Pangrol 10 000

Package Leaflet: Information for the User

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.

Pangrol 10 000 (Pangrol 10000 V)

10 000 Ph.Eur. lipase, enteric-coated capsules, hard
Pancreatinum
Pangrol 10 000 and Pangrol 10000 V are different trade names for the same medicine.

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or the patient feels worse after 7-14 days, they should contact their doctor.

Table of Contents of the Leaflet:

• 1. What is Pangrol 10 000 and what is it used for
• 2. Important information before taking Pangrol 10 000
• 3. How to take Pangrol 10 000
• 4. Possible side effects
• 5. How to store Pangrol 10 000
• 6. Contents of the pack and other information

1. What is Pangrol 10 000 and what is it used for

What is Pangrol 10 000?

Pangrol 10 000 contains digestive enzymes (of porcine origin, powdered pancreas, also known as pancreatin).

What is Pangrol 10 000 used for?

Pangrol 10 000 is used as a supplement to pancreatic enzymes in people with digestive disorders due to a lack or insufficient secretion and/or action of pancreatic enzymes in the duodenum. Such disorders may occur, for example, in the following circumstances:

• chronic pancreatitis, regardless of the cause (alcoholic, traumatic, autoimmune, drug-induced, tropical calcification, idiopathic);
• specific pancreatic dysfunction (cystic fibrosis);
• constriction of the pancreatic duct caused by, for example, a tumor or gallstones;
• liver and biliary disorders;
• previous pancreatic surgery or pancreatectomy and duodenectomy;
• accelerated intestinal passage after gastric or intestinal surgery, due to stress or inflammatory bowel disease;
• consumption of hard-to-digest plant foods, fats, or foods to which the digestive system is not accustomed, leading to impaired absorption of nutrients and digestive disorders with accompanying loss of appetite, bloating, nausea, and diarrhea (malabsorption);
• intestinal disease;
• inflammatory bowel disease (especially Crohn's disease);
• diabetes;
• acquired immune deficiency syndrome (AIDS);
• Shwachman syndrome;
• Sjögren's syndrome.

The medicine can be used in adults (including the elderly) and children. If there is no improvement or the patient feels worse after 7-14 days, they should contact their doctor.

2. Important information before taking Pangrol 10 000

When not to take Pangrol 10 000

• if the patient is hypersensitive to pancreatin, pork meat, or any of the other ingredients of this medicine (listed in section 6).
• in patients with acute pancreatitis and acute exacerbations of chronic pancreatitis, during the acute phase of the disease.

However, occasional administration of the medicine is appropriate during the recovery phase of the disease, during the expansion of the oral diet (light diet), if symptoms of persistent pancreatic dysfunction occur.

Warnings and precautions

Before starting to take Pangrol 10 000, the patient should discuss it with their doctor or pharmacist:

• in case of symptoms indicating intestinal obstruction (e.g., abdominal pain, lack of bowel movements, nausea, vomiting). Intestinal obstruction is a common complication in patients with cystic fibrosis.
• as a precaution, any unusual abdominal or stomach and intestinal symptoms or changes in existing symptoms should be examined by a doctor to rule out intestinal damage. This is especially true for patients taking more than 10,000 Ph.Eur. lipase units per kilogram of body weight per day.
• This medicine contains active enzymes that, if released in the mouth, for example, by chewing, can cause damage (ulcers) to the oral mucosa. Therefore, caution should be exercised, and the medicine should only be taken whole.

Pangrol 10 000 and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take. Taking ready-made medicines containing pancreatic enzymes may reduce the absorption of folic acid, which means that additional folic acid may be necessary. Taking Pangrol 10 000 at the same time may reduce the effect of oral anti-diabetic medicines: acarbose and miglitol.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. There is no experience with the use of Pangrol 10 000 in pregnant women. Only incomplete data from animal studies on the effect on pregnancy, fetal development, childbirth, and postnatal development are available. The potential risk to humans is not known. If the patient is pregnant or breastfeeding, they should not take Pangrol 10 000 unless, in the doctor's opinion, it is absolutely necessary.

Driving and using machines

Pangrol 10 000 has no influence or negligible influence on the ability to drive and use machines.

3. How to take Pangrol 10 000

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This medicine should always be taken in accordance with the information provided in the leaflet or the doctor's or pharmacist's instructions. In case of doubt, the patient should consult their doctor or pharmacist.

Dosage

The recommended dose is 2-4 capsules of Pangrol 10 000 per meal (corresponding to 20,000-40,000 Ph.Eur. lipase units). The dosage depends on the severity of the digestive disorders. Higher doses may be necessary. Increasing the dosage requires prior consultation with a doctor, and its purpose should be to achieve improvement in relation to symptoms (e.g., fatty stools, stomach pain). Do not exceed the daily dose of 15,000-20,000 lipase units per kilogram of body weight. In cystic fibrosis, Pangrol 10 000 can be used in adults and children with a body weight of 10 kg or more. Unless the doctor recommends a different dosage, patients with cystic fibrosis with a body weight of 10 kg or more should take 1-2 capsules of Pangrol 10 000 per meal (equivalent to 10,000-20,000 Ph.Eur. lipase units per meal). The 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

The dosage for children is determined by the doctor.

Method of administration

Pangrol 10 000 capsules should be swallowed whole during meals, with a large amount of water. Patients who do not want to swallow the capsule whole can open it over a suitable container (e.g., a glass) and swallow only the contents of the capsule with a small amount of liquid.

Be careful not to swallow the tablets whole, as chewing can reduce the effectiveness of the medicine, and the enzymes released in the mouth can cause damage to the oral mucosa. Drink a large amount of liquid (water or juice).

Duration of treatment

The duration of treatment with Pangrol 10 000 is not limited. 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, they should contact their doctor. If the patient feels that the effect of Pangrol 10 000 is too strong or too weak, they should consult their doctor or pharmacist.

Overdose of Pangrol 10 000

In case of taking a higher dose than recommended, the patient should drink a large amount of water and consult their doctor. Taking very high doses of pancreatin, especially in patients with cystic fibrosis, can lead to increased levels of uric acid in the blood (hyperuricemia) and urine (hyperuricosuria).

Missed dose of Pangrol 10 000

Do not take a double dose to make up for a missed dose. Take the next dose as directed.

Stopping treatment with Pangrol 10 000

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In case of premature termination or interruption of treatment with Pangrol 10 000, the patient should expect the symptoms to return. They should contact their doctor. If the patient has any further doubts about the use of this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Pangrol 10 000 can cause side effects, although not everybody gets them.

Important side effects and symptoms to look out for

If any of the following symptoms occur, the patient should stop taking Pangrol 10 000 immediately and consult their doctor. The doctor will decide on further action.

Very rare side effects (may affect up to 1 in 10,000 people)

• Diarrhea, abdominal discomfort, stomach pain, nausea, vomiting
• Immediate allergic reactions, such as: skin rash, hives, sneezing, tearing, shortness of breath due to bronchospasm, shortness of breath
• Allergic reactions from the gastrointestinal tract
• In patients with cystic fibrosis, after taking high doses of pancreatin, narrowing of the lower parts of the intestine (in the ileocecal and ascending colon) has been reported, which can lead to intestinal obstruction (see section 2 "Warnings and precautions").

Frequency not known (cannot be estimated from the available data)

In patients with cystic fibrosis, mainly those taking high doses of pancreatin, increased excretion of uric acid in the urine may occur. Therefore, the uric acid concentration in the urine of these patients should be monitored to prevent the formation of uric acid stones.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, Phone: (22) 49-21-301, Fax: (22) 49-21-309, Website: https://smz.ezdrowie.gov.pl. Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Pangrol 10 000

Keep out of sight and reach of children. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month. The container should be closed. Storage conditions: Store below 25°C. After opening the bottle, the medicine remains stable for 6 months. Page 4 6Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Pangrol 10 000 contains

The active substance is pancreatin. One enteric-coated capsule, hard (with minitablets resistant to gastric juice), contains pancreatin with enzymatic activity:

• lipase 10,000 Ph.Eur.
• amylase 9,000 Ph.Eur.
• protease 500 Ph.Eur.

Excipients

minitablets:
Croscarmellose sodium
Microcrystalline cellulose
Hydrogenated castor oil
Colloidal anhydrous silica
Magnesium stearate
Methacrylic acid and ethyl acrylate copolymer (1:1), 30% dispersion
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 10 000 looks like and contents of the pack

Pangrol 10 000 is a hard enteric-coated capsule. The capsule is size 2, with a light orange, opaque body and a yellow-green, opaque cap, containing light brown, shiny, uniform minitablets. Packaging: a polypropylene bottle with a polyethylene cap and a desiccant, containing 50 capsules. For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Latvia, the country of export:

Berlin-Chemie AG (Menarini Group), Glienicker Weg 125, 12489 Berlin, Germany

Manufacturer:

Berlin-Chemie AG (Menarini Group), Glienicker Weg 125, 12489 Berlin, Germany

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorization number in Latvia, the country of export: 98-0159

Parallel import authorization number: 187/24

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Date of leaflet approval: 07.05.2024

[Information about the trademark]
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