PANKREATIN

PANCREATIN Laves 10,000 Ph.Eur.-Unit msr.Hardcaps.

Important notes (mandatory information)

Pankreatin Laves 10,000 Ph.Eur. units, enteric-coated hard capsules. 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

Pankreatin Laves 10,000 Ph.Eur. units, enteric-coated hard capsules with pancreatic powder from pigs (pancreatin) corresponding to 10,000 Ph.Eur. units of lipase/capsule

Please read the entire package leaflet carefully because it contains important information for you. This medicine is also available without a doctor's prescription. However, to achieve the best possible treatment results, Pankreatin Laves 10,000 must be taken as directed.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If your symptoms worsen or do not improve, you must see a doctor.
• If any of the listed side effects affect you significantly or if you notice side effects that are not listed in this package leaflet, please inform your doctor or pharmacist.

This package leaflet contains

1. WHAT IS PANKREATIN LAVES 10,000 AND WHAT IS IT USED FOR?
2. WHAT DO YOU NEED TO CONSIDER BEFORE TAKING IT?
3. HOW SHOULD PANKREATIN LAVES 10,000 BE TAKEN?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD PANKREATIN LAVES 10,000 BE STORED?
6. FURTHER INFORMATION

1. WHAT IS PANKREATIN LAVES 10,000 AND WHAT IS IT USED FOR?

Pankreatin Laves 10,000 is a medicine that contains digestive substances (enzymes) from the pancreas of pigs. It is used to treat digestive disorders caused by reduced or absent function of the pancreas. Such digestive disorders can manifest themselves, for example, as abdominal pain, flatulence, fatty stools or diarrhoea, as frequent bowel movements or weight loss.

2. WHAT DO YOU NEED TO CONSIDER BEFORE TAKING IT?

Pankreatin Laves 10,000 must not be taken

Pankreatin Laves 10,000 must not be taken if you are hypersensitive (allergic) to:

• pancreatin,
• pork
• or any of the other ingredients (see section 6) of Pankreatin Laves 10,000.

Special care must be taken when taking Pankreatin Laves 10,000
This medicine contains active enzymes (digestive substances) that can cause damage to the mucous membrane if released in the mouth. Therefore, always take it whole. If you have acute pancreatitis, consult your doctor before taking it. The following symptoms may indicate intestinal obstruction: abdominal pain, lack of bowel activity, nausea and vomiting. Intestinal obstruction is also a known complication in patients with cystic fibrosis, an inherited metabolic disorder. Contact your doctor if you experience the symptoms mentioned.

When taking Pankreatin Laves 10,000 with other medicines

Please inform your doctor or pharmacist if you are taking/using or have recently taken/used any other medicines, even if they are non-prescription medicines.

Folic acid

The absorption of folic acid into the body may be reduced when taking Pankreatin Laves 10,000, so additional folic acid supplementation may be necessary.

Acarbose, miglitol (medicines for the treatment of diabetes)

The blood sugar-lowering effect of medicines with acarbose or miglitol may be reduced if Pankreatin Laves 10,000 is taken at the same time.

Please contact your doctor if you are taking such medicines.

Pregnancy and breast-feeding

You can take Pankreatin Laves 10,000 during pregnancy and breast-feeding after consulting your doctor. Ask your doctor or pharmacist for advice before using any medicine.

Driving and operating machinery

Pankreatin Laves 10,000 has no influence on the ability to drive and operate machinery.

3. HOW SHOULD PANKREATIN LAVES 10,000 BE TAKEN?

Always take Pankreatin Laves 10,000 exactly as described in this package leaflet. Please ask your doctor or pharmacist if you are not sure.

Unless otherwise prescribed by your doctor, the usual dose is

2 - 4 capsules with main meals. The dosage also depends on the fat content of the food. Your doctor may increase the recommended dose several times over if necessary.

Method of administration

Take the capsules directly with meals, whole and with plenty of liquid, e.g. a glass of water (see also section 2, Special care when taking). If you cannot swallow the whole capsules, you may also open the capsules. In this case, only take the capsule contents (microfilm tablets) into your mouth and swallow them whole with plenty of liquid, e.g. a glass of water.

Opening and closing the container

1. Grasp the glass bottle with your hand and press the lid rim vertically from bottom to top with your thumb.
2. To close, press the lid firmly onto the glass bottle.

Duration of use

The duration of use is not limited. You should take Pankreatin Laves 10,000 as long as the digestive weakness persists.

Please talk to your doctor or pharmacist if you have the impression that the effect of this medicine is too strong or too weak.

If you have taken more Pankreatin Laves 10,000 than you should

No cases of overdose are known to date.

If you forget to take Pankreatin Laves 10,000

Do not take a double dose to make up for the previous dose you forgot to take. Continue taking it as recommended.

If you stop taking Pankreatin Laves 10,000

You must expect your symptoms to return. Therefore, consult your doctor if you want to end or interrupt treatment.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Pankreatin Laves 10,000 can have side effects, although not everybody gets them. Please inform your doctor or pharmacist if any of the side effects listed significantly affect you or if you notice side effects that are not listed in this package leaflet. Please note that some of the events listed below may also be signs (symptoms) of your condition. In such a case, a dosage adjustment may be necessary. Therefore, be sure to talk to your doctor about it.

Uncommon (1 to 10 out of 1,000 treated patients are affected):

• Metabolism and nutrition disorders: loss of appetite*.
• Nervous system: dizziness, balance disorder.
• Respiratory system, chest: runny nose.
• Gastrointestinal tract: diarrhoea*, abdominal pain*, nausea*, vomiting*, heartburn/acid reflux*, oral mucosal inflammation.
• Skin and subcutaneous tissue: skin rashes/redness.
• General disorders and local symptoms: malaise*.

Frequency not known (cannot be estimated from the available data, individual case reports from long-term use of pancreatin preparations)

• Immune system: hypersensitivity reactions (e.g. skin rash, sneezing, watery eyes, shortness of breath, signs of shock), allergic reactions of the digestive tract (e.g. diarrhoea, stomach upset, abdominal cramps).
• Gastrointestinal tract: Constrictions in the small or large intestine have been described in the medical literature in patients with cystic fibrosis who have received high doses. * The symptoms marked with an asterisk (*) can also be signs of persistent digestive weakness. It may be necessary to adjust the dosage of Pankreatin Laves 10,000 (see section 3). Please consult your doctor about this. The symptoms abdominal pain, vomiting, nausea may be due to intestinal obstruction, especially if you have cystic fibrosis (see section 2, Special care when taking). Please have this clarified by your doctor.

Reporting of side effects

If you get 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 about the safety of this medicine.

5. HOW SHOULD PANKREATIN LAVES 10,000 BE STORED?

Keep out of reach of children! Keep the container tightly closed. Do not store above 25°C. Do not use the medicine after the expiry date which is stated on the folding box and label after "use by". The expiry date refers to the last day of the month.

Note on shelf life after opening

After opening the pack, you may use the medicine for another 4 months.

6. FURTHER INFORMATION

What Pankreatin Laves 10,000 contains

The active ingredient is pancreatic powder from pigs (pancreatin). One capsule contains 97.6 mg of this. This corresponds to: 10,000 Ph.Eur. units of lipase/capsule, at least 7,500 Ph.Eur. units of amylase/capsule, at least 450 Ph.Eur. units of protease/capsule. The other ingredients are: crospovidone, microcrystalline cellulose, highly dispersed silicon dioxide, magnesium stearate (Ph. Eur.), methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30% (Ph. Eur.), polysorbate 80, water, triethyl citrate, talc, simethicone emulsion (contains simethicone, methylcellulose, sorbic acid (Ph. Eur.) and water), montan glycol wax, gelatine, titanium dioxide (E 171), iron oxides and hydroxides (E 172), sodium dodecyl sulphate.

What Pankreatin Laves 10,000 looks like and contents of the pack

Brown glass bottle(s) in a cardboard box with 50 enteric-coated hard capsules [N1], 100 enteric-coated hard capsules [N2] and 200 (2 x 100) enteric-coated hard capsules [N3]. The hard gelatine capsule consists of a brown upper part and a transparent lower part and contains white-grey micro-film tablets.

Pharmaceutical entrepreneur and manufacturer

Nordmark Arzneimittel GmbH & Co. KG
Pinnauallee 4
25436 Uetersen

Co-distributor

Laves-Arzneimittel GmbH
Barbarastraße 14
30952 Ronnenberg
Phone: 0511-43874-0
Fax: 0511-43874-44

This package leaflet was last revised in September 2019.

Source: Information from the package leaflet
Status: 04/2022
Areas of application: for the treatment of digestive disorders caused by reduced or absent function of the pancreas.