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URSODEOXYCHOLIC ACID GLENMARK 250 MG HARD CAPSULE

Active substance(s): URSODEOXYCHOLIC ACID / URSODEOXYCHOLIC ACID / URSODEOXYCHOLIC ACID

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Ursodeoxycholic Acid 250 mg hard capsule - UK - PIL
Package leaflet: Information for the patient

Ursodeoxycholic Acid 250 mg hard capsule
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 is and what it is used for
2. What you need to know before you use Ursodeoxycholic Acid
3. How to use Ursodeoxycholic Acid
4. Possible side effects
5. How to store Ursodeoxycholic Acid
6. Contents of the pack and other information

1. What Ursodeoxycholic Acid is and what it
is used for
Ursodeoxycholic acid (UDCA), the active substance from
Ursodeoxycholic Acid is a bile acid produced naturally, which is
found in small amounts in human bile.
Ursodeoxycholic Acid is used for:
- 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 cirrhosis
- to dissolve gallstones caused by excess cholesterol in the gall
bladder (in patients for whom surgery is not an option), where the
gallstones are not visible on a plain x-ray (gallstones that are visible
will not dissolve) and not more than 15 mm in diameter. The gall
bladder should still be working despite the gallstone(s)
- for liver disease associated with a condition called cystic fibrosis in
children 6 to 18 years.

2. What you need to know before you use
Ursodeoxycholic Acid
Do not use Ursodeoxycholic Acid:
- If you are allergic to bile acids like UDCA or any of the other
ingredients of this medicine (listed in section 6).
- If you have an acute inflammation of the gall bladder or biliary tract.
- If you have a blockage of the common bile duct or cystic duct
(obstruction of the biliary tract).
- If you have frequent cramp-like upper abdomen pain (biliary colic).
- If your doctor has said you have calcified gallstones.
- If you have an insufficiency of the contractility of the gall bladder.
- If you are or have a child with biliary atresia or has poor bile flow
even after surgery.
Please ask your doctor about the conditions mentioned above. You
should also ask if you have previously had any of these conditions.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking
Ursodeoxycholic Acid. Ursodeoxycholic Acid should be administered
under medical supervision.
Your doctor should test your liver function regularly every 4 weeks
for the first 3 months of treatment. After this time, it should be
monitored at 3 month intervals.
When used to dissolve gallstones, your doctor should arrange for a
scan of your gall bladder after the first 6-10 months of treatment.
Talk to your doctor immediately if you have diarrhoea, as this may
require a reduction in the dose or discontinuation of the treatment with
Ursodeoxycholic Acid.
If you suffer from primary biliary cirrhosis and your symptoms get
worse at the beginning of the treatment a reduction in the dose may be
required and gradually increased again as described in section 3
(How to take Ursodeoxycholic Acid).
If you are a woman of childbearing potential you must use
contraception. Non-hormonal or oral contraceptives containing small
amounts of estrogen are recommended. However, if you take
Ursodeoxycholic Acid for dissolve gallstones, you should use
non-hormonal contraception because hormonal contraceptives may
increase gallstone risk.
Other medicines and Ursodeoxycholic Acid
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines, including those without medical
prescription. Treatment with Ursodeoxycholic Acid may still be
allowed. Your doctor will know what is right for you.
A reduction in the effects of the following medicines is possible
when taking Ursodeoxycholic Acid:

- colestyramine, colestipol (to lower blood lipids) or antacids (drugs
that bind hydrochloric acid in the gastric juice) containing aluminium
hydroxide or smectite (aluminium oxide). If you must take
medication that contains any of these ingredients, it must be taken at
least two hours before or after Ursodeoxycholic Acid.
- rosuvastatin (used to lower blood lipids). It may be necessary for
your doctor to alter the dose of these medicines.
- ciprofloxacin, dapsone (antibiotics), nitrendipine (used to treat high
blood pressure) and other medicines which are metabolised in a
similar way. It may be necessary for your doctor to alter the dose of
these medicines.
Ursodeoxycholic Acid may increase the effects of the following
medicines:
- ciclosporin (to reduce the activity of the immune system). If you are
being treated with ciclosporin, your doctor should check the amount
of ciclosporin in your blood. Your doctor will adjust its dose, if
necessary.
If you are taking Ursodeoxycholic Acid for the dissolution of
gallstones, please inform your doctor in case you are taking any
medicines that contain oestrogenic hormones or blood cholesterol
lowering agents such as clofibrate. These medicines stimulate the
formation of gallstones, which is a counter-effect to the treatment with
Ursodeoxycholic Acid.
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 during pregnancy unless
your doctor thinks it is absolutely necessary. The use of
Ursodeoxycholic Acid during the first 3 months of pregnancy may
cause foetal harm.
Check that you are not pregnant before taking this medicine
Women of child-bearing potential
Even if you are not pregnant you should talk to your doctor because
women of childbearing potential must use contraception. Non-hormonal
or oral contraceptives containing small amounts of estrogen are
recommended. However, if you take Ursodeoxycholic Acid for dissolve
gallstones, you should use non-hormonal contraception because
hormonal contraceptives may increase gallstone risk.
Your doctor must exclude the possibility of a pregnancy before
beginning of treatment.
Breastfeeding
You should not take Ursodeoxycholic Acid during breast-feeding. It is
not known whether Ursodeoxycholic Acid passes into breast milk. If
treatment with Ursodeoxycholic Acid is absolutely necessary, you
should stop breastfeeding.
Driving and using machines
Ursodeoxycholic Acid has no or negligible influence on the ability to
drive and use machines.

3. How to take Ursodeoxycholic Acid
Always take this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.
The daily dose is determined by therapeutic indication.
For the treatment of the of primary biliary cirrhosis (PBC)
The recommended daily dose will be determined by the doctor based
on body weight and is between 3 to 7 hard capsules of
Ursodeoxycholic Acid (12 – 16 mg of UDCA per kg of body weight
per day).
During the first 3 months of treatment you should take Ursodeoxycholic
Acid in the morning, to midday and evening.
The recommended treatment schedule is as follows:
Body
weight
(kg)
47 – 62 kg
63 – 78 kg
79 – 93 kg
94 – 109 kg
Over 110 kg

Daily dose
(mg/ kg of body
weight)
12-16
13-16
13-16
14-16
7 hard capsules

Morning Midday Evening
1
1
1
2
2

1
1
2
2
2

1
2
2
2
3

With improvement of the liver values your doctor will advise to take
the daily dose once daily in the evening.
The use of Ursodeoxycholic Acid in primary biliary cirrhosis may be
continued indefinitely.

Ursodeoxycholic Acid 250 mg hard capsule - UK - PIL
For dissolution of cholesterol gallstones:

- nettle rash (urticaria)

Adults: The usual dose is 8–12 mg/ ursodeoxycholic acid (UDCA) per
kg body weight per day, taken in the evening before bedtime
according to:
- up to 60 kg: 2 capsules
- 61-80 kg: 3 capsules
- 81-100 kg: 4 capsules
- above 100 kg: 5 capsules
Care should be taken to ensure that they are taken regular.

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.

In general, the time required for dissolution of gallstones is generally
6-24 months, depending on stone size and composition.
Every 6 months the doctor will check the effectiveness of treatment
(reduction in size until such calculi) by radiographic examination
(cholecystography) or ultrasound.
Your doctor may stop treatment unless noted a reduction in the size of
gallstones after 2 cholecystography and/or successive ultrasound.
For children with cystic fibrosis aged 6 years to less than 18 years
The recommended dose is 20mg per kg of body weight daily taken in
2 or 3 divided doses. It may be increased if necessary to 30mg per kg
of body weight daily.
Daily dose Ursodesoxycholic Acid 250mg capsules
Body
weight BW (mg/kg BW)
Evening
Midday
Morning
(kg)
1
1
17-25
20-29
1
1
1
19-25
30-39
2
1
1
20-25
40-49
2
2
1
21-25
50-59
2
2
2
22-25
60-69
3
2
2
22-25
70-79
3
3
2
22-25
80-89
3
3
3
23-25
90-99
4
3
3
23-25
100-109
4
4
3
>110
Take the capsules two to three times a day as advised for your doctor
or pharmacist. Take the capsules regularly.
How to use Ursodeoxycholic Acid
Swallow the capsules whole with a glass of water.
Elderly
There is no evidence to suggest that any alteration in the adult dose is
needed.
Use in children and adolescents
Cholesterol rich gallstones are very rare in children but when they
occur, dosage should be related to bodyweight and medical
conditions.
There is no age limit for ursodeoxycholic acid administration, the
active ingredient of Ursodeoxycholic Acid. If the patient cannot
swallow capsules or has a bodyweight below 47 kg, other
pharmaceutical forms (suspension) are available.
If you take more Ursodeoxycholic Acid than you should
Diarrhoea may occur as a result of overdose. Please inform your
doctor immediately if you have persistent diarrhoea. Make sure you
drink enough liquids to replace your fluid and salt balance.
If you forget to take Ursodeoxycholic Acid
Do not take more doses the next time, but just continue the treatment
with the prescribed dose. Do not take a double dose to make up for a
forgotten dose.
If you stop taking Ursodeoxycholic Acid
Always speak to your doctor before you decide to interrupt treatment
with Ursodeoxycholic Acid 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.
Contact your doctor immediately if you experience any of the
following symptoms after taking Ursodeoxycholic Acid:
Common side effects (may affect up to 1 in 10 people):
- soft, loose stools or diarrhoea. Inform your doctor immediately if
you have persistent diarrhoea, as this may require a reduction in the
dose of your medicine. If you do suffer from diarrhoea, make sure
you drink enough liquids to replace your fluid and salt balance.
Very rare side effects (may affect up to 1 in 10,000 people):
- during the treatment of primary biliary cirrhosis: severe right-sided
upper abdominal pain, severe worsening of liver cirrhosis which
partially eases after treatment is discontinued
- hardening of gallstones due to build-up of calcium

5. How to store Ursodeoxycholic Acid
Keep this medicine out of the sight and reach of children.
The medicinal product does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the
carton after 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.

6. Contents of the pack and other information
What Ursodeoxycholic Acid contains
- The active substance is ursodeoxycholic acid.
- The other ingredients are: hard capsule contents: StarCap (maize
starch, pregelatinized starch), crospovidone (E1202), sodium lauryl
sulphate, silica colloidal anhydrous, magnesium stearate (E572),
capsule: gelatine (E441), sunset yellow (E110), titanium dioxide
(E171).
What Ursodeoxycholic Acid looks like and contents of the pack
Hard gelatin capsules, orange, containing white or almost white
granules.
Box of 3 blisters packs PVC-PVDC/Aluminium, each containing 10
hard capsules.
Box of 5 blisters packs PVC-PVDC/Aluminium, each containing 10
hard capsules.
Box of 3 blisters packs PVC-PVDC/Aluminium, each containing 20
hard capsules.
Box of 5 blisters packs PVC-PVDC/Aluminium, each containing 20
hard capsules.
Box of 10 blisters packs PVC-PVDC/Aluminium, each containing 20
hard capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Glenmark Pharmaceuticals Europe Limited
Laxmi House
2B Draycott Avenue
Kenton, Middlesex
HA3 0BU
United Kingdom
Manufacturer
Glenmark Pharmaceuticals Europe Limited
Building 2
Croxley Green Business Park
Croxley Green
Hertfordshire
WD18 8YA
Or
Glenmark Pharmaceuticals s.r.o.
Hvězdova 1716/2b
Prague 4, 140 78
Czech Republic
Site Address:
Glenmark Pharmaceuticals s.r.o.
Fibichova 143
Vysoké Mýto, 566 17
Czech Republic
Or
Polisano Pharmaceuticals S.R.L.
SIBIU, 156 ALBA IULIA Highway
550052
Romania
This leaflet was last revised in October 2016

Expand Transcript

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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