Pangrol® 20,000 film-coated tablets

Active substance: Pancreas powder (pork)

Application:
To replace digestive enzymes in digestive disorders (maldigestion) due to insufficient or missing function of the pancreas (exocrine pancreatic insufficiency).

Note: contains lactose.

PANGROL Active ingredients

• Pork Pancreas Powder 160-222.22 mg

• Auxiliary materials

  • Lactose-1 water 55.57-133.34 mg
  • Cellulose, microcrystalline
  • Crospovidone
  • Silica, finely divided
  • Magnesium stearate (vegetable)
  • Hypromellose
  • Methacrylic acid-ethyl acrylate copolymer (1: 1) dispersion 30%
  • Triethyl citrate
  • talc
  • Simeticon emulsion 30%
  • Macrogol 6000
  • Carmellose sodium
  • Polysorbate 80 (vegetable)
  • Vanilla flavor
  • Bergamot flavor
  • Titanium dioxide
  • Sodium hydroxide for pH adjustment.

  • PANGROL Indication application

    • 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 or missing function of the pancreas.

    • PANGROL dosage

      • Always take the preparation exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
      • dosage
        • The recommended dose is:
          • 1 – 2 tablets per meal (corresponding to 20,000 to 40,000 Ph.-Eur. Units of lipase per meal).
          • The dosage depends on the severity of the indigestion, so the required dose can be higher. The dose should only be increased under medical supervision and aimed at improving 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 intake.
          • The doctor should decide on the dosage in children.

          • • •  

                • Duration of application
                  • The duration of the application is not subject to any restriction. It depends on the course of the disease and is determined by the doctor. If you don t feel better or 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 pancreatic powder can lead to an increase in uric acid in the blood (hyperuricemia) and urine (hyperuricosuria), especially in cystic fibrosis patients.

                        • •  

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

                              • •  

                                  • If you stop taking it
                                    • If you end or interrupt treatment prematurely, you must expect that your symptoms can return. Consult your doctor.

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

                                        • PANGROL way

                                          • Swallow the medicine whole with plenty of liquid, preferably around the middle of the meal.
                                          • Please ensure that the tablets are swallowed whole, as the drug loses its effectiveness when chewed and the enzymes contained can damage the mucous membrane if released in the oral cavity. You should drink plenty of fluids (water or juice).

                                          • PANGROL Side effects

                                            • As with all medicines, this medicine can also have side effects, although not everybody receives them.
                                            • Please note:
                                              • If you notice any of the following side effects, stop taking the product and contact your doctor immediately. This will then decide on the type of further treatment.
                                                • Very rare side effects (affects less than 1 in 10,000 people):
                                                  • Diarrhea, 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, constrictions of the small intestine appendix region and the ascending colon sections have been described after administration of high doses of pancreatic powder. These constrictions can sometimes lead to an intestinal obstruction.
                                                  • If unusual gastrointestinal complaints or changes in the symptoms occur, you should have these examined by your doctor as a precautionary measure in order to rule out the possibility of damage to the intestine. This applies particularly to patients who take more than 10,000 Ph.-Eur. Units of lipase per kilogram of body weight per day.
                                                  • • 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 pancreatic powder. Therefore, uric acid excretion in the urine of these patients should be monitored to avoid the formation of uric acid stones.
                                                      • • • • If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not specified.

                                                            • PANGROL Interactions

                                                              • Taking with other medicines
                                                                • Tell your doctor or pharmacist if you are taking, have recently used, or are planning to 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 pancreatic powder, so that additional folic acid intake may be necessary.
                                                                • The effect of the blood sugar lowering agents acarbose and miglitol can be reduced by taking the preparation at the same time.

                                                                • • PANGROL Contraindications

                                                                    • Do not take the medicine
                                                                      • if you are allergic to pancreatic 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 fully developed phase of the disease. In the decay phase during the dietary build-up (light food), however, the administration of the preparation is occasionally useful in the case of persistent digestive disorders.

                                                                      • • PANGROL pregnancy and breast feeding period

                                                                          • Ask your doctor or pharmacist for advice before using any medicine if you are pregnant or breast-feeding, if you suspect you may be pregnant or planning to become pregnant.
                                                                          • There is insufficient experience with the use of the drug in pregnant women. There are insufficient data from animal studies with regard to pregnancy, development of the unborn child, parturition and development of the child after birth. The potential risk to humans is unknown. If you are pregnant or if you are breastfeeding, you should not take the preparation unless your doctor considers it absolutely necessary.

                                                                          • PANGROL Patient information

                                                                            • Warnings and Precautions
                                                                              • Please talk to your doctor or pharmacist before taking the preparation,
                                                                                • if you notice symptoms similar to bowel obstruction (e.g. abdominal pain, lack of bowel movement, nausea, vomiting). Bowel obstruction is a known complication in people with cystic fibrosis.
                                                                                • This medicine contains active enzymes which if released into the oral cavity (e.g. by chewing) may cause damage to the lining of the mucous membrane (e.g. wounds in the lining of the mouth). Therefore, make sure to swallow the preparation whole.

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