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This is a text only leaflet, designed for the visually impaired. Please visit our electronic Medicines Compendium (eMC) website to view the original document which may contain images or tables.

You may be able to get this leaflet in large print, Braille or as an audio CD, call the RNIB Medicine Leaflet line on 0800 198 5000 for more information.

The product code for this leaflet is: PL 00322/0076

 

DESTOLIT 150 mg tablets

Company Details

Norgine Limited


Norgine HouseWidewater PlaceMoorhall RoadHarefieldMiddlesexUB9 6NS
Telephone:
Fax:
E-mail:
Medical Information e-mail:medinfo@norgine.com
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PATIENT INFORMATION LEAFLET

Destolit®

150 mg Tablets

Ursodeoxycholic acid

Read all of this leaflet carefully before you start taking this medicine

  • 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
  • If any of the side effects become serious, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

If you need the information on this leaflet in an alternative format, such as large text, or Braille please ring from the UK: 0800 198 5000.

In this leaflet:

1. What DESTOLIT is and what it is used for
2. Before you take DESTOLIT
3. How to take DESTOLIT
4. Possible side effects
5. How to store DESTOLIT
6. Further information

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1. What DESTOLIT is and what it is used for

DESTOLIT contains ursodeoxycholic acid, which is one of a group of medicines used to dissolve gallstones.

Not all gallstones are suitable for treatment with DESTOLIT but your doctor has decided that your condition may be treated this way. Ursodeoxycholic acid is a chemical present naturally in the body and it helps to control the amount of cholesterol in the blood. DESTOLIT tablets help dissolve gallstones that are made mainly of cholesterol.

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2. Before you take DESTOLIT

Do not take DESTOLIT if:

  • You have acute inflammation of the gall bladder or biliary tract.
  • You have a blockage of the biliary tract.
  • You have frequent episodes of biliary colic (recurrent pain in the upper abdomen).
  • You have a stomach or duodenal ulcer
  • You have had bowel surgery (removal of a part of the small bowel)
  • You have inflammatory bowel disease
  • Your gall bladder does not work properly
  • You have any liver disease
  • Your doctor has told you that you have gallstones which are radio-opaque
  • You are allergic (hypersensitive) to ursodeoxycholic acid or any of the other ingredients of DESTOLIT.

Taking other medicines

You should tell your doctor if you are taking:

  • hormone replacement therapy or the contraceptive pill,
  • Colestyramine, colestipol and clofibrate (medicines which lower blood cholesterol).
  • antacids (which are medicines to relieve indigestion or heartburn),
  • Ciclosporin (used to dampen down the body’s immune reactions).
  • Activated charcoal for indigestion, wind and heartburn.
  • Ciprofloxacin and dapsone (antibacterials used to treat infections).
  • Nitrendipine (used to treat high blood pressure).

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Taking DESTOLIT with food and drink

DESTOLIT should be taken after meals, with one dose always being taken after the evening meal.

Pregnancy and breast-feeding

  • DESTOLIT should not be taken during pregnancy unless recommended by your doctor.
  • Women should use adequate contraception during treatment with DESTOLIT. Contraception should either be non-hormonal e.g. barrier methods or a low oestrogen contraceptive pill. Other oral contraceptive pills should not be taken with DESTOLIT. Ask your doctor or pharmacist for advice.

Do not take DESTOLIT whilst breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

DESTOLIT should not affect your ability to drive or use machines.

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3. How to take DESTOLIT

Adults and the elderly

Always take DESTOLIT exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

  • The usual dose is between 3 and 4 tablets a day. The dose is usually divided up and taken twice a day, i.e. 1 or 2 tablets taken with water after meals. One of the doses should always be taken after your evening meal.
  • DESTOLIT will work best if taken together with a low cholesterol and calorie controlled diet. You should discuss this with your doctor.
  • You will not normally take DESTOLIT for more than 2 years. Your doctor will give you regular check-ups.
  • If you develop diarrhoea when taking DESTOLIT please consult your doctor.

Children and adolescents

DESTOLIT is not recommended in children and adolescents.

If you take more DESTOLIT than you should

You should tell your doctor if you have taken more DESTOLIT than you should. It is unlikely that you will notice any problems but you may experience diarrhoea.

If you forget to take DESTOLIT tablets

  • Do not worry, take them as soon as you remember. If it is nearly time for the next dose then take only that dose.
  • Do not take a double dose to make up for a forgotten dose.

If you stop taking DESTOLIT tablets even for a short amount of time, it may cause the gall stones to come back. Do not stop taking DESTOLIT until you are advised by your doctor.

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

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4. Possible side effects

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

Possible side effects include:

Common (affects less than 1 in 10 patients)

  • Diarrhoea, pasty stools

Very Rare (affects less than 1 in 10,000 patients)

  • A nettle like rash, gallstone calcification (a process in which the mineral calcium builds up in tissue causing it to harden).

Other side effects may include:

  • Feeling or being sick and itchy skin

If any of the side effects become serious, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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5. How to store DESTOLIT

Keep all medicines out of the reach and sight of children.

Do not store above 25°C.

Do not use DESTOLIT after the expiry date which is printed or embossed on the carton and blister as month/year. The expiry date refers to the last day of the month.

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6. Further information

What DESTOLIT contains

The active substance is ursodeoxycholic acid. Each tablet contains 150 mg ursodeoxycholic acid.

The other ingredients are lactose, pregelatinised maize starch, acacia gum, talc, magnesium stearate and purified water.

What DESTOLIT looks like and contents of the pack

Each carton contains 6 blisters of 10 white tablets.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation Holder is

Norgine Ltd
Moorhall Road
Harefield
Middlesex
UB9 6NS
UK

It is made by

Norgine Ltd
Hengoed
Mid Glamorgan
CF82 8SJ
UK

UK Marketing Authorisation Number: PL 00322/0076

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The leaflet was last approved in December 2010.

DESTOLIT is a registered trademark.

08601401


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