Package Leaflet: Information for the user

Dacepton 10 mg/ml injectable solution in EFG cartridge

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, pharmacist or nurse.

-This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

The name of your medicine is Dacepton 10 mg/ml injectable solution in EFG cartridge, and it will be referred to as Dacepton 10 mg/ml cartridge throughout this leaflet.

1. What Dacepton 10 mg/ml cartridge is and what it is used for

2. What you need to know before you start using Dacepton 10 mg/ml cartridge

3. How to use Dacepton 10 mg/ml cartridge

4. Possible side effects

5. Storage of Dacepton 10 mg/ml cartridge

6. Contents of the pack and additional information

Dacepton contains an injectable solution of apomorphine. It is injected under the skin (subcutaneously) using only the D-mine Pen device intended for this purpose. The active ingredient of Dacepton is apomorphine hydrochloride hemihydrate. Each milliliter of solution contains 10 mg of apomorphine hydrochloride hemihydrate.

Apomorphine hydrochloride hemihydrate belongs to a group of medicines known as dopamine agonists. Dacepton is used to treat Parkinson's disease. Apomorphine helps to reduce the time in the 'off' state or immobility of 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 indicate when you should use your medication.

Despite its name, apomorphine does not contain morphine.

Do not use Dacepton 10 mg/ml in cartridge:

-if you are allergic to apomorphine or any of the other ingredients of this medicine (listed in section 6).

-if you are under 18 years old.

-if you have breathing difficulties.

-if you have dementia or Alzheimer's disease.

-if you have any mental illness with symptoms such as hallucinations, delusions, confused thoughts, loss of contact with reality.

-if you have liver problems.

-if you have severe dyskinesia (involuntary movements) or severe dystonia (inability to move) despite taking levodopa.

-if you know that you or a family member has a heart rhythm disorder called 'long QT interval syndrome'. Inform your doctor.

-if you are taking ondansetron (medicine to treat nausea and vomiting).

Warnings and precautions

Before using Dacepton, your doctor will perform an ECG (electrocardiogram), and ask for a list of all other medicines you are taking. This ECG will be repeated in the first days of treatment, and at any time your doctor considers necessary. They will also ask about other diseases you may have, especially related to the heart. Some of the questions and additional investigations may be repeated at each medical visit. If you have symptoms that may be related to the heart, such as palpitations, fainting, or dizziness, you must inform your doctor immediately. If you have diarrhea or start taking a new medicine, you must also inform your doctor.

Consult your doctor, pharmacist, or nurse before starting to use Dacepton:

-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 feel dizzy

-if Parkinson's disease causes any mental problems such as hallucinations and confusion.

-if you are elderly or weak

Inform your doctor if you, your family, or your caregiver observe that you have impulses or irresistible desires to behave in an unusual way, and 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 may include behaviors such as excessive gambling, eating, or spending, abnormally high sexual desire, or an increase in sexual thoughts or feelings.Your doctor may need to adjust or stop the dose.

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

Children and adolescents

Dacepton should not be used in children and adolescents under 18 years old.

Use of Dacepton 10 mg/ml in cartridge with other medicines

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

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 (medicine to treat nausea and vomiting), as this may result in a severe drop in blood pressure and loss of consciousness.

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

This occurs especially with:

- Medicines such as clozapine to treat some mental disorders.

- Medicines to reduce 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 taking.

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

Use of Dacepton 10 mg/ml in cartridge with food and drinks

Foods and drinks do not affect the way Dacepton works.

Pregnancy, breastfeeding, and fertility

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

Dacepton should not be used during pregnancy unless strictly necessary.

It is not known if Dacepton 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 stop breastfeeding or if you should continue or stop this medicine.

Driving and operating machines

Dacepton may cause drowsiness and a strong desire to sleep. Do not drive or operate tools or machines if Dacepton causes this effect.

Dacepton 10 mg/ml in cartridge contains sodium metabisulfite

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

This medicine contains less than 23 mg (1 mmol) of sodium per 10 ml; it is 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, your doctor will verify that you tolerate this medication and an antiemetic medication that you must take simultaneously.

You must take domperidone for at least 2 days before starting with Dacepton 10 mg/ml to avoid nausea or feeling dizzy.

DO NOT use Dacepton 10 mg/ml in cartridge if

-The solution has turned green.

-The solution is cloudy or you can see particles in it.

How much to use

The amount of Dacepton you should use and the number of daily injections needed will depend on your personal needs. Your doctor will analyze this with you and tell you the amount of medication to administer and how often.

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

-The usual daily dose varies between 3 mg and 30 mg.

-You may need up to 100 mg per day.

-You will usually need between 1 and 10 injections per day.

-Each individual injection should not contain more than 10 mg.

The D-mine Pen plunger needed for the application of Dacepton 10 mg/ml in cartridge is not suitable for patients who need doses greater than 6 mg per injection.

For these patients, other products must be used.

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

• Your doctor will indicate the dose of Dacepton you should use and how often. They will also inform you how to change the dose of Dacepton, if necessary. Do not change your Dacepton dose or use it more frequently unless your doctor tells you to.
• Your doctor will provide you and your caregivers with detailed instructions on the preparation and administration of the doses, paying special attention to the correct use of the required administration pen.

Before using Dacepton 10 mg/ml in cartridge

Note: This package does not include the pen or needles of the pen.

Dacepton 10 mg/ml in cartridge is designed to be administered only with the "D-minePen" intended for this purpose and disposable needles, as specified in the Pen Usage Instructions.

Description of the pen

• Always use a new needle for each injection to prevent contamination.
• Needles and pens should not be shared.

Before using Dacepton 10 mg/ml in cartridge, examine your pen and the pen manual to familiarize yourself with its correct handling.

• If your pen is damaged or does not function correctly (due to mechanical defects), read the Pen Usage Instructions.

Where and how to inject Dacepton 10 mg/ml in cartridge

• First, wash your hands.
• Before using the pen, you will need surgical wipes and a needle with its protective cone.
• Follow the instructions in your pen manual.

Preparation of the pen / cartridge change

Remove the pen from its package and remove the cap.

Remove the cartridge cover by turning it in the direction of the needles.

Insert the new cartridge into the cover.

Push the threaded rod until it reaches the bottom. This is best done with the tip of your finger.

Insert the cartridge cover into the casing and turn it in the opposite direction of the needles to secure it.

Adjustment of the cartridge needle

Follow the pen needle usage instructions. Remove the protective sheet.

Insert / turn the pen needle into the cartridge cover.

Remove the outer protective cover of the needle. Store it to safely dispose of the needle after use.

Remove and dispose of the inner protective cover of the needle.

Control of priming / function

All air from the cartridge must be removed before use. Mark the dose forward by turning the dosing wheel. Check the marked dose by looking through the vertical window from above, and not at an angle, so that the symbol“?“is clearly visible. This is called "priming" and is important to ensure that you receive a complete dose when using the pen.

To control the function, hold the pen pointing upwards and gently tap the cartridge cover, so that the air rises upwards.

Push the button.

A few drops will come out of the pen needle. If no drops come out, repeat this step.

Adjustment of the dose

Mark your dose by turning the dosing wheel in the direction of the needles. Correct your dose by turning in the opposite direction of the needles.

Injection

• With the help of a surgical wipe, clean the area of skin where you plan to inject the medication and the surrounding area.
• Inject Dacepton into the central area of your waist (abdomen) or in the outer part of your thigh, below the skin (subcutaneously) as indicated by your doctor or nurse.

To inject, push the button until the end. Keep the button pressed during the medication discharge. Once the medication has been completely discharged, wait 6 seconds and then remove the pen needle slowly. You can keep the button pressed or release it during the 6 seconds. Check in the window that the "0,0" position is visible to confirm that the complete dose has been administered.

• Change the injection site each time you use Dacepton 10 mg/ml in cartridge. This will reduce the likelihood of a skin reaction at the site where you injected Dacepton. Do not inject Dacepton into an area of skin that is painful, red, infected, or damaged.

• Never inject directly into a vein (intravenously) or muscle (intramuscularly).

After using Dacepton 10 mg/ml in cartridge

Dispose of and discard the needle after each injection (to see how to safely dispose of it, see section 5).

Safe disposal of the pen needle after each injection

Place the outer protective cover carefully over the pen needle.

Remove the pen needle by turning the outer casing in the direction of the needles and dispose of it safely.

Optional:

Place the outer protective cover of the pen needle in the corresponding hole of the case. The opening of the cover should be pointing upwards. Carefully insert the pen (with the needle) into the opening of the case. Without touching the cover, push firmly downwards and turn in the opposite direction of the needles to remove the pen needle.

Carefully close the pen cap after each use.

• Leave the cartridge in the pen.
• You can use a new cartridge for a maximum of 15 days (for more information, see section 5 "Storage of Dacepton 10 mg/ml in cartridge").
• If there is not enough solution left for your next dose, dispose of and discard the cartridge.
• Dispose of the needle safely, as described in the usage instructions for your pen.

If you use more Dacepton 10 mg/ml in cartridge than you should

-Inform your doctor or contact the emergency department of the nearest hospital immediately.

-You may notice that your heart beats slower, excessive dizziness, excessive somnolence, and/or difficulty breathing. You may also feel weak or dizzy, especially when standing up, due to low blood pressure. Lying down with your feet elevated may help combat low blood pressure.

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

If you forgot to use Dacepton 10 mg/ml in cartridge

Administer the next dose when needed. Do not use a double dose to compensate for missed doses.

If you interrupt treatment with Dacepton 10 mg/ml in cartridge

Do not interrupt treatment with Dacepton without consulting your doctor first.

If you have any other questions 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.

If you experience an allergic reaction,stop using Dacepton 10 mg/ml in cartridge and contact your doctor or the nearest hospital emergency serviceimmediately.

The signs of an allergic reaction may include:

-Hives

-Difficulty breathing or

-Chest tightness,

-Swelling of the eyelids, face, or lips,

-Inflammation or redness of the throat or tongue.

Dacepton may sometimes cause the following side effects.

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

-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)

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

-Nausea or vomiting, especially at the beginning. 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.

-Excessive fatigue or drowsiness.

-Confusion or hallucinations.

-Yawning.

-Sensation of dizziness or mild dizziness when standing up

Uncommon 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 an uncommon side effect that may occur in patients who are also taking levodopa.

-Sudden sleepiness.

-Hives.

-Difficulty breathing.

-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.

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

-Allergic reaction

-Eosinophilia, an abnormally high number of white blood cells in the blood or in the body tissues.

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

-Swelling of the legs, feet, or fingers.

-Fainting

- Aggression, agitation

- Headache

-Inability to resist the impulse, desire, or temptation to perform an action that could be harmful to you or to 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 you or to others, for example, increased libido.
• Uncontrollable excessive spending or buying.
• Binge eating (eating large amounts of food in a short space of time) or compulsive eating (eating more food than normal and more than needed to satisfy hunger).

Inform your doctor if any of these behaviors occur; they will instruct you on how to control or reduce the symptoms.

Reporting 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 it directly to the Spanish System for the 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.

Do not store at a temperature above 25°C.

Do not refrigerate or freeze.

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

Store in the same conditions once opened and between openings.

When starting to use a new cartridge, it may be used for up to 15 days. Do not reuse the cartridge after this period of time. Use a new cartridge.

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 disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point of your usual pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need. This way, you will be helping to protect the environment.

Composition of Dacepton 5 mg/ml

Theactive principleis 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 (E223) 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 perfusion solution, transparent and colourless to slightly yellowish.

Glass vials of 20 ml of perfusion solution, in boxes 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 about 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 and 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 this leaflet: October 2023

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