Enzelo 10000 Capsules

Pancreatin

ENZELO 10000

Each hard gelatin capsule contains:

Pancreatin IP 170 mg

(As enteric coated pellets)

Declared enzyme activity

Amylase (Ph.Eur.U)/U 8000

Lipase (Ph.Eur.U)/U 10000

Protease (Ph.Eur.U)/U 600

Approved Colours used in capsule shell

ENZELO 25000

Each hard gelatin capsule contains: Pancreatin IP 350 mg

(As enteric coated pellets)

Declared enzyme activity

Amylase (Ph.Eur.U)/U 18000

Lipase (Ph.Eur.U)/U 25000

Protease (Ph.Eur.U)/U 1000

Approved Colours used in capsule shell

Capsule

Pancreatin 170 mg / 350 mg

4.1 Therapeutic Indication

For the treatment of pancreatic exocrine insufficiency

4.2 Posology and method of administration

Adults (including the elderly) and children:

Initially one or two capsules during each meal. Dose increases, if required, should be added slowly, with careful monitoring of response and symptomatology.

It is important to ensure adequate hydration of patients at all times whilst dosing Enzelo 25000.

Fibrosing colonopathy has been reported in patients with cystic fibrosis taking in excess of 10,000 units of lipase/kg/day

Method of administration

Oral use.

Capsule should be swallowed whole & not to be opened, chewed or crushed.

4.3 Contraindications

Hypersensitivity to Pancreatin of porcine origin or to any of the excipients

4.4 Special warnings and precautions for use

Strictures of the ileo-caecum and large bowel (fibrosing colonopathy) have been reported in patients with cystic fibrosis taking high doses of pancreatin preparations. As a precaution, unusual abdominal symptoms or changes in abdominal symptoms should be medically assessed to exclude the possibility of fibrosing colonopathy, especially if the patient is taking in excess of 10,000 units of lipase/kg/day.

4.5 Drugs interactions

No interaction studies have been performed.

4.6 Use in special populations

Pregnancy

For pancreatic enzymes no clinical data on exposed pregnancies are available.

Animal studies show no evidence for any absorption of porcine pancreatic enzymes. Therefore, no reproductive or developmental toxicity is to be expected.

Caution should be exercised when prescribing to pregnant women.

Nursing Mothers

No effects on the suckling child are anticipated since animal studies suggest no systemic exposure of the breast-feeding woman to pancreatic enzymes. Pancreatic enzymes can be used during breast-feeding.

If required during pregnancy or lactation Enzelo should be used in doses sufficient to provide adequate nutritional status.

4.7 Effects on ability to drive and use machines

Enzelo has no or negligible influence on the ability to drive or use machines.

4.8 Undesirable effects

*Gastrointestinal disorders are mainly associated with the underlying disease. Similar or lower incidences compared to placebo were reported for abdominal pain and diarrhoea.

Strictures of the ileo-caecum and large bowel (fibrosing colonopathy) have been reported in patients with cystic fibrosis taking high doses of pancreatin preparations, see section 4.4 Special warnings and precautions for use.

Allergic reactions mainly but not exclusively limited to the skin have been observed and identified as adverse reactions during post-approval use. Because these reactions were reported spontaneously from a population of uncertain size, it is not possible to reliably estimate their frequency.

Paediatric population

No specific adverse reactions were identified in the paediatric population. Frequency, type and severity of adverse reactions were similar in children with cystic fibrosis as compared to adults.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via email to: medico@zuventus.com

4.9 Overdose

Extremely high doses of pancreatin have been reported to be associated with hyperuricosuria and hyperuricaemia.

Supportive measures including stopping enzyme therapy and ensuring adequate rehydration are recommended.

5.1 Mechanism of Action

The capsules dissolve rapidly in the stomach releasing plenty of minimicrospheres, a multidose principle which is designed to achieve good mixing with the chyme, emptying from the stomach together with the chyme and after release, good distribution of enzymes within the chyme.

When the minimicrospheres reach the small intestine the coating rapidly disintegrates (at pH > 5.5) to release enzymes with lipolytic, amylolytic and proteolytic activity to ensure the digestion of fats, starches and proteins. The products of pancreatic digestion are then either absorbed directly, or following further hydrolysis by intestinal enzymes.

5.2 Pharmacodynamic properties

Treatment with enzelo markedly improves the symptoms of pancreatic exocrine insufficiency including stool consistency, abdominal pain, flatulence and stool frequency, independent of the underlying disease.

5.3 Pharmacokinetic properties

Pharmacokinetic data are not available as the enzymes act locally in the gastro-intestinal tract. After exerting their action, the enzymes are digested themselves in the intestine.

6.1 Animal Toxicology or Pharmacology

Not applicable.

Pancreatin is a pancreatic enzyme supplement, containing Lipase, Amylase, Protease

8.1 Incompatibilities

Not applicable

8.2 Shelf-life

Refer on Pack

8.3 Packaging information

10 Blister strips of 10 capsules each

8.4 Storage and handing instructions

Store below 25°C.

Protect from light & moisture.

Keep out of reach of children.

• Capsule should be swallowed whole & not to be opened, chewed or crushed.
• Capsule should be taken with the first bite of a meal
• Should be taken with sufficient fluid, adequate hydration should be ensured
• Dosage should not be changed or increased without the physician direction
• Sporadic doses (not taken with food) should be avoided
• Do not take this medicine, if you are allergic to porcine pancreatin.
• Signs of an allergic reaction include a rash, itching or shortness of breath.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
• If you have any further questions, ask your doctor or pharmacist.