Dacepton

Leaflet attached to the packaging: information for the user

Dacepton, 5 mg/ml, solution for infusion

Apomorphine hydrochloride hemihydrate

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

The full name of this medicine is Dacepton, 5 mg/ml, solution for infusion - in the leaflet, the name Dacepton will be used.

Table of contents of the 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 packaging and other information

1. What is Dacepton and what is it used for

Apomorphine hydrochloride belongs to a group of medicines known as dopamine agonists. Dacepton is used to treat Parkinson's disease. Apomorphine helps to shorten the time spent in the "off" state, i.e. immobility in people who have previously been treated for Parkinson's disease with levodopa (another medicine 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 medicine.

2. Important information before using Dacepton

When not to use Dacepton

• if the patient is under 18 years old;
• if the patient has breathing difficulties or asthma;
• if the patient has dementia or Alzheimer's disease;
• if the patient has thinking disorders, hallucinations, delusions or other similar disorders;
• if the patient has liver disorders;
• if the patient has severe dyskinesia (involuntary movements) or severe dystonia (inability to perform movements) despite taking levodopa;
• if the patient is allergic to apomorphine or any of the other ingredients of this medicine (listed in section 6);
• 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 medicine used to treat nausea and vomiting).

Warnings and precautions

Before using Dacepton, the doctor will perform an ECG (electrocardiogram) and ask the patient what other medicines they are currently taking. The ECG examination will be repeated on the first day of treatment and then at any time during treatment if the doctor deems it necessary. The doctor will ask questions about the patient's diseases, especially heart diseases. Some questions and examinations may be repeated at each of the patient's visits. If the patient experiences symptoms related to the heart, such as palpitations, fainting or feeling like they are about to faint, they should immediately tell their doctor. They should also immediately inform their doctor if they experience diarrhea or start taking any new medicine. Before starting to use Dacepton, the patient should discuss it with their doctor, pharmacist or nurse:

• if the patient has kidney disorders;
• if the patient has lung disorders;
• if the patient has heart disorders;
• if the patient has low blood pressure or feels weak and dizzy when standing up;
• if the patient is taking medicines for high blood pressure;
• if the patient has nausea or vomiting;
• if the patient has experienced mental disorders after starting treatment with Dacepton;
• if the patient is elderly or weakened;
• if the patient drives vehicles or operates machines, as apomorphine may cause drowsiness and sudden episodes of uncontrollable drowsiness (the patient should not drive vehicles or operate machines if Dacepton causes drowsiness);
• the doctor will regularly examine the patient if they are taking Dacepton together with levodopa (another medicine used to treat Parkinson's disease).

The patient should tell their doctor if they, a family member or caregiver notice that the patient has an impulse or desire to behave in an unusual way and if the patient cannot resist the impulse, urge or temptation to perform certain actions that may be harmful to them or others. These behaviors are referred to as impulse control disorders and may include compulsive gambling, uncontrolled overeating or spending money, excessive sexual desire or increased sexual thoughts and feelings. The doctor may adjust the dose or stop the patient's use of the medicine. In some patients, symptoms similar to addiction may appear, leading to a desire to take large doses of Dacepton and other medicines used to treat Parkinson's disease. If any of these situations occur to the patient, they should inform their doctor or nurse.

Dacepton and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those available without a prescription. Before using the medicine, the patient should consult their doctor or pharmacist: if they are taking medicines that are known to affect the heart, 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 medicine used to treat nausea and vomiting), as this may lead to a severe decrease in blood pressure and loss of consciousness. If the patient is taking Dacepton and other medicines, it may change the effect of these medicines. This is especially important in the case of:

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

The doctor will inform the patient if it is necessary to change the dose of apomorphine or other medicines being taken. If the patient is taking levodopa (another medicine used to treat Parkinson's disease) and apomorphine, the doctor should regularly check the results of blood tests.

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 their doctor or pharmacist before using this medicine. Dacepton should not be used in pregnant women unless it is 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 or to stop/continue taking the medicine/stop it.

Driving and using machines

Dacepton may cause drowsiness and a strong need to sleep. The patient should not drive vehicles or operate machines if Dacepton affects them in this way. Dacepton contains sodium metabisulfiteDacepton contains sodium metabisulfite, which in rare cases can 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 3.4 mg of sodium per 1 ml. This should be taken into account in patients controlling their sodium intake.

3. How to use Dacepton

This medicine should always be used as directed by the doctor. If the patient has any doubts, they should consult their doctor, nurse or pharmacist. Before using Dacepton, the doctor will make sure that the patient tolerates this medicine and the anti-emetic medicine that must be taken at the same time.

When not to use Dacepton

• The solution has changed color to green.
• The solution is cloudy or particles are visible.

Where to inject Dacepton

Dacepton should be injected under the skin (subcutaneously), as shown by the doctor or nurse.

Do not inject Dacepton into a vein

Dose of the medicine

The amount of Dacepton to be used and the required treatment time during the day depend on the individual needs of the patient. The doctor will discuss this with the patient and inform them of the dose of the medicine to be administered. The optimal dose for the patient will be determined during a visit to a specialist clinic.

• The usual dose of continuous infusion is from 1 mg to 4 mg of apomorphine hydrochloride per hour.
• The dose is usually administered during wakefulness and discontinued before going to sleep.
• The dose of apomorphine hydrochloride that the patient should receive each day should not be more than 100 mg.
• The doctor will decide what the best dose is for the patient.
• The infusion site should be changed every 12 hours.

There is no need to dilute Dacepton before administration. Additionally, it should not be mixed with other medicines. Dacepton has been prepared for administration in a continuous infusion using a minipump or syringe pump. It should not be used for repeated injections. The doctor will decide on the choice of minipump and/or syringe pump and adjust the dosing according to the individual needs of the patient. If the patient has any further doubts about the use of the medicine, they should consult their doctor or nurse.

Using a higher dose of Dacepton than recommended

• The patient should immediately contact their doctor or the emergency department of the nearest hospital.
• It is important to use the correct dose of Dacepton and not exceed the dose recommended by the doctor. Using too high a dose may cause slow heart rate, increased nausea, excessive drowsiness and/or difficulty breathing. As a result of 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

The patient should take the next dose at the usual time. They should not take a double dose to make up for the missed dose.

Stopping the use of Dacepton

The patient should not stop using Dacepton without first consulting their doctor. If they have any further doubts about the use of this medicine, they should consult their doctor, nurse or pharmacist.

4. Possible side effects

Like all medicines, Dacepton can cause side effects, although not everybody gets them. The patient should contact their doctor if they feel worse after using the medicine or if the following symptoms occur: Very common side effects (occurring in more than 1 in 10 patients):

• Lumps under the skin at the injection site, which are painful, troublesome and may be red and itchy. To avoid 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 real)

Common side effects (occurring in 1 to 10 patients in 100):

• Nausea or vomiting, especially at the beginning of apomorphine treatment. Domperidone should be taken for at least 2 days before starting Dacepton to prevent nausea or vomiting.
• If the patient is taking domperidone and still experiences nausea or if they are not taking domperidone and experience nausea, they should inform their doctor or nurse as soon as possible.
• Feeling tired or very sleepy
• Confusion or hallucinations
• Dizziness or fainting when standing up

Uncommon side effects (occurring in 1 to 10 patients in 1,000):

• Increased involuntary movements or increased tremors during "on" periods
• Hemolytic anemia, abnormal breakdown of red blood cells in the blood vessels or in 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 can cause the skin to turn pale yellow and may cause weakness or shortness of breath
• Decreased platelet count, which can increase the risk of bleeding or bruising

Rare side effects (occurring in 1 to 10 patients in 10,000):

• Allergic reaction such as difficulty breathing or shortness of breath, swelling of the eyelids, face or lips, swelling or redness of the tongue
• Eosinophilia - an abnormally high number of white blood cells in the blood or other tissues of the body

Side effects with an unknown frequency:

• Swelling of the legs, feet or fingers
• Fainting
• Headache
• Inability to resist the impulse, urge or temptation to behave in a certain way, which may be harmful to the patient or their environment, including:
• inability to resist the urge to gamble despite serious personal or family consequences;
• changes in sexual interests and behaviors of great importance to the patient or others, such as increased sexual desire;
• uncontrolled excessive buying or spending money;
• binge eating (consuming large amounts of food in a short time) or compulsive eating (consuming more food than usual and more than needed to satisfy hunger).
• Aggression, agitation.

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 side effects not listed in the leaflet, the patient should tell their doctor, pharmacist or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Dacepton

The medicine should be stored out of sight and reach of children. The vials should be stored in the outer packaging to protect them from light. Do not store in the refrigerator or freeze. The chemical and physical stability after opening and filling the syringes in the infusion sets has been confirmed for a period of up to 7 days at 25°C. From a microbiological point of view, the product should be used immediately, unless the opening and dilution took place in controlled and validated aseptic conditions. If the solution is not used immediately, the user is responsible for the storage time and conditions before use. Do not use this medicine after the expiry date stated on the carton and label after "EXP". The expiry date refers to the last day of the month stated. Do not use the medicine if the solution has changed color to green. The medicine can only be used if the solution is clear, colorless to yellowish and does not contain particles. Used syringes and needles should be disposed of in a sharps container or other suitable container. After filling the sharps container, it should be handed over to the doctor or pharmacist for safe disposal. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Dacepton contains

The active substance of Dacepton is apomorphine hydrochloride hemihydrate. Each milliliter of Dacepton contains 5 mg of apomorphine hydrochloride hemihydrate. Dacepton is available in vials of 20 ml containing 100 mg of apomorphine hydrochloride hemihydrate. The other ingredients are:

• Sodium metabisulfite
• Sodium chloride
• Hydrochloric acid 1M
• Water for injections

Information about Dacepton related to sodium metabisulfite and sodium chloride is provided in section 2.

What Dacepton looks like and what the packaging contains

Dacepton is a clear, colorless to yellowish solution for infusion. The vials are made of colorless glass type I with a bromobutyl rubber stopper and an aluminum flip-off cap, containing 20 ml of solution for infusion, in a carton. The packaging includes 1, 5 or 30 vials. Bulk packaging: 5 x 1; 10 x 1; 30 x 1; 2 x 5 and 6 x 5. Not all pack sizes may be marketed.

Marketing authorization holder

EVER Neuro Pharma GmbH, Oberburgau 3, 4866 Unterach am Attersee, Austria

Manufacturer

• 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 medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria: Dacepton 5mg/ml Infusionslösung, Belgium: Dacepton 5 mg/ml oplossing voor infusie, Bulgaria: Dacepton 5 mg/ml Инфузионен разтвор, Czech Republic: Dacepton 5 mg/ml Infuzní roztok, Denmark: Dacepton 5 mg/ml infusionsvæske, opløsning, Estonia: Dacepton 5 mg/ml, Greece: Dopaceptin 5 mg/ml Διάλυμα για έγχυση, Netherlands: Dacepton 5 mg/ml oplossing voor infusie, Finland: Dacepton 5 mg/ml infuusioneste, liuos, France: Dopaceptin 5 mg/ml Solution pour perfusion, Germany: Dacepton 5 mg/ml Infusionslösung, Norway: Dacepton, Spain: Dacepton 5 mg/ml Solución para perfusión, Ireland: Dacepton 5 mg/ml solution for infusion, Lithuania: Dacepton 5 mg/ml Infuzinis tirpalas, Latvia: Dacepton 5 mg/ml šķīdums infūzijām, Poland: Dacepton, Portugal: Dacepton, Romania: Dacepton 5 mg/ml Soluţie perfuzabilă, Slovakia: Dacepton 10mg/ml Infúzny roztok, Slovenia: Dacepton 5 mg/ml raztopina za infundiranje, Sweden: Dacepton 5 mg/ml infusionsvätska, lösning, Hungary: Dacepton 5 mg/ml Oldatos infúzió, United Kingdom (Northern Ireland): Dacepton 5 mg/ml solution for infusion, Date of last revision of the leaflet:10.2023