Hepa-Merz Granulate

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

L, ORNITHINE, ASPARTATE

Available from:

Merz Pharmaceuticals GmbH Eckenheimer Landstrasse 100, D-60318 Frankfurt am Main, Germany

ATC code:

A05BA

INN (International Name):

L-ORNITHINE 3 g/5g L-ASPARTATE 3 g/5g

Pharmaceutical form:

GRANULES FOR ORAL SOLUTION

Composition:

L-ORNITHINE 3 g/5g L-ASPARTATE 3 g/5g

Prescription type:

POM

Therapeutic area:

BILE AND LIVER THERAPY

Authorization status:

Withdrawn

Authorization date:

2006-11-08

Patient Information leaflet

Instructions for use, please read carefully!
Composition:
One 5 g sachet contains:
Active ingredient: L-ornithine-L-aspartate 3 g
Excipients: citric acid, saccharin sodium, sodium cyclamate, fructose, povidone 25, flavourings, colouring agent orange yellow 
S (E 110).
Properties:
Hepa-Merz  granulate  is  a  medicine  which  stimulates  ammonia  detoxification  by  increasing  urea  synthesis  in  the  urea  cycle. 
It serves extrahepatic ammonia detoxification in the tissues.
Indications:
Hepa-Merz  granulate  is  used  in  the  treatment  of  co-existing  and  subsequent  disorders  resulting  from  impaired  detoxification
activity in the liver (e.g. in cirrhosis of the liver) with symptoms
of latent and manifest hepatic encephalopathy.
Contraindications:
Hepa-Merz granulate may not be taken: 
- if you react hypersensitively (allergically) to L-ornithine-L-aspartate, orange yellow S (E 110) or any of the other ingredients of
Hepa-Merz granulate 
- if you suffer from severely impaired kidney function (renal insufficiency). A serum creatinine level exceeding 3 mg/100 ml can
be regarded as a reference value 
- if  you  suffer  from  the  rare,  hereditary  conditions  of  fructose  intolerance,  glucose-galactose  malabsorption  or  sucrose-
isomaltose deficiency.
Side-effects:
Like all medicines, Hepa-Merz granulate can cause side effects,
although not everybody gets them.
Nausea, vomiting, stomach ache, flatulence and diarrhoea are uncommon
occurrences. In very rare cases, pain in the limbs has
been observed. These side effects are usually transient and do not require withdrawal of the medicine. Orange yellow S (E 110)
can trigger hypersensitivity reactions.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Interaction with other d

Summary of Product characteristics

Page 1 of 5 
SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
NAME OF THE MEDICINAL PRODUCT 
Hepa-Merz granules, 3 g/5 g  
Granules for oral solution 

2.  
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Active substance: L-ornithine L-aspartate. 
Each sachet with 5 g contains 3.0 g L-ornithine-L-aspartate. 

Excipients: yellow orange S (E 110) and fructose, see also chapter
4.4. 

For a full list of excipients, see section 6.1. 

3.  PHARMACEUTICAL 
FORM 
Granules for oral solution. 

The granules are orange in colour. 

4. CLINICAL 
PARTICULARS 
4.1 THERAPEUTIC 
INDICATIONS 
Treatment of concomitant disease and sequelae due to
impaired hepatic detoxification activity (e.g. 
in cirrhosis of the liver) with the symptoms of latent and
manifest hepatic encephalopathy. 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 
Granules for oral solution. 
The dissolved contents of 1-2 sachets of Hepa-Merz granules
are taken up to 3 times daily. 
Hepa-Merz granules are dissolved in plenty of fluid (e.g. a
glass of water, tea or juice) and taken 
with or after meals. 
The experiences on the use of the drug in children are limited (see
chapter 4.4).  

4.3 CONTRAINDICATIONS 
Severely impaired renal function (renal insufficiency). A
serum creatinine value over 3 mg / 100 ml 
can be used as a guideline value. 

Hepa-Merz granules may not be taken by patients with known
hypersensitivity to L-ornithine-L-
aspartate, orange yellow S or any of the excipients. 

Page 2 of 5 

Patients with the rare hereditary conditions
of fructose intolerance, glucose-galactose 
malabsorption or sucrose-isomaltose deficiency should not
take Hepa-Merz granules. 

4.4 
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE 
This medicine contains the colouring agent orange yellow S (E
110), which can trigger allergic 
reactions. 
Hepa-Merz granules contain 1.13 g fructose per sachet
(equivalent to 0.11 CEU