Consumer medicine information

Biotic Jnr.

Bifidobacterium infantis; Bifidobacterium lactis; Bifidobacterium longum; Bovine lactoferrin; Lactobacillus rhamnosus

BRAND INFORMATION

Brand name

Biotic Jnr

Active ingredient

Bifidobacterium infantis; Bifidobacterium lactis; Bifidobacterium longum; Bovine lactoferrin; Lactobacillus rhamnosus

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Biotic Jnr..

1. What is in the leaflet

This leaflet answers some common questions about Biotic Jnr.™ powder.

It does not contain all of the available information. It does not take the place of talking to a healthcare professional or pharmacist.

All medicines and supplements have risks and benefits. A healthcare professional or pharmacist has weighed the risks of infants or children taking Biotic Jnr.™ powder against the benefits they expect it will have for them.

If you have any concerns about this supplement, ask your healthcare professional or pharmacist.

Keep this leaflet with the supplement. You may need to read it again.

2. What Biotic Jnr.™ is used for

Biotic Jnr.™ is a formulated multi-species probiotic preparation to support gastrointestinal and immune maturation.

Biotic Jnr.™ may assist in the management of allergies including eczema and helps to maintain healthy digestive function.

Biotic Jnr™ contains Glycomax™ Lactoferrin that is naturally found in colostrum and human milk and is a component of the innate immune response providing broad-spectrum anti-microbial and anti-viral activity. The selected probiotic species have demonstrated safety and efficacy for numerous health benefits in infants, both preterm and full-term.

The probiotic species have demonstrated ability to maintain healthy digestive function, growth, development and immunological tolerance.

Your healthcare professional or pharmacist may have prescribed Biotic Jnr.™ for another reason.

Ask your healthcare professional or pharmacist if you have any questions concerning why Biotic Jnr.™ as been prescribed.

Biotic Jnr.™ is not addictive.

3. Before Biotic Jnr.TM is given™

3a) When Biotic Jnr.™ MUST NOT be given

Do not give Biotic Jnr.™ if:

  1. Your baby has had an allergic reaction to Biotic Jnr.™ or any ingredient listed in section 8b.
  2. The packaging is torn, missing or shows signs of tampering.
  3. The expiry date (EXP) printed on the pack has passed. If it has expired or is damaged, return it to a pharmacist for disposal.

If this supplement is given after the expiry date has passed, it may not work as well.

If you are not sure when Biotic Jnr.™ should be given contact a healthcare professional or pharmacist.

3b) Before Biotic Jnr.™ is given

You must tell your doctor if:

  1. Your child has any allergies to any other medicines, foods, preservatives, dyes or additives.
    Biotic Jnr.™ contains five probiotic species and lactoferrin which is derived from whey. It contains less than 0.1% of lactose and does not contain casein.
    If your child experiences any allergic reaction or other side effects after consuming Biotic Jnr.™ discontinue use and consult with a healthcare professional or pharmacist.
  2. They have or have had any of the following:
    - Antibiotic treatment
    - Colic
    - Rotavirus
    - Diarrhoea and/or vomiting
    - Atopic Eczema (allergic dermatitis)
    - Necrotising Enterocolitis

If you have not told your healthcare professional or pharmacist about any of the above, tell them before giving Biotic Jnr.™ to your child.

3c) Giving other medicines

Tell your healthcare professional or pharmacist if your child is taking any other medicines, including any that you get without a prescription from a naturopath, supermarket, health food store or pharmacy.

Healthcare professionals and pharmacists have more information on medicines to be careful with or avoid while giving Biotic Jnr.™.

4. How to give Biotic Jnr.™

4a) How much to give

Follow all directions given by the healthcare professional or pharmacist carefully.

Give Biotic Jnr.™ exactly as your healthcare professional or pharmacist has prescribed. They may differ from the information contained in this leaflet.

4b) How much Biotic Jnr™ should be given

Add 500 mg (1 scoop) to warm or cool liquids or solid food, one (1) to two (2) times per day or as described by the healthcare practitioner.

Your healthcare professional or pharmacist will tell you how much Biotic Jnr.™ powder to give each day. This depends on the condition being treated and whether any other medicines are being used.

4c) How to give Biotic Jnr.™

Powder should be stirred into cooled or slightly warm liquids or foods.

4d) When to give Biotic Jnr.™

Before meals, or otherwise prescribed by the healthcare professional.

4e) How long to give Biotic Jnr.™

Give Biotic Jnr.™ as long as the healthcare professional prescribes.

4f) If you forget to give Biotic Jnr.™

Do not try to make up for missed doses by giving an extra dose.

This may increase the chance of getting an unwanted side effect.

If it is almost time for the next dose, skip the dose you missed and give the next dose when you are meant to.

If you are unsure of what to do, check with your healthcare professional or pharmacist.

4g) If you have given too much Biotic Jnr.™ (overdose)

Visit your healthcare professional or pharmacist as soon as possible. Tell them how much Biotic Jnr.™ you have administered and they can determine what action is best. Please visit your healthcare professional or pharmacist if there are signs of discomfort or poisoning.

5. While you are giving Biotic Jnr.™

5a) Things you MUST do

If your child is about to start a new medicine, you must tell your healthcare professional or pharmacist they are being given Biotic Jnr.™

Always follow your healthcare professional or pharmacist’s instructions carefully.

5b) Things you MUST NOT do

Do not heat Biotic Jnr.™ or add it into hot foods.

Do not expose Biotic Jnr.™ to extreme heat conditions for extended periods of time.

5c) Things to be careful of

As Biotic Jnr.™ contains probiotic species, taking antibiotics along with probiotics can reduce their effectiveness. To avoid this interaction give Biotic Jnr.™ at least 2 hours before or after antibiotics.

You should discuss this with your healthcare professional.

6. Side effects

All medicines can have side effects. Sometimes they are serious, most of the time they are not. Do not be alarmed by this list of possible side effects. They may not experience any of them.

Ask your healthcare professional or pharmacist to answer any questions you may have.

Tell your healthcare professional or pharmacist if you notice any of the following and they worry you:

  • Cramps or pain in the stomach area
  • Constipation
  • Diarrhoea
  • Mucus in the stool
  • Bloated stomach area
  • Gas

These side effects are usually mild and dose related. Most of them disappear completely in a few days after the dose of Biotic Jnr.™ is lowered or stopped.

If symptoms persist consult your healthcare practitioner. If diarrhoea persists for more than 6 hours in infants under 6 months; 12 hours in children under 3 years; 24 hours in children aged 3 - 6 years or 48 hours in children over 6 years and adults, seek medical advice.

7. After giving Biotic Jnr.™

7a) Storage

Keep Biotic Jnr.™ in its bottle until it is time to use. If you take the powder out of the bottle before use, it may not keep well.

Always store Biotic Jnr.™ only in its original container. Store below 25°C. Recommended to keep refrigerated. Do not freeze.

Do not store Biotic Jnr.™, or any other medicine, in a bathroom or near a sink.

Do not leave it in the car or on windowsills. Heat and dampness can destroy the medicine.

Keep out of reach of children.

Protect Biotic Jnr.™ from light.

8. Product description

8a) What Biotic Jnr.™ looks like

Biotic Jnr.™ is an off-white powder. It is in a white cylinder bottle and each container holds 60 g of powder (120 doses).

8b) Ingredients

Active Ingredients per 500 mg (1 scoop) dose:

Bifidobacterium infantis (Med 14) - 500 million
Bifidobacterium longum (Med 15) - 500 million
Lactobacillus rhamnosus (Med 26) - 500 million
Streptococcus thermophilus (Med 51) - 500 million
Saccharomyces cerevisiae ssp. boulardii (Med 41) - 500 million
Glycomax™ Lactoferrin - 50 mg

Excipient Ingredients:

Inulin

Biotic Jnr.™ does not contain any artificial colours, flavour or sweeteners.

Biotic Jnr.™ is suitable for vegetarians.

Biotic Jnr.™ is gluten and casein free.

Lactoferrin in Biotic Jnr.™ is derived from whey and contains less than 0.1% lactose.

Biotic Jnr.™ is suitable 0-3 years.

Biotic Jnr.™ is suitable for breast-fed or formula fed infants.

9. Translation

To read this information in other languages go to www.medlab.co/translate.

10. Manufacturer

Biotic Jnr.™ is supplied in Australia by:

A division of Medlab Clinical Limited™
66 McCauley Street
Alexandria NSW 2015
Toll free: 1300 369 570

Australian Listing Number
AUST L 239097

This Leaflet was prepared in May 2015.

Last Updated May 2015.

Medlab Clinical Limited™



Published by MIMS November 2015

BRAND INFORMATION

Brand name

Biotic Jnr

Active ingredient

Bifidobacterium infantis; Bifidobacterium lactis; Bifidobacterium longum; Bovine lactoferrin; Lactobacillus rhamnosus

Schedule

Unscheduled