Label: information for the patient

Kynmobi 10 mg sublingual film

Kynmobi 15 mg sublingual film

Kynmobi 20 mg sublingual film

Kynmobi 25 mg sublingual film

Kynmobi 30 mg sublingual film

apomorphine hydrochloride

Kynmobi 10 mg + 15 mg + 20 mg + 25 mg + 30 mg sublingual film

apomorphine hydrochloride

Package for the start of treatment

Read this label carefully before starting to take this medicine, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

Step-by-step instructions

Kynmobi is a medication that is placed under the tongue (sublingual film), which contains the active ingredient apomorphine hydrochloride. It is used, as needed, with other oral medications for Parkinson's disease taken through the mouth, to reduce the time in "OFF": a period during the day when symptoms of the disease worsen significantly. Parkinson's disease is a progressive nervous system disorder, which causes tremors and affects movement.

Do not take Kynmobi

• if you are allergic to apomorphine hydrochloride or any of the other ingredients of this medication (listed in section 6).
• if you are taking certain medications to treat nausea called 5HT3 antagonists, including granisetron, dolasetron, palonosetron, and alosetron.
• if you are taking ondansetron (medication to treat nausea and vomiting).
• if you have a psychotic disorder, a medical term that describes many mental illnesses that cause abnormal thoughts and perceptions; people with psychosis lose contact with reality.
• if you have dementia.
• if you have aphthous ulcers: small flat lesions that appear in the soft tissues of the mouth and can cause discomfort when eating and speaking.
• if you have liver problems.
• if you have difficulty breathing.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Kynmobi:

• if you have lung problems.
• if you have heart problems.
• if you have liver problems.
• if you have nausea frequently (feeling of dizziness) or vomiting.
• if you have low blood pressure or feel like you are going to faint or dizzy when you get up.After taking Kynmobi, you should get up slowly if you are sitting or lying down.
• if you are taking any medication to treat high blood pressure.
• if you or a family member have an abnormality in the electrocardiogram (ECG) called "long QT syndrome".
• if you have a mental illness with symptoms such as hallucinations, delusions, disorganized thoughts, loss of contact with reality.

Oral irritation is a very common side effect of Kynmobi. Inform your doctor if you develop any of the following signs or symptoms:

• redness,
• mouth sores (ulceration),
• dryness in the mouth, lips, or tongue,
• swelling,
• pain in the mouth or difficulty swallowing.

These signs and symptoms disappear when you stop taking Kynmobi.

Inform your doctor if you or your family/caregiver notice that you are developing impulses or desires to behave in an unusual way and cannot resist the impulse, push, or temptation to carry out certain activities that could harm you or others. These behaviors are called "impulse control disorders" and may include: addiction to gambling, eating excessively, or spending excessively, an abnormally elevated sexual desire or an increase in sexual thoughts or feelings. Your doctor may need to review your treatments.

Some patients develop symptoms similar to addiction, which lead them to a compulsive desire to take high doses of Kynmobi and other medications used to treat Parkinson's disease.

Kynmobi can cause neuroleptic malignant syndrome (a disorder of the nervous system that is usually caused by antipsychotics). This is a disorder that causes high fever, confusion, changes in breathing and heart rate, and muscle rigidity.

When you reduce your dose of Kynmobi or stop treatment, you may experience withdrawal symptoms such as: lack of interest, anxiety, depression, fatigue, sweating, panic attacks, insomnia, irritability, and pain.

This medication can cause penile erections. If these evolve into prolonged painful erections, consult your doctor.

Children and adolescents

This medication should not be used in children or adolescents under 18 years of age.

Other medications and Kynmobi

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

Inform your doctor if you are taking:

• Ondansetron (medication to treat nausea and vomiting), as this can result in a severe drop in blood pressure and loss of consciousness.
• Domperidone, a medication to prevent nausea.
• Medications to lower blood pressure or treat heart disease, such as sublingual nitroglycerin. Your blood pressure may drop and cause dizziness. Lie down before and after taking sublingual nitroglycerin.
• Medications such as clozapine to treat mental disorders.
• Determined medications that affect heart rate.
• Medications that can affect the concentrations of electrolytes (salts) in your body.
• Other medications for Parkinson's disease.

Taking Kynmobi with alcohol

You should not drink alcohol while taking this medication.

Pregnancy and breastfeeding

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

Kynmobi is not recommended if you are pregnant. Use an effective contraceptive method if you are fertile.

It is unknown whether Kynmobi is excreted in breast milk. Consult your doctor, they will indicate whether you should stop breastfeeding or suspend Kynmobi, considering the benefit of your treatment and that of breastfeeding for your baby.

Driving and operating machinery

Kynmobi may cause dizziness, dizziness, or somnolence. Do not drive or operate machinery if you experience any of these side effects.

Kynmobi contains metabisulfito

Kynmobi contains metabisulfito, which may rarely cause severe hypersensitivity reactions and bronchospasm, with symptoms such as skin rash or itching, difficulty breathing, swollen eyelids, face, or lips, swelling or redness of the tongue. If you experience these side effects, go to the nearest hospital immediately.

This medication contains less than 1 mmol of sodium (23 mg) per sublingual film; that is, it is essentially "sodium-free".

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

Starting dose:

A starter pack is available that contains 2 sublingual films of each dose. This pack is usually required for your doctor to find the right dose for you.

Your doctor will decide how much Kynmobi you should take and how often. It is possible that not all the sublingual films in the starter pack will be needed (for example, if the correct dose for you is 20 mg, then the 25 mg and 30 mg films will not be needed).

Maintenance dose:

The recommended dose of this medication will depend on your needs and will be determined by your doctor. Do not take more than one Kynmobi film for an episode of "OFF". You can take Kynmobi up to 5 times a day, but there must be at least 2 hours between doses.

Do not use more than 5 films a day. The maximum daily dose of Kynmobi is 150 mg.

You must place the medication under your tongue and take it whole. Do not cut, chew, or swallow it.See the complete information in the«Step-by-Step Instructions»in this leaflet.

If you take more Kynmobi than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested, or go to the hospital immediately. Bring the medication packaging and this leaflet with you. This will help the doctor to identify what you have taken.

If you interrupt treatment with Kynmobi

Do not stop taking Kynmobi unless your doctor tells you to, as your symptoms may worsen.

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

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

Inform your doctor as soon as possibleif you experience any of the following side effects:

Very common: may affect more than 1 in 10 people.

• Drowsiness.
• Yawning.
• Dizziness.
• Pain, redness, ulcers, or a change in sensation in the mouth, lips, or tongue.

Common: may affect up to 1 in 10 people.

• Seeing, hearing, feeling, smelling, or tasting things that do not exist.
• Uncontrolled, involuntary movements.
• Shortness of breath.
• Oral candidiasis (candida - a fungal infection in the mouth).
• Dizziness.
• Headache.
• Fatigue.
• Blurred vision.
• A drop in blood pressure when standing, which may cause dizziness, lightheadedness, or fatigue.
• Low blood pressure.
• Sudden feeling of heat.
• High blood pressure.
• Coughing.
• Vomiting.
• Swelling or dryness of the mouth, lips, tongue, or gums.
• Regurgitation without vomiting.
• Excessive sweating.
• Cold sweat.
• Feeling of having little energy or fatigue.
• Discomfort.
• Feeling of cold.
• Chills.
• Falls.
• Dermatological eruption.
• Extreme fatigue or somnolence.

Uncommon: may affect up to 1 in 100 people.

• Psychotic disorder: a medical term that describes many mental illnesses that cause abnormal thoughts and perceptions; people with psychosis lose contact with reality.
• Cardiac arrest.
• Irregular or slow heart rate.
• Allergic reaction. Symptoms may include rash, hives, itching, redness, drop in blood pressure, sensation of throat constriction.
• Imperative need to take high doses of Kynmobi and other medicines used to treat Parkinson's disease.
• Recurring, unwanted thoughts, ideas, or sensations that drive you to do something repeatedly.
• Red, swollen patches at the corners of the mouth.
• Loss of appetite.
• Anxiety.
• Confusion.
• Stuttering.
• Episodes of sudden sleep.
• Excessive tearing, watery eyes.
• Rapid redness of the neck, upper chest, or face.
• Pallor.
• Constipation.
• Indigestion.
• Belching.
• Difficulty or discomfort swallowing.
• Changes in tooth color or cavities in the teeth.
• Spontaneous penile erection.
• Feeling drunk.
• Elevated vitamin B6.
• Restlessness.
• Swelling in the legs and arms.
• Positive Coombs test.
• Autoimmune hemolytic anemia, an abnormal destruction of red blood cells in the blood vessels or another part of the body.
• Reduction of blood platelets, increasing the risk of bleeding or bruising.

Rare: may affect up to 1 in 1,000 people.

• Eosinophilia, an abnormally high number of white blood cells in the blood or tissues of the body.

The frequency of side effects not known (cannot be estimated from available data) are:

• Inability to resist the impulse to perform a dangerous action, such as compulsive behavior, repetitive actions without sense, increased sexual interest, impulsive purchases, or excessive spending.
• Aggression.

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 leaflet. 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 packaging and the box after EXP. The expiration date is the last day of the month indicated.

Do not store above 25°C. Store in the packaging to protect it from light and humidity.

Store Kynmobi in the packaging until you are ready to take it.

Medications should not be disposed of through drains or 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.By doing so, you will help protect the environment.

Composition ofKynmobi

• The active ingredient is apomorphine hydrochloride.
• The other ingredients are: sodium edetate (E385), FD&C Blue No. 1 (E133), glycerol (E422), mono- and diglycerides (E471), hydroxyethylcellulose 250 G and 250 L (E1525), hydroxypropylcellulose (E463), maltodextrin, levomenthol, pyridoxine hydrochloride (for pH adjustment), sodium hydroxide (E524) (for pH adjustment), sodium metabisulfite (E223) (see section 2), sucralose (E955), white ink (Shellac [E904], anhydrous alcohol [E1510], isopropyl alcohol, butyl alcohol, propylene glycol [E1520], concentrated ammonia solution [E527], purified water, potassium hydroxide [E525], titanium dioxide [E171]).

Appearance of the product and contents of the pack

Kynmobi sublingual film is a rectangular blue to green film with a white printed number indicating the concentration (e.g., "10" means 10 mg).

Kynmobi is available in the following pack sizes:

The starting treatment pack contains 10 sublingual films with 2 films of 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg each.

The other packs contain 15 or 30 sublingual films.

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Bial - Portela & Cª, S.A.

À Av. da Siderurgia Nacional

4745-457 S. Mamede do Coronado

Portugal

Tel: +351 22 986 61 00

Fax: +351 22 986 61 90

e-mail: [email protected]

Manufacturer responsible

Tesa Labtec GmbH

Heykenaukamp 10

21147 Hamburg

Germany

Local representative

Laboratorios BIAL, S.A.

C/Alcalá 265, Edificio 2, Planta 2ª

28027 Madrid

Spain

Tel: +34 915624196

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

Portugal, Italy, Germany, France: Kynmobi

Date of the last revision of this leaflet: February 2024.

The detailed 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/).

Step-by-step instructions