Pancrex V 125mg capsules

Ülke: Birleşik Krallık

Dil: İngilizce

Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktif bileşen:

Amylase; Lipase; Protease

Mevcut itibaren:

Essential Pharma Ltd

ATC kodu:

A09AA02

INN (International Adı):

Amylase; Lipase; Protease

Doz:

3300unit ; 2950unit ; 160unit

Farmasötik formu:

Oral capsule

Uygulama yolu:

Oral

Sınıf:

No Controlled Drug Status

Reçete türü:

Never Valid To Prescribe As A VMP

Ürün özeti:

BNF: 01090400; GTIN: 5015001142111

Bilgilendirme broşürü

P
P
EAN CODE
5060312430051
EAN CODE
5060312430051
BN:
EXP:
Pan125mgCap-LPL-UK-4
Pan125mgCap-LPL-UK-4
Pan125mgCap-LPL-UK-4
Tear here,
BUT DO NOT REMOVE
_PACKAGE LEAFLET: INFORMATION FOR THE USER_
PANCREX V 125 MG HARD CAPSULES
pancreatin
The full name of this medicine is “Pancrex V 125 mg hard
capsules”. The short form of the
name “Pancrex V” is used throughout the remainder of the package
leaflet.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist have
told you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
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.
-
You must talk to a doctor if you do not feel better or if you feel
worse.
WHAT IS IN THIS LEAFLET
1.
What Pancrex V is and what it is used for
2.
What you need to know before you take Pancrex V
3.
How to take Pancrex V
4.
Possible side effects
5.
How to store Pancrex V
6.
Contents of the pack and other information
1.
WHAT PANCREX V IS AND WHAT IT IS USED FOR
Pancrex V contains the active substance pancreatin.
Pancreatin is a combination of enzymes normally produced by the
pancreas which
help to digest protein, fat, starch and sugars in the food that you
eat.
Pancreatin is given to people who do not produce enough enzymes to
digest their
food properly, in conditions such as cystic fibrosis, persistent
inflammation of the
pancreas, and when the pancreas has been removed. Pancrex V may also
be used
when the stomach has been removed, as an aid to digestion.
These low-dose capsules may be used when small amounts of pancreatin
are required,
such as in newborns.
The pancreatin in Pancrex V is derived from pancreases of pigs.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PANCREX V
DO NOT TAKE PANCREX V
-
If you are allergic to pancreat

Ürün özellikleri

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Pancrex V 125 mg hard capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 125 mg pancreatin to provide enzymatic
activity per
capsule not less than:
Free protease
160 BP units
Lipase
2950 BP units
Amylase
3300 BP units
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Hard capsule (capsule).
A white or buff coloured powder in clear hard gelatin capsules.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Pancrex V is used to compensate for reduced intestinal enzyme activity
in pancreatic
deficiency states.
It is indicated for the treatment of fibrocystic disease of the
pancreas (cystic fibrosis),
chronic pancreatitis and pancreatic steatorrhoea following
pancreatectomy. It may
also be indicated following gastrectomy as an aid to digestion.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
These low dose capsules may be used when small amounts of Pancrex V
are required,
for example for neonates.
Dosage should be adjusted according to the needs of the individual
patient and the
amount of food consumed.
The following dosage scale provides a suitable basis for adjustment.
_Paediatric population _
Neonates: The contents of 1-2 capsules mixed with feeds.
Method of administration
Oral use.
The capsules should be taken with each feed or before a meal.
If the capsule contents are mixed with liquids or feeds the resulting
mixture should
not be allowed to stand for more than one hour prior to use.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section
6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
It is possible that some irritation of the skin of the mouth may occur
if capsules are
chewed or the contents retained in the mouth. Irritation of the anus
may also occur. A
barrier cream may prevent this local irritation.
Allergic/asthmatic reactions have occasionally occurred on handling
the capsule
contents.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND