CREON 25000

Country: Ísrael

Tungumál: enska

Heimild: Ministry of Health

Virkt innihaldsefni:

PANCREATIN

Fáanlegur frá:

ABBOTT MEDICAL LABORATORIES LTD, ISRAEL

ATC númer:

A09AA02

Lyfjaform:

CAPSULES

Samsetning:

PANCREATIN 300 MG

Stjórnsýsluleið:

PER OS

Gerð lyfseðils:

Required

Framleitt af:

ABBOTT LABORATORIES GMBH , GERMANY

Meðferðarhópur:

MULTIENZYMES (LIPASE, PROTEASE ETC.)

Lækningarsvæði:

MULTIENZYMES (LIPASE, PROTEASE ETC.)

Ábendingar:

For the treatment of pancreatic exocrine insufficiency.

Leyfisdagur:

2020-08-31

Upplýsingar fylgiseðill

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only
CREON 25,000
CAPSULES
Each capsule contains: Pancreatin 300 mg, comprising:
Lipase 25,000 Ph. Eur. Units
Amylase 18,000 Ph. Eur. Units
Protease 1,000 Ph. Eur. Units
For a list of 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.
This medicine has been prescribed for you. Do not pass it on
to others. It may harm them, even if it seems to you that their
medical condition is similar.
- Creon 25,000 is a high-dosage 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 medicine should 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, excision of the pancreas and partial excision of
the digestive system in adults and children.
THERAPEUTIC GROUP: Digestive enzymes.
2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF:
you are sensitive (

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
CREON
® 25000
1. NAME OF THE MEDICINAL PRODUCT
CREON
® 25000, CAPSULES
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule Creon 25000 contains 300 mg pancreatin (pancreas powder)
corresponding
to:
Amylase
18,000 Ph.Eur. units
Lipase
25,000 Ph.Eur. units
Protease
1,000 Ph.Eur. units
3. PHARMACEUTICAL FORM
Gastro-resistant
capsule,
hard
(hard
gelatin
capsules
filled
with
gastro-resistant
pellets
(=Minimicrospheres™).
Bicoloured capsule with Swedish orange opaque cap and transparent
body.
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of pancreatic exocrine deficiency.
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 capsule with meals. Dose increases, if required, should
be added slowly with
careful monitoring of response and symptomatology.
For infants and children a median lipase intake of 10,000 Ph.Eur.
units per kg body weight a day
is recommended. A daily lipase intake of 15,000 - 20,000 Ph.Eur. units
per kg body weight
should not be exceeded.
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 impor