Pangrol 25 000
Poland
Table of Contents
Package leaflet: Information for the user
Pangrol 25 000, 25 000 Ph.Eur. units of lipase, capsules
(Pancreatinum)
Please read this leaflet carefully before using the medicine, as it contains important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you need advice or further information, please consult your pharmacist.
- If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
- If there is no improvement after 7–14 days, or if you feel worse, contact your doctor.
Contents of the leaflet:
- What Pangrol 25 000 is and what it is used for
- Important information before taking Pangrol 25 000
- How to take Pangrol 25 000
- Possible side effects
- How to store Pangrol 25 000
- Contents of the pack and other information
1. What Pangrol 25 000 is and what it is used for
What is Pangrol 25 000?
Pangrol 25 000 contains digestive enzymes derived from porcine sources (powdered pancreas, also known as pancreatin).
What is Pangrol 25 000 used for?
Pangrol 25 000 is used as a replacement therapy for pancreatic enzymes in patients with digestive disorders due to insufficient or inadequate secretion and/or function of pancreatic enzymes in the duodenum. Such disorders may occur in the following conditions:
- Chronic pancreatitis of any cause (alcoholic, traumatic, autoimmune, drug-induced, tropical calcific pancreatitis, idiopathic);
- Specific pancreatic dysfunction (cystic fibrosis);
- Pancreatic duct obstruction, e.g., due to tumour disease or gallstones;
- Liver and biliary tract disorders;
- Previous surgery involving the pancreas or resection of the pancreas and duodenum;
- Accelerated intestinal transit following previous gastric or intestinal surgery, due to stress, or inflammatory bowel diseases;
- Consumption of hard-to-digest plant foods, fats, or foods to which the digestive system is unaccustomed, leading to impaired nutrient absorption and digestive disturbances accompanied by loss of appetite, belching, nausea, and diarrhoea (indigestion);
- Coeliac disease;
- Inflammatory bowel disease (particularly Crohn's disease);
- Diabetes mellitus;
- Acquired immunodeficiency syndrome (AIDS);
- Shwachman's syndrome;
- Sjögren's syndrome.
This medicine can be used in adults (including elderly individuals) and children.
If there is no improvement after 7–14 days, or if you feel worse, contact your doctor.
2. Important information before taking Pangrol 25 000
When not to take Pangrol 25 000
- If you are hypersensitive to pancreatin, pork meat, or any of the other ingredients of this medicine (listed in section 6).
- In patients with acute pancreatitis or acute exacerbations of chronic pancreatitis during the active phase of the disease.
However, occasional use of the medicine may be appropriate during the resolution phase of the disease, while gradually expanding the oral diet (light diet), if signs of persistent pancreatic dysfunction are present.
Warnings and precautions
Before starting Pangrol 25 000, discuss with your doctor or pharmacist:
- If symptoms indicating intestinal obstruction occur (e.g., abdominal pain, absence of bowel movements, nausea, vomiting). Intestinal obstruction is a common complication in patients with cystic fibrosis.
- As a precaution, any unusual gastrointestinal symptoms or changes in existing symptoms should be evaluated by a doctor to rule out intestinal damage. This particularly applies to patients receiving more than 10,000 Ph.Eur. units of lipase per kg body weight per day.
This medicine contains active enzymes which, if released in the oral cavity (e.g., by chewing), may cause damage (ulceration) to the oral mucosa.
Therefore, caution is required, and the medicine should be taken whole without chewing.
Pangrol 25 000 with other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Concomitant use of enzyme-containing pancreatic preparations may reduce the absorption of folic acid, which may necessitate additional folic acid supplementation.
Concomitant use of Pangrol 25 000 may reduce the efficacy of oral antidiabetic agents: acarbose and miglitol.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
There is no clinical experience with the use of Pangrol 25 000 in pregnant women.
Only incomplete animal data are available regarding effects on pregnancy, fetal development, parturition, and postnatal development. The potential risk in humans is unknown.
If you are pregnant or breastfeeding, you should not take Pangrol 25 000 unless, in the opinion of your doctor, it is absolutely necessary.
Driving and operating machinery
Pangrol 25 000 has no effect or negligible effect on the ability to drive and operate machinery.
3. How to use Pangrol 25 000
This medicine should always be used according to the information provided in the leaflet or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Dosage
The recommended dose is 1 capsule of Pangrol 25000 per meal (corresponding to 25,000 Ph. Eur. units of lipase).
The dosage depends on the severity of digestive disturbances. Higher doses may be necessary.
Any increase in dosage should be discussed with your doctor beforehand, with the aim of improving symptoms (e.g. fatty stools, stomach pain).
Do not exceed a daily dose of 15,000–20,000 lipase units per kilogram of body weight.
In cystic fibrosis, Pangrol 25 000 can be used in adults and children with a body weight of at least 25 kg. Unless otherwise directed by a doctor, patients with cystic fibrosis weighing 25 kg or more should take 1 to 2 capsules of Pangrol 25 000 per meal (equivalent to 25,000–50,000 Ph. Eur. units of lipase per meal). Your doctor may decide to increase the dose depending on body weight and symptom severity.
Do not exceed the maximum dose of 15,000–20,000 lipase units per kilogram of body weight per day.
Children and adolescents
Dosage in children should be determined by a doctor.
Method of administration
Pangrol 25 000 capsules should be swallowed whole during a meal, with a large amount of liquid.
Patients who do not wish to swallow the capsule whole may open it over a suitable container (e.g. a glass) and swallow only the capsule contents with a small amount of liquid.
Care should be taken to swallow the granules whole, as chewing may reduce the effectiveness of the medicine and enzymes released in the oral cavity may cause damage to the oral mucosa. The medicine should be taken with a large amount of liquid (water or juice).
Duration of treatment
There is no fixed duration for treatment with Pangrol 25 000. The length of treatment depends on the course of the disease and is determined by the doctor.
If the patient does not feel better or feels worse, medical advice should be sought.
If you feel that the effect of Pangrol 25 000 is too strong or too weak, consult your doctor or pharmacist.
Taking more Pangrol 25 000 than recommended
If you take more than the recommended dose, drink plenty of water and consult your doctor.
Taking very high doses of pancreatin, especially in patients with cystic fibrosis, may lead to increased levels of uric acid in the blood (hyperuricaemia) and in the urine (hyperuricosuria).
If you forget to take Pangrol 25 000
Do not take a double dose to make up for a missed dose. Take the next dose as recommended.
Stopping Pangrol 25 000 treatment prematurely
If treatment with Pangrol 25 000 is stopped or interrupted prematurely, symptoms may return. Consult your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Important adverse reactions or symptoms to be aware of
If any of the following symptoms occur, stop taking
the medicine Pangrol 25 000 immediately and seek medical advice without delay. The doctor will decide on further
management.
Very rare adverse reactions (may affect up to 1 in 10,000 people)
Diarrhoea, feeling of discomfort in the abdominal cavity, abdominal pain, nausea, vomiting
Immediate-type allergic reactions, such as: skin rash, urticaria, sneezing,
lacrimation, shortness of breath due to airway constriction (bronchospasm)
Gastrointestinal allergic reactions
In patients with cystic fibrosis, following administration of high doses of pancreatin, narrowing of the distal intestine (in the ileocaecal and ascending colon regions) has been reported. This may lead to intestinal obstruction (see section 2 "Warnings and precautions").
Frequency unknown (cannot be estimated from available data)
In patients with cystic fibrosis, mainly in those receiving high doses of pancreatin, increased urinary excretion of uric acid may occur. Therefore, uric acid concentration in urine should be monitored in these patients to prevent formation of uric acid stones.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Telephone: (22) 49-21-301
Fax: (22) 49-21-309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the Marketing Authorisation Holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.
5. How to store Pangrol 25 000
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, bottle, or
blister after the "EXP" symbol. The expiry date refers to the last day of the specified month.
The container should be kept closed.
Storage conditions
Store below 25°C.
After first opening the bottle, the medicine remains stable for 6 months. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.
6. Contents of the pack and other information
What Pangrol 25 000 contains
The active substance is powdered porcine pancreas. One capsule contains enteric-coated minitablets containing powdered porcine pancreas with the following activity:
Lipase 25 000 IU Ph. Eur.
Amylase 22 500 IU Ph. Eur.
Protease 1 250 IU Ph. Eur.
Excipients
minitablets:
Sodium croscarmellose
Microcrystalline cellulose
Hardened castor oil
Anhydrous colloidal silicon dioxide
Magnesium stearate
30% aqueous dispersion of ethyl acrylate and methacrylic acid copolymer (1:1), type C
Triethyl citrate
Simethicone emulsion 30%
Talc
capsule shell:
Gelatin
Iron oxide, red (E 172)
Quinoline yellow (E 104)
Iron oxide, yellow (E 172)
Indigo carmine (E 132)
Titanium dioxide (E 171)
What Pangrol 25 000 looks like and contents of the pack
Pangrol 25 000 is in the form of gelatin capsules. The upper part of the capsule is light green, the lower part is light brown. The capsules are filled with enteric-coated minitablets.
Packaging: polypropylene bottle closed with a polyethylene cap containing a desiccant, containing 20 or 50 capsules.
Aluminum blisters (OPA/Al/PVC)/Aluminum in a cardboard box. Boxes contain 20 or 50 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
BERLIN-CHEMIE AG
Glienicker Weg 125
12489 Berlin, Germany
For further information, please contact the Marketing Authorisation Holder's representative:
Berlin-Chemie/Menarini Polska Sp. z o.o.
Tel: (022) 566 21 00
Fax: (022) 566 21 01