Medikinet 20 mg

Poland
Brand name Medikinet 20 mg
Form tablets
Active substance / Dosage
methylphenidate hydrochloride · 20 mg
Prescription type Prescription only – contains narcotic or psychotropic substances
ATC code
N06BA04
Registration number 100175989
Manufacturer Medice Arzneimittel Puetter GmbH & Co. KG
Medikinet 20 mg tablets

Table of Contents

Package leaflet: Information for the user

Medikinet 5 mg, tablets
Medikinet 10 mg, tablets
Medikinet 20 mg, tablets
Methylphenidate hydrochloride
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

  • Keep this leaflet, as you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm others, even if their symptoms are the same.
  • If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

  1. What Medikinet is and what it is 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 Medikinet is and what it is used for

Purpose of use
Medikinet is used in the treatment of attention deficit hyperactivity disorder (ADHD).

  • It is used in children and adolescents aged 6 to 18 years.
  • It is used only after prior attempts at non-pharmacological treatment. Such treatments include psychological counselling and behavioural therapy. Medikinet is not used in the treatment of ADHD in children under 6 years of age or in adults. It is not known whether the medicine is safe and beneficial in these age groups.

How Medikinet works
Medikinet improves reduced activity in certain areas of the brain. This medicine may help improve attention (prolong attention span), enhance concentration, and reduce impulsive behaviours.
It is used as part of a treatment programme that usually includes:

  • psychotherapy,
  • educational therapy,
  • social therapy.

Treatment with Medikinet must be initiated and continued only under the supervision of a doctor specialising in the treatment of behavioural disorders in children and adolescents. Although there is no cure for ADHD, the condition can be managed through appropriate therapeutic programmes.

About ADHD
Children and adolescents with ADHD have difficulty:

  • sitting still, and
  • paying attention.

It is not their fault that these activities are so difficult for them.
Many children and young people struggle with these issues. However, in ADHD, these problems cause significant difficulties in daily life. Children and adolescents with ADHD may have trouble learning and completing homework. They may also find it hard to behave appropriately at home, at school, and in other settings.
ADHD does not negatively affect a child's or young person's intelligence.

2. Important information before taking Medikinet

When not to use Medikinet
If the patient:

  • is allergic to methylphenidate or any of the other ingredients of this medicine (listed in section 6);
  • has a thyroid disorder;
  • has increased intraocular pressure (glaucoma);
  • has a tumour of the adrenal gland (chromaffin tumour – phaeochromocytoma);
  • has eating disorders involving lack of appetite or desire to eat, e.g. anorexia nervosa;
  • has very high blood pressure or narrowing of blood vessels which may cause pain in arms and legs;
  • has ever had heart problems, such as heart attack, irregular heartbeat, chest pain or discomfort, heart failure, heart disease or congenital heart defects;
  • has cerebrovascular diseases – such as stroke, localised enlargement and weakening of a blood vessel wall (aneurysm), narrowing or blockage of a blood vessel, or inflammation of blood vessels;
  • is currently taking or has taken antidepressant medicines (called monoamine oxidase inhibitors) within the last 14 days – see: "Medikinet and other medicines";
  • has psychiatric problems such as:
    • psychopathic disorders or borderline personality;
    • delusions or hallucinations, or a condition known as "schizophrenia";
    • symptoms of severe mood disorders, such as: suicidal thoughts; severe depression, when the patient feels profound sadness, worthlessness and hopelessness; mania, when the patient feels extremely excited, overly active and lacking in self-control;

If any of the above situations apply to the patient, methylphenidate should not be used.
If in doubt, consult a doctor or pharmacist before taking
methylphenidate. This is important because methylphenidate may worsen the conditions listed above.

Warnings and precautions
Talk to a doctor before taking Medikinet if:

  • the patient has liver or kidney problems;
  • the patient has difficulty swallowing whole tablets;
  • the patient has had seizures (fits, convulsions, epilepsy) or abnormal brain test results (e.g. EEG);
  • the patient has ever abused or been dependent on alcohol, prescription medicines or drugs;
  • the patient is a woman who has started menstruating (see: "Pregnancy and breastfeeding", below);
  • the patient has uncontrollable, repetitive movements of various body parts or repeats sounds and words (tics);
  • the patient has high blood pressure;
  • the patient has heart conditions not listed under “When not to use Medikinet” above;
  • the patient has psychiatric disorders not listed under “When not to use Medikinet” above. Other psychiatric disorders include:
    • mood swings (from mania to depression – a condition called "bipolar disorder");
    • emergence of aggressive or hostile behaviours, or increased aggression;
    • seeing, hearing or feeling things that are not real (hallucinations);
    • believing in things that are not true (delusions);
    • excessive suspiciousness (paranoia);
    • feelings of restlessness, anxiety or tension;
    • feelings of sadness or guilt.

Before starting treatment, inform the doctor or pharmacist if any of the conditions described above are present. This is important because methylphenidate may worsen them.
The doctor will monitor how the medicine affects the patient.
During treatment, unexpected prolonged erections may occur in boys and young men. This may be painful and can happen at any time. If an erection lasts longer than 2 hours, especially if it is painful, contact a doctor immediately.
If the patient experiences visual disturbances or other vision problems, contact a doctor. The doctor may consider discontinuing Medikinet.

Medical examination before taking methylphenidate
The purpose is to determine whether methylphenidate is suitable for the patient. The doctor will discuss with the patient:

  • all other medicines being taken;
  • any family history of sudden unexplained death;
  • any other medical conditions (e.g. heart diseases) present in the patient or family members;
  • the patient’s emotional state, e.g. depression or euphoria, unusual thoughts, or such conditions in the past;
  • presence of tics (uncontrollable, repetitive movements of body parts or repetition of sounds or words) in the patient’s family members;
  • any history of mental health or behavioural problems in the patient or family members.

The doctor will discuss with the patient the risk of mood swings (from mania to depression – so-called "bipolar disorder"). The doctor will also take a psychiatric history and determine whether there have been 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, the doctor will decide whether methylphenidate is appropriate for the patient. The doctor will also decide whether additional medical tests are required before starting treatment.

Drug screening tests
This medicine may cause a positive result in drug screening tests.
Athletes should be aware that this medicinal product may lead to positive results in anti-doping tests.

Medikinet and other medicines
Tell your doctor or pharmacist about all medicines currently taken or taken recently, as well as any medicines the patient plans to take.
Do not take methylphenidate if the patient:

  • is taking or has taken within the last 14 days a medicine known as a monoamine oxidase inhibitor (MAOI) used to treat depression. Concomitant use of 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 adverse effects. Before taking methylphenidate, inform the doctor or pharmacist if the patient is taking:

  • other medicines used to treat depression;
  • medicines used to treat serious psychiatric disorders;
  • medicines used to treat epilepsy;
  • medicines used to lower or raise blood pressure;
  • certain cough and cold medicines containing substances that may affect blood pressure. When purchasing any such product, consult a pharmacist.
  • medicines that thin the blood and prevent blood clots.

If there is any doubt whether a medicine is on the above list, ask a doctor or pharmacist before taking methylphenidate.

Surgical procedures
Inform the doctor about any planned surgery. Methylphenidate should not be taken on the day of surgery if a certain type of anaesthesia is to be used. This is due to the risk of sudden increase in blood pressure during the procedure.

Taking Medikinet with food and drink
Taking Medikinet with a meal may help avoid stomach pain, nausea or vomiting.

Taking methylphenidate with alcohol
Do not consume alcohol while taking this medicine. Alcohol may worsen the adverse effects of this medicine. Remember that alcohol is also present in certain food products and medicines.

Pregnancy and breastfeeding
Available data do not indicate an overall increased risk of congenital malformations, although a small increased risk of heart developmental defects during the first three months of pregnancy cannot be ruled out. The doctor can provide the patient with additional information about this risk. Before taking methylphenidate, inform the doctor or pharmacist if the patient:

  • is sexually active. The doctor will recommend appropriate contraception.
  • is pregnant or may be pregnant. The doctor will decide whether to continue or discontinue methylphenidate.
  • is breastfeeding or plans to start breastfeeding. Methylphenidate may pass into breast milk. Therefore, the doctor will decide whether breastfeeding is possible during treatment with methylphenidate.

Driving and operating machinery
While taking methylphenidate, dizziness, drowsiness, difficulty focusing vision, blurred vision, hallucinations or other adverse effects on the central nervous system may occur. If such symptoms occur, activities such as driving, operating machinery, cycling, horse riding, or climbing trees may be dangerous.

Medikinet contains lactose
If the patient has previously been diagnosed with an intolerance to certain sugars, the patient should contact a doctor before taking this medicine.

3. How to take Medikinet

What dose should be taken?
Medikinet should always be taken exactly as prescribed by the doctor. If in doubt, consult your doctor or pharmacist.
The maximum daily dose is 60 mg.

  • The doctor usually starts treatment with a low dose of 5 mg once or twice daily during breakfast and lunch, gradually increasing it according to individual needs.
  • Your doctor will inform you which tablet strength you should take each day.
  • The last dose should be taken no later than 4 hours before bedtime to avoid sleep disturbances.

Your doctor will carry out certain examinations

  • before starting treatment – to ensure that Medikinet is safe and appropriate for you;
  • after starting treatment – at least every 6 months, but possibly more frequently, especially whenever the dose is changed.
  • During these check-ups, the doctor will:
    • ask about your appetite;
    • measure your height and body weight;
    • measure your blood pressure and pulse;
    • ask about your mood, mental state, or any unusual feelings, and whether such problems have worsened during treatment with Medikinet.

How to take it?
This medicine is for oral use.
Medikinet tablets should be swallowed whole with water. If necessary, the tablet may be divided into halves. Take the medicine during or after meals.
If there is no improvement in the patient's health after 1 month of treatment
If there is no improvement after 1 month of treatment, inform your doctor. The doctor may decide to change the treatment approach.
Long-term treatment
There is no need to take Medikinet indefinitely. If a patient has been taking Medikinet for over a year, the doctor should interrupt treatment for a short period. It is advisable to plan such a break during school holidays. This will allow assessment of whether continued treatment is necessary.
Misuse of Medikinet
Misuse of Medikinet may lead to unusual behaviors and may result in drug dependence. If you have ever abused or been dependent on alcohol, prescription medicines, or drugs, inform your doctor. This medicine is intended only for the person to whom it was prescribed. Do not give it to others, even if their symptoms seem similar.
Taking more than the recommended dose of Medikinet
If you take too much Medikinet, contact your doctor immediately or call emergency services. Inform them of the amount taken. Medical treatment may be necessary.
Symptoms of overdose may include: vomiting, feeling of overstimulation, tremors, increased involuntary movements, muscle twitching, seizures (possibly followed by coma), feeling of extreme happiness, disorientation, seeing, feeling, or hearing things that are not real (hallucinations), sweating, facial flushing, headache, high fever, changes in heart rate (slow, fast, or irregular), high blood pressure, dilated pupils, dryness of the nasal and oral mucous membranes, muscle cramps, fever, and reddish-brown urine, which may indicate abnormal muscle breakdown (rhabdomyolysis).
If you miss 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
Suddenly stopping this medicine may lead to a return of ADHD symptoms or the appearance of unexpected symptoms such as depression. Before completely discontinuing the medicine, your doctor will gradually reduce the daily dose. Always consult your doctor before stopping Medikinet.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The doctor will inform the patient about such side effects.
Some side effects may be serious. If any of the following occur,
seek medical advice 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 desire to take one's own life;
  • Experiencing or hearing things that are not real – these are symptoms of psychosis;
  • Uncontrolled speech and body movements (Tourette's syndrome);
  • Allergic reactions such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other body parts, shortness of breath, wheezing or difficulty breathing;
  • Mood changes, mood swings.

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

  • Unusual excitement, excessive activity and lack of inhibition (mania).

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

  • Heart attack;
  • Seizures (epileptic fits, epilepsy with convulsions);
  • 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 associated with transient cerebral ischaemia;
  • Paralysis or problems with movement and vision, difficulties with speech (these may be symptoms of problems affecting blood vessels in the brain);
  • Decrease in blood cell count (red blood cells, white blood cells and platelets), which may lead to increased susceptibility to infections, as well as increased risk of bleeding and bruising;
  • Sudden high body temperature, very high blood pressure and severe convulsions (neuroleptic malignant syndrome). It is not certain whether this adverse reaction is caused by methylphenidate or by other medicines that may be used in combination with methylphenidate.

Not known: frequency cannot be estimated from available data

  • Recurrent unwanted thoughts;
  • Loss of consciousness for unknown reasons, chest pain, shortness of breath (these may be symptoms of heart disease).

If any of the listed side effects occur, seek medical advice immediately.
Below 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 body temperature (fever);
  • Excessive hair loss or thinning;
  • Unusual drowsiness or sluggishness;
  • Loss of appetite;
  • Panic attacks;
  • Decreased sex drive;
  • Toothache;
  • Itching, rash or raised, red, itchy skin eruptions (urticaria);
  • Excessive sweating;
  • Cough, sore throat or nasal pain, 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, inner restlessness, unusual activity;
  • Aggression, agitation, anxiety, nervousness, depression, stress, irritability and abnormal behaviour, difficulty falling asleep, fatigue;
  • Abdominal pain, diarrhoea, nausea, abdominal discomfort, indigestion, thirst, vomiting. These symptoms usually occur at the beginning of treatment and may be reduced by taking the medicine with food.

Uncommon: may affect up to 1 in 100 people

  • Constipation;
  • Chest discomfort;
  • Presence of blood in the urine;
  • Double vision or blurred vision;
  • Dry eye syndrome;
  • Muscle pain, cramps and stiffness;
  • Elevated liver function test results (in blood tests);
  • Irritability, tearfulness, excessive awareness of surroundings, tension.

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

  • Changes in sexual desire;
  • Feeling of disorientation;
  • Dilated pupils, vision difficulties;
  • Breast swelling in men;
  • Skin redness, red raised rash on the skin;
  • Obsessive-compulsive disorder (OCD) (including irresistible urge to pull out hair, skin picking, recurring unwanted thoughts, feelings, images or desires (obsessions), performing repetitive behaviours or mental rituals (compulsions)).

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

  • Heart attack;
  • Sudden death;
  • Muscle spasms;
  • Small red spots on the skin;
  • Stroke or arterial blockage in the brain;
  • Liver dysfunction, including liver failure and coma;
  • Changes in laboratory test results – including liver function tests and blood counts;
  • Suicide attempts (including completed suicides), disturbances in thinking, lack of feelings or emotions;
  • Numbness in fingers and toes, tingling, and skin colour changes (from pale to blue, then to red) triggered by cold (Raynaud's phenomenon).

Frequency not known: frequency cannot be estimated from available data

  • Migraine;
  • Very high fever;
  • Slow, fast or irregular heartbeat;
  • Severe seizures (major epileptic seizure – "grand mal");
  • Belief in false things, confusion;
  • Severe abdominal pain, often with nausea and vomiting;
  • Problems with blood vessels in the brain (stroke, cerebral arteritis or cerebral artery occlusion);
  • Erectile dysfunction;
  • Prolonged erections, sometimes painful, or increased number of erections;
  • Excessive, uncontrollable talking;
  • Inability to control urination (urinary incontinence);
  • Jaw muscle spasm making it difficult to open the mouth (trismus);
  • Stuttering;
  • Nosebleeds;
  • Increased intraocular pressure;
  • Eye disorders that may cause vision deterioration due to damage to the optic nerve (glaucoma).

Effect on growth and body weight
When methylphenidate is used for longer than one year, in some children this medicine may slow growth. This affects fewer than 1 in 10 children.

  • The child may not gain weight or grow at the expected rate.
  • The treating doctor will carefully monitor the child's growth, body weight and food intake.
  • If the child does not grow as expected, treatment with methylphenidate may be temporarily interrupted.

Reporting of side effects
If any symptoms of side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist.
Side effects can be reported directly to:
Department of Monitoring Adverse Drug Reactions, 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 authorisation holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Medikinet

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after:
"EXP". The expiry date refers to the last day of the stated month.
Do not store above 25 °C.
Store in the original packaging to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. 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, equivalent to 4.35 mg of methylphenidate.
Medikinet 10 mg, tablets
Each tablet contains 10 mg of methylphenidate hydrochloride, equivalent to 8.65 mg of methylphenidate.
Medikinet 20 mg, tablets
Each tablet contains 20 mg of methylphenidate hydrochloride, equivalent to 17.30 mg of methylphenidate.

Other ingredients are:
Microcrystalline cellulose, pregelatinized starch (maize), 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" engraved. The tablet can be divided into halves.
Pack sizes: 20, 28, 30, 50 or 56 tablets
Box containing tablets in blisters made of PVC/PE/PVDC/Aluminium

Medikinet 10 mg, tablets
White, round tablets with the letter "M" engraved. The tablet can be divided into halves.
Pack sizes: 20, 28, 30, 50, 56, 98 or 100 tablets
Box containing tablets in blisters made of PVC/PVDC/Aluminium

Medikinet 20 mg, tablets
White, round tablets with the letter "L" engraved. The tablet can be divided into halves.
Pack sizes: 30, 50 or 56 tablets
Box containing tablets in blisters made of PVC/PVDC/Aluminium

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Medice Arzneimittel Pütter GmbH & Co. KG
Kuhloweg 37, 58638 Iserlohn
Germany
Tel.: +48 885 050 178

This medicinal product is authorised in the European Economic Area and the United Kingdom (Northern Ireland) under the following names:
Germany: Medikinet 5 mg, 10 mg, 20 mg Tabletten
Denmark: Medikinet 5 mg, 10 mg, 20 mg
Finland: Medikinet 5 mg, 10 mg, 20 mg
Iceland: Medikinet 5 mg, 10 mg, 20 mg tafla
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
(Northern Ireland)