Hepa-merz 3000
Poland
Table of Contents
Package leaflet: Information for the patient
Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Hepa-Merz 3000 (Hepa-Merz 3 g Granulate)
3 g/5 g, granulate for oral solution
Ornithini aspartas
Hepa-Merz 3000 and Hepa-Merz 3 g Granulate are different trade names for the same medicinal product.
Please read this leaflet carefully before taking the medicine, as it contains important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by the doctor or pharmacist.
- Keep this leaflet so that you can read it again if necessary.
- If you need advice or further information, please consult your pharmacist.
- If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
- If your condition does not improve or worsens, contact your doctor.
Table of contents of the leaflet:
- What Hepa-Merz 3000 is and what it is used for
- Important information before taking Hepa-Merz 3000
- How to take Hepa-Merz 3000
- Possible side effects
- How to store Hepa-Merz 3000
- Contents of the pack and other information
1. WHAT HEP A-MERZ 3000 IS AND WHAT IT IS USED FOR
Hepa-Merz 3000 is used in the treatment of covert and overt hepatic encephalopathy occurring in the course of chronic liver diseases, such as chronic hepatitis, liver cirrhosis.
2. IMPORTANT INFORMATION BEFORE USING HEPA-MERZ 3000
When not to use Hepa-Merz 3000
Do not use Hepa-Merz 3000 in patients with the following conditions:
- hypersensitivity to L-ornithine L-aspartate, tartrazine (E 110), or any of the other ingredients of the medicine;
- severe renal insufficiency (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 coloring agent – tartrazine (E 110), which may cause allergic reactions (including asthma symptoms). This type of allergy is particularly common in individuals sensitive to acetylsalicylic acid.
Hepa-Merz 3000 contains fructose (1.13 g per sachet, equivalent to 0.11 carbohydrate exchange unit). This should be taken into account in patients with diabetes.
Prolonged use of Hepa-Merz 3000 may lead to dental caries.
Children:
There is a lack of data on the use of the medicine in children.
Before administering the medicine to infants or children, consultation with a physician is essential, as there may be previously undiagnosed fructose intolerance in the child.
Hepa-Merz 3000 and other medicines
Inform your doctor about all medicines currently or recently taken, as well as any medicines you plan to take.
No interactions between Hepa-Merz 3000 and other medicines are known.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to have a baby, you should consult your doctor before using this medicine.
Pregnancy:
There are insufficient data on the safety of Hepa-Merz 3000 during pregnancy; therefore, the use of this medicine during pregnancy should be avoided. Hepa-Merz 3000 may be used in pregnant women only if recommended by a physician.
Breastfeeding:
It is unknown whether L-ornithine L-aspartate (the active substance of Hepa-Merz 3000) passes into breast milk. The use of Hepa-Merz 3000 during breastfeeding should be avoided. Hepa-Merz 3000 may be used in breastfeeding women only if recommended by a physician.
Driving and operating machinery
The ability to drive vehicles and operate machinery may be impaired due to the underlying disease for which Hepa-Merz 3000 is used.
Hepa-Merz 3000 contains tartrazine (E 110) and fructose.
See section "Warnings and precautions".
3. HOW TO USE HEPA-MERZ 3000
This medicine should always be used as directed by a physician. In case of doubt, consult your doctor or pharmacist.
The usual dose is 1 or 2 sachets 1 to 3 times daily.
The contents of a sachet should be dissolved in a glass of water. Take during or after meals.
If you feel the effect of the medicine is too strong or too weak, you should contact your doctor or pharmacist.
Route of administration
Oral use.
Use of a higher than recommended dose of Hepa-Merz 3000
No symptoms of poisoning have been observed following overdose of Hepa-Merz 3000.
In case of overdose, symptomatic treatment should be applied.
Missed dose of Hepa-Merz 3000
Take the next dose at the scheduled time according to the dosing instructions.
Do not take a double dose to make up for a missed dose. In case of any doubts regarding use of the medicine, consult your doctor or pharmacist.
4. POSSIBLE ADVERSE REACTIONS
Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
Uncommon adverse reactions (occurring in fewer than 1 in 100 people):
nausea; vomiting; stomach pain; bloating; diarrhoea.
Very rare adverse reactions (occurring in fewer than 1 in 10,000 people):
limb pain.
The listed adverse reactions are usually transient and do not require discontinuation of the medicine.
The excipient - sunset yellow (E 110) may cause allergic reactions.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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.
Reporting adverse reactions enables further information on the safety of the medicine to be collected.
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 stated month.
Do not store above 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.
6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION
What Hepa-Merz 3000 contains
The active substance is L-ornithine L-aspartate.
One sachet (5 g of granules) contains 3 g of L-ornithine L-aspartate.
Excipients:
citric acid, lemon flavour, orange flavour, sodium saccharin, sodium cyclamate,
orange yellow (E 110), povidone K 25, fructose.
What Hepa-Merz 3000 looks like and contents of the pack
Hepa-Merz 3000 is an orange-coloured granule.
Packaging contains 10, 30, 50 or 100 sachets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Austria, 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.
Strumykowa 28/11
03-138 Warsaw
Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
Chełmżyńska 249
04-458 Warsaw
Poland
Austria marketing authorisation number, country of export: 1-20706
Parallel import authorisation number: 153/13