KYNMOBI 10 mg Film Sublingwalny

Treść ulotki

1. Kynmobi 10 mg sublingual film, 15 mg sublingual film, 20 mg sublingual film, 25 mg sublingual film, 30 mg sublingual film
   1. What is Kynmobi and what is it used for
   2. What you need to know before you take Kynmobi
   3. How to take Kynmobi
   4. Possible side effects
   5. How to store Kynmobi
   6. Package contents and other information

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

apomorphine hydrochloride

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
Starter pack
apomorphine hydrochloride

Read this leaflet carefully before you start to take this medicine because it contains important information for you.

• Keep this leaflet. 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. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Kynmobi is and what it is used for
• 2. What you need to know before you take 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 is Kynmobi and what is it used for

Kynmobi is a medicine to be placed under the tongue (sublingual film), containing the active substance
apomorphine hydrochloride. It is used, as needed, together with other medicines for Parkinson's disease to be taken orally (by mouth), to reduce the duration of “OFF” periods, i.e. the
periods during the day when Parkinson's symptoms worsen considerably. Parkinson's disease is a progressive disease of the nervous system that causes tremors and impairs
movements.

2. What you need to know before you take Kynmobi

Do not take Kynmobi

• if you are allergic to apomorphine hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
• if you are taking certain medicines for the treatment of nausea, called 5HT3 antagonists, including ondansetron, granisetron, dolasetron, palonosetron and alosetron.
• 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 suffer from dementia
• if you have mouth ulcers (also called aphthous ulcers), i.e. small superficial lesions on the soft tissues of the mouth that can make eating and speaking uncomfortable.
• if you have liver problems
• if you have difficulty breathing

Warnings and precautions
Talk to your doctor or pharmacist before taking Kynmobi

• if you have lung problems
• if you have heart problems
• if you have liver problems
• if you often feel nauseous (feeling unwell) or vomit
• if you have low blood pressure or feel faint or dizzy when you stand up. Get up slowly from a sitting or lying position after taking Kynmobi
• if you are taking any medicine for high blood pressure
• if you or a family member is known to have an abnormality on an electrocardiogram (ECG) called “long QT syndrome”.
• if you suffer from a mental illness with symptoms such as hallucinations, delusions, confused thinking, loss of contact with reality

Mouth (oral) irritation is a very common side effect of Kynmobi. Tell your doctor
if you experience any of the following signs or symptoms.

• redness
• mouth sores (ulceration)
• dry mouth, lips or tongue
• swelling
• pain in the mouth or pain when swallowing These signs and symptoms may disappear if you stop taking Kynmobi.

Talk to your doctor if you, a family member or the person who cares for you notices that you are
developing an urge or craving to behave in a way that is unusual for you and that you cannot resist
the urge, desire or temptation to engage in activities that could harm yourself or
others. These behaviors are called “impulse control disorders” and may include: pathological gambling, excessive eating or spending, an increased sexual desire or increased thoughts or sensations of a sexual nature. Behaviors of
this type have been observed in patients treated with other medicines for Parkinson's disease. Your
doctor may need to re-evaluate your treatment.
Some patients may develop symptoms similar to withdrawal symptoms, resulting in an impulsive desire
to take high doses of Kynmobi and other medicines used to treat
Parkinson's disease.
Kynmobi can cause neuroleptic malignant syndrome (a nervous system disorder generally caused by
antipsychotic medicines). This is a disorder that causes high fever, confusion, changes in breathing and
heart rate, and muscle rigidity.
If you reduce the dose of Kynmobi or stop treatment, withdrawal symptoms may appear such as: loss of interest, anxiety, depression, fatigue, sweating, panic attacks,
insomnia, irritability and pain.
This medicine can cause erections of the penis. If the erections become prolonged and painful, see
your doctor.

Children and adolescents
Kynmobi must not be used in children and adolescents under the age of 18 years.

Other medicines and Kynmobi
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Tell your doctor if you are taking:

• domperidone, a medicine used to prevent nausea,
• medicines used to lower blood pressure or treat heart disease, such as nitroglycerin under the tongue (sublingual). Blood pressure may decrease and cause dizziness. You should lie down before and after taking sublingual nitroglycerin.
• medicines such as clozapine, for the treatment of mental illnesses.
• certain medicines that affect heart rate
• medicines that can affect electrolyte (salt) levels in the body
• other medicines for Parkinson's disease.

Kynmobi with alcohol
Do not drink alcohol while taking this medicine.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor or
pharmacist for advice before taking this medicine.
Kynmobi is not recommended if you are pregnant. You should use effective contraceptive
measures if you could become pregnant.
It is not known whether Kynmobi passes into breast milk. Ask your doctor, who will tell you whether to
stop breastfeeding or stop taking Kynmobi, considering the benefit of
therapy for you and the benefit of breastfeeding for the baby.

Driving and using machines
Kynmobi can cause a feeling of dizziness, lightheadedness or drowsiness. Do not drive or
use machines if you experience any of these side effects.

Kynmobi contains metabisulfite
Kynmobi contains metabisulfite, which can rarely cause severe hypersensitivity reactions and
bronchospasm, with symptoms such as skin rash or itching, difficulty breathing, swelling of the
eyelids, face or lips, swelling or redness of the tongue. If you experience these effects
indesiderati, go immediately to the nearest hospital.
This medicine contains less than 1 mmol (23 mg) of sodium per sublingual film, i.e. it is
essentially “sodium-free”.

3. How to take Kynmobi

Take this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist.

Starting dose:
A starter pack is available, containing 2 sublingual films for each dosage.
This pack is generally used by the doctor to find the dose that is right for you.
The doctor will decide which dose of Kynmobi you should take and how often. You may not
need to take all the sublingual films in the starter pack (for example, if the dose
that is right for you is 20 mg, the 25 mg and 30 mg films will not be needed).

Maintenance dose:
The recommended dose of Kynmobi depends on your need and is established by the doctor. You should not
take more than one Kynmobi film for an “OFF” episode. You can take Kynmobi up to 5 times a day, but not before at least 2 hours have passed between doses.
Do not use more than 5 films per day. The maximum dose of Kynmobi is 150 mg per day.
This medicine must be placed under the tongue and must be taken whole. It must not be
cut, chewed or swallowed. For detailed information, see “Step-by-step instructions”

If you take more Kynmobi than you should
If you take more Kynmobi than you should, inform your doctor or pharmacist or go immediately to
the doctor to understand what you have taken.

If you stop taking Kynmobi
Do not stop treatment with Kynmobi unless your doctor tells you to, as your
symptoms may worsen.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Tell your doctor as soon as possibleif you notice any of the following side effects:
Very common: may affect more than 1 in 10 people

• Feeling sleepy
• Yawning
• Feeling unwell
• Pain, redness, sores or changes in sensation in the mouth, lips or tongue

Common: may affect up to 1 in 10 people

• Hearing, seeing or feeling things that are not there, or smelling or tasting things that are not there
• Abnormal, uncontrollable, involuntary movements
• Shortness of breath
• Oral thrush (Candida - yeast infection in the mouth)
• Feeling dizzy
• Headache
• Fainting
• Blurred vision
• Low blood pressure when standing up, which can 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
• Excessive sweating
• Cold sweat
• Feeling of lack of energy or fatigue
• Discomfort
• Feeling cold
• Chills
• Falls
• Rash

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 touch with reality
• Cardiac arrest
• Irregular or slow heartbeat
• Allergic reaction. Signs can include rash, hives, itching, flushing, low blood pressure, feeling of tightness in the throat
• An uncontrollable need and impulsive desire to take high doses of Kynmobi and other medicines used for Parkinson's disease.
• Recurring, unwanted thoughts, ideas or sensations, leading to repetitive behaviours
• Red and swollen patches at the corners of the mouth
• Loss of appetite
• Anxiety
• Feeling confused
• Excessive salivation
• Sudden sleepiness
• Excessively watery or tearful eyes
• Rapid flushing of the neck, upper chest or face
• Pallor
• Constipation
• Digestive disorders
• Belching
• Difficulty or discomfort when swallowing
• Changes in tooth colour or tooth decay
• Spontaneous erection
• Feeling of intoxication
• Increased vitamin B6
• Agitation
• Swelling of the legs and arms
• Positive Coombs test
• Hemolytic anemia, an abnormal breakdown of red blood cells in the blood vessels or other parts of the body.
• Reduced number of platelets, with an increased risk of bleeding or bruising.

Rare: may affect up to 1 in 1,000

• Eosinophilia: an abnormal increase in certain white blood cells in the blood or body tissues.

Not known (frequency cannot be estimated from the available data):

• Inability to resist the urge to perform harmful actions, which may include pathological gambling, repetitive and senseless actions, increased sexual interest, compulsive shopping or excessive spending
• Aggression

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Kynmobi

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the sachet and the package after
Exp. The expiry date refers to the last day of that month.
Do not store at a temperature above 25 °C. Store in the sachet to protect the medicine
from light and moisture.
Keep Kynmobi in the sachet until the time of taking it.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Kynmobi contains

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

Description of Kynmobi and package contents
Kynmobi sublingual film is a rectangular film, colored from blue to green, with a number printed on it
that identifies the dosage (e.g., “10” is 10 mg).
Kynmobi is available in the following packs:
The starter pack contains 10 sublingual films, with 2 sublingual films for each
dosage of 10 mg, 15 mg, 20 mg, 25 mg, 30 mg each.
Packs containing 15 or 30 sublingual films.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Bial - Portela & Cª, S.A.
À Av. da Siderurgia Nacional
4745-457 S. Mamede do Coronado
Portugal
e-mail: [email protected]
Manufacturer
Tesa Labtec GmbH
Heykenaukamp 10
21147 Hamburg
Germany

Step-by-step instructions
Taking Kynmobi
Step 1
Your doctor has told you to take 10 mg, 15 mg, 20 mg, 25 mg or 30 mg. Follow steps
2 to 7to take Kynmobi.

Step 2Drink water.Each time, drink
water before taking Kynmobi
to moisten your mouth. This will help the
film to dissolve more easily (see

Figure A).

Figure A
Step 3Open the Kynmobi pouch.
Hold the pouch tabs between the
thumb and index finger of both hands.
Make sure to place your fingers
directly on the raised areas of each
tab.
Gently separate the tabs to open
the pouch (see Figure B).

Figure B
Step 4Remove Kynmobi from the pouch.
Hold Kynmobi between your fingers at
the outer edges and
remove Kynmobi completely from the
pouch (see Figure C).
Kynmobi must be taken whole.
Discard Kynmobi if it is broken or if
pieces are missing. Take a new Kynmobi as a dose.

Figure C

Step 5Place Kynmobi whole under the
tongue.
Place Kynmobi under the tongue, as far
back as possible (see Figure D).
Close your mouth.

Figure D
Step 6Hold Kynmobi under the tongue until
completely dissolved(see

Figure E).

• Do notchew or swallow Kynmobi.
• Do notswallow saliva or speak while Kynmobi is dissolving, as this may affect the absorption of the medicine contained in Kynmobi. Figure E

Step 7Open your mouth and check if Kynmobi has dissolved completely.
It may take about 3 minutesfor Kynmobi to dissolve. When Kynmobi has dissolved
completely, you can swallow.