Hepa-merz

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Hepa-Merz
5 g/10 ml (0.5 g/ml), concentrate for solution for infusion
Ornithini aspartas
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm other people, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents:

1. What Hepa-Merz is and what it is used for
2. Important information before using Hepa-Merz
3. How to use Hepa-Merz
4. Possible side effects
5. How to store Hepa-Merz
6. Contents of the pack and other information

1. What Hepa-Merz is and what it is used for

Hepa-Merz is a medicine that promotes the removal of ammonia from the body by enhancing the synthesis of urea in the liver. Hepa-Merz also supports the elimination of ammonia from tissues other than the liver.
Hepa-Merz is used in the treatment of hepatic encephalopathy associated with acute and chronic liver diseases, such as fatty liver, cirrhosis, and in hyperammonemia.

2. Important information before using Hepa-Merz

When not to use Hepa-Merz
Do not use Hepa-Merz in patients with the following conditions:

• hypersensitivity to L-ornithine L-aspartate;
• severe renal insufficiency (serum creatinine concentration above 3 mg/100 ml);
• disorders of amino acid metabolism involved in the urea cycle, e.g. due to enzymatic defects.

Warnings and precautions
When administering high doses of the medicinal product, serum and urinary urea concentrations should be monitored.
In patients with severe liver dysfunction, the infusion rate should be individually adjusted to avoid gastrointestinal disturbances such as nausea and vomiting.
Children
There is a lack of data on the use of Hepa-Merz in children.
Hepa-Merz and other medicinal products
Inform your doctor about all medicinal products currently used or recently used, as well as those planned for use.
No interactions between Hepa-Merz and other medicinal products are known.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicinal product.
Pregnancy
There are insufficient data on the safety of Hepa-Merz during pregnancy; therefore, the use of this medicinal product should be avoided during pregnancy. However, if treatment with Hepa-Merz in a pregnant woman is necessary, the physician should weigh the potential benefit against the potential risk before deciding to administer the medicinal product.
Breastfeeding
It is not known whether L-ornithine L-aspartate (the active substance of Hepa-Merz) passes into human milk. The use of Hepa-Merz should be avoided during breastfeeding. However, if treatment with Hepa-Merz in a breastfeeding woman is necessary, the physician should weigh the potential benefit against the potential risk before deciding to administer the medicinal product.
Driving and operating machinery
The ability to drive vehicles and operate machinery may be impaired due to the underlying disease being treated with Hepa-Merz.

3. How to use Hepa-Merz

Dosage
This medicine should always be used as directed by the physician. In case of doubt, consult a
physician or pharmacist.
The usual dose is up to 20 g (4 ampoules) per day.
In pre-comatose and comatose states, up to 40 g (8 ampoules) per day, depending on the patient's
condition.
If the patient feels that the effect of the medicine is too strong or too weak, they should contact a
physician or pharmacist.
Route of administration
Intravenous administration.
Before administration, the contents of the ampoule should be dissolved in an infusion fluid. Hepa-Merz may be administered with all commonly used infusion fluids.
No incompatibilities associated with dissolution have been observed to date.
It is recommended to prepare the infusion solution immediately before use.
Due to the risk of vein damage, no more than 6 ampoules should be administered in 500 ml of fluid.
Infusion rate: maximum 5 g (1 ampoule) per hour.
Do not administer intra-arterially.
Use of higher than recommended doses of Hepa-Merz
No symptoms of poisoning have been observed following overdose of Hepa-Merz.
In case of overdose, symptomatic treatment should be administered.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody gets them.
Uncommon adverse effects (occurring in fewer than 1 in 100 people): nausea.
Rare adverse effects (occurring in fewer than 1 in 1,000 people): vomiting.
Frequency not known (cannot be estimated from the available data):
hypersensitivity, allergic reactions (anaphylactic reactions).
Nausea and vomiting are usually transient and do not require discontinuation of the medicine.
They resolve after reducing the dose or infusion rate.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in the leaflet,
inform a doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions
of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Hepa-Merz

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the specified month.
Store in the original packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Hepa-Merz contains
The active substance is L-ornithine L-aspartate.
Each vial (10 ml) of concentrate for solution for infusion contains 5 g of L-ornithine L-aspartate.
The excipient is water for injections.

What Hepa-Merz looks like and contents of the pack
Hepa-Merz, concentrate for solution for infusion, is a clear solution.
The pack contains 10 vials of 10 ml each.

For further information, contact the marketing authorisation holder or the parallel importer.

Marketing authorisation holder in Romania, country of export:
Merz Pharmaceuticals GmbH
Eckenheimer Landstrasse 100
60318 Frankfurt am Main
Germany

Manufacturer:
MERZ PHARMA GmbH & Co. KGaA
Ludwigstraße 22
64354 Reinheim
Germany

Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing authorisation number in Romania, country of export: 7377/2006/01
Parallel import authorisation number: 416/22