ENZYSTAL P Tablet, Enteric Coated - nil

Nazione: Tanzania

Lingua: inglese

Fonte: Tanzania Medicinces & Medical Devices Authority

Principio attivo:

Pancreatin

Commercializzato da:

Torrent Pharmaceuticals Limited, INDIA

Codice ATC:

All other non-therapeutic products

INN (Nome Internazionale):

Pancreatin

Dosaggio:

- nil

Forma farmaceutica:

Tablet, Enteric Coated

Prodotto da:

Torrent Pharmaceuticals Limited, INDIA

Dettagli prodotto:

Physical description: Pink colored, round, biconvex, enteric coated tablet; Local technical representative: Phillips Distributors Limited (9823)

Stato dell'autorizzazione:

Registered/Compliant

Data dell'autorizzazione:

2022-04-11

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Trade name : ENZYSTAL P
Generic name : Pancreatin Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each enteric coated tablet contains:
Pancreas powder Ph. Eur. equivalent to
Amylase activity ........... 4200 Ph. Eur. Units
Lipase activity .............. 3500 Ph. Eur. units
Protease activity ............ 250 Ph. Eur. units
Colours: Lake of Carmoisine and Titanium
dioxide Excipients ............ q.s.
3.
PHARMACEUTICAL FORM
Pink coloured, round, biconvex enteric coated tablet.
4.
CLINICAL PARTICULAR
4.1
THERAPEUTIC INDICATION
Pancreatin Tablets 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
Dosage should be adjusted according to the needs of the individual
patient and the amount
and type of food consumed.
The following dosage ranges provide a suitable basis for adjustment.
Adults, the Elderly, and Children
6 - 10 tablets before each snack or meal, swallowed whole.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active ingredient (porcine pancreatin) or any
of the excipients.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Unsuitable
for
people
with
lactase
insufficiency,
galactosaemia
or
glucose/galactose
malabsorption syndrome.
Variations in response to treatment may be due to enteric coating. It
is possible that some
irritation of the skin of the mouth may occur if tablets are chewed or
preparations retained in
the mouth. Irritation of the anus may also occur. A barrier cream may
prevent this local
irritation.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None known.
4.6
FERTILITY, PREGNANCY AND LACTATION
Pancreatin
Tablets
should
not
be
used
in
pregnancy
and
lactation
unless
clearly
necessary but