PROSPECTO: Information for the User

APO-go PFS 5 mg/ml Solution for Infusion in Pre-filled Syringe

Apomorphine Hydrochloride

For use in adults

Read this prospectus carefully before starting to take this medication, because it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor, nurse or pharmacist.
• This medication has been prescribed to you and should not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist even if they do not appear in this prospectus. See section 4.

Apo-go contains apomorphine hydrochloride.Apomorphine hydrochloride belongs to a group of medicines called dopamine agonists that are used to treat Parkinson's disease. It helps to reduce the amount of time spent in a "off" or immobile state in people who have previously been treated for Parkinson's disease with levodopa and/or other dopamine agonists. Your doctor or nurse will help you recognize the signs that will indicate when you should use this medicine.

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

Before using APO-go PFS, your doctor will perform an ECG (electrocardiogram) and ask for a list of all other medications you are taking. This ECG will be repeated in the first 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 questions and additional explorations may be repeated at each medical visit. If you have symptoms that may be related to the heart, such as palpitations, fainting, or dizziness, you must inform your doctor immediately. If you have diarrhea or start taking a new medication, you must also inform your doctor.

Do not use APO-go PFS if:

• You are under 18 years old
• You have breathing difficulties or suffer from asthma
• You have dementia or Alzheimer's disease
• You experience confusion, hallucinations, or a similar problem
• You have liver problems
• You have severe dyskinesia (involuntary movements) or severe dystonia (inability to move) due to levodopa treatment
• You are allergic to apomorphine or any of the other components of this medication (listed in section 6)
• You or a family member has an electrocardiogram (ECG) anomaly called "long QT syndrome".
• You are taking ondansetron (a medication used to treat nausea and vomiting)

Warnings and precautions:

Consult your doctor, pharmacist, or nurse before starting to use Apo-go PFS 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 blood pressure
• You have nausea or vomiting
• You have any mental disorder when starting to use APO-go PFS
• You are elderly or weak

Inform your doctor if you or your family/caregiver notice that you are developing impulses or desires to behave in an unusual way and cannot resist the urge, push, or temptation to drive or perform an act that could be harmful to you or another person.These behaviors are called impulse control disorders and may include addictive behavior, excessive eating or spending, abnormal elevated sexual desire, or an increase in sexual thoughts or feelings. Your doctor may need to adjust or discontinue your dose.

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

If any of the situations described occur, please inform your doctor or nurse.

Children and adolescents

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

Use of APO-go PFS with other medications

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

Consult your doctor or pharmacist before taking this medication if:

• You are using medications that affect heart rate. This includes medications used for heart rhythm problems such as (quinidine and amiodarone), for depression (including tricyclic antidepressants such as amitriptyline and imipramine), and for 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 may 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 these medications may be altered. This occurs particularly with:

• Medications such as clozapine for mental disorders.
• Medications to lower blood pressure.
• Other medications used to treat Parkinson's disease.

Your doctor will inform you if you need to change the dose of apomorphine or any other medication you are using.

If you are also using levodopa (another medication for Parkinson's disease), your doctor should perform regular blood tests.

Use of APO-go PFS with food and drinks

Foods and drinks do not affect how this medication works.

Pregnancy and breastfeeding

APO-go PFS should not be used during pregnancy unless strictly necessary. Consult your doctor or pharmacist before using APO-go PFS if you are pregnant, think you may be pregnant, or are planning to become pregnant.

It is not known if APO-go PFS is excreted in breast milk. Inform your doctor if you are breastfeeding or plan to do so; your doctor will explain if you should continue or stop breastfeeding or taking this medication.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

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

APO-go PFS contains metabisulfito de sodio

APO-go PFS contains metabisulfito de sodio, which, in rare cases, may cause severe allergic reactions with symptoms such as hives or itching of the skin, difficulty breathing, swelling of eyelids, face, or lips, inflammation or redness of the tongue. If you experience these adverse effects, go to the nearest hospital immediately.

APO-go PFS contains less than 1 mmol (23 mg) of sodium per ml, making it essentially "sodium-free".

Before using APO-go PFS, your doctor will check that you can tolerate this medication and an antiemetic medication that you must take simultaneously.

The infusion is administered subcutaneously (i.e., in the area under the skin).

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

Do not use Apo-go PFS if;

• The solution has turned green.
• APO-go PFS is designed to be administered in continuous infusion with a mechanical syringe pump. It should not be used by intermittent injection. Your doctor will decide which mini-pump infusion and/or mechanical syringe to use and what dose.

How much you should use:Both the amount of APO-go PFS that you should use and the total amount of time you should receive your medication daily will depend on your personal needs. Your doctor will discuss this with you and indicate how much medication should be administered. The amount that will work best for you will be determined at your specialist visit. The average infusion rate per hour is between 1 mg and 4 mg of apomorphine hydrochloride. Continuous infusion is usually administered while awake and is generally stopped before sleeping. The amount of apomorphine hydrochloride you receive daily should not exceed 100 mg. Your doctor or nurse will decide what is the most appropriate dose for you.

You should use a different infusion site every 12 hours.

This medication should not be administered intravenously.

APO-go PFS does not need to be diluted before use. It should also not be mixed with other medications.

If you use more APO-go PFS than you should;

In case of overdose or accidental ingestion, consult your doctor immediately or call the Toxicological Information Service, telephone 91 562 04 20, indicating the medication and the amount ingested.

• It is essential to administer the correct dose of APO-go PFS 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 due to low blood pressure. Lying down with your feet elevated will help to treat low blood pressure.

If you forget to take APO-go PFS;

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

If you interrupt treatment with APO-go PFS;

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

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them. 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 side effects(may affect more than 1 in 10 people):

• Appearance of lumps under the skin at the injection site that are painful, itchy 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 feeling things that do not exist)

Common side effects(may affect up to 1 in 10 people):

• Nausea or vomiting, particularly when starting treatment with APO-go PFS. Domperidone should be started 2 days before APO-go PFS to prevent nausea and vomiting. If you are taking domperidone and still experience nausea or if you are not taking domperidone and experience vomiting, consult your doctor as soon as possible.
• Excessive fatigue or drowsiness.
• Confusion or hallucinations.
• Yawning.
• Sensation of dizziness or weakness when standing up.

Uncommon side effects(may affect up to 1 in 100 people):

• Increased involuntary movements or tremors during the "on" periods.
• Haemolytic anaemia (abnormal destruction of red blood cells in the blood vessels or other parts of the body). This is an uncommon side effect that may occur in patients also taking levodopa.
• Sudden sleep.
• Hives.
• Difficulty breathing.
• Ulceration of the injection site.
• Reduction in the number of red blood cells, which may cause pale skin and cause weakness and shortness of breath.
• Reduction in the number of platelets, which increases the risk of bleeding or haematoma.

Rare side effects(may affect up to 1 in 1,000 people):

• An allergic reaction, such as:
• • Difficulty breathing or chest tightness
  • Swelling of the eyelids, face or lips
  • Inflammation or redness of the tongue
• Eosinophilia, an abnormally high number of white blood cells in the blood or tissues.

Side effects of unknown frequency(frequency cannot be estimated with available data):

• Swelling of the legs, feet or toes.
• Inability to resist the urge ortemptation to perform an act that could be harmful to you or another person, which may include:

- Strong urge to gamble excessively despite having severe personal or family consequences.

• Altered or increased sexual interest or behavior that affects the patient or their relationship with others, for example, increased sexual activity.
• Excessive or uncontrolled 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 needed to satisfy hunger).
• Fainting.
• Aggression, agitation.
• Headache.

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

Reporting 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 Pharmacovigilance of Medicines for Human Use:https://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/box after CAD.The expiration date is the last day of the month indicated.

Store the pre-filled syringes in the outer box to protect them from light.

Do not store at a temperature above25°C.

Once opened, APO-go PFS must be used immediatelyand discard any unused solution.

For single use only.

Do not use this medication if the solution has turned greenIt should only be used when the solution is clear, colorless, and free of visible particles.

Remove the contents immediately after opening. Be careful not to splash or spill on the carpet, as it may stain green. After use, the pre-filled glass syringe must be discarded in a sharps container, as well as any plastic syringe that has been used and the adapter.

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

Composition of APO-go PFS

The active ingredient is apomorphine hydrochloride. 1 ml of solution contains 5 mg of apomorphine hydrochloride. Each pre-filled syringe of 10 ml contains 50 mg of apomorphine hydrochloride.

The other components (excipients) are:

– Sodium metabisulphite (E223)

– Concentrated hydrochloric acid

– Water for injection preparations

See section 2: Apo-go PFS contains sodium metabisulphite.

Appearance of APO-go PFS and contents of the pack

APO-go PFS is a solution for infusion in pre-filled syringes. The solution is clear and colourless.

Contents of the pack

APO-go PFS is supplied in pre-filled syringes of clear glass. Each pack contains 5 syringes with 10 ml of solution in a cardboard case. Some pack sizes may only be marketed.

Some pack sizes may only be marketed.

Marketing authorisation holder and manufacturer

STADA Arzneimittel AG

Stadastraße 2- 18

61118 Bad Vilbel, Germany

Manufacturer

Catalent Belgium S.A.

Font Saint Landry 10

B-1120 Brussels (Neder Over Heembeek)

Belgium

O

Rovi Pharma Industrial Services S.A.

Julián Camarillo, 35

Madrid

28037 Madrid

Spain

O

STADAArzneimittelAG

Stadastrasse 2 – 18 D-61118 Bad Vilbel, Germany

Further information on this medicinal product can be obtained by contacting the local representative of the marketing authorisation holder:

ITALFARMACO S.A.

San Rafael, 3

28108 Alcobendas (Madrid)

Tel. 916572323

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

Austria, Germany:APO-go 5mg/ml Infusionslösung in einer Fertigspritze

Bulgaria:APO-go PFS 5mg/ml ??????? ?? ??????? ? ????????????? ????????? ??????????

Cyprus: APO-go® PFS 5mg/ml Δι?λυμα για ?γχυση σε Προγεμισμ?νη Σ?ριγγα

Denmark:APO-go Pumpfill 5 mg/ml infusionsvæske, opløsning i fyldt injektionssprøjte

Finland:APO-go PFS 5mg/ml

Ireland, United Kingdom (Northern Ireland),

Malta: APO-go PFS 5mg/ml Solution for Infusion in Pre-filled Syringe

Netherlands:APO-go 5mg/ml oplossing voor infusie in een voorgevulde spuit

Norway:Britaject 5mg/ml infusjonsvæske, oppløsning i ferdigfylt sprøyte

Portugal:Apo-go 5mg/ml Solução para perfusão em seringa pré-cheia

Romania:APO-go 5mg/ml solutie perfuzabila în seringa preumpluta unidoza

Slovenia: APO-go 5 mg/ml raztopina za infundiranje v napolnjeni injekcijski brizgi

Spain: APO-go PFS 5 mg/ml Solución para Perfusión en Jeringa Precargada

Sweden: APO-go Pumpfill 5 mg/ml infusionsvätska, lösning i förfylld spruta

Date of the last revision of this leaflet: November 2023

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