InfoCons Consumer Protection informs you – Onerji – Package Leaflet

Before anything else

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others . It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor , pharmacist or nurse . This includes any possible side effects not listed in this leaflet. See section 4.

ℹ️ 1. What Onerji is and what it is used for

Onerji contains t he active substances levodopa and carbidopa , which belong to a class of medicines known as anti -Parkinson drugs .

Onerji is used to treat alternat ing changes in the ability to move (motor fluctuations ) in adult s with advanced Parkinson’s disease when these can not be adequately controlled by other medicines taken by mouth . Parkinson’s disease is a progressive disease of the nervous system that causes shaking, stiffness, slow movement and problems maintaining balance.

In people with Parkinson’s disease, the cells in the brain that make a chemical messenger known as dopamine begin to die causing the amount of dopamine in the brain to decrease. The active substance in Onerji, levodopa, increases dopamine in your body because the body converts levodopa into dopamine. This helps reduc e the symptoms of Parkinson’s disease . The other active substance in Onerji, c arbidopa , helps levodopa work better by stopping it from being broken down too early in the body, so more of it reac hes the brain. This also reduces side effects allowing levodopa to be used more effectively .

⚠️ 2. What you need to know before you use Onerji

Do not use Onerji

• if you are allergic to levodopa, carbidopa or any of the other ingredients of this medicine (listed in section 6)
• if you have narrow -angle glaucoma, damage to the nerve in the eye caused by pressure inside the eye rising rapidly because fluid cannot drain out
• if you take medicines to treat depression called non -selective monoamine oxidase (MAO) inhibitors , such as phenelzine , tranylcypromine
• if you have significant difficult y think ing clear ly and remember ing things (cognitive impairment)
• if you have a tumour of the adrenal gland (ph aeochromocytoma) 30 • if you have hormone problems such as too much cortisol (Cushing’s syndrome) or your thyroid hormone levels are too high (hyperthyroidism)

Do not use Onerji if any of the above apply to you. Talk to your doctor if you are unsure .

Warnings and precautions

Talk to your doctor, pharmacist or nurse before or during use of Onerji if one or more of the following applies to you:

• had a heart attack, blocked blood vessels in your heart or any other heart problems including irregular heartbeat ;
• have chronic wide -angle glaucoma, an eye disorder in which increased pressure inside the eye gradually damages the nerve in the eye. You will need to have regular checks on the pressure in your eye;
• have a stomach ulcer ;
• hear, see or feel things that do not exist (hallucinations) which can cause confusion, trouble sleeping (insomnia) and vivid dreams. Or you have u nusual thoughts and behavio urs, such as paranoia, confusion, aggressive behavio ur or restlessness ;
• have depression with thoughts of suicide;
• have urges or cravings to behave in ways that are unusual for you or you cannot resist the impulse, drive or temptation to carry out certain activities that could harm yourself or others.

These behaviours are called impulse control disorders and can include addictive gambling, excessive eati ng or spending, an abnormally high sex drive or an increase in sexual thoughts or feelings ;

• feel dizzy or lightheaded on standing or sitting up because of a drop in blood pressure (orthostatic hypotension) ;
• are very sleepy or suddenly fall asleep during daily activities;
• have involuntary and uncontrollable movements of limbs, back, neck or chin , or increase d stiffness or slowness of movements (dyskinesia) ;
• have weakness, pain, numbness or loss of sensation in your fingers or feet (polyneuropathy).

Your doctor will check for these signs and symptoms before you start Onerji and periodically thereafter. Tell your doctor if you already have any nerve disorders;

• develop skin changes at the site where you are given the infusion (drip) of Onerji. This includes redness, warmth, swelling or pain suggestive of infection , particularly if associated with fever .

Do not stop using Onerji unless your doctor tells you to. Suddenly stopping or lowering your Onerji dose quickly may cause a serious problem called withdrawal -induced hyperpyrexia and confusion .

This is characterised by fever, muscle stiffness, accelerated breathing, excessive sweating and changes in consciousness.

During treatment , regular liver, kidney , heart function , blood and blood circulation checks by the doctor are recommended.

Onerji may affect certain values of tests including blood and urine measurements.

Children and adolescents

Onerji should not be used in children and adolescents under 18 years as it has not been studied in this age group .

Other medicines and Onerji

Tell your doctor or pharmacist if you are using, have recently used or might use.

• medicines to treat depression called non -selective monoamine oxidase (MAO) inhibitors such as phenelzine, tranylcypromine. Do not use Onerji when using these medicines. They must be stopped at least two weeks before you start using Onerji.

Also tell your doctor or pharmacist if you are using:

• medicines to treat depression called tricyclic antidepressant s such as trimipramine , amitriptyline
• medicines to treat Parkinson’s disease called :

31 – selective MAO -B inhibitors such as rasagiline and selegiline

• COMT (catechol -O-methyl transferase) inhibitors such as entacapone, opicapone , tolcapone
• amantadine
• medicines to treat high blood pressure
• medicines to treat mental or anxiety disorders such as phenothiazines, butyrophenones , risperidone
• medicines against nausea or vomiting – particularly metoclopramide
• isoniazid , a medicine to treat tuberculosis Pregnancy and breast -feeding If you are pregnant or breast -feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using Onerji.

There are no adequate data regarding the use of medicines containing levodopa and carbidopa in pregnant women. However, studies in animals have shown that it may cause damage to the unborn baby. Onerji is not recommended during pregnancy and in women who can become pregnant who are not using effective contraception (birth control) .

Breast -feeding is not recommended during treatment with Onerji .

Driving and using machines

Onerji can have a major influence on your ability to drive or use tools/machines. This is because Onerji may make you feel very sleepy, or you may sometimes find yourself suddenly falling asleep (sleep attacks). Onerji may lower your blood pressure, which can make you feel light -headed or dizzy.

Do not drive or use any tools or machines until you are sure how Onerji affects you.

Do not drive , use tools or machines until you feel fully awake , or no longer feel light-headed or dizzy.

Onerji contains polysorbate 80

This medicine contains 3 mg of polysorbate 80 in each mL. Polysorbates may cause allergic reactions.

Tell your doctor if you have any known allergies .

💊 3. How to use Onerji

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you have questions.

Stop using medicines that treat depression called non -selective monoamine oxidase (MAO) inhibitors, such as phenelzine, tranylcypromine medicines at least two weeks before you start using Onerji .

Before home use, you, and your caregiver (if applicable) , will be trained on how to handle Onerji and the delivery pump . You and your caregiver may use the infusion pumps only after being trained and deemed competent. Refresher training should be provided if difficulties in use are identified.

Before using Onerji, refer to the delivery pump instructions for use provided in section 7.

When using Yurway Delivery System also refer to the Yurway Delivery System user manual for detailed instructions.

When using Crono Twin ND also refer to Crono Twin ND instructions for use for detailed instructions.

Always follow sterile techniques while using Onerji , change the infusion site and use new infusion sets daily. Avoid infusion sites over skin lesions like nodules, bruises, areas of redness or swelling, over bone, blood vessels, tattoos or scar tissue .

32 How much medicine to use Always use this medicine as your doctor has instructed. Your doctor will decide how much Onerji you will use and adjust other medicines as needed . The Onerji levodopa daily dose will be prescribed by your doc tor according to your needs, choosing from 8 regimens ranging from 370 mg to 720 mg.

Onerji is given with a morning dose or levodopa taken by mouth (oral).

Your doctor may adjust the dose of Onerji when you take COMT inhibitors .

How Onerji is given Onerji is given as an infusion (drip) under the skin (subcutaneously) of either the abdomen (belly) , the flanks (areas on the sides of the body between the lower ribs and hips) or outer thighs . If needed, the outer back of the upper arm can also be used.

The infusion is given using a pump (Yurway Delivery System or Crono Twin ND) . Onerij is given continuously through the pump over 24 hours for each cycle.

Use a different infusion site each day and do not use the same site again for at least 2 weeks . Clean the infusion area with a disinfectant as recommended by your doctor, pharmacist or nurse. Avoid infusion sites over skin lesions (e.g. bumps, redness or swelling), or over bone, blood vessels, tattoos or scar tissue (see section.

Place t he thin tubes that connect to the infusion pumps and allow the medicine to flow into the body (cannulas ) at least 5 cm apart and 5 cm away from the belly button ( navel ).).

If you forget to use Onerji

If you forget to use Onerji, start your pump with your normal dose as soon as possible.

If you stop using Onerji

Do not stop using Onerji permanently unless your doctor tells you to. Suddenly stopping Onerji dose may cause a serious problem called withdrawal -induced hyperpyrexia and confusion (see also warnings and precautions) .

Onerji use can be stopped for brief periods of time, such as when taking a shower. If stop ping Onerji use for more than 3 hours , take oral levodopa medicine under doctor ’s instruction until Onerji treatment resume s.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse .

❗ 4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop using Onerji and tell your doctor immediately , if you notice any of the following serious side effects :

• swelling of the face, tongue or throat which make s it difficult to swallow or breathe , or nettle – type skin rash. These may be s ymptom s of a severe allergic reaction.

Frequency of these events cannot be estimated from available data. Your doctor will decide if you can keep using Onerji.

Other side effects of Onerji

Very common: may affect more than 1 in 10 people

• infection at the site of infusion
• redness (erythema) at the site of infusion
• a dry, dark scab (eschar) at the site of infusion
• a collection of blood under the skin (haematoma) at the site of infusion
• pain at the site of infusion
• a bump (nodule) at the site of infusion 33 • movement disorder s (dyskinesia) , characteris ed by involuntary muscle movements
• low blood levels of vitamin B6

Common: may affect up to 1 in 10 people

• a change in the colour of the skin (discolouration) at the site of infusion
• bleeding (haemorrhage) at the site of infusion
• hardening (induration) at the site of infusion
• itching ( prurit us) at the site of infusion
• reactions at the site of infusion
• swelling at the site of infusion
• blisters (vesicles) at the site of in fusion
• reduced control of symptoms of Parkinson’s disease as effects of the medicine wears off faster (worsening of off periods)
• low blood levels of v itamin B12
• low blood levels of folate
• seeing, hearing or feeling things that do not exist (hallucinations)
• nerve problems in hands or feet, such as weakness , pain, numbness , loss of sensation (peripheral neuropathy)
• skin inflammation (dermatitis contact)
• nausea
• dizziness
• falling
• low blood pressure (hypotension)
• uncontrollable shaking (tremor)
• anxiety
• sleeplessness (insomnia)
• headache
• increased blood level of homocysteine (hyperhomocysteinaemia) , a substance which helps build proteins in the body

Uncommon: may affect up to 1 in 100 people

• weakness (asthenia)
• infusion site reactions (other than above ), irritation , peeling or breakdown of outer layers of the skin and others resulting f rom leakage of the medicine .
• feeling dizzy or lightheaded on standing or sitting up because of a drop in blood pressure (orthostatic hypotension)
• unpleasant, abnormal sense of touch (dysaesthesia)
• abnormal sensation, such as tingling , numbness, burning or prickling feeling (paraesthesia)
• swelling in lower legs or hands caused by too much fluid (peripheral oedema )
• sleep iness (somnolence)
• abnormal dreams
• difficulty to perform movements (hypokinesia)
• not being able to move muscles voluntarily (akinesia)
• decreased appetite
• muscle spasms you cannot control – affecting your eyes, head, neck and body (d ystonia )
• confusion (confusional state)
• false beliefs (d elusion )
• depression
• discomfort
• dry mouth
• impaired or altered sense of taste ( taste disorder )
• allergic reaction
• rash
• difficulty controlling actions or reactions (impulse control disorders) 34 • pain in arms or legs (extremity)
• inflammation in the fatty tissue below the skin (panniculitis)
• feeling faint (presyncope)
• fever
• sleep disorder in which you physically act out vivid, often unpleasant dreams with vocal sounds and sudden movements (sleep behaviour disorder)
• poor quality sleep (sleep disorder )
• vomiting
• involuntary movements , together with fever and other symptoms such as consciousness disturbance (dyskinesia hyperpyrexia syndrome)
• rapid eye movement

Not known: these side effects have not been reported with Onerji, but are expected

• urinary infection
• can’t empty bladder fully
• coloured urine
• leaking urine
• skin cancer
• low red blood cells (causing tiredness, weakness)
• very low white blood cells (Agranulocytosis )
• low white blood cells (Leukopenia )
• low platelets
• thoughts of harming yourself
• losing touch with reality (psychotic disorder)
• agitation
• disorientation
• uncontrolled urges (dopamine dysregulation syndrome)
• extreme happiness or high energy
• heightened sex drive
• unfounded fear or suspicion
• problems with thinking, memory, or focus
• falling asleep suddenly without warning
• fever, muscle stiffness, accelerated breathing, excessive sweating and changes in consciousness (neuroleptic malignant syndrome)
• loss of coordination (unsteady walking)
• droopy eyelid, small pupil, no sweat on one face side (Horner’s syndrome)
• decline in memory and thinking skills
• vision blurred
• double vision
• dilated pupils
• eyes stuck looking up or to the side (oculogyric crisis)
• uncontrollable eyelid twitching or blinking
• palpitations
• abnormal heart rhythms
• high blood pressure
• fainting
• inflamed veins with blood clots
• sudden waves of heat
• shortness of breath
• irregular breathing
• hoarse or changed voice
• hiccups
• stomach ache
• hard to pass stool 35 • loose stools
• flatulence
• bleeding in the gut
• sore in stomach lining
• trouble swallowing
• indigestion
• burning tongue pain
• jaw lock (can’t open mouth fully)
• teeth grinding
• saliva discolouration
• too much saliva
• swelling under the skin (face, lips)
• excessive sweating
• itchy skin
• rash with small purple spots (Henoch -Schonlein purpura)
• hives
• a change in the colour of sweat
• hair loss
• muscle spasms
• prolonged, painful erection
• extreme tiredness
• feeling unwell
• unsteady walking
• chest pain
• weight gain
• weight loss

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V . By reporting side effects, you can help provide more information on the safety of this medicine.

🌡️ 5. How to store Onerji

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and carton . The expiry date refers to the last day of that month .

Store in the original package in order to protect from light.

This medicine is stored in a freezer before dispensed to patients or caregivers. You or your caregiver will receive Onerji only after thawing.

After opening: use immediately. The product is to be used within 24 hours (infusion period).

After thawing , do not store Onerji above 25 °C and do not refrigerate or refreeze. Once removed from the freezer, unopened vial s may be stored for up to 45 days (use-by-date) . Do not use this medicine after the use -by-date.

Only 2 vials should be taken out of the carton at a time for administration of the daily dose. Store the remaining Onerji vials in the original package.

36 Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

📦 6. Contents of the pack and other information

What Onerji contains

• The active substances are levodopa and carbidopa . Each millilitre contains 60 mg levodopa and 7.5 mg carbidopa (as monohydrate). Each 7.2 mL vial contains 432 mg levodopa and 54 mg carbidopa (as monohydrate) .
• The other ingredients are arginine , ascorbic acid (E 300), acetylcysteine , polysorbate 80 (E 433)

(see section 2 “Onerji contains polysorbate 80” ), water for injection s.

What Onerji looks like and contents of the pack

Onerji is a clear , yellowish solution for infusion (infusion). It is available in c lear glass vial s with a rubber stopper and a royal blue flip-off plastic cap with aluminium seal. Each vial contains 7.2 mL solution for infusion.

Pack size of 30 vials.

Marketing Authorisation Holder

Tanabe Pharma GmbH Schiessstrasse 47 40549 Duesseldorf Germany

Manufacturer

The Qp Services GmbH Am Wasserturm 38 01616 Strehla Germany

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu .

7. Instructions on how to prepare Onerji infusion for administration General precautions when preparing Onerji for administration

• Onerji vials are for single use only.
• Prepare the daily infusion dose just before it is given , to ensure that no more than 25 hours pass from the period between initiation of preparation to end of daily administration.
• Do not use any component if it or its packaging is damaged; safely dispose and use a new item.
• Do not use Onerji if the solution’s colour is brown.
• If the solution contains bubbles, wait for them to disappear before removing the blue cap from the vial.
• Do not use teeth to remove the blue cap from the O nerji vial.
• Do not touch the gr ey rubber stopper (grey septum) on top of the Onerji vial to minimi se risk of contamination.
• If any Onerji is spilled, it must be cleaned up immediately to prevent accidental contact with skin and eyes .
• Any remaining medicin e in the reservoir at the end of the daily infusion should be discarded.

37 Infusion sites selections Onerji is administered under the skin of the :

• abdomen
• flanks
• outer thighs
• outer back of the upper arm, if needed Place the cannulas at least 5 cm apart and at least 5 cm away from the nave l.

Do not use the following infusion sites

• skin lesions , such as bumps, redness, swelling, irritations, bleeding, bruise, infections
• over bone, blood vessels
• tattoos
• scar tissue Change the infusion site locations daily (every 24 -hours) and avoid reusing an infusion site for at least 2 weeks. Therefore, systematically rotate the infusion site locations.

Onerji may only be used with one of the following delivery systems:

• Yurway Delivery System
• Crono Twin ND pump Preparation of Onerji infusion when using the Yurway Delivery System For detail ed instructions on how to deliver Onerji when using the Yurway Delivery System, refer to the Yurway Delivery System user manual .
• Wash hands thoroughly with soap and water .
• Prepare a clean working area on a flat and level surface .
• Gather the components : 1 Yurway cartridge (preassembled with 2 vial adapters ), alcohol pads, 2 infusion sets, 2 Onerji vials, 2 clean gauze pads 38 • Set up the Yurway C ontrol Station according to the Yurway Delivery System user manual section 4.3.2 .
• Insert the pump into the pump holder .
• Insert the Yurway Rechargeable Pump into the pump holder.
• Wait until the Yurway Control Station establishes a connection with the Y urway Rechargeable Pump (approximately 30 seconds) .

Do not use the Y urway Medication C artridge if dropped; safely dispose and use a new cartridge .

• Attach Yurway Medication Cartridge to pump .
• Open a new Yurway Medication Cartridge and remove from packaging.
• Slide the Yurway Medication Cartridge onto the Yurway Rechargeable Pump.
• Tap NEXT on the Yurway Control Station screen to proceed .
• Check Onerji solution in the vials
• Gently invert each Onerji vial 5 times . Do not shake to avoid forming bubbles.
• The solution should be clear, yellowish and without particles.
• Insert vial in to vial adapter connected to the cartridge (reservoirs) .
• Remove the blue cap from the Onerji vials .
• Dispose of the blue cap in the trash .
• Insert the two Onerji vials , so they face down, into the vial ad apters until they “click” into place .
• Tap NEXT on the Yurway Control Station screen to proceed.

39 • Check vials are inserted correctly .

• Press down on the Onerji vials to ensure that they are fully inserted.
• Press the button on the Yurway Control Station according the Yurway user manual section 4.4.3 .
• Wait while Yurway Medication Cartridge fills .
• Leave the Yurway Infusion Pump (Yurway Rechargeable Pump connected to the Yurway Medication Cartridge) in the pump holder until fill is complete . This takes approximately 7 minutes.
• The Yurway Control Station will show the progress of the filling and inform when the process is complete.
• Remove vial adapters from Yurway Medication Cartridge .
• Unscrew the vial adapters (counter -clockwise); there may be residual solution in the Onerji vials, this is normal.
• Dispose of used vials and connected vial adapters according to local regulations.

Refer to your Yurway Delivery System user manual for the next steps.

Preparation of Onerji infusion when using the Crono Twin ND For detail ed instructions on how to deliver Onerji when using the Crono Twin ND, refer to the Crono Twin ND instructions for use.

• Wash hands thoroughly with soap and water .
• Prepare a clean working area on a flat and level surface .
• Gather the components: 2 CRN C rono 10 mL Luer -Lock syringes, 2 vial adapters, alcohol pads, 2 infusion sets, 2 Onerji vials, 2 clean gauze pads.
• Check Onerji solution in the vials:
• Gently invert each O nerji vial 5 times . Do not shake to avoid forming bubbles.
• The solution should be clear, yellowish and without particles.
• Take 2 Onerji vials and remove the blue caps .
• Attach the vial adapters to the vials (perform for 2 vials) .
• Fully peel off the vial adapter lid .
• Hold the vial firmly on a hard surface; push the adapter tray straight onto the vial until it ‘clicks’ .
• Lift the vial adapter tray by holding the outer rim, straight off the vial.
• Connect the syringes to the vials .
• Remove the syringe from the packaging .
• Screw the syringe clockwise down onto the vial adapter connector .
• Draw up the solution from the vials .
• Invert the vial. Push the plunger up until it stops.
• Hold vertically and pull back the plunger to withdraw 6.5 mL.
• Confirm you have at least 6.5 mL before you disconnect the vial.
• Remove the vials from the syringes
• Invert the vial and unscrew counter -clockwise to remove the syringe.
• Dispose of the used Onerji vials and connected vial adapters according to local regulations.

Refer to your Crono Twin ND instructions for use for the next steps.

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Onerji (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/26/2026).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.