APODEV 5 mg/ml SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

Apodev 5 mg/ml solution for infusion 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, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Apodev and what is it used for
2. What you need to know before you use Apodev
3. How to use Apodev
4. Possible side effects

5 Conservation of Apodev

1. Contents of the pack and further information

1. What is Apodev and what is it used for

Apomorphine hydrochloride belongs to a group of medicines known as dopamine agonists, which are used to treat Parkinson's disease. It helps to reduce the amount of time spent in an "off" state or immobility in people who have been previously treated for Parkinson's disease with levodopa and/or other dopamine agonists.

Your doctor or nurse will help you recognize the signs of when to use your medicine.

2. What you need to know before you use Apodev

Do not use Apodev

• if you are allergic to apomorphine or any of the other ingredients of this medicine (listed in section 6).
• if you are under 18 years old.
• if you have breathing difficulties or suffer from asthma.
• if you have dementia or Alzheimer's disease.
• if you suffer from confusion, hallucinations or any other similar problem.
• if you have liver problems.
• if you have severe hyperkinesia, which is called dyskinesia (involuntary movements), or abnormal muscle tension (called dystonia) due to treatment with levodopa.
• if you are taking ondansetron (a medicine to treat nausea and vomiting).

Warnings and precautions

Talk to your doctor before starting to use this medicine:

• if you or a member of your family has an abnormality of the electrocardiogram (ECG) called "long QT syndrome".
• if you have kidney problems.
• if you have lung problems.
• if you have heart problems.
• if you have low blood pressure or feel weak and dizzy when standing up.
• if you are taking any medicine to treat high blood pressure.
• if you feel sick or are being sick.
• if you are elderly or weak.
• if you have any mental disorder at the time of starting Apodev.
• if you are taking levodopa (another treatment for Parkinson's disease) in addition to apomorphine, your doctor should check your blood regularly.

Before using this medicine, your doctor will perform an ECG (electrocardiogram) and ask for a list of all other medicines you are taking. This ECG will be repeated in the first days of treatment and at any time if your doctor considers it necessary. Your doctor will also ask about other diseases you may have, particularly about your heart. Some of the questions and investigations may be repeated at each medical visit. If you experience symptoms that may come from the heart, such as palpitations, fainting or near-fainting, you should inform your doctor immediately. Also, if you experience diarrhea or start taking a new medicine, you should inform your doctor.

Tell your doctor if you or your family/caregiver notice that you are developing impulses or desires to behave in an unusual way for you and cannot resist the impulse, desire or temptation to perform certain activities that could harm yourself or others. These are called impulse control disorders and may include behaviors such as gambling addiction, overeating or overspending, abnormally high sexual desire or increased sexual thoughts or feelings. Your doctor may need to adjust or stop your dose.

Some patients develop symptoms similar to those of addiction that lead to a compulsive desire to consume high doses of this medicine and other medicines used to treat Parkinson's disease.

If any of the above situations apply to you, inform your doctor or nurse.

Other medicines and Apodev

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

If you take this medicine in combination with other medicines (such as clozapine or medicines to reduce your blood pressure or medicines for Parkinson's disease), the effect of your medicines may be altered. Your doctor will advise you if you need to adjust the dose of this medicine or any of your other medicines.

Check with your doctor or pharmacist before taking your medicine 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.

Consult your doctor or pharmacist before using this medicine if:

You are using medicines that are known to affect the rhythm of your heart. This includes medicines used for heart rhythm problems (such as quinidine and amiodarone), for depression (e.g. tricyclic antidepressants such as amitriptyline and imipramine) and for bacterial infections ("macrolide antibiotics" such as erythromycin, azithromycin and clarithromycin) and domperidone.

Using Apodev with food and drinks

Food and drink do not affect the way this medicine works.

Pregnancy and breast-feeding

Pregnancy

This medicine must not be used during pregnancy unless strictly necessary. Ask your doctor or nurse for advice before using this medicine if you are pregnant, think you may be pregnant or plan to become pregnant.

Breast-feeding

It is not known whether this medicine is excreted in breast milk. Consult your doctor if you are breast-feeding or plan to breast-feed. Your doctor will explain if you should continue or stop breast-feeding or if you should continue or stop the medicine.

If you are pregnant or breast-feeding, think you may be pregnant or plan to become pregnant, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines

Pay special attention when driving or using machines because apomorphine can cause drowsiness, including sudden episodes of sleep (do not drive or use machines if this medicine makes you feel drowsy).

Apodev contains sodium metabisulfite and sodium

Sodium metabisulfite may, in rare cases, cause hypersensitivity reactions and bronchospasm.

This medicine contains 3.3 mg of sodium (main component of cooking/table salt) per ml of solution. This equals 0.17% of the maximum daily intake of salt recommended for adults.

3. How to use Apodev

Before using this medicine, your doctor will make sure you tolerate it and determine an antiemetic medicine that you should take at the same time.

The infusion is administered subcutaneously (e.g. in the area under the skin).

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

This medicine is designed for continuous infusion with an infusion pump. Your doctor will decide which infusion pump and which dosage adjustments are suitable for you. Follow your doctor's instructions and recommendations on how to use this medicine with an infusion pump. Read the instruction leaflet for the infusion pump and follow it carefully.

Both the amount of this medicine you should use and the total amount of time during which you should receive the medicine each day depend on your personal needs. Your doctor will inform you about the amount of medicine to be administered.

The most suitable dose will have been determined in an initial assessment in a specialized clinic. The usual infusion dose per hour is between 1 mg and 4 mg of apomorphine hydrochloride. It is usually administered while you are awake and stopped before sleeping. The amount of apomorphine hydrochloride you receive each day should not exceed 100 mg. Your doctor or nurse will decide which dose is most suitable for you.

The infusion site should be changed every 12 hours.

This medicine should not be administered into a vein. It is not necessary to dilute this medicine before use. This medicine should not be mixed with other medicines.

Instructions for using Apodev

• Clean the rubber stopper with a disinfectant swab.
• Insert the needle of the syringe into the vial through the center of the rubber stopper.
• Place the vial and syringe upside down.
• Take the desired volume from the vial with the syringe.
• Remove the needle from the vial.
• Then, carefully follow the instructions of your infusion pump.

Your doctor will start the treatment and inform you in detail about how to use the infusion pump, infusion technique, and handling to administer the medicine.

If you use more Apodev than you should

• if you have received too much medicine or, for example, the medicine has been administered to a child by mistake, contact your doctor or a hospital immediately for a risk assessment and advice.
• it is important to use the correct dose of this medicine and not a higher amount than recommended by your doctor. A higher dose may decrease your pulse, cause greater discomfort, drowsiness and/or breathing difficulties. You may also feel weak or dizzy, especially when standing up, due to low blood pressure. Lying down with your feet up may help alleviate low blood pressure.

In case of overdose or accidental ingestion, contact your doctor or call the Toxicological Information Service, phone 91 562 04 20, indicating the medicine and the amount received.

If you forget to use Apodev

• take it when you need it again.
• do not take a double dose to make up for forgotten doses.

If you stop treatment with Apodev

• contact your doctor before stopping treatment and discuss the suitability of your decision with them.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Talk to your doctor if you think this medicine has caused you any problems or if you experience any of the following side effects:

Serious side effects:

Rarely, serious allergic reactions may occur, with symptoms such as:

• difficulty breathing or pressure in the chest.
• swelling of the eyelids, face or lips.
• swelling or redness of the tongue.

Other side effects

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

• hallucinations (seeing, hearing or feeling things that are not present), lumps under the skin at the injection site with pain, discomfort and possibly redness and itching. To avoid these lumps, it is recommended to change the injection site each time you insert the needle.

Common (may affect up to 1 in 10 people)

• feeling or being sick, particularly when starting this medicine. Treatment with domperidone should start at least 2 days before apomorphine so that you do not feel sick. If you take domperidone and still feel sick, or if you are not taking it and feel unwell, tell your doctor or nurse as soon as possible.
• transient fatigue with each dose of apomorphine at the start of treatment. This usually disappears during the first weeks of treatment.
• excessive fatigue or drowsiness.
• dizziness or fainting.
• confusion or hallucinations.
• yawning.

Uncommon (may affect up to 1 in 100 people)

• increased number of involuntary movements (called dyskinesia, excessive movement) or more tremors during the "on" periods (i.e. when the medicine is working).
• patients who also take levodopa may develop hemolytic anemia, an abnormal breakdown of red blood cells in the blood vessels or other parts of the body, which can turn the skin yellow and cause weakness and shortness of breath.
• rash.
• breathing difficulties.
• a drop in blood pressure when standing up that causes dizziness, fainting or near-fainting.
• ulceration at the injection site.
• reduction in platelet count with a higher risk of bleeding and bruising.
• the use of levodopa and apomorphine may affect the result of a laboratory test called the Coombs test.

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

• eosinophilia, an unusually high count of white blood cells in the blood or tissues.

Unknown frequency (cannot be estimated from the available data)

• fainting.
• swelling of legs, feet or fingers.

• inability to resist the impulse, desire or temptation to perform something that may be harmful to yourself or others, which may include:
• strong impulse to gamble excessively despite serious personal or family consequences.
• altered or increased sexual interest and behavior that may cause concern to you or others, for example, increased sexual desire.
• excessive shopping or spending.
• binge eating (eating large amounts of food in a short period) or compulsive eating (eating more food than normal and more than needed to satisfy your appetite).
• aggression.
• agitation.
• headache.

Tell your doctor if you experience any of the above; they will manage or reduce the symptoms

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Monitoring System for Human Use: www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Conservation of Apodev

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

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

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

Do not store above 25°C.

For single use only.

After opening and filling the syringes with the product: physical and chemical stability has been demonstrated for 96 hours (4 days) at a temperature of 30-35°C, if protected from light. From a microbiological point of view, the product should be used immediately, unless the method of opening and handling precludes the risk of microbial contamination. If not used immediately, the in-use storage times and conditions are the responsibility of the user. Discard any unused solution.

The solution should be inspected visually before use. Do not use this medicine if you notice that the solution has turned green. You should only use this medicine if the solution is clear and does not contain visible particles.

Be careful not to splash the solution or, for example, onto textiles or household surfaces, as the solution may cause green stains. Used needles and the vial should be disposed of in a puncture-proof container.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at your usual pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Container Content and Additional Information

Composition of Apodev

• The active substance is apomorphine hydrochloride hemihydrate.

Each 1 ml contains 5 mg of apomorphine hydrochloride hemihydrate.

A vial with 20 ml of solution contains 100 mg of apomorphine hydrochloride hemihydrate.

• The other components (excipients) are:

• Sodium chloride.
• Sodium metabisulfite (E223).
• Hydrochloric acid for pH adjustment.
• Water for injectable preparations.

Appearance of the Product and Container Content

Apodev is a solution for infusion. The solution is transparent and practically colorless.

Apodev is supplied in glass vials with bromobutyl rubber stoppers and aluminum caps containing 20 ml.

Package sizes: 1 vial, 5 vials, or 30 (6 x 5) vials (grouped package).

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder

Evolan Pharma AB

P.O. Box 120

182 12 Danderyd

Sweden

Manufacturer

Anfarm Hellas S.A 61st km National Road Athens-Lamia,

Schimatari Viotias, 32009

Greece

Local Representative

Vegal Farmacéutica, S.L.

Vía de las Dos Castillas 9C, portal 2, 2ºC

28224 Pozuelo de Alarcón, Madrid

Spain

This medicinal product is authorized in the Member States of the European Economic Areaunder the following names:

Sweden Apomorfin PharmSwed

Denmark Apomorfin PharmSwed

Norway Apomorfin PharmSwed

Iceland Apomorfin PharmSwed

Netherlands Apomorfine hydrochloride PharmSwed 5 mg/ml, oplossing voor infusie

Germany Apomorphinhydrochlorid PharmSwed 5 mg/ml Infusionslösung

United Kingdom Apomorphine hydrochloride 5 mg/ml solution for infusion

Ireland Apomorphine hydrochloride 5 mg/ml solution for infusion

Spain Apodev 5mg/ml solucion para perfusión EFG

Date of the last revision of thisleaflet:September 2023

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