Ursodeoxycholic acid 300mg tablets

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Viambatanisho vya kazi:

Ursodeoxycholic acid

Inapatikana kutoka:

Wockhardt UK Ltd

ATC kanuni:

A05AA02

INN (Jina la Kimataifa):

Ursodeoxycholic acid

Kipimo:

300mg

Dawa fomu:

Oral tablet

Njia ya uendeshaji:

Oral

Darasa:

No Controlled Drug Status

Dawa ya aina:

Valid as a prescribable product

Bidhaa muhtasari:

BNF: 01090100; GTIN: 5012727901008

Taarifa za kipeperushi

CHANGE CONTROL : Version changes due to change in:
Size/Layout Regulatory Non-Regulatory
Changes in detail:
• Regulatory text amends
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READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
− Keep this leaflet. You may need to read it again.
− If you have further questions, please ask your doctor or
pharmacist.
− This medicine has been prescribed for you personally and you
should not pass it on to
others. It may harm them, even if their symptoms are the same as
yours.
The name of your medicine is Ursodeoxycholic Acid 300mg Film-Coated
Tablets. In the
rest of this leaflet it is called Ursodeoxycholic Acid Tablets.
IN THIS LEAFLET:
1. What Ursodeoxycholic Acid Tablets are and what they are used for
2. Before you take Ursodeoxycholic Acid Tablets
3. How to take Ursodeoxycholic Acid Tablets
4. Possible side effects
5. How to store Ursodeoxycholic Acid Tablets
6. Further information
1. WHAT URSODEOXYCHOLIC ACID TABLETS ARE AND WHAT
THEY ARE USED FOR
The active ingredient in Ursodeoxycholic Acid Tablets is
ursodeoxycholic acid, which is a
naturally occurring substance (bile acid) normally present in the
bile.
Ursodeoxycholic Acid Tablets may be used for the following:
• To dissolve certain types of gall stones (stones in the gall
bladder), which contain
cholesterol. Ursodeoxycholic Acid Tablets may be suitable for patients
who are unable to
have surgery or do not wish to have surgery.
• To treat a type of liver disease known as primary biliary
cirrhosis (PBC).
• To treat liver disease associated with cystic fibrosis in children
aged 6 years to less than
18 years.
2. BEFORE YOU TAKE URSODEOXYCHOLIC ACID TABLETS
DO NO

Tabia za bidhaa

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Urdox 300mg Film-Coated Tablets,
Ursodeoxycholic Acid 300mg Film-Coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ursodeoxycholic acid 300mg.
Excipients: lactose.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Urdox tablets are white. film coated, convex tablets with “URDOX”
on one side.
4.1
THERAPEUTIC INDICATIONS
Urdox tablets are indicated in the treatment of primary biliary
cirrhosis (PBC) and for
the dissolution of small to medium sized radiolucent, cholesterol-rich
gall-stones in
patients with a functioning gall bladder.
Cholesterol stones coated with calcium or stones composed of bile
pigments are not
dissolved by ursodeoxycholic acid. Urdox has a particular place in the
treatment of
patients in whom surgery is contraindicated or who are anxious to
avoid surgery.
Paediatric population
Hepatobiliar disorder associated with cystic fibrosis in children aged
6 years to less than
18 years.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Urdox tablets are for oral administration
To be taken with a drink of water.
_ _
Primary Biliary Cirrhosis
_Adults and Elderly:_ 10 - 15mg ursodeoxycholic acid (UDCA) per kg per
day in two to
four divided doses.
_Children:_ Dosage should be related to bodyweight.
Dissolution of gallstones
_ _
_Adults and Elderly:_
The usual dose is 6 - 12mg/kg/day either as a single night time dose
or in divided doses.
This may be increased to 15mg/kg/day in obese patients, if necessary.
The duration of treatment may be up to two years, depending on the
size of the stone(s),
and should be continued for three months after the apparent
dissolution of the stone(s).
_ _
_Children: _Dosage should be related to bodyweight.
Paediatric population
Children with cystic fibrosis aged 6 year to less than 18 years: 20
mg/kg/day in 2-3
divided doses, with further increase to 30 mg/kg/day if necessary.
4.3
CONTRAINDICATIONS
Ursodeoxycholic acid should not be used in patients:
1.
with radio-opaque calcified gall-st