Instructions for Use (IFU)

Gastrointestinal adsorbent Enterosgel for use In acute and chronic diarrhoea.

  • Oral Suspension in tube 225 g
  • Tube 90 g
  • Sachet 15 g (10 sachets per pack)

Intended Use

Enterosgel is an oral suspension indicated for the symptomatic treatment of acute diarrhoea and chronic diarrhoea associated with Irritable Bowel Syndrome (IBS).

Mechanism of Action

Enterosgel is an oral intestinal adsorbent (enterosorbent). It is based on organic mineral with adsorption capacity towards some toxic and harmful substances in the gut (e.g. endotoxins, enterotoxins), physically binding them to its surface, reducing stool frequency and duration of diarrhoea.
Enterosgel is expelled from the body with the stool, this way eliminating the adsorbed toxins and harmful substances, which can be beneficial for treatment of indicated conditions of acute and chronic diarrhoea. Composition: polymethylsiloxane polyhydrate (methylsilicic acid hydrogel) – 70 %, purified water – 30 %. Enterosgel is free from preservatives, colouring, gluten, fat, sugar, lactose, flavours, colouring, plant or animal-derived ingredients.

Instructions for Use

Take Enterosgel treatment 2 hours before or after meal and taking oral medications. Duration of treatment with Enterosgel is 3–5 days for acute diarrhoea and up to 21 days for chronic diarrhoea. Dilute the dose in water of room temperature prior to its administration.

Duration and Dosage

For children: 

1–6 years old: 5 g (approximately 1 teaspoon or 1/3 of a sachet) diluted in 50–100 ml of water 3 times a day.

For children 1–3 years old it is advisable to consult a doctor prior to use of Enterosgel. For children Enterosgel can be suspended in the bottle feeder.

For children 7–14 years old: 10 g (approximately 2 teaspoons or 2/3 of a sachet) diluted in 50–100 ml of water 3 times a day

For children 15+ and adults: 15 g to 22.5 g (approximately 1 table spoon or 1–1,5 sachet) diluted in 200 ml of water 3 times a day. In  the  beginning  of  the  treatment  (on  Day  1)  you  can  double the first dose and then continue with a single dose after each bowel movement from 3 to 6 times a day.

Stop  the  treatment  with  Enterosgel  if  you  do  not  have bowel movement for 1–2 days, increase intake of water and continue the treatment after the next bowel movement.

During  treatment  of  chronic  diarrhoea  you  may  adjust  your dosage to suit your stool consistency and bowel movements. You can increase treatment to a double dose up to 3 times a day if your stool is loose, or reduce to a single dose once a day if your stool is normal.

Contraindications

Do not use Enterosgel if:

  • you are currently taking modified-release orally
    administrated medications.
  • you have intestinal atony (severe constipation due to
    bowel obstruction) or intestinal blockage.
  • you have intolerance based on prior use of Enterosgel.

Known Side Effects

Constipation, nausea.

Pregnancy and Breastfeeding

Enterosgel can be used during pregnancy and breastfeeding. It is advisable to consult with your healthcare professional if you are unwell during pregnancy or breastfeeding.

Precautions

Enterosgel may affect the absorption of some medicines that are administered orally – use Enterosgel 2 hours before or after taking oral medication. If you are taking any medication, you may wish to consult with your doctor or pharmacist regarding taking Enterosgel.

  • Enterosgel should be administered orally between meals.
  • In case of long-term diarrhoea it is advisable to consult a doctor to obtain the diagnose of the underlining condition before taking Enterosgel.
  • In children, treatment of diarrhoea must be accompanied by the early administration of the oral rehydration solution (ORS) to avoid dehydration.
  • In adults, it is advisable to consume ORS during the treatment with Enterosgel to assure proper rehydration.
  • If diarrhoea symptoms persist (most cases pass after 5–7 days), you should consult your doctor. If there is blood in your stools, signs of dehydration, six or more episodes of diarrhoea in the last 24 hours, diarrhoea and vomiting at the same time, or a severe or continuous stomach ache, seek medical advice especially in the case of children.
  • Do not use after expiration date.
  • Do not use if package is damaged.
  • Keep out of the reach of children.
  • Do not exceed the recommended dose.
  • Do not exceed the recommended duration of treatment and do not take together with meal to avoid possible vitamin or nutrient deficiency.
  • Please, consult your doctor if you are currently taking other intestinal adsorbents, for example treatments which contain activated charcoal, clay, kaolin. Your doctor may advise not to use them together with Enterosgel treatment.
  • Enterosgel is not indicated for use in case of acute chemical or drug poisoning or medicinal overdose.
  • For sachets: each sachet should be used only once after it is opened.  Each sachet is disposable and should be opened immediately before use. Do not reuse partially used sachets to prevent microbial  contamination.
  • For tubes: shake the tube well before opening and each use.  When  squeezing  Enterosgel  out  of  the  tube  or  a  sachet some amount of liquid may appear. Close the lid of the tube tightly after opening and after each  use to avoid drying and to prevent microbial contamination. Use tube within 30 days after opening.

Storage Instructions

  • Enterosgel should not be used after the expiry date on the package.
  • Keep out of reach of children.
  • Store Enterosgel at temperature between 4 °C and 30 °C .
  • Do not freeze.
  • Keep away from direct sunlight and heat.
  • The expiration date on the package refers to the product is unopened and when properly stored.

Disposal

There are no special disposal requirements for unused Enterosgel. It can be safely disposed into the domestic waste. Packaging can be recycled.

Packaging

Oral suspension in tube 225 g, tube 90 g, sachet 15 g (10 sachets per package).

Shelf life

Three years. Not to be used beyond the expiry date indicated on the package.

If you have any further questions about use of Enterosgel please email at info@enterosgel.eu. This instructions for use leaflet (IFU) is also available in other languages on www.enterosgel.eu