Description

Lipancrea 8000 is a medicinal product containing pancreatin, a mixture of pancreatic enzymes. It is used to replenish pancreatic enzyme levels after pancreatectomy and to improve digestion in conditions of reduced enzyme secretion.

Composition

The active substance is: pancreatin (Pancratinum )

1 capsule contains pancreatin with the activity of: lipase 8000 Ph. Eur. units, amylase 5750 Ph. Eur. units, proteases 450 Ph. Eur. units.

Excipients: methacrylic acid and ethyl acrylate copolymer (1:1), simethicone, 30% triethyl citrate emulsion; talc, gelatin; red iron oxide (E 172); titanium dioxide (E 171).

Dosage

Always use this medicine exactly as described in the package leaflet or as directed by your doctor or pharmacist. If you have any further questions, ask your doctor or pharmacist.

The dosage of the drug should be determined individually, depending on the patient's need for pancreatic enzymes.

Action

Lipancrea 8000 contains enzymes that work by digesting food as it passes through the small intestine. Treatment significantly reduces the symptoms of exocrine pancreatic insufficiency, including abdominal pain and bloating, regulates bowel movement frequency, and improves stool consistency.

Indications

Lipancrea 8000 is used in children, adolescents and adults with digestive disorders due to exocrine pancreatic insufficiency.

Contraindications

Do not use this medicine if you are allergic to pancreatin, pork protein or any of the other ingredients of this medicine.

Side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common side effects (more than 1 in 10 patients): abdominal pain.

Common side effects (in less than 1 in 10 patients): nausea, vomiting, constipation, flatulence, diarrhea.

Uncommon side effects (affecting less than 1 in 100 patients): rash.

Warnings and precautions

Store at a temperature below 25 ^o C,

Keep the medicine out of the sight and reach of children.

Caution should be exercised if the drug is administered to children with cystic fibrosis taking high doses of enzymes, as intestinal stenosis has been reported in rare cases in these children.

Use of other medications

Please tell your doctor or pharmacist about all the medicines you are taking, have recently taken or might take, including medicines obtained without a prescription.

Lipancrea 8000 may interact with:

• drugs used for heartburn and hyperacidity (e.g. cimetidine, ranitidine, famotidine),
• folic acid and iron salts (also present in food).

Taking the medicine with food and drink

Take this medicine with or immediately after a meal or snack, with each capsule washed down with liquid.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

If you are pregnant or think you may be pregnant, talk to your doctor before taking Lipancrea 8000. Your doctor will decide whether you can take the medicine and at what dose.

The drug can be used during breastfeeding.

Use of the drug in children and adolescents

Use in children: only after consultation with a doctor.

Driving and operating machinery

Lipancrea 8000 has no or negligible influence on the ability to drive and use machines.