Leaflet: Information for the user

Dacepton 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.

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

The 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 in an '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 signsthat will indicatewhen you should use your medication.

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 components of this medication (listed in section 6).
• if you know that you or a family member have a heart rhythm alteration (ECG) called 'long QT interval syndrome'. Inform your doctor.
• if you are taking ondansetron (a medication for nausea and vomiting).

Warnings and precautions

Before using Dacepton 5 mg/ml, 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 necessary. They will also ask about other health conditions you may have, especially related to the heart. Some questions and additional examinations may be repeated at each medical visit. If you experience symptoms that may be related to the heart, such as palpitations, dizziness, or fainting, inform your doctor immediately. If you have diarrhea or start taking a new medication, 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 medications for high blood pressure
• if you have nausea or vomiting
• if you experience any mental disorders 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 (do not drive or operate machinery if Dacepton causes drowsiness).
• your doctor should monitor your body regularly if you use Dacepton with levodopa (another treatment for Parkinson's disease).

Inform your doctor if you, your family, or your caregiver observe that you have impulses or irresistible desires to behave in an unusual manner that you cannot resist, which may harm yourself or others. These are called impulse control disorders and may include excessive gambling, eating, or spending, abnormal sexual desire, or increased thoughts or feelings of sex. Your doctor may need to adjust or discontinue the dose.

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

If any of the situations described above affect you, inform your doctor or nurse.

Use of Dacepton 5 mg/ml with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

Consult your doctor or pharmacist before taking your medication if::

You are taking medications that are known to affect the way your heart beats. This includes medications 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 medication for nausea and vomiting), as this may result in severe low blood pressure and loss of consciousness.

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

This is especially true with:

• Medications such as clozapine for treating mental disorders.
• Medications for reducing blood pressure.
• Other medications for Parkinson's disease.

Your doctor will indicate if you need to adjust the dose of apomorphine or any other medication you are taking.

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

Use of Dacepton 5 mg/ml with food and drinks

Foods and drinks do not affect the way Dacepton 5 mg/ml works.

Pregnancy and breastfeeding

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

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

It is not known if Dacepton 5 mg/ml is transferred to breast milk. Consult your doctor if you are breastfeeding or plan to breastfeed. Your doctor will explain if you should continue or discontinue breastfeeding or if you should continue or discontinue this medication.

Driving and operating machinery

Dacepton 5 mg/ml may cause drowsiness and a strong desire to sleep. Do not drive or operate tools or machinery if Dacepton causes this effect.

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

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

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

Before using Dacepton 5mg/ml, your doctor will check that you tolerate this medication and an antiemetic medication that you must take simultaneously.

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 in an 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

The amount of Dacepton 5 mg/ml you should use and the total time you should receive the medication each day will depend on your personal needs. Your doctor will analyze this with you and tell you the amount of medication to 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.
• Normally, you will be administered when awake and generally will be interrupted when going to sleep.
• The amount of apomorphine hydrochloride you receive each day should not exceed 100 mg.
• Your doctor or nurse will decide what is the best dose for you.
• You should change the infusion site every 12 hours.

No dilution of Dacepton is necessary before use. Also, it should not be mixed with any other medication.

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

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

If more Dacepton 5 mg/ml is used than it should

• In case of overdose or accidental ingestion, consult your doctor immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.
• It is essential to administer the correct dose of Dacepton and not use more than the amount recommended by your doctor. Higher doses may 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 elevated may help you feel better.

If you forgot to use Dacepton 5 mg/ml

Administer the next dose you need. Do not use a double dose to compensate for the missed doses.

If you interrupt the treatment with Dacepton 5 mg/ml

Do not interrupt the treatment without consulting your doctor and analyzing if this is or is not suitable.

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. Consult your doctor if you think this medicine is causing discomfort or if you experience any of the following side effects:

Frequent side effects (may affect more than 1 in 10 patients):1in10patients):

• Lumps under the skin at the injection site that are painful, itchy, and may become red and itchy. To avoid having 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).

Frequent side effects (may affect up to 1 in 10 patients):

• Nausea or vomiting, especially at the beginning of treatment with Dacepton 5 mg/ml. Domperidone should be started at least 2 days before Dacepton 5 mg/ml to avoid feeling or experiencing 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.
• Fatigue or excessive drowsiness.
• Confusion or hallucinations.
• Yawning.
• Sensation of dizziness or weakness when standing up.

Rare side effects (may affect up to 1 in 100 patients):

• Increased involuntary movements or tremors during the 'on' periods.
• Autoimmune hemolytic anemia, an abnormal destruction of red blood cells in the blood vessels or other parts of the body. This is a rare side effect that may occur in patients also taking levodopa.
• Sudden sleepiness.
• Hives.
• Dyspnea.
• Ulcers at the injection site.
• Reduction of red blood cells that may cause yellow skin and cause weakness or shortness of breath.
• Reduction of platelets in the blood, which increases the risk of bleeding or hematomas.

Very rare side effects (may affect up to 1 in 1000 patients):

• 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 of the body.

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

• Swelling of the legs, feet, or fingers of the hands.
• Syncope.
• Aggression, agitation.
• Headache.
• Inability to resist the impulse, desire, or temptation to perform an action that could be harmful to yourself or others, which may include:
• Strong impulse to gamble excessively, despite severe personal or family consequences.
• Alteration or increase in sexual interest and behavior, significant to yourself or others, for example, increased libido.
• Uncontrolled excessive spending or purchases.
• 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).

Reporting of 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 prospectus. You can also report them directly through the Spanish System of 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 box and on the label after “CAD”. The expiration date is the last day of the month indicated.

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

Do not refrigerate or freeze.

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

From a microbiological point of view, except that the opening and subsequent handling have been made in conditions that exclude the risk of microbial contamination, the product must be used immediately. If not used immediately, the times and conditions of storage in use are the responsibility of the user.

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

Medications should not be thrown away through drains or in the trash. Dispose of the containers and medications that you do not need at the SIGRE collection point of your usual pharmacy. Ask your pharmacist how to dispose of the containers and medications that you do not need. In this way, you will help protect the environment.

The used syringes and needles must be disposed of in a sharp objects container or other suitable container. When the container for sharp objects is full, hand it over to your doctor or pharmacist for safe disposal.

Composition of Dacepton 5 mg/ml

Theactive 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 vials of 20 ml containing 100 mg of apomorphine hydrochloride hemihydrate.

The other components (excipients) are:

-Sodium metabisulphite (E223)

-Sodium chloride

-Hydrochloric acid (for pH adjustment)

-Water for injection

See section 2: Dacepton 5 mg/ml contains sodium metabisulphite and sodium chloride with regard to sodium metabisulphite and sodium chloride.

Appearance of the product and contents of the pack

Dacepton 5 mg/ml is a transparent and colourless to slightly yellowish infusion solution.

Glass vials of 20 ml infusion solution, in packs of 1.5 or 30 vials.

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

Only some pack sizes may be marketed.

Marketing authorisation holder

EVER Neuro Pharma GmbH

A-4866 Unterach

Austria

Manufacturer responsible

EVER Pharma Jena GmbH

Brüsseler Strasse 18

07747 Jena

Germany

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

EVER Pharma Therapeutics Spain, S.L.

C/Toledo 170

28005Madrid

Spain

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:

ATDacepton®5mg/ml Infusionslösung

BEDacepton®5 mg /ml oplossing voor infusie

BGDacepton®5mg/ml ?????????? ???????

CZDacepton®5mg/ml Infuzní roztok

DEDacepton®5mg/ml Infusionslösung

DKDacepton®5 mg /ml infusionsvæske, opløsning

EEDacepton®5 mg /ml

ELDopaceptin®5 mg /mlΔι?λυμαγια?γχυση

ESDacepton®5mg/ml Solución para perfusión

FIDacepton®5 mg /ml infuusioneste, liuos

FRDopaceptin®5 mg /ml Solution pour perfusion

HUDacepton®5 mg /ml Oldatos infúzió

IEDacepton®5 mg /ml solution for infusion

ITDacepton®

LTDacepton®5mg/ml Infuzinis tirpalas

LVDacepton®5mg/ml škidums infuzijam

NLDacepton®5 mg /ml oplossing voor infusie

NODacepton®

PLDacepton®

PTDacepton®

SEDacepton®5 mg /ml infusionsvätska, lösning

SIDacepton®5 mg /ml raztopina za infundiranje

SKDacepton®5mg/ml Infúzny roztok

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

Last update of the summary of product characteristics: October 2023

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