Leaflet: information for the user

APO-go POD 5mg/ml solution for infusion in cartridge

Apomorphine hydrochloride hemihydrate

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section4.

APO-go POD contains apomorphine hydrochloride hemihydrate (referred to in the leaflet asapomorphine).

Each milliliter of solution contains 5mg. of apomorphine.

Apomorphine belongs to a group of medicines called dopamine agonists, which are used to treat Parkinson's disease. Apomorphine helps to reduce the amount of time patients spend in an "off" (or immobile) state who have previously been treated for Parkinson's disease with levodopa and/or other dopamine agonists. Your doctor, pharmacist, or nurse will help you recognize the signs that indicate when you should use this medicine. This medicine is for use only in adults.

Despite the name of the medicine, apomorphine does not contain morphine.

Before using APO-go POD, your doctor will perform an ECG (electrocardiogram) and ask you to list all the other medications you are taking. This ECG will be repeated in the first few days of treatment and at any time your doctor considers necessary. Your doctor will also ask about other health conditions you may have, especially those related to the heart. Some of the questions and additional examinations may be repeated at each medical visit. If you experience any symptoms that may be related to the heart, such as palpitations, fainting, or dizziness, you must inform your doctor immediately. Additionally, if you experience diarrhea or start taking a new medication, you must inform your doctor.

Do not use APO-go POD if:

• You are under 18 years old.
• You have breathing difficulties.
• You have dementia or Alzheimer's disease.
• You have a mental illness with symptoms such as hallucinations, delusions, thought disorders, or loss of contact with reality.
• You have liver problems.
• You have severe dyskinesia (involuntary movements) or severe dystonia (sustained or repetitive movements that can cause a fixed posture) during the "on" periods due to levodopa treatment.
• You are allergic to apomorphine or any of the other components of this medication (listed in section 6).
• You are taking medications for nausea and vomiting of a certain class (5HT3 antagonists), such as ondansetron, granisetron, dolasetron, and palonosetron.
• You are taking medications for diarrhea, such as alosetron.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use APO-go POD if:

• You have kidney problems.
• You have lung problems.
• You have heart problems.
• You have low blood pressure or feel dizzy or lightheaded when standing up.
• You are taking any medication for high blood pressure.
• You have nausea or vomiting.
• You have a mental disorder when starting to use APO-go POD.
• You are an elderly person or are weak.
• You or your family members or caregivers observe that you are developing impulses or desires to behave in an unusual way and cannot resist the impulse, need, or temptation to carry out certain activities that may be harmful to you or others. These behaviors are called impulse control disorders and may include addictive gaming, excessive eating or spending, abnormal sexual desire, or an increase in sexual thoughts or sensations. Your doctor may need to adjust or discontinue your dose.

Some patients develop symptoms related to addiction that lead to a compulsive desire to consume high doses of APO-go POD and other medications used to treat Parkinson's disease.

If any of these situations occur, please inform your doctor, pharmacist, or nurse.

Children and adolescents

APO-go POD should not be used in children and adolescents under 18 years old.

Use of APO-go POD with other medications

Inform your doctor, pharmacist, or nurse if you are taking, have taken recently, or may need to take any other medication.

Consult your doctor, pharmacist, or nurse before starting to use your medication if:

• You are using medications that affect heart rate. This includes medications used to treat heart rhythm problems (such as quinidine and amiodarone), depression (including tricyclic antidepressants, such as amitriptyline and imipramine), and bacterial infections (macrolide antibiotics such as erythromycin, azithromycin, and clarithromycin) and domperidone.
• You are taking ondansetron (a medication used to treat nausea and vomiting) as this can cause severe drops in blood pressure and loss of consciousness..

If you use this medication at the same time as other medications, the effect of your medications may be altered. This occurs particularly with:

• Medications such as clozapine for mental disorders.
• Medications to reduce blood pressure.
• Other medications to treat Parkinson's disease.
• Medications to prevent nausea and vomiting such as ondansetron, granisetron, dolasetron, palonosetron, and medications to treat diarrhea such as alosetron (if you are taking these medications, do not use APO-go POD; see section 2).
• Antidopaminergic medications such as haloperidol, chlorpromazine, promethazine, prochlorperazine, metoclopramide, levopromazine, and droperidol.

Your doctor will inform you if you need to adjust the dose of APO-go POD or any other medication you are taking.

If you are taking levodopa (another medication for Parkinson's disease) in addition to apomorphine, your doctor should perform regular blood tests.

Use of APO-go POD with food and drinks

Foods and drinks do not affect the way this medication works.

Pregnancy and breastfeeding

APO-go POD should not be used during pregnancy, unless it is strictly necessary.

It is not known if apomorphine is excreted in breast milk. Inform your doctor if you are breastfeeding or intend to breastfeed. Your doctor will explain if you should continue or discontinue breastfeeding, or continue or discontinue the medication.

If you are pregnant or breastfeeding, or think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

APO-go POD may cause drowsiness and a strong desire to sleep. You should not drive or operate machinery if this medication causes this effect.

APO-go POD contains sodium metabisulfite.

This medication may cause severe allergic reactions and bronchospasm (sudden feeling of choking) because it contains sodium metabisulfite.

This medication contains less than 23 mg of sodium (1 mmol) per 20 ml cartridge; this is, essentially "sodium-free".

Before using APO-go POD, your doctor will check that you can tolerate this medication and an antiemetic medication (domperidone) that you must take at the same time.

Follow exactly the administration instructions for this medication indicated by your doctor, pharmacist, or nurse. In case of doubt, consult your doctor, pharmacist, or nurse again.

Do not use APO-go POD if:

• The solution turns green.
• The solution is cloudy or contains particles in suspension.

Where to inject APO-go POD

• Inject APO-go POD in an area under the skin (subcutaneous route) as indicated by your doctor, pharmacist, or nurse.
• Do not inject APO-go POD into a vein.

APO-go POD has been designed to be administered in continuous infusion with a pump (also known as a perfusor) and a CronoBell Sleeve cartridge adapter. The perfusor you will receive will be the Crono APO-go III or Crono PAR4 20 model.

How much to use

The amount of APO-go POD you should use and the total daily time you should receive your medication will depend on your personal needs. Your doctor will discuss this with you and indicate the amount of medication to be administered.This amount that will work best for you will be determined at your specialist visit.The average infusion rate per hour is between 2 mg and 8 mg of apomorphine. Continuous infusion is usually administered while awake and is generally interrupted before bedtime at night. The daily amount of apomorphine you receive should not exceed 100 mg.Your doctor, pharmacist, or nurse will decide on the most appropriate dose for you.

You can use a cartridge for a maximum of 48 hours, provided that a new infusion line is used every 24 hours and in a different area of the body.

No dilution of APO-go POD is required before use. Additionally, it should not be mixed with other medications.

Your doctor or nurse will teach you how to prepare and use APO-go POD. Consult also the instructions on how to prepare the infusion with APO-go POD that are found at the end of this prospectus “Preparation of the infusion with Apo-go POD”

If you use more APO-go POD than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 915.620.420, indicating the medication and the amount ingested.

• Inform your doctor or contact the hospital's emergency service immediately.

• It is essential to administer the correct dose of APO-go POD and not use more than the recommended amount by your doctor. Higher doses may cause a slower heart rate, excessive vomiting, excessive drowsiness, and/or difficulty breathing. You may also feel dizzy or faint, especially when standing up, due to low blood pressure. Lying down with your feet elevated will help to treat low blood pressure.

If you forget to use APO-go POD

• Wait for the next dose. Do not use a double dose to compensate for the missed doses.

If you interrupt treatment with APO-go POD

• Consult with your doctor before stopping the use of APO-go POD to decide if it is or is not appropriate.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you experience an allergic reaction,interruptthe treatment with APO-go POD and contact your doctor or go to the nearest hospital's emergency serviceimmediately. The symptoms of an allergic reaction may include:

• Rash.
• Difficulty breathing.
• Swelling of the face, lips, throat, or tongue.

Inform your doctor if you think the medicine is making you feel unwell or if you experience any of the following side effects:

Very common: may affect more than 1 in 10people

• Appearance of lumps under the skin at the injection site that are painful, annoying, and may become red and cause itching. To avoid the appearance of these lumps, it is recommended to change the injection site each time the needle is inserted.
• Hallucinations (seeing, hearing, or perceiving things that do not exist).

Common: may affect up to 1 in 10people

• Nausea or vomiting, especially when starting treatment with APO-go POD. Domperidone treatment should be initiated at least two days before starting APO-go POD treatment to prevent nausea and vomiting. If you are taking domperidone and still experience nausea or vomiting, or if you are not taking domperidone and experience nausea or vomiting, inform your doctor, pharmacist, or nurse as soon as possible.
• Excessive drowsiness.
• Confusion or hallucinations.
• Yawning.
• Sensation of dizziness or lightheadedness.
• Feeling drowsy for a short period of time, especially when starting treatment. It usually resolves within a few weeks.

Uncommon: may affect up to 1 in 100people

• Increased involuntary movements or tremors during the "on" periods
• Autoimmune hemolytic anemia (abnormal destruction of red blood cells in the blood vessels or other parts of the body). This is a rare side effect that may occur in patients taking levodopa.
• Sudden sleep.
• Hives.
• Difficulty breathing.
• Ulceration at the injection site and tissue damage.
• Reduction in the number of platelets, which increases the risk of bleeding or hematomas.
• Sensation of dizziness or lightheadedness when standing up while sitting or lying down due to decreased blood pressure.

Rare: may affect up to 1 in 1,000 people

• Eosinophilia, an abnormally high number of white blood cells in the blood or tissues.

Unknown frequency: the frequencycannot be estimated from the available data

• Swelling of the arms, legs, feet, or hands.
• Inability to resist the impulse, need, or temptation to perform actions that may be harmful to yourself or others, such as the following:
• • Strong desire to gamble or play excessively, despite the severe personal or family consequences that may result.
  • Alteration or increase in sexual interest and behavior, affecting the patient or others, for example, an increase in sexual desire.
  • Excessive buying or spending.
  • Binge eating (eating large amounts of food in a short period of time) or compulsive eating (eating more food than normal and more than necessary to satisfy your appetite).

  • Fainting.

• Aggression, agitation.
• Headache.

Inform your doctor if you experience any of these behaviors; your doctor will agree with you on how to control or reduce the symptoms.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse,even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the label and the box after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Once opened, APO-go POD must be used immediately. Any unused solution must be discarded after 48 hours and a new cartridge must be used.

Do not use this medication if you observe that the solution has turned green. It should only be used if the solution is transparent, colorless, and free of visible particles.

Be careful not to splash the solution on yourself or the floor, as it may stain green.

After use, the infusion site, the cartridge adapter (CronoBell Sleeve), and the cartridge must be discarded and deposited in a sharps container.

Medications should not be disposed of through the drains or in the trash. If in doubt, ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of APO-go POD

• The active ingredient is apomorphine hydrochloride hemihydrate. One milliliter of APO-go POD solution contains 5 mg of apomorphine hydrochloride hemihydrate. Each cartridge of 20 ml contains 100 mg of apomorphine hydrochloride hemihydrate.
• The other components are:
• • sodium metabisulphite (E-223)
  • concentrated hydrochloric acid (for pH adjustment)
  • water for injection preparations

See section 2: APO-go POD contains sodium metabisulphite.

Appearance of APO-go POD and packaging contents

APO-go POD is a solution for infusion in a cartridge. The solution is transparent and colorless.

Packaging contents

APO-go POD is supplied in a transparent siliconized glass cartridge with a chlorobutyl rubber stopper (with aluminum seal and purple-colored push cap) and a siliconized chlorobutyl rubber plunger.

Each pack contains 5 cartridges with 20 ml of solution arranged in a cardboard tray inside an outer cardboard box.

The CronoBell Sleeve cartridge adapter is supplied separately in blister packs containing 5 units.

Single-use Luer lock stoppers will be supplied as needed.

Where packs of packaging are available:

Packs of 25 cartridges contain 5 packs of 5 cartridges.

Packs of 50 cartridges contain 10 packs of 5 cartridges.

Only certain pack sizes may be marketed.

Marketing authorization holder and responsible manufacturer

STADA Arzneimittel AG

Stadastraße 2- 18

61118 Bad Vilbel

Germany

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

ITALFARMACO S.A.

San Rafael, 3

28108 Alcobendas (Madrid)

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Germany:APO-go 5 mg/ml Infusionslösung in einer Patrone

Austria:APO-go 5 mg/ml Infusionslösung in einer Patrone

Denmark:APO-go Pod

Slovenia:APO-go 5 mg/mlraztopinaza infundiranjev vložku

Spain:APO-goPOD 5 mg/ml solución paraperfusión en cartucho

Greece:APO-go POD 5 mg/mlΔι?λυμα για?γχυση σε φυσ?γγιο

Ireland:APO-go POD 5 mg/ml solution for infusion in cartridge

Luxembourg:APO-go POD 5 mg/ml solution pour perfusionen cartouche

Norway:Britaject

Netherlands:APO-go Pod 5 mg/ml oplossing voor infusie in een patroon

Portugal:Apo-go POD 5 mg/mlsoluçãopara perfusãoem cartucho

United Kingdom (Northern Ireland):APO-go POD 5 mg/ml solution for infusion in cartridge

Romania:APO-go 5 mg/ml solutie perfuzabilaîn cartu?

Sweden:APO-go för POD 5 mg/ml infusionsvätska, lösning i cylinderampull

Last review date of this leaflet: September 2024

The detailed information about this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/

Preparation of the infusion with APO-go POD

Wash and dry your hands before handling any infusion equipment.

Before starting, make sure you have a container for sharp objects and the following items:

• 1 infusion set* (for each 24 hours)
• 1 CronoBell Sleeve cartridge adapter*
• 1 cartridge (containing the medication)
• 1 infusion pump (Crono APO-go III or Crono PAR4 20) with locking piece*.
• 1 tray*

You may also be provided with:

(*)The pack does not contain the infusion set, the CronoBell Sleeve cartridge adapter, the infusion pump with locking piece for activating the infusion, the tray, and the Luer stoppers. These items are supplied separately.

Please note that there are three different scenarios for using and changing the cartridge, which are shown below. Please follow the instructions below according to the indications of your healthcare professional.

Instructions for using the cartridge for one day

Please follow the steps below if you use the cartridge for one day, without changing the cartridge during the day:

Instructions for using the same cartridge for 2 days

Please follow the steps below if you use the cartridge for up to 48 hours:

Instructions for changing the cartridge during the day

If you use the cartridge for more than one day, you may need to use a new cartridge when the old one is finished. Please follow the steps below to change the cartridge during the day:

Nota: Each infusion line requires a different insertion technique. The choice of needle will be determined by the doctor.

The user guide for the pump and the CronoBell Sleeve cartridge adapter is intended for healthcare professionals. If you want to consult the detailed information about how to prepare APO-go POD for continuous infusion and additional administrations (known as a boost or a bolus dose), consult with healthcare professionals.

The administration pump for this product is different from that of other apomorphine-containing medications available on the market. Therefore, if you have changed from one medication to another, you must relearn how to use it with the supervision of a healthcare professional.

The detailed and updated information about this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/