Apo-Go PFS 5 mg/ml solution for infusion in pre-filled syringe

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

Apomorphine Hydrochloride

For use in adults

Read the entire leaflet carefully before you start using this medicine, as 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, nurse or pharmacist.
• This medicine has been prescribed for you and should not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What APO-go PFS is and what it is used for
2. What you need to know before using APO-go PFS
3. How to use APO-go PFS
4. Possible side effects
5. How to store APO-go PFS
6. Contents of the pack and other information

1. What Apo-go PFS is and what it is used for

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

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

2. What you need to know before using APO-go PFS

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

Do not use APO-go PFS if:

• you are under 18 years of age
• you have difficulty breathing or suffer from asthma
• you have dementia or Alzheimer's disease
• you suffer from confusion, hallucinations, or similar problems
• you have liver problems
• you have severe dyskinesia (involuntary movements) or severe dystonia (inability to move) due to treatment with levodopa
• you are allergic to apomorphine or any of the other components of this medicine (listed in section 6)
• you or a family member has an abnormality in the electrocardiogram (ECG) known as "long QT syndrome"
• you are taking ondansetron (a medicine used to treat nausea and vomiting)

Warnings and precautions:

Talk to 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 faint or dizzy when standing up
• you are taking any medication for blood pressure
• you have nausea or vomiting
• you have a mental disorder when starting to use APO-go PFS
• you are elderly or feel weak

Inform your doctor if you or your family/caregiver notice that you are developing impulses or urges to behave in an unusual way and are unable to resist the impulse, drive, or temptation to carry out an act that could be harmful to yourself or others. These behaviors are called impulse control disorders and may include compulsive gambling, excessive eating or spending, abnormally increased sex drive, or an increase in sexual thoughts or feelings. Your doctor may need to adjust or stop your dose.

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

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

Children and adolescents

Apo-go PFS must not be used in children and adolescents under 18 years of age.

Use of Apo-go PFS with other medicines

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

Talk to your doctor or pharmacist before taking this medicine if:

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

If you use this medicine at the same time as other medicines, the effect of those medicines may be altered. This is particularly true with:

• medicines such as clozapine used to treat mental disorders
• medicines used to lower blood pressure
• other medicines used to treat Parkinson's disease

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

If, in addition to APO-go PFS, you are also using levodopa (another medicine for Parkinson's disease), your doctor should perform regular blood tests.

Use of Apo-go PFS with food and drink

Food and drink do not affect how this medicine 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 might be pregnant, or are planning to become pregnant.

It is not known whether APO-go PFS is excreted in breast milk. Inform your doctor if you are breastfeeding or plan to breastfeed; your doctor will advise you whether you should continue breastfeeding or taking this medicine.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

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

APO-go PFS contains sodium metabisulfite

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

Apo-go PFS contains less than 1 mmol (23 mg) of sodium per ml and is therefore considered essentially "sodium-free".

3. How to use APO-go PFS

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

The infusion is administered subcutaneously (i.e., into the area beneath the skin).

Always follow exactly the instructions for administration of this medicine as given by your doctor. If you are unsure, consult your doctor, nurse, or pharmacist again.

Do not use APO-go PFS if:

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

What amount to use: Both the amount of APO-go PFS you will need to use and the total length of time over which you should receive your medicine each day will depend on your individual needs. Your doctor will discuss this with you and tell you how much medicine you should receive. The most suitable amount will be determined during your visit to the specialist. The average hourly infusion dose ranges between 1 mg and 4 mg of apomorphine hydrochloride. Continuous infusion is usually given while you are awake and is generally stopped before going to sleep. The daily dose of apomorphine hydrochloride must not exceed 100 mg. Your doctor or nurse will decide the most appropriate dose for you.

A different infusion site should be used every 12 hours.

This medicine must not be administered intravenously.

It is not necessary to dilute APO-go PFS before use. It must not be mixed with other medicines.

If you use more APO-go PFS than you should

In case of overdose or accidental ingestion, contact your doctor immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

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

If you forget to use APO-go PFS

• Wait for your next scheduled dose.
• Do not use a double dose to make up for a missed dose.

If you stop using APO-go PFS

• Consult your doctor before stopping APO-go PFS to determine whether or not it is appropriate.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse 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 adverse effects:

Very common adverse effects (may affect more than 1 in 10 people):

• Appearance of lumps under the skin at the injection site that are painful, bothersome, and may become red and itchy. To prevent 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 adverse 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 have vomiting, consult your doctor as soon as possible.
• Tiredness or excessive drowsiness.
• Confusion or hallucinations.
• Yawning.
• Dizziness or weakness when standing up.

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

• Increased involuntary movements or worsening of tremors during "on" periods.
• Haemolytic anaemia (abnormal destruction of red blood cells in blood vessels or other parts of the body). This is an uncommon adverse effect that may occur in patients also taking levodopa.
• Sudden sleep.
• Rash.
• Difficulty breathing.
• Ulceration at the injection site.
• Reduction in the number of red blood cells, which may lead to pale skin and cause weakness and breathlessness.
• Reduction in the number of platelets, increasing the risk of bleeding or bruising.

Rare adverse 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
  • Swelling or redness of the tongue
• Eosinophilia, an abnormally high number of white blood cells in the blood or tissues.

Adverse effects of unknown frequency (frequency cannot be estimated from the available data):

• Swelling of legs, feet, or fingers.

• Inability to resist the impulse or temptation to carry out an action that could be harmful to yourself or others, which may include:

• Strong urge to gamble excessively despite serious personal or family consequences.

  • Altered or increased sexual interest and behaviour affecting the patient or their relationships with others, for example, increased sexual activity.
  • Compulsive buying 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 behaviours; your doctor will discuss with you how to manage or reduce the symptoms.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of APO-go PFS

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

Do not use this medicine after the expiry date stated on the label/box after EXP. The expiry date refers to the last day of the month indicated.

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

Do not store above 25°C.

Once opened, APO-go PFS must be used immediately and any unused solution should be discarded.

For single use only.

Do not use this medicine if the solution has turned green. It should only be used when the solution is clear, colourless, and free from visible particles.

Remove the contents immediately after opening. Take care to avoid splashing or spilling onto carpets, as it may cause green staining. After use, the glass pre-filled syringe must be disposed of in a sharps container, together with any plastic syringes used and the adapter.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of APO-go PFS

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

The other components (excipients) are:

• Sodium metabisulfite (E223)
• Hydrochloric acid, concentrated
• Water for injections

See section 2: APO-go PFS contains sodium metabisulfite.

Appearance of APO-go PFS and contents of the pack

APO-go PFS is a clear, colourless infusion solution in pre-filled syringes.

Contents of the pack

APO-go PFS is supplied in clear glass pre-filled syringes. Each pack contains 5 syringes with 10 ml of solution in a cardboard carton. Only certain pack sizes may be marketed. Packs of 25 (5 x 5) and 50 (10 x 5) are available in some countries.

Only certain pack sizes may be marketed.

Marketing Authorization 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

Or

Rovi Pharma Industrial Services S.A.
Julián Camarillo, 35
Madrid
28037 Madrid
Spain

Or

STADA Arzneimittel AG
Stadastrasse 2–18
D-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)
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 Διάλυμα για έγχυση σε Προγεμισμένη Σύριγγα

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

Greece: 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 latest revision of this leaflet: November 2023

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)