Ornispar

Package Leaflet: Information for the Patient

Ornispar, 3 g/5 g, Granules for Oral Solution, in a Sachet

Ornithine Aspartate

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed for a specific person. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Ornispar and what is it used for
• 2. Important information before taking Ornispar
• 3. How to take Ornispar
• 4. Possible side effects
• 5. How to store Ornispar
• 6. Contents of the pack and other information

1. WHAT IS ORNISPAR AND WHAT IS IT USED FOR

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

2. IMPORTANT INFORMATION BEFORE TAKING ORNISPAR

When not to take Ornispar

Do not take Ornispar if you have the following disorders:

• hypersensitivity to L-ornithine L-aspartate or any of the other ingredients of the medication;
• severe kidney failure (serum creatinine 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

Ornispar contains 360 mg of sorbitol in 1 sachet. Sorbitol is a source of fructose. If the patient has previously been diagnosed with intolerance to some sugars or has been diagnosed with hereditary fructose intolerance, a rare genetic disease in which the patient's body does not break down fructose, the patient should consult a doctor before taking the medication.
Ornispar contains isomalt. If the patient has previously been diagnosed with intolerance to some sugars, the patient should consult a doctor before taking the medication.
Ornispar contains 1% propylene glycol.
Before administering the medication to a child under 4 weeks, consult a doctor or pharmacist, especially if the child is taking other medications containing propylene glycol or alcohol.
Long-term use of Ornispar may cause tooth decay.
Children:
There is 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 previously undiagnosed fructose intolerance.

Ornispar and other medications

Tell your doctor about all medications you are currently taking or have recently taken, as well as any medications you plan to take.
There are no known interactions between Ornispar and other medications.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medication.
Pregnancy:
There are insufficient data on the safety of Ornispar during pregnancy, so the medication should be avoided during pregnancy. Ornispar may be taken by pregnant women only if recommended by a doctor.
Breastfeeding:
It is not known whether L-ornithine L-aspartate (the active substance of Ornispar) passes into breast milk. The medication should be avoided during breastfeeding.
Ornispar may be taken by breastfeeding women only if recommended by a doctor.

Driving and using machines

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

Ornispar contains sorbitol, isomalt, and propylene glycol.

See the "Warnings and precautions" section.

3. HOW TO TAKE ORNISPAR

Always take this medication exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The usual 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 a meal.
If you feel that the effect of the medication is too strong or too weak, consult your doctor or pharmacist.

Method of administration

Oral use.

Overdose

No symptoms of overdose have been observed with Ornispar so far.
In case of overdose, symptomatic treatment should be used.

Missed dose

Take the next dose at the right time, according to the dosing instructions. Do not take a double dose to make up for a missed dose. If you have any doubts about taking the medication, consult your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medications, Ornispar 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 temporary and do not require discontinuation of the medication.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. 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,
Aleje Jerozolimskie 181C
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.
Reporting side effects will help to gather more information on the safety of the medication.

5. HOW TO STORE ORNISPAR

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

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Ornispar contains

The active substance is L-ornithine L-aspartate.
1 sachet (5 g granules) contains 3 g of L-ornithine L-aspartate.
Excipients:
citric acid, sorbitol, ananas flavor (flavor enhancers, corn starch, modified corn starch), sucralose (E 955),
silica colloidal anhydrous, peppermint flavor (natural menthol, peppermint oil Mentha piperita L., spearmint oil Mentha spicata L.,
maltodextrin, arabic gum, propylene glycol), sodium riboflavin phosphate (E 101), isomalt.

What Ornispar looks like and contents of the pack

Ornispar is white or slightly yellow granules.
Packaging: 10, 20, 30, 50 or 100 sachets of 4-layer laminate (paper/PE/aluminum/Surlyn)
or sachets of 5-layer laminate (paper/polyurethane solvent-based/dual-component aluminum/polyurethane solvent-based/LDPE) in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder:

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

Manufacturer:

Mako Pharma Sp. z o.o.
Kolejowa 231A
05-092 Dziekanów Polski
Medicofarma S.A.
ul. Tarnobrzeska 13
26-613 Radom

Date of approval of the leaflet: 04.2024