Kynmobi 25 mg orodispersible sublingual film

Package leaflet: Information for the user

Introduction

Package leaflet: 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

Starter pack for treatment initiation

Read the entire leaflet carefully before you start taking 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 reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Kynmobi is and what it is used for
2. What you need to know before taking Kynmobi
3. How to take Kynmobi
4. Possible side effects
5. How to store Kynmobi
6. Contents of the pack and other information

Step-by-step instructions

1. What Kynmobi is and what it is used for

Kynmobi is a medication administered under the tongue (sublingual film) that contains the active substance apomorphine hydrochloride. It is used, as needed, in combination with other orally administered (taken by mouth) Parkinson's disease medications, to reduce "OFF" time: periods during the day when your Parkinson's symptoms worsen significantly. Parkinson's disease is a progressive disorder of the nervous system that causes tremors and affects movement.

2. What you need to know before taking Kynmobi

Do not take Kynmobi

• if you are allergic to apomorphine hydrochloride or any of the other ingredients of this medicine (listed in section 6).
• if you are taking certain medicines used to treat nausea called 5HT3 antagonists, including granisetron, dolasetron, palonosetron, and alosetron.
• if you are taking ondansetron (a medicine used to treat nausea and vomiting).
• if you have a psychotic disorder, a medical term describing various mental illnesses that cause abnormal thinking and perception; people with psychosis lose touch with reality.
• if you have dementia.
• if you have aphthous ulcers: small, flat sores that develop on the soft tissues in the mouth and may cause discomfort when eating or speaking.
• if you have liver problems.
• if you have difficulty breathing.

Warnings and precautions

Talk to your doctor or pharmacist before starting Kynmobi:

• if you have lung problems.
• if you have heart problems.
• if you have liver problems.
• if you frequently experience nausea (feeling dizzy) or vomiting.
• if you have low blood pressure or feel faint or dizzy when standing up. After taking Kynmobi, you should rise slowly if you have been sitting or lying down.
• if you are taking any medicine for high blood pressure.
• if you or a family member has an abnormality in the electrocardiogram (ECG) known as "long QT syndrome".
• if you suffer from a mental illness with symptoms such as hallucinations, delusions, disordered thinking, or loss of touch with reality.

Mouth (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,
• mouth pain or pain when swallowing.

These signs and symptoms resolve when treatment with Kynmobi is stopped.

Inform your doctor if you or your family/caregiver notice that you are developing impulses or urges to behave in an unusual way and are unable to resist the impulse, drive, or temptation to carry out certain activities that could harm you or others. These behaviors are called "impulse control disorders" and may include: gambling addiction, binge eating or excessive spending, abnormally increased sexual desire, or increased sexual thoughts or feelings. Such behaviors have been reported in patients taking other medicines for Parkinson’s disease. Your doctor may need to review your treatment.

Some patients develop addiction-like symptoms, leading to a compulsive desire to take high doses of Kynmobi and other medicines used in the treatment of Parkinson’s disease.

Kynmobi may cause neuroleptic malignant syndrome (a nervous system disorder usually caused by antipsychotics). This condition causes high fever, confusion, changes in breathing and heartbeat, and muscle rigidity.

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

This medicine may cause penile erections. If these develop into prolonged painful erections, consult your doctor.

Children and adolescents

This medicine must not be used in children or adolescents under 18 years of age.

Other medicines and Kynmobi

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

Inform your doctor 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.
• Domperidone, a medicine to prevent nausea.
• Medicines 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.
• Medicines such as clozapine used to treat mental disorders.
• Certain medicines that affect heart rate.
• Medicines that may affect electrolyte (salt) concentrations in your body.
• Other medicines for Parkinson’s disease.

Taking Kynmobi with alcohol

Do not drink alcohol while taking this medicine.

Pregnancy and breastfeeding

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.

Kynmobi is not recommended during pregnancy. Use an effective method of contraception if you are of childbearing age.

It is unknown whether Kynmobi is excreted in breast milk. Consult your doctor, who will advise whether you should discontinue breastfeeding or stop Kynmobi, taking into account the benefits of your treatment and the benefits of breastfeeding for your baby.

Driving and using machines

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

Kynmobi contains metabisulfite

Kynmobi contains metabisulfite, which rarely may 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 immediately to the nearest hospital.

This medicine contains less than 1 mmol of sodium (23 mg) per sublingual film; essentially "sodium-free".

3. How to take Kynmobi

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

Dosage when starting treatment:

A starter pack is available containing 2 sublingual films of each dose. This pack is usually necessary for your doctor to find the appropriate dose for you.

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

Maintenance dosage:

The recommended dose of this medicine will depend on your individual needs and will be determined by your doctor. Do not take more than one Kynmobi film per "OFF" episode. You may 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 per day. The maximum daily dose of Kynmobi is 150 mg.

You must place the medicine under your tongue and take it whole. Do not cut, chew, or swallow it. See 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, contact your doctor or pharmacist immediately, call the Toxicology Information Service at 91 562 04 20, stating the medicine and the amount taken, or go to hospital immediately. Take the medicine packaging and this leaflet with you. This will help the doctor identify what has been taken.

If you stop taking Kynmobi

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

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 everybody gets them.

Tell your doctor as soon as possible if you experience any of the following adverse effects:

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

• Feeling sleepy.
• Yawning.
• Dizziness.
• Pain, redness, sores, or a change in sensation in the mouth, lips, or tongue.

Common: may affect up to 1 in 10 people.

• Hearing, seeing, feeling, smelling, or tasting things that do not exist.
• Abnormal, uncontrolled, involuntary movements.
• Shortness of breath.
• Oral candidiasis (candida – a fungal infection in the mouth).
• Dizziness.
• Headache.
• Fainting.
• Blurred vision.
• A drop in blood pressure upon standing, which may cause dizziness, lightheadedness, or fainting.
• Low blood pressure.
• Sudden feeling of warmth.
• High blood pressure.
• Runny nose.
• Vomiting.
• Swelling or dryness of the mouth, lips, tongue, or gums.
• Nausea without vomiting.
• Excessive sweating.
• Cold sweats.
• Feeling of low energy or tiredness.
• Malaise.
• Feeling cold.
• Chills.
• Falls.
• Skin rash.
• Feeling of fatigue or extreme drowsiness.

Uncommon: may affect up to 1 in 100 people.

• Psychotic disorder: a medical term describing various mental illnesses that cause abnormal thoughts and perceptions; people with psychosis lose touch with reality.
• Cardiac arrest.
• Irregular or slow heart rate.
• Allergic reaction. Signs may include rash, hives, itching, redness, drop in blood pressure, or a sensation of throat tightness.
• Compulsive need to take high doses of Kynmobi and other medicines used to treat Parkinson's disease.
• Recurrent, unwanted thoughts, ideas, or sensations that drive you to repeatedly perform certain actions.
• Red, swollen patches at the corners of the mouth.
• Loss of appetite.
• Anxiety.
• Feeling confused.
• Drooling.
• Sudden sleep episodes.
• Excessive tearing, watery eyes.
• Rapid redness of the neck, upper chest, or face.
• Paleness.
• Constipation.
• Indigestion.
• Belching.
• Difficulty or discomfort when swallowing.
• Changes in tooth color or cavities in the teeth.
• Spontaneous penile erection.
• Feeling of drunkenness.
• Elevated vitamin B6.
• Agitation.
• Swelling in the arms and legs.
• Positive Coombs test.
• Hemolytic anemia, an abnormal destruction of red blood cells in blood vessels or elsewhere in the body.
• Reduction in blood platelets, which increases 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.

Adverse effects with unknown frequency (cannot be estimated from available data):

• Inability to resist the impulse to carry out a dangerous action, such as gambling, repetitive meaningless actions, increased sexual interest, impulsive buying, or excessive spending.
• Aggressiveness.

Reporting of adverse effects

If you experience any 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: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Kynmobi

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the sachets and the outer carton after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25°C. Store in the sachet to protect from light and moisture.

Keep Kynmobi in the sachet until ready to take.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Kynmobi

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

Appearance of the product and contents of the pack

Kynmobi orodispersible 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 starter pack contains 10 orodispersible films with 2 films of 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg each.

Other packs contain 15 or 30 orodispersible films.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Bial - Portela & Cª, S.A.
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

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 European Economic Area member states under the following names:

Portugal, Italy, Germany, France: Kynmobi

Date of the most recent review of this leaflet: February 2024.

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

Step-by-step instructions