOL looks like and contents of the pack
• SAMBUCOL is a berry flavoured, thick reddish-brown liquid.
  Pack sizes of 120 ml.

Holder of Certificate of Registration
SFI South Africa (Pty) Ltd
121 Mitchell Street
George, 6529
Tel: +27 (44) 874 2927

The leaflet was last revised in March 2023.
Application number:
To be allocated.
Access to the corresponding Professional information:
Visit www.flordis.co.za