Ursodeoxycholic acid 150mg tablets

Ülke: Birleşik Krallık

Dil: İngilizce

Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktif bileşen:

Ursodeoxycholic acid

Mevcut itibaren:

Teva UK Ltd

ATC kodu:

A05AA02

INN (International Adı):

Ursodeoxycholic acid

Doz:

150mg

Farmasötik formu:

Oral tablet

Uygulama yolu:

Oral

Sınıf:

No Controlled Drug Status

Reçete türü:

Valid as a prescribable product

Ürün özeti:

BNF: 01090100; GTIN: 5060032242064

Bilgilendirme broşürü

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
URSODEOXYCHOLIC ACID 150 MG TABLETS
EAS2019e
WHAT IS IN THIS LEAFLET:
1. What Ursodeoxycholic Acid is and what it is used for
2. What you need to know before you take Ursodeoxycholic
Acid
3. How to take Ursodeoxycholic Acid
4. Possible side effects
5. How to store Ursodeoxycholic Acid
6. Contents of the pack and other information 1. WHAT URSODEOXYCHOLIC ACID IS AND WHAT IT IS USED FOR
Ursodeoxycholic Acid contains the active substance
ursodeoxycholic acid, which is one of a group of medicines
used to dissolve gallstones. Not all gallstones are suitable
for treatment with Ursodeoxycholic Acid 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. Ursodeoxycholic Acid tablets help dissolve gallstones
that are made mainly of cholesterol. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE URSODEOXYCHOLIC ACID
DO NOT TAKE URSODEOXYCHOLIC ACID:
-
if you are allergic to ursodeoxycholic acid other bile acids
or to any of the other ingredients of this medicine (listed in
section 6).
-
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 your doctor has told you that you have gallstones which
are radio-opaque
-
if your gall bladder does not work properly
-
if you have inflammatory bowel disease
-
if you have a liver or intestinal condition which interferes
with the circulation of bile substances e.g. blockage of the
bile duct, removal of part of the small bowel.
-
if you have any liver disease
-
if you have a stomach or duodenal ulcer
Do not take this medicine if any of the above applies to you.
If you are not sure, talk to your doctor or pharmacist before
taking this medicine.
OTHER MEDICINES AND URSODEOXYCHOLIC ACID
Tell your doctor or pharmacist if you are taking, have
recently taken or migh

Ürün özellikleri

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ursodeoxycholic Acid 150 mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 150 mg of ursodeoxycholic acid.
Excipient with known effect
Each tablet contains 142.50 mg of lactose monohydrate and 0.2 mg of
sodium.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
White to off-white, round tablet, 11 mm diameter with a break line.
The tablets are
marked with ‘URS 150’.
The break line is only to facilitate breaking for ease of swallowing
and not to divide
into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
The dissolution of radiolucent (i.e. 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 ursodeoxycholic acid 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, o