Dacepton

Package Leaflet: Information for the User

Dacepton, 10 mg/ml, Solution for Injection in a Cartridge

Apomorphine Hydrochloride Hemihydrate

Read the Package Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet, as you may need to read it again.
• In case of any doubts, consult a doctor, nurse, or pharmacist.
• This medication has been prescribed specifically for you. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any not listed in this package leaflet, they should inform their doctor, nurse, or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Dacepton and What is it Used For
• 2. Important Information Before Using Dacepton
• 3. How to Use Dacepton
• 4. Possible Side Effects
• 5. How to Store Dacepton
• 6. Contents of the Package and Other Information

1. What is Dacepton and What is it Used For

Dacepton contains apomorphine in the form of a solution for injection. The medication is administered subcutaneously, only using the dedicated D-mine Pen injector.

The active substance of Dacepton is apomorphine hydrochloride hemihydrate. Each milliliter of the solution contains 10 mg of apomorphine hydrochloride hemihydrate.

Apomorphine hydrochloride belongs to a group of medications known as dopamine agonists. Dacepton is used to treat Parkinson's disease. Apomorphine helps reduce the time spent in the "off" state, i.e., immobility, in patients who have previously been treated with levodopa (another medication used to treat Parkinson's disease) and/or other dopamine agonists.

The doctor or nurse will help the patient recognize the symptoms indicating the need to use the medication.

Despite its name, apomorphine does not contain morphine.

2. Important Information Before Using Dacepton

When Not to Use Dacepton

• If the patient is allergic to apomorphine or any other component of the medication (listed in section 6);
• If the patient is under 18 years of age;
• If the patient has breathing difficulties;
• If the patient has dementia or Alzheimer's disease;
• If the patient has a mental illness with symptoms such as hallucinations, delusions, unusual thoughts, or loss of contact with reality;
• If the patient has liver disease;
• If the patient experiences severe dyskinesia (involuntary movements) or severe dystonia (inability to perform movements), despite taking levodopa;
• If it is known that the patient or a family member has abnormalities in the ECG image (long QT interval syndrome). The doctor should be informed;
• If the patient is taking ondansetron (a medication used to treat nausea and vomiting).

Warnings and Precautions

Before using Dacepton, the doctor will perform an ECG (electrocardiogram) and ask about other medications the patient is currently taking. The ECG will be repeated on the first day of treatment and at any other time during treatment if the doctor deems it necessary. The doctor will ask questions about the patient's medical history, especially heart conditions. Some questions and tests may be repeated at each patient visit. If the patient experiences heart-related symptoms, such as palpitations, fainting, or feeling like they are about to faint, they should immediately inform their doctor. The patient should also immediately inform their doctor if they experience diarrhea or start taking any new medication.

• If the patient has kidney disease;
• If the patient has lung disease;
• If the patient has heart disease;
• If the patient has low blood pressure or feels weak and dizzy when standing up;
• If the patient is taking medications for high blood pressure;
• If the patient has nausea or vomiting;
• If the patient with Parkinson's disease experiences psychiatric disturbances, such as hallucinations and disorientation;
• If the patient is elderly or weakened.

The patient should inform their doctor if they or a family member/caregiver notice the occurrence of impulses or a desire to behave in ways that are not typical and the patient cannot resist the impulse, need, or temptation to engage in behavior that may be harmful to themselves or their environment. These symptoms are called impulse control disorders and may include behaviors such as pathological gambling, excessive eating or spending money, unusually increased sexual drive, or increased interest in sexual activities. The doctor may consider it necessary to change the dose of the medication or stop treatment.

In some patients, symptoms similar to addiction may occur, involving the use of large amounts of Dacepton and other medications used to treat Parkinson's disease.

Children and Adolescents

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

Dacepton and Other Medications

The patient should tell their doctor or pharmacist about all medications they are currently taking or plan to take.

Before Using the Medication, Consult a Doctor or Pharmacist;

If the patient is taking medications known to affect heart function, such as those used to treat arrhythmias (e.g., quinidine and amiodarone), depression (including tricyclic antidepressants, e.g., amitriptyline and imipramine), and bacterial infections (macrolide antibiotics, e.g., erythromycin, azithromycin, and clarithromycin) and domperidone.

If the patient is taking ondansetron (a medication used to treat nausea and vomiting), as this may lead to severe hypotension and loss of consciousness.

If the patient is taking Dacepton and other medications, it may affect the action of these medications. This is especially important in the case of:

• Medications such as clozapine, used to treat certain mental disorders;
• Medications that lower blood pressure;
• Other medications used to treat Parkinson's disease.

The doctor will inform the patient if it is necessary to change the dose of apomorphine or other medications being taken.

If the patient is taking levodopa (another medication used to treat Parkinson's disease) and apomorphine, the doctor should regularly monitor blood test results.

Using Dacepton with Food and Drink

Food and drink do not affect the action of Dacepton.

Pregnancy and Breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor, nurse, or pharmacist before using this medication.

Dacepton should not be used in pregnant women unless absolutely necessary.

It is not known whether Dacepton passes into breast milk. If the patient is breastfeeding or plans to breastfeed, they should discuss this with their doctor. The doctor will inform the patient whether to continue breastfeeding, stop breastfeeding and continue taking the medication, or stop taking the medication.

Driving and Operating Machines

Dacepton may cause drowsiness and a strong need to sleep. The patient should not drive vehicles or operate any tools or machines if Dacepton affects them in this way.

Dacepton Contains Sodium Metabisulfite

Sodium metabisulfite can rarely cause allergic reactions with symptoms such as rash or itching of the skin, difficulty breathing, swelling of the eyelids, face, or lips, swelling or redness of the tongue.

If such side effects occur, the patient should go to the emergency department of the nearest hospital.

Dacepton contains less than 1 mmol of sodium (23 mg) per 10 ml, which means the medication is considered "sodium-free".

3. How to Use Dacepton

This medication should always be used as directed by the doctor. In case of doubts, the patient should consult their doctor, nurse, or pharmacist.

Before using Dacepton, the doctor will ensure that the patient tolerates the medication and the anti-emetic medication that must be taken at the same time.

To prevent nausea and vomiting, the patient should start taking a medication containing domperidone at least 2 days before taking Dacepton.

Do Not Use Dacepton If

• The solution has changed color to green.
• The solution is cloudy or contains solid particles.

Recommended Dose:

The amount of Dacepton to be used and the number of injections per day depend on the individual needs of the patient. The doctor will discuss this with the patient and inform them about the doses and frequency of administration.

The optimal dose for the patient will be determined during a visit to a specialized clinic.

• The usual dose is between 3 mg and 30 mg.
• The patient may require a dose of up to 100 mg per day.
• Usually, the patient will require 1 to 10 injections per day.
• A single injection should not contain more than 10 mg.

The D-mine Pen injector used to administer Dacepton in the form of a solution for injection in a cartridge is not suitable for patients who require a dose greater than 6 mg per injection. Such patients should use other medications.

There is no need to dilute Dacepton before administration. It should not be mixed with other medications.

• The doctor will tell the patient what dose to use and how often to use Dacepton. The doctor will also tell the patient how to change the dose if necessary. The patient should not change the dose of Dacepton or use it more frequently without consulting their doctor.
• The patient and their caregiver will receive detailed instructions on how to prepare and administer the medication, with particular attention to the proper use of the dedicated injector.

Before Using Dacepton

Note: This packaging does not include an injector or needles.

Dacepton in the injector is intended for use only with the D-mine Pen injector and needles for single use, as described in the Injector Instructions.

• D-mine Pen and single-use needles, as described in the Injector Instructions.

Injector Description

• Always use a new needle for each injection to prevent contamination.
• Do not pass the needles and injector to other people.
• Before administering Dacepton, familiarize yourself with the injector and its Instructions for Use, so that you can proceed correctly.
• If the injector is damaged or does not work properly (due to a mechanical defect), refer to the information in the Injector Instructions.

Where and How to Inject Dacepton

• Wash your hands.
• Before using the injector, prepare surgical swabs and one needle with a protective cap.
• Follow the Injector Instructions.

Preparing the Injector / Replacing the Cartridge

Remove the injector from the packaging and remove the protective cap.

Remove the cartridge cap by turning it clockwise.

Insert a new cartridge into the injector.

Push the threaded rod to the end, preferably by pressing the thumb on the collar.

Insert the cartridge sleeve into the body and lock it by turning it counterclockwise.

Attaching the Injector Needle

Follow the instructions for using the needle. Remove the protective foil.

Click / attach the needle to the injector body.

Remove the outer protective cap from the needle. Keep it for safe disposal of the needle after injection.

Remove and discard the inner protective cap from the needle.

Arming and Checking the Function

Before use, remove any air from the cartridge. Set the test dose by turning the knob. Check the dose setting by looking straight down at the display window, not at an angle, and the symbol " " must be clearly visible. This step is called arming and is important because it allows you to ensure that the full dose of the medication will be administered after using the injector.

To check the function of the injector, hold it upright and gently tap the cartridge holder so that any air bubbles rise to the top.

Press the plunger.

A few drops of the medication will be released from the needle. If this does not happen, repeat the previous step.

Setting the Dose

Set the target dose by turning the knob clockwise. Adjust the dose by turning the knob counterclockwise.

Injecting the Medication

• Clean the skin at the planned injection site and surrounding area with a surgical swab.
• Dacepton should be injected into the abdominal area (stomach) or the outer surface of the thigh, subcutaneously, as shown by the doctor or nurse.

To perform the injection, press the plunger all the way down. Keep the plunger fully pressed while injecting the medication. After administering the full dose, wait 6 seconds, then slowly withdraw the needle. During the 6 seconds of waiting, the plunger may be pressed or released. To ensure that the full dose has been administered, check that the display window shows "0.0".

• Each time, change the injection site of Dacepton. This will reduce the risk of skin reactions at the injection site. Do not inject Dacepton into an area of skin that is painful, red, infected, or damaged.
• Never inject Dacepton directly into a vein (intravenously) or into a muscle (intramuscularly).

After Using Dacepton

After each injection, remove and dispose of the needle (follow the safe disposal procedure, see section 5).

Removing the Injector Needle After Each Injection

Carefully put the outer protective cap back on the needle.

Twist the outer protective cap of the needle clockwise and safely remove the needle.

Alternatively:

Place the outer protective cap of the needle in the appropriate compartment of the supplied box. The opening of the outer protective cap should face upwards. Carefully insert the needle (attached to the injector) into the opening of the cap. Without touching the cap, firmly press and twist the injector counterclockwise, which will detach the needle.

After each use of the injector, put the cap back on.

• Leave the cartridge with the medication in the injector.
• A new cartridge with the medication can be used for up to 15 days (see section 5 for more information).
• If the amount of solution is too small to administer the next dose, the cartridge should be removed and discarded.
• The needle should be removed safely, as described in the Injector Instructions.

Using a Higher Than Recommended Dose of Dacepton

• Immediately contact a doctor or the emergency department of the nearest hospital.
• Taking too much of the medication may cause slow heart rate, increased nausea, excessive drowsiness, and/or breathing difficulties. Due to low blood pressure, fainting or dizziness may also occur, especially when standing up. Lying down with elevated legs may help.

Missing a Dose of Dacepton

Take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

Stopping the Use of Dacepton

Do not stop using Dacepton without first consulting a doctor.

In case of any further doubts about the use of this medication, consult a doctor, nurse, or pharmacist.

4. Possible Side Effects

Like all medications, Dacepton can cause side effects, although not everybody gets them.

If an allergic reaction occurs, stoptaking Dacepton and immediatelycontact a doctor or the emergency department of the nearest hospital.

Symptoms of an allergic reaction may include:

• rash,
• difficulty breathing, or
• feeling of tightness in the chest,
• swelling of the eyelids, face, or lips,
• swelling or redness of the throat or tongue.

Dacepton may sometimes cause the following side effects:

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

• Subcutaneous nodules at the injection site, which are painful, troublesome, and may be red and itchy. To avoid these nodules, 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 (may affect up to 1 in 10 people):

• Nausea or vomiting, especially at the beginning of Dacepton treatment. If the patient is taking domperidone and still experiences nausea or vomiting, or if they are not taking domperidone and experience nausea or vomiting, they should inform their doctor or nurse as soon as possible.
• Feeling of tiredness or excessive drowsiness.
• Confusion or hallucinations.
• Yawning.
• Dizziness or lightheadedness when standing up.

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

• Increased involuntary movements or increased tremors during "on" periods.
• Hemolytic anemia, abnormal breakdown 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 are also taking levodopa.
• Sudden sleepiness.
• Rash.
• Breathing difficulties.
• Ulcers at the injection site.
• Decreased red blood cell count, which may cause pale yellow skin and weakness or shortness of breath.
• Decreased platelet count, which may increase the risk of bleeding or bruising.

Rare (may affect up to 1 in 1000 people):

• Allergic reaction.
• Eosinophilia, an abnormally high number of white blood cells in the blood or other tissues.

Frequency not known (frequency cannot be estimated from the available data):

• Swelling of the feet, ankles, or hands.
• Fainting.
• Aggression, agitation.
• Headache.
• Inability to resist an impulse, need, or temptation to engage in behavior that may be harmful to the patient or their environment, including:

The patient should tell their doctor if they experience any of these behaviors. The doctor will help them decide what to do or how to reduce the symptoms.

Reporting Side Effects

If side effects occur, including any not listed in this package leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:

Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309,

Website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

Reporting side effects will help gather more information on the safety of the medication.

5. How to Store Dacepton

Store the medication out of sight and reach of children.

Do not use this medication after the expiration date stated on the carton and label after the abbreviation: EXP. The expiration date refers to the last day of the specified month.

Do not store above 25°C.

Do not store in the refrigerator or freeze.

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

The storage conditions are the same after opening and during the period between taking consecutive doses.

If the patient has started using a new cartridge with the medication, it can be used for up to 15 days.

After this time, do not reuse the cartridge with the medication. Use a new cartridge.

Do not use the medication if the solution has changed color to green. The medication can only be used if the solution is clear, colorless to yellowish, and does not contain solid particles.

Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the Package and Other Information

What Dacepton Contains

The active substance of Dacepton is apomorphine hydrochloride hemihydrate. Each milliliter of Dacepton contains 10 mg of apomorphine hydrochloride hemihydrate.

Dacepton is available in 3 ml cartridges containing 30 mg of apomorphine hydrochloride hemihydrate.

The other ingredients are:

• sodium metabisulfite (E 223)
• hydrochloric acid (to adjust pH)
• sodium hydroxide (to adjust pH)
• water for injections

Information about sodium metabisulfite can be found in the "Dacepton contains sodium metabisulfite" section in point 2.

What Dacepton Looks Like and What the Package Contains

Dacepton is a clear, colorless to yellowish solution for injection, without solid particles, supplied in cartridges made of colorless glass type I, with a bromobutyl rubber stopper, an aluminum flip-off cap, and a bromobutyl rubber/synthetic polyisoprene seal, placed on a plastic tray in a carton.

Each cartridge contains 3 ml of solution for injection. The carton contains 5 cartridges.

Marketing Authorization Holder

EVER Neuro Pharma GmbH

Oberburgau 3

4866 Unterach am Attersee

Austria

Manufacturers

• 1. EVER Neuro Pharma GmbH, Oberburgau 3, 4866 Unterach am Attersee, Austria
• 2. EVER Pharma Jena GmbH, Otto-Schott-Str. 15, Jena 07745, Germany
• 3. EVER Pharma Jena GmbH, Brüsseler Str. 18, Jena 07747, Germany

This Medication is Authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) Under the Following Names:

Austria

Dacepton 10 mg/ml Injektionslösung in einer Patrone

Belgium

Dacepton 10 mg/ml oplossing voor injectie in een patroon

Bulgaria

Дацептон 10 mg/ml инжекционен разтвор в патрон

Czech Republic

Dacepton

Germany

Dacepton 10 mg/ml Injektionslösung in einer Patrone

Denmark

Dacepton

Spain

Dacepton 10 mg/ml solución inyectable en cartucho EFG

Finland

Dacepton 10 mg/ml injektioneste, liuos, sylinteriampulli

France

Dopaceptin 10 mg/ml Solution injectable en cartouche

Greece

Dopaceptin 10 mg/ml ενέσιμο διάλυμα σε φυσίγγιο

Croatia

Dacepton 10 mg/ml otopina za injekciju u ulošku

Hungary

Dacepton 10 mg/ml oldatos injekció patronban

Ireland

Dacepton 10 mg/ml solution for injection in cartridge

Italy

Dopaceptin 10 mg/ml soluzione iniettabile in cartuccia

Luxembourg

Dacepton 10 mg/ml Solution injectable en cartouche

Netherlands

Dacepton 10 mg/ml oplossing voor injectie in een patroon

Norway

Dacepton

Poland

Dacepton 10 mg/ml roztwór do wstrzykiwań we wkładzie

Portugal

Dacepton 10mg/ml solução injetável em cartucho

Romania

Dacepton 10 mg/ml soluţie injectabilă în cartuş

Sweden

Dacepton 10 mg/ml injektionsvätska, lösning i cylinderampull

Slovenia

Dacepton 10 mg/ml raztopina za injiciranje v vložku

Slovakia

Dacepton 10mg/ml Injekčný roztok v náplni

United Kingdom (Northern Ireland)

Dacepton 10 mg/ml solution for injection in cartridge

Date of Last Revision of the Package Leaflet:10.2023