Medikinet 5 mg

Leaflet accompanying the packaging: information for the user

Medikinet 5 mg, tablets

Medikinet 10 mg, tablets

Medikinet 20 mg, tablets

Methylphenidate hydrochloride

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the 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 previous attempts at treatment without medication. Such treatment methods include 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 whether 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 focus attention (prolong attention span), improve concentration, and reduce impulsive behavior.

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

• psychotherapy,
• educational treatment,
• social therapy.

Treatment with Medikinet must be started and continued 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 their 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 a lot of trouble in everyday life. Children and adolescents with ADHD may have difficulty learning and doing homework. They may have trouble behaving properly 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 an allergy to methylphenidate or any of the other ingredients of this medicine (listed in section 6);
• has a thyroid disease;
• has increased pressure in the eyeball (glaucoma);
• has an adrenal gland tumor (pheochromocytoma);
• has eating disorders, such as a lack of appetite or need to eat, e.g., 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 cerebrovascular diseases, 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 situations apply to the patient, they should not take methylphenidate.

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

Warnings and precautions

Before taking Medikinet, talk to your doctor if:

• the patient has liver or kidney problems;
• the patient has difficulty swallowing or taking whole tablets;
• the patient has had seizures (convulsions, epilepsy) or abnormal brain test results (e.g., EEG);
• the patient has ever abused or been dependent on alcohol, prescription drugs, or narcotics;
• the patient is a female who has started menstruating (see "Pregnancy and breastfeeding" below);
• the patient has uncontrollable, repetitive movements of any part of the body or repeats sounds or words (tics);
• the patient has high blood pressure;
• the patient has heart diseases not listed in the "When not to take Medikinet" section above;
• the patient has 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 - a condition called "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 suspicion (paranoia);
• feeling excited, restless, or tense;
• feeling depressed or guilty.

Before starting treatment, inform your doctor or pharmacist if any of the above conditions exist. This is important because methylphenidate may worsen these conditions.

Your doctor will monitor how the medicine affects the patient's condition.

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 longer than 2 hours, especially if it is painful, seek medical attention immediately.

Medical examination before taking Medikinet

The examination is intended to determine whether 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, e.g., their depression or euphoria, strange thoughts, or a history of such conditions;
• the presence of tics (uncontrollable, repetitive movements of any part of the body or repetition of sounds or words) 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 - a condition called "bipolar disorder"). The doctor will also take a mental health history and determine if 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 determine whether Medikinet is a suitable medicine for the patient and decide whether any additional medical examinations are necessary 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 doping tests.

Medikinet and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or plan to take.

Do not take Medikinet if:

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

If you are taking other medicines, methylphenidate may affect their action or cause side effects. Before taking Medikinet, inform your doctor or pharmacist if you are taking:

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

If in doubt about whether a medicine is on the above list, ask your doctor or pharmacist before taking Medikinet.

Surgery

Inform your doctor about any planned surgery. Do not take Medikinet on the day of surgery if a certain type of anesthesia is used. This is due to the possibility of a sudden increase in blood pressure during surgery.

Taking Medikinet with food and drink

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

Taking Medikinet with alcohol

Do not drink alcohol while taking this medicine. Alcohol may increase the side effects of this medicine. Remember that alcohol is also found 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. Your doctor will provide you with more information about this risk.

Before taking Medikinet, inform your doctor or pharmacist if:

• you are sexually active. Your doctor will recommend appropriate contraception.
• you are pregnant or may be pregnant. Your doctor will decide whether to continue or stop Medikinet.
• you are breastfeeding or plan to breastfeed. Methylphenidate may pass into breast milk. Therefore, your doctor will decide whether breastfeeding is possible while taking Medikinet.

Driving and using machines

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

Medikinet contains lactose

If you have been diagnosed with an intolerance to some sugars, consult your doctor before taking the medicine.

3. How to take Medikinet

What dose to take?

Always take Medikinet exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

The maximum daily dose is 60 mg.

• Your doctor will usually start treatment with a small dose of 5 mg once or twice a day during breakfast and lunch and gradually increase it as needed.
• Your doctor will inform you 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.

Your doctor will perform certain checks

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

How to take it?

This medicine is for oral use only.

Swallow the Medikinet tablets with water. If necessary, the tablet can be divided into two halves. Take the medicine 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, inform your 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 should interrupt the treatment for a short period. Such an interruption is best planned during school holidays. This will allow the doctor to assess whether the medicine is still necessary.

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 narcotics, inform your doctor. This medicine is intended only for the person it has been prescribed for. Do not pass it on to others, even if their symptoms are similar.

Taking more than the recommended dose of Medikinet

If you have taken too much Medikinet, contact your doctor or call emergency services immediately. Tell them how much medicine you have 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 spasms, fever, and reddish-brown urine, which may be a sign of abnormal muscle breakdown (rhabdomyolysis).

Missing a dose of Medikinet

Do not take a double dose to make up for a missed dose. If you miss a dose, take the next dose at the usual time.

Stopping Medikinet treatment

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

If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Your doctor will inform you about these side effects.

Some side effects can be serious. If you experience any of the following, contact your doctor 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

• suicidal thoughts or intentions;
• 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 spasms, affecting the eyes, head, neck, or other parts of the body, and neurological symptoms related to temporary cerebral ischemia;
• paralysis or problems with movement and vision, difficulty speaking (may be symptoms of cerebral vascular 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 in combination with methylphenidate.

Unknown: frequency cannot be estimated from the available data

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

If you experience any of the above side effects, contact your doctor immediately.

The following is a list of other side effects. If they worsen, inform your 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 drowsy 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 problems, fatigue;
• stomach pain, diarrhea, nausea, discomfort in the stomach, indigestion, thirst, vomiting. These symptoms usually occur at the start of treatment and can 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 men;
• 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 spasms;
• 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), thought disorders, lack of feelings or emotions, repetitive behaviors, obsessive focus on one thing;
• numbness of fingers on the hands and feet, tingling, and color change of the skin (from pale to blue and then to red) in response to cold (Raynaud's phenomenon).

Frequency not known: 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;
• cerebrovascular 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 (incontinence);
• jaw muscle spasm making it difficult to open the mouth (trismus);
• stuttering;
• nosebleeds.

Effect on growth and weight

In the case of long-term use of methylphenidate (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.
• Your 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 methylphenidate may be interrupted for a short period.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your 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, you can help provide more information on the safety of this medicine.

5. How to store Medikinet

Keep the medicine out of the 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.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines no longer required. 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, maize starch, 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 two halves.

Available in packs of 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 two halves.

Available in packs of 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 two halves.

Available in packs of 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 leaflet: 06/2023