Hepa-mezh

Package Leaflet: Information for the Patient

Hepa-Merz, 5 g/10 ml, Concentrate for Solution for Infusion

Ornithine aspartate

Read the Package Leaflet Carefully Before Using the Medicinal Product, as it Contains Important Information for the Patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicinal product 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 experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 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 medicinal product 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 hepatic 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 renal impairment (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

Before starting the use of Hepa-Merz, discuss it with your doctor or pharmacist.
During the use of high doses of the medicinal product, monitor the urea concentration in serum and urine.
In the case 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 medicinal products

Tell your doctor about all the medicinal products you are taking or have recently taken, as well as any medicinal products you plan to take.
No interactions between Hepa-Merz and other medicinal products are known.

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 medicinal product.
Pregnancy:
There are insufficient data on the safety of using Hepa-Merz during pregnancy, therefore, the use of the medicinal product during pregnancy should be avoided. However, if the use of the medicinal product in a pregnant woman is necessary, the doctor should weigh the potential benefits against the risks before making a decision.
Breastfeeding:
It is not known whether L-ornithine L-aspartate (the active substance of Hepa-Merz) passes into breast milk. The use of the medicinal product during breastfeeding should be avoided. However, if the use of the medicinal product in a breastfeeding woman is necessary, the doctor should weigh the potential benefits against the risks before making a decision.

Driving and using machines

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

3. How to use Hepa-Merz

Dosage:

This medicinal product should always be used as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
Usually, up to 20 g (4 ampoules) per day are administered.
In pre-comatose states and coma, up to 40 g (8 ampoules) per day, depending on the patient's condition.
If you feel that the effect of the medicinal product 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 the infusion fluid. Hepa-Merz can be administered in all commonly used infusion fluids. No incompatibilities related to dissolution have been observed so far.
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.

Use of a higher than recommended dose of Hepa-Merz

No symptoms of overdose have been observed with Hepa-Merz so far.
In the event of an overdose, symptomatic treatment is used.

4. Possible side effects

Like all medicinal products, 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 medicinal product.
They subside after reducing the dose or infusion rate.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181 C, 02-222 Warsaw
Phone: +48 22 49 21 301, Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of the medicinal product.

5. How to store Hepa-Merz

Store the medicinal product out of sight and reach of children.
Do not use this medicinal product after the expiry date stated on the carton.
The expiry date refers to the last day of the month.
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 of the medicinal product is L-ornithine L-aspartate.
1 ampoule (10 ml) of concentrate for solution for infusion contains 5 g of L-ornithine L-aspartate.
The other ingredient (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.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Merz Pharmaceuticals GmbH
Eckenheimer Landstrasse 100
60318 Frankfurt/Main
Germany
Phone: +49 69 1503 0
e-mail: [email protected]

Manufacturer:

Merz Pharma GmbH & Co.KGaA
Eckenheimer Landstrasse 100
60318 Frankfurt/Main
Germany

Date of last revision of the package leaflet: