EUROBIOL 25 000 U Gél gastro-rés Fl/100+bouch pres

Gastro-resistant hard capsule.

Pancreatin powder of porcine origin*.................................................................................................244– mg

Per capsule

*Quantity corresponding to an enzymatic activity of:

Lipolytic activity......................................................................................................................25 000 U Ph. Eur

Amylolytic activity.................................................................................................at least 18 750 U Ph. Eur

Proteolytic activity..................................................................................................at least 1 125 U Ph. Eur

Excipients:

Treatment of exocrine pancreatic insufficiency in adults and children in the course of:

• cystic fibrosis;

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

• 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:

• infants up to 18 months: 2 capsules

• children: 4 capsules

• adults: 6 capsules

Method of administration

EUROBIOL 25 000 U, gastro-resistant capsule must be administered during meals: full dose for main meals and half dose for snacks.

The capsules may be opened in children unable to swallow them and in infants. Care should be taken not to chew the microgranules and to administer them in a non-alkaline medium (orange juice for example) so as to avoid premature disintegration. It is also recommended to open the capsules in case of gastrectomy.

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).

Stéatorrhoea ≥ 6 g/24 h should be checked before prescribing EUROBIOL 25 000 U, gastro-resistant capsule in documented chronic pancreatitis.

The risk of infectious disease due to transmission of infectious agents cannot be completely ruled out when administering medicines containing pancreatic powder extracts of animal origin.

Porcine parvovirus may be present in these extracts. However, this virus is not recognised as transmissible to humans or pathogenic for them.

Detection of porcine parvovirus in pancreatic powder extracts may indicate the possible presence of other viruses of animal origin, but no case of infectious disease transmission has been reported with these medicines, although they have been used for a long time.

The potential viral risk appears much lower than the therapeutic benefit of this medicine in the indication of documented exocrine pancreatic insufficiency, notably cystic fibrosis.

Hepatitis E virus infection

Despite the measures taken during manufacturing to reduce the risk, the presence of hepatitis E virus (HEV) in medicines containing powder extracts of animal (porcine) pancreas 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 as to the timing of past infection, as well as the possibility of other HEV sources. 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.

Precautions for use

This specialty is strongly dosed in lipase; therefore, in some people, the dose should be increased very gradually when starting treatment due to 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. 0,4 capsule/kg/day; example: for a child of 10 kg, do not exceed 4 capsules per day), and 250 000 units of lipase/day in adults (i.e. 10 capsules per day).

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

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

No interaction studies have been performed.

Pregnancy

There is no reliable data on teratogenicity in animals.

Clinically, there are currently no sufficiently relevant data to assess a possible malformative or foetotoxic effect of EUROBIOL 25 000 U, gastro-resistant capsule when administered during pregnancy.

The use of EUROBIOL 25 000 U, gastro-resistant capsule 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 25 000 U, gastro-resistant capsule 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).

MedDRA system organ class	Frequency not known
Gastrointestinal disorders	Abdominal pain, nausea, vomiting, constipation, diarrhoea, colonic strictures*
Skin and subcutaneous tissue disorders	Rash, pruritus, urticaria
Immune system disorders	Hypersensitivity reaction

* 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. In all cases the doses were at least 4 times higher 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, ATC code: A09AA02.

The presentation of EUROBIOL 25 000 U, gastro-resistant capsule, in the form of a gastro-resistant capsule, protects the pancreatic enzymes from gastric acidity. The enzymatic activity can thus be released at the duodeno-jejunal level.

The micro-tablets remain stable in an acidic medium at a pH below 5,5. They disintegrate at the duodeno-jejunal level.

No treatment-related effect was found in a repeated-dose toxicity study of 28 days conducted in rats that received EUROBIOL 25 000 U, gastro-resistant capsule, orally.

No animal study of reproductive and developmental toxicity has been conducted with EUROBIOL 25 000 U, gastro-resistant capsule.

No study in juvenile animals has been conducted with EUROBIOL 25 000 U, gastro-resistant capsule.

The components of EUROBIOL 25 000 U, gastro-resistant capsule are physiological-type substances that are not absorbed intact by the gastrointestinal tract. Therefore, significant systemic effects are unlikely.

Glass bottle presentation: 3 years.

Other presentations: 2 years.

After opening, the product must be used within 4 months.

Store at a temperature not exceeding 25°C, protected from moisture.

No special requirements.

List I

Marketing authorisation (AMM)

CIP 3400955988939 (Blister/100). CIP 3400930303337 (Bottle/100+child-resistant cap).

Price:

31,39 euros (Bottle/100+child-resistant cap).

Social Security reimbursement at 65% (Bottle/100+child-resistant cap) in the indications:

• Indication(s) appearing in the marketing authorisation at the date of publication of this decree (Bottle/100+child-resistant cap)

Hospital model(s) (Blister/100).
Collection.