Optihepan

Package Leaflet: Information for the Patient

OptiHepan, 3g/5g, Granules for Oral Solution, in Sachets

Ornithine Aspartate

Read the Package Leaflet Carefully Before Using the Medicinal Product

• This medicinal product should always be taken exactly as described in this package leaflet or as directed by your doctor or pharmacist.
• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your pharmacist.
• If you experience any side effects, including any not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.
• If after 4 weeks there is no improvement or you feel worse, you should consult your doctor.

Table of Contents of the Package Leaflet

• 1. What is OptiHepan and What is it Used For
• 2. Important Information Before Using OptiHepan
• 3. How to Use OptiHepan
• 4. Possible Side Effects
• 5. How to Store OptiHepan
• 6. Contents of the Pack and Other Information

1. What is OptiHepan and What is it Used For

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

2. Important Information Before Using OptiHepan

When Not to Use OptiHepan

• If you are hypersensitive (allergic) to L-ornithine L-aspartate or any of the other ingredients of this medicinal product (listed in section 6).
• In case of severe renal impairment (renal failure) (serum creatinine concentration above 3 mg/100 ml).
• In case of disorders of amino acid metabolism involved in the urea cycle, e.g. due to enzymatic defects.

Warnings and Precautions

Before starting the use of OptiHepan, you should discuss it with your doctor or pharmacist.
Children and Adolescents
There are no data on the use of the medicinal product in children and adolescents.
This medicinal product contains 1492.60 mg of isomalt in each sachet.If you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicinal product.
OptiHepan contains less than 1 mmol (23 mg) of sodium per sachet, which means that the medicinal product is considered "sodium-free".

OptiHepan and Other Medicinal Products

You should inform your doctor or pharmacist about all the medicinal products you are currently taking or have recently taken, as well as any medicinal products you plan to take.
No interactions of OptiHepan with other medicinal products are known.

Pregnancy, Breast-Feeding, and Fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicinal product.
Pregnancy
The safety of using OptiHepan during pregnancy has not been established, therefore the use of the medicinal product during pregnancy should be avoided.
OptiHepan may be used by pregnant women only if recommended by a doctor.
Breast-Feeding
It is not known whether the active substance of OptiHepan passes into breast milk.
The use of the medicinal product during breast-feeding should be avoided.
OptiHepan may be used by breast-feeding women only if recommended by a doctor.
Fertility
There are no data on the effect of the medicinal product on fertility.

Driving and Using Machines

The ability to drive and use machines may be impaired due to the disease being treated with OptiHepan.

3. How to Use OptiHepan

This medicinal product should always be taken exactly as described in this package leaflet or as directed by your doctor. In case of doubt, consult your doctor or pharmacist.
The usual dose of the medicinal product is 1 or 2 sachets up to 3 times a day.
The contents of the sachet should be dissolved in a glass of water and well mixed to dissolve.
If after 4 weeks there is no improvement or you feel worse, you should consult your doctor.
In case of improvement during the use of ornithine aspartate and disappearance of symptoms such as weakness and general malaise, decreased appetite, weight loss, pain on the right side of the abdomen, bloating and belching after meals, nausea, poor tolerance to fatty products and alcohol, in accordance with the treatment and control scheme of the underlying disease, in case of further doubts, the patient should consult a doctor or pharmacist.

Use in Children and Adolescents

There are no data on the use of the medicinal product in children and adolescents.

Overdose of OptiHepan

No symptoms of overdose have been observed with OptiHepan so far. In case of overdose, symptomatic treatment is used.

Missed Dose of OptiHepan

You should take the next dose of the medicinal product at the right time, according to the dosing instructions. Do not take a double dose to make up for a missed dose. In case of doubts related to the use of the medicinal product, consult your doctor or pharmacist.

Stopping the Use of OptiHepan

In case of any further doubts related to the use of this medicinal product, consult your doctor or pharmacist.

4. Possible Side Effects

Like all medicinal products, OptiHepan 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 discontinuation of the medicinal product.

Reporting Side Effects

If you experience any side effects, including any not listed in this package leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicinal product.

5. How to Store OptiHepan

Keep the medicinal product out of the sight and reach of children.
Do not use this medicinal product after the expiry date stated on the carton. The expiry date refers to the last day of the month.
There are no special storage precautions for the medicinal product.
Medicinal products should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicinal products that are no longer needed. This will help protect the environment.

6. Contents of the Pack and Other Information

What OptiHepan Contains

• The active substance of 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

OptiHepan is a granulate for oral solution. Sachets made of three-layer foil (paper/aluminum/polyethylene) in a cardboard box. The pack contains 5, 10, 15, 20, 30, or 45 sachets.

Marketing Authorization Holder and Manufacturer

Natur Produkt Pharma Sp. z o. o.,
ul. Podstoczysko 30
07-300 Ostrów Mazowiecka
Tel.: +48 29 644 29 00

Date of Last Revision of the Package Leaflet: