DACEPTON 5 mg/ml SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

Dacepton 5 mg/ml solution for infusion EFG

Apomorphine, hydrochloride hemihydrate

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

The name of your medicine is Dacepton 5mg/ml solution for infusion, and it will be referred to as Dacepton 5mg/ml throughout this leaflet.

Contents of the pack

1. What Dacepton 5 mg/ml is and what it is used for
2. What you need to know before you use Dacepton 5 mg/ml
3. How to use Dacepton 5 mg/ml
4. Possible side effects
5. Storage of Dacepton 5 mg/ml
6. Contents of the pack and other information

1. What Dacepton 5 mg/ml is and what it is used for

Apomorphine hydrochloride hemihydrate belongs to a group of medicines known as dopamine agonists. Dacepton 5 mg/ml is used to treat Parkinson's disease. Apomorphine helps to reduce the time spent in the 'off' state or immobility in people previously treated for Parkinson's disease with levodopa (another treatment for Parkinson's disease) and/or with other dopamine agonists.

Your doctor or nurse will help you recognize the signs that will tell you when you need to use your medicine.

2. What you need to know before you use Dacepton 5 mg/ml

Do not use Dacepton 5 mg/ml:

• if you are under 18 years old.
• if you have breathing difficulties or suffer from asthma.
• if you suffer from dementia or Alzheimer's disease.
• if you suffer from confusion, hallucinations, or similar problems.
• if you have liver problems.
• if you suffer from severe dyskinesia (involuntary movements) or severe dystonia (inability to move) despite taking levodopa.
• if you are allergic to apomorphine or any of the other ingredients of this medicine (listed in section 6).
• if you know that you or a family member have a heart condition known as 'long QT syndrome'. Inform your doctor.
• if you are taking ondansetron (a medicine used to treat nausea and vomiting).

Warnings and precautions

Before using Dacepton 5 mg/ml, your doctor will perform an electrocardiogram (ECG), and ask you for a list of all other medicines 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 you about other diseases you may have, especially those related to the heart. Some of the questions and additional tests may be repeated at each medical visit. If you experience symptoms that may be related to your heart, such as palpitations, fainting, or dizziness, you should inform your doctor immediately. If you have diarrhea or start using a new medicine, you should also inform your doctor.

Consult your doctor, pharmacist, or nurse before starting to use Dacepton 5 mg/ml:

• if you have kidney problems
• if you have lung problems
• if you have heart problems
• if you have low blood pressure or feel weak or dizzy when standing up
• if you are taking medicines to treat high blood pressure
• if you have nausea or vomiting
• if you have any mental disorder when starting to use Dacepton
• if you are elderly or weak
• when driving or operating machinery, as apomorphine can cause drowsiness, including sudden onset of sleep (you should not drive or operate machinery if Dacepton makes you drowsy).
• your doctor should regularly check your body if you use Dacepton with levodopa (another treatment for Parkinson's disease).

Tell your doctor if you, your family, or your caregiver notice that you have impulses or irresistible desires to behave in a way that is not usual for you and that you cannot resist the impulse, desire, or temptation to perform certain activities that could harm you or others. These are called impulse control disorders and can include behaviors such as 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 the dose.

Some patients develop symptoms of addiction that lead to a compulsive desire to consume high doses of Dacepton 5 mg/ml and other medicines used to treat Parkinson's disease.

If you are affected by any of the situations described above, inform your doctor or nurse.

Using Dacepton 5 mg/ml with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Consult your doctor or pharmacist before taking your medicine if

You are taking medicines that are known to affect the way your heart beats. This includes medicines 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.

If you are taking ondansetron (a medicine used to treat nausea and vomiting), as this may result in a severe drop in blood pressure and loss of consciousness.

If you use Dacepton 5 mg/ml with other medicines, the effect of those medicines may be altered.

This is especially true with:

• Medicines such as clozapine to treat certain mental disorders.
• Medicines to lower blood pressure.
• Other medicines for Parkinson's disease.

Your doctor will tell you if you need to adjust the dose of apomorphine or any other medicine you are using.

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

Using Dacepton 5 mg/ml with food and drink

Food and drink do not affect the way Dacepton 5 mg/ml works.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Dacepton 5 mg/ml should not be used during pregnancy unless it is strictly necessary.

It is not known if Dacepton 5 mg/ml passes into breast milk. Ask your doctor if you are breastfeeding or think you may be breastfeeding. Your doctor will explain if you should continue or stop breastfeeding or if you should continue or stop this medicine.

Driving and using machines

Dacepton 5 mg/ml can cause drowsiness and a strong desire to sleep. Do not drive or operate tools or machines if Dacepton 5 mg/ml has this effect on you.

Dacepton 5mg/ml contains sodium metabisulfite whichcan rarely cause severe allergic reactions and bronchospasm with symptoms such as rash or itching of the skin, difficulty breathing, swelling of the eyelids, face, or lips, inflammation or redness of the tongue. If you experience these side effects, go immediately to the emergency department of the nearest hospital.

Dacepton 5 mg/ml contains less than 23 mg (1 mmol) of sodium per milliliter, so it is considered essentially "sodium-free".

3. How to use Dacepton 5 mg/ml

Follow exactly the administration instructions of this medicine given by your doctor. If you are in doubt, consult your doctor or pharmacist again.

Before using Dacepton 5mg/ml, your doctor will check that you tolerate this medicine and an antiemetic medicine that you must take at the same time.

Do not use Dacepton 5 mg/ml if

• The solution has turned green.
• The solution is cloudy or you can see particles in it.

Where to inject Dacepton 5 mg/ml

Inject Dacepton 5 mg/ml into a area under the skin (subcutaneously) as indicated by your doctor or nurse.

Do not inject Dacepton 5 mg/ml into a vein.

How much to use

Both the amount of Dacepton 5 mg/ml you should use and the total time you should receive the medicine each day will depend on your personal needs. Your doctor will discuss this with you and tell you the amount of medicine you should administer.

The most suitable amount for you will be determined during your visit to the specialist.

• The average infusion dose per hour is between 1 mg and 4 mg of apomorphine hydrochloride.
• It is usually administered when you are awake and generally stopped when you go to sleep.
• The amount of apomorphine hydrochloride you receive each day should not exceed 100 mg.
• Your doctor or nurse will decide what the best dose is for you.
• The infusion site should be changed every 12 hours.

Dacepton does not need to be diluted before use. Also, it should not be mixed with any other medicine.

Dacepton 5 mg/ml is designed for continuous infusion with a mini-pump or a syringe pump. It should not be used for intermittent injections. The choice of mini-pump or syringe pump to be used, as well as the dose adjustment, will be determined by the doctor according to the patient's particular needs.

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

If you use more Dacepton 5 mg/ml 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 medicine and the amount ingested.
• It is important to administer the correct dose of Dacepton and not use more than the amount recommended by your doctor. Higher doses can reduce heart rate, cause excessive nausea, excessive drowsiness, and/or difficulty breathing. You may also feel weak or dizzy when standing up due to a drop in blood pressure. Lying down with your feet raised may help you feel better.

If you forget to use Dacepton 5 mg/ml

Administer the next dose you need. Do not use a double dose to make up for forgotten doses.

If you stop treatment with Dacepton 5 mg/ml

Do not stop treatment without consulting your doctor first and discussing whether this is or is not appropriate.

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

4. Possible side effects

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

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

• Lumps under the skin at the injection site that are painful, annoying, and may become red and itchy. To avoid getting these lumps, it is recommended to change the injection site each time the needle is inserted.
• Hallucinations (seeing, hearing, or feeling things that are not there).

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

• Nausea or vomiting, especially at the start of treatment with Dacepton 5 mg/ml. You should start taking domperidone at least 2 days before Dacepton 5 mg/ml to avoid feeling or having nausea.
• If you are taking domperidone and still feel nauseous, or if you are not taking domperidone and feel dizzy, inform your doctor or nurse as soon as possible.
• Feeling tired or excessively sleepy.
• 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, an abnormal destruction of red blood cells in the blood vessels or other parts of the body. This is an uncommon side effect that can occur in patients who also take levodopa.
• Sudden onset of sleep.
• Rash.
• Difficulty breathing.
• Ulcers at the injection site.
• Reduction of red blood cells, which can cause the skin to turn yellow and lead to weakness or shortness of breath.
• Reduction of blood platelets, which increases the risk of bleeding or bruising.

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

• An allergic reaction, such as difficulty breathing or tightness in the chest, 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 of the body.

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

• Swelling of the legs, feet, or hands.
• Fainting.
• Aggression, agitation.
• Headache.
• Inability to resist the impulse, desire, or temptation to perform an action that could be harmful to you or others, which may include:
• Strong impulse to gamble excessively, despite serious personal or family consequences.
• Alteration or increase in sexual interest and behavior, significant to you or others, for example, increased sexual impulse.
• Uncontrollable excessive shopping or spending.
• Binge eating (eating large amounts of food in a short time) or compulsive eating (eating more food than normal and more than necessary to satisfy hunger).

Reporting of side effects:

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Dacepton 5 mg/ml

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

Do not use this medicine after the expiry date which is stated on the carton and label after "EXP". The expiry date is the last day of the month shown.

Keep the vials in the outer packaging to protect them from light.

Do not refrigerate or freeze.

After opening and filling the medicine in syringes equipped with infusion devices: chemical and physical stability has been demonstrated for 7 days at 25 °C.

From a microbiological point of view, except for the fact that opening and subsequent handling were done under conditions that exclude the risk of microbial contamination, the product should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user.

Do not use this medicine if you notice that the solution has turned green. It should only be used if the solution is clear, colorless, or slightly yellowish and does not contain particles.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to your usual pharmacy. Ask your pharmacist how to dispose of containers and any unused medicines. This will help protect the environment.

Used syringes and needles should be disposed of in a puncture-proof container or other suitable container. When the container or puncture-proof container is full, hand it over to your doctor or pharmacist for safe disposal.

6. Contents of the pack and other information

Composition of Dacepton 5 mg/ml

The active ingredientis apomorphine hydrochloride hemihydrate. Each milliliter of Dacepton 5 mg/ml contains 5 mg of apomorphine hydrochloride hemihydrate.

Dacepton 5 mg/ml is presented in 20 ml vials containing 100 mg of apomorphine hydrochloride hemihydrate.

The other components (excipients) are:

• Sodium metabisulfite (E223)
• Sodium chloride
• Hydrochloric acid (for pH adjustment)
• Water for injectable preparations

Refer to section 2: Dacepton 5 mg/ml contains sodium metabisulfite (E223) and sodium chloride regarding sodium metabisulfite and sodium chloride.

Appearance of the product and packaging content

Dacepton 5 mg/ml is a perfusion solution, transparent and colorless to slightly yellowish.

Glass vials with 20 ml of perfusion solution, in boxes of 1, 5, or 30 vials.

Packaging sizes: 5 x 1, 10 x 1, 30 x 1, 2 x 5, and 6 x 5

Only some packaging sizes may be marketed.

Marketing authorization holder

EVER Neuro Pharma GmbH

A-4866 Unterach

Austria

Manufacturer

EVER Pharma Jena GmbH

Brüsseler Strasse 18

07747 Jena

Germany

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

EVER Pharma Therapeutics Spain, S.L.

C/Toledo 170

28005 Madrid

Spain

This medication is authorized in the member states of the European Economic Area and the United Kingdom (Northern Ireland), under the following names:

AT Dacepton® 5mg/ml Infusionslösung

BE Dacepton® 5 mg /ml oplossing voor infusie

BG Dacepton® 5mg/ml ?????????? ???????

CZ Dacepton® 5mg/ml Infuzní roztok

DE Dacepton® 5mg/ml Infusionslösung

DK Dacepton® 5 mg /ml infusionsvæske, opløsning

EE Dacepton® 5 mg /ml

EL Dopaceptin® 5 mg /ml Δι?λυμαγια?γχυση

ES Dacepton® 5mg/ml Solución para perfusión

FI Dacepton® 5 mg /ml infuusioneste, liuos

FR Dopaceptin® 5 mg /ml Solution pour perfusion

HU Dacepton® 5 mg /ml Oldatos infúzió

IE Dacepton® 5 mg /ml solution for infusion

IT Dacepton®

LT Dacepton® 5mg/ml Infuzinis tirpalas

LV Dacepton® 5mg/ml škidums infuzijam

NL Dacepton® 5 mg /ml oplossing voor infusie

NO Dacepton®

PL Dacepton®

PT Dacepton®

SE Dacepton® 5 mg /ml infusionsvätska, lösning

SI Dacepton® 5 mg /ml raztopina za infundiranje

SK Dacepton® 5mg/ml Infúzny roztok

UK (Northern Ireland) Dacepton® 5 mg /ml solution for infusion

Date of the last revision of this prospectus: October 2023

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