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URSODEOXYCHOLIC ACID 250 MG CAPSULES HARD

Active substance(s): URSODEOXYCHOLIC ACID / URSODEOXYCHOLIC ACID

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Package leaflet: Information for the user

Ursodeoxycholic Acid 250 mg Capsules, hard
Ursodeoxycholic acid
Read all of this leaflet carefully before you start
taking this medicine because it contains important
information for you.
− Keep this leaflet. You may need to read it again.
− If you have any further questions, ask your doctor
or pharmacist.
− This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as
yours.
− 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.
What is in this leaflet:
1. What Ursodeoxycholic Acid Capsules are and
what they are used for
2. What you need to know before you take
Ursodeoxycholic Acid Capsules
3. How to take Ursodeoxycholic Acid Capsules
4. Possible side effects
5. How to store Ursodeoxycholic Acid Capsules
6. Contents of the pack and other information
1. What Ursodeoxycholic Acid Capsules are
and what they are used for
This medicine contains ursodeoxycholic acid – a
natural bile acid. However, only a small amount is
found in human bile.
Ursodeoxycholic Acid Capsules is used:
• For the dissolution of gallstones that are
composed of cholesterol in patients:
- having one or more radio-opaque (radionegative) gallstones, preferably with a
diameter of no more than 2 cm, in a
properly functioning gallbladder;
- for whom surgery is not an option;
- in whom cholesterol supersaturation has
been demonstrated by chemical testing on
bile.
- Before and after gallstone shockwave
dissolution (lithotripsy).
• For the treatment of a condition where the bile
ducts in the liver become damaged leading to a
build-up of bile. This may cause scarring of the
liver. The liver should not be so damaged that it is
not functioning properly. This condition is called
primary biliary cholangitis (PBC, also known as
primary biliary cirrhosis).
• For the treatment of liver disease associated with
cystic fibrosis (mucoviscidosis) in children and
adolescents aged 6-18 years.
2. What you need to know before you take
Ursodeoxycholic Acid Capsules
Do not take Ursodeoxycholic Acid Capsules
• if you are allergic to ursodeoxycholic acid or
bile acids, or any of the other ingredients of this
medicine (listed in section 6);
• if you have an acute inflammation of the
gallbladder or biliary tract;
• if your bile ducts are closed (common duct or
cystic duct occlusion);
• if you suffer from frequent cramp-like pains in the
upper abdomen (biliary colic);
• if your doctor has told you that you have a
gallstone calcification;
• if your gallbladders ability to contract is impaired;
• if you are a child with a closure of bile ducts
(biliary atresia) and have poor bile flow, even after
surgery.
Please ask your doctor about any of the conditions
mentioned above. You should also ask if you have
previously had any of these conditions or if you are
unsure whether you have any of them.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Ursodeoxycholic Acid Capsules. This medicine should
be used under medical supervision.
In the first 3 months of treatment your doctor should
monitor your liver function regularly every 4 weeks.
Thereafter, the controls should be carried out every 3
months.
If you are taking this medicine to dissolve gallstones,
your doctor should perform scans of your gallbladder
after 6-10 months of treatment.
If you are a woman and are taking this medicine to
dissolve gallstones, you should use effective nonhormonal contraceptive measures because hormonal
contraceptives (such as the “pill”) may promote the
formation of gallstones.
If you take this medicine for the treatment of PBC, in
rare cases, the symptoms (e.g. itching) may worsen
at the beginning of treatment. In this case you should
talk to your doctor about reducing your initial dose.
Inform your doctor if you suffer from diarrhoea
as this may require a reduction of the dose
or discontinuation of the treatment with
Ursodeoxycholic Acid Capsules.

Children
There are no age restriction for the use of
Ursodeoxycholic Acid Capsules except for cystic
fibrosis (ages 6 to 18 years).
Other medicines and Ursodeoxycholic Acid
Capsules
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
The effects of the following medicines can be
changed (interactions):
A reduction in the effect of the following medicines
is possible when taking Ursodeoxycholic Acid
Capsules:
• colestyramine, colestipol (medicines used to
lower blood lipid levels) or antacids containing
aluminium hydroxide or smectite (aluminium
oxide) (preparations binding gastric acids). If you
are taking a medicine containing one of these
active ingredients, it should be taken at least 2
hours before or after taking Ursodeoxycholic Acid
Capsules;
• ciprofloxacin, dapsone (antibiotics), nitrendipine
(medicine used to treat high blood pressure) and
other medicines that are eliminated in a similar
way: it may be necessary for your doctor to alter
the dose of these medicines.
A change of the effect of the following medicines is
possible by taking Ursodeoxycholic Acid Capsules:
• ciclosporin (medicine that reduces the activity
of the immune system). If you are being treated
with ciclosporin your doctor should check the
ciclosporin concentration in your blood. Your
doctor will adjust the dose, if necessary;
• rosuvastatin (medicine used to treat high blood
lipids).
If you are taking Ursodeoxycholic Acid Capsules
to dissolve gallstones please inform your doctor if
you are simultaneously taking medicines containing
oestrogen (e.g. the “pill”) or certain medicines
for lowering cholesterol, e.g. clofibrate. These
medicines may promote the formation of gallstones
and thus counteract the dissolution of gallstones by
Ursodeoxycholic Acid Capsules.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this
medicine.
Pregnancy
You should not take Ursodeoxycholic Acid Capsules
during pregnancy unless your doctor considers it
absolutely necessary.
Use of ursodeoxycholic acid during the first three
months of pregnancy may affect the foetus.
Women of childbearing potential
Even if you are not pregnant, you should still discuss
this matter with your doctor. Women of childbearing
potential should only be treated with concomitant use
of reliable contraceptive measures. Non-hormonal
contraceptive measures or oral contraceptives
containing a low dose of oestrogen (the “pill”) are
recommended. If you are taking Ursodeoxycholic
Acid Capsules to dissolve gallstones you should
use effective non-hormonal contraceptive measures
because hormonal contraceptives can promote the
formation of gallstones.
Before starting treatment your doctor will check that
you are not pregnant.
Breast-feeding
There are only a few documented cases of taking
ursodeoxycholic acid during lactation. The levels of
ursodeoxycholic acid in breast milk are very low.
Therefore adverse reactions in nursing infants are
unlikely.
Fertility/ability to give birth
Animal studies have shown no effect of this medicine
on the fertility/ability to give birth.
So far there is no experience showing an influence of
this medicine on human fertility/childbearing.
Driving and using machines
No particular precautions are necessary.
3. How to take Ursodeoxycholic Acid Capsules
Always take this medicine exactly as your doctor has
told you. Check with your doctor or pharmacist if you
are not sure.
For dissolution of cholesterol gallstones (alone or
in combination with lithotripsy)
Dosage
The recommended dose is 2-4 capsules of
Ursodeoxycholic Acid Capsules (8-10 mg/kg body
weight of ursodeoxycholic acid), to be taken with a
meal as follows:
• at a daily dose of 2 capsules: both capsules with
an evening meal;
• at a daily dose of 3 capsules: 1 capsule in the
morning and 2 in the evening;
• at a daily dose of 4 capsules: 2 capsule in the
morning and 2 in the evening.
Continued overleaf...

Method of administration
Swallow the capsules whole with a drink of water or
other liquid. Take the capsules regularly.
Duration of treatment
It generally takes 6-24 months to dissolve the
gallstones. The duration of the treatment depends
on the size of the existing gallstones at the start of
the treatment. If there is no reduction in the size of
the gallstones after 12 months, therapy should be
stopped.
Every 6 months, your doctor should check whether
the treatment is working. At each of these followup examinations, it should be checked whether a
build-up of calcium causing hardening of the stones
has occurred since the last time. If this happens, your
doctor will stop the treatment.
Even if your symptoms have disappeared, you should
continue treatment: interruption of treatment results
in the extension of the total treatment duration. After
the dissolution of gallstones, treatment should be
continued for 3-4 months.
For the treatment of primary biliary cholangitis
(chronic inflammatory disease of the bile ducts)
Dosage
Stage I-III
The daily dose depends on body weight. During
the first 3 months of treatment you should take
Ursodeoxycholic Acid Capsules in the morning,
afternoon and in the evening. With improvement of
the liver function values the daily dose may be taken
once a day in the evening.
Body
Ursodeoxycholic Acid
weight

250 mg Capsules, hard
(kg)
First 3 months Subsequently
Morning Afternoon Evening Evening

(once 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

If you take more Ursodeoxycholic Acid Capsules
than you should
Diarrhoea may occur as a result of overdose. Inform
your doctor immediately if you have persistent
diarrhoea. If you do suffer from diarrhoea, make sure
you drink enough liquids to replace your fluid and salt
(electrolyte) balance.
If you forget to take Ursodeoxycholic Acid
Capsules
Do not take more capsules the next time, but just
continue the treatment with the prescribed dose.
If you stop taking Ursodeoxycholic Acid Capsules
Always talk to your doctor before you decide to
interrupt treatment with Ursodeoxycholic Acid
Capsules or decide to stop your treatment early.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Common (may affect less than 1 in 10 patients):
• soft, loose stools or diarrhoea.
Very rare (may affect less than 1 in 10 000
patients):
• in the treatment of primary biliary cholangitis:
severe right sided upper abdominal pain, severe
worsening of liver scarring which partially eases
after treatment is stopped;
• calcification (hardening of gallstones due to buildup of calcium) of gallstones;
• hives (urticaria).
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly via Yellow Card Scheme.
Website: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more
information on the safety of this medicine.
5. How to store Ursodeoxycholic Acid Capsules

Stage IV
In the beginning of the treatment 2 to 3 capsules
per day of Ursodeoxycholic Acid Capsules should be
taken with a meal:
• at a daily dose of 2 capsules: 1 capsule in the
morning and 1 in the evening;
• at a daily dose of 3 capsules: 1 capsule in the
morning and 2 in the evening.
If you have good response to this dosage (after blood
test and/or in the judgment of your doctor), your
doctor will prescribe a higher dose (dosage as for the
treatment of stage I-III).

Do not store above 30°C.
Store in the original packaging in order to protect
from moisture.
Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date which
is stated on the carton after the “EXP”. The expiry
date refers to the last day of that month.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help protect the environment.

Method of administration
Swallow the capsules whole with a drink of water or
other liquid. Take the capsules regularly.

6. Contents of the pack and other information

Duration of administration
The administration of Ursodeoxycholic Acid Capsules
in primary biliary cholangitis is not time limited.
Note
If you suffer from primary biliary cholangitis
the symptoms of your illness, e.g. the itching,
may worsen at the beginning of treatment. This
occurs in rare cases only. In this case the therapy
can be continued with a reduced daily dose of
Ursodeoxycholic Acid Capsules. Then your doctor
will increase the daily dose every week until the
required dose is reached again.
Use in children and adolescents (from 6 to
18 years) for the treatment of liver disease
associated with cystic fibrosis
Dosage
The recommended daily dose is 20 mg/kg of body
weight, divided into 2-3 doses. If necessary, your
doctor may increase the dose to 30 mg/kg of body
weight daily.
Daily dose
Body
Ursodeoxycholic Acid
(mg/kg
weight
250 mg Capsules, hard
of body
(kg)
weight) Morning Afternoon Evening

20-29
17-25
1
-1
30-39
19-25
1
1
1
40-49
20-25
1
1
2
50-59
21-25
1
2
2
60-69
22-25
2
2
2
70-79
22-25
2
2
3
80-89
22-25
2
3
3
90-99
23-25
3
3
3
100-109
23-25
3
3
4
> 110
3
4
4
Method of administration
Swallow the capsules whole with a drink of water or
other liquid. Take the capsules regularly.
If you have difficulty swallowing, the capsule may,
if necessary, be opened and the contents added to
yoghurt, for example.
Please talk to your doctor or pharmacist if you feel
that the effect of Ursodeoxycholic Acid Capsules is
too strong or too weak.

What Ursodeoxycholic Acid Capsules contain
− The active substance is ursodeoxycholic
acid. Each hard capsule contains 250 mg
ursodeoxycholic acid.
− The other excipients are: maize starch, silicon
dioxide (E 551), magnesium stearate (E 470B),
water purified; hard gelatin capsule (body and cap
composition): titanium dioxide (E 171), gelatin (E
441).
What Ursodeoxycholic Acid Capsules look like
and contents of the pack
White hard gelatin capsules size 0.
The content – white or almost white powder.
The capsules are packed in PVC/aluminium blisters.
10 capsules per blister.
5, 6 or 10 blisters (50, 60 or 100 capsules) are
packed per cardboard box.
Not all pack sizes may be marketed
Marketing Authorisation Holder & Manufacturer
- LV-1057, Latvia
AS GRINDEKS, Krustpils iela 53, Rıga,
UK Distributor:
Alissa Healthcare Research Limited, Unit 5, Fulcrum
1, Solent Way, Whiteley, Fareham, Hampshire,
United Kingdom, PO15 7FE
This medicinal product is authorised in the
Member States of the EEA under the following
names:
Belgium
URSOGRIX 250 mg harde capsules
Czech Republic URSOGRIX
Estonia
URSOGRIX
Latvia
URSOGRIX 250 mg cietas kapsulas
Lithuania
Ursodeoxycholic Acid Grindeks
250 mg kietosios
kapsules
the Netherlands GRINTEROL 250 mg harde capsules
Poland
URSOXYN
Portugal
GRINTEROL 250 mg cápsulas duras
United Kingdom Ursodeoxycholic Acid 250 mg
Capsules, hard
This leaflet was last revised in 12/2016.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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