Package leaflet: Information for the user

CHOLURSO⁸ 250 mg, film-coated tablets CHOLURSO⁸ 500 mg, film-coated tablets

Ursodeoxycholic acid

1 .What Cholurso 250 mg or 500 mg film-coated tablets is and what it is used for

2.    What you need to know before you take Cholurso 250 mg or 500 mg film-coated tablets

3.    How to take Cholurso 250 mg or 500 mg film-coated tablets

4.    Possible side effects

5.    How to store Cholurso 250 mg or 500 mg film-coated tablets

6.    Contents of the pack and other information

1. What Cholurso 250 mg or 500 mg

film-coated tablets are and what they are used for_

Cholurso contains the active substance ursodeoxycholic acid.

Ursodeoxycholic acid is a chemical present naturally in the body and it helps to control the amount of cholesterol in the blood.

Cholurso Is used

•    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 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.

2.    What you need to know before you take Cholurso 250 mg or 500 mg film-coated tablets

Do not take Cholurso:

•    if you are allergic to bile acids like ursodeoxycholic acid or any of the other ingredients of this medicine (listed in section 6);

•    if you are allergic to peanut or soya, because Cholurso contains soya lecithin.

•    if your gall bladder does not work properly;

•    if you have gallstones that are visible on an x-ray;

•    if you have acute inflammation of the gall bladder or biliary tract;

•    if you have an obstruction of the biliary tract (blockage of the common bile duct or a cystic duct);

•    if you suffer from frequent cramp-like pains in the upper abdomen (biliary colic);

•    if you have hardening of the gallstones caused by a build-up of calcium;

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.

Warning and precautions

Talk to your doctor, pharmacist or nurse before taking Cholurso.

Cholurso must be used 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.

If you are taking Cholurso for dissolution of gallstones, you should use an effective non-hormonal method of contraception, since hormonal contraceptives may increase biliary lithiasis (see ‘Other medicines and Cholurso" and ‘Pregnancy, breast-feeding and fertility").

Inform your doctor immediately if you have diarrhoea as this may require a reduction in the dose or stopping the treatment.

Other medicines and Cholurso

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines, even if they are obtainable without a prescription.

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Treatment with Cholurso 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 Cholurso:

•    colestyramine, charcoal, colestipol (to lower blood lipids) or antacids containing aluminium hydroxide or smectite (aluminium oxide). If you must take medicines that contain any of these ingredients, you should take these at least two hours before or after Cholurso.

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

An increase in the effects of the following medicines is possible when taking Cholurso:

•    cidosporin (to reduce the activity of the immune system). If you are being treated with cidosporin, your doctor should check the amount of cidosporin in your blood. Your doctor will adjust its dose, if necessary.

Inform your doctor if you are taking any blood cholesterol lowering agents such as dofibrate or medicines that contain oestrogen (estrogen), especially if you are taking Cholurso 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.

•    You should not take this medicine during pregnancy unless your doctor thinks it is absolutely necessary. Use of Cholurso during the first three months of pregnancy may affect the foetus.

•    Check that you are not pregnant before taking this medicine.

•    Use a reliable method of contraception - nonhormonal contraceptives (barrier methods) or low-oestrogen oral contraceptives are recommended. If you are taking this medicine for dissolution of gallstones, only use non-hormonal contraceptives, as hormonal oral contraceptives may stimulate the formation of gallstones.

•    Do not take this medicine if you are breast-feeding as the active ingredient in this medicine may pass into breast milk. If treatment with Cholurso is necessary, then stop breast-feeding.

Driving and using machines

No particular precautions are necessary.

Important information about some of the ingredients of Cholurso

This medicine contains soya lecithin. If you are allergic to peanut or soya, do not use this medicinal product.

3. How to take Cholurso 250 mg or 500 mg film-coated tablets_

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Swallow the tablets whole with a drink of water or other liquid. Take the tablets regularly.

The daily dose below serves as an example of how you can take the tablets.

Dosage

For Cholurso 250 mo lilm-coated tablets

Use in patients with damage to liver tissue by impaired bile flow (Primary Biliary Cirrhosis)

Your doctor will determine your dose depending on your body weight. During the first 3 months of treatment, you should take 3-7 tablets in divided doses throughout the day at mealtime.

As the liver function improves, the total daily dose can be taken once, in the evening.

If you do not experience any problems at this dose (after blood tests and/or according to an evaluation), your doctor will prescribe you a higher dose (dosage in accordance with the treatment of stage l-lll).

For Cholurso 500 mg film-coated tablets

Use in patients with damage to liver tissue by

impaired bile flow (Primary Biliary Cirrhosis)

Your doctor will determine your dose depending on your body weight. During the first 3 months of treatment, you should take 1V4 -3% tablets in divided doses throughout the day at mealtime.

As the liver function improves, the total daily dose can be taken once, in the evening.

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If you do not experience any problems at this dose (after blood tests and/or according to an evaluation), your doctor will prescribe you a higher dose (dosage in accordance with the treatment of stage l-lll).

Duration of treatment

Your doctor will determine the duration of treatment. It may be necessary to get your blood checked regularly by the laboratory. Cholurso may be continued indefinitely in cases of primary biliary cirrhosis.

Note:

In patients with primary biliary cirrhosis, the symptoms may worsen at the start of treatment, for example the itching may increase. This only occurs in rare cases. If this happens, therapy can be continued with a lower daily dose of Cholurso. Each week, your doctor will then gradually increase the daily dose, until you reach the required dose.

Use in patients with gallstones

The recommended dose is approximately 10 mg ursodeoxycholic acid per kg body weight per day, taken as follows:

Duration of treatment

It generally takes 6-24 months to dissolve gallstones. The duration of your treatment depends on the size of the existing gallstones at the beginning of the treatment. Even if your symptoms have disappeared, you should continue with the treatment. Stopping treatment may result in the extension of the total treatment time. After the gallstones have been dissolved, the treatment should be continued for 3-4 months. 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 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.

If you feel that the effect of Cholurso is too strong or too weak, talk to your doctor or pharmacist.

Use in children

Cholurso 250 or 500 mg film-coated tablets are not intended for children.

The administration of Cholurso film-coated tablets is based on body weight and the medical condition. If the patient cannot swallow tablets or has a bodyweight below 47 kg, other pharmaceutical forms (suspension) are available.

If you take more Cholurso than you should

If you or anyone else take too many film-coated tablets, seek immediate medical attention.

If you forget to take Cholurso

Do not take a double dose to make up for a forgotten dose.

If you stop taking Cholurso

Always speak to your doctor before you decide to interrupt treatment with Cholurso or to stop your treatment early.

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.

Contact your doctor immediately if you experience any of the following symptoms after taking Cholurso:

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.

Diarrhoea may also occur as a result of overdose.

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 scarring - this partially improves 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).

Not known (frequency cannot be estimated from the available data):

•    vomiting.

•    in patients with cirrhosis, exacerbation (increase in severity) of pruritus (itching) at the beginning of the treatment cannot be completely ruled out.

•    in patients with stage IV primary biliary cirrhosis, there may be an increase in the concentration of

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certain enzymes (alkaline phosphates, gamma-glutamyltransferase) and bilirubin.

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.oov.uk/vellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Cholurso 250 mg or 500 mg film-coated tablets_

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 blister label and 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 Cholurso 250 mg or 500 mg film-coated tablets contains

•The active substance is ursodeoxycholic acid.

For Cholurso 250 ma film-coated tablets

Each film-coated tablet contains 250 mg ursodeoxycholic

acid.

For Cholurso 500 ma film-coated tablets

Each film-coated tablet contains 500 mg ursodeoxycholic acid.

• The other ingredients are:

Core

Maize starch, sodium laurilsulfate, povidone (E1201), colloidal anhydrous silica, magnesium stearate.

Film-coat

Lecithin (Soya) (E322), polyethylene glycol (E1521), polyvinyl alcohol (El 203), talc (E553b), titanium dioxide (E171).

What CHOLURSO 250 mg, film-coated tablets look like and contents of the pack

CHOLURSO 250 mg film-coated tablets are white, round and biconvex.

Pack size: 20,30,50 or 60 tablets in blister packs (PVC / PVDC/Aluminium).

Not all pack sizes may be marketed.

What CHOLURSO 500 mg, film-coated tablets look like and contents of the pack

Cholurso 500 mg film-coated tablets are white and oblong with a score line on each side.

The tablet can be divided into equal doses.

Pack size: 20,30,50 or 60 tablets in blister packs (PVC / PVDC/Aluminium).

Not all pack sizes may be marketed.

Marketing Authorisation Holder

LABORATOIRES MAYOLY SPINDLER 6, avenue de I'Europe 78400 Chatou France

Manufacturer

CENEXI

52, Rue Marcel et Jacques Gaucher 94120 Fontenay sous Bois FRANCE

This medicinal product is authorised in the Member States of the EEA under the following names:

Belgium, France, Germany, Hungary, Italy, Portugal:

Dozurso

UK: Cholurso.

Distributed in the UK by:

HFA Healthcare Products Limited

This leaflet was last revised in 11/2014.

jt- MAYOLY Air SPINDLER

For medical information queries please call: 08443358270