APOMORPHINE KALCEKS 5 mg/ml SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

Apomorfina Kalceks 5 mg/ml solution for infusion

apomorfine 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, pharmacist, or nurse.
• 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Apomorfina Kalceks is and what it is used for
2. What you need to know before you use Apomorfina Kalceks
3. How to use Apomorfina Kalceks
4. Possible side effects
5. Storing Apomorfina Kalceks
6. Contents of the pack and other information

1. What Apomorfina Kalceks is and what it is used for

Apomorfine hydrochloride hemihydrate (hereafter referred to as apomorfine) belongs to a group of medicines called dopaminergic agonists. Apomorfine is used to treat Parkinson's disease. Apomorfine helps to reduce the time spent in the "off" state or immobile in people previously treated for Parkinson's disease with levodopa (another treatment for Parkinson's disease) and/or other dopaminergic agonists.

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

2. What you need to know before you use Apomorfina Kalceks

Do not use Apomorfina Kalceks

• if you are allergic to apomorfine or any of the other ingredients of this medicine (listed in section 6);
• if you have difficulty breathing;
• if you have dementia, e.g. Alzheimer's disease;
• if you suffer from a mental illness with symptoms such as hallucinations, delirium, disordered thoughts, loss of contact with reality;
• if you have liver problems;
• if you have severe dyskinesia (involuntary movements) or severe dystonia (muscle contractions) caused by taking levodopa;
• if you know that you or a family member have an abnormality in the electrocardiogram (ECG) called "long QT syndrome";
• if you are taking ondansetron (a medicine for treating nausea and vomiting);
• if you are under 18 years old.

Warnings and precautions

Before using apomorfine, your doctor will perform an ECG (electrocardiogram) and ask for a list of all other medicines you are taking. This ECG will be repeated within the first few days of your treatment and at any time if your doctor considers it necessary. Your doctor will also ask about other illnesses you may have, especially those related to the heart. Some of the questions and examinations may be repeated at each medical visit. If you experience symptoms that may come from the heart, e.g. palpitations, fainting, or dizziness, you should immediately inform your doctor. If you have diarrhea or start using a new medicine, you should also inform your doctor.

Consult your doctor, pharmacist, or nurse before starting to use apomorfine:

• if you have kidney problems;
• if you have lung problems;
• if you have heart problems;
• if you have low blood pressure or feel that you are going to faint or feel dizzy when you get up after sitting or lying down;
• if you are taking medicines for high blood pressure;
• if you feel nauseous or suffer from nausea;
• if Parkinson's disease causes you certain mental problems such as hallucinations and confusion;
• if you are an elderly person or are weak;
• if you are taking medicines that are known to affect the way the heart beats (see Other medicines and Apomorfina Kalceks);
• if you are taking ondansetron (used to treat nausea or vomiting).

Tell your doctor if you or your relative/caregiver notice that you are developing impulses or cravings to behave abnormally and cannot resist the impulse, desire, or temptation to perform certain activities that could harm you or others. This is called impulse control disorders and may include behaviors such as addiction to gambling, excessive eating or spending, and abnormally high increase in sexual desire or sexual thoughts or feelings. Your doctor may need to adjust the dose or interrupt treatment.

Some patients develop symptoms of addiction that cause them to crave large doses of apomorfine and other medicines used in the treatment of Parkinson's disease.

Other medicines and Apomorfina Kalceks

Tell your doctor, pharmacist, or nurse if you are using, have recently used, or might use any other medicines.

Check with your doctor or pharmacist before taking your medicine if you are taking ondansetron (a medicine for treating nausea and vomiting), as this may result in a severe drop in blood pressure and loss of consciousness.

If you use Apomorfina Kalceks with other medicines, the effect of those medicines or side effects may be altered. This is especially true in the case of:

• medicines such as clozapine for treating certain mental disorders;
• medicines for reducing blood pressure;
• medicines that are known to affect the way the heart beats:

• medicines used for heart rhythm problems (such as quinidine and amiodarone);
• medicines for depression (including tricyclic antidepressants such as amitriptyline and imipramine);
• medicines for bacterial infections (the so-called "macrolide antibiotics" such as erythromycin, azithromycin, and clarithromycin);
• domperidone (for treating nausea or vomiting);

• ondansetron (for treating nausea or vomiting);
• other medicines for Parkinson's disease.

Your doctor will inform you if it is necessary to adjust the dose of apomorfine or any other medicine.

If you are taking levodopa (another medicine for Parkinson's disease) as well as apomorfine, your doctor should perform regular blood tests.

Using Apomorfina Kalceks with food and drink

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

Pregnancy and breast-feeding

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

This medicine should not be used during pregnancy unless clearly necessary.

It is not known if apomorfine is excreted in breast milk. If you are breast-feeding or plan to breast-feed, ask your doctor for advice. Your doctor will explain if you should continue/break off breast-feeding or continue/interrupt the use of this medicine.

Driving and using machines

Apomorfine may cause drowsiness and a strong desire to sleep. Do not drive or use tools or machines if the medicine affects you in this way.

Apomorfina Kalceks contains sodium metabisulfite

Sodium metabisulfite (E223) may rarely cause severe allergic reactions with symptoms such as skin rash or itching, difficulty breathing, swelling of eyelids, face, or lips, inflammation or redness of the tongue, and bronchospasm. If you experience these side effects, seek medical help immediately.

Apomorfina Kalceks contains sodium

If large amounts of the solution are administered (e.g. 10 ml or more), the following should be taken into account: This medicine contains 3.27 mg of sodium (the main component of cooking/table salt) in each ml of solution. This is equivalent to 0.16% of the maximum recommended daily intake of sodium for an adult.

3. How to use Apomorfina Kalceks

Follow the instructions for administration of this medicine exactly as prescribed by your doctor. If you are unsure, consult your doctor, pharmacist, or nurse again.

Before using this medicine, your doctor will check that you tolerate this medicine and an antiemetic medicine that you should take at the same time. If the doctor prescribes the antiemetic domperidone, you should take it at least 2 days before starting apomorfine so that you stop having nausea or vomiting.

Apomorfina Kalceks is injected under the skin (subcutaneously) and is designed for continuous infusion with a mini-pump or syringe pump. It is not intended for use as an intermittent injection. The choice of mini-pump and/or syringe pump to be used and the necessary dosing regimens will be determined by the doctor according to the specific needs of the patient.

Do not use this medicine if:

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

How much apomorfine to use

The amount of this medicine that you should use and the total time that 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 to administer.

The amount that works best in your case will have been determined during your visit to the doctor.

• The average infusion dose per hour is between 1 mg and 4 mg of apomorfine.
• It is usually administered when you are awake and is generally stopped before you go to sleep.
• The amount of apomorfine you receive each day should not exceed 100 mg.
• Your doctor will decide what the best dose is for you.

How to use

• Apomorfina Kalceks does not need to be diluted before use.
• It must not be mixed with other medicines.
• A different infusion site should be used every 12 hours.
• Do not inject the medicine into a vein.
• Each ampoule is for single use only.

Steps to follow to load the medicine into the syringes

• You will need a needle to withdraw the medicine from the ampoule.
• Visually inspect the ampoule before use. Only solutions that are clear, colorless to yellowish, particle-free, in undamaged ampoules should be used.
• Open the ampoule:

1. Hold the ampoule with the colored spot facing upwards. If some solution remains in the top part of the ampoule, gently tap it with your finger so that all the solution goes down to the bottom.
2. Use both hands to open it and while holding the bottom part of the ampoule with one hand, use the other to break the top part of the ampoule in the opposite direction to the colored spot (see the images below).

• After opening the ampoule, use the medicine immediately.
• Firmly attach the needle to the end of the syringe.
• Withdraw the required volume of medicine for the dose indicated by the doctor.
• After loading the medicine into the syringe, visually inspect the solution. Do not use it if the solution has turned green.
• Discard any unused product and the used needles and ampoules in a "sharps" container or other suitable container. The disposal of unused medicine and all materials that have come into contact with it will be carried out in accordance with local regulations.
• Place the loaded syringe in a mini-pump or syringe pump.

Apomorfina Kalceks is compatible with polypropylene and polycarbonate syringes and polyvinyl chloride and polyethylene tubes.

If you use more Apomorfina Kalceks than you should

• Tell your doctor or go immediately to the emergency department of the nearest hospital.
• It is important to administer the correct dose of apomorfine and not use more than the dose recommended by the doctor. Higher doses may cause slow heart rate, excessive nausea, excessive sleepiness, and/or difficulty breathing. You may also feel faint or dizzy, especially when standing up, due to low blood pressure. Lying down and elevating your feet will help treat 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 Apomorfina Kalceks

Use it the next time you need it. Do not use a double dose to make up for forgotten doses.

If you stop using Apomorfina Kalceks

Do not stop using this medicine without consulting your doctor first.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience an allergic reaction stop usingthis medicine and contact a doctor or go immediatelyto the emergency department of the nearest hospital. The signs of an allergic reaction may include:

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

The following side effects may also occur:

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

• lumps under the skin at the injection site that are painful and annoying and may cause redness and itching. To avoid these lumps, it is recommended to change the injection site each time the needle is inserted.
• hallucinations (seeing, hearing, or feeling things that do not exist).

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

• nausea or vomiting, especially when starting treatment with apomorfine. Domperidone should be started at least 2 days before starting apomorfine so that you stop having nausea or vomiting. If you are taking domperidone and continue to have nausea, or if you are not taking domperidone and have nausea, tell your doctor or nurse as soon as possible.

• feeling tired or sleepy.
• confusion or hallucinations.
• yawning.
• feeling dizzy or lightheaded when standing up.

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

• increased involuntary movements or increased tremors during "on" periods.
• hemolytic anemia, an abnormal destruction of red blood cells in the blood vessels or elsewhere in the body. This is an uncommon side effect that may occur in patients who are also taking levodopa.
• sudden onset of sleep.
• skin rash.
• difficulty breathing.
• ulceration at the injection site.
• reduction in red blood cells, which may cause the skin to turn pale yellow and cause weakness or difficulty breathing.
• reduction in platelets in the blood, which increases the risk of bleeding or bruising.

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

• allergic reaction.
• eosinophilia (an abnormally high number of white blood cells in the blood or body tissues).

Frequency not known(cannot be estimated from the available data):

• swelling of legs, feet, and toes.
• fainting.
• aggression, agitation.
• headache.
• inability to resist the impulse, desire, or temptation to perform an action 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 sexual interest or behavior that may cause concern to you or others, for example, an increased sexual desire.
• uncontrollable excessive shopping or spending.
• binge eating (eating large amounts of food in a short period) or compulsive overeating (eating more food than normal and more than needed to satisfy your appetite).

Tell your doctor if you experience any of these behaviors; the doctor will discuss alternatives to control or reduce the symptoms with you.

Reporting of side effects

If you experience any side effects, talk to your doctor or nurse, even if it is possible side effects that are not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es

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

5. Storage of Apomorfina Kalceks

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

Do not store above 30 °C. Store in the original packaging to protect from light. Do not refrigerate or freeze.

After opening the ampoule: Once opened, the product must be used immediately.

After loading the medicine into syringes connected to infusion equipment: physical-chemical stability has been demonstrated for 24 hours at 25 °C when the product is stored in aluminum or black polyethylene bags to protect it from light.

From a microbiological point of view, the product must be used immediately, unless the opening and subsequent handling method avoids the risk of microbial contamination. If not used immediately, the storage times and conditions in use are the responsibility of the user.

Do not use this medicine after the expiration date that appears on the box and on the ampoule after 'CAD'. The expiration date is the last day of the indicated month.

The syringes and needles used must be discarded in a "sharp objects" container or in another suitable container. When your "sharp objects" container is full, hand it over to the doctor or pharmacist for safe disposal.

Medicines should not be thrown down the drain or into the trash. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Apomorfina Kalceks

The active ingredient is apomorphine hydrochloride hemihydrate.

Each 1 ml of solution contains 5 mg of apomorphine hydrochloride hemihydrate.

Each 10 ml ampoule contains 50 mg of apomorphine hydrochloride hemihydrate.

The other components are sodium chloride, sodium metabisulfite (E223), hydrochloric acid (for pH adjustment), and water for injectable preparations.

Appearance of the Product and Package Contents

Transparent solution, colorless to yellowish, free of visible particles.

The 10 ml solution is presented in amber glass ampoules with a break point.

The ampoules are placed on a tray. The trays are packaged in a cardboard box.

Package sizes:

5, 10, 25, or 50 ampoules.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

AS KALCEKS

Krustpils iela 71E, Riga, LV‑1057, Latvia

Date of the Last Revision of this Leaflet: November 2023

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