Dacepton 10 mg/ml solution for injection in cartridge EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Dacepton 10 mg/ml solution for injection in cartridge EFG

Apomorphine, hydrochloride hemihydrate

Read all of 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

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

Contents of the leaflet

1. What Dacepton 10 mg/ml in cartridge is and what it is used for
2. What you need to know before using Dacepton 10 mg/ml in cartridge
3. How to use Dacepton 10 mg/ml in cartridge
4. Possible side effects
5. How to store Dacepton 10 mg/ml in cartridge
6. Contents of the pack and other information

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

Dacepton contains an injectable solution of apomorphine. It is injected under the skin (subcutaneously) using only the D-mine Pen device specifically designed for this purpose. The active substance in 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 reduce the amount of 'off' time or immobility in people previously treated for Parkinson's disease with levodopa (another Parkinson's treatment) and/or other dopamine agonists.

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

Despite its name, apomorphine does not contain morphine.

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

DO NOT use Dacepton 10 mg/ml in cartridge:

• if you are allergic to apomorphine or to any of the other ingredients of this medicine (listed in section 6).
• if you are under 18 years of age.
• if you have breathing difficulties.
• if you suffer from dementia or Alzheimer's disease.
• if you have a mental illness with symptoms such as hallucinations, delusions, confused thinking, or loss of contact with reality.
• if you have liver problems.
• if you suffer from severe dyskinesia (involuntary movements) or severe dystonia (inability to move) despite taking levodopa.
• if you know that you or a family member have an electrocardiogram (ECG) abnormality called 'long QT interval syndrome'. Inform your doctor.
• if you are taking ondansetron (a medicine used 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 during the first days of treatment and at any time your doctor considers it necessary. Your doctor will also ask about any 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 could be related to your 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 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 for high blood pressure
• if you have nausea or feel dizzy
• if Parkinson's disease causes you any mental problems such as hallucinations or confusion
• if you are elderly or feel weak

Inform your doctor if you, your family, or your caregiver notice that you have uncontrollable impulses or urges to behave in ways that are unusual for you and that you cannot resist the impulse, desire, or temptation to carry out certain activities that could harm yourself or others. These are known as impulse control disorders and may include behaviours such as compulsive gambling, eating, or spending, abnormally increased sex drive, 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 take high doses of Dacepton and other medicines used to treat Parkinson's disease.

Children and adolescents

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

Using Dacepton 10 mg/ml in cartridge with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Talk to 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 amitriptyline and imipramine), bacterial infections (macrolide antibiotics such as erythromycin, azithromycin, and clarithromycin), and domperidone.

If you are taking ondansetron (a medicine used to treat nausea and vomiting), as this may lead to a severe drop in blood pressure and loss of consciousness.

If you use Dacepton 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 you whether the dose of apomorphine or any other medicine you are taking needs to be adjusted.

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

Using Dacepton 10 mg/ml in cartridge with food and drink

Food and drink do not affect how Dacepton works.

Pregnancy, breastfeeding, and fertility

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 must not be used during pregnancy unless strictly necessary.

It is not known whether Dacepton passes into breast milk. Consult your doctor if you are breastfeeding or planning to breastfeed. Your doctor will advise you whether to continue or stop breastfeeding or whether to continue or stop this medicine.

Driving and using machines

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

Dacepton 10 mg/ml in cartridge contains sodium metabisulfite

Sodium metabisulfite may rarely cause severe allergic reactions 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.

This medicine contains less than 23 mg (1 mmol) of sodium per 10 ml; this is essentially "sodium-free".

3. How to use Dacepton 10 mg/ml in cartridge

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

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

You should take domperidone for at least 2 days before starting Dacepton 10 mg/ml to avoid nausea or dizziness.

DO NOT use Dacepton 10 mg/ml in cartridge if

• the solution has turned green.
• the solution is cloudy or if you can see particles in it.

How much to use

Both the amount of Dacepton you should use and the number of daily injections required will depend on your individual needs. Your doctor will discuss this with you and tell you how much medicine you should administer and how often.

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

• The usual daily dose ranges between 3 mg and 30 mg.
• You may require up to 100 mg per day.
• You will usually need between 1 and 10 injections per day.
• Each individual injection must not contain more than 10 mg.

The D*-mine* Pen device required for administering Dacepton 10 mg/ml in cartridge is not suitable for patients who require doses higher than 6 mg per injection.

For these patients, other products should be used.

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

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

Before using Dacepton 10 mg/ml in cartridge

Note: this package does NOT include the pen or pen needles.

Dacepton 10 mg/ml in cartridge is designed to be administered only with the dedicated “D-mine Pen” delivery pen and disposable needles, as specified in the Pen’s Instructions for Use.

Description of the pen

• Always use a new needle for each injection to prevent contamination.
• Needles and the pen must not be shared.

Before using Dacepton 10 mg/ml in cartridge, examine your pen and the pen user manual to become familiar with its proper handling.

• If your pen is damaged or not working properly (due to mechanical defects), refer to the Pen’s Instructions for Use.

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 cap.
• Follow the instructions in your pen user manual.

Preparing the pen / changing the cartridge

Remove the pen from its packaging and remove the cap.

Remove the cartridge holder by turning it clockwise.

Insert the new cartridge into the cartridge holder.

Push the threaded rod fully down. This is best done with the fingertip.

Insert the cartridge holder into the pen housing and turn counterclockwise to lock it in place.

Attaching the pen needle to the cartridge holder

Follow the instructions for use of the pen needle. Remove the protective tab.

Attach / screw the pen needle onto the cartridge holder.

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

Remove and discard the inner protective needle cap.

Priming / function check

All air must be removed from the cartridge before use. Set the dose by turning the dose dial forward. Check the set dose by viewing the dose window vertically from above, not at an angle, so that the “?” symbol is clearly visible. This process is called “priming” and is important to ensure you receive a full dose when using the pen.

To check function, hold the pen with the needle pointing upward and gently tap the cartridge holder so that any air rises to the top.

Press the button.

A few drops should appear at the tip of the pen needle. If no drops appear, repeat this step.

Setting the dose

Set your dose by turning the dose dial clockwise. Correct your dose by turning counterclockwise.

Injection

• Using a surgical wipe, clean the area of skin where you plan to inject the medicine and the surrounding area.
• Inject Dacepton into the central area of your waist (abdomen) or the outer part of your thigh, under the skin (subcutaneously), as instructed by your doctor or nurse.

For the injection, press the button fully. Keep the button pressed during delivery of the medicine. After the medication has been completely delivered, wait 6 seconds, then slowly withdraw the pen needle. You may keep the button pressed or release it during the 6 seconds. Check the dose window to confirm that “0.0” is visible, ensuring the full 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 injection site. Do not inject Dacepton into an area of skin that is painful, red, infected, or damaged.

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

After using Dacepton 10 mg/ml in cartridge

Dispose of and discard the needle after each injection (for safe disposal instructions, see section 5).

Removing the pen needle after each injection

Carefully place the outer protective cap over the pen needle.

Unscrew the needle from the pen by turning the outer housing clockwise and dispose of it properly.

Optional:

Place the outer needle cap into the designated slot in your pen case. The opening of the needle cap should face upward. Carefully insert the needle (attached to the pen) into the opening of the case. Without touching the cap, press down firmly and turn counterclockwise to unscrew the needle from the pen.

Replace the pen cap securely after each use.

• Leave the cartridge in the pen.
• A new cartridge may be used for up to 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, discard and replace the cartridge.
• Dispose of the needle safely, as described in the Instructions for Use of your pen.

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

• Inform your doctor or contact the nearest hospital emergency department immediately.
• You may notice a slower heartbeat, excessive dizziness, excessive drowsiness, and/or difficulty breathing. You may also feel weak or dizzy, especially when standing up, due to a drop in blood pressure. Lying down with your feet elevated may help relieve low blood pressure.

In case of overdose or accidental ingestion, contact your doctor or the Toxicology Information Service immediately at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

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

Administer the next dose when needed. Do not use a double dose to make up for a missed dose.

If you stop using Dacepton 10 mg/ml in cartridge

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

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse 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 your nearest hospital emergency service immediately.

Signs of an allergic reaction may include:

• Rash
• Difficulty breathing or
• Chest tightness,
• Swelling of the eyelids, face or lips,
• Swelling or redness of the throat or tongue.

Dacepton may sometimes cause the following adverse effects.

Very common adverse 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 are not there)

Common adverse 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.
• Tiredness or excessive drowsiness.
• Confusion or hallucinations.
• Yawning.
• Dizziness or mild lightheadedness when standing up.

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

• Increased 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 adverse 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, increasing the risk of bleeding or bruising.

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

• An allergic reaction
• Eosinophilia, an abnormally high number of white blood cells in the blood or body tissues.

Adverse effects with 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).

Tell your doctor if you experience any of these behaviours; he or she will advise you on how to manage or reduce the symptoms.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Dacepton 10 mg/ml in cartridge

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 month indicated.

Do not store above 25°C.

Do not refrigerate or freeze.

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

Store under the same conditions once opened and between uses.

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

Do not use this medicine if you notice that the solution has turned green. The solution should only be used if it is clear, colourless or slightly yellowish, and free from particles.

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

6. Contents of the container 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 metabisulphite (E223)
• Sodium chloride
• Hydrochloric acid (for pH adjustment)
• Water for injections

See section 2: "Dacepton 5 mg/ml contains sodium metabisulphite (E223) and sodium chloride" for information regarding 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 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 some 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, 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 in the United Kingdom and Northern Ireland under the following names:

AT Dacepton® 5mg/ml Infusionslösung
BE Dacepton® 5 mg/ml solution for infusion
BG Dacepton® 5mg/ml инфузионен разтвор
CZ Dacepton® 5mg/ml Infuzní roztok
DE Dacepton® 5mg/ml Infusionslösung
DK Dacepton® 5 mg/ml infusion solution, 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 infuusioneste, liuos
FR Dopaceptin® 5 mg/ml Solution pour 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 šķidums 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 latest revision 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/