Both Indications:

Use in elderly:

There is no evidence to suggest that any alteration in the adult dose is needed but your doctor will take your age and health into consideration.

Use in children and adolescents

The administration of Ursodeoxycholic acid capsules is based on body weight and the condition being treated.

Use in children (6 to 18 years) for treatment of liver disease associated with cystic fibrosis:

DtiSSfJe

The recommended daily dose is 20mg per kg body weight, divided in 2-3 doses. Your doctor may want to increase the dose further to 30mg per kg body weight daily if necessary.

Body weight BW (kg)	Daily dose (mg/kg BW)	Ursodeoxycholic Acid 250 mg capsules
		Morning	Midday	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

How to take Ursodeoxycholic acid capsules

Take the capsules two to three times per day, as advised. Take the capsules regularly.

Duration of treatment

Treatment can be continued long term (up to 12 years) in children with cystic fibrosis associated hepatobiliary disorders.

If you feel that the effect of Ursodeoxycholic acid capsules is too strong or too weak, please talk to your doctor or pharmacist.

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. If you do suffer from diarrhoea, make sure you drink enough liquids to replace your fluid and electrolyte balance.

If you forget to take Ursodeoxycholic acid

Donot takemore capsulesThe nexHimerbut jusTcontinuelie treafmenfwifh the prescriEed dose.

If you stop taking Ursodeoxycholic acid

Always talk to your doctor before you decide to interrupt treatment with Ursodeoxycholic acid capsules or decide to stop your treatment eady.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common: may affect up to 1 in 10 people

•    Soft, loose stools or diarrhoea.

VefyrareTmay affect up tol in 10000 people

•    during the treatment of PBC: severe right-sided upper abdominal pain, severe worsening of liver scarring - this partially eases after treatment is stopped

•    hardening of gallstones due to build up of calcium. There are no additional symptoms of this but it will show up in tests

•    nettle rash (urticaria).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at 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

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 EXP The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions.

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 capsules contains:

-    The active substance is ursodeoxycholic acid. One capsules contains 250 mg ursodeoxycholic acid

-    The other ingredients are magnesium stearate, maize starch, Silica colloidal anhydrous, titanium dioxide (E171) and gelatin. What Ursodeoxycholic a"cIcTcapsUIes looks like"and contents oflfie pack"

Hard gelatin capsules with white body and cap filled with powder. The length of the capsules is 21.7 ± 0.3 mm Blister (PVC/Alu): 25,50, 60, 75,100 capsules Not all pack sizes may be marketed.

Manufacturer

ABC Farmaceutici S.p.A.

Canton Moretti, 29 Loc. S. Bernardo Ivrea (TO), 10090, Italy Marketing Authorisation Holder

Mercury Pharmaceuticals Limited,

Capital House, 1st Floor, 85 King William Street, London EC4N 7BL, United Kingdom

This medicinal product is~authurisud in the Member Status olKicEEA under ttnrfollowhig names:

Belgium: Ursodeoxycholic acid amdipharm 250 mg gdlules Ireland: Ursodeoxycholic acid 250 mg hard capsules Luxembourg: Ursodeoxycholic acid 250 mg gblules United Kingdom: Ursodeoxycholic acid 250 mg hard capsules

This leaflet was last revised in November 2015

MercuryPharma

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, pharmacist or nurse.

-    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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Whal 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-ta takeJJtsodeoxycholic-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

Ursodeoxycholic acid capsules contains the active substance ursodeoxycholic acid which is a naturally occurring bile acid which is found in small amounts in human bile.

Ursodeoxycholic acid capsules are used:

•    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 (PBC).

—to dissolve gaHstones-eaused-by excess-cholesterol ie-the gaH-btedderwhere the-gallsteses are-set visibte-on a-plain x-ray-(gallstenes thaFare 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 aged 6 to 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, other bile acids like UDCA or any of the other ingredients of this medicine (listed in section 6)

-    if your gall bladder does not work properly

-    if your doctor have told you that you have calcified gallstones (visible on an x-ray)

-    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)

-^1- if yotmave frequentTiramp-IIKirpainslirthe upper abdomen (Btilary colic)"

-    if you are a child with biliary atresia and have 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 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.

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 in the treatment of PBC, in rare cases the symptoms may worsen at the beginning of treatment. If this happens, please speak to your doctor about reducing your initial dose.

-When used to dissolve-gaHstonesryour-doctor should arrange fonrscarrofyourgaH-bladderafterlhefirsHHO months ottreatment— — Please inform your doctor immediately if you have diarrhoea as this may require a reduction in the dose or discontinuation of treatment.

Other medicines end Ursodeoxycholic acid capsules

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

A reduction in the effects of the following medicines is possible when taking Ursodeoxycholic acid capsules:

•    colestyramine, colestipol (to lower blood lipids) or antacids 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 capsules.

•    ciprofloxacin and dapsone (antibiotics), nitrendipine (used to treat high blood pressure). It may be necessary for your doctor to alter the dose of these medicines.

A change in the effects of the following medicines is possible when taking Ursodeoxycholic acid capsules:

•    ciclosporin (to reduce the activity of the immune system) If ynn are hBing treated with ciclnspnrin, ynnr doctor should check the amount nf ciclosporin in your blood. Your doctor will adjust its dose, if necessary.

•    rosuvastatin (for high cholesterol and related conditions).

Please inform your doctor if you are taking any blood cholesterol lowering agents such as clofibrate or medicines that contain oestrogen (estrogen) especially if you are taking Ursodeoxycholic acid capsules for the dissolution of gallstones, as they may stimulate the formation of gallstones.

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 thinks it is absolutely necessary.

Women of child-bearing potential

Even if you are not pregnant, you should still discuss this possibility with your doctor. Before starting treatment with Ursodeoxycholic acid capsules, your doctor will check that you are not pregnant and review your contraceptive method to make sure it is appropriate.

Breastfeeding

It is not known if Ursodeoxycholic acid passes into breast milk. Therefore consult your doctor before use if you are breast-feeding or about to start breast-feeding.

Driving and using machines

There are no known effects on the ability to drive or use machines.

3. HOW TO TAKE URSODEOXYCHOLIC ACID CAPSULES

^—SlwaysUtke thfirmedintne exactly as yunr doctor or ptiarmaclsttias tottfyou."Check with yourdoctororpharmacist tTyou annrot surer For Primary biliary cirrhosis (chronic inflammation of the bile ducts):

Dosage

During the first 3 months of treatment, you should take Ursodeoxycholic acid capsules in the morning, at midday and in the evening. As liver function values improve, the total daily dose may be taken once a day in the evening.

Body weight BW (kg)	Daily dose (mg/kg BW)	Ursodeoxycholic Acid 250 mg capsules
		First 3 months			Subsequently
		Morning	Midday	Evening	Evening — (ones-daily)— —
47-62	12-16	1	1	1	3
63-78	13-16	1	1	2	4
79-93	13-16	1	2	2	5
94-109	14-16	2	2	2	6
Over 110		2	2	3	7

How to take Ursodeoxycholic acid capsules

Swallow the capsules whole with a drink of water or other liquid. Take your medicine regularly.

103604-383/LF/XXX/01

-Buratiorrof treatment—    —    —    —    — — —    —    —    —    —    —    —    —    —

Ursodeoxycholic acid capsules may be continued indefinitely in cases of PBC.

Dissolution of cholesterol gallstones:

Dosage

The recommended dose in adults is: 10 mg/kg body weight daily, as follows:

50-62 kg: 2 capsules daily 63-85 kg 3 capsules daily 86-120 kg 4 capsules daily

How to take Ursodeoxycholic acid capsules

Swallow the capsules whole with a drink of water or other liquid. Take the    capsules    in the    evening at bedtime. Take your medicine

—regularljr — —    —    —    —    — — —    —    —    —    —    —    —    —    —

Duration of treatment

It generally takes 6-24 months to dissolve gallstones. If there are no reduction in the size of the gallstones after 12 months, treatment should be stopped.

Every 6 months, your doctor should check whether the treatment is working. At each of these follow-up 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.