Hepa-mezh 3000

Package Leaflet: Information for the Patient

Hepa-Merz 3000, 3 g/5 g, Granules for Oral Solution

(Ornithine Aspartate)

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

This Medication Should Always be Taken Exactly as Described in the Package Leaflet or as Advised by the Doctor or Pharmacist.

• Keep this Package Leaflet, You May Need to Read it Again.
• If You Need Advice or Further Information, Consult a Pharmacist.
• If You Experience any Side Effects, Including those not Listed in the Package Leaflet, Inform Your Doctor or Pharmacist. See Section 4.
• If You do not Feel Better or if You Feel Worse, Consult a Doctor.

Table of Contents of the Package 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 Package and Other Information

1. What is Hepa-Merz 3000 and What is it Used for

Hepa-Merz 3000 is Used to Treat Latent and Manifest Hepatic Encephalopathy in Patients with 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 Conditions:

• Hypersensitivity to L-Ornithine L-Aspartate, Orange Yellow S (E 110), or any Other Excipients of the Medication;
• Severe Renal Insufficiency (Serum Creatinine Above 3 mg/100 ml);
• Amino Acid Metabolism Disorders Participating in the Urea Cycle, e.g., Due to Enzyme Defects;
• Fructose Intolerance.

Warnings and Precautions

Before Starting to Take Hepa-Merz 3000, Discuss it with Your Doctor or Pharmacist.
Hepa-Merz 3000 Contains a Dye - Orange Yellow S (E 110), which can Cause Allergic Reactions (Including Asthma Symptoms). This Type of Allergy is Especially 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 can Cause Tooth Decay.
The Medication Contains Less than 1 mmol (23 mg) of Sodium per Sachet, i.e., the Medication is Considered "Sodium-Free".
Children:
There are no Data on the Use of the Medication in Children.
Before Administering the Medication 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 Medications

Tell Your Doctor About all Medications You are Currently Taking or Have Recently Taken, as well as Medications You Plan to Take.
No Interactions of Hepa-Merz 3000 with Other Medications are Known.

Pregnancy and Breastfeeding

If You are Pregnant or Breastfeeding, Think You May be Pregnant, or Plan to Have a Child, Consult a Doctor Before Taking this Medication.
Pregnancy:
There are no Sufficient Studies on the Safety of Hepa-Merz 3000 During Pregnancy, so the Medication Should be Avoided During Pregnancy. Hepa-Merz 3000 can be Taken by Pregnant Women only if Advised by a Doctor.
Breastfeeding:
It is not Known if L-Ornithine L-Aspartate (the Active Substance of Hepa-Merz 3000) Passes into Breast Milk. The Medication Should be Avoided During Breastfeeding. Hepa-Merz 3000 can be Taken by Breastfeeding Women only if Advised by a Doctor.

Driving and Operating Machines

The Ability to Drive 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 Section "Warnings and Precautions".

3. How to Take Hepa-Merz 3000

This Medication Should Always be Taken Exactly as Advised by the Doctor. In Case of Doubts, Consult a Doctor or Pharmacist.
Usually, the Recommended 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 Meals.
If You Feel that the Effect of the Medication is too Strong or too Weak, Consult a Doctor or Pharmacist.

Route of Administration

Oral Administration.

Overdose of Hepa-Merz 3000

So Far, no Symptoms of Overdose have been Observed with Hepa-Merz 3000.
In Case of Overdose, Symptomatic Treatment is Applied.

Missed Dose of Hepa-Merz 3000

Take the Next Dose at the Right Time, as Described in the Dosage Instructions.
Do not Take a Double Dose to Make up for the Missed Dose.
In Case of any Doubts Related to the Use of this Medication, Consult a Doctor or Pharmacist.

4. Possible Side Effects

Like all Medications, Hepa-Merz 3000 can Cause Side Effects, although not Everybody gets them.

Uncommon Side Effects (Less than 1 in 100 People):

Nausea; Vomiting; Stomach Pain; Bloating; Diarrhea.

Very Rare Side Effects (Less than 1 in 10,000 People):

Limb Pain.
The Mentioned Side Effects are Usually Transient and do not Require Discontinuation of the Medication.
The Excipient - Orange Yellow S (E 110) can Cause Allergic Reactions.

Reporting Side Effects

If You Experience any Side Effects, Including those not Listed in this Package Leaflet, Inform Your Doctor or Pharmacist. 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 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.
Reporting Side Effects will Help to Gather more Information on the Safety of the Medication.

5. How to Store Hepa-Merz 3000

Store the Medication out of Sight and Reach of Children.
Do not Use this Medication After the Expiration Date Stated on the Carton.
The Expiration Date Refers to the Last Day of the Specified Month.
Do not Store Above 25°C.
Medications Should not be Disposed of via Wastewater or Household Waste. Ask a Pharmacist how to Dispose of Medications that are no Longer Needed. This will Help Protect the Environment.

6. Contents of the Package and Other Information

What Hepa-Merz 3000 Contains

The Active Substance of the Medication is L-Ornithine L-Aspartate.
1 Sachet (5 g of Granules) Contains 3 g of L-Ornithine L-Aspartate.
Other Ingredients (Excipients) are:
Anhydrous Citric Acid, Citrus Flavor, Orange Flavor, Sodium Saccharin, Sodium Cyclamate, Orange Yellow S (E 110), Povidone K25, Fructose.

What Hepa-Merz 3000 Looks Like and What the Package Contains

Hepa-Merz 3000 is an Orange Granule.
The Package Contains 10, 30, 50, or 100 Sachets.
Not all Pack Sizes may be Marketed.

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 the Last Revision of the Package Leaflet: