Pregnancy and Breastfeeding Probiotic for Maternal & Infant Health

Consumer Medicine Information

1. What is in the leaflet?

This leaflet answers some common questions about BioticNatal™ capsules.

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

All medicines have risks and benefits. Your doctor has weighed the risks of you taking BioticNatal™ capsules against the benefits they expect it will have for you.

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

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

2. What BioticNatal™ is used for

BioticNatal™ is a scientifically formulated multi-species probiotic for pregnancy and breastfeeding mothers that may modulate maternal intestinal, breast milk and vaginal microbiota profiles to assist with neonatal bacterial colonisation. Beneficial bacterial promote healthy gastrointestinal and immune maturation in the infant. Lactoferrin provides broad-spectrum anti-microbial and anti-viral activity that is passed on to the infant.

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

Ask your healthcare professional or pharmacist if you have any questions concerning why BioticNatal™ has been prescribed for you.

BioticNatal™ is not addictive.

3. Before you take BioticNatal™

3a) When you must not take it

Do not take BioticNatal™ if:

  1. You have had an allergic reaction to BioticNatal™, or any ingredient listed in section 8b.
  2. The packaging is torn or shows signs of tampering.
  3. The expiry date (EXP) printed on the pack has passed.
    If you take this supplement after the expiry date has passed, it may not work as well.

If you are not sure if you should start taking BioticNatal™ contact your healthcare professional or pharmacist.

Do not give BioticNatal™ to children.

There is limited information on the use of BioticNatal™ in children.

3b) Before you start to take it

You must tell your doctor if:

  1. You have any allergies to any other medicines, foods, preservatives, dyes or additives.
    BioticNatal™ contains Cellulose-Microcrystalline, Silica and Magnesium Strearate.
    If you experience any allergic reaction or other side effects after consuming BioticNatal™ you should discontinue use and consult with your healthcare professional or pharmacist. If you should discontinue use and consult with your healthcare professional or pharmacist.
  2. You have or have had any other health problems or issues including:
  • Stomach or bowel disease
  • Compromised immune system (HIV/ AIDS or during cancer treatment)
  • Short bowel syndrome

If you have not told your healthcare professional or pharmacist about any of the above, tell them before you start taking BioticNatal™.

3c) Taking other medicines

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

Tell your healthcare professional or pharmacist if you are taking either of the following:

  • Immunosuppressant Drugs
  • Antibiotics

Some medicines may be affected by BioticNatal™, or may affect how well it works. You may need to take different amounts of your medicine, or you may need to take different medicines. Your doctor will advise you.

Your healthcare professional or pharmacist has more information on medicines to be careful with or avoid while taking BioticNatal™.

Ask your healthcare professional or pharmacist if you are not sure about this list of medicines.

4. How to take BioticNatal™

4a) How much to take

Follow all directions given to you by your healthcare professional or pharmacist carefully.

Take BioticNatal™ exactly as your healthcare professional or pharmacist has prescribed.

They may differ from the information contained in this leaflet.

4b) How much BioticNatal™ should be taken?

Take one (1) capsule, one (1) to two (2) times per day, or as directed by your healthcare practitioner.

Your healthcare professional or pharmacist will tell you how many BioticNatal™ capsules to take each day. This depends on the condition being treated and whether any other medicines are being used.

4c) How to take BioticNatal™

Capsules should be swallowed whole with water daily before meals.

Capsules can be broken open and put on cold foods. Consult with your healthcare practitioner or pharmacist if you are unsure.

Do not take any capsules that are damaged.

4d) When to take BioticNatal™

Before meals, unless otherwise advised by your healthcare practitioner.

4e) How long to take BioticNatal™

Take BioticNatal™ as long as your healthcare practitioner or pharmacist prescribes.

4f) If you forget to take BioticNatal™

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

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

If it is almost time for your next dose, skip the dose you missed and take 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 taken too much BioticNatal™ (overdose)

Visit your healthcare professional or pharmacist as soon as possible. Tell them how much BioticNatal™ you took and he/she can determine what action is best for your health. Please visit your healthcare professional or pharmacist even if there are no signs of discomfort or poisoning.

5. While you are taking BioticNatal™

5a) Things you MUST do:

If you are about to start taking a new medicine, tell your healthcare professional or pharmacist that you are taking BioticNatal™.

If you are planning to have surgery, including dental surgery, tell your healthcare professional or pharmacist that you are taking BioticNatal™.

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

5b) Things you MUST NOT do

Do not heat BioticNatal™ or add into hot foods.

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

5c) Things to be careful of

As BioticNatal™ contains probiotic strains, taking antibiotics along with probiotics can reduce the effectiveness.

To avoid this interaction take BioticNatal™ 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. You 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
  • Swollen or bloated stomach area
  • Gas
  • Discomfort in the upper stomach area

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

Serious allergic reactions to these ingredients are rare; however tell your healthcare professional or pharmacist immediately if you experience any of the following:

  • Skin rash
  • Swelling of the face and/or throat
  • Difficulty breathing
  • Itching of the skin

7. After taking BioticNatal™

7a) Storage

Keep BioticNatal™ in its bottle until it is time to take it. If you take the capsules out of the bottle they may not keep well.

Always store BioticNatal™ only in its original container.

Keep BioticNatal™ refrigerated. Do not freeze.

Do not store BioticNatal™, 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.

Protect BioticNatal™ from light.

8. Product description

8a) What BioticNatal™looks like

BioticNatal™ is a hard clear capsule.

BioticNatal™ is packed in a recyclable plastic bottle with a safety seal over the cap.

BioticNatal™ is available in bottles containing 60 capsules.

8b) Ingredients

Active ingredients

Bifidobacterium infantis (Med 14) 2 billion

Bifidobacterium longum (Med 15) 2 billion

Lactobacillus rhamnosus (Med 26) 2 billion

Streptococcus thermophilus (Med 51) 2 billion

Saccharomyces cerevisiae ssp. boulardii (Med 41) 2 billion

Lactoferrin 100 mg

Inactive ingredients
Cellulose-Microcrystalline, Silica, Magnesium Strearate.

The capsule shell contains
Vegetable Hydroxypropyl Methycellulose

BioticNatal™ is suitable for vegetarians.

BioticNatal™ is derived from cow's milk.

9. Translation

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

10. Manufacturer

BioticNatal™ is supplied in Australia by:

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

BioticNatal™ is supplied in Northern America by:

A division of InMed Technologies™
Suite 400, 29883 Santa Margarita Pkwy
Rancho Santa Margarita CA 92688
Toll free 1800 921 1710

Australian Listing Number
AUST L 260283

This Leaflet was prepared in November 2015.

Last Updated November 2015.

Medlab Clinical Limited™

Published by MIMS July 2016

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