Package leaflet: Information for the patient

OptiHepan, 3g/5g, granules for oral solution in sachet
Ornithini aspartas
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

This medicine should always be taken 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 there is no improvement after 4 weeks, or if you feel worse, you should contact your doctor.

Contents of the leaflet

What OptiHepan is and what it is used for
Important information before taking OptiHepan
How to take OptiHepan
Possible side effects
How to store OptiHepan
Contents of the pack and other information

1. What OptiHepan is and what it is used for

Adjunctive treatment in chronic liver diseases, such as fatty liver, hepatitis, cirrhosis, liver diseases associated with viral infections, toxic liver damage, or other liver diseases of toxicological origin.
If there is no improvement after 4 weeks, or if you feel worse, consult your doctor.

2. Important information before using OptiHepan

When not to use OptiHepan

If the patient is hypersensitive (allergic) to L-ornithine L-aspartate or any of the other ingredients of this medicine (listed in section 6).
In case of severe renal function impairment (severe kidney failure) (serum creatinine concentration above 3 mg/100 ml).
In case of amino acid metabolism disorders involving the urea cycle, for example due to enzymatic defects.

Warnings and precautions
Before starting treatment with OptiHepan, consult a doctor or pharmacist.
Children and adolescents
There is no data available on the use of OptiHepan in children and adolescents.

OptiHepan and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines planned for future use.
No interactions between OptiHepan and other medicines are known.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
The safety of OptiHepan during pregnancy has not been established; therefore, the use of this medicine during pregnancy should be avoided.
OptiHepan may be taken by pregnant women only if recommended by a doctor.
Breastfeeding
It is unknown whether the active substance of OptiHepan passes into breast milk.
The use of OptiHepan should be avoided during breastfeeding.
OptiHepan may be taken by breastfeeding women only if recommended by a doctor.
Effect on fertility
There is no data available on the effect of OptiHepan on fertility.

Driving and operating machinery
The ability to drive and operate machinery may be impaired due to the underlying disease being treated with OptiHepan.

This medicine contains 1492.60 mg of isomaltose per sachet. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
OptiHepan contains less than 1 mmol (23 mg) of sodium per sachet, meaning the medicine is considered "sodium-free".

3. How to use OptiHepan

This medicine should always be taken exactly as described in this patient information leaflet, or as directed by a doctor. If in doubt, consult a doctor or pharmacist.
The usual dose is 1 or 2 sachets taken up to 3 times daily.
The contents of the sachet should be dissolved in a glass of water and mixed well to ensure complete dissolution.
If there is no improvement or if the patient feels worse after 4 weeks, medical advice should be sought.
If symptoms improve during treatment with L-ornithine L-aspartate, such as fatigue and general malaise, reduced appetite, weight loss, right-sided abdominal pain, bloating and belching after meals, nausea, and poor tolerance of fatty foods and alcohol, continue treatment according to recommendations for managing and monitoring the underlying condition.
In case of any doubts, consult a doctor or pharmacist.
Use in children and adolescents
There is no data available on the use of this medicine in children and adolescents.
Taking more OptiHepan than recommended
No symptoms of poisoning have been observed following overdose of OptiHepan. In case of overdose, symptomatic treatment should be administered.
Missed dose of OptiHepan
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. If in doubt about how to use the medicine, consult a doctor or pharmacist.
Stopping OptiHepan treatment
If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Uncommon adverse reactions (occurring in less than 1 in 100 people):
nausea; vomiting; stomach pain; bloating; diarrhoea.
Very rare adverse reactions (occurring in less than 1 in 10,000 people):
limb pain.
The listed adverse reactions are usually transient and do not require discontinuation of the medicine.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181 C, 02-222 Warsaw,
Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions enables the collection of further information on the safety of the medicine.

5. How to store OptiHepan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the stated month.
There are no special requirements for the storage temperature of this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What OptiHepan contains

The active substance in OptiHepan is L-ornithine L-aspartate. Each sachet contains 3 g of L-ornithine L-aspartate.
The excipients are: isomalt, citric acid, magnesium citrate, sodium saccharin (E 954).

What OptiHepan looks like and contents of the pack
The medicine is a granulate for oral solution. The sachets are made of three-layer foil (Paper/Aluminum/Polyethylene) and are packed in a cardboard box. The pack contains 5, 10, 15, 20, 30 or 45 sachets.
Marketing Authorisation Holder and Manufacturer
Natur Produkt Pharma Sp. z o.o.
ul. Podstoczysko 30
07-300 Ostrów Mazowiecka
Tel.: +48 29 644 29 00