5 mg / ml Infusion solution 

1. What Dacepton is and what it is used for

Apomorphine hydrochloride hemihydrate belongs to a group of medicines called dopamine agonists. Dacepton is used to treat Parkinson’s disease. Apomorphine works by reducing the time of “off” or immobile periods 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 when you need to use the medicine.

Apomorphine hydrochloride hemihydrate contained in Dacepton may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before you use Dacepton

Do not use Dacepton

  • if you are under 18 years of age
  • if you have difficulty breathing, or if you suffer from asthma
  • if you have dementia or Alzheimer’s disease
  • if you suffer from confusion, hallucinations, or any other similar problems
  • if you have any liver disease
  • if you have severe dyskinesia (involuntary movements), or severe dystonia(inability to move) due to treatment with levodopa
  • if you are allergic to apomorphine or any of the other ingredients of this medicine (listed in section 6).
  • if you or someone in your family has an abnormal electrocardiogram ( ECG ), so-called “long QT syndrome”. Tell your doctor.
  • if you are taking ondansetron, a medicine for nausea and vomiting (antiemetics).

Warnings and cautions

Before using the drug Dacepton 5 mg/ml, your doctor will take an ECG ( electrocardiogram ) and ask for a list of all medicines you are taking. The ECG examination will be repeated during the first days of treatment and at those times when the doctor deems it necessary. He or she will also ask if you have any other illnesses, especially about the heart.

Some questions and examinations may be repeated at each doctor’s visit. If you get symptoms that may come from the heart, e.g. palpitations, fainting, or fainting, tell your doctor immediately. You should also tell your doctor if you get diarrhea or start using new medicine.

Talk to your doctor, nurse, or pharmacist before using Dacepton:

  • if you have kidney problems
  • if you have any lung disease
  • if you have any heart disease
  • if you have low blood pressure or feel dizzy or dizzy when you get up
  • if you are taking any medicine for high blood pressure
  • if you are nauseous or vomiting
  • if you have mental health problems when starting Dacepton
  • if you are older or weak
  • when driving or using machines, as apomorphine may make you drowsy, or cause sudden sleep episodes (do not drive or use machines, if Dacepton makes you drowsy)
  • Your doctor should examine you regularly when you are taking Dacepton with levopoda (another treatment for Parkinson’s disease ).

Tell your doctor if you or your family/carer notice that you develop a strong desire or desire to behave in ways that are unusual for you, or if you can not resist the impulse, drive, or temptation to perform certain activities. which may harm you or others. These behaviors are called impaired impulse control and may include gambling addiction, compulsive eating, compulsive buying, an abnormally high sex drive, or an increase in sexual thoughts and feelings. Your doctor may need to adjust your dose or discontinue treatment.

Some patients experience addictive symptoms that lead to cravings for large doses ofDacepton 5 mg/ml and other medicines used to treat Parkinson’s disease.

Talk to your doctor or nurse if any of the above conditions apply to you.

Talk to your doctor or pharmacist before using this medicine if:

You are using medicines that can affect your heart rhythm. These include drugs used for heart rhythm problems (such as quinidine and amiodarone ), for depression (including tricyclic antidepressants such as amitriptyline and imipramine), and bacterial infections (macrolide antibiotics such as erythromycin, azithromycin, and clarithromycin) and domperidone.

Other medicines and Dacepton

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.

If you use Dacepton with other medicines, the effect of the other medicines may change.

This is especially true:

  • drugs such as clozapine used to treat certain mental disorders
  • antihypertensive drugs
  • other medicines for Parkinson’s disease.

Your doctor will tell you if you need to adjust the dose of apomorphine or any of your other medicines.

If you are taking both levodopa (another medicine for Parkinson’s disease ) and apomorphine, your doctor should take regular blood tests.

Dacepton with food, drink, and alcohol

Food and drink do not affect the effect of Dacepton.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Dacepton should not be used during pregnancy unless clearly necessary.

It is not known if Dacepton is excreted in human milk. Talk to your doctor if you are breast-feeding or intend to breast-feed. Your doctor will tell you if you should continue/stop breast-feeding or continue/stop taking this medicine.

Driving and using machines

Dacepton can cause drowsiness and a heavy need for sleep. Do not drive or use any tools or machines if Dacepton makes you sleepy.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Daceptone contains excipients

Deception contains sodium metabisulphite, which in rare cases can cause severe allergic reactions and bronchospasm with symptoms such as rash or itching of the skin, difficulty breathing, swelling of the eyelids, face or lips, swelling, or red tongue. If you get any of these side effects, consult your nearest emergency department immediately.

Daceptone contains 3.4 mg of sodium per ml. This should be considered by patients on a low-salt diet.

3. How to use Dacepton

Always use this medicine exactly as your doctor has told you. If you are not sure, talk to your doctor, nurse, or pharmacist.

Before using the drug Dacepton 5 mg/ml, your doctor will make sure that you are taking this medicine and anti-nausea medicine that you need to take at the same time.

Do not use Dacepton again

  • The solution has become green.
  • The solution is cloudy or you see particles in it.

Where to inject Dacepton

Inject Dacepton under the skin ( subcutaneously ) as shown by your doctor or nurse.

Dacepton must not be injected into a vein

Dosage

The amount and how often you need to use Dacepton are governed by your individual needs. Your doctor will discuss this with you and will tell you how much medicine to use and how often. The dose that is suitable for you has been determined during your visit to the specialist clinic.

  • The usual infusion dose per hour is 1 mg to 4 mg apomorphine hydrochloride.
  • This is usually given when you are awake and generally ends before you go to bed.
  • The amount of apomorphine hydrochloride you receive every day should not exceed 100 mg.
  • Your doctor or nurse will decide which dose is best for you.
  • A new infusion site should be selected every 12 hours.

Daceptone does not need to be diluted before use. Also, it should not be mixed with other drugs.

Daceptone 5 mg/ml has been developed for continuous infusion with a minipump or syringe pump. The drug should not be used for intermittent injection. The doctor decides which mini-pump and/or syringe pump to use as well as which dosage settings are required according to the patient’s special needs.

If you have any further questions on the use of this product, ask your doctor or nurse.

If you use more Dacepton then you should 

  • If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
  • It is important to use the correct dose of Dacepton and not to exceed the prescribed dose. Higher doses may lead to a slow heart rate, severe nausea, drowsiness, and/or difficulty breathing. You may also feel weak or dizzy due to low blood pressure, especially when you get up. Lying down with your legs raised helps with low blood pressure

If you forget to use Dacepton

Take it next time you need it. Do not take a double dose to make up for a forgotten dose.

If you stop using Dacepton

Contact your doctor before stopping treatment and discuss whether this is appropriate or not.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Tell your doctor if you think the medicine makes you feel unwell or if you get any of the following symptoms:

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

  • Hardening and lumps under the skin at the injection site, which is tender, painful, and maybe red and itchy. To avoid getting these knots, you should change the injection site every time you insert the needle.
  • Hallucinations (seeing, hearing, or feeling things that are not real).

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

Nausea or vomiting, especially when you start using Dacepton. Domperidone should be started at least two days before Dacepton to stop nausea and vomiting.

  • If you are nauseous even though you are taking domperidone, or if you are not taking domperidone and are nauseous, talk to your doctor or nurse as soon as possible.
  • Fatigue or heavy sleepiness
  • Confusion or hallucinations
  • Yawning
  • Feeling dizzy or dizzy when you get up.

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

  • Increased involuntary movements or aggravated tremors during so-called “on” periods
  • Hemolytic anemia, which involves the abnormal breakdown of red blood cells in blood vessels or other parts of the body. This is a less common side effect that may occur in patients who are also taking levodopa
  • Falling asleep suddenly
  • Rash
  • Breathing difficulties
  • Ulceration at the injection site
  • Decreased number of red blood cells, which can cause the skin to turn pale yellow and cause weakness or shortness of breath
  • Decreased platelet count, which may increase the risk of bleeding or bruising.

Rare side effects (may affect up to 1 in 1,000 people):

  • An allergic reaction, such as difficulty breathing or pressure in the chest, swelling of the eyelids, face, or lips, swelling or red tongue.
  • Eosinophilia, an abnormally high number of white blood cells in the blood or your tissues.

Has been reported (occurs in an unknown number of users):

  • Swollen legs, feet, or fingers
  • Fainting
  • Aggression, anxiety, restlessness
  • Inability to resist the impulse, drive, or temptation to perform an act that may be harmful to you or anyone else, which may include:
    • Strong impulse to excessive gambling despite serious consequences for you personally or your family
    • Altered or increased sexual interest or behavior that makes you or others noticeably concerned, e.g. an increased sexual drive
    • Uncontrollable and excessive need to buy things and spend money
    • Binge eating (intake of large amounts of food for a short time), or compulsive eating (intake of more food than normal and more than is needed to satisfy hunger).

Tell your doctor if you experience any of these behaviors to discuss ways to manage or reduce the symptoms.

5. How to store Dacepton

Keep this medicine out of the sight and reach of children.

Store the vials in the outer carton. Sensitive to light.

Store in a cold place. Do not freeze.

After opening and filling the medicinal product in syringes connected to the infusion set: Chemical and physical in-use stability has been demonstrated for seven days at 25 ° C. From a microbiological point of view, the product should be used immediately, unless the method of opening and further handling the product excludes the risk of bacterial contamination. If the product is not used immediately, the storage time and circumstances before use are the responsibility of the user.

Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The expiration date is the last day of the specified month.

Do not use it if the solution turns green. The drug may only be used if the solution is clear and colorless to yellowish and free of particles.

Used syringes and needles should be discarded in a sharp-edged container or another suitable container. When the container for sharp objects is full, leave it to the doctor or pharmacist for safe disposal.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substance is apomorphine hydrochloride hemihydrate. One milliliter of Daceptone contains 5 mg of apomorphine hydrochloride hemihydrate.

Daceptone is available in 20 ml vials containing 100 mg of apomorphine hydrochloride hemihydrate.

Other ingredients are:

  • Sodium metabisulfite (E223)
  • Sodium chloride
  • Hydrochloric acid (for adjusting the pH value)
  • Water for injections

For information on sodium metabisulfite and sodium chloride, see section 2: Daceptone contains sodium metabisulfite and sodium chloride ”.

What the medicine looks like and the contents of the pack

Dacepton is a clear and colorless to light yellow solution for infusion.

Glass vials containing 20 ml solution for infusion in packs of 1, 5, or 30 vials.

Multiple packs: 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 and Manufacturer

EVER Neuro Pharma GmbH

Oberburgau 3

4866 Unterach

Austria

Manufacturer

EVER Neuro Pharma GmbH

Oberburgau 3

4866 Unterach

Austria

EVER Pharma Jena GmbH

Otto-Schott-Strasse 15

07745 Jena

Germany

Information is provided by

NordicInfu Care AB

Box 14026

167 14 Bromma

This medicinal product is authorized under the European Economic Area under the names:

AT Dacepton 5 mg / ml Infusion solution

BE Dacepton 5 mg / ml solution for infusion

BG Dacepton 5 mg / ml Infusion solution

CZ Dacepton 5 mg / ml Infusion tablets

DE Dacepton 5 mg / ml infusion solution

DK Dacepton 5 mg / ml solution for infusion

EE Dacepton 5 mg / ml

EL Dopaceptin 5 mg / ml Icemia

ES Dacepton 5 mg / ml Perfusion Solution

FI Dacepton 5 mg / ml infusion test, liuos

FR Dopaceptin 5 mg / ml Solution pour perfusion

HU Dacepton 5 mg / ml Oldatos infusion

IE Dacepton 5 mg / ml solution for infusion

IT Dacepton

LT Dacepton 5 mg / ml Infuzinis tirpalas

LV Dacepton 5 mg / ml skin infusion

NL Dacepton 5 mg / ml solution for infusion

NO Dacepton

PL Dacepton

PT Dacepton

RO Dacepton 5 mg / ml Perfusion Solution

SE Dacepton 5 mg / ml Infusion solution

SI Dacepton 5 mg / ml raztopina for infusion

SK Dacepton 5 mg / ml Infusion solution

UK Dacepton 5 mg / ml solution for infusion

Muhammad Nadeem

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