PANKREATAN 10,000 enteric-coated hard capsules, 50 pcs

Instructions for use for PANKREATAN 10,000 enteric-coated hard capsules, 50 pcs

Dosage for the age groups is explained in section 3 of the package leaflet.

Treatment with this medicine improves symptoms of exocrine pancreatic insufficiency, including stool consistency (e.g. greasy stools), abdominal pain, flatulence and stool frequency (diarrhoea or constipation).

It should be taken during or immediately after a meal or snack to allow thorough mixing of enzymes with food.

Dosage and directions for use

• This medicine should always be taken exactly as described in the package leaflet or as directed by your doctor or pharmacist.
• Dosage is based on lipase units, which is one of the enzymes in pancreatic powder.
• Dosage depends on the severity of the disease, weight, diet and the amount of fat in the patient's stool.
• For children under 4 years of age, the usual starting dose is 1,000 lipase units per kilogram of body weight per meal.
• For children 4 years and older, the usual starting dose is 500 lipase units per kilogram of body weight per meal.
• For adolescents and adults, the weight-based enzyme dosage is 500 lipase units per kilogram of body weight per meal.
• The usual dose for a meal is between 25,000 and 80,000 lipase units and for a snack half the dose for a meal.
• The total daily dose should not exceed certain limits, based on the patient's body weight and fat intake.
• The medicine should be taken during or immediately after a meal or snack.
• The capsules should be swallowed whole with sufficient liquid and not crushed or chewed.
• If swallowing is difficult, the capsules can be opened carefully and the microfilm tablets contained can be taken unchewed with sufficient liquid.

Contraindications

• The use of this medicinal product is contraindicated in case of hypersensitivity to the ingredients and in case of inflammation of the pancreas in an acute state.
• With regard to pregnancy and lactation, there are no restrictions on the use of this medicinal product.
• In certain contraindications, the therapeutic benefit of use may be greater than the risk.

Side effects

• Possible side effects of this medicine may include abdominal pain, nausea, vomiting, constipation, diarrhoea, bloating, flatulence, allergic reactions and skin rash.
• A doctor or pharmacist should be consulted if there are any abnormalities in the way the patient feels or if there are any changes during treatment.
• The most common side effects affect one in 1,000 patients treated.

Composition

• Each capsule of this medicinal product contains 97.6 mg of porcine pancreatic powder, corresponding to 10,000 Ph.Eur. units of lipase, at least 7,500 Ph.Eur. units of amylase and at least 450 Ph.Eur. units of protease.
• The other ingredients are crospovidone, microcrystalline cellulose, highly dispersed silicon dioxide, magnesium stearate, methacrylic acid-ethyl acrylate copolymer, polysorbate 80, water, triethyl citrate, talc, simeticon emulsion, montanglycol wax, gelatin, titanium dioxide, iron oxides and hydroxides and sodium dodecyl sulphate.

Important notes

• Caution should be exercised if allergic to pork protein.

Storage

• This medicinal product should be kept out of the reach of children.
• It should be protected from heat and moisture and stored at room temperature.
• After opening the pack, the medicinal product can be stored for 4 months.
• Medicinal products should not be disposed of in waste water. Information on disposal is available at the pharmacy.

Commercial forms

• This medicinal product is available in the form of enteric-coated hard capsules.
• It is manufactured by NORDMARK.