DEOXXA 250 mg / 5 ml Oral Suspension

• 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.

The full name of your medicine is DEOXXA 250 mg / 5 ml Oral Suspension but it will be referred to as DEOXXA throughout this leaflet.

1. What DEOXXA is and what it is used for
2. What you need to know before you take DEOXXA
3. How to take DEOXXA
4. Possible side effects
5. How to store DEOXXA
6. Contents of the pack and other information

• for the treatment of primary biliary cholangitis (PBC), 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
• to dissolve gallstones caused by excess cholesterol in the gall bladder 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 aged 1 month to 18 years.

• you are allergic to ursodeoxycholic acid, to other bile acids or any of the other ingredients of this medicine (listed in section 6)
• your gall bladder does not work properly
• you have gallstones that are visible on an X-ray (calcified)
• you have acute inflammation of the gall bladder or biliary tract
• you have a blockage of the common bile duct or cystic duct (obstruction of the biliary tract)
• you have frequent cramp-like upper abdominal pain (biliary colic)
• you are a child with 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.

Talk to your doctor or pharmacist before taking DEOXXA.

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 gallbladder after the first 6 – 10 months of treatment.

When used in the treatment of PBC, in rare cases the symptoms may worsen when you start treatment. Talk to your doctor if this happens as the dose may need to be reduced.

Please inform your doctor immediately if you have diarrhoea as this may require a reduction in the dose or discontinuation of treatment.

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

The effects of these medicines may be altered:

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

• 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 this medicine
• 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:

• 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
• 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 this medicine for the dissolution of gallstones as they may stimulate the formation of gallstones.

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 this medicine 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 this medicine, your doctor will check that you are not pregnant and review your contraceptive method to make sure it is appropriate.

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding.

No particular precautions are necessary.

This medicine contains 7.5 mg benzoic acid in each 5 ml of suspension. Benzoic acid may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old).

This medicine contains 51.75 mg propylene glycol in each 5 ml of suspension. If your baby is less than 4 weeks old, talk to your doctor or pharmacist before giving them this medicine, in particular if the baby is given other medicines that contain propylene glycol or alcohol.

This medicine contains 1600 mg xylitol in each 5 ml of suspension. May have a laxative effect. The calorific value of xylitol is 2.4 kcal/g.

This medicine contains 1.5 mg alcohol (ethanol) in each 5 ml of suspension which is equivalent to 0.03% w/v. The amount in each 5 ml dose of this medicine is equivalent to less than 1 ml of beer or wine. The small amount of alcohol in this medicine will not have any noticeable effects.

This medicine contains 11.07 mg sodium (main component of cooking / table salt) in each 5 ml of suspension. This is equivalent to 0.6 % of the recommended maximum daily dietary intake of sodium for an adult.

During the first 3 months of treatment, this medicine should be taken 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. The recommended dose is as follows:

Body Weight 8–11 kg

Daily dose: 12–16 mg per kg body weight

• First 3 months:
  • Morning: None
  • Midday: 1.25 ml
  • Evening: 1.25 ml
• Subsequently:
  • Evening (once daily): 2.5 ml

Body Weight 12–15 kg

Daily dose: 12–16 mg per kg body weight

• First 3 months:
  • Morning: 1.25 ml
  • Midday: 1.25 ml
  • Evening: 1.25 ml
• Subsequently:
  • Evening (once daily): 3.75 ml

Body Weight 16–19 kg

Daily dose: 13–16 mg per kg body weight

• First 3 months:
  • Morning: 2.5 ml
  • Midday: None
  • Evening: 2.5 ml
• Subsequently:
  • Evening (once daily): 5 ml

Body Weight 20–23 kg

Daily dose: 13–15 mg per kg body weight

• First 3 months:
  • Morning: 1.25 ml
  • Midday: 2.5 ml
  • Evening: 2.5 ml
• Subsequently:
  • Evening (once daily): 6.25 ml

Body Weight 24–27 kg

Daily dose: 13–16 mg per kg body weight

• First 3 months:
  • Morning: 2.5 ml
  • Midday: 2.5 ml
  • Evening: 2.5 ml
• Subsequently:
  • Evening (once daily): 7.5 ml

Body Weight 28–31 kg

Daily dose: 14–16 mg per kg body weight

• First 3 months:
  • Morning: 1.25 ml
  • Midday: 2.5 ml
  • Evening: 5 ml
• Subsequently:
  • Evening (once daily): 8.75 ml

Body Weight 32–39 kg

Daily dose: 12–16 mg per kg body weight

• First 3 months:
  • Morning: 2.5 ml
  • Midday: 2.5 ml
  • Evening: 5 ml
• Subsequently:
  • Evening (once daily): 10 ml

Body Weight 40–47 kg

Daily dose: 13–16 mg per kg body weight

• First 3 months:
  • Morning: 2.5 ml
  • Midday: 5 ml
  • Evening: 5 ml
• Subsequently:
  • Evening (once daily): 12.5 ml

Body Weight 48–62 kg

Daily dose: 12–16 mg per kg body weight

• First 3 months:
  • Morning: 5 ml
  • Midday: 5 ml
  • Evening: 5 ml
• Subsequently:
  • Evening (once daily): 15 ml

Body Weight 63–80 kg

Daily dose: 12–16 mg per kg body weight

• First 3 months:
  • Morning: 5 ml
  • Midday: 5 ml
  • Evening: 10 ml
• Subsequently:
  • Evening (once daily): 20 ml

Body Weight 81–95 kg

Daily dose: 13–16 mg per kg body weight

• First 3 months:
  • Morning: 5 ml
  • Midday: 10 ml
  • Evening: 10 ml
• Subsequently:
  • Evening (once daily): 25 ml

Body Weight 96–115 kg

Daily dose: 13–16 mg per kg body weight

• First 3 months:
  • Morning: 10 ml
  • Midday: 10 ml
  • Evening: 10 ml
• Subsequently:
  • Evening (once daily): 30 ml

Body Weight over 115 kg

Daily dose: Not specified

• First 3 months:
  • Morning: 10 ml
  • Midday: 10 ml
  • Evening: 15 ml
• Subsequently:
  • Evening (once daily): 35 ml

Duration of treatment

Take this medicine regularly. Ursodeoxycholic acid may be continued indefinitely in cases of primary biliary cholangitis.

To dissolve cholesterol gallstones

The recommended dose is approximately 10 mg per kg body weight daily as follows:

Body Weight 5-7 kg:

• 1.25 ml

Body Weight 8-12 kg:

• 2.50 ml

Body Weight 13-18 kg:

• 3.75 ml

Body Weight 19-25 kg:

• 5 ml

Body Weight 26-35 kg:

• 7.5 ml

Body Weight 36-50 kg:

• 10 ml

Body Weight 51-65 kg:

• 12.5 ml

Body Weight 66-80 kg:

• 15 ml

Body Weight 81-100 kg:

• 20 ml

Body Weight Over 100 kg:

• 25 ml

Take the suspension in the evening at bedtime. Take the suspension regularly.

Duration of treatment

It generally takes 6-24 months to dissolve gallstones. 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.

Both indications:

Use in children and adolescents:

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

Use in children (1 month to 18 years) for treatment of liver disease associated with cystic fibrosis

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

Single doses for children with a body weight up to 10 kg should be given with an oral syringe as the spoon provided does not cover volumes below 1.25 ml. Use a 2 ml oral syringe with a graduation of 0.1 ml.

Please note: Oral syringes are not included in the pack but may be purchased from your pharmacist.

To administer the required dose by syringe:

1. Shake the bottle well before opening
2. Pour a small amount of suspension into a glass
3. Draw the appropriate volume into the syringe
4. Tap against the barrel of the syringe to remove any large air bubbles
5. Check the appropriate volume of suspension is in the syringe, adjust if necessary
6. Carefully dispense the syringe contents directly into the child’s mouth
7. Wash the syringe with water after each use and allow it to dry completely before you next use it.

Do NOT put the syringe into the bottle. Do NOT put unused suspension from the syringe or the glass back into the bottle.

Up to 10 kg body weight: Dosing 20 mg ursodeoxycholic acid/kg/day

Measuring device: 2 ml graduated oral syringe (not provided).

Body Weight 4 kg:

• Morning: 0.8 ml
• Evening: 0.8 ml

Body Weight 4.5 kg:

• Morning: 0.9 ml
• Evening: 0.9 ml

Body Weight 5 kg:

• Morning: 1.0 ml
• Evening: 1.0 ml

Body Weight 5.5 kg:

• Morning: 1.1 ml
• Evening: 1.1 ml

Body Weight 6 kg:

• Morning: 1.2 ml
• Evening: 1.2 ml

Body Weight 6.5 kg:

• Morning: 1.3 ml
• Evening: 1.3 ml

Body Weight 7 kg:

• Morning: 1.4 ml
• Evening: 1.4 ml

Body Weight 7.5 kg:

• Morning: 1.5 ml
• Evening: 1.5 ml

Body Weight 8 kg:

• Morning: 1.6 ml
• Evening: 1.6 ml

Body Weight 8.5 kg:

• Morning: 1.7 ml
• Evening: 1.7 ml

Body Weight 9 kg:

• Morning: 1.8 ml
• Evening: 1.8 ml

Body Weight 9.5 kg:

• Morning: 1.9 ml
• Evening: 1.9 ml

Body Weight 10 kg:

• Morning: 2.0 ml
• Evening: 2.0 ml

The spoon provided can be used for children over 10 kg body weight.

More than 10 kg body weight: Dosing 20-25 mg ursodeoxycholic acid/kg/day

Measuring device: Spoon

Body Weight 11–12 kg

Daily dose: 21–23 mg per kg body weight

• Morning: 2.5 ml
• Evening: 2.5 ml

Body Weight 13–15 kg

Daily dose: 21–24 mg per kg body weight

• Morning: 2.5 ml
• Evening: 3.75 ml

Body Weight 16–18 kg

Daily dose: 21–23 mg per kg body weight

• Morning: 3.75 ml
• Evening: 3.75 ml

Body Weight 19–21 kg

Daily dose: 21–23 mg per kg body weight

• Morning: 3.75 ml
• Evening: 5 ml

Body Weight 22–23 kg

Daily dose: 22–23 mg per kg body weight

• Morning: 5 ml
• Evening: 5 ml

Body Weight 24–26 kg

Daily dose: 22–23 mg per kg body weight

• Morning: 5 ml
• Evening: 6.25 ml

Body Weight 27–29 kg

Daily dose: 22–23 mg per kg body weight

• Morning: 6.25 ml
• Evening: 6.25 ml

Body Weight 30–32 kg

Daily dose: 21–23 mg per kg body weight

• Morning: 6.25 ml
• Evening: 7.5 ml

Body Weight 33–35 kg

Daily dose: 21–23 mg per kg body weight

• Morning: 7.5 ml
• Evening: 7.5 ml

Body Weight 36–38 kg

Daily dose: 21–23 mg per kg body weight

• Morning: 7.5 ml
• Evening: 8.75 ml

Body Weight 39–41 kg

Daily dose: 21–22 mg per kg body weight

• Morning: 8.75 ml
• Evening: 8.75 ml

Body Weight 42–47 kg

Daily dose: 20–22 mg per kg body weight

• Morning: 8.75 ml
• Evening: 10 ml

Body Weight 48–56 kg

Daily dose: 20–23 mg per kg body weight

• Morning: 11.25 ml
• Evening: 11.25 ml

Body Weight 57–68 kg

Daily dose: 20–24 mg per kg body weight

• Morning: 13.75 ml
• Evening: 13.75 ml

Body Weight 69–81 kg

Daily dose: 20–24 mg per kg body weight

• Morning: 16.25 ml
• Evening: 16.25 ml

Body Weight 82–100 kg

Daily dose: 20–24 mg per kg body weight

• Morning: 20 ml
• Evening: 20 ml

Body Weight >100 kg

Daily dose: Not specified

• Morning: 22.5 ml
• Evening: 22.5 ml

Conversion table:

5 ml is equivalent to 250 mg of ursodeoxycholic acid

3.75 ml is equivalent to 187.5 mg of ursodeoxycholic acid

2.5 ml is equivalent to 125 mg of ursodeoxycholic acid

1.25 ml is equivalent to 62.5 mg of ursodeoxycholic acid

Take your medicine two to three times per day, as advised. Take this medicine regularly.

Duration of treatment

Treatment can be continued long term (up to 18 years) in children with cystic fibrosis associated hepatobiliary disorders.

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

Method of administration

For oral administration.

Always shake the closed bottle well before use.

A 5ml measuring spoon with graduations of 1.25 ml, 2.5 ml, 3.75 ml and 5 ml is provided and can be used to deliver the majority of doses e.g. 6.25 ml is given as 1 x 5 ml and 1 x 1.25 ml and 8.75 ml is given as 1 x 5 ml and 1 x 3.75 ml. Pour the suspension into the spoon to the required dose – see diagram below – and then swallow the medicine. Repeat as required for further doses. Ensure you rinse the spoon with water after each use and allow to dry. A measuring cup or oral syringe (not supplied) can also be used if available.

Doses under 2 ml for children with cystic fibrosis weighing under 10 kg should be administered with a 2 ml oral syringe (not supplied).

This medicine can be administered via a gastric, duodenal or nasal feeding tube if required. Larger tubes should be rinsed twice with at least 10 ml of water following administration while smaller tubes should be rinsed at least once with a minimum of 3 ml of water.

If you take more DEOXXA than you should, you are likely to suffer from diarrhoea. If you or anyone else take more of this medicine than you should, contact your doctor or nearest hospital casualty department as soon as possible. Take the bottle and this leaflet with you so the medical staff will know what you have taken.

Take the next dose at the correct time and then go on as before. Do not take a double dose to make up for a forgotten dose.

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

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 or search for ‘MHRA Yellow Card’ in the Google Play or Apple App Store.

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

The active substance is ursodeoxycholic acid. Each 5 ml of suspension contains 250 mg of ursodeoxycholic acid.

The other ingredients are benzoic acid (E 210), citric acid, glycerol, microcrystalline cellulose, carmellose sodium, sodium chloride, sodium citrate dihydrate, sodium cyclamate, propylene glycol (E 1520), purified water, xylitol and citrus flavouring (contains propylene glycol (E 1520) and ethanol).

DEOXXA is a white suspension with small air bubbles and a lemon smell supplied in brown plastic (polyethylene terephthalate (PET)) bottles with a polypropylene / polyethylene child-resistant cap. Each bottle contains 250 ml of suspension. The carton also contains a transparent 5 ml plastic (polystyrene) measuring spoon with 4 graduations of 1.25 ml, 2.5 ml, 3.75 ml and 5 ml for dispensing the suspension.