Dacepton 5 mg/ml solution for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Dacepton 5 mg/ml solution for infusion EFG

Apomorphine, hydrochloride hemihydrate

Read the entire 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, and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.

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

Leaflet contents

1. What Dacepton 5 mg/ml is and what it is used for
2. What you need to know before using Dacepton 5 mg/ml
3. How to use Dacepton 5 mg/ml
4. Possible side effects
5. How to store 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 reduce the amount of 'off' time or immobility in people previously treated for Parkinson's disease with levodopa (another treatment for Parkinson's disease) and/or other dopamine agonists.

Your doctor or nurse will help you recognize the signs that will indicate when you should use your medicine.

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

DO NOT use Dacepton 5 mg/ml:

• if you are under 18 years of age.
• if you have breathing difficulties or suffer from asthma.
• if you have dementia or Alzheimer's disease.
• if you experience confusion, hallucinations, or other 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 to any of the other components of this medicine (listed in section 6).
• if you know that you or a family member have an electrocardiogram (ECG) abnormality called '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 ECG (electrocardiogram) and ask for a list of all other medicines you are taking. This ECG will be repeated during the first days of treatment and at any time your doctor considers necessary. Your doctor will also ask about other medical conditions you may have, especially those related to the heart. Some of these questions and additional tests may be repeated at each medical visit. If you experience symptoms that may be related to the heart, such as palpitations, fainting, or dizziness, you must inform your doctor immediately. If you have diarrhoea or start taking a new medicine, you should also inform your doctor.

Talk to your doctor, pharmacist, or nurse before using Dacepton 5 mg/ml if:

• you have kidney problems
• you have lung problems
• you have heart problems
• you have low blood pressure or feel weak or dizzy when standing up
• you are taking medicines for high blood pressure
• you have nausea or vomiting
• you develop any mental disturbances when starting Dacepton
• you are elderly or feel weak
• when driving or operating machinery, as apomorphine may cause drowsiness, including sudden onset of sleep episodes (you must not drive or operate machinery if Dacepton causes drowsiness).
• your doctor should regularly monitor your body if you are using Dacepton together with levodopa (another treatment for Parkinson's disease).

Inform your doctor if you, your family, or your caregiver notice that you have uncontrollable impulses or urges to behave in ways unusual for you and that you cannot resist the impulse, desire, or temptation to carry out certain activities that could harm you or others. These are called impulse control disorders and may include behaviors such as compulsive gambling, eating, or spending money, abnormally increased sexual desire, or increased sexual thoughts or feelings. Your doctor may need to adjust or stop your dose.

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

If any of the situations described above affect you, 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 need to take any other medicines, including those obtained without a prescription.

Consult your doctor or pharmacist before taking your medicine if:

You are taking medicines 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 amitriptiline and imipramine), bacterial infections (macrolide antibiotics such as erythromycin, azithromycin, and clarithromycin), and domperidone.

If you are taking ondansetron (a 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 5 mg/ml with other medicines, the effect of these medicines may be altered.

This is especially true with:

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

Your doctor will advise whether 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 periodically perform blood tests.

Using Dacepton 5 mg/ml with food and drinks

Food and drinks do not affect how Dacepton 5 mg/ml works.

Pregnancy and breastfeeding

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

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

It is not known whether Dacepton 5 mg/ml passes into breast milk. Consult your doctor if you are breastfeeding or plan to breastfeed. Your doctor will advise whether you should continue or stop breastfeeding or whether you should continue or stop taking this medicine.

Driving and using machines

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

Dacepton 5 mg/ml contains sodium metabisulfite which, in rare cases, may cause serious allergic reactions and bronchospasm with symptoms such as skin rash or itching, difficulty breathing, swelling of the eyelids, face, or lips, or swelling 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 millilitre, and is therefore considered essentially "sodium-free".

3. How to use Dacepton 5 mg/ml

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

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

DO NOT use Dacepton 5 mg/ml if

• The solution has turned green.
• The solution is cloudy or particles are visible in it.

Where to inject Dacepton 5 mg/ml

Inject Dacepton 5 mg/ml into an area beneath the skin (subcutaneous route), as directed 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 medicine each day will depend on your individual needs. Your doctor will discuss this with you and tell you how much medicine you should administer.

The most appropriate dose for you will be determined during your visit to the specialist.

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

Dacepton does not need to be diluted before use. It must not be mixed with any other medicine.

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

If you have any further 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, contact your doctor immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.
• It is important to administer the correct dose of Dacepton and not to 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 upon standing 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 missed doses.

If you stop using Dacepton 5 mg/ml

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

If you have any further 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 everyone gets them. Consult your doctor if you think this medicine is making you feel unwell or if you experience any of 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, bothersome, and may become red and itchy. To avoid these lumps, it is advisable 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 of treatment with Dacepton 5 mg/ml. Domperidone should be started at least 2 days before Dacepton 5 mg/ml to prevent nausea.
• If you are taking domperidone and still experience nausea, or if you are not taking domperidone and feel dizzy, inform your doctor or nurse as soon as possible.
• Tiredness or excessive drowsiness.
• Confusion or hallucinations.
• Yawning.
• Dizziness or weakness when standing up.

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

• Increase in involuntary movements or increased tremors during 'on' periods.
• Haemolytic anaemia, an abnormal destruction of red blood cells in blood vessels or other parts of the body. This is an uncommon side effect that may occur in patients also taking levodopa.
• Falling asleep suddenly.
• Rash.
• Difficulty breathing.
• Ulcers at the injection site.
• Reduction in red blood cells which may cause yellowing of the skin and lead to weakness or shortness of breath.
• Reduction in blood platelets, which increases the risk of bleeding or bruising.

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, swelling or redness of the tongue.
• Eosinophilia, an abnormally high number of white blood cells in the blood or 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 carry out an action that could be harmful to you or others, which may include:
• Strong urge to gamble excessively, despite serious personal or family consequences.
• Change or increase in sexual interest and behaviour, significant to you or others, for example, increased sexual drive.
• Uncontrollable excessive shopping or spending.
• 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 they are possible side effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human 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 stated on the carton and label after "EXP". The expiry date refers to the last day of the stated month.

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

Do not refrigerate or freeze.

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

From a microbiological standpoint, unless the opening and subsequent handling have been carried out under conditions that exclude the risk of microbial contamination, the product should be used immediately. If not used immediately, the storage times and conditions during use 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, colourless or slightly yellowish, and free from particles.

Medicines must not be disposed of via wastewater or household waste. Unused containers and medicines should be returned to the SIGRE Point at your usual pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

Used syringes and needles must be discarded in a sharps container or another suitable container. When the sharps container or other container is full, return it to your doctor or pharmacist for safe disposal.

6. Contents of the pack and other information

Composition of Dacepton 5 mg/ml

The active substance is apomorphine hydrochloride hemihydrate. Each millilitre of Dacepton 5 mg/ml contains 5 mg of apomorphine hydrochloride hemihydrate.

Dacepton 5 mg/ml is supplied 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 injections

See section 2: Dacepton 5 mg/ml contains sodium metabisulfite (E223) and sodium chloride, for information regarding sodium metabisulfite 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 with 20 ml of perfusion 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 certain pack sizes may be marketed.

Marketing Authorisation Holder

EVER Neuro Pharma GmbH
A-4866 Unterach
Austria

Manufacturer

EVER Pharma Jena GmbH
Brüsseler Strasse 18
07747 Jena
Germany

For further information about this medicinal product, please contact the local representative of the marketing authorisation holder:

EVER Pharma Therapeutics Spain, S.L.
C/Toledo 170
28005 Madrid
Spain

This medicinal product is authorised in the European Economic Area member states and the United Kingdom (Northern Ireland), under the following names:

AT Dacepton® 5mg/ml Infusionslösung
BE Dacepton® 5 mg/ml solution for infusion
BG Dacepton® 5mg/ml ?????????? ???????
CZ Dacepton® 5mg/ml Infuzní roztok
DE Dacepton® 5mg/ml Infusionslösung
DK Dacepton® 5 mg/ml infusion liquid, solution
EE Dacepton® 5 mg/ml
EL Dopaceptin® 5 mg/ml Διάλυμα για έγχυση
ES Dacepton® 5mg/ml Solución para perfusión
FI Dacepton® 5 mg/ml infusion, solution
FR Dopaceptin® 5 mg/ml Solution for 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 šķīdums infūzijām
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 most recent review of this leaflet: October 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/