Prospecto: Information for the User

APO-go PEN 10 mg/ml injectable solutionApomorphine hydrochloride

(* Abbreviated in the text to APO-go)

For use in adults

Read this prospectus carefully before starting to use this medication, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor, nurse or pharmacist.
• This medication has been prescribed to you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist even if they do not appear in this prospectus. See section 4.

APO-go Pen contains an injectable solution of apomorphine that is injected under the skin (subcutaneously). The active ingredient of APO-go Pen is apomorphine hydrochloride. Each milliliter of solution contains 10 mg of apomorphine.

Apomorphine hydrochloride is a medication belonging to the group known as dopamine agonists. APO-go Pen is used to treat Parkinson's disease. Apomorphine helps to reduce the time in the ""off"state or state of immobility in patients who have been previously treated with levodopa and/or other dopamine agonists for Parkinson's disease. Your doctor or nurse will help you recognize the signs that will indicate when you should use this medication.

Despite the name of the medication, apomorphine does not contain morphine.

Before using APO-go Pen, your doctor will perform an ECG (electrocardiogram) and ask for a list of all the other medications you are taking. This ECG will be repeated in the first days of treatment and at any time your doctor considers necessary. Your doctor will also ask about other health conditions you may have, especially those related to the heart. Some of the questions and additional examinations may be repeated at each medical visit. If you have symptoms that may be related to the heart, such as palpitations, fainting, or dizziness, you must inform your doctor immediately. If you have diarrhea or start taking a new medication, you must also inform your doctor.

Do not use APO-go Pen if:

• You are under 18 years old
• You have breathing difficulties
• You have dementia or Alzheimer's disease
• You have any mental illness that is characterized by symptoms such as hallucinations, delirium, confusion, or loss of contact with reality
• You have liver problems
• You have severe dyskinesia (involuntary movements) or severe dystonia (inability to move) despite taking levodopa
• You are allergic to apomorphine or any of the other components of this medication (listed in section 6)
• You or a family member have a heart rhythm disorder called "long QT interval syndrome."
• You are taking ondansetron (a medication used to treat nausea and vomiting)

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use APO-go Pen if:

• You have kidney problems
• You have lung problems
• You have heart problems
• You have low blood pressure or feel weak or dizzy when standing up
• You are taking another medication to treat high blood pressure
• You have nausea or vomiting
• Your Parkinson's disease causes certain mental problems such as hallucinations and confusion
• You are elderly or weak

Inform your doctor if you or your family members/caregivers notice that you are developing impulses or unusual behavior that you cannot resist, which may be harmful to you or others. These behaviors are called impulse control disorders and may include addictive gaming, excessive eating or spending, abnormal sexual desire, or increased sexual thoughts or feelings. Your doctor may need to adjust or discontinue your dose.

Some patients develop symptoms of addiction that lead to a compulsive desire to consume high doses of APO-go Pen and other medications used to treat Parkinson's disease.

If any of these situations occur, please inform your doctor or nurse.

Children and adolescents

APO-go Pen should not be used in children and adolescents under 18 years old.

Use of APO-go Pen and other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Consult your doctor or pharmacist before taking this medicationif:

• You are using medications that affect how your heart beats. This includes medications used to treat heart rhythm problems (such as quinidine and amiodarone), depression (such as tricyclic antidepressants like amitriptyline and imipramine), and bacterial infections (macrolide antibiotics like erythromycin, azithromycin, and clarithromycin) and domperidone.
• You are taking ondansetron (a medication used to treat nausea and vomiting) as this may cause severe drops in blood pressure and loss of consciousness.

If you use this medication at the same time as other medications, the effect of these medications may be altered. This occurs particularly with:

• Medications like clozapine for mental disorders
• Medications to lower blood pressure
• Other medications used to treat Parkinson's disease.

Your doctor will inform you if you need to change the dose of apomorphine or any other medication you are taking.

If you are also using levodopa (another medication for Parkinson's disease), your doctor should perform regular blood tests.

Use of APO-go Pen with food and drinks

Foods and beverages do not affect how this medication works.

Pregnancy and breastfeeding

APO-go Pen should not be used during pregnancy unless it is clearly necessary.

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

The excretion of APO-go Pen in breast milk is unknown. Consult your doctor if you are breastfeeding or plan to start. Your doctor will explain whether you should continue or discontinue breastfeeding, and whether you should continue taking this medication or discontinue it.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

APO-go Pen may cause drowsiness and a strong desire to sleep. You should not drive or operate machinery if this medication causes this effect.

APO-go Pen contains sodium acid sulfite:APO-go Pen contains sodium acid sulfite (E-222), which, in rare cases, may cause severe allergic reactions with symptoms such as hives or skin itching, difficulty breathing, swelling of eyelids, face, or lips, inflammation or redness of the tongue. If you experience these adverse effects, go to the nearest hospital immediately.

APO-go Pen contains less than 23 mg (1 mmol) of sodium per 10 ml, making it essentially "sodium-free."

Before using APO-go Pen, your doctor will check that you can tolerate this medication and an antiemetic medication that you must take simultaneously.

Follow exactly the administration instructions for this medication indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

You should take domperidone, at least 2 days before using APO-go Pen to avoid nausea or vomiting.

Do not use APO-go Pen if:

• The solution has turned green.
• The solution is cloudy or you observe the presence of particles.

Where to inject APO-go Pen

-Inject APO-go Pen in an area under the skin (subcutaneously) according to the instructions of your doctor or nurse.

-Do not inject APO-go Pen into a vein.

How much to use

The amount of APO-go Pen you should use and how often will depend on your personal needs. Your doctor will discuss this with you and recommend the amount of medication you should use. The appropriate dose for you will be determined during your visit to the specialist.

• The normal daily dose is between 3 mg and 30 mg.
• You may need up to 100 mg per day.
• You will usually need between 1 and 10 injections per day.
• Each injection should not exceed a dose of 10 mg.

Before using APO-go Pen, study the following diagram and your pen to familiarize yourself with your medication.

* The packaging does not contain needles to use with your pen. Use needles for pens with a length of no more than 12.7 mm and a caliber of no less than 0.31 mm (30G).

Needles for pens recommended for use with insulin pens are compatible with APO-go Pen.

IMPORTANT: Do not pull the dose dial of the red cap (see 1) before selecting the dose (see “How to select your correct dose”).

Mounting the needle

(a)Before using APO-go Pen, you will need sterile gauze and a needle with its protective cone (see 2).

(b) Remove the pen from its packaging and remove the cap (see 3).

(c) Clean the membrane of the pen (see 4) with a sterile gauze.

(d)Remove the paper from the protective cone (see 2).

(e)It is essential to place the needle in a straight line with the pen, as shown in the previous drawing.If the needle is tilted, it may cause the pen to leak.

(f)Twist the cone (see 2) onto the membrane in a clockwise direction until it is securely tightened. This will safely secure the needle.

(g) Remove the protective cone (see 5), but do not throw it away. Do not remove the needle protector (see 6yet.

(h) Replace the pen cap (see 3).

How to select the correct dose

(i) Press the dose dial of the red cap (see 1) and turn it clockwise while keeping it pressed until the arrow points to the dose prescribed by your doctor (see 7, 8); then release the pressure on the dose dial of the red cap. The dose is now selected, and it will not be necessary to manipulate the dial for subsequent injections.

Important:If you have exceeded the prescribed dose while turning the dial, continue pressing and turning in the same direction until it points to the prescribed dose by your doctor.Never pull and turn the dose dial of the red cap at the same time.

If your dose is 1 mg, start by emptying a dose of 1 mg onto a paper towel and then discard the towel. This is called “purging” the pen and is essential to ensure that the correct dose is administered the first time the pen is used. After purging, select the required dose and inject the pen as usual (see “How to administer the injection”). If the first dose is greater than 1 mg, it is not necessary to “purge” the pen.

How to administer the injection

(j) Once you have selected your dose, carefully pull the dose dial of the red cap to its stop. Check the red scale on the plunger (see 9) and inject only if the visible line corresponds to the desired dose.

(k) Clean the area of the skin where the injection will be administered with a sterile gauze.

(l) Remove the pen cap (see 3).

(m) Remove the needle protector (see 6).

(n) Insert the needle (see 10) into the skin, according to your doctor's instructions.

(o) To administer the dose, press the dose dial of the red cap (see 1) downwards as far as possible, using your thumb if possible. Once the dose dial of the red cap is fully pressed, count to three before removing the needle.

(p) Place the protective cone (see 5) over the used needle, gently pushing it into place. Once secure, twist the needle in the opposite direction to the clock to unscrew it. Keep the needle inside the protective cone and dispose of it safely in a container or empty coffee cup.

How to prepare the next injection

(q) Remove the pen cap and check if there is enough apomorphine left in the cartridge to administer the next injection. If so, place a new needle in its position in the same way as previously indicated.

(r) If there is not enough apomorphine for another injection, prepare another pen.

(s) Finally, replace the pen cap.

If you use more APO-go Pen than you should

In case of overdose or accidental ingestion, consult your doctor immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

- Inform your doctor or contact the emergency department of the nearest hospital immediately.

-You may notice that your heart beats slower, you feel nauseous or want to vomit, excessive drowsiness, and/or difficulty breathing. You may also feel weak or dizzy, especially when getting up due to a drop in blood pressure. Lying down with your feet elevated will help you feel better.

If you forget to use APO-go Pen

In case of forgotten dose, wait for the next one. Do not use a double dose to compensate for the missed dose.

If you interrupt treatment with APO-go Pen

Do not stop using APO-go Pen without consulting your doctor first.

If you have any other questions about using this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

If you experience an allergic reactioninterrupt treatment with APO-go Pen and contact your doctor or the nearest hospital emergency serviceimmediately. The symptoms of an allergic reaction may be:

• hives
• difficulty breathing
• swelling of the face, lips, throat, or tongue.

APO-go Pen may cause, sometimes, the following side effects:

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

-the appearance of lumps under the skin at the injection site that are painful, annoying, and may become red and cause itching. To avoid the appearance of 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 and vomiting, particularly when starting treatment with APO-go Pen. If you are taking domperidone and still feel nauseous or have vomiting, or if you are not taking domperidone and feel nauseous or have vomiting, consult your doctor as soon as possible.
• excessive fatigue or drowsiness.
• confusion or hallucinations.
• yawns.
• sensation of dizziness or weakness when standing up.

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

• increase in involuntary movements or tremors during the "on" periods.
• hemolytic anemia (abnormal destruction of red blood cells in the blood vessels or in other parts of the body).This is a rare side effect that may occur in patients who also take levodopa.
• sudden sleep.
• hives.
• difficulty breathing.
• ulceration of the injection site.
• reduction in the number of red blood cells, which may cause pale skin and cause weakness and shortness of breath.
• reduction in the number of platelets, which increases the risk of bleeding or hematoma.

Rare (may affect up to 1 in 1,000 patients):

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

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

• swelling of the legs, feet, or toes.
• inability to resist the impulse, desire, or temptation to perform an action that could be harmful to you or others, which may include:

• strong impulse to gamble excessively, despite severe personal or family consequences.
• alteration or increase in sexual interest and behavior, either with oneself or with others, for example, an increased sexual impulse.
• uncontrollable spending or excessive purchases
• 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).
  

• syncope.
• aggression, agitation.
• headache.

Tell your doctor if you experience any of these behaviors; your doctor will instruct you on how to control or reduce the symptoms.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist,even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the label and in the box.The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C. Store the cartridge in the cardboard case to protect it from light.

Store in the same conditions of conservation after opening and between successive uses.

Do not use this medication if the solution has turned green. It should only be used if the solution is clear and colorless and free of visible particles.

When starting to use a new container of APO-go Pen, it can be used up to 48 hours. Do not reuse it after this time. Use a new pen.

To dispose of your pens safely, always remove the needle from the penbeforedisposing of it, for example, in a sharps container or an empty coffee cup.

When the sharps container is full, give it to your doctor or pharmacist for safe disposal. If the pen is completely empty, you can throw it away with household waste.

Medications should not be thrown away through the drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment..

Composition of APO-go PEN

• The active ingredient is apomorphine hydrochloride. Each milliliter of APO-go PEN contains 10 mg of apomorphine hydrochloride. Each APO-go PEN contains 3 ml of injectable solution.
• The other components (excipients) are:
• sodium metabisulphite (E223)
• hydrochloric acid (37%)
• injection water.

See section 2: Apo-go PEN contains sodium sulphite.

Appearance of the product and contents of the pack

APO-go PEN 10 mg/ml is a disposable, multiple-dose injection pen, which incorporates a transparent glass cartridge containing the apomorphine injectable solution. The solution is clear, practically colourless, odourless and free from visible particles.

The packs contain 1, 5 or 10 pens in a moulded plastic tray in a cardboard carton.

APO-go Pen is available in packs of 1, 5 or 10 pens and in multiple packs containing 5 cartons with 5 pens each.

Only some pack sizes may be marketed.

Marketing authorisation holder

STADA Arzneimittel AG

Stadastraße 2- 18

61118 Bad Vilbel, Germany

Responsible person

Laboratoire Aguettant

1 Rue Alexander Fleming

Boite Postale 7144

69353 Lyon, Cedex 07 – France

or

STADA Arzneimittel AG

Stadastr. 2 – 18

61118 Bad Vilbel

Germany

Further information on this medicinal product can be obtained by contacting the local representative of the marketing authorisation holder:

ITALFARMACO S.A.

San Rafael, 3

28108 Alcobendas (Madrid)

Spain

This medicinal product is authorised in theMember States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria, Germany:APO-go PEN 10 mg/ml Injektionslösung

Belgium:APO-GO®-PEN 10 mg/ml oplossing voor injectie

Bulgaria:A?O-?o®???????10mg/ml??????????????????

Cyprus:APO-goΣυσκευ? τ?που π?νας10 mg/mlΕν?σιμοΔι?λυμα

Czech Republic:Britaject PEN

Denmark:APO-go PEN 10mg/ml Injektionsv?ske, opl?sning

Estonia:APO-go, 10 mg/ml süstelahus pen-süstlis

Finland:Apogo PEN 10 mg/ml injektioneste, liuos

Greece:APO-goΣυσκευ? τ?που π?νας10 mg/ml Εν?σιμο Δι?λυμα

Ireland, Malta, United Kingdom:APO-go Pen 10mg/ml solution for injection

Latvia:APO-go PEN 10 mg/ml škidums injekcijam

Lithuania:Britaject 10 mg/ml injekcinis tirpalas

Luxembourg:APO-go® PEN 10mg/ml Solution Injectable

Netherlands:APO-go PEN, Oplossing Voor injectie 10mg/ml

Norway:Britaject 10mg/ml injeksjonsvæske, oppl?sning i ferdigfylt penn

Portugal:Apo-go Pen 10 mg/ml Solução injectável

Romania:APO-go 10mg/ml solutie injectabila în pen multidoza

Slovenia:APO-go 10 mg/ml raztopina za injiciranje v peresniku

Spain:APO-go PEN 10 mg/ml Solución inyectable

Sweden:APO-go PEN 10 mg/ml Injektionsvätska, lösning

Last update of the summary of product characteristics:March 2025

Further information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es