Medikinet Cr 30 mg

Leaflet accompanying the packaging: information for the user

Medikinet CR 5 mg modified-release hard capsules

Medikinet CR 10 mg modified-release hard capsules

Medikinet CR 20 mg modified-release hard capsules

Medikinet CR 30 mg modified-release hard capsules

Medikinet CR 40 mg modified-release hard capsules

Medikinet CR 50 mg modified-release hard capsules

Medikinet CR 60 mg modified-release hard capsules

Methylphenidate hydrochloride
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. To learn how to report side effects, see section 4.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those 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 CR and what is it used for
• 2. Important information before taking Medikinet CR
• 3. How to take Medikinet CR
• 4. Possible side effects
• 5. How to store Medikinet CR
• 6. Contents of the pack and other information

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

What is it used for?

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

• It is used in children aged 6 and over and in adults.
• It is used only if previous attempts to treat the disorder without medication, such as psychological counseling and behavioral therapy, have been unsuccessful.

Medikinet CR is not used to treat ADHD in children under 6 years of age.

How does Medikinet CR work?

Medikinet CR improves reduced activity in certain areas of the brain. The medicine may help prolong attention span, improve concentration, and reduce impulsive behavior.
The medicine is used as part of a treatment program that usually includes psychotherapy, educational treatment, and social therapy.
Treatment with Medikinet CR should only be initiated and continued by a doctor specializing in the treatment of ADHD, such as a pediatrician, child and adolescent psychiatrist, or psychiatrist.
A thorough examination by such a doctor is required. If the patient is an adult and has not been treated before, the doctor will conduct examinations to confirm that ADHD has been present since childhood, and only then will treatment with Medikinet CR be initiated.
Although there is no cure for ADHD, the condition can be controlled with 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.
ADHD can occur in patients with varying degrees of severity, with symptoms such as:

• lack of concentration
• restlessness
• increased motor activity
• impulsiveness
• emotional instability
• disorganized thinking

This is exemplified by:

• difficulty concentrating
• forgetfulness
• talking too much
• difficulty planning and completing tasks
• acting "on the spur of the moment"
• impatience

ADHD does not negatively affect the patient's intelligence.

2. Important information before taking Medikinet CR

When not to take Medikinet CR

If the patient:

• has been diagnosed with hypersensitivity 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 characterized by a lack of appetite or need to eat, such as anorexia nervosa;
• has very high blood pressure or narrowing of blood vessels, which can cause arm and 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 problems, such as a stroke, aneurysm, or vasculitis;
• is currently taking or has taken monoamine oxidase inhibitors (MAOIs) in the last 14 days. Concomitant use of MAOIs with methylphenidate may cause a sudden increase in blood pressure.
• has a history of mental health problems, such as:
• psychopathic disorders or borderline personality disorder;
• abnormal thoughts or visions, or a condition called "schizophrenia";
• symptoms of severe mood disorders, such as suicidal thoughts; severe depression, when the patient feels deep sadness, has a sense of worthlessness and hopelessness; mania, when the patient feels extremely agitated, overly active, and uninhibited;
• has a history of a large gastric acid deficiency (achlorhydria) with a pH above 5.5;
• is taking medications that reduce gastric acid secretion or treat hyperacidity, such as H2 receptor antagonists, proton pump inhibitors, or antacids.

If any of the above situations apply to the patient, they should not take methylphenidate.
In case of doubts, the patient should consult a doctor or pharmacist before taking methylphenidate. This is important because methylphenidate may worsen the above problems.

Warnings and precautions

Before taking Medikinet CR, 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 narcotics;
• they are a woman who has started menstruating (see "Pregnancy and breastfeeding" below);
• they have uncontrollable, repetitive movements of any body part or repeat sounds or words (tics);
• they have high blood pressure;
• they have heart problems not listed in the "When not to take Medikinet CR" section above;
• they have mental health problems not listed in the "When not to take Medikinet CR" section above. Other mental health problems include:
• mood swings (from mania to depression - a condition called "bipolar disorder");
• appearance of aggressive or hostile behavior, or increased aggression;
• seeing, hearing, or feeling things that do not exist (hallucinations);
• believing in things that are not real (delusions);
• excessive suspiciousness (paranoia);
• feeling agitated, restless, or tense;
• feeling depressed or guilty. Before starting treatment, the patient should inform their doctor or pharmacist if they experience any of these conditions. Methylphenidate may worsen them. The doctor will monitor how the medicine affects the patient's condition.

During treatment, boys and young men may experience unexpected, prolonged erections. This can be painful and can occur at any time. If an erection lasts longer than 2 hours, especially if it is painful, the patient should immediately consult a doctor.

Medical examination before taking methylphenidate

The examination aims to determine whether methylphenidate 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, and any history of such conditions;
• any history of tics (uncontrollable, repetitive movements of any body part or repetition of sounds or words) in the patient's family;
• 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 of the patient 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 methylphenidate is a suitable medicine for the patient. The doctor will also 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 medicine may produce positive results in anti-doping tests.

Medikinet CR and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Do not take methylphenidate if:

• the patient is taking a monoamine oxidase inhibitor (MAOI) for depression or has taken an MAOI in the last 14 days. 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 side effects. The patient should tell their doctor or pharmacist if they are taking medicines for:

• depression;
• psychiatric disorders;
• epilepsy;
• blood pressure problems;
• cough and colds. Some of these products contain substances that can affect blood pressure. When purchasing any such product, the patient should consult a pharmacist.
• medicines that thin the blood and prevent blood clots.

Medikinet CR should not be taken at the same time as H2 receptor antagonists, proton pump inhibitors, or antacids used to reduce gastric acid secretion or treat hyperacidity, as this may lead to faster release of the active substance into the body.
If in doubt, the patient should ask their doctor or pharmacist before taking methylphenidate.

Surgery

The patient should inform their doctor about any planned surgery. Methylphenidate should not be taken 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 methylphenidate with alcohol

The patient should not consume 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 food products 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 cardiac malformations 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 methylphenidate, 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 treatment with methylphenidate.
• 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 methylphenidate.

Driving and using machines

During treatment with methylphenidate, the patient may experience dizziness, drowsiness, difficulty focusing their eyes, blurred vision, hallucinations, or other central nervous system side effects. If such symptoms occur, performing activities such as driving, operating machinery, riding a bicycle, or horseback riding, as well as climbing trees, may be dangerous.

Medikinet CR contains sucrose

Sucrose

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

Sodium

The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means the medicine is considered "sodium-free".

3. How to take Medikinet CR

Medikinet CR should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.

Dosage

Use in children
The maximum daily dose is 60 mg.

• The doctor usually starts treatment with a small dose and gradually increases it as needed.
• The doctor will inform the patient about the strength of the capsule to be taken daily.
• The capsule should not be divided. The patient should always take the whole contents.
• Medikinet CR should not be taken too late in the morning, as it may cause sleep disturbances.

Use in adults
Adult patients who have previously taken Medikinet CR

• If the patient took Medikinet CR as a child or adolescent, the same daily dose (mg/day) can be used. The doctor will regularly monitor the patient's condition to determine if the dose needs to be adjusted.
• Adult patients may require a higher daily dose than children, but the doctor will aim to administer the smallest effective dose to the patient.
• The maximum daily dose is determined based on factors such as the patient's body weight (see below).

Adult patients who have not previously taken Medikinet CR
The recommended initial dose is 10 mg per day.

• The doctor will increase the dose taken by the patient by 10 mg per day, depending on the patient's tolerance and response to the medicine.
• The goal should be the smallest effective dose for the patient.
• The maximum daily dose is determined based on factors such as the patient's body weight (see below).
• The doctor will decide on the maximum daily dose for the patient.
• The daily dose is 1 mg per kilogram of body weight, up to a maximum of 80 mg of methylphenidate per day.

Tasks to be performed by the doctor before and during treatment of the patient (adult or child)

The doctor will perform certain examinations

• before starting treatment - to ensure that Medikinet CR is safe and beneficial for the patient.
• after starting treatment - at least every 6 months, but possibly much more frequently. Such examinations will also be performed when the dose of the medicine is changed.
• during the examination, the doctor will:
• ask about the patient's appetite;
• measure the child's height and weight;
• weigh the adult patient;
• measure the patient's blood pressure and heart rate;
• ask about the patient's mood, mental state, or other unusual feelings and determine if these problems have worsened during treatment with Medikinet CR.

Method of administration

This medicine is intended for oral use.
Children take Medikinet CR in the morning, during or afterbreakfast.
Adults take Medikinet CR during or afterbreakfast andafter the mid-day meal (lunch).
Medikinet CR is a "controlled-release" form of methylphenidate, which means that the medicine is released into the body slowly over a longer period. Taking the capsule during or after meals is very important for achieving this delayed, prolonged action.
The capsules can be swallowed whole with water. The capsule can also be opened, and its contents can be sprinkled over a small amount (a tablespoon) of applesauce or yogurt and taken immediately. The medicine sprinkled from the capsule should not be stored for later use.
The capsules or their contents should not be crushed or chewed.

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 CR indefinitely. If the patient has been taking Medikinet CR for more than a year, the doctor should interrupt treatment at least once a year. In the case of children, it is advisable to plan such a break in treatment during school vacations. This will allow for an assessment of whether continued treatment with the medicine is necessary.

Incorrect use of Medikinet CR

Incorrect use of Medikinet CR can lead to abnormal behavior. It can also cause dependence on the medicine. If the patient has ever abused or been dependent on alcohol, prescription drugs, or narcotics, 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 a higher dose of Medikinet CR than recommended

If the patient takes too much of the medicine, they should immediately consult a doctor or call emergency services. They should report the amount of medicine taken. Treatment may be necessary.
Overdose symptoms may include: vomiting, feeling agitated, 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, 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 CR

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 treatment with Medikinet CR

Sudden stopping of treatment with this medicine may lead to a recurrence of ADHD symptoms or the appearance of unexpected symptoms, such as depression. Before completely stopping the medicine, the doctor will gradually reduce the daily dose. Before stopping treatment with Medikinet CR, the patient should consult their doctor.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Medikinet CR can cause side effects, although not everybody gets them.
The doctor will inform the patient about such side effects.

Some side effects can be serious. If the patient experiences any of the following, they should immediately consult a doctor:

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

• mood swings, mood changes;
• suicidal thoughts or desire to end their life.
• feeling or hearing things that do not exist - these are symptoms of psychosis;
• uncontrolled speech and movements and their intensification (Tourette's syndrome) or their intensification;
• chest pain;
• 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.

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

• extreme excitement, excessive activity, and lack of restraint (mania).

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

• heart attack;
• seizures (convulsions, epilepsy);
• peeling of the skin or purple-red spots on the skin;
• involuntary muscle contractions, affecting the eyes, head, neck, or the rest of the body, and neurological symptoms related to temporary brain ischemia;
• paralysis or problems with movement and vision, speech difficulties (these may be symptoms of cerebrovascular problems), transient lack of sufficient blood and oxygen supply to the brain (ischemia);
• reduced number of blood cells (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 unknown reasons, shortness of breath (these may be symptoms of heart disease).

If the patient experiences any of the above side effects, they should immediately consult a doctor.

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;
• dry mouth;
• nausea.

Common: may affect up to 1 in 10 people

• feeling depressed or lacking emotions or feelings or showing excessive interest;
• 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 hives on the skin;
• cough, sore throat, or nose and throat irritation, shortness of breath, 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;
• excessive activity;
• aggression, agitation, restlessness, emotional instability, anxiety, depression, stress, irritation, abnormal behavior, sleep problems, fatigue;
• stomach pain, diarrhea, abdominal discomfort, indigestion, thirst, vomiting. These symptoms usually occur at the beginning of treatment and can be reduced by taking the medicine with food;
• loss of appetite/aversion to food;
• weight loss;
• excessive sweating.

Uncommon: may affect up to 1 in 100 people

• muscle pain, muscle spasms, muscle stiffness;
• constipation;
• chest discomfort;
• gastritis;
• additional heart sounds (detected by examination);
• blood in the urine;
• double vision or blurred vision;
• elevated liver test results (in blood tests);
• anger, tearfulness, excessive awareness of surroundings;
• feeling very calm or drowsy;
• general sleep problems;
• fatigue.

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

• changes in sex drive;
• feeling disoriented;
• dilated pupils, vision problems;
• breast enlargement in men;
• redness of the skin, red, raised rash on the skin;
• chest pain due to insufficient blood flow to the heart;
• menstrual changes.

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 brain blood vessels;
• abnormal liver function, including liver failure and coma;
• changes in laboratory test results, including liver function and blood tests;
• suicide attempts (including successful attempts), abnormal thinking, lack of emotions or feelings, repetitive behaviors, obsessive focus on one thing;
• lack of energy;
• short-term feeling of sadness;
• numbness of fingers on the hands and feet, feeling cold, tingling, and color change (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 seizure);
• believing in things that are not true;
• confusion;
• sad or gloomy thoughts;
• feeling that the body needs the medicine or feeling its absence;
• cerebrovascular problems (stroke, cerebral vasculitis, or cerebral artery occlusion);
• erectile dysfunction;
• prolonged erections, sometimes painful, or increased frequency of erections;
• excessive, uncontrolled talking;
• after stopping the medicine: recurrence of ADHD symptoms or appearance of side effects, such as depression;
• feeling of tingling;
• speech and language problems;
• nausea;
• attention problems;
• flu-like symptoms;
• loss of energy/feeling of weakness;
• feeling thirsty;
• increased thyroid-stimulating hormone levels in the blood;
• mouth and throat pain;
• nosebleeds;
• heart discomfort;
• dry eye syndrome;
• increased eye pressure;
• partner stress, family stress;
• chest pain;
• hot flashes/flushing;
• "ringing" in the ears (tinnitus);
• medicine abuse;
• pancytopenia (reduced number of all blood cells);
• inability to control urination (urinary incontinence);
• jaw muscle spasm making it difficult to open the mouth (jaw lock);
• stuttering.

Effect on growth and body weight

When methylphenidate is taken for more than a year, it 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 methylphenidate may be interrupted for a short period.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Medikinet CR

The medicine should be stored out of sight and reach of children.
The medicine should not be taken after the expiry date stated on the blister pack and carton after "EXP". The expiry date refers to the last day of the month.
The medicine should not be stored above 30°C.
The medicine should be stored in its original packaging to protect it 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 CR contains:

The active substance of the medicine is methylphenidate hydrochloride
Medikinet CR 5 mgmodified-release hard capsules
Each modified-release hard capsule contains 5 mg of methylphenidate hydrochloride, which corresponds to 4.35 mg of methylphenidate.
Medikinet CR 10 mgmodified-release hard capsules
Each modified-release hard capsule contains 10 mg of methylphenidate hydrochloride, which corresponds to 8.65 mg of methylphenidate.
Medikinet CR 20 mgmodified-release hard capsules
Each modified-release hard capsule contains 20 mg of methylphenidate hydrochloride, which corresponds to 17.30 mg of methylphenidate.
Medikinet CR 30 mgmodified-release hard capsules
Each modified-release hard capsule contains 30 mg of methylphenidate hydrochloride, which corresponds to 25.95 mg of methylphenidate.
Medikinet CR 40 mgmodified-release hard capsules
Each modified-release hard capsule contains 40 mg of methylphenidate hydrochloride, which corresponds to 34.60 mg of methylphenidate.
Medikinet CR 50 mgmodified-release hard capsules
Each modified-release hard capsule contains 50 mg of methylphenidate hydrochloride, which corresponds to 43.25 mg of methylphenidate.
Medikinet CR 60 mgmodified-release hard capsules
Each modified-release hard capsule contains 60 mg of methylphenidate hydrochloride, which corresponds to 51.90 mg of methylphenidate.

Other ingredients are:

Capsule contents:

Sucrose, pellets (containing sucrose and cornstarch), methacrylic acid and ethyl acrylate copolymer (1:1), talc, triethyl citrate, polyvinyl alcohol, macrogol 3350, polysorbate 80, sodium hydroxide, sodium lauryl sulfate, simethicone, silica colloidal anhydrous, methylcellulose, sorbic acid, indigo carmine (E 132)

Capsule shell:

Gelatin, titanium dioxide (E 171), sodium lauryl sulfate, purified water
Additionally, in the shell of Medikinet CR 10 mg/20 mg capsules:
erythrosine (E 127), patent blue V (E 131)
Additionally, in the shell of Medikinet CR 30 mg/40 mg/50 mg/60 mg capsules:
erythrosine (E 127), iron oxide black (E 172); indigo carmine (E 132).

What Medikinet CR looks like and contents of the pack

Medikinet CR 5 mgmodified-release hard capsules
White, opaque capsule body/white opaque cap (15.9 mm), the capsule contains white and blue pellets.
Medikinet CR 10 mgmodified-release hard capsules
White, opaque capsule body/purple-pink opaque cap (15.9 mm), the capsule contains white and blue pellets.
Medikinet CR 20 mgmodified-release hard capsules
Purple-pink, opaque capsule body/purple-pink opaque cap (15.9 mm), the capsule contains white and blue pellets.
Medikinet CR 30 mgmodified-release hard capsules
Light gray, opaque capsule body/dark purple opaque cap (15.9 mm), the capsule contains white and blue pellets.
Medikinet CR 40 mgmodified-release hard capsules
Gray, opaque capsule body/dark purple opaque cap (18.0 mm), the capsule contains white and blue pellets.
Medikinet CR 50 mgmodified-release hard capsules
Purple, opaque capsule body/dark purple opaque cap (18.0 mm), the capsule contains white and blue pellets.
Medikinet CR 60 mgmodified-release hard capsules
Dark purple, opaque capsule body/dark purple opaque cap (19.4 mm), the capsule contains white and blue pellets.
Pack sizes:
Medikinet CR 5 mgmodified-release hard capsules
Boxes containing 20, 24, 27, 30, 36, 45, 48, 50, 54, 60, 90, 96, or 99 modified-release hard capsules in hard PVC/PVdC blisters sealed with aluminum foil.
Medikinet CR 10 mg/20 mgmodified-release hard capsules
Boxes containing 20, 24, 27, 28, 30, 36, 45, 48, 50, 54, 60, 90, 96, or 99 modified-release hard capsules in hard PVC/PVdC blisters sealed with aluminum foil.
Medikinet CR 30 mg/40 mgmodified-release hard capsules
Boxes containing 20, 24, 27, 28, 30, 36, 45, 48, 50, 54, 60, 90, 96, or 99 modified-release hard capsules in hard PVC/PVdC blisters sealed with aluminum foil.
Medikinet CR 50 mgmodified-release hard capsules
Boxes containing 20, 24, 27, 28, 30, 36, 40, 45, 48, 54, 60, 90, 96, or 99 modified-release hard capsules in hard PVC/PVdC blisters sealed with aluminum foil.
Medikinet CR 60 mgmodified-release hard capsules
Boxes containing 20, 24, 27, 28, 30, 36, 40, 45, 48, 54, 60, 90, 96, or 99 modified-release hard capsules in hard PVC/PVdC blisters sealed with aluminum foil.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Medice Arzneimittel Pütter GmbH & Co. KG
Kuhloweg 37, 58638 Iserlohn
Germany
Phone: +48 885 050 178

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

Germany:
Medikinet retard 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg
Hard capsules with modified release
Austria:
Medikinet retard 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg
Hard capsules with modified release
Denmark:
Medikinet CR 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg
Spain:
Medikinet 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg hard capsules with modified release
Finland:
Medikinet CR 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg
Iceland:
Medikinet CR 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg hard capsules with modified release
Luxembourg:
Medikinet retard 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg
Hard capsules with modified release
Netherlands:
Medikinet CR 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg capsules with regulated release, hard
Norway:
Medikinet 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg capsules with modified release, hard
Poland:
Medikinet CR 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg
Sweden:
Medikinet 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg capsules with modified release, hard
United Kingdom:
Medikinet XL 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg modified-release capsules, hard

Date of last revision of the leaflet: 05/2023