Patient Information Leaflet

For Children & Adults • Non-allergenic

Enterosgel® is free from preservatives, colouring, gluten, fat, sugar, lactose, flavours and sweeteners.

Please read this Leaflet carefully before you start taking Enterosgel®. Keep this Leaflet. You may need to read it again. Always consult a Doctor or Pharmacist to check if this product is suitable for you. Do not use the Device as an alternative to the standard treatment. If symptoms persist seek further medical advice. You may require tests to check for certain symptoms before any treatment or that the device is suitable for you.

1. What is Enterosgel® and what it is used for?

Enterosgel® is an innovative intestinal absorbent with a high sorption capacity, selective sorption of medium-weight toxic metabolites. It is developed for binding toxins, allergens, pathogens and other harmful substances in the gastrointestinal tract, to help remove them from the body.
Enterosgel® is to be used as ancillary treatment to other standard management therapies for acute enteric intestinal complaints.

2. Directions for Use

Read leaflet before use.

  • Shake well before opening.
  • For children 1 to 3 years old Enterosgel® can be used under advice of a doctor. Enterosgel® should be administered orally 1–2 hours before or after a meal.

When this product is taken it is recommended to wash it down with sufficient quantity of water or dilute the dose in water of room temperature prior to its administration (in 200 ml of water for adults and children aged 7 and over, 50–100 ml of water for children aged 1–6).

Enterosgel® may affect the absorption of some medicines that are administered orally – use Enterosgel® 1–2 hours before or after taking medication. If you are taking any medication, it is recommended you consult your doctor or pharmacist prior to using Enterosgel®.

3. Contraindications

Intestinal atony (severe constipation due to bowel obstruction). Intolerance, based on prior use of ENTEROSGEL®.

4. Pregnancy and breastfeeding

Enterosgel® can be taken during pregnancy and breastfeeding. It is recommended to speak to your GP or midwife if you are unwell during pregnancy.

5. Additional information

Composition: polymethylsiloxane polyhydrate (methyIsiIicic acid hydrogel) – 70 %, water purified – 30 %.

Packaging:
Enterosgel® is an oral suspension (a soft paste that you take by mouth) and it comes in either a tube or sachet inside a carton in the following pack sizes: 90g tube, 225g tube, 15g sachet (10 sachets per pack).

Storage parameters:
Store at temperatures between 4–25 °C.
Do not freeze.
Keep out of the reach of children.

Avoid drying out after opening the package. Use this product within 30 days of opening the tube.

Shelf life:
3 years from the date of release. The expiry date is provided on the bottom flap of the carton next to the hourglass symbol.

What to do if the package is damaged:
Do not use the product if the seal has been broken, damaged or appears to have been tampered with.

6. Possible side effects

Any treatment can have side effects. Sometime they can be serious, most of the time they are not. Some common side effects that you may experience are nausea, vomiting, constipation. There may be other side effect that occur.

Enterosgel® is a patent of Swiss company Bioline Pharmaceutical

Manufacture
Bioline Products s.r.o., Krakovská 1338/10, 110 00 Prague 1, Czech Republic
tel./fax: + 420 266 317 783
e-mail: info@enterosgel.eu

Sponsor in Australia
Medsilica Australia Pty. Ltd
55 Oceano St, Copacabana, NSW 2251, Australia
Freephone: 1800 757 700
info@medsilica.com
www.medsilica.com.au

For Children & Adults
Non-allergenic

ENTEROSGEL
Medical device 0088