FESTAL® N (Pancreatin) 20 EC Tablets

What is FESTAL® N (Pancreatin)?

FESTAL® N (Pancreatin) is a digestive enzyme supplement that aids in the digestion of fats, proteins, and carbohydrates.
It contains pancreatin, a mixture of enzymes such as lipase, amylase, and protease.
FESTAL® N is used to treat conditions like pancreatic insufficiency, where the body does not produce enough digestive enzymes.
It helps improve nutrient absorption and reduces symptoms like bloating and indigestion.
FESTAL® N should be taken with meals to enhance its effectiveness

Each FESTAL® N Tablet Contains:

• Active Ingredient: Pancreatin – 212.5 mg, including:

  • Lipase – 6000 FIP units
  • Amylase – 4500 FIP units
  • Protease – 300 FIP units

• Excipients: Sodium chloride, colloidal silicon dioxide, microcrystalline cellulose, crospovidone, purified water.

• Lower Layer Coating: Hydroxypropylmethylcellulose, polyethylene glycol 8000, talc, titanium dioxide (E 171).

• Enteric Coating: Methacrylic acid copolymer, sodium hydroxide, polyethylene glycol 8000, talc, titanium dioxide (E 171).

• Sugar Coating: Sucrose, methylparaben, propylparaben, gelatin, glucose syrup, talc, calcium carbonate, acacia powder, glycerin, titanium dioxide (E 171), polyethylene glycol 6000, purified water.

How Does FESTAL® N Work?

FESTAL® N contains pancreatin, which is a natural extract from the pancreas that contains essential digestive enzymes.

These enzymes are crucial for breaking down food in the small intestine.

Lipase helps digest fats, amylase breaks down carbohydrates, and protease aids in the digestion of proteins.

By supplementing these enzymes, FESTAL® N helps those with pancreatic insufficiency or other digestive issues to better absorb nutrients from their food.

Who Should Use FESTAL® N?

FESTAL® N is recommended for adults and children over the age of 6 who experience digestive issues due to a lack of pancreatic enzymes.

This includes those with chronic pancreatitis, cystic fibrosis, or other conditions that impair the pancreas's ability to produce these vital enzymes.

It can also be used for temporary digestive discomfort related to dietary issues or as part of preparation for certain medical examinations like radiography or ultrasound.

What Are the Precautions for Using FESTAL® N?

Before using FESTAL® N, it's important to be aware of several precautions:

• Allergic Reactions: Do not use if you are allergic to pancreatin or any of the other ingredients in the tablet.
• Acute Pancreatitis: This product is not recommended during an acute pancreatitis attack or during the exacerbation of chronic pancreatitis. Consult your healthcare provider before use.
• Pediatric Use: Children under the age of 6 should not use FESTAL® N. For children over 6, usage should be determined by a healthcare provider.
• Pregnancy and Breastfeeding: The safety of FESTAL® N during pregnancy or breastfeeding has not been established, so it is recommended to avoid use during these times unless advised by a doctor.
• Gout and Kidney Conditions: This product contains purines, so use it with caution if you have gout, hyperuricemia, or kidney problems.

What Are the Possible Side Effects of FESTAL® N?

While FESTAL® N is generally well-tolerated, some individuals may experience side effects, including:

• Digestive Issues: Abdominal pain, diarrhea, constipation, and nausea.
• Allergic Reactions: Rare cases of allergic reactions such as rashes, itching, or swelling (including angioedema) have been reported.
• High Uric Acid Levels: Prolonged use, especially in high doses, may lead to an increase in uric acid levels, potentially causing gout or kidney stones.
• Fibrosing Colonopathy: Rare but serious cases of colon narrowing have been reported in children with cystic fibrosis taking high doses of pancreatin.

How Should FESTAL® N Be Taken?

• Dosage for Adults: The typical dose is 1-2 tablets taken three times a day with meals.
• Dosage for Children: For children over 6 years old, the dosage should be determined by a healthcare provider, typically starting with 1 tablet three times a day.
• Method of Administration: Swallow the tablets whole with a small amount of liquid during or immediately after meals. Do not chew or crush the tablets as this can reduce their effectiveness and cause mouth irritation.

What to Do in Case of Overdose?

In case of overdose, symptoms may include high levels of uric acid in the blood or urine, and in children, it may cause irritation around the mouth or in the anal area.

If you suspect an overdose, discontinue use and seek medical attention for symptomatic treatment.

How Should FESTAL® N Be Stored?

Store FESTAL® N at a temperature below 25°C (77°F) in a dry place, away from moisture and out of reach of children.

Do not use the tablets after the expiration date.