URSOLIT 100

Land: Israel

Sprache: Englisch

Quelle: Ministry of Health

Wirkstoff:

URSODEOXYCHOLIC ACID

Verfügbar ab:

CTS CHEMICAL INDUSTRIES LTD, ISRAEL

ATC-Code:

A05AA02

Darreichungsform:

TABLETS

Zusammensetzung:

URSODEOXYCHOLIC ACID 100 MG

Verabreichungsweg:

PER OS

Verschreibungstyp:

Required

Hergestellt von:

CTS CHEMICAL INDUSTRIES LTD, ISRAEL

Therapiegruppe:

URSODEOXYCHOLIC ACID

Therapiebereich:

URSODEOXYCHOLIC ACID

Anwendungsgebiete:

Dissolution or reductin in size of radiolucent cholesterol in patient with a functioning gallbladder. Treatment of chronic liver diseases including primary billiary cirrhosis, primary sclerosing cholangitis, cystic fibrosis associated liver disease, biliary atresia, chronic hepatitis, and alcohol cirrhosis.

Berechtigungsdatum:

2021-12-31

Gebrauchsinformation

PATIENT LEAFLET IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS
(PREPARATIONS) – 1986
The medicine is dispensed with a doctor’s
prescription only
URSOLIT 100, 300 TABLETS
THE ACTIVE INGREDIENT:
URSOLIT 100:
Ursodeoxycholic Acid 100 mg
URSOLIT 300:
Ursodeoxycholic Acid 300 mg
Inactive ingredients and allergens in the
preparation – see the subsection “Important
information about some of the ingredients of the
medicine” and section 6.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE
MEDICINE. This leaflet contains concise information
about the medicine. If you have any other questions,
refer to the doctor or the pharmacist.
This medicine has been prescribed for treatment
of your illness. Do not pass it on to others. It may
harm them even if it seems to you that their medical
condition is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
The medicine is intended for the dissolution
or reduction in size of gallstones composed of
cholesterol, and for treatment of certain chronic liver
diseases.
THERAPEUTIC CLASS: bile acids.
Ursodeoxycholic acid affects the bile composition, so
that the gallstones dissolve.
The effect of ursodeoxycholic acid in some chronic
liver diseases results from a variety of mechanisms,
such as a protective activity on liver cells and effect
on the immune system.
2. BEFORE USING THE MEDICINE DO NOT USE THIS MEDICINE IF:
• You are sensitive (allergic) to the active
ingredient (bile acids) or to any of the additional
components the medicine contains (for a list of
inactive ingredients, see section 6).
• You suffer from an inflammatory exacerbation of
the gallbladder and/or biliary tract.
• You have a biliary obstruction or stenosis.
• You suffer from a gastric or intestinal ulcer.
• You suffer from calcified gallstones.
• Your gallbladder is not contracting properly.
• You suffer from biliary colic (can manifest in pain/
frequent cramps in the upper abdomen).
SPECIAL WARNINGS REGARDING THE USE OF THE
MEDICINE
• The medicine should be used under medical
supervision (see al

Fachinformation

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Ursolit 100 mg tablets
Ursolit 300 mg tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Ursolit 100 mg tablet contains: Ursodeoxycholic acid 100 mg
Each Ursolit 300 mg tablet contains: Ursodeoxycholic acid 300 mg
Ursolit 100mg also contains 75 mg Lactose monohydrate.
Ursolit 300mg also contains 100 mg Lactose monohydrate.
For full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablets for oral administration.
Appearance:
Ursolit 100: white round biconvex scored tablets.
Ursolit 300: white round biconvex scored tablets.
4. CLINICAL PARTICULARS.
4.1 THERAPEUTIC INDICATIONS
Dissolution or reduction in size of radiolucent cholesterol in patient
with a functioning
gallbladder.
Treatment of chronic liver diseases including primary billiary
cirrhosis, primary
sclerosing cholangitis, cystic fibrosis associated liver disease,
billiary atresia, chronic
hepatitis, and alcohol cirrhosis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Gallstone dissolution:_ 8 to 12 mg/kg/day given in 2 divided doses.
If doses are unequal the larger dose should be taken in late evening
to counteract
the rise in biliary cholesterol saturation which occurs in the early
morning. The late
evening dose may usefully be taken with food to help maintain bile
flow overnight.
The time required for dissolution of gallstones is likely to range
from 6 to 24 months
depending on stone size and composition. Follow-up cholecystograms or
ultrasound
investigation may be useful at 6 month intervals until the gallstones
have
disappeared.
Treatment should be continued until 2 successive cholecystograms
and/or ultrasound
investigations 4-12 weeks apart have failed to demonstrate gallstones.
This is
because these techniques do not permit reliable visualisation of
stones less than
2mm in diameter.
The efficiency of Ursolit in treating radio-opaque or partially radio
opaque gallstones
has not been tested but these are generally thought to be less soluble
than
radiolucent stones.
Non-ch