Hepa-mezh 3000

Leaflet attached to the packaging: Patient information

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

Ornithine aspartate
Hepa-Merz 3000 and Hepa-Merz 3 g Granules are different trade names for the same medicine.

You should carefully read the contents of the leaflet 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 your doctor or pharmacist.

• You should keep this leaflet so that you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist. 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 packaging 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 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 colorant – 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, equivalent 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 are 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.
No interactions with other medicines are known for Hepa-Merz 3000.

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.

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 are unsure, 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, you should contact your doctor or pharmacist.

Route of administration

Oral use.

Overdose of Hepa-Merz 3000

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

Missed dose of Hepa-Merz 3000

You should 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 transient and do not require withdrawal 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 possible side effects not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department for 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.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, you can help provide 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 given 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 that are no longer needed. This will help protect the environment.

6. CONTENTS OF THE PACKAGING 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 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 packaging contains
Hepa-Merz 3000 is an orange granule.
The packaging contains 10, 30, 50, or 100 sachets.
To obtain more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Austria, the country of export:

Merz Pharma Austria GmbH
Guglgasse 17
1110 Vienna
Austria

Manufacturer:

Merz Pharma GmbH & Co. KGaA
Eckenheimer Landstraße 100
D-60318 Frankfurt
Germany

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Austrian marketing authorization number, the country of export:1-20706
Parallel import authorization number:153/13
Date of leaflet approval: 14.02.2023
[Information about the trademark]