Enzepi

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

pancreas powder

Saatavilla:

Allergan Pharmaceuticals International Ltd

ATC-koodi:

A09AA02

INN (Kansainvälinen yleisnimi):

pancreas powder

Terapeuttinen ryhmä:

Digestives, incl. enzymes

Terapeuttinen alue:

Exocrine Pancreatic Insufficiency

Käyttöaiheet:

Pancreatic enzyme replacement treatment in exocrine pancreatic insufficiency due to cystic fibrosis or other conditions (e.g. chronic pancreatitis, post pancreatectomy or pancreatic cancer).Enzepi is indicated in infants, children, adolescents and adults.

Tuoteyhteenveto:

Revision: 1

Valtuutuksen tilan:

Withdrawn

Valtuutus päivämäärä:

2016-06-29

Pakkausseloste

32
PACKAGE LEAFLET
Medicinal product no longer authorised
33
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ENZEPI 5,000 UNITS GASTRO-RESISTANT HARD CAPSULES
ENZEPI 10,000 UNITS GASTRO-RESISTANT HARD CAPSULES
ENZEPI 25,000 UNITS GASTRO-RESISTANT HARD CAPSULES
ENZEPI 40,000 UNITS GASTRO-RESISTANT HARD CAPSULES
Pancreas powder
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Enzepi is and what it is used for
2.
What you need to know before you take Enzepi
3.
How to take Enzepi
4.
Possible side effects
5.
How to store Enzepi
6.
Contents of the pack and other information
1.
WHAT ENZEPI IS AND WHAT IT IS USED FOR
Enzepi
is a pancreatic enzyme replacement medicine for people whose bodies do
not make enough of
enzymes to digest food.
Enzepi contains a mixture of natural digestive enzymes which are used
to digest food. These include lipases
for digesting fat, proteases for digesting protein and amylases for
digestions carbohydrates. The enzymes are
taken from pig pancreas glands.
Enzepi is for use by adults, adolescents, children and infants with
‘exocrine pancreatic insufficiency’, a
condition that makes the body less able to break down and digest food.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ENZEPI
DO NOT TAKE ENZEPI
-
if you are allergic to the active subtance or any of the other
ingredients of this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Enzepi
if you have ever had gout, kidney disease, or high uric acid levels in
your blood (hyperur

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Enzepi 5,000 units gastro-resistant hard capsules
Enzepi 10,000 units gastro-resistant hard capsules
Enzepi 25,000 units gastro-resistant hard capsules
Enzepi 40,000 units gastro-resistant hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Enzepi 5,000 units gastro-resistant hard capsules
One capsule contains 39.8 mg of pancreas powder of porcine origin
including the following enzymatic
activities:
lipolytic activity:
5,000 units*,
amylolytic activity:
not less than
1,600 units*,
proteolytic activity:
not less than
130 units*.
Enzepi 10,000 units gastro-resistant hard capsules
One capsule contains 83.7 mg of pancreas powder of porcine origin
including the following enzymatic
activities:
lipolytic activity:
10,000 units*,
amylolytic activity:
not less than
3,200 units*,
proteolytic activity:
not less than
270 units*.
Enzepi 25,000 units gastro-resistant hard capsules
One capsule contains 209.3 mg of pancreas powder of porcine origin
including the following enzymatic
activities:
lipolytic activity:
25,000 units*,
amylolytic activity:
not less than
4,800 units*,
proteolytic activity:
not less than
410 units*.
Enzepi 40,000 units gastro-resistant hard capsules
One capsule contains 334.9 mg of pancreas powder of porcine origin
including the following enzymatic
activities:
lipolytic activity:
40,000 units*,
amylolytic activity:
not less than
7,800 units*,
proteolytic activity:
not less than
650 units*.
* Ph. Eur. units
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gastro-resistant hard capsule.
Enzepi 5,000 units gastro-resistant hard capsules
Hard capsules with a white opaque cap and a white opaque body, printed
with “Enzepi 5” and containing
light-brown gastro-resistant granules.
Medicinal product no longer authorised
3
Enzepi 10,000 units gastro-resistant hard capsules
Hard capsule with a yellow opaque cap and a white opaque body, printed
with “Enzepi 10” an