Pankreatan 36,000 gastro-resistant capsules, 200 pieces

Description of the preparation

This preparation contains a mixture of enzymes called pancreas powder or pancreatin.It is obtained from pig pancreas and supports digestion.The preparation consists of small enteric-coated microfilm tablets that slowly release the pancreas powder in the intestine.No prescription is required for this product.

Area of application

The preparation is used to treat exocrine pancreatic insufficiency.The pancreas does not produce enough enzymes to digest food.It can be used on children, adolescents and adults.The dosage instructions for different age groups are explained in the “Dosage” category.

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

Active ingredients and ingredients

The preparation contains 303.5 mg of porcine pancreas powder with 36,000 Ph.Eur. units of triacylglycerol lipase, amylase and proteases.Other ingredients include:

Cellulose, microcrystalline, crospovidone, iron hydroxide, iron oxide, Eudragit L 30 D-55, gelatin, magnesium stearate, montan glycol wax, sodium dodecyl sulfate, polysorbate 80, silicon dioxide, highly disperse, simeticon emulsion, simeticon, methylcellulose, sorbic acid, water, talc, titanium dioxide, triethyl citrate and 23 mgTotal sodium ion.

Contraindications

The product must not be taken if you are allergic to pancreatin or any of the other ingredients of this medicine.

Dosage

Always take this medicine exactly as described or as directed by your doctor or pharmacist.Check with your doctor or pharmacist if you are unsure.

Your dosage is given in “lipase units”.Lipase is one of the enzymes in pancreas powder.Different strengths of this medicine contain different amounts of lipase.Always follow your doctor's instructions about how much to take.Your doctor will determine the appropriate dose for you.

This depends on the severity of your illness, your weight, your diet and the fat content in your stool.If you continue to have fatty stools or other stomach or intestinal problems, talk to your doctor as your dosage may need to be adjusted.

Dosage for children

The strength of this drug may not be appropriate for initiating therapy in children, depending on the child's age and weight.The required dose for a child should be determined by the doctor using dosage forms containing fewer lipase units (e.g. 10,000 lipase units).Once the dose per meal has been established, this strength of the drug can be used in children.

The usual starting dose for children under 4 years of age is 1,000 lipase units per kilogram of body weight per meal.The usual starting dose for children aged 4 years and over is 500 lipase units per kilogram of body weight per meal.

Dosage for teenagers and adults

Weight-based enzyme dosing should begin with 500 lipase units per kilogram of body weight per meal in adolescents and adults.The usual dose for a meal is between 25,000 and 80,000 lipase units.The usual dose for a snack is half the dose for a meal.

Maximum dosage

Your total daily dosage should not exceed 2,500 lipase units per kilogram of body weight per meal, or 10,000 lipase units per kilogram of body weight per day, or 4,000 lipase units per gram of fat intake.

Intake

Always take this medicine during or immediately after a meal or snack.This allows the enzymes to mix thoroughly with the food and digest it as it passes through the intestines.

The capsules should be swallowed whole with sufficient liquid.Do not crush or chew the capsules as this may cause irritation in your mouth or change how they work in your body.

If you find it difficult to swallow the capsules, open them carefully and swallow the microfilm-coated tablets whole with enough liquid.Do not mix, crush or chew the microfilm tablets in non-acidic food or liquid as this may cause mouth irritation or change the way they work in your body.

Do not keep the capsules or their contents in your mouth.Make sure the medicine is swallowed completely and no microfilm tablets are left in your mouth.

Patient information

Please talk to your doctor or pharmacist before taking this product.A rare intestinal disorder called “fibrosing colonopathy,” in which their intestines become narrowed, has been reported in patients with cystic fibrosis taking high-dose pancreas powder products.

Tell your doctor if you have cystic fibrosis and take more than 10,000 lipase units per kilogram of body weight per day and have unusual abdominal discomfort or changes in abdominal symptoms.

If an allergic reaction occurs, stop your treatment and talk to your doctor.An allergic reaction could include itching, hives, or rash.In rare cases, a serious allergic reaction may occur with a feeling of warmth, dizziness and fainting, and difficulty breathing.

Mouth pain, irritation (stomatitis), bleeding and mouth ulceration may occur if the capsules are chewed and/or held in the mouth for too long.Rinsing your mouth and drinking a glass of water can help when the first signs of mouth irritation appear.

Pregnancy

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.

Your doctor will decide whether you can take this product during pregnancy.This medicine can be used during breastfeeding.

Notes

For information about risks and side effects, read the package leaflet and ask your doctor or pharmacy.

Other

In the case of a hereditary metabolic disease with the formation of thick mucus (cystic fibrosis), the formation of narrowings in the area of the hip and appendix and the large intestine has been described in individual cases after taking large amounts of the drug.

In cystic fibrosis, increased uric acid excretion in the urine can occur, especially when high amounts of the drug are taken.Therefore, in this case, uric acid excretion in the urine should be controlled to avoid the formation of uric acid stones.

The development of narrowings in the gastrointestinal tract are well-known complications in cystic fibrosis.If symptoms are similar to those of an intestinal obstruction (very severe abdominal pain, no bowel movements), the possibility of intestinal strictures should also be taken into account.