URSOFALK 500

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

URSODEOXYCHOLIC ACID

Available from:

RAFA LABORATORIES LTD

ATC code:

A05AA02

Pharmaceutical form:

FILM COATED TABLETS

Composition:

URSODEOXYCHOLIC ACID 500 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

DR. FALK PHARMA, GERMANY

Therapeutic group:

URSODEOXYCHOLIC ACID

Therapeutic area:

URSODEOXYCHOLIC ACID

Therapeutic indications:

For the symptomatic treatment of primary biliary cirrhosis (PBC), in patients without decompensated hepatic cirrhosis.

Authorization date:

2018-08-31

Patient Information leaflet

PATIENT LEAFLET ACCORDING TO THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is sold with a doctor's prescription only
URSOFALK
® 500 FILM-COATED TABLETS
ACTIVE INGREDIENT:
Each tablet of URSOFALK 500 contains: Ursodeoxycholic acid 500 mg.
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?
This medicine is intended for the symptomatic treatment of primary
biliary cirrhosis, in
patients without decompensated liver cirrhosis.
THERAPEUTIC GROUP: Bile acids.
_ _
2. BEFORE YOU TAKE THE MEDICINE
DO NOT USE THE MEDICINE IF:

Do not use if you are sensitive (allergic) to the active ingredient
(bile acids) or
to any of the other 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

This 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 your doctor
immediately, as your doctor may decide to reduce the dosage of the
medicine
or to stop its use.

In rar

Summary of Product characteristics

1
Ursofalk 500mg -DL-Feb 2016-02
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
URSOFALK 500MG FILM-COATED TABLETS
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 mg of ursodeoxycholic acid as the active
substance.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets.
Appearance: white, oval, biconvex film-coated tablets with a break
line on both sides.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the symptomatic treatment of primary biliary cirrhosis (PBC), in
patients without
decompensated hepatic cirrhosis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
There are no age restrictions on the use of Ursofalk 500mg tablets.
For patients weighing less than
47 kg or patients who are unable to swallow Ursofalk 500mg tablets,
Ursofalk 250 mg capsules
are available.
For the symptomatic treatment of primary biliary cirrhosis (PBC)
The daily dose depends on body weight and ranges from 1½ to 3½
tablets (14

2 mg of
ursodeoxycholic acid per kg of body weight).
For the first 3 months of treatment, Ursofalk 500mg tablets should be
taken divided over the day.
When the liver function parameters improve, the daily dose may be
taken once daily in the
evening.
Body
weight (kg)
Ursofalk 500mg tablets
FIRST 3 MONTHS
SUBSEQUENTLY
morning
midday
evening
evening
(1 x daily)
47 – 62
½
½
½
1½
63 – 78
½
½
1
2
79 – 93
½
1
1
2½
94 – 109
1
1
1
3
2
Over 110
1
1
1½
3½
The tablets should be swallowed with some liquid. They must be taken
regularly.
The use of Ursofalk 500mg tablets in primary biliary cirrhosis may be
continued indefinitely.
In patients with primary biliary cirrhosis, 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 half an Ursofalk 500mg tablet or one Ursofalk
250mg capsule daily, and the dose
then gradually increased (weekly increase of the daily dose by half a
tablet or one Ursofalk 250
mg capsule) until th