• Pork pancreas powder 319.05-414.35 mg

• triethyl citrate
• Iron(III) oxide hydrate, black
• Methacrylic acid ethyl acrylate copolymer (1:1) dispersion 30%
• ferric oxide
• Simethicone Emulsion 20%
• gelatin
• Sodium Lauryl Sulfate
• titanium dioxide
• indigo carmine
• talc

indication Fat maldigestion, exocrine pancreatic insufficiency, PANGROL 40,000

• This preparation is a medicine that contains digestive substances (enzymes) from the pancreas of pigs (pancreas powder, also called pancreatin).
• It is used to treat indigestion caused by decreased pancreatic function.

Fat maldigestion, exocrine pancreatic insufficiency, PANGROL 40,000 dosage

• Always take the medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
• dosage
  • The recommended dose is:
  • 1 capsule per meal (equivalent to 40,000 Ph. Eur. units of lipase per meal).
  • The dosage depends on the severity of the indigestion, so the required dose can also be higher. The dose should only be increased under medical supervision and aimed at improving the symptoms (e.g. fatty stools, abdominal pain).
  • A daily enzyme dose of 15,000 to 20,000 units of lipase per kilogram of body weight should not be exceeded. Especially in patients with cystic fibrosis, the enzyme dose should not be higher than necessary for adequate fat absorption.

• duration of use
  • The duration of the application is not subject to any restrictions. It depends on the course of the disease and is determined by the doctor. If you do not feel better or if you feel worse, contact your doctor.
  • Please talk to your doctor or pharmacist if you have the impression that the effect of the medicine is too strong or too weak.

• If you take more than you should
  • Drink plenty of water and talk to your doctor or pharmacist. Extremely high doses of pancreas powder can lead to an increase in uric acid in the blood (hyperuricaemia) and urine (hyperuricosuria), particularly in patients with cystic fibrosis.

• If you forget to take a dose
  • Do not take a double dose to make up for the previous dose, but please continue with the treatment as recommended.

• If you stop taking it
  • If you stop or interrupt treatment prematurely, you must be aware that your symptoms may return. Consult your doctor.

• If you have any further questions on the use of the medicine, ask your doctor or pharmacist.

Fat maldigestion, exocrine pancreatic insufficiency, PANGROL 40,000 way

• Swallow the medicine whole with plenty of liquid, preferably halfway through a meal.
• Patients who do not want to swallow the entire capsule can also place it over a suitable vessel, such as a B. a drinking glass, open by pulling apart and only swallow the contents with some liquid without chewing.
• Please make sure that the capsules or, when opening the capsules, the pellets they contain are swallowed whole, as the preparation loses its effectiveness when chewed and the enzymes contained in the capsules can damage the mucous membrane when they are released in the oral cavity. You should drink plenty of fluids (water or juice).

side effects

• Like all medicines, this medicine can have side effects, although not everyone gets them.
• Please note:
  • If you notice any of the following side effects, stop taking the preparation and inform your doctor immediately. He will then decide on the type of further treatment.
• Very rare side effects (affects less than 1 user in 10,000):
  • Diarrhoea, abdominal discomfort, abdominal pain, nausea, vomiting
  • Immediate-type allergic reactions, e.g. B. Rash, hives (urticaria), sneezing, tearing, shortness of breath due to narrowing of the airways (bronchospasm), shortness of breath
  • allergic reactions of the digestive tract
  • In patients with cystic fibrosis, narrowing of the small intestine/cecum and the ascending sections of the large intestine have been described after administration of high doses of pancreas powder. These narrowings can sometimes lead to an intestinal blockage.
  • If you have any unusual gastrointestinal symptoms or changes in symptoms, you should have them checked out by your doctor as a precautionary measure to rule out the possibility of damage to the intestines. This particularly affects patients who take more than 10,000 Ph. Eur. units of lipase per kilogram of body weight daily.
• Frequency of side effects not known (cannot be estimated from the available data):
  • In patients with cystic fibrosis, increased uric acid excretion in the urine can occur, especially when taking high doses of pancreas powder. Therefore, urinary uric acid excretion should be monitored in these patients to avoid the formation of uric acid stones.
• If you get any side effects, stop taking the medicine and tell your doctor right away. This also applies to side effects that are not specified.

interactions

• Taking the preparation together with other medicines
  • Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
  • The absorption of folic acid (uptake of folic acid into the blood) can be reduced by taking finished medicinal products containing pancreas powder, so that an additional supply of folic acid may be necessary.
  • The effect of the blood sugar-lowering active ingredients acarbose and miglitol can be reduced by taking the preparation at the same time.

Contraindications

• This medicine must not be taken
  • if you are allergic to pancreas powder, pork or any of the other ingredients of this medicine
  • if you suffer from acute inflammation of the pancreas or have an acute flare-up of chronic inflammation of the pancreas during the full-blown disease phase. In the cooling-off phase during the dietary build-up (light diet), however, the administration of the drug occasionally makes sense if digestive disorders persist.

pregnancy and breast feeding period

• 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 any medicine.
• There is insufficient experience with the use of the drug in pregnant women. There are insufficient data from animal studies regarding pregnancy, unborn child development, parturition and child development after birth. The potential risk for humans is unknown. If you are pregnant or breastfeeding, you should not take the medicine unless your doctor thinks it is absolutely necessary.

patient notes

• Warnings and Precautions
  • Talk to your doctor or pharmacist before taking this medicine
    • if you experience symptoms similar to an intestinal obstruction (e.g. abdominal pain, lack of bowel movements, nausea, vomiting). Intestinal obstruction is a known complication in patients with cystic fibrosis.
    • This medicinal product contains active enzymes which, if released in the oral cavity (e.g. by chewing), may cause damage to the mucous membranes (e.g. sores in the oral mucosa). Therefore, make sure to take the preparation whole.
  • children and young people
    • Children under the age of 15 with cystic fibrosis should not be treated with this medicine.

• Ability to drive and use machines
  • The drug has no or negligible influence on the ability to drive and use machines.