EUROBIOL 12500 U/dose Glé Fl/20g

Pancreas powder of porcine origin............................................................................................152,250 mg*

For a dose of 30 granules per dosing spoon.

*Quantity corresponding to:

Lipolytic activity:....................................................................................................................12 500 U Ph Eur.

Amylolytic activity.................................................................................................................11 250 U Ph. Eur.

Proteolytic activity......................................................................................................................625 U Ph. Eur.

In patients not controlled with a gastro-resistant formulation at the recommended doses, treatment of exocrine pancreatic insufficiency in adults and children in the course of:

• cystic fibrosis;

• documented chronic pancreatitis (notably evidenced by the existence of pancreatic calcifications), in the presence of steatorrhea ≥ 6 g/24h;

• monitoring after cephalic or total pancreatic resections.

Dosage

The optimal dosage must be sought and adjusted over time, according to the patient's diet and digestive status, that is to say the number of stools and steatorrhea.

The usual daily dosage is:

• Infant/child: 1 dosing spoon of 30 granules per meal or more depending on the pancreatic involvement.

• Adult: 8 to 12 dosing spoons of 30 granules per day.

Method of administration

EUROBIOL 12500 U/dose, granules must be administered during meals: full dose for main meals and half dose for snacks.

The granules may be mixed into a lukewarm or cold food; they may be dissolved in water, optionally sparkling.

It is important to maintain good hydration of patients, particularly during hot weather.

Hypersensitivity to the active substance or to any of the excipients listed in section Composition.

Special warnings

Colonic strictures have been observed abroad, in children with cystic fibrosis, when high daily doses of pancreatic extracts, presented in gastro-resistant form, were used. The doses were in all cases at least 4 times higher than the doses usually recommended in France (see section Adverse effects).

It is necessary to ensure steatorrhoea ≥ 6 g/24h before prescribing EUROBIOL 12500 U/dose, granules during documented chronic pancreatitis.

Hepatitis E virus infection

Despite the measures taken during manufacturing to reduce the risk, the presence of hepatitis E virus (HEV) in medicines containing pancreatic powder extracts of animal (porcine) origin is possible.

A cross-sectional study suggested a higher HEV seroprevalence in patients with cystic fibrosis using pancreatic enzyme replacement therapy than in people not using pancreatin. This study has important limitations, including uncertainty regarding the timing of past infection, as well as the possibility of other sources of HEV. As a precaution, immunosuppressed patients receiving high daily doses must be informed of the symptoms of viral hepatitis and consult a doctor if such symptoms occur.

Special precautions for use

This medicine is strongly dosed in lipase; therefore, in some people, the dose should be increased very gradually when starting treatment because of the risk of severe constipation in case of overdose.

The recommended dose may sometimes be increased on medical prescription depending on the severity of exocrine pancreatic insufficiency. In all cases, the dose of 10 000 units of lipase/kg/day must never be exceeded in children (i.e. 0,8 spoonful/kg/day; example: for a child of 10 kg, do not exceed 8 spoonfuls of 30 granules per day), and 250 000 units of lipase/day in adults (i.e. 20 spoonfuls of 30 granules per day).

Digestive disorders may occur in subjects with hypersensitivity to pancreatic extracts.

Particular vigilance is required in subjects with cystic fibrosis who have had meconium ileus, intestinal resection, or manifestations equivalent to late ileus.

No interaction studies have been performed.

Pregnancy

There is no reliable data on teratogenicity in animals.

In clinical practice, there are currently no sufficiently relevant data to assess a possible malformative or foetotoxic effect of EUROBIOL 12 500 U/dose, granules when administered during pregnancy.

The use of EUROBIOL 12500 U/dose, granules, during pregnancy should only be considered if necessary.

Breast-feeding

There are no data on the passage of pancreatic extracts into breast milk. However, due to the absence of expected side effects in the newborn, this medicine may be prescribed during breastfeeding.

Fertility

There are no data on the effects of pancreatic extracts on fertility. No effect is expected since pancreatic enzymes are not absorbed from the gastrointestinal tract.

EUROBIOL 12500 U/dose, granules has no or negligible effect on the ability to drive vehicles and use machines.

The following undesirable effects are classified by organ system class and may occur with an unknown frequency (cannot be estimated from the available data).

* Colonic strictures have been observed abroad, in children with cystic fibrosis, when high daily doses of pancreatic extracts, presented in gastro-resistant form, were used. The doses were in all cases higher by at least 4 times than the doses usually recommended in France (see section Warnings and precautions).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Centres of Pharmacovigilance - Website: https://signalement.social-sante.gouv.fr/.

Extremely high doses of pancreatin have been associated with hyperuricosuria and hyperuricaemia.

In children, risk of severe constipation.

Pharmacotherapeutic class: Enzymatic preparations (A: alimentary tract and metabolism), ATC code: A09AA02.

Pancreatic enzymes act as catalysts in the breakdown of fats into monoglycerides, glycerol and free fatty acids, of proteins into peptides and amino acids, and of starches into dextrins and sugars. Therefore, EUROBIOL 12500 U/dose, granules replaces the digestive enzymes physiologically secreted by the pancreas, and thus ensures digestion by compensating for exocrine pancreatic insufficiency.

A study in vitro Use with EUROBIOL 12500 U/dose, granules has shown a pH-dependent activity of pancreatic preparations and immediate release of the enzymes at pH values  low (from pH 4.5).

In addition, the components of EUROBIOL 12500 U/dose, granules are proteins and, as such, undergo proteolytic digestion throughout the gastrointestinal tract before being absorbed as peptides and amino acids.

Preclinical data have not shown repeated-dose toxicity.

No animal reproduction and developmental toxicity study has been performed with EUROBIOL 12 500 U/dose, granules.

No study in juvenile animals has been performed with EUROBIOL 12 500 U/dose, granules.

The components of EUROBIOL 12 500 U/dose, granules are physiological-type substances that are not absorbed intact by the gastrointestinal tract. Therefore, significant systemic effects are unlikely.

3 years.

No special precautions for storage.

No special requirements.

• Indication(s) appearing in the marketing authorisation at the date of publication of this decree