What is Dropcys - Pancreas Powder used for and what is it used for?
Enzepi is a medicine used to treat adults and children whose pancreas does not produce enough enzymes (a condition known as pancreatic insufficiency) due to cystic fibrosis or other conditions such as pancreatic cancer. Pancreatic enzymes are needed to digest fats, carbohydrates and proteins. Lack of these enzymes leads to poor growth, weight loss, abdominal pain and diarrhea.
The active ingredient in Enzepi is the pancreas powder obtained from porcine pancreas. It contains enzymes that promote the digestion of fats, carbohydrates and proteins.
How is Dropcys - Pancreas Powder used?
Enzepi is available in capsules (5 000, 10 000, 25 000 and 40 000 units). The appropriate dose depends on the symptoms of the disease, the amount of fat in the stool, the fat content in the diet and the weight of the patient. Treatment is started with a low dose which the doctor can gradually increase until the appropriate dose is reached.
Enzepi should be taken with meals or snacks with a glass of water or fruit juice. The capsules must be swallowed whole, without being chewed or crushed. Patients unable to swallow the capsules can open them and mix the contents with a small amount of acid food, such as fruit puree, and swallow the mixture immediately without chewing.
Enzepi can only be obtained with a prescription. For more information, see the package leaflet
How does Dropcys - Pancreas Powder work?
The active ingredient in Enzepi, pancreas powder, is designed to replace the missing enzymes in patients whose pancreas does not produce sufficient amounts of these enzymes. Therefore, Enzepi will help the body better absorb nutrients, especially fats.
Pancreas powder is a known substance authorized for several years for the treatment of pancreatic insufficiency.
What benefit has Dropcys - Pancreas Powder shown during the studies?
Enzepi has been shown to be as effective as a medicine containing already authorized pancreas powder and used to treat pancreatic insufficiency. In a main study involving 96 patients, treatment with Enzepi resulted in the absorption of 84% of the fats consumed by the patient over 72 hours compared to 85% of the fats absorbed with the already authorized medicine.
What are the risks associated with Dropcys - Pancreas Powder?
The most common side effects with Enzepi (which may affect more than 1 in 100 people) are those affecting the intestine (abdominal pain, swelling, diarrhea, vomiting, constipation and nausea) and headache. Most of the side effects seen in clinical studies were mild to moderate in intensity. The most important serious side effects observed with all pancreatic enzyme medicines are anaphylactic (allergic) reactions and fibrosing colonopathy (scarring and thickening of the intestinal wall).
For the full list of restrictions and side effects reported with Enzepi, see the package leaflet.
Why has Dropcys - Pancreas Powder been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Enzepi's benefits are greater than its risks and recommended that it be approved for use in the EU.
The CHMP considered that the use of pancreas powder for the treatment of pancreatic insufficiency has been well established in medical practice for more than 20 years. Enzepi has been shown to be just as effective as a well-known medicine already on the market. As for safety, the side effects of Enzepi are comparable to those of other products on the market.
What measures are being taken to ensure the safe and effective use of Dropcys - Pancreas Powder?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Enzepi have been included in the summary of product characteristics and the package leaflet.
More information on Dropcys - Pancreas Powder
For the full EPAR for Enzepi, consult the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about treatment with Enzepi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
