Package leaflet: Information for the patient

Ornispar, 6 g/10 g, granules for oral solution in sachet
Ornithini aspartas
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm others, even if their symptoms are the same.
If the patient experiences any adverse reactions, including those not listed in this leaflet, inform a doctor or pharmacist immediately. See section 4.

Table of contents:

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

1. WHAT ORNISPAR IS AND WHAT IT IS USED FOR

Ornispar is used in the treatment of latent and manifest hepatic encephalopathy occurring in the course of chronic liver diseases, such as chronic hepatitis, liver cirrhosis.

2. IMPORTANT INFORMATION BEFORE USING ORNISPAR

When not to use ORNISPAR
Do not use ORNISPAR in patients with the following conditions:

hypersensitivity to L-ornithine L-aspartate or any of the other components of the medicinal product;
severe renal impairment (serum creatinine concentration above 3 mg/100 ml);
amino acid metabolism disorders involved in the urea cycle, e.g. due to enzymatic defects;
fructose intolerance.

Warnings and precautions
ORNISPAR contains 720 mg of sorbitol per sachet. Sorbitol is a source of fructose. If the patient has previously been diagnosed with intolerance to certain sugars or hereditary fructose intolerance, a rare genetic disorder in which the patient's body cannot break down fructose, the patient should consult a physician before taking this medicinal product.
ORNISPAR contains isomalt. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a physician before taking this medicinal product.
ORNISPAR contains 1% propylene glycol.
Before administering ORNISPAR to a child under 4 weeks of age, consult a physician or pharmacist, especially if the child is taking other medicinal products containing propylene glycol or alcohol.
Long-term use of ORNISPAR may lead to dental caries.
Children:
There are no data on the use of ORNISPAR in children.
Before administering ORNISPAR to infants or children, it is essential to consult a physician, as there may be unrecognized hereditary fructose intolerance in the child.

Interaction of ORNISPAR with other medicinal products
Inform the physician about all medicinal products currently taken or recently taken, as well as any medicinal products planned for use.
No interactions between ORNISPAR and other medicinal products are known.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a physician before using this medicinal product.
Pregnancy:
There are insufficient data on the safety of ORNISPAR during pregnancy; therefore, use of the medicinal product during pregnancy should be avoided. ORNISPAR may be taken by pregnant women only upon medical advice.
Breastfeeding:
It is unknown whether L-ornithine L-aspartate (the active substance of ORNISPAR) passes into human milk. Use of the medicinal product during breastfeeding should be avoided.
ORNISPAR may be taken by breastfeeding women only upon medical advice.

Driving and operating machinery
The ability to drive motor vehicles and operate machinery may be impaired due to the underlying disease for which ORNISPAR is used.

ORNISPAR contains sorbitol, isomalt, and propylene glycol.
See section "Warnings and precautions".

3. HOW TO USE THE MEDICINAL PRODUCT ORNISPAR

This medicinal product should always be used as directed by the physician. In case of doubts, consult
your doctor or pharmacist.
The usual dose is 1 sachet up to 3 times daily.
The contents of the sachet should be dissolved in a glass of water. Take during or after a meal.
If the patient feels that the effect of the medicinal product is too strong or too weak, they should
contact their doctor or pharmacist.
Route of administration
Oral administration.
Use of a higher than recommended dose of Ornispar
Symptoms of poisoning following overdose with Ornispar have not been observed so far.
In case of overdose, symptomatic treatment is applied.
Missed dose of Ornispar
Take the next dose at the correct time, according to the dosing instructions. Do not use a double dose to make up for a missed dose. In case of doubts
regarding the use of the medicinal product, 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 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.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, please inform your doctor, pharmacist, or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. HOW TO STORE ORNISPAR MEDICINE

Keep the medicine out of the sight and reach of children.
No special storage instructions apply for this medicine.
Do not use the medicine after the expiry date stated on the cardboard box. The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Ornispar contains
The active substance in Ornispar is L-ornithine L-aspartate.
Each sachet (10 g of granules) contains 6 g of L-ornithine L-aspartate.
Excipients:
citric acid, sorbitol, pineapple flavour (taste-improving substances: maltodextrin from waxy maize, modified starch from waxy maize), sucralose (E 955), anhydrous colloidal silicon dioxide, peppermint flavour (natural menthol, peppermint oil Mentha piperita L., spearmint oil Mentha spicata L., maltodextrin, gum arabic, propylene glycol), disodium riboflavin phosphate (E 101), isomalt.

What Ornispar looks like and contents of the package
Ornispar is a white or slightly yellow granule.
Packaging: 10, 20, 30, 50 or 100 sachets made of 4-layer laminate (paper/PE/aluminium/Surlyn) or 5-layer laminate (paper/solvent-based two-component polyurethane/aluminium/solvent-based two-component polyurethane/LDPE), packed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Solinea Sp. z o.o.
Elizówka, ul. Szafranowa 6
21-003 Ciecierzyn
Poland
tel.: +48 81 463 48 82
[logo Solinea]

Manufacturer:
Mako Pharma Sp. z o.o.
ul. Władysława Reymonta 2
05-092 Dziekanów Leśny
Medicofarma S.A.
ul. Tarnobrzeska 13
26-613 Radom