Apodev 5 mg/ml solution for infusion EFG

Package leaflet: Information for the user

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, as you may need to read it again.

• If you have any questions, ask your doctor or pharmacist.

• 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 or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Apodev is and what it is used for

2. What you need to know before using Apodev

3. How to use Apodev

4. Possible side effects

5. Storage of Apodev

6. Contents of the pack and other information

1. What Apodev is and what it is used for

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

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

2. What you need to know before using Apodev

Do not use Apodev

• 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 or suffer from asthma.
• if you have dementia or Alzheimer's disease.
• if you experience confusion, hallucinations, or any similar problems.
• if you have liver problems.
• if you have severe involuntary movements, known as dyskinesia, or abnormal muscle tension (called dystonia) due to treatment with levodopa.
• if you are taking ondansetron (a medicine used to treat nausea and vomiting).

Warnings and precautions

Talk to your doctor before starting to use this medicine:

• if you or a family member has an abnormality in 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 for high blood pressure.
• if you feel unwell or are suffering from illness.
• if you are elderly or frail.
• 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 must 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 during the first days of treatment and at any time if your doctor considers it necessary. Your doctor will also ask about other medical conditions you may have, especially concerning your heart. Some of these questions and tests may be repeated at each medical visit. If you experience symptoms that may come from the heart, such as palpitations, fainting or near-fainting episodes, you must inform your doctor immediately. Likewise, if you develop diarrhoea or start taking a new medicine, you must inform your doctor.

Tell your doctor if you or your family/caregiver notice that you are developing impulses or urges to behave in a way that is 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 gambling addiction, excessive eating or spending, abnormally high sex drive, or increased sexual thoughts or feelings. Your doctor may need to adjust or stop your dose.

Some patients develop symptoms similar to addiction, leading to a compulsive desire to take 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 need to take any other medicines.

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

Review with your doctor or pharmacist before taking your medicine if you are taking ondansetron (a medicine used 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 taking medicines known to affect your heart rhythm. This includes medicines used for heart rhythm problems (such as quinidine and amiodarone), for depression (e.g., tricyclic antidepressants (e.g., tricyclic antidepressants such as amitriptyline and imipramine)) and for bacterial infections ("macrolide antibiotics" such as erythromycin, azithromycin and clarithromycin) and domperidone.

Use of Apodev with food and drink

Food and drink do not affect how this medicine works.

Pregnancy and breastfeeding

Pregnancy

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

Breastfeeding

It is unknown whether this medicine is excreted in breast milk. Consult your doctor if you are breastfeeding or plan to breastfeed. Your doctor will advise you whether you should continue or stop breastfeeding or whether you should continue or stop taking the medicine.

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.

Driving and using machines

Be especially careful when driving or operating machinery, because apomorphine may cause drowsiness, including sudden sleep episodes (do not drive or operate machinery 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 (a main component of household/table salt) per ml of solution. This corresponds to 0.17% of the maximum daily salt intake recommended for adults.

3. How to use Apodev

Before using this medicine, your doctor will ensure that you tolerate it and will determine an antiemetic medicine that you must take simultaneously.

The infusion is administered subcutaneously (e.g., into the area beneath the skin).

Always follow exactly the instructions for administration of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

This medicine is designed for continuous infusion using an infusion pump. Your doctor will decide which infusion pump and which dosage settings 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 length of time you should receive the medicine each day depend on your individual needs. Your doctor will inform you about the amount of medicine to be administered.

The appropriate dose will have been determined during an initial assessment at a specialized clinic. The usual hourly infusion dose is between 1 mg and 4 mg of apomorphine hydrochloride. It is generally administered while you are awake and is usually stopped before going to sleep. The total daily amount of apomorphine hydrochloride you receive must not exceed 100 mg. Your doctor or nurse will decide the most appropriate dose for you.

The infusion site must be changed every 12 hours.

This medicine must not be administered into a vein. This medicine does not need to be diluted before use. This medicine must not be mixed with other medicines.

Instructions for using Apodev

• Disinfect the rubber stopper with an antiseptic swab.
• Insert the syringe needle into the vial through the center of the rubber stopper.
• Turn the vial and syringe upside down.
• Draw the desired volume from the vial into the syringe.
• Remove the needle from the vial.
• Then, carefully follow the instructions for your infusion pump.

Your doctor will start your treatment and provide you with detailed information on how to use the infusion pump, the infusion technique, and the handling procedures for administering the medicine.

If you use more Apodev than you should

• If you have received too much medicine, or if, for example, the medicine has been accidentally administered to a child, contact your doctor or a hospital immediately for risk assessment and advice.
• It is important to use the correct dose of this medicine and not to exceed the amount recommended by your doctor. A higher dose may reduce your pulse, cause increased 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 raised may help relieve low blood pressure.

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

If you forget to use Apodev

• Take it when you next need it.
• Do not take a double dose to make up for missed doses.

If you stop using Apodev

• Contact your doctor before stopping treatment and discuss with them the appropriateness of your decision.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. Please consult your doctor if you think this medicine is making you feel unwell or if you experience any of the following adverse effects:

Serious adverse effects:

Severe allergic reactions may occur rarely, with symptoms such as:

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

Other adverse 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 help prevent these lumps, it is recommended to change the injection site each time the needle is inserted.

Common (may affect up to 1 in 10 people)

• feeling unwell or nausea, particularly when starting this medicine. Treatment with domperidone should begin at least 2 days before apomorphine to prevent nausea. If you are taking domperidone and still feel unwell, or if you are not taking it and experience nausea, inform your doctor or nurse as soon as possible.
• transient fatigue with each dose of apomorphine at the beginning of treatment. This usually resolves during the first weeks of treatment.
• fatigue or excessive drowsiness.
• dizziness or lightheadedness.
• confusion or hallucinations.
• yawning.

Uncommon (may affect up to 1 in 100 people)

• increased number of involuntary movements (called dyskinesia, excessive movement) or increased tremors during "on" periods (i.e., when the medicine is working).
• patients also taking levodopa may develop hemolytic anemia, an abnormal breakdown of red blood cells in blood vessels or other parts of the body, which may cause yellowing of the skin and lead to weakness and shortness of breath.
• skin rashes.
• difficulty breathing.
• a drop in blood pressure upon standing, causing dizziness, lightheadedness, or fainting.
• ulceration at the injection site.
• reduced platelet count, increasing the risk of bleeding and bruising.
• the use of levodopa and apomorphine may affect the results 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 available data)

• fainting.

• swelling of legs, feet, or fingers.

• inability to resist the impulse, desire, or temptation to carry out an activity that could be harmful to you or others, which may include:

• a strong impulse to gamble excessively despite serious personal or family consequences.

• altered or increased interest in and engagement in sexual behavior, which may be a cause of considerable concern to you or others, for example, increased sexual desire.

• compulsive shopping or uncontrolled 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).

• aggression.

• agitation.

• headache.

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es.

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

5. Storage of Apodev

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 on the label of the vial after "EXP". The expiry date refers to the last day of the month indicated.

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 in use has been demonstrated for 96 hours (4 days) at a temperature of 30–35 °C, provided it is protected from light. From a microbiological standpoint, the product should be used immediately, unless the method of opening and handling excludes the risk of microbial contamination. If not used immediately, the storage times and conditions during use 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. This medicine should only be used if the solution is clear and free from visible particles.

Take care to avoid splashing the solution, for example onto textiles or household surfaces, as the solution may cause green staining. Used needles and the vial must be disposed of in a sharps container.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE collection point at your usual pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Apodev

• The active substance is apomorphine hydrochloride hemihydrate.

Each 1 ml contains 5 mg of apomorphine hydrochloride hemihydrate.

One vial containing 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 injections.

Nature of the product and pack contents

Apodev is an infusion solution. The solution is clear and practically colourless.

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

Pack sizes: 1 vial, 5 vials or 30 (6 x 5) vials (multipack).

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Marketing Authorisation 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 authorised in the Member States of the European Economic Area under 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 5 mg/ml solution for infusion EFG

Date of the most recent review of this leaflet: September 2023

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios - AEMPS) http://www.aemps.gob.es/