DESTOLIT 150MG TABLETS

Active substance: URSODEOXYCHOLIC ACID

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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.

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
The leaflet was last approved in December 2010.
DESTOLIT is a registered trademark.

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

®

Destolit
150 mg Tablets
Ursodeoxycholic acid

08601401

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.

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

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.

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.

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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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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