Bone Balance

Patient Information

PATIENT INFORMATION LEAFLET – click here for Afrikaans

SCHEDULING STATUS: Unscheduled.

Category D: Complementary medicine.

Discipline: Health supplement

D33.12: Multiple substance formulation

PROPRIETARY NAME, STRENGTH, AND PHARMACEUTICAL FORM

BONE BALANCE , 30 Tablets

READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU

• BONE BALANCE  is available without a doctor’s prescription.
• Nevertheless, you still need to use BONE BALANCE  carefully to get the best results from it.
• Keep this leaflet.  You may need to read it again.
• Do not share BONE BALANCE  with any other person.
• Ask your pharmacist or healthcare practitioner if you need more information or advice.

WHAT IS IN THIS LEAFLET

• What is BONE BALANCE and what it is used for.
• What do you need to know before you take BONE BALANCE.
• How is BONE BALANCE taken.
• Possible side effects.
• How to store BONE BALANCE.
• Contents of the pack and other information.

WHAT BONE BALANCE CONTAINS

Each 1 tablet of BONE BALANCE contains the following actives:

Other ingredients:

Calcium phosphate

Magnesium stearate

Cellulose

Povidone K30

Orange coating material.

Contains no animal products. 

Free from: Gluten, wheat, salt, sugar, dairy, soya, yeasts, preservatives, artificial flavours.

SUITABLE FOR VEGANS.

WHAT BONE BALANCE  IS USED FOR

BONE BALANCE is formulated to assist with the development and maintenance of normal bones, teeth and heart health.

BEFORE YOU TAKE BONE BALANCE 

Do not take BONE BALANCE  if you are hypersensitive (allergic) to any of the ingredients.

This medicine has not been evaluated by SAHPRA for quality, safety, or intended use. This   medicine is not intended to diagnose, treat, cure or prevent any disease.

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 healthcare practitioner before using this medicine.

TAKING OTHER MEDICINES WITH BONE BALANCE 

Always tell your healthcare provider if you are taking any other medicine.

HOW TO TAKE BONE BALANCE 

Do not share medicines prescribed for you with any other person. Always take BONE BALANCE  exactly as described in this leaflet, or as your doctor, healthcare provider has instructed you.  You should check with your doctor, pharmacist or healthcare provider if you are unsure.

Directions for use:  Adults: 1 tablet per daiy or as directed by your health practitioner.

Never exceed dosage. Take after a meal.

Not suitable for use by Children.

IF YOU TAKE MORE BONE BALANCE  THAN YOU SHOULD

In the event of overdosage, consult your doctor, pharmacist.  Should none of these be available, contact the nearest hospital or poison control centre.

IF YOU FORGET TO TAKE BONE BALANCE 

Do not take a double dose to make up for a missed dose.

POSSIBLE SIDE EFFECTS

BONE BALANCE  may have side effects.

If you have been diagnosed with kidney disease, high blood pressure, bleeding disorder, restless leg syndrome, diabetes, liver diesease, or have a hormone sensitive condition, consult your healthcare professional for advice before use.

Should you be taking any of the following medication, do not take before consulting your healthcare practitioner before use: antibiotics, diurectics, lithium, antacids, blood thinning medication, blood pressure medication and medicine for diabetes.

If any of the following happens, stop using BONE BALANCE  and tell your doctor or go to the casualty department at your nearest hospital:

• Upset stomach, nasea, vomiting
• Diarrhoea, constipation, and stomach pain

These are all serious effects. If you have them, you may have had a serious reaction to BONE BALANCE . You may need urgent medical attention.

Not all side effects reported for BONE BALANCE  are included in this leaflet.

Should your general health worsen or if you experience any untoward effects while taking this medicine, please consult your doctor, pharmacist or other healthcare professional for advice. If you notice any side effects not mentioned in this leaflet, please inform your doctor, pharmacist or healthcare professional.

REPORTING OF SIDE EFFECTS

If you get side effects, talk to your doctor, pharmacist or other healthcare professional.  You can also report side effects to SAHPRA via “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 BONE BALANCE.

STORAGE AND DISPOSING OF BONE BALANCE 

Store all medicines out of the reach of children.

Store in a cool, dark place, below 25 °C.

Protect from direct sunlight and heat.

Store in the original packaging.

Keep the bottle tightly closed.

Replace the protective cap after each use.

Do not use after the expiry date stated on the bottle/packaging.

Do not use BONE BALANCE  if you notice visible signs of deterioration.

Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).

PRESENTATION OF BONE BALANCE 

Product is presented in a bottle, with a black lid and a branded label.

IDENTIFICATION OF BONE BALANCE 

Orange coloured coated tablet

REGISTRATION NUMBER

TBA.

NAME AND ADDRESS OF REGISTRATION HOLDER

Manufactured for:

Whole Again Nutriceuticals (Pty) Ltd

PostNet Suite 216

Private Bag X1

Melrose Arch

2076

Phone no:  010 109 6177

Email :  info@whole-again.co.za

www.whole-again.co.za

Applicant:

Sparta Pharmaceuticals (Pty) Ltd

20 Plane Road,

Spartan,

Kempton Park,

1619

ACCESS TO THE CORRESPONDING PROFESSIONAL INFORMATION

See information on the website above.

THIS LEAFLET WAS LAST REVISED ON

24th October 2022.