Hepa-mezh

Package Leaflet: Information for the Patient

Warning! Keep the 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

Ornithine aspartate

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

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

Hepa-Merz is a medicine that stimulates the removal of ammonia from the body by increasing the synthesis of urea in the liver. Hepa-Merz also supports the removal of ammonia from tissues other than the liver. Hepa-Merz is used to treat liver encephalopathy in the course of acute and chronic liver diseases, such as fatty liver, cirrhosis, and hyperammonemia.

2. Important information before using Hepa-Merz

When not to use Hepa-Merz

Do not use Hepa-Merz in patients with the following disorders:

• hypersensitivity to L-ornithine L-aspartate;
• severe kidney failure (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 using high doses of the medicine, monitor the urea concentration in serum and urine. In cases of severe liver dysfunction, the infusion rate should be adjusted individually to avoid gastrointestinal disorders, such as nausea and vomiting.

Children

There are no data on the use of Hepa-Merz in children.

Hepa-Merz and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. There are no known interactions between Hepa-Merz and other medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before using this medicine. PregnancyThere are insufficient studies on the safety of using Hepa-Merz during pregnancy; therefore, avoid using the medicine during pregnancy. However, if the use of the medicine in a pregnant woman is necessary, the doctor should consider the potential benefit versus the risk before making a decision. BreastfeedingIt is not known whether L-ornithine L-aspartate (the active substance of Hepa-Merz) passes into breast milk. Avoid using the medicine during breastfeeding. However, if the use of the medicine in a breastfeeding woman is necessary, the doctor should consider the potential benefit versus the risk before making a decision.

Driving and using machines

The ability to drive and use machines may be reduced due to the disease being treated with Hepa-Merz.

3. How to use Hepa-Merz

Dosage:

Always use this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist. Usually, up to 20 g (4 ampoules) per day is administered. In pre-coma and coma states, up to 40 g (8 ampoules) per day, depending on the patient's condition. If you feel that the effect of the medicine is too strong or too weak, contact your doctor or pharmacist.

Method of administration

Intravenous administration. Before administration, dissolve the contents of the ampoule in an infusion fluid. Hepa-Merz can be administered in all commonly used infusion fluids. No incompatibilities related to dissolution have been observed to date. It is recommended to prepare the infusion solution immediately before administration. Due to the risk of vein damage, do not administer more than 6 ampoules in 500 ml of fluid. Infusion rate: maximum 5 g (1 ampoule)/hour. Do not administer intra-arterially.

Using more than the recommended dose of Hepa-Merz

No symptoms of overdose have been observed with Hepa-Merz to date. In case of overdose, symptomatic treatment is used.

4. Possible side effects

Like all medicines, Hepa-Merz can cause side effects, although not everybody gets them.

Uncommon side effects (less than 1 in 100 people):

nausea

Rare side effects (less than 1 in 1,000 people):

vomiting

Frequency not known (cannot be estimated from the available data):

hypersensitivity, allergic reactions (anaphylactic) Nausea and vomiting are usually transient and do not require discontinuation of the medicine. They subside after reducing the dose or infusion rate.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Hepa-Merz

Keep the medicine out of the 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 month stated. Do not store above 30°C. Medicines should 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 pack and other information

What Hepa-Merz contains

The active substance is L-ornithine L-aspartate. One ampoule (10 ml) of the 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 ampoules of 10 ml each. For more detailed information, contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Romania, the country of export:

Merz Pharmaceuticals GmbH, Eckenheimer Landstr. 100, 60318 Frankfurt am Main, Germany

Manufacturer:

Merz Pharma GmbH & Co. KGaA, Ludwigstraße 22, 64354 Reinheim, Germany

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Romania export authorization number: 7377/2006/01

Parallel import authorization number: 151/22 Date of approval of the leaflet: 05.04.2022

[Information about the trademark]