Orphacol 50mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Cholic acid

Available from:

Laboratoires CTRS

ATC code:

A05AA03

INN (International Name):

Cholic acid

Dosage:

50mg

Pharmaceutical form:

Capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01090100

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
_ _
ORPHACOL 50 MG HARD CAPSULES
ORPHACOL 250 MG HARD CAPSULES
cholic acid
This medicine is subject to additional monitoring. This will allow
quick identification of new safety
information. You can help by reporting any side effects you may get.
See the end of section 4 for how to
report side effects.
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. Do not pass it on to
others. It may harm them, even if
their symptoms are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
_ _
WHAT IS IN THIS LEAFLET:
1.
What Orphacol is and what it is used for
2.
What you need to know before you take Orphacol
3.
How to take Orphacol
4.
Possible side effects
5.
How to store Orphacol
6.
Contents of the pack and other information
1.
WHAT ORPHACOL IS AND WHAT IT IS USED FOR
Orphacol contains cholic acid, a bile acid which is normally produced
by the liver. Certain medical
conditions are caused by defects in bile acid production and Orphacol
is used to treat infants from one
month to 2 years of age, children, adolescents and adults with these
medical conditions. The cholic acid
contained in Orphacol replaces the bile acids that are missing due to
the defect in bile acid production.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ORPHACOL
_ _
DO NOT TAKE ORPHACOL
-
if you are allergic to cholic acid or any of the other ingredients of
this medicine (listed in section
6)..
-
if you are taking phenobarbital, a medicine to treat epilepsy.
WARNINGS AND PRECAUTIONS
Your doctor will prescribe laboratory tests on your blood, urine and
liver for you when you start treatment
and regularly thereafter. Make sure you see your doctor for these
regular examination

Summary of Product characteristics

OBJECT 1
ORPHACOL 50 MILLIGRAM CAPSULES
Summary of Product Characteristics Updated 16-Oct-2017 | Laboratoires
CTRS
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
1. Name of the medicinal product
Orphacol 50 mg hard capsules
2. Qualitative and quantitative composition
Each hard capsule contains 50 mg of cholic acid.
Excipient(s) with known effect: Lactose (145.79 mg per capsule).
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Hard capsule (capsule).
Oblong, opaque, blue and white capsule.
4. Clinical particulars
4.1 Therapeutic indications
Orphacol is indicated for the treatment of inborn errors in primary
bile acid synthesis due to 3β-Hydroxy-
Δ
5
-C
27
-steroid oxidoreductase deficiency or Δ
4
-3-Oxosteroid-5β-reductase deficiency in infants, children
and adolescents aged 1 month to 18 years and adults.
4.2 Posology and method of administration
Treatment must be initiated and monitored by an experienced
gastroenterologist/hepatologist or a
paediatric gastroenterologist/hepatologist in the case of paediatric
patients.
In case of persistent lack of therapeutic response to cholic acid
monotherapy, other treatment options
should be considered (see section 4.4). Patients should be monitored
as follows: 3-monthly during the
first year, 6-monthly during the subsequent three years and annually
thereafter (see below).
Posology
The dose must be adjusted for each patient in a specialised unit
according to blood and/or urine
chromatographic bile acid profiles.
_3β-Hydroxy-Δ_
_5_
_-C_
_27_
_-steroid oxidoreductase deficiency_
The daily dose ranges from 5 to 15 mg/kg in infants, children,
adolescents and adults. In all age groups,
the minimum dose is 50 mg and the dose is adjusted in 50 mg steps. In
adults, the daily dose should not
exceed 500 mg.
_Δ_
_4_
_-3-Oxosteroid-5β-reductase deficie