Medikinet Cr 50 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 for the quick identification of new safety information. The user of the medicinal product can also help by reporting any adverse reactions that occur after taking the medicinal product. To learn how to report adverse reactions, see section 4.

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

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicinal product has been prescribed specifically for you. Do not pass it on to others. The medicinal product may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, they should inform 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 adverse reactions
• 5. How to store Medikinet CR
• 6. Contents of the packaging 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 above and in adults.
• It is used only if previous attempts at treatment without medication, such as psychological counseling and behavioral therapy, have been insufficient.

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. This medicinal product may help to prolong attention span, improve concentration, and reduce impulsive behavior.
This medicinal product is used as part of a treatment program that usually includes psychotherapy, educational treatment, and social therapy.
Treatment with Medikinet CR may 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 by using appropriate therapeutic programs.

About ADHD

Children and adolescents with ADHD have difficulty:

• sitting still and
• focusing their attention.

This is not their fault, as these activities are very difficult for them.
ADHD can occur in patients with varying severity, with symptoms such as:

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

This is exemplified by, for example:

• 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 medicinal product (listed in section 6);
• has a thyroid disease;
• has increased intraocular pressure (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 pain in the arms and legs;
• 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 CR and other medicinal products";
• has 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, where the patient feels deep sadness, worthlessness, and hopelessness; mania, where the patient feels extremely stimulated, overactive, and uninhibited;
• has a history of significant gastric acid deficiency (achlorhydria) with a pH above 5.5;
• is taking medicinal products 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-mentioned problems.

Warnings and precautions

Before taking Medikinet CR, the patient should consult a 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 female 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 diseases not listed in the "When not to take Medikinet CR" section above;
• they have mental health disorders not listed in the "When not to take Medikinet CR" section above. Other mental health disorders 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 stimulated, 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 medicinal product affects the patient's condition.

During treatment, unexpected, prolonged erections may occur in boys and young men. 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 medicinal product for the patient. The doctor will discuss with the patient:

• any other medicinal products 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 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 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 medicinal product for the patient. The doctor will also decide whether any additional medical examinations are necessary before starting treatment with this medicinal product.

Drug test

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

Medikinet CR and other medicinal products

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

The patient should not take methylphenidate if:

• they are taking a medicinal product called a monoamine oxidase inhibitor (MAOI) used to treat depression or have 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 medicinal products, methylphenidate may affect their action or cause adverse reactions. The patient should inform their doctor or pharmacist if they are taking or have taken medicinal products used to treat:

• depression;
• mental disorders;
• epilepsy;
• blood pressure problems;
• coughs and colds. Some of these products contain substances that can affect blood pressure. When purchasing any such products, the patient should consult a pharmacist.
• medicinal products that thin the blood and prevent clotting.

The patient should not take Medikinet CR 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 the patient is unsure whether a medicinal product is on the above list, they 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 medicinal product. Alcohol may increase the adverse reactions of this medicinal product. The patient should remember that alcohol is also contained in some food products and medicinal products.

Pregnancy and breastfeeding

Available data do not indicate an increased risk of congenital malformations overall, although a small 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

While taking methylphenidate, the patient may experience dizziness, drowsiness, difficulty focusing their eyes, blurred vision, hallucinations, or other adverse reactions affecting the central nervous system. If such symptoms occur, performing activities such as driving, operating machinery, riding a bicycle or horse, or 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 medicinal product.

Sodium

The medicinal product contains less than 1 mmol (23 mg) of sodium per capsule, which means that the medicinal product 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 which strength of capsule to take 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.
• 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 by 10 mg per day, depending on the patient's tolerance and response to the medicinal product.
• The goal is to achieve 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 medicinal product 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 medicinal product is intended for oral use.
Children take Medikinet CR in the morning, during or afterbreakfast.
Adults take Medikinet CR during or afterbreakfast andafter a meal eaten in the afternoon (lunch).
Medikinet CR is a "controlled-release" form of methylphenidate, which means that the medicinal product is released into the body slowly over a longer period. Taking the capsule during or aftermeals is very important for achieving this prolonged action.
The capsules can be swallowed whole with water. The capsule can also be opened, and its contents can be sprinkled onto a small amount (a tablespoon) of applesauce or yogurt and taken immediately. The medicinal product 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 treating 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 beneficial to plan such a break in treatment during school vacations. This will allow for an assessment of whether continued treatment with the medicinal product is necessary.

Incorrect use of Medikinet CR

Incorrect use of Medikinet CR can lead to unusual behavior. It can also cause dependence on the medicinal product. If the patient has ever abused or been dependent on alcohol, prescription drugs, or narcotics, they should inform their doctor. This medicinal product is intended only for the person to whom it was prescribed. It should not be given to others, even if the symptoms of their illness are similar.

Taking a higher dose of Medikinet CR than recommended

If the patient takes too much of the medicinal product, they should immediately consult a doctor or call emergency services. They should report the amount of medicinal product taken. Treatment may be necessary.
Overdose symptoms may include: vomiting, feeling stimulated, tremors, increased involuntary movements, muscle twitching, seizures (which may be followed by coma), feeling extremely happy, disorientation, seeing, feeling, or hearing 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 stoppage of this medicinal product may lead to a recurrence of ADHD symptoms or the appearance of unexpected symptoms, such as depression. Before completely stopping the medicinal product, the treating doctor will gradually reduce the daily dose. Before stopping treatment with Medikinet CR, the patient should consult their treating doctor.
If the patient has any further doubts about taking this medicinal product, they should consult their doctor or pharmacist.

4. Possible adverse reactions

Like all medicinal products, Medikinet CR can cause adverse reactions, although not everybody gets them.
The doctor will inform the patient about such adverse reactions.

Some adverse reactions 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, changes in mood;
• thoughts of suicide or self-harm.
• feeling or hearing things that do not exist - these are symptoms of psychosis;
• uncontrolled speech and movements and their worsening (Tourette's syndrome) or their worsening;
• 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

• unusual excitement, overactivity, and lack of inhibition (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 cerebral 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 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 adverse reaction is caused by methylphenidate or other medicinal products that may be used 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 adverse reactions, they should immediately consult a doctor.

The following is a list of other adverse reactions. 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 unemotional or showing too much interest;
• joint pain;
• high body 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, as well as difficulty breathing, wheezing, or shortness of breath;
• changes in blood pressure (usually high blood pressure);
• rapid heartbeat (tachycardia), cold hands and feet;
• tremors and shaking, dizziness;
• involuntary movements, feeling of inner restlessness;
• unusual activity;
• aggression, stimulation, restlessness, emotional instability, anxiety, depression, stress, irritation, abnormal behavior, sleep problems, fatigue;
• abdominal pain, diarrhea, discomfort in the abdominal cavity, nausea, thirst, vomiting. These symptoms usually occur at the beginning of treatment and can be reduced by taking the medicinal product 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;
• discomfort in the chest;
• inflammation of the lining of the stomach and small intestine;
• 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, difficulty seeing;
• 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 disorders.

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 tests;
• suicide attempts (including successful attempts), abnormal thinking, lack of emotions, 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 change in skin color (from pale to blue, 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 seizures);
• believing in things that are not real;
• confusion;
• depressed or gloomy thoughts;
• feeling that the body needs the medicinal product 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 medicinal product: recurrence of ADHD symptoms or appearance of adverse reactions, such as depression;
• feeling of tingling;
• speech and language problems;
• nausea;
• attention problems;
• flu-like symptoms;
• loss of energy/feeling of weakness;
• feeling of thirst;
• increased levels of thyroid-stimulating hormone 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);
• medicinal product abuse;
• pancytopenia (reduced blood cell count);
• inability to control urination (urinary incontinence);
• jaw muscle spasm making it difficult to open the mouth (trismus);
• stuttering.

Effect on growth and body weight

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

• The child may not gain weight or grow at a normal rate.
• The treating doctor will carefully monitor the child's growth and body 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 adverse reactions

If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, they should inform their doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Drug Adverse Reaction Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to gather more information on the safety of the medicinal product.

5. How to store Medikinet CR

The medicinal product should be stored out of sight and reach of children.
The medicinal product should not be used 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.
The medicinal product should not be stored at temperatures above 30 °C.
The medicinal product should be stored in its original packaging to protect it from moisture.
Medicinal products should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of unused medicinal products. This will help protect the environment.

6. Contents of the packaging and other information

What Medikinet CR contains:

The active substance of the medicinal product 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:

Contents of the capsule:

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 medicinal product 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