Neo-pancreatinum Forte

Package Leaflet: Information for the Patient

NEO-PANCREATINUM FORTE, 10,000 Ph.Eur. lipase, enteric-coated capsules
Pancreatinum

Read the package 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 package leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, ask your pharmacist.
• If you experience any side effects, including those not listed in the leaflet, tell your doctor or pharmacist. See section 4.
• If you do not feel better or if you feel worse, contact your doctor.

Table of Contents of the Leaflet:

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

1. What is Neo-Pancreatinum Forte and what is it used for

Neo-Pancreatinum Forte belongs to a group of medicines called "pancreatic enzyme replacement therapy".
Neo-Pancreatinum Forte contains three enzymes: protease, amylase, and lipase. These are proteins (called enzymes) that help digest and absorb food. Without them, the body does not receive the nutrients it needs. Each capsule of Neo-Pancreatinum Forte contains so-called enteric-coated pellets, which release pancreatin after leaving the stomach.
Neo-Pancreatinum Forte is used in conditions of pancreatic enzyme deficiency of various causes, such as:

• chronic pancreatitis (long-term inflammation of the pancreas - a gland behind the abdomen that produces enzymes),
• cystic fibrosis (a hereditary disease characterized by the production of excessively thick mucus, causing serious disorders in organs such as the lungs or pancreas),
• obstruction of the pancreatic or bile ducts caused by a tumor,
• removal of the pancreas or stomach.

2. Important information before taking Neo-Pancreatinum Forte

When not to take Neo-Pancreatinum Forte:

• If you are allergic to pancreatin or pork protein or any of the other ingredients of this medicine (listed in section 6)
• In acute pancreatitis and in exacerbation of chronic pancreatitis.

Warnings and precautions

Before taking Neo-Pancreatinum Forte, discuss it with your doctor or pharmacist.

Children

A number of cases of intestinal narrowing have been reported in children with cystic fibrosis treated with high doses of certain pancreatin-containing medicines. Children aged 2-8 years are particularly at risk, so special caution and careful monitoring of patients treated with high doses of enzymes are recommended. If abdominal symptoms or worsening of existing symptoms occur, contact your doctor immediately.

Neo-Pancreatinum Forte and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.

• The effectiveness of Neo-Pancreatinum Forte may be reduced if you are taking any medicines that neutralize stomach acid (e.g., antacids or H2 receptor antagonists such as cimetidine, ranitidine, famotidine).
• The medicine may reduce the absorption of folic acid and iron salts.

Taking Neo-Pancreatinum Forte with food and drink

Take Neo-Pancreatinum Forte with meals and a large amount of fluid (see section 3 "How to take Neo-Pancreatinum Forte").

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before taking this medicine.

Driving and using machines

Taking the medicine does not affect the ability to drive and use machines.

3. How to take Neo-Pancreatinum Forte

Always take this medicine exactly as described in the package leaflet or as directed by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.
Take Neo-Pancreatinum Forte during meals, drinking plenty of fluids.

• Swallow the capsules whole; do not chew, crush, or hold them in your mouth, as this may cause irritation of the mucous membranes and reduce the effectiveness of the medicine.
• In case of difficulty swallowing whole capsules (especially in small children), you can empty the pellets from the capsule, mix with a small amount of "acidic" food (e.g., apple or tomato puree), and swallow immediately without chewing, then drink a glass of water or juice.

Recommended dose:
Doses are determined individually based on the degree of pancreatic insufficiency.
Adults
From 2 to 4 capsules per meal.
The dose can only be increased after consulting a doctor.

Use in children

The dose for children should always be determined by a doctor.

Overdose of Neo-Pancreatinum Forte

Immediately consult a doctor or go to the nearest hospital emergency department.
Bring the package leaflet or tablets with you so the doctor knows what you have taken.

Missed dose of Neo-Pancreatinum Forte

Do not take a double dose to make up for a missed dose.
Take the next dose at the scheduled mealtime.

Stopping Neo-Pancreatinum Forte

If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Neo-Pancreatinum Forte can cause side effects, although not everybody gets them.
Immune system disorders:
Taking Neo-Pancreatinum Forte may be associated with the occurrence of allergic symptoms.
These symptoms may include rash, sneezing, tearing.
Gastrointestinal disorders:
When taking high doses of the medicine (significantly exceeding the recommended dose), the following may occur:
diarrhea, nausea, vomiting. Pancreatin may cause irritation of the mucous membranes of the mouth and anus, especially in children.
Renal and urinary disorders:
When taking high doses of the medicine (significantly exceeding the recommended dose), an increase in uric acid levels in serum and urine, kidney stones may occur.
Metabolism and nutrition disorders:
The medicine inhibits the absorption of folic acid and iron salts.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department for 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, tel.: 22 49-21-301, fax: 22 49-21-309, e-mail: ndl@urpl.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Neo-Pancreatinum Forte

Store below 25°C. Protect from light and moisture.
Keep the medicine out of the 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 month.
Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Neo-Pancreatinum Forte contains

• The active substance of the medicine is pancreatin. 1 capsule contains pancreatin in the form of enteric-coated pellets. Pancreatin in each capsule has the following enzymatic activity: lipase 10,000 Ph.Eur., amylase 8,000 Ph.Eur., protease 500 Ph.Eur. (Ph.Eur. is the unit of enzymatic activity according to the European Pharmacopoeia).
• Other ingredients are: pellet: copolymer of methacrylic acid and ethyl acrylate (1:1), triethyl citrate, talc, simethicone; capsule shell outer part: gelatin, purified water, titanium dioxide (E 171), iron oxide red (E 172), iron oxide black (E 172); capsule shell inner part: gelatin, purified water, titanium dioxide (E 171), iron oxide red (E 172), aluminum lake quinoline yellow (E 104).

What Neo-Pancreatinum Forte looks like and contents of the pack

Neo-Pancreatinum Forte is a yellow-brown, elongated, gelatin capsule containing pancreatin in the form of pellets.
Pack size: 20 or 50 capsules in a container with a desiccant.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

PharmaSwiss Česká republika s.r.o.
Jankovcova 1569/2c
170 00 Prague 7
Czech Republic

Manufacturer

Przedsiębiorstwo Farmaceutyczne Jelfa S.A.
ul. Wincentego Pola 21
58-500 Jelenia Góra
Poland
To obtain more detailed information about the medicine, contact the local representative of the marketing authorization holder.
Valeant sp. z o.o. sp. j.
ul. Przemysłowa 2
35-959 Rzeszów
tel. (+48) 17 865 51 00
fax: (+48) 17 862 46 18

Date of last revision of the leaflet: