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Medically reviewed by Oliinyk Elizabeth Ivanovna, PharmD. Last updated on 15.05.2022
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Pancreatic insufficiency
Pancreatic enzyme supplements commonly cause gastrointestinal adverse effects such as abdominal discomfort and nausea and vomiting. They may also cause buccal and perianal irritation, particularly in infants. Colonic strictures (fibrosing colonopathy) have occurred, mainly in children with cystic fibrosis receiving high doses of Pancreatin (Neo Life Enzyme) preparations; the use of high doses in patients with cystic fibrosis should preferably be avoided. Adequate hydration should be maintained at all times in patients receiving higher strength preparations.
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.Papain (Neo Life Enzyme) consists chiefly of a mixture of Papain (Neo Life Enzyme) and chymopapain, proteolytic enzymes that hydrolyse polypeptides, amides, and esters, especially at bonds involving basic amino acids, or leucine or glycine, yielding peptides of lower molecular weight. It is used with urea as a topical debriding agent. It is also used for the removal of protein deposits from the surface of soft contact lenses ().
Preparations of Papain (Neo Life Enzyme), alone or combined with antibacterial agents and/or other substances, have been taken by mouth for their supposed anti-inflammatory properties, and it has also been used as an ingredient of various mixtures claimed to aid digestion.
Papain (Neo Life Enzyme) is widely used as a meat tenderiser and in the clarification of beverages.
Malignant neoplasms.
Papain (Neo Life Enzyme) has been included in proteolytic enzyme preparations used in oncology to reduce the adverse effects of chemotherapy and radiotherapy. Although the number of clinical studies on which to judge efficacy is limited, a review1 of such studies suggested that systemic enzyme therapy might be beneficial. Clinical studies have used a preparation containing Papain (Neo Life Enzyme), trypsin, and chymotrypsin in a weight ratio of 5:2:2, and the beneficial effect seems to be based on its anti-inflammatory potential.
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.dyspepsia without hyperacidity, oral vehicle
Pancreatin (Neo Life Enzyme) (pancrelipase) is a combination of three enzymes (proteins): lipase, protease, and amylase. These enzymes are normally produced by the pancreas and are important in the digestion of fats, proteins, and sugars.
Pancreatin (Neo Life Enzyme) is used to replace these enzymes when the body does not have enough of its own. Certain medical conditions can cause this lack of enzymes, including cystic fibrosis, chronic inflammation of the pancreas, or blockage of the pancreatic ducts.
Pancreatin (Neo Life Enzyme) may also be used following surgical removal of the pancreas.
Pancreatin (Neo Life Enzyme) may also be used for purposes not listed in this medication guide.
Pancreatin (Neo Life Enzyme) is not interchangeable with other pancrelipase products.
Pancreatin (Neo Life Enzyme) is orally administered. Therapy should be initiated at the lowest recommended dose and gradually increased. The dosage of Pancreatin (Neo Life Enzyme) should be individualized based on clinical symptoms, the degree of steatorrhea present, and the fat content of the diet as described in the Limitations on Dosing below.
Administration
Infants (up to 12 months)
Pancreatin (Neo Life Enzyme) should be administered to infants immediately prior to each feeding, using a dosage of 3,000 lipase units per 120 mL of formula or prior to breast-feeding. Contents of the capsule may be administered directly to the mouth or with a small amount of applesauce. Administration should be followed by breast milk or formula. Contents of the capsule should not be mixed directly into formula or breast milk as this may diminish efficacy. Care should be taken to ensure that Pancreatin (Neo Life Enzyme) is not crushed or chewed or retained in the mouth, to avoid irritation of the oral mucosa.
Children and Adults
Pancreatin (Neo Life Enzyme) should be taken during meals or snacks, with sufficient fluid. Pancreatin (Neo Life Enzyme) capsules and capsule contents should not be crushed or chewed. Capsules should be swallowed whole.
For patients who are unable to swallow intact capsules, the capsules may be carefully opened and the contents added to a small amount of acidic soft food with a pH of 4.5 or less, such as applesauce, at room temperature. The Pancreatin (Neo Life Enzyme)-soft food mixture should be swallowed immediately without crushing or chewing, and followed with water or juice to ensure complete ingestion. Care should be taken to ensure that no drug is retained in the mouth.
Dosage
Dosage recommendations for pancreatic enzyme replacement therapy were published following the Cystic Fibrosis Foundation Consensus Conferences.1, 2, 3 Pancreatin (Neo Life Enzyme) should be administered in a manner consistent with the recommendations of the Cystic Fibrosis Foundation Consensus Conferences (also known as Conferences) provided in the following paragraphs, except for infants. Although the Conferences recommend doses of 2,000 to 4,000 lipase units in infants up to 12 months, Pancreatin (Neo Life Enzyme) is available in a 3,000 lipase unit capsule. Therefore, the recommended dose of Pancreatin (Neo Life Enzyme) in infants up to 12 months is 3,000 lipase units per 120 mL of formula or per breast-feeding. Patients may be dosed on a fat ingestion-based or actual body weight-based dosing scheme.
Additional recommendations for pancreatic enzyme therapy in patients with exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy are based on a clinical trial conducted in these populations.
Infants (up to 12 months)
Pancreatin (Neo Life Enzyme) is available in the strength of 3,000 USP units of lipase thus infants may be given 3,000 lipase units (one capsule) per 120 mL of formula or per breast-feeding. Do not mix Pancreatin (Neo Life Enzyme) capsule contents directly into formula or breast milk prior to administration.
Children Older than 12 Months and Younger than 4 Years
Enzyme dosing should begin with 1,000 lipase units/kg of body weight per meal for children less than age 4 years to a maximum of 2,500 lipase units/kg of body weight per meal (or less than or equal to 10,000 lipase units/kg of body weight per day), or less than 4,000 lipase units/g fat ingested per day.
Children 4 Years and Older and Adults
Enzyme dosing should begin with 500 lipase units/kg of body weight per meal for those older than age 4 years to a maximum of 2,500 lipase units/kg of body weight per meal (or less than or equal to 10,000 lipase units/kg of body weight per day), or less than 4,000 lipase units/g fat ingested per day.
Usually, half of the prescribed Pancreatin (Neo Life Enzyme) dose for an individualized full meal should be given with each snack. The total daily dose should reflect approximately three meals plus two or three snacks per day.
Enzyme doses expressed as lipase units/kg of body weight per meal should be decreased in older patients because they weigh more but tend to ingest less fat per kilogram of body weight.
Adults with Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis or Pancreatectomy
The initial starting dose and increases in the dose per meal should be individualized based on clinical symptoms, the degree of steatorrhea present, and the fat content of the diet.
In one clinical trial, patients received Pancreatin (Neo Life Enzyme) at a dose of 72,000 lipase units per meal while consuming at least 100 g of fat per day. Lower starting doses recommended in the literature are consistent with the 500 lipase units/kg of body weight per meal lowest starting dose recommended for adults in the Cystic Fibrosis Foundation Consensus Conferences Guidelines. If symptoms and signs of steatorrhea persist, the dosage may be increased by the healthcare professional. Patients should be instructed not to increase the dosage on their own. There is great inter-individual variation in response to enzymes; thus, a range of doses is recommended. Changes in dosage may require an adjustment period of several days. If doses are to exceed 2,500 lipase units/kg of body weight per meal, further investigation is warranted. Doses greater than 2,500 lipase units/kg of body weight per meal (or greater than 10,000 lipase units/kg of body weight per day) should be used with caution and only if they are documented to be effective by 3-day fecal fat measures that indicate a significantly improved coefficient of fat absorption. Doses greater than 6,000 lipase units/kg of body weight per meal have been associated with colonic stricture, indicative of fibrosing colonopathy, in children less than 12 years of age. Patients currently receiving higher doses than 6,000 lipase units/kg of body weight per meal should be examined and the dosage either immediately decreased or titrated downward to a lower range.
How supplied
Dosage Forms And Strengths
The active ingredient in Pancreatin (Neo Life Enzyme) evaluated in clinical trials is lipase. Pancreatin (Neo Life Enzyme) is dosed by lipase units.
Other active ingredients include protease and amylase. Each Pancreatin (Neo Life Enzyme) delayed-release capsule strength contains the specified amounts of lipase, protease, and amylase as follows:
- 3,000 USP units of lipase; 9,500 USP units of protease; 15,000 USP units of amylase delayed-release capsules have a white opaque cap with imprint “Pancreatin (Neo Life Enzyme) 1203” and a white opaque body.
- 6,000 USP units of lipase; 19,000 USP units of protease; 30,000 USP units of amylase delayed-release capsules have an orange opaque cap with imprint “Pancreatin (Neo Life Enzyme) 1206” and a blue opaque body.
- 12,000 USP units of lipase; 38,000 USP units of protease; 60,000 USP units of amylase delayed-release capsules have a brown opaque cap with imprint “Pancreatin (Neo Life Enzyme) 1212” and a colorless transparent body.
- 24,000 USP units of lipase; 76,000 USP units of protease; 120,000 USP units of amylase delayed-release capsules have an orange opaque cap with imprint “Pancreatin (Neo Life Enzyme) 1224” and a colorless transparent body.
- 36,000 USP units of lipase; 114,000 USP units of protease; 180,000 USP units of amylase delayed-release capsules have a blue opaque cap with imprint “Pancreatin (Neo Life Enzyme) 1236” and a colorless transparent body.
Pancreatin (Neo Life Enzyme) (pancrelipase) Delayed-Release Capsules
3,000 USP units of lipase; 9,500 USP units of protease; 15,000 USP units of amylase
Each Pancreatin (Neo Life Enzyme) capsule is available as a two piece hypromellose capsule with a white opaque cap with imprint “Pancreatin (Neo Life Enzyme) 1203” and a white opaque body that contains tan colored, delayed-release pancrelipase supplied in bottles of:
70 capsules (NDC 0032-1203-70)
Pancreatin (Neo Life Enzyme) (pancrelipase) Delayed-Release Capsules
6,000 USP units of lipase; 19,000 USP units of protease; 30,000 USP units of amylase
Each Pancreatin (Neo Life Enzyme) capsule is available as a two-piece gelatin capsule with orange opaque cap with imprint “Pancreatin (Neo Life Enzyme) 1206” and a blue opaque body that contains tan-colored, delayed-release pancrelipase supplied in bottles of:
100 capsules (NDC 0032-1206-01)
250 capsules (NDC 0032-1206-07)
Pancreatin (Neo Life Enzyme) (pancrelipase) Delayed-Release Capsules
12,000 USP units of lipase; 38,000 USP units of protease; 60,000 USP units of amylase
Each Pancreatin (Neo Life Enzyme) capsule is available as a two-piece gelatin capsule with a brown opaque cap with imprint “Pancreatin (Neo Life Enzyme) 1212” and a colorless transparent body that contains tan-colored, delayed-release pancrelipase supplied in bottles of:
100 capsules (NDC 0032-1212-01)
250 capsules (NDC 0032-1212-07)
Pancreatin (Neo Life Enzyme) (pancrelipase) Delayed-Release Capsules
24,000 USP units of lipase; 76,000 USP units of protease; 120,000 USP units of amylase
Each Pancreatin (Neo Life Enzyme) capsule is available as a two-piece gelatin capsule with orange opaque cap with imprint “Pancreatin (Neo Life Enzyme) 1224” and a colorless transparent body that contains tan-colored, delayed-release pancrelipase supplied in bottles of:
100 capsules (NDC 0032-1224-01)
250 capsules (NDC 0032-1224-07)
Pancreatin (Neo Life Enzyme) (pancrelipase) Delayed-Release Capsules
36,000 USP units of lipase; 114,000 USP units of protease; 180,000 USP units of amylase
Each Pancreatin (Neo Life Enzyme) capsule is available as a two-piece gelatin capsule with blue opaque cap with imprint “Pancreatin (Neo Life Enzyme) 1236” and a colorless transparent body that contains tan-colored, delayed-release pancrelipase supplied in bottles of:
100 capsules (NDC 0032-3016-13)
250 capsules (NDC 0032-3016-28)
Storage and Handling
Pancreatin (Neo Life Enzyme) must be stored at room temperature up to 25°C (77°F) and protected from moisture. Temperature excursions are permitted between 25°C to 40°C (77°F and 104°F) for up to 30 days. Product should be discarded if exposed to higher temperature and moisture conditions higher than 70%. After opening, keep bottle tightly closed between uses to protect from moisture.
Bottles of Pancreatin (Neo Life Enzyme) 3,000 USP units of lipase must be stored and dispensed in the original container.
Do not crush Pancreatin (Neo Life Enzyme) delayed-release capsules or the capsule contents.
REFERENCES
1 Borowitz DS, Grand RJ, Durie PR, et al. Use of pancreatic enzyme supplements for patients with cystic fibrosis in the context of fibrosing colonopathy. Journal of Pediatrics. 1995; 127: 681-684.
2 Borowitz DS, Baker RD, Stallings V. Consensus report on nutrition for pediatric patients with cystic fibrosis. Journal of Pediatric Gastroenterology Nutrition. 2002 Sep; 35: 246-259.
3 Stallings VA, Stark LJ, Robinson KA, et al. Evidence-based practice recommendations for nutrition-related management of children and adults with cystic fibrosis and pancreatic insufficiency: results of a systematic review. Journal of the American Dietetic Association. 2008; 108: 832-839.
4 Dominguez-Munoz JE. Pancreatic enzyme therapy for pancreatic exocrine insufficiency. Current Gastroenterology Reports. 2007; 9: 116-122.
Manufactured by: Abbott Laboratories GmbH, Hannover, Germany. Marketed by: AbbVie Inc., North Chicago, IL 60064, U.S.A. Revised: September, 2012
Chew or suck 2 tab qds for the 1st day, then 1 tab qds for at least 5 days.
See also:
What is the most important information I should know about Pancreatin (Neo Life Enzyme)?
Hypersensitivity to Pancreatin (Neo Life Enzyme) or to any of the excipients of Pancreatin (Neo Life Enzyme).
Patients w/ generalised or systemic infections or w/ disorders of blood coagulation.
Use Pancreatin (Neo Life Enzyme) as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Pancreatin (Neo Life Enzyme) comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Pancreatin (Neo Life Enzyme) refilled.
- Take Pancreatin (Neo Life Enzyme) by mouth with each meal or snack as directed by your doctor.
- Swallow Pancreatin (Neo Life Enzyme) whole with enough liquid to swallow it completely. Do not break, crush, chew, or hold Pancreatin (Neo Life Enzyme) in your mouth before swallowing. Doing so may increase the risk of mouth irritation from Pancreatin (Neo Life Enzyme). Follow with a glass of water or juice. Contact your doctor if you experience mouth irritation while taking Pancreatin (Neo Life Enzyme).
- If the patient is an infant (up to 12 months old), open the capsule and sprinkle the contents into the infant's mouth or over a small amount of applesauce at room temperature. Do NOT mix Pancreatin (Neo Life Enzyme) directly in breast milk or formula. If sprinkled onto applesauce, give the mixture to the infant right away. After giving Pancreatin (Neo Life Enzyme), follow it with breast milk or formula. Be sure that none of the medicine is crushed, chewed, or left in the mouth.
- If the patient is an adult or child older than 12 months old who cannot swallow the capsule whole, open it and sprinkle the contents over a small amount of acidic soft food (such as applesauce) at room temperature. Mix the medicine with the food and swallow the entire mixture right away, followed by a glass of water or juice. Be sure that none of the medicine is crushed, chewed, or left in the mouth. Check with your doctor if you are unsure which foods you may mix with Pancreatin (Neo Life Enzyme).
- If you miss a dose of Pancreatin (Neo Life Enzyme), skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once or take a dose without a snack or a meal.
Ask your health care provider any questions you may have about how to use Pancreatin (Neo Life Enzyme).
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.This medication contains digestive enzymes, which are natural substances needed by the body to help break down and digest food. It is used when the pancreas cannot make or does not release enough digestive enzymes into the gut to digest the food. Depending on the amount of enzymes in your product, it may be used for indigestion, as a supplement, or as replacement therapy (e.g., in chronic pancreatitis, cystic fibrosis, cancer of the pancreas, after surgery on the pancreas or gut).
Some supplement products have been found to contain possibly harmful impurities/additives. Check with your pharmacist for more details about the brand you use.
The FDA has not reviewed this product for safety or effectiveness. Consult your doctor or pharmacist for more details.
How to use Pancreatin (Neo Life Enzyme)
Take this medication by mouth with meals and snacks as directed by your doctor.
The dosage is based on your medical condition, diet, and response to treatment.
If you are using the tablet form of the medication, make sure not to keep it in the mouth because doing so can cause irritation to the gums and cheeks. Swallow the medication with water. For the chewable tablets, chew thoroughly before swallowing.
If you are using the capsule form of the medication and swallowing is difficult, the capsule may be opened and the powder mixed with food or liquid.
Be careful not to inhale any of the powder because doing so can irritate the inside of the nose or cause an asthma attack.
Use this medication regularly to get the most benefit from it.
If your doctor has recommended that you follow a special diet, it is very important to follow the diet to get the most benefit from this medication.
Do not change brands or dosage forms of this product without consulting your doctor or pharmacist. Different products may contain different amounts of the digestive enzymes.
Tell your doctor if your condition persists or worsens.
See also:
What other drugs will affect Pancreatin (Neo Life Enzyme)?
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Some products that may interact with this drug include: acarbose, miglitol.
Anti-coagulants.
See also:
What are the possible side effects of Pancreatin (Neo Life Enzyme)?
The most serious adverse reactions reported with different pancreatic enzyme products of the same active ingredient (pancrelipase) that are described elsewhere in the label include fibrosing colonopathy, hyperuricemia and allergic reactions.
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The short-term safety of Pancreatin (Neo Life Enzyme) was assessed in clinical trials conducted in 121 patients with exocrine pancreatic insufficiency (EPI): 67 patients with EPI due to cystic fibrosis (CF) and 25 patients with EPI due to chronic pancreatitis or pancreatectomy were treated with Pancreatin (Neo Life Enzyme).
Cystic Fibrosis
Studies 1 and 2 were randomized, double-blind, placebo-controlled, crossover studies of 49 patients, ages 7 to 43 years, with EPI due to CF. Study 1 included 32 patients ages 12 to 43 years and Study 2 included 17 patients ages 7 to 11 years. In these studies, patients were randomized to receive Pancreatin (Neo Life Enzyme) at a dose of 4,000 lipase units/g fat ingested per day or matching placebo for 5 to 6 days of treatment, followed by crossover to the alternate treatment for an additional 5 to 6 days. The mean exposure to Pancreatin (Neo Life Enzyme) during these studies was 5 days.
In Study 1, one patient experienced duodenitis and gastritis of moderate severity 16 days after completing treatment with Pancreatin (Neo Life Enzyme). Transient neutropenia without clinical sequelae was observed as an abnormal laboratory finding in one patient receiving Pancreatin (Neo Life Enzyme) and a macrolide antibiotic.
In Study 2, adverse reactions that occurred in at least 2 patients (greater than or equal to 12%) treated with Pancreatin (Neo Life Enzyme) were vomiting and headache. Vomiting occurred in 2 patients treated with Pancreatin (Neo Life Enzyme) and did not occur in patients treated with placebo; headache occurred in 2 patients treated with Pancreatin (Neo Life Enzyme) and did not occur in patients treated with placebo.
The most common adverse reactions (greater than or equal to 4%) in Studies 1 and 2 were vomiting, dizziness, and cough. Table 1 enumerates adverse reactions that occurred in at least 2 patients (greater than or equal to 4%) treated with Pancreatin (Neo Life Enzyme) at a higher rate than with placebo in Studies 1 and 2.
Table 1: Adverse Reactions Occurring in at Least 2 Patients (greater than or equal to 4%) in Cystic Fibrosis (Studies 1 and 2)
Adverse Reaction | Pancreatin (Neo Life Enzyme) Capsules n = 49(%) | Placebo n = 47(%) |
Vomiting | 3 (6) | 1 (2) |
Dizziness | 2 (4) | 1 (2) |
Cough | 2 (4) | 0 |
An additional open-label, single-arm study assessed the short-term safety and tolerability of Pancreatin (Neo Life Enzyme) in 18 infants and children, ages 4 months to 6 years, with EPI due to cystic fibrosis. Patients received their usual pancreatic enzyme replacement therapy (mean dose of 7,000 lipase units/kg/day for a mean duration of 18.2 days) followed by Pancreatin (Neo Life Enzyme) (mean dose of 7,500 lipase units/kg/day for a mean duration of 12.6 days). There were no serious adverse reactions. Adverse reactions that occurred in patients during treatment with Pancreatin (Neo Life Enzyme) were vomiting, irritability, and decreased appetite, each occurring in 6% of patients.
Chronic Pancreatitis or Pancreatectomy
A randomized, double-blind, placebo-controlled, parallel group study was conducted in 54 adult patients, ages 32 to 75 years, with EPI due to chronic pancreatitis or pancreatectomy. Patients received single-blind placebo treatment during a 5-day run-in period followed by an intervening period of up to 16 days of investigatordirected treatment with no restrictions on pancreatic enzyme replacement therapy. Patients were then randomized to receive Pancreatin (Neo Life Enzyme) or matching placebo for 7 days. The Pancreatin (Neo Life Enzyme) dose was 72,000 lipase units per main meal (3 main meals) and 36,000 lipase units per snack (2 snacks). The mean exposure to Pancreatin (Neo Life Enzyme) during this study was 6.8 days in the 25 patients that received Pancreatin (Neo Life Enzyme).
The most common adverse reactions reported during the study were related to glycemic control and were reported more commonly during Pancreatin (Neo Life Enzyme) treatment than during placebo treatment.
Table 2 enumerates adverse reactions that occurred in at least 1 patient (greater than or equal to 4%) treated with Pancreatin (Neo Life Enzyme) at a higher rate than with placebo.
Table 2: Adverse Reactions in at Least 1 Patient (greater than or equal to 4%) in the Chronic Pancreatitis or Pancreatectomy Trial
Adverse Reaction | Pancreatin (Neo Life Enzyme) Capsules n = 25(%) | Placebo n = 29 (%) |
Hyperglycemia | 2 (8) | 2 (7) |
Hypoglycemia | 1 (4) | 1 (3) |
Abdominal Pain | 1 (4) | 1 (3) |
Abnormal Feces | 1 (4) | 0 |
Flatulence | 1 (4) | 0 |
Frequent Bowel Movements | 1 (4) | 0 |
Nasopharyngitis | 1 (4) | 0 |
Postmarketing Experience
Postmarketing data from this formulation of Pancreatin (Neo Life Enzyme) have been available since 2009. The following adverse reactions have been identified during post approval use of this formulation of Pancreatin (Neo Life Enzyme). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Gastrointestinal disorders (including abdominal pain, diarrhea, flatulence, constipation and nausea), skin disorders (including pruritus, urticaria and rash), blurred vision, myalgia, muscle spasm, and asymptomatic elevations of liver enzymes have been reported with this formulation of Pancreatin (Neo Life Enzyme).
Delayed- and immediate-release pancreatic enzyme products with different formulations of the same active ingredient (pancrelipase) have been used for the treatment of patients with exocrine pancreatic insufficiency due to cystic fibrosis and other conditions, such as chronic pancreatitis. The long-term safety profile of these products has been described in the medical literature. The most serious adverse reactions included fibrosing colonopathy, distal intestinal obstruction syndrome (DIOS), recurrence of pre-existing carcinoma, and severe allergic reactions including anaphylaxis, asthma, hives, and pruritus.
Hypersensitivity reactions have occurred.
Effects on the eyes.
Ocular and periorbital angioedema occurring within 4 hours of use of a contact lens cleansing solution containing Papain (Neo Life Enzyme) has been reported.1
Extensive destruction of the oesophageal wall, with perforation, resulted from the use of a Papain (Neo Life Enzyme) suspension given to treat an obstruction caused by impacted meat.1 The patient had been given 1.2 g of Papain (Neo Life Enzyme) over a 12-hour period. Ten days after a thoracotomy, the descending thoracic aorta ruptured, and she died from haemorrhage.
Each hard-gelatin capsule contains Pancreatin (Neo Life Enzyme) (pancreas powder) 150 mg corresponding to amylase 8000 Ph Eur units, lipase 10,000 Ph Eur units and protease 600 Ph Eur units. It also contains the following excipients: Core Pellet: Macrogol 4000. Pellet Coating: Hypermellose phthalate, dimethicone 1000, triethyl citrate, cetyl alcohol. Capsule: Iron oxide (E172), titanium dioxide (E171), sodium lauryl sulphate, gelatin.
Diastase + Pepsin (Neo Life Enzyme) is indicated as a digestive aid and for the treatment of acid indigestion, sour stomach, flatulence, epigastric distress, dyspepsia, eructation and to increase appetite.