Hepa-mezh 3000

Package Leaflet: Information for the Patient

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.

Hepa-Merz 3000 (Hepa-Merz 3 g Granules)

3 g/5 g, granules for oral solution preparation
Ornithine aspartate
Hepa-Merz 3000 and Hepa-Merz 3 g Granules are different trade names for the same drug.

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

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. See section 4. If there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet:

• 1. What is Hepa-Merz 3000 and what is it used for
• 2. Important information before taking Hepa-Merz 3000
• 3. How to take Hepa-Merz 3000
• 4. Possible side effects
• 5. How to store Hepa-Merz 3000
• 6. Contents of the pack and other information

1. WHAT IS HEPA-MERZ 3000 AND WHAT IS IT USED FOR

Hepa-Merz 3000 is used to treat latent and overt hepatic encephalopathy occurring in the course of chronic liver diseases, such as chronic hepatitis, liver cirrhosis.

2. IMPORTANT INFORMATION BEFORE TAKING HEPA-MERZ 3000

When not to take Hepa-Merz 3000

Do not take Hepa-Merz 3000 if you have the following disorders:

• hypersensitivity to L-ornithine L-aspartate, orange yellow S (E 110), or any of the other ingredients of the medicine;
• 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;
• fructose intolerance.

Warnings and precautions

Hepa-Merz 3000 contains a dye – orange yellow S (E 110), which may cause allergic reactions (including asthma symptoms). This type of allergy is particularly common in people allergic to acetylsalicylic acid.
Hepa-Merz 3000 contains fructose (1.13 g in one sachet, which corresponds to 0.11 bread units). This should be taken into account in patients with diabetes.
Long-term use of Hepa-Merz 3000 may cause tooth decay.
Children:
There is no data on the use of the medicine in children.
Before administering the medicine to infants or children, it is necessary to consult a doctor, as there is a possibility of undiagnosed fructose intolerance in the child.

Hepa-Merz 3000 and other medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
There are no known interactions between Hepa-Merz 3000 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 taking this medicine.
Pregnancy:
There are insufficient studies on the safety of using Hepa-Merz 3000 during pregnancy, so the medicine should be avoided during pregnancy. Hepa-Merz 3000 may be taken by pregnant women only if recommended by a doctor.
Breastfeeding:
It is not known whether L-ornithine L-aspartate (the active substance of Hepa-Merz 3000) passes into breast milk. The medicine should be avoided during breastfeeding. Hepa-Merz 3000 may be taken by breastfeeding women only if recommended by a doctor.

Driving and using machines

The ability to drive vehicles and operate machines may be impaired due to the disease being treated with Hepa-Merz 3000.

Hepa-Merz 3000 contains orange yellow S (E 110) and fructose.

The medicine contains orange yellow S, which may cause allergic reactions.
The medicine contains 1.13 g of fructose in each sachet. The fructose in the medicine may harm teeth.
See the "Warnings and precautions" section.

3. HOW TO TAKE HEPA-MERZ 3000

This medicine should always be taken as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The usual dose is 1 or 2 sachets 1 to 3 times a day.
The contents of the sachet should be dissolved in a glass of water. Take during or after a meal.
If you feel that the effect of the medicine is too strong or too weak, contact your doctor or pharmacist.

Route of administration

Oral administration.

Overdose of Hepa-Merz 3000

No symptoms of overdose have been observed with Hepa-Merz 3000 so far.
In case of overdose, symptomatic treatment is used.

Missed dose of Hepa-Merz 3000

Take the next dose at the right time, according to the dosing instructions.
Do not take a double dose to make up for a missed dose. If you have any doubts about taking the medicine, consult your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

nausea; vomiting; stomach pain; bloating; diarrhea.

Rare side effects (less than 1 in 10,000 people):

limb pain.
The listed side effects are usually temporary and do not require discontinuation of the medicine.
The excipient – orange yellow S (E 110) may cause allergic reactions.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, tell 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting side effects will help gather more information on the safety of the medicine.

5. HOW TO STORE HEPA-MERZ 3000

Keep out of sight and reach of children.
Do not use the medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the specified month.
Do not store above 25°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 3000 contains

The active substance of the medicine is L-ornithine L-aspartate.
1 sachet (5 g granules) contains 3 g of L-ornithine L-aspartate.
Excipients:
citric acid, lemon flavor, orange flavor, sodium saccharin, sodium cyclamate, orange yellow S (E 110), povidon K 25, fructose.

What Hepa-Merz 3000 looks like and what the pack contains

Hepa-Merz 3000 is an orange granule.
The pack contains 10, 30, 50, or 100 sachets.
For more detailed information, contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Austria, the country of export:

Merz Pharma Austria GmbH
Guglgasse 17
AT - 1110 Vienna
Austria

Manufacturer:

Merz Pharma GmbH & Co. KGaA
Eckenheimer Landstraße 100
D-60318 Frankfurt
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
Austrian export license number: 1-20706

Parallel import license number: 16/13 Date of leaflet approval: 13.01.2023

[Information about the trademark]