Destolit 150mg tablets

Country: যুক্তরাজ্য

ভাষা: ইংরেজি

সূত্র: MHRA (Medicines & Healthcare Products Regulatory Agency)

সক্রিয় উপাদান:

Ursodeoxycholic acid

থেকে পাওয়া:

Norgine Pharmaceuticals Ltd

এটিসি কোড:

A05AA02

INN (International Name):

Ursodeoxycholic acid

ডোজ:

150mg

ফার্মাসিউটিকাল ফর্ম:

Oral tablet

প্রশাসন রুট:

Oral

শ্রেণী:

No Controlled Drug Status

প্রেসক্রিপশন টাইপ:

Valid as a prescribable product

পণ্য সারাংশ:

BNF: 01090100; GTIN: 5015265300012

তথ্য লিফলেট

FONTS USED:
Frutiger LT Std-57 Condensed
Frutiger LT Std-75 Black
Frutiger LT Std-77 Black Condensed
Helvetica LT Std-Roman
AVERAGE TEXT SIZE (BODY TEXT):
9.0 pt
Page 1 of 2
Package leaflet: Information for the patient
Destolit 150 mg tablets
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 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 side effects not listed in this leaflet.
See section 4.
What is in this leaflet:
1.
What Destolit is and what it is used for
2.
What you need to know before you take Destolit
3.
How to take Destolit
4.
Possible side effects
5.
How to store Destolit
6.
Contents of the pack and other 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.
2. What you need to know before you take Destolit
Do not take Destolit:
•
if you have acute inflammation of the gall bladder or biliary tract
•
if you have a blockage of the biliary tract
•
if you have frequent episodes of biliary colic (recurrent pain in the
upper abdomen)
•
if you have a stomach or duodenal ulcer
•
if you have had bowel surgery (removal of a part of the small bowel)
•
if you have inflammatory bowel disease
Other side effects may include:
•
Feeling or being sick and itchy sk

পণ্য বৈশিষ্ট্য

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Destolit 150 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 150 mg ursodeoxycholic acid (UDCA)
Excipient(s) with known effect: Lactose
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
The dissolution of radiolucent (ie non-radio opaque) cholesterol
gallstones in
patients with a functioning gallbladder.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
-
Posology
_Adults and the elderly _
Dissolution of gallstones:
A daily dose of 8 to 12mg/kg UDCA will produce cholesterol
desaturation in
the majority of cases. The measurement of the lithogenic index on
bile-rich
duodenal drainage fluid after 4-6 weeks of therapy may be useful for
determining the minimum effective dose. The lowest effective dose has
been
found to be 4 mg/kg. The daily dose for most patients is 3 or 4
tablets,
according to body weight. The dose should be divided into two
administrations after meals, with one administration always after the
evening
meal.
The duration of treatment needed to achieve dissolution will not
usually
exceed 2 years, and should be monitored with regular cholecystograms.
Treatment should be continued for 3-4 months after the radiological
disappearance of gallstones.
Any temporary discontinuation of treatment, if prolonged for 3-4
weeks, will
allow the bile to return to a state of supersaturation, and will
extend the total
time taken for litholysis. In some cases stones may recur after
successful
treatment.
_Paediatric population _
_ _
Not recommended.
Method of administration
For oral administration.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in
section 6.1.
Acute inflammation of the gallbladder or biliary tract.
Occlusion of the biliary tract (occlusion of the common bile duct or a
cystic
duct).
Frequent episodes of biliary colic.
Radio-opaque calcified gallstones.
Impaired contractility of the gallbladder