PANGROL

PANGROL 25,000 hard capsules with enteric-coated pellets

Important notes (mandatory information)

Pangrol 25000 enteric-coated hard capsules. Active ingredient: Pancreas powder from pigs. Areas of application: for the treatment of digestive disorders caused by reduced or absent function of the pancreas.

For risks and side effects, read the package leaflet and consult your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Pangrol 25000 enteric-coated hard capsules, 25,000 Ph. Eur. units of lipase
Active ingredient: Pancreas powder from pigs

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information. Always take this medicine exactly as described in this package leaflet or exactly as your doctor or pharmacist has told you.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you notice any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or if you feel worse, talk to your doctor.

What this package leaflet contains

1. WHAT IS PANGROL 25,000 AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING PANGROL 25,000?
3. HOW SHOULD YOU TAKE PANGROL 25,000?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD PANGROL 25,000 BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS PANGROL 25,000 AND WHAT IS IT USED FOR?

Pangrol 25,000 is a medicine that contains digestive enzymes from the pancreas of pigs (pancreas powder, also known as pancreatin).

What is Pangrol 25,000 used for?
It is used to treat digestive disorders caused by reduced or absent function of the pancreas.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING PANGROL 25,000?

Pangrol 25,000 must not be taken:

• if you are allergic to pancreas powder, pork or any of the other ingredients of this medicine listed in section 6
• 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. However, during the recovery phase during dietary build-up (light diet), the administration of Pangrol 25,000 is occasionally useful if digestive disorders persist.

Warnings and precautions

Please talk to your doctor or pharmacist before taking Pangrol 25,000:

• if you experience symptoms similar to intestinal obstruction (e.g. abdominal pain, absent bowel movements, nausea, vomiting). Intestinal obstruction is a known complication in patients with cystic fibrosis.
• If unusual gastrointestinal symptoms or changes in the symptoms occur, you should have them examined by your doctor as a precaution to rule out the possibility of damage to the intestine. This particularly applies to patients who take more than 10,000 Ph. Eur. units of lipase per kilogram of body weight per day.
• This medicine contains active enzymes that can cause damage to the mucous membrane (e.g. sores in the oral mucosa) if released in the oral cavity (e.g. by chewing). Therefore, make sure to take Pangrol 25,000 without chewing.

Taking Pangrol 25,000 with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or intend to take any other medicines. The absorption of folic acid (uptake of folic acid into the blood) can be reduced by taking medicines containing pancreas powder, so that additional folic acid may be required. The effect of the blood sugar-lowering active ingredients acarbose and miglitol can be reduced by the simultaneous administration of Pangrol 25,000.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before using any medicine. There is insufficient experience with the use of Pangrol 25,000 in pregnant women. There are only insufficient data from animal studies with regard to pregnancy, development of the unborn child, delivery and development of the child after birth. The potential risk for humans is unknown. If you are pregnant or breast-feeding, you should not take Pangrol 25,000 unless your doctor considers it absolutely necessary.

Driving and using machines

Pangrol 25,000 has no or negligible influence on the ability to drive and use machines.

3. HOW SHOULD YOU TAKE PANGROL 25,000?

Always take this medicine exactly as agreed with your doctor. Check with your doctor or pharmacist if you are not sure.

Dosage

The recommended dose is: 1 capsule of Pangrol 25,000 per meal (corresponding to 25,000 Ph. Eur. units of lipase per meal). The dosage depends on the severity of the digestive disorder, so the required dose may also be higher. The dose should only be increased under medical supervision and should be based on the improvement of the symptoms of the disease (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. Particularly in patients with cystic fibrosis, the enzyme dose should not be higher than necessary for adequate fat absorption. The dosage for children should be determined by the doctor.

Method of administration

Take the medicine without chewing with plenty of liquid, preferably in the middle of the meal. Patients who do not want to swallow the entire capsule can also open it over a suitable container, such as a drinking glass, by pulling it apart and taking only the contents with a little liquid without chewing. Please make sure that the capsules or the mini-tablets contained when the capsules are opened are swallowed without chewing, as Pangrol 25,000 loses its effect when chewed and the enzymes it contains can damage the mucous membrane if released in the oral cavity. You should drink plenty of liquid (water or juice) afterwards.

Duration of use

The duration of use is not limited. 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, talk to your doctor. Please talk to your doctor or pharmacist if you have the impression that the effect of Pangrol 25,000 is too strong or too weak.

If you have taken more Pangrol 25,000 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 (hyperuricemia) and urine (hyperuricosuria), particularly in patients with cystic fibrosis.

If you forget to take Pangrol 25,000

Do not take double the dose to make up for the forgotten dose, but continue the treatment as recommended.

If you stop taking Pangrol 25,000

If you end or interrupt the treatment prematurely, you must expect your symptoms to return. Consult your doctor.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them. Please note: If you experience any of the following side effects, do not take Pangrol 25,000 any further and notify your doctor immediately. He will then decide on the type of further treatment.

Very rare side effects (affect less than 1 in 10,000 people):

• Diarrhea, abdominal discomfort, abdominal pain, nausea, vomiting
• immediate-type allergic reactions, e.g. rash, hives (urticaria), sneezing, watery eyes, 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 region and the ascending colon sections have been described after administration of high doses of pancreas powder. This narrowing can lead to intestinal obstruction under certain circumstances (see section 2. "Warnings and precautions").

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, uric acid excretion in the urine should be monitored in these patients to avoid the formation of uric acid stones.

Reporting of side effects

If you notice any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW SHOULD PANGROL 25,000 BE STORED?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton and the label after "use by". The expiry date refers to the last day of the month indicated. Keep the container tightly closed. Do not store above 25°C. Shelf life after first opening: 3 months. Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of this medicine when you are no longer using it. This helps to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Pangrol 25,000 contains

The active ingredient is pancreas powder from pigs. 1 enteric-coated hard capsule (hard capsule with enteric-coated mini-tablets) contains 188.9 - 343.5 mg of pancreas powder from pigs: Lipase activity 25,000 Ph. Eur. units/capsule, amylase activity at least 22,500 Ph. Eur. units/capsule, protease activity at least 1,250 Ph. Eur. units/capsule. The other ingredients are: Hydrogenated castor oil, highly dispersed silicon dioxide, magnesium stearate (Ph. Eur.) [vegetable], croscarmellose sodium, microcrystalline cellulose, methacrylic acid-ethyl acrylate copolymer-(1:1)-dispersion 30% (Ph. Eur.), talc, triethyl citrate, simethicone emulsion 30%, iron(III) oxide (E 172), iron(III) hydroxide oxide x H2O (E 172), indigo carmine (E 132), quinoline yellow (E 104), titanium dioxide, gelatin.

What Pangrol 25,000 looks like and contents of the pack

Pangrol 25,000 hard capsules consist of a yellow-green upper part and a light orange lower part and contain light brown, shiny, homogeneous mini-tablets (enteric-coated). The capsules are filled into polypropylene containers, which are closed with a polyethylene closure with desiccant. The containers are packed in a cardboard box (folding box) together with the package leaflet. Pangrol 25,000 is available in packs of 50 (N1), 100 (N2) and 200 (2 x 100) enteric-coated hard capsules (N3). Not all pack sizes may be marketed.

Pharmaceutical entrepreneur and manufacturer

BERLIN-CHEMIE AG
Glienicker Weg 125
12489 Berlin
Germany

This package leaflet was last revised in January 2015.

Source: Information from the package leaflet
Status: 02/2017
Active ingredient: Pancreas powder from pigs. Areas of application: for the treatment of digestive disorders caused by reduced or absent function of the pancreas.