Heptral 500mg Gastroresistant Tablets

国家: 马来西亚

语言: 英文

来源: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

有效成分:

Ademetionine 1,4-butanedisulfonate

可用日期:

ABBOTT LABORATORIES (M) SDN. BHD.

INN（国际名称）:

Ademetionine 1,4-butanedisulfonate

每包单位数:

10 Tablets; 20 Tablets; 10 Tablets; 20 Tablets

厂商:

ABBVIE S.R.L.

资料单张

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
HEPTRAL® 500MG GASTRORESISTANT TABLETS
Ademetionine 1,4-butanedisulfonate (500mg)
Page no. 1
WHAT IS IN THIS LEAFLET
1. What Heptral® is used for
2. How Heptral® works
3. Before you use Heptral®
4. How to use Heptral®
5. While you are using it
6. Side effects
7. Storage and disposal of Heptral®
8. Product description
9. Manufacturer and product
registration holder
10. Date of revision
WHAT HEPTRAL®
IS USED FOR
Heptral® is used to treat cholestasis
(a type of liver disease) in pregnant
and non-pregnant individuals. It is
also used to relief tiredness caused by
chronic liver disease.
HOW HEPTRAL® WORKS
Heptral® contains amino acid called
S-adenosyl-L-methionine
(ademetionine). It acts as a coenzyme
to maintain and restore metabolic
processes in the liver and produce
antioxidants (glutathione) that help in
liver detoxification.
BEFORE YOU USE HEPTRAL®
_- When you must not use it_
Do not take Heptral® if:
•
You are allergic
(hypersensitive) to
ademetionine or any of the
other ingredients of
Heptral®
•
You have genetic defects
affecting the methionine
cycle (a pathway that is
essential in growth and
development).
Do not use Heptral® if any of the
above applies to you. If you are not
sure, talk to your doctor or
pharmacist before taking Heptral®.
_- Before you start to use it _
Talk to your doctor or pharmacist
before taking Heptral® if you suffer
from any medical conditions
or illnesses, in particular:
•
if you have bipolar disease
(a type of mental disorder)
or anxiety
•
if you have liver or kidney
problem
•
if you are anemic or
vegetarian
•
if you are pregnant, or could
be pregnant
If any of the above applies to you,
your doctor will tell you whether it is
safe for you to start taking Heptral®.
_- Taking other medicines _
Tell your doctor or pharmacist if you
are taking, have recently taken or
might take any other medicines, in
particular:
•
tricyclic antidepressants (eg.
Clomipramine), used in
treating psychological
disorder
•
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产品特点

HEPTRAL
ADEMETIONINE
PRODUCT DESCRIPTION:
Heptral 500mg Gastroresistant Tablets
_Quality and Quantity Composition _
One tablet contains:
Ademetionine 1,4-butanedisulfonate equivalent to 500 mg ion.
_Pharmaceutical forms _
White to yellowish, oval tablet
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Ademetionine is indicated for treatment of adults with:
•
Intrahepatic cholestasis in pre-cirrhotic and cirrhotic states
•
Intrahepatic cholestasis in pregnancy
•
Relief of fatigue caused by chronic liver disease
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment can be initiated with parenteral administration and
continued orally or initiated orally.
_INTRAHEPATIC CHOLESTASIS/ FATIGUE IN CHRONIC LIVER DISEASE _
Oral: The recommended dosing is 10-25 mg/kg/day orally. The usual
starting dose is 400-800 mg/day,
total daily dose not to exceed 1600mg.
_Maintenance therapy: _
Oral: 800 to 1,600 mg/day.
_Pediatric Population _
The safety and efficacy of ademetionine for the use in children has
not been established.
_Elderly Population _
Clinical studies of ademetionine did not include sufficient numbers of
subjects’ aged 65 and over to
determine whether they respond differently from younger subjects.
Reported clinical experience has not
identified differences in responses between the elderly and younger
patients. In general, dose selection
for an elderly patient should be cautious, usually starting at the low
end of the dosing range, reflecting
the greater frequency of decreased hepatic, renal, or cardiac
function, and of concomitant disease or
other drug therapy.
_Renal Impairment _
There is limited clinical data in patients with renal impairment.
Caution is recommended when
administering ademetionine to these patients.
_Hepatic Impairment _
Pharmacokinetic parameters are similar in healthy volunteers and
patients with chronic liver disease.
_Method of Administration _
Treatment can be initiated orally.
Ademetionine tablets should be swallowed whole and not chewed.
For better absorption of the active ingredient and comp