APO-GO 10 mg/ml INJECTABLE SOLUTION OR PERFUSION SOLUTION IN AMPULES

Introduction

Leaflet: Information for the user

APO-go 10 mg/ml Solution for Injection or Infusion in Ampoules*

Apomorphine Hydrochloride

• Abbreviated in the text as APO-go Ampoules

For use in adults

Read the entire leaflet carefully before starting to use this medication, 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 medication has been prescribed to you and should not be given to others, even if they have the same symptoms, as it may harm them. If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What APO-go Ampoules are and what they are used for
2. What you need to know before starting to use APO-go Ampoules
3. How to use APO-go Ampoules
4. Possible side effects
5. Storage of APO-go Ampoules
6. Contents of the pack and further information

1. What APO-go Ampoules are and what they are used for

APO-go Ampoules contain an injectable solution of apomorphine that is injected under the skin (subcutaneously). The active ingredient of APO-go Ampoules is apomorphine hydrochloride. Each milliliter of solution contains 10 mg of apomorphine.

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

Despite its name, apomorphine does not contain morphine.

2. What you need to know before starting to use APO-go Ampoules

Before using APO-go Ampoules, 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 few days of treatment and at any time your doctor considers it necessary. Your doctor will also ask about other diseases you may have, especially those related to the heart. Some of the questions and complementary tests 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 should inform your doctor immediately. If you have diarrhea or start using a new medication, you should also inform your doctor.

Do not use APO-go Ampoules if:

• you are under 18 years old
• you have breathing difficulties
• you have dementia or Alzheimer's disease
• you suffer from a mental illness with symptoms such as hallucinations, delusions, confused thoughts, or loss of contact with reality
• you have liver problems
• you have severe dyskinesia (involuntary movements) or severe dystonia (inability to move) despite taking levodopa
• 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 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 Ampoules if:

• you have kidney problems

• you have lung problems
• you have heart problems
• you have low blood pressure or feel dizzy or faint when standing up
• you are taking medication for high blood pressure
• you have nausea or vomiting
• your Parkinson's disease causes certain mental problems, such as hallucinations and confusion
• you are an elderly patient or are weak

Inform your doctor if you or your family members/caregivers notice that you are developing impulses or cravings to behave in an unusual way for you or cannot resist the impulse, drive, 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 gambling, overeating, or excessive spending, an abnormally high sexual desire, or an increase in sexual thoughts or feelings. Your doctor may need to adjust or interrupt your dosage.

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

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

Children and adolescents

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

Using APO-go Ampoules with other medications

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

Consult your doctor or pharmacist before using 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.

Using APO-go Ampoules with food and drinks

Food and drink do not affect the functioning of this medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication. APO-go Ampoules should not be used during pregnancy unless it is strictly necessary.

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

Consult your doctor or pharmacist before using any medication.

Driving and using machinery

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

APO-go Ampoules contain sodium metabisulfite:APO-go Ampoules contain sodium metabisulfite, which can rarely cause severe allergic reactions with symptoms such as skin rashes, itching, difficulty breathing, swelling of the eyelids, face, or lips, inflammation, or redness of the tongue. If you experience any of these effects, go to the nearest emergency hospital immediately.

APO-go contains less than 1 mmol (23 mg) of sodium per 10 ml, so it is considered essentially "sodium-free".

3. How to use APO-go Ampoules

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

Follow the administration instructions of this medication exactly as indicated by your doctor. If you are unsure, consult your doctor, nurse, or pharmacist again.

Domperidone should be taken at least 2 days before starting APO-go Ampoules to avoid nausea and vomiting.

Do not use APO-go Ampoules if

• the solution has turned green
• the solution is cloudy or particles are visible

Where to inject APO-go Ampoules

• Inject APO-go Ampoules into an area under the skin (subcutaneously) as your doctor or nurse has taught you.
• Do not inject APO-go Ampoules into a vein.

How much to use

The amount of APO-go Ampoules you should use and the number of injections required each day will depend on your personal needs. Your doctor will discuss and prescribe the amount of medication to be injected and how often. The amount that works best for you will be determined during your visit to the specialist.

• The usual daily dose is between 3 and 30 mg
• You may need up to 100 mg per day
• Normally, you will need between 1 and 10 daily injections
• Each injection should not have a dose greater than 10 mg

If your symptoms are not controlled enough with separate injections or if you find that you need more than 10 daily injections, you may need continuous infusion of apomorphine. Your doctor or nurse will decide if this is the case. For continuous infusion:

• The usual dose is between 1 mg and 4 mg per hour
• The infusion is usually administered while you are awake and stopped when you go to sleep
• A different site will be used for the infusion every 12 hours

Your doctor will decide which mini-infusion pump and/or mechanically driven syringe to use. Consult your doctor, pharmacist, or nurse if you are unsure.

What you need to inject APO-go Ampoules

For an injection, you will need:

• A syringe and needle
• A container called a "sharps container" to safely dispose of used needles and glass ampoules. These can be obtained from your doctor or nurse. Alternatively, you can use other containers that may be suitable, such as an empty jar

How to open APO-go Ampoules

• Locate the pointsituated directly above the small line that marks the thin part of the ampoule neck. This line is the point where the ampoule breaks.
• Hold the bottom of the ampoule with one hand
• Cover the black point with your thumband use your index finger to hold the ampoule neck as indicated in the diagram
• Press your thumb backwards
• Carefully discard the top part of the ampoule in the "sharps container"

Once APO-go Ampoules are opened, they must be used immediately.

How to inject APO-go Ampoules

• Place the needle on the end of the syringe
• Draw up the volume needed for the recommended dose by your doctor or nurse
• You may need to dilute APO-go Ampoules before use. Your doctor or nurse will have told you if you need to do this and how to do it
• Inject the medication under the skin (subcutaneously) as your doctor or nurse has taught you
• Discard the syringes, needles, and ampoules in a sharps container (which can be provided by your doctor or pharmacist) or in another suitable container, such as an empty jar
• Be careful not to spill the solution or splash it on the carpet, as it may stain green

If you have any other questions about using this medication, consult your doctor or nurse.

If you use more APO-go Ampoules than you should

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

• Tell your doctor or contact the emergency department of the nearest hospital immediately
• You may notice that your heart beats slower, you feel like vomiting, you are excessively sleepy, and/or you have 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 you feel better

If you forget to use APO-go Ampoules

Wait for the next dose. Do not use a double dose to make up for the missed dose.

If you stop treatment with APO-go Ampoules

Do not stop using APO-go Ampoules without talking to your doctor first.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

If you experience an allergic reaction, stopusing APO-go Ampoules and contact a doctor or the emergency department of the nearest hospital immediately. The signs of an allergic reaction may include:

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

APO-go Ampoules may sometimes cause 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, annoying, and may become red and itchy. 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, especially when starting treatment with APO-go Ampoules. If you are taking domperidone and still feel nauseous or if you are not taking domperidone and have vomiting, consult your doctor as soon as possible
• Fatigue or excessive sleepiness
• Confusion or hallucinations
• Yawning
• Feeling dizzy or weak when standing up

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

• Increased involuntary movements or increased tremors during "on" periods
• Hemolytic anemia (abnormal destruction of red blood cells in blood vessels or other parts of the body). This is an uncommon side effect that may occur in patients who also take levodopa
• Sudden sleep
• Rash
• Difficulty breathing
• Ulceration at the injection site
• Reduced number of red blood cells, which can cause paleness of the skin and lead to weakness and shortness of breath
• Reduced number of platelets, which increases the risk of bleeding or bruising

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

• Allergic reaction

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

Side effects that occur in an unknown number of patients:

• Swelling of the legs, feet, or toes
• Inability to resist the impulse, desire, or temptation to perform an action that may be harmful to you or others, which may include:- strong impulse to gamble excessively, despite serious personal or family consequences- altered or increased sexual interest or behavior in a significant way, either with yourself or with others, for example, increased sexual desire- uncontrolled spending or buying- binge eating (eating large amounts of food in a short period) or compulsive eating (eating more food than normal and more than necessary to satisfy your hunger)
• Fainting
• Aggression, agitation
• Headache

Tell your doctor if you experience any of these behaviors; your doctor will indicate how to control or reduce the symptoms.

Reporting side effects:

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of APO-go Ampoules

Keep this medication out of sight and reach of children.

Do not store above 25 °C. Store in the original package to protect from light.

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

Once the ampoule is opened, use it immediately.

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

Used syringes, needles, and ampoules should be disposed of in a sharps container or another suitable container, such as an empty jar. When the sharps container is full, please give it to your doctor or pharmacist to dispose of it safely.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Content of the vial and additional information

Composition of APO-go Ampoules

The active ingredient is apomorphine hydrochloride. Each milliliter of APO-go Ampoules contains 10 mg of apomorphine hydrochloride.

The other components (excipients) are:

• Sodium metabisulfite (E223)
• Hydrochloric acid (or sodium hydroxide)
• Water for injectable preparations

APO-go Ampoules are available in 2 ml ampoules containing 20 mg of apomorphine hydrochloride or 5 ml ampoules containing 50 mg of apomorphine hydrochloride.

Regarding sodium metabisulfite, see 'Section 2: APO-go Ampoules contain sodium metabisulfite'.

Appearance of APO-go Ampoules and packaging content

APO-go Ampoules are a solution for injection or infusion. The solution is clear and colorless.

Packaging content

Glass ampoules containing 2 ml of Solution for Injection or Infusion, in packs of 5 ampoules.

Glass ampoules containing 5 ml of Solution for Injection or Infusion, in packs of 5 ampoules.

The ampoules are packaged in a plastic tray inside a cardboard box.

Each ampoule has a black mark located above the marked line (partial division). This line is the point where the ampoule is broken.

In some countries, packs of 25 and 50 ampoules are available.

The packs of 25 ampoules contain 5 packs of 5 ampoules each.

The packs of 50 ampoules contain 10 packs of 5 ampoules each.

Only some packaging sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

STADA Arzneimittel AG

Stadastraße 2-18

61118 Bad Vilbel, Germany

Manufacturer

STADA Arzneimittel AG

Stadastrasse 2 – 18 D-61118 Bad Vilbel, Germany

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

ITALFARMACO S.A.

San Rafael, 3

28108 Alcobendas (Madrid)

Tel. 916572323

This medication is authorized in the member states oftheEuropean Economic Areaand in the United Kingdom (Northern Ireland)with the following names:

Austria, Germany:APO-go® Ampullen 10 mg/ml Injektions-/Infusionslösung

Belgium:APO-GO-AMP 10 mg/ml oplossing voor injectie of infusie

Bulgaria:???_??® ?????? 10mg/ml

Slovenia:APO-go 10 mg/ml raztopina za injiciranje ali infundiranje v ampuli

Spain:APO-go 10 mg/ml Solución Inyectable o para Perfusión en Ampollas

Estonia:APO-go 10 MG/ML, süste-või infusioonilahus

Ireland, United Kingdom(Northern Ireland):APO-go Ampoules 10mg/ml Solution for Injection or Infusion

Lithuania:Britaject 10mg/ml injekcinis/infuzinis tirpalas

Luxembourg:APO-go® Ampoules 10mg/ml Solution Injectable/ pour Perfusion

Netherlands:APO-go Ampullen 10mg/ml oplossing voor injectie of infusie

Portugal:Apo-go 10mg/ml Solução injectável ou para perfusão

Romania:APO-go 10 mg/ml solutie injectabila/perfuzabila

Sweden:APO-go 10mg/ml injetionsvätska, lösning

Date of the last revision of this prospectus: November 2023

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