EUROBIOL 12 500 U Gél gastrorés Fl/100

Pancreatin powder of porcine origin.....................................................................................................122mg*

For one capsule.

*Quantity corresponding to:

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

Amylolytic activity .................................................................................................at least 9 375 U Ph. Eur.

Proteolytic activity ...................................................................................................at least 563 U Ph. Eur.

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

• cystic fibrosis;

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

• cephalic or total pancreatic resections.

Dosage

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

Child over 4 years: the recommended initial dose is 500 IU / kg per meal.

Do not exceed 2 500 IU / kg per meal or 10 000 IU / kg/day or 4 000 lipase units/g of fat ingested.

Adolescent and adult: the recommended initial dose is 500 IU / kg per meal.

Do not exceed the dose of 250 000 IU / day.

Method of administration

EUROBIOL 12 500 U, gastro-resistant capsule must be administered during meals: full dose for main meals and half dose for snacks.

If swallowing is difficult (for example for children or elderly people), the capsules may be carefully opened and the granules added to an acidic semi-liquid food [pH < 5,5] that does not need to be chewed, or taken with an acidic liquid [pH < 5.5]. For example: apple compote, or fruit juice with a pH below 5,5, such as apple, orange or pineapple. This mixture must not be kept.

It is not recommended to crush or chew the granules, or to mix them with food or liquid whose pH is above 5,5. This may damage the enteric coating of the granules and lead to premature release of the enzymes in the oral cavity, a reduction in their effectiveness and mucosal irritation.

Make sure no product remains in the mouth.

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

Warnings en keep

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/24 h before prescribing EUROBIOL 12 500 U, gastro-resistant capsule in documented chronic pancreatitis.

It is important to maintain good hydration of patients, particularly during hot weather. Insufficient hydration may worsen constipation. Mixtures of granules with food or liquid must be used immediately and must not be kept.

Pancreatin may cause digestive disorders.

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

The dose should be increased very gradually when starting treatment because of the risk of severe constipation in case of overdosage.

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 is currently no sufficiently relevant data to assess a possible teratogenic or foetotoxic effect of EUROBIOL 12 500 U, gastro-resistant capsule when administered during pregnancy.

The use of EUROBIOL 12 500 U, gastro-resistant capsule should not be considered during pregnancy unless 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 12 500 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).

* 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.

Risk of severe constipation.

Pharmacotherapeutic class: ENZYMATIC PREPARATIONS, ATC code: A09AA02.

(A: Alimentary tract and metabolism)

The presentation of EUROBIOL 12 500 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 duodenojejunal level.

The granules remain stable in an acidic medium at a pH below 5,5. They disintegrate at the level of the duodenojejunum.

Preclinical data did not reveal any particular risk in humans based on acute toxicity, repeated-dose toxicology or chronic toxicity studies.

No genotoxicity, carcinogenesis or reproductive toxicology studies have been performed.

3 years

After first opening of the bottle, the medicinal product must be stored for a maximum of 3 months.

Store at a temperature not exceeding 25°C.

Store in the original packaging, protected from moisture.

For storage conditions of the medicine after first opening, see section Shelf life.

No special requirements.

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