CREON 10000

Nazione: Israele

Lingua: inglese

Fonte: Ministry of Health

Principio attivo:

PANCREATIN

Commercializzato da:

ABBOTT MEDICAL LABORATORIES LTD, ISRAEL

Codice ATC:

A09AA02

Forma farmaceutica:

CAPSULES

Composizione:

PANCREATIN 150 MG

Via di somministrazione:

PER OS

Tipo di ricetta:

Not required

Prodotto da:

ABBOTT LABORATORIES GMBH , GERMANY

Gruppo terapeutico:

MULTIENZYMES (LIPASE, PROTEASE ETC.)

Area terapeutica:

MULTIENZYMES (LIPASE, PROTEASE ETC.)

Indicazioni terapeutiche:

Pancreatic exocrine insufficiency.

Data dell'autorizzazione:

2022-02-23

Foglio illustrativo

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed without a doctor’s prescription
CREON 10,000
CAPSULES
Each capsule contains: Pancreatin 150 mg, comprising:
Lipase 10,000 Ph. Eur. Units
Amylase 8,000 Ph. Eur. Units
Protease 600 Ph. Eur. Units
For the inactive ingredients in the medicine, see section 6.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE
MEDICINE. This leaflet contains concise information about the
medicine. If you have further questions, refer to the doctor or
pharmacist. Use this medicine in the correct manner.
Consult a pharmacist if you need further information.
- Creon 10,000 is a pancreatic enzyme supplement indicated
for people whose bodies cannot produce enough enzymes
required to digest food.
- The capsules contain a mix of natural enzymes used to
digest food.
- The enzymes are extracted from pig pancreas.
- The capsules must be taken as per the doctor’s
instructions.
- Take the medicine together with a meal or snack, with a lot
of water (see section 3).
- Do not take the medicine if you are allergic to pig-derived
ingredients, pig proteins (see section 2).
- If you experience SEVERE ABDOMINAL PAINS during the
course of treatment with the medicine, refer to the doctor
immediately (see section 4).
1. WHAT IS THE MEDICINE INTENDED FOR?
The medicine is intended to treat exocrine pancreatic
insufficiency. The medicine contains pancreatic enzymes
which aid digestion, in cases where the pancreas does not
produce these enzymes, or does not produce enough of them.
The medicine is intended to balance low enzymatic activity in
the intestine, in cases of pancreatic insufficiency, e.g., cystic
fibrosis, chronic pancreatitis and malabsorption of lipids also
related to the pancreas.
THERAPEUTIC GROUP: Digestive enzymes.
2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF:
you are sensitive (allergic) to the active ingredient,
pancreatin, to products of pig origin, pig proteins or to any
of the additional ingredient

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
CREON
®
10,000
1. NAME OF THE MEDICINAL PRODUCT
Creon
®
10,000, Capsules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains:
150 mg pancreatin (pancreas powder) corresponding to
Amylase
8,000 Ph.Eur. units
Lipase
10,000 Ph.Eur. units
Protease
600 Ph.Eur. units
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Brown/clear capsules containing gastro-resistant granules.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of Pancreatic exocrine insufficiency.
Enzyme replacement therapy in patients with deficient exocrine
pancreatic secretions, cystic
fibrosis, chronic pancreatitis, postpancreatectomy, ductal
obstructions caused by cancer of the
pancreas,
pancreatic
insufficiency
and
for
steatorrhea
of
malabsorption
syndrome
and
postgastrectomy (Billroth II and Total).
Presumptive test for pancreatic function, especially in pancreatic
insufficiency due to chronic
pancreatitis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The posology aims at individual needs and depends on the severity of
the disease and the
composition of food.
It is recommended to take the enzymes during or immediately after each
meal or snack.
Adults (including the elderly) and children:
Initially one to two capsules with each meal.
Dose increases, if required, should be added slowly, with careful
monitoring of response and
symptomatology.
The capsules can be swallowed whole, or for ease of administration
they may be opened
and the granules taken with acidic fluid or soft food, but without
chewing.
This could be apple sauce or yoghurt or any fruit juice with a pH less
than 5.5, e.g. apple,
orange or pineapple juice. If the granules are mixed with fluid or
food it is important that they
are taken immediately and the mixture not stored, otherwise
dissolution of the enteric
coating may result. In order to protect the enteric coating, it is
important that the granules
are not crushed or chewed
Crushing and chewing of the minimicrospheres or mixing with food or
flui