Medikinet 20 mg

Package Leaflet: Information for the User

Medikinet 5 mg, tablets

Medikinet 10 mg, tablets

Medikinet 20 mg, tablets

Methylphenidate hydrochloride

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

1. What is Medikinet and what is it used for

What is it used for

Medikinet is used to treat attention deficit hyperactivity disorder (ADHD).

• It is used in children and adolescents from 6 to 18 years of age.
• It is used only after other treatments have been tried first, such as psychological counseling and behavioral therapy. Medikinet is not used to treat ADHD in children under 6 years of age or in adults. It is not known if the medicine is safe and effective in these age groups.

How Medikinet works

Medikinet improves the reduced activity of certain areas of the brain. This medicine may help to improve attention span (prolong attention time), improve concentration, and reduce impulsive behavior.

This medicine is used as part of a treatment program that usually includes:

• psychotherapy,
• educational treatment,
• social therapy.

Treatment with Medikinet must be started and continued only under the supervision of a doctor specializing in the treatment of behavioral disorders in children and adolescents. Although there is no cure for ADHD, the condition can be controlled by using appropriate therapeutic programs.

About ADHD

Children and adolescents with ADHD have difficulty:

• sitting still and
• focusing attention.

It's not their fault that these activities are so difficult for them.

Many children and young people struggle with these problems. However, in ADHD, these problems cause significant difficulties in daily life. Children and adolescents with ADHD may have difficulty learning and doing homework. They may have difficulty behaving appropriately at home, school, and other places.

ADHD does not negatively affect a child's or young person's intelligence.

2. Important information before taking Medikinet

When not to take Medikinet

If the patient:

• has been diagnosed with hypersensitivity to methylphenidate or any of the other ingredients of this medicine (listed in section 6);
• has thyroid disease;
• has increased eye pressure (glaucoma);
• has an adrenal gland tumor (pheochromocytoma);
• has eating disorders, such as anorexia nervosa;
• has very high blood pressure or narrowing of the blood vessels, which can cause arm or leg pain;
• has had heart problems, such as a heart attack, irregular heartbeat, chest pain or discomfort, heart failure, heart disease, or congenital heart defects;
• has had brain blood vessel problems, such as stroke, aneurysm, or vasculitis;
• is currently taking or has taken monoamine oxidase inhibitors (MAOIs) in the last 14 days. See "Medikinet and other medicines" below;
• has mental health problems, such as:
• psychopathic disorders or borderline personality disorder;
• abnormal thoughts or visions, or a condition called "schizophrenia";
• severe mood disorders, such as suicidal thoughts, severe depression, mania, or hypomania.

If any of the above applies to the patient, they should not take methylphenidate.

If in doubt, the patient should consult their doctor or pharmacist before taking methylphenidate. This is important because methylphenidate may worsen the above problems.

Warnings and precautions

Before taking Medikinet, the patient should talk to their doctor if:

• they have liver or kidney problems;
• they have difficulty swallowing or taking whole tablets;
• they have had seizures (convulsions, epilepsy) or abnormal brain test results (e.g., EEG);
• they have ever abused or been dependent on alcohol, prescription drugs, or street drugs;
• they are a female who has started menstruating (see "Pregnancy and breastfeeding" below);
• they have uncontrollable, repetitive movements or sounds (tics);
• they have high blood pressure;
• they have heart problems not listed in the "When not to take Medikinet" section above;
• they have mental health problems not listed in the "When not to take Medikinet" section above. Other mental health problems include:
• mood swings (from mania to depression - also known as "bipolar disorder");
• aggressive or hostile behavior, or increased aggression;
• seeing, hearing, or feeling things that do not exist (hallucinations);
• believing in things that are not true (delusions);
• excessive suspiciousness (paranoia);
• feeling excited, restless, or tense;
• feeling depressed or guilty.

Before starting treatment, the patient should inform their doctor or pharmacist if they have any of the above conditions. This is important because methylphenidate may worsen these conditions.

The doctor will monitor how the medicine affects the patient.

During treatment, boys and young men may experience unexpected, prolonged erections. These can be painful and can occur at any time. If an erection lasts for more than 2 hours, especially if it is painful, the patient should seek medical help immediately.

Medical examination before taking Medikinet

The examination is to determine if Medikinet is a suitable medicine for the patient. The doctor will discuss with the patient:

• any other medicines being taken;
• any cases of sudden, unexplained death in the family;
• any other medical problems (e.g., heart disease) that the patient or their family members may have;
• the patient's well-being, such as their depression or euphoria, strange thoughts, or past experiences;
• any tics (uncontrollable, repetitive movements or sounds) in the patient's family members;
• any mental health or behavioral problems that the patient or their family members may have had.

The doctor will discuss with the patient the risk of mood swings (from mania to depression - also known as "bipolar disorder"). The doctor will also ask about the patient's mental health history and whether there have been any cases of suicide, bipolar disorder, or depression in the patient's family.

It is very important to provide the doctor with as much information as possible. Based on this information, the doctor will decide if Medikinet is a suitable medicine for the patient. The doctor will also decide if any other medical tests are needed before starting treatment with this medicine.

Drug test

This medicine may cause a positive result in drug tests.

Athletes should be aware that this medicinal product may give positive results in anti-doping tests.

Medikinet and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or plan to take.

Do not take Medikinet if:

• the patient is taking a monoamine oxidase inhibitor (MAOI) for depression, or has taken an MAOI in the last 14 days. Taking MAOIs with methylphenidate may cause a sudden increase in blood pressure.

If the patient is taking other medicines, methylphenidate may affect their action or cause side effects. Before taking Medikinet, the patient should inform their doctor or pharmacist if they are taking:

• other medicines for depression;
• medicines for severe mental disorders;
• medicines for epilepsy;
• medicines to lower or increase blood pressure;
• certain cough and cold medicines that contain substances that can affect blood pressure. When buying such products, the patient should consult their pharmacist.
• medicines that thin the blood and prevent blood clots.

If in doubt, the patient should ask their doctor or pharmacist before taking Medikinet.

Surgery

The patient should inform their doctor about any planned surgery. Medikinet should not be taken on the day of surgery if a certain type of anesthesia is used. This is because methylphenidate may cause a sudden increase in blood pressure during surgery.

Taking Medikinet with food and drink

Taking Medikinet with food may help avoid stomach upset, nausea, or vomiting.

Taking Medikinet with alcohol

The patient should not drink alcohol while taking this medicine. Alcohol may increase the side effects of this medicine. The patient should remember that alcohol is also contained in some foods and medicines.

Pregnancy and breastfeeding

Available data do not indicate an increased risk of congenital malformations overall, although a slight increase in the risk of congenital heart defects during the first three months of pregnancy cannot be ruled out. The doctor will be able to provide the patient with more information about this risk.

Before taking Medikinet, the patient should inform their doctor or pharmacist if:

• they are sexually active. The doctor will recommend appropriate contraception.
• they are pregnant or may be pregnant. The doctor will decide whether to continue or stop Medikinet.
• they are breastfeeding or plan to breastfeed. Methylphenidate may pass into breast milk. Therefore, the doctor will decide whether breastfeeding is possible during treatment with Medikinet.

Driving and using machines

While taking Medikinet, the patient may experience dizziness, drowsiness, difficulty focusing, blurred vision, hallucinations, or other central nervous system side effects. If these symptoms occur, activities such as driving, operating machinery, riding a bike, or horse riding, as well as climbing trees, may be dangerous.

Medikinet contains lactose

If the patient has been diagnosed with an intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Medikinet

What dose to take

Medikinet should always be taken as directed by the doctor. If in doubt, the patient should consult their doctor or pharmacist.

The maximum daily dose is 60 mg.

• The doctor usually starts treatment with a small dose of 5 mg once or twice a day, during breakfast and lunch, and gradually increases it as needed.
• The doctor will inform the patient which strength of tablet to take each day.
• The last dose of Medikinet should be taken no later than 4 hours before bedtime to avoid sleep disturbances.

The doctor will perform certain tests

• before starting treatment - to make sure Medikinet is safe and suitable for the patient.
• after starting treatment - at least every 6 months, but possibly more often. These tests will also be performed when the dose of Medikinet is changed.
• during the test, the doctor will:
• ask about the patient's appetite;
• measure the patient's height and weight;
• measure the patient's blood pressure and heart rate;
• ask about the patient's mood, mental state, or any unusual feelings and find out if these problems have worsened while taking Medikinet.

How to take it

This medicine is for oral use only.

Medikinet tablets should be swallowed with water. If necessary, the tablet can be divided into halves. The medicine should be taken with or after food.

If the patient's condition does not improve after 1 month of treatment

If the patient's condition does not improve after 1 month of treatment, they should inform their doctor. The doctor may decide to change the treatment.

Long-term treatment

There is no need to take Medikinet indefinitely. If the patient has been taking Medikinet for more than a year, the doctor may stop treatment for a short period. This break in treatment is best planned during school holidays. This will help to assess whether the medicine is still needed.

Incorrect use of Medikinet

Incorrect use of Medikinet may lead to abnormal behavior. It may also cause dependence on the medicine. If the patient has ever abused or been dependent on alcohol, prescription drugs, or street drugs, they should inform their doctor. This medicine is intended only for the person it has been prescribed for. It should not be given to others, even if their symptoms are similar.

Taking more Medikinet than prescribed

If the patient takes too much Medikinet, they should seek medical help immediately. They should tell their doctor how much medicine was taken. Treatment may be necessary.

Symptoms of overdose may include: vomiting, feeling overexcited, trembling, increased involuntary movements, muscle twitching, seizures (which may be followed by coma), feeling extremely happy, disorientation, seeing, hearing, or feeling things that do not exist (hallucinations), sweating, flushing, headache, high fever, changes in heart rate (slow, fast, or irregular), high blood pressure, dilated pupils, dryness of the mouth and throat, muscle contractions, fever, and reddish-brown urine, which may be a sign of abnormal muscle breakdown (rhabdomyolysis).

Missing a dose of Medikinet

The patient should not take a double dose to make up for a missed dose. If a dose is missed, the next dose should be taken at the usual time.

Stopping Medikinet treatment

Suddenly stopping treatment with this medicine may lead to a return of ADHD symptoms or the appearance of unexpected symptoms, such as depression. Before stopping treatment completely, the doctor will gradually reduce the daily dose. Before stopping Medikinet, the patient should consult their doctor.

If the patient has any further questions about taking this medicine, they should ask their doctor or pharmacist.

4. Possible side effects

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

The doctor will inform the patient about these side effects.

Some side effects can be serious. If the patient experiences any of the following, they should seek medical help immediately:

Common: may affect up to 1 in 10 people

• irregular heartbeat (palpitations);
• changes in personality.
• excessive teeth grinding (bruxism).

Uncommon: may affect up to 1 in 100 people

• thoughts of suicide or wanting to harm themselves;
• seeing, hearing, or feeling things that do not exist (psychotic symptoms);
• uncontrolled speech and movements (Tourette's syndrome);
• allergic reactions, such as rash, itching, or hives on the skin, swelling of the face, lips, tongue, or other parts of the body, difficulty breathing, wheezing, or shortness of breath;
• mood changes, mood swings.

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

• unusual excitement, overactivity, and lack of restraint (mania).

Very rare: may affect up to 1 in 10,000 people

• heart attack;
• seizures (convulsions, epilepsy);
• skin peeling or purple-red spots on the skin;
• uncontrollable muscle contractions, affecting the eyes, head, neck, or other parts of the body, and neurological symptoms related to temporary brain ischemia;
• paralysis or problems with movement and vision, speech difficulties (which may be symptoms of brain blood vessel problems);
• decrease in blood cell count (red blood cells, white blood cells, and platelets), which can lead to increased susceptibility to infections, as well as bleeding and bruising;
• sudden increase in body temperature, very high blood pressure, and severe convulsions (malignant neuroleptic syndrome). It is not certain whether this side effect is caused by methylphenidate or other medicines that may be taken with it.

Unknown: frequency cannot be estimated from the available data

• recurring unwanted thoughts;
• loss of consciousness for an unknown reason, chest pain, shortness of breath (which may be symptoms of heart disease).

If the patient experiences any of the above side effects, they should seek medical help immediately.

The following is a list of other side effects. If they worsen, the patient should inform their doctor or pharmacist:

Very common: may affect more than 1 in 10 people

• decreased appetite
• headache;
• nervousness;
• insomnia;
• nausea;
• dry mouth.

Common: may affect up to 1 in 10 people

• joint pain;
• high temperature (fever);
• excessive hair loss or thinning;
• feeling unusually sleepy or sluggish;
• loss of appetite;
• panic attacks;
• decreased sex drive;
• toothache;
• itching, rash, or raised, red, and itchy patches on the skin;
• excessive sweating;
• cough, sore throat, or nose and throat irritation, shortness of breath, or chest pain;
• changes in blood pressure (usually high blood pressure), rapid heartbeat (tachycardia), cold hands and feet;
• trembling and shaking, dizziness, involuntary movements, feeling of inner restlessness, unusual activity;
• aggression, excitement, restlessness, anxiety, depression, stress, irritability, and abnormal behavior, sleep disturbances, fatigue;
• stomach pain, diarrhea, nausea, discomfort in the abdomen, indigestion, thirst, vomiting. These symptoms usually occur at the start of treatment and may be reduced by taking the medicine with food;

Uncommon: may affect up to 1 in 100 people

• constipation;
• chest discomfort;
• blood in the urine;
• double vision or blurred vision;
• muscle pain, cramps, and stiffness;
• elevated liver test results (in blood tests); anger, tearfulness, increased awareness of surroundings, tension.

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

• changes in sex drive;
• feeling disoriented;
• dilated pupils, difficulty seeing;
• breast swelling in males;
• redness of the skin, red, raised rash on the skin.

Very rare: may affect up to 1 in 10,000 people

• heart attack;
• sudden death;
• muscle contractions;
• small, red spots on the skin;
• inflammation or blockage of blood vessels in the brain;
• abnormal liver function, including liver failure and coma;
• changes in laboratory test results, including liver function and blood morphology;
• suicide attempts (including successful attempts), abnormal thinking, lack of feelings or emotions, repetitive behaviors, obsessive focus on one thing;
• numbness of fingers and toes, tingling, and color change of the skin (from pale to blue and then to red) in response to cold (Raynaud's phenomenon).

Unknown: frequency cannot be estimated from the available data

• migraine;
• very high fever;
• slow, fast, or irregular heartbeat;
• severe seizures (grand mal);
• believing in things that are not true, confusion;
• severe stomach pain, often with nausea and vomiting;
• brain blood vessel problems (stroke, cerebral vasculitis, or cerebral artery occlusion);
• erectile dysfunction;
• prolonged erections, sometimes painful, or increased frequency of erections;
• uncontrolled talking;
• inability to control urination (urinary incontinence);
• muscle contraction of the jaw, making it difficult to open the mouth (trismus);
• stuttering;
• nosebleeds.

Effect on growth and weight

In the case of long-term use of Medikinet (more than one year), the medicine may slow down growth in some children. This affects less than 1 in 10 children.

• The child may not gain weight or grow at the expected rate.
• The doctor will carefully monitor the child's growth and weight, as well as their food intake.
• If the patient is not growing as expected, their treatment with Medikinet may be stopped for a short period.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist.

Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products

Al. Jerozolimskie 181C, 02-222 Warsaw

Tel: +48 22 49 21 301

Fax: +48 22 49 21 309

Website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, more information can be gathered on the safety of this medicine.

5. How to store Medikinet

The medicine should be stored out of sight and reach of children.

Do not take this medicine after the expiry date stated on the blister pack and carton after "EXP". The expiry date refers to the last day of the month stated.

Do not store above 25°C.

Store in the original package to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Medikinet contains

The active substance is methylphenidate hydrochloride

Medikinet 5 mg, tablets

Each tablet contains 5 mg of methylphenidate hydrochloride, which corresponds to 4.35 mg of methylphenidate.

Medikinet 10 mg, tablets

Each tablet contains 10 mg of methylphenidate hydrochloride, which corresponds to 8.65 mg of methylphenidate.

Medikinet 20 mg, tablets

Each tablet contains 20 mg of methylphenidate hydrochloride, which corresponds to 17.30 mg of methylphenidate.

Other ingredients are:

Microcrystalline cellulose, cornstarch, calcium hydrogen phosphate dihydrate, lactose monohydrate, magnesium stearate

What Medikinet looks like and contents of the pack

Medikinet 5 mg, tablets

White, round tablets with the letter "S" embossed on them. The tablet can be divided into halves.

Available pack sizes:

20, 28, 30, or 50 tablets

Carton containing tablets in PVC/PE/PVDC/Aluminum blisters

Medikinet 10 mg, tablets

White, round tablets with the letter "M" embossed on them. The tablet can be divided into halves.

Available pack sizes:

20, 28, 30, 50, 56, 98, or 100 tablets

Carton containing tablets in PVC/PVDC/Aluminum blisters

Medikinet 20 mg, tablets

White, round tablets with the letter "L" embossed on them. The tablet can be divided into halves.

Available pack sizes:

30 or 50 tablets

Carton containing tablets in PVC/PVDC/Aluminum blisters

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Medice Arzneimittel Pütter GmbH & Co. KG

Kuhloweg 37, 58638 Iserlohn

Germany

Tel: +48 885 050 178

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

Germany:

Medikinet 5 mg, 10 mg, 20 mg Tablets

Denmark:

Medikinet 5 mg, 10 mg, 20 mg

Finland:

Medikinet 5 mg, 10 mg, 20 mg

Iceland:

Medikinet 5 mg, 10 mg, 20 mg tablets

Luxembourg:

Medikinet 5 mg, 10 mg, 20 mg

Netherlands:

Medikinet 5 mg, 10 mg, 20 mg

Norway:

Medikinet 5 mg, 10 mg, 20 mg

Poland:

Medikinet 5 mg, 10 mg, 20 mg

Spain:

Medicebran 5 mg, 10 mg, 20 mg

Sweden:

Medikinet 5 mg, 10 mg, 20 mg

United Kingdom:

Medikinet 5 mg, 10 mg, 20 mg

Date of last revision of the package leaflet: 06/2023