URSOFALK CAPSULES 250

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

URSODEOXYCHOLIC ACID

Available from:

RAFA LABORATORIES LTD

ATC code:

A05AA02

Pharmaceutical form:

CAPSULES

Composition:

URSODEOXYCHOLIC ACID 250 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

DR. FALK PHARMA, GERMANY

Therapeutic group:

URSODEOXYCHOLIC ACID

Therapeutic area:

URSODEOXYCHOLIC ACID

Therapeutic indications:

Treatment of chronic liver diseases Primary Biliary Cirrhosis & Primary Sclerosing Cholangitis.

Authorization date:

2014-04-30

Patient Information leaflet

PATIENT LEAFLET ACCORDING TO THE PHARMACISTS‘ REGULATIONS
(PREPARATIONS) –
1986
This medicine is sold with a doctor‘s prescription only
URSOFALK
® CAPSULES 250
ACTIVE INGREDIENT:
Each URSOFALK 250 capsule contains: 250 mg ursodeoxycholic acid.
For a list of inactive ingredients, please see section 6.
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE.
This leaflet contains concise information about the medicine. If you
have any
further questions, please refer to your doctor or pharmacist.
This medicine has been prescribed for the treatment of your illness.
Do not pass it
on to others. It may harm them, even if it seems to you that their
illness is similar
to yours.
1. WHAT IS THE MEDICINE INTENDED FOR?
Treatment of chronic liver diseases: primary biliary cirrhosis and
primary scelrosing
cholangitis.
THERAPEUTIC GROUP: Bile acids.
2. BEFORE TAKING THE MEDICINE
DO NOT USE THE MEDICINE IF:
• You are sensitive (allergic) to the active ingredient (bile acids)
or to any of the
additional ingredients this medicine contains (for a list of inactive
ingredients,
please see section 6).
• Do not use if you suffer from acute inflammation of the gall
bladder and/or
biliary tract.
• Do not use if you suffer from an obstruction of the biliary tract.
• Do not use if you suffer from biliary colic (may be manifested by
frequent pain/
cramps in the upper abdomen).
• Do not use if you suffer from calcified gallstones.
• Do not use if your gall bladder does not contract properly.
SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE
• The medicine should be used under medical supervision (see also
'Tests and
follow up' in section 3).
• If you have suffered in the past from any of the conditions
mentioned in the
section 'Do not use the medicine if' - inform your doctor.
• If you suffer from diarrhea during the treatment, inform the
doctor immediately,
as the doctor may decide to reduce the dosage of the medicine or to
stop its use.
• In rare cases, some of the symptoms of biliary cirrhosis (such as
i

Summary of Product characteristics

Ursofalk 250 -DL-Nov 2014-02
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
_URSOFALK_

_ 250 CAPSULES _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 capsule of Ursofalk

250 capsules contains 250 mg ursodeoxycholic acid (UDCA)
as the active substance.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsules.
Appearance: white, opaque hard gelatin capsules, capsule size 0, which
contain a
white compressed powder or granulate.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of chronic liver diseases Primary Biliary Cirrhosis &
Primary Sclerosing
Cholangitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
There are no age restrictions on the use of Ursofalk

250 capsules.
The following daily dose is recommended for the various indications:
For the treatment of primary biliary cirrhosis (PBC)
The daily dose depends on body weight, and ranges from 3 to 7 capsules
(14 ± 2 mg
UDCA per kg of body weight). For the first 3 months of treatment,
Ursofalk

250
capsules should be taken in divided doses throughout the day. When the
liver function
parameters improve, the daily dose may be taken once daily in the
evening.
Body
weight (kg)
Ursofalk

250 capsules
FIRST 3 MONTHS
SUBSEQUENTLY
morning
midday
evening
evening
(1 x daily)
47 – 62
1
1
1
3
63 – 78
1
1
2
4
79 – 93
1
2
2
5
94 – 109
2
2
2
6
Over 110
2
2
3
7
The capsules should be swallowed whole with some liquid. Ursofalk

250 capsules
must be taken regularly.
2
The use of Ursofalk

250 capsules in PBC may be continued indefinitely.
In patients with PBC, in rare cases the clinical symptoms may worsen
at the beginning
of treatment, e.g. the itching may increase. In this event, therapy
should first be
continued with one Ursofalk

250 capsule daily, and the dose then gradually increased
(weekly increase of the daily dose by one capsule) until the dose
indicated in the
respective dosage regimen is reached again.
General recommendation for PSC:
10 to 15 mg/kg/day administered in 2 to 4 divide