Package Leaflet: Information for the User

Apodev 5 mg/ml infusion solution EFG

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, ask your doctor or pharmacist.

-This medicine has been prescribed for you only.Do not pass it on to others even if their symptoms are the same as yours.It may harm them.

• If you experience any side effects, talk to your doctor or pharmacist.See section 4.

1.What Apodev is and what it is used for

2.What you need to know before using Apodev

3.How to use Apodev

4.Possible side effects

5Storage of Apodev

6.Contents of the pack and additional information

Apomorphine hydrochloride belongs to a group of medications known as dopamine agonists used to treat Parkinson's disease. It helps to reduce the amount of time spent in an "off" or immobility 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 of when to use your medication.

No use Apodev

• If you are allergic to apomorphine or any of the other components of this medication (listed in section 6).
• If you are under 18 years old.
• If you have breathing difficulties or suffer from asthma.
• If you have dementia or Alzheimer's disease.
• If you experience confusion, hallucinations, or any other similar problem.
• If you have liver problems.
• If you have severe restlessness, known as dyskinesia (involuntary movements), or abnormal muscle tension, known as dystonia, due to levodopa treatment.
• If you are taking ondansetron (a medication to treat nausea and vomiting).

Warnings and precautions

Consult your doctor before starting to use this medication:

• If you or a family member has a heart rhythm anomaly called "long QT syndrome" as shown by an electrocardiogram (ECG).
• If you have kidney problems.
• If you have lung problems.
• If you have heart problems.
• If you have low blood pressure or feel weak and dizzy when standing up.
• If you are taking any medication to treat high blood pressure.
• If you feel sick or are experiencing nausea.
• If you are elderly or weak.
• If you have any mental disorder when starting to take Apodev.
• If you are taking levodopa (another treatment for Parkinson's disease) in addition to apomorphine, your doctor must check your blood regularly.

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 your treatment and at any time if your doctor considers it necessary. They will also ask about other health conditions you may have, particularly about your heart. Some of the questions and investigations may be repeated at each medical visit. If you experience symptoms that may be related to your heart, such as palpitations, fainting, or near-fainting, you must inform your doctor immediately. Also, if you experience diarrhea or start taking a new medication, you must inform your doctor.

Inform your doctor if you or your family/caregiver notice that you are developing impulses or desires to behave in an unusual way for you and cannot resist the impulse, desire, or temptation to perform certain activities that could harm yourself or others. This is known as impulse control disorder and may include behaviors such as excessive gaming, eating, or spending, abnormally high sexual desire, or an increase in sexual thoughts or feelings. Your doctor may need to adjust or discontinue your dose.

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

If any of the above situations apply to you, inform your doctor or nurse.

Other medications and Apodev

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

If you take this medication in combination with other medications (such as clozapine or medications to reduce your blood pressure or medications for Parkinson's disease) the effect of your medications may be altered. Your doctor will advise you if you need to adjust the dose of this medication or any of your other medications.

Check with your doctor or pharmacist before taking your medication if you are taking ondansetron (a medication to treat nausea and vomiting), as this may result in a severe drop in blood pressure and loss of consciousness.

Consult your doctor or pharmacist before using this medication if:

You are taking medications that are known to affect your heart rhythm. This includes medications used to treat heart rhythm problems (such as quinidine and amiodarone), for depression (for example, tricyclic antidepressants such as amitriptyline and imipramine), and for bacterial infections ("macrolide antibiotics" such as erythromycin, azithromycin, and clarithromycin) and domperidone.

Using Apodev with food and drinks

Foods and drinks do not affect how this medication works.

Pregnancy and breastfeeding

Pregnancy

This medication should not be used during pregnancy unless it is essential. Ask your doctor or nurse before using this medication if you are pregnant, think you may be pregnant, or intend to become pregnant.

Breastfeeding

It is unknown whether this medication is excreted in breast milk. Consult your doctor if you are breastfeeding or intend to do so. Your doctor will explain whether you should continue or discontinue breastfeeding or whether you should continue or discontinue the medication.

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

Driving and operating machinery

Be particularly careful when driving or operating machinery because apomorphine may cause drowsiness, including sudden episodes of sleep (do not drive or use machinery if this medication makes you feel drowsy).

Apodev contains metabisulphite of sodium and sodium

Metabisulphite of sodium may, in rare cases, cause hypersensitivity reactions and bronchospasm.

This medication contains 3.3mg of sodium (the main component of table salt) in each ml of solution. This is equivalent to 0.17% of the maximum daily sodium intake recommended for adults.

Before usingthis medication, your doctor will ensure that you can tolerate it and determine an antiemetic medication that you should take simultaneously.

This medication is administered subcutaneously (e.g., in the area below the skin).

Follow exactly the administration instructions forthis medicationprovided by your doctor or pharmacist.In case of doubt, consult your doctor or pharmacist again.

This medicationhas been designed for continuous infusion with a pump. Your doctor will decide which pump and dosage adjustments are suitable for you. Follow your doctor's instructions and recommendations on how to use this medication with a pump. Read the pump instructions manual and follow them carefully.

The amount of this medication you should use and the total amount of time you should receive the medication each day depend on your personal needs. Your doctor will inform you about the amount of medication to be administered.

The most suitable dose will have been determined in an initial assessment at a specialized clinic. The usual hourly infusion dose is between 1mg and 4mg of apomorphine hydrochloride. It is usually administered while awake and is usually stopped before sleep. The amount of apomorphine hydrochloride you receive each day should not exceed 100mg. Your doctor or nurse will decide what dose is most suitable for you.

The infusion site should be changed every 12hours.

This medication should not be administered in a vein. It is not necessary to dilute this medication before using it. This medication should not be mixed with other medications.

Instructions for using Apodev

• Clean the rubber stopper with a disinfectant swab.
• Insert the needle of the syringe into the vial through the center of the rubber stopper.
• Place the vial and syringe upside down.
• Take the desired volume from the vial with the syringe.
• Remove the needle from the vial.
• Then, follow the instructions for your pump carefully.

Your doctor will start the treatment and inform you in detail about how to use the pump, infusion technique, and manipulation to administer the medication.

If you use more Apodev than you should

• if you have received too much medication or if, for example, the medication has been administered to a child by mistake, contact your doctor or a hospital immediately for a risk assessment and advice.
• it is essential to use the correct dose ofthis medication and not a higher dose than recommended by your doctor. A higher dose may decrease your pulse, cause more discomfort, drowsiness, and/or breathing difficulties. You may also feel weak or dizzy, especially when standing up, due to low blood pressure. Lying down with your feet elevated may help alleviate low blood pressure.

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

If you forgot to use Apodev

• take it when you need it again.
• do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Apodev

• contact your doctor before interrupting treatment and discuss the appropriateness of your decision with them.

If you have any other questions about the use of thismedication, ask your doctororpharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. Consult your doctor if you think this medicine is causing discomfort or if you experience any of the following side effects:

Severe side effects:

In rare cases, severe allergic reactions may occur, with symptoms such as:

• difficulty breathing or chest pressure.
• swelling of the eyelids, face, or lips.
• swelling or redness of the tongue.

Other side effects

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

• hallucinations (seeing, hearing, or feeling things that are not present), lumps under the skin at the injection site with pain, discomfort, and possibly redness and itching. To prevent these lumps from forming, it is recommended to change the injection site each time the needle is inserted.

Common (may affect up to 1 in 10 people)

• feeling or being sick, particularly when starting this medicine. Domperidone treatment should begin at least 2 days before apomorphine to prevent discomfort. If you are taking domperidone and continue to feel unwell, or if you are not taking domperidone and experience discomfort, inform your doctor or nurse as soon as possible.
• transient fatigue with each dose of apomorphine at the beginning of treatment. This usually resolves over the first few weeks of treatment.
• excessive fatigue or drowsiness.
• dizziness or vertigo.
• confusion or hallucinations.
• yawning.

Uncommon (may affect up to 1 in 100 people)

• an increased number of involuntary movements (called dyskinesia, excessive movement) or more tremors during the "on" periods (i.e., when the medicine is acting).
• patients taking levodopa may develop hemolytic anemia, an abnormal breakdown of red blood cells in the blood vessels or other parts of the body, which can turn the skin yellow and cause weakness and shortness of breath.
• skin eruptions.
• difficulty breathing.
• a decrease in blood pressure when standing, causing dizziness, vertigo, or fainting
• ulceration at the injection site.
• reduction in platelet count with an increased risk of bleeding and hematomas.
• the use of levodopa and apomorphine may affect the result of the laboratory test called the Coombs test.

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

• eosinophilia, an abnormally high count of white blood cells in the blood or tissues.

Unknown (cannot be estimated from available data)

• fainting.
• swelling of the legs, feet, or fingers of the hands.

• inability to resist the impulse, desire, or temptation to do something that may be harmful to yourself or others, which may include:
• excessive urge to gamble despite severe personal or family consequences.
• alteration or increase in sexual interest and behavior that may be of considerable concern to yourself or others, for example, increased sexual desire.
• excessive shopping or uncontrolled spending.
• binges (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 your appetite).
• aggression.
• agitation.
• headache.

Inform your doctor if you experience any of the above; they will manage or reduce the symptoms.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano:www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears on the box and onthe vial labelafter “EXP”. The expiration date is the last day of the month indicated.

Store the vial in the outer packaging to protect it from light.

Do not store at a temperature above 25°C.

Single use only.

After opening and filling the syringes with the product: physical and chemical stability has been demonstrated in use for 96hours (4days) at a temperature of 30‑35°C, if protected from light. From a microbiological standpoint, the product should be used immediately, unless the opening and handling method excludes the risk of microbial contamination. If not used immediately, storage times and conditions in use are the responsibility of the user. Dispose of any unused solution.

The solution must be inspected visually before use.Do not use this medication if you observe that the solution has turned green. Only use this medication if the solution is transparent and does not contain visible particles.

Be careful not to splash the solution or, for example, onto textiles or household surfaces, as the solution may cause green stains. Used needles and the vial must be disposed of in a sharps container.

Medications should not be disposed of through drains or in the trash. Deposit containers and unused medications at the SIGREpoint of your usual pharmacy. Ask your pharmacist how to dispose of containers and unused medications. By doing so, you will help protect the environment.

Composition of Apodev

• The active substance is apomorphine hydrochloride hemihydrate.

Each 1ml contains 5mg of apomorphine hydrochloride hemihydrate.

A vial with 20ml of solution contains 100mg of apomorphine hydrochloride hemihydrate.

• The other components (excipients) are:

• Sodium chloride.
• Sodium metabisulphite (E223).
• Hydrochloric acid to adjust the pH.
• Water for injection preparations.

Aspect of the product and contents of the package

Apodev is a solution for perfusion. The solution is transparent and practically colorless.

Apodev is supplied in glass vials with bromobutyl rubber stoppers and aluminum caps containing 20ml.

Package sizes: 1vial, 5viales or 30 (6x5) vials (grouped package).

Only some package sizes may be commercially available.

Holder of the marketing authorization and manufacturer:

Holder of the marketing authorization

Evolan Pharma AB

P.O. Box 120

182 12 Danderyd

Sweden

Manufacturer

Anfarm Hellas S.A
61st km National Road Athens-Lamia,

Schimatari Viotias, 32009

Greece

Local Representative

Vegal Farmacéutica, S.L.

Vía de las Dos Castillas 9C, portal 2, 2ºC

28224 Pozuelo de Alarcón, Madrid

Spain

This medicine is authorized in the member states of the European Economic Areawith the following names:

SwedenApomorfin PharmSwed

Denmark Apomorfin PharmSwed

NorwayApomorfin PharmSwed

IcelandApomorfin PharmSwed

NetherlandsApomorfine hydrochloride PharmSwed 5 mg/ml, oplossing voor infusie

GermanyApomorphinhydrochlorid PharmSwed 5 mg/ml Infusionslösung

United KingdomApomorphine hydrochloride 5 mg/ml solution for infusion

IrelandApomorphine hydrochloride 5 mg/ml solution for infusion

SpainApodev 5mg/ml solucion para perfusión EFG

Date of the last review of thisleaflet:September 2023

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