Adehader

Leaflet accompanying the packaging: information for the user

Adehader, 5 mg, modified-release capsules, hard

Adehader, 10 mg, modified-release capsules, hard

Adehader, 20 mg, modified-release capsules, hard

Adehader, 30 mg, modified-release capsules, hard

Adehader, 40 mg, modified-release capsules, hard

Adehader, 50 mg, modified-release capsules, hard

Adehader, 60 mg, modified-release capsules, hard

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 find out how to report adverse reactions, see section 4.

It is essential to carefully read the contents of the leaflet before taking the medicinal product, as it contains important information for the patient.

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, the patient should consult a doctor or pharmacist.
• This medicinal product has been prescribed to a specific person. It should not be given 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 those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Adehader and what is it used for
• 2. Important information before taking Adehader
• 3. How to take Adehader
• 4. Possible adverse reactions
• 5. How to store Adehader
• 6. Contents of the packaging and other information

1. What is Adehader and what is it used for

What is it used for?

Adehader is used to treat attention deficit hyperactivity disorder (ADHD) in children aged 6 and above and in adults.

• It is used when previous attempts to treat the condition without medication, such as psychological counseling and behavioral therapy, have been insufficient.

Adehader should not be used to treat ADHD in children under 6 years of age.

How does Adehader work?

Adehader improves the reduced activity of certain areas of the brain. The medicinal product may help to prolong attention span, improve concentration, and reduce impulsive behavior. It is used as part of a treatment program that usually includes psychotherapy, educational treatment, and social therapy.

About ADHD

Children and adolescents with ADHD have difficulty:

• sitting still and
• focusing their attention.

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

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

This can manifest in various ways, such as:

• difficulty concentrating
• forgetfulness
• talking excessively
• difficulty planning and completing tasks
• acting impulsively
• impatience

ADHD does not negatively affect the patient's intelligence.

2. Important information before taking Adehader

When not to take Adehader

If the patient:

• has been diagnosed with hypersensitivity to methylphenidate or any other component of the medicinal product (listed in section 6);
• has thyroid disease;
• has increased intraocular pressure (glaucoma);
• has a pheochromocytoma (a tumor of the adrenal gland);
• has eating disorders, such as anorexia nervosa;
• has very high blood pressure or narrowing of the 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 heart failure;
• 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;
• has psychiatric problems, such as:
• psychopathic disorders or borderline personality disorder;
• abnormal thoughts or visions, or schizophrenia;
• severe mood disorders, such as suicidal thoughts, severe depression, mania, or bipolar disorder;
• has a history of gastric hyposecretion (achlorhydria) with a pH above 5.5;
• is taking medications that reduce gastric acid secretion or treat hyperacidity (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 their doctor or pharmacist before taking methylphenidate. This is important because methylphenidate may worsen the above-mentioned problems.

Warnings and precautions

Before taking Adehader, the patient should consult 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 wave tests (e.g., EEG);
• they have a history of alcohol, prescription medication, or drug abuse;
• they are a female who has started menstruating (see "Pregnancy and breastfeeding" below);
• they have uncontrollable, repetitive movements or sounds (tics);
• they have high blood pressure;
• they have heart problems not listed in the "When not to take Adehader" section above;
• they have mental health problems not listed in the "When not to take Adehader" section above. Other mental health problems include:
• mood swings (from mania to depression - bipolar disorder);
• aggressive or hostile behavior;
• hallucinations;
• delusions;
• paranoia;
• feeling anxious, agitated, or tense;
• feeling depressed or guilty.

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 their 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 medications being taken;
• any cases of sudden, unexplained death in the family;
• any other medical problems (e.g., heart problems) that the patient or their family members may have;
• the patient's overall well-being, such as their mood, mental state, or any unusual feelings or past experiences;
• any history of tics (uncontrollable, repetitive movements or sounds) 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 - 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 essential 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 and decide if any additional medical examinations are necessary before starting treatment.

Drug test

This medicinal product may cause a positive result in drug tests.

Adehader and other medicinal products

The patient should inform their doctor or pharmacist about all medicinal products they are currently taking or plan to take.

Do not take Adehader if:

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

If the patient is taking other medicinal products, methylphenidate may affect their action or cause adverse reactions. The patient should inform their doctor or pharmacist if they are taking medicinal products for:

• depression;
• mental health problems;
• epilepsy;
• blood pressure problems;
• cough and cold symptoms. Some of these products contain substances that can affect blood pressure. When purchasing any of these products, the patient should consult their pharmacist.
• medicinal products that thin the blood and prevent clotting.

The patient should not take Adehader with H2 receptor antagonists, proton pump inhibitors, or antacids, 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 consult 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, as this may cause a sudden increase in blood pressure during surgery.

Taking Adehader 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 present in some food products and medicinal products.

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 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 methylphenidate treatment.
• they are breastfeeding or plan to breastfeed. Methylphenidate may pass into breast milk. The doctor will decide whether breastfeeding is possible during methylphenidate treatment.

Driving and using machines

While taking methylphenidate, the patient may experience dizziness, drowsiness, difficulty focusing, blurred vision, hallucinations, or other adverse reactions affecting the central nervous system. If these symptoms occur, the patient should not perform activities such as driving, operating machinery, cycling, or horse riding, as this may be dangerous.

Adehader contains sucrose

Sucrose

If the patient has 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 it is considered "sodium-free".

3. How to take Adehader

Adehader 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 will usually start with a small dose and gradually increase 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.
• Adehader should not be taken too late in the morning, as it may cause sleep disturbances.

Use in adults:

• If the patient has taken Adehader 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 prescribe 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 taken Adehader before:

• The recommended starting 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 find 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

The doctor will perform certain examinations

• before starting treatment - to ensure that Adehader is safe and suitable for the patient;
• after starting treatment - at least every 6 months, but possibly more frequently. These examinations will also be performed when the dose 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 any unusual feelings and determine if these problems have worsened during Adehader treatment.

Method of administration

This medicinal product is intended for oral use.

Children take Adehader in the morning, during or after breakfast.

Adults take Adehader in the morning and at lunchtime, during or after a meal.

Adehader is a modified-release formulation, which means that the active substance is released into the body slowly over a longer period. Taking the capsule during or after meals is crucial for achieving this prolonged action.

The capsule can be swallowed whole with water. The capsule can also be opened, and the contents can be sprinkled onto a small amount (one tablespoon) of applesauce or yogurt and taken immediately. The contents of the capsule should not be stored for later use.

The capsule or its 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 Adehader indefinitely. If the patient has been taking Adehader for more than a year, the doctor should interrupt treatment at least once a year for a short period. For children, it is recommended to plan this interruption during school vacations. This will allow the doctor to assess whether continued treatment is necessary.

Incorrect use of Adehader

Incorrect use of Adehader may lead to abnormal behavior. It may also cause the patient to become dependent on the medicinal product. If the patient has a history of alcohol, prescription medication, or drug abuse, they should inform their doctor. This medicinal product is intended only for the person it has been prescribed to. It should not be given to others, even if their symptoms are similar.

Taking a higher dose of Adehader than recommended

If the patient takes too much of the medicinal product, they should immediately consult their doctor or call the emergency services. They should inform their doctor about the amount of medicinal product taken. Treatment may be necessary.

Symptoms of overdose may include: vomiting, feeling overstimulated, tremors, 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 brownish-red urine, which may be a sign of abnormal muscle breakdown (rhabdomyolysis).

Missing a dose of Adehader

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 Adehader

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

4. Possible adverse reactions

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

Some adverse reactions can be serious. If the patient experiences any of the following, they should immediately consult their 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;
• suicidal thoughts or attempts.
• feeling, seeing, or hearing things that do not exist (psychotic symptoms');
• uncontrolled speech and movements and their worsening (Tourette's syndrome');
• 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

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

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

• heart attack;
• seizures (convulsions, epilepsy');
• skin peeling or purple-red spots on the skin;
• uncontrollable muscle contractions, affecting the eyes, head, neck, or other parts of the body, and neurological symptoms related to temporary cerebral ischemia;
• paralysis or problems with movement and vision, speech difficulties (which may be symptoms of cerebrovascular problems);
• 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 (neuroleptic malignant syndrome). It is not certain whether this adverse reaction is caused by methylphenidate or other medicinal products 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 (which may be symptoms of heart problems).

If the patient experiences any of the above adverse reactions, they should immediately consult their 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 fever;
• excessive hair loss or thinning;
• feeling unusually sleepy or sluggish;
• loss of appetite;
• anxiety attacks;
• decreased sex drive;
• toothache;
• itching, rash, or hives on the skin;
• cough, sore throat, or nasal congestion, as well as irritation of the throat;
• changes in blood pressure (usually high blood pressure);
• rapid heartbeat (tachycardia), cold hands and feet;
• tremors and shaking, dizziness;
• involuntary movements, feeling restless;
• excessive activity;
• aggression, overstimulation, restlessness, emotional instability, anxiety, depression, stress, abnormal behavior, sleep problems, fatigue;
• abdominal pain, diarrhea, discomfort in the abdomen, nausea, 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;
• extra heart sound (detected by examination);
• blood in the urine;
• double vision or blurred vision;
• elevated liver function test results (in blood tests);
• anger, tearfulness, excessive awareness of surroundings, tension;
• feeling very calm or sleepy;
• 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;
• changes in menstrual cycle.

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;
• suicidal attempts (including successful attempts), abnormal thinking, lack of emotions, repetitive behaviors, obsessive focus on one thing;
• lack of energy;
• brief feeling of sadness;
• numbness of fingers on the hands and feet, feeling cold, tingling, and change in skin color (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 seizures);
• believing in things that are not true;
• confusion;
• depressed or gloomy thoughts;
• feeling that the body needs the medicinal product or feeling its absence;
• problems with blood vessels in the brain (stroke, cerebral vasculitis, or cerebral artery occlusion);
• erectile dysfunction;
• prolonged erections, sometimes painful, or increased frequency of erections;
• excessive, uncontrolled talking;
• after stopping treatment: recurrence of ADHD symptoms or adverse reactions, such as depression;
• feeling of tingling;
• speech and language problems;
• nausea;
• attention problems;
• flu-like symptoms;
• loss of energy/feeling weak;
• feeling thirsty;
• increased levels of thyroid-stimulating hormone in the blood;
• mouth and throat pain;
• nosebleeds;
• discomfort in the chest;
• dry eye syndrome;
• increased eye pressure;
• stress in relationships with partners, stress in the family;
• chest pain;
• hot flashes/flushing;
• "ringing" in the ears (tinnitus);
• medicinal product abuse;
• pancytopenia (reduced blood cell count);
• inability to control urination (urinary incontinence);
• muscle spasm in the jaw, 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 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 those not listed in this leaflet, they should inform their doctor or pharmacist.

Adverse reactions can be reported directly to the Department of Adverse Reaction Monitoring 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

Adverse reactions can also be reported to the marketing authorization holder.

Reporting adverse reactions will help to gather more information on the safety of the medicinal product.

5. How to store Adehader

The medicinal product should be stored out of sight and reach of children.

Do not use this medicinal product 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 30°C.

Store in the original packaging to protect from moisture.

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

6. Contents of the packaging and other information

What Adehader contains:

The active substance is methylphenidate hydrochloride.

Adehader, 5 mg

Each modified-release capsule, hard, contains 5 mg of methylphenidate hydrochloride, which corresponds to 4.35 mg of methylphenidate.

Adehader, 10 mg

Each modified-release capsule, hard, contains 10 mg of methylphenidate hydrochloride, which corresponds to 8.65 mg of methylphenidate.

Adehader, 20 mg

Each modified-release capsule, hard, contains 20 mg of methylphenidate hydrochloride, which corresponds to 17.30 mg of methylphenidate.

Adehader, 30 mg

Each modified-release capsule, hard, contains 30 mg of methylphenidate hydrochloride, which corresponds to 25.95 mg of methylphenidate.

Adehader, 40 mg

Each modified-release capsule, hard, contains 40 mg of methylphenidate hydrochloride, which corresponds to 34.60 mg of methylphenidate.

Adehader, 50 mg

Each modified-release capsule, hard, contains 50 mg of methylphenidate hydrochloride, which corresponds to 43.25 mg of methylphenidate.

Adehader, 60 mg

Each modified-release capsule, hard, contains 60 mg of methylphenidate hydrochloride, which corresponds to 51.90 mg of methylphenidate.

Other ingredients:

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, anhydrous colloidal silica, methylcellulose, sorbic acid (E 200), indigo carmine (E 132)

Capsule shell:

Gelatin, titanium dioxide (E 171), sodium lauryl sulfate, purified water

In addition to the capsule shell of Adehader 10 mg and 20 mg:

Erythrosine (E 127), patent blue V (E 131)

In addition to the capsule shell of Adehader 30 mg, 40 mg, 50 mg, and 60 mg:

Erythrosine (E 127), iron oxide black (E 172); indigo carmine (E 132)

What Adehader looks like and contents of the pack

Adehader, 5 mgmodified-release capsules, hard

White, opaque body of the capsule/white opaque cap (15.9 mm), the capsule contains white and blue pellets.

Adehader, 10 mgmodified-release capsules, hard

White, opaque body of the capsule/purple-pink opaque cap (15.9 mm), the capsule contains white and blue pellets.

Adehader, 20 mgmodified-release capsules, hard

Purple-pink, opaque body of the capsule/purple-pink opaque cap (15.9 mm), the capsule contains white and blue pellets.

Adehader, 30 mgmodified-release capsules, hard

Light gray, opaque body of the capsule/dark purple opaque cap (15.9 mm), the capsule contains white and blue pellets.

Adehader, 40 mgmodified-release capsules, hard

Gray, opaque body of the capsule/dark purple opaque cap (18.0 mm), the capsule contains white and blue pellets.

Adehader, 50 mgmodified-release capsules, hard

Purple, opaque body of the capsule/dark purple opaque cap (18.0 mm), the capsule contains white and blue pellets.

Adehader, 60 mgmodified-release capsules, hard

Dark purple, opaque body of the capsule/dark purple opaque cap (19.4 mm), the capsule contains white and blue pellets.

Pack sizes:

Adehader, 5 mgmodified-release capsules, hard

Cartons containing 20, 24, 27, 30, 36, 45, 48, 50, 54, 60, 90, 96, or 99 modified-release capsules, hard, in PVC/PVdC/Aluminum blisters.

Adehader, 10 mg/20 mgmodified-release capsules, hard

Cartons containing 20, 24, 27, 28, 30, 36, 45, 48, 50, 54, 60, 90, 96, or 99 modified-release capsules, hard, in PVC/PVdC/Aluminum blisters.

Adehader, 30 mg/40 mgmodified-release capsules, hard

Cartons containing 20, 24, 27, 28, 30, 36, 45, 48, 50, 54, or 60 modified-release capsules, hard, in PVC/PVdC/Aluminum blisters.

Adehader, 50 mgmodified-release capsules, hard

Cartons containing 20, 24, 27, 28, 30, 36, 40, 45, or 48 modified-release capsules, hard, in PVC/PVdC/Aluminum blisters.

Adehader, 60 mgmodified-release capsules, hard

Cartons containing 20, 24, 27, 28, 30, 36, or 40 modified-release capsules, hard, in PVC/PVdC/Aluminum blisters.

Not all pack sizes may be marketed.

Marketing authorization holder

Humantis GmbH

Kuhloweg 37, 58638 Iserlohn

Germany

Tel: +48 (22) 370 21 05

Manufacturer

MEDICE Arzneimittel Pütter GmbH & Co. KG

Kuhloweg 37, 58638 Iserlohn

Germany

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

Germany:

Methylphenidat Humantis, 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, Hartkapseln mit veränderter Wirkstofffreisetzung

Denmark:

Methylphenidathydrochlorid Humantis, 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg

Iceland:

Methylphenidathydrochlorid Humantis, 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, hart hylki með breyttan losunarhraða

Netherlands:

Methylfenidaat HCl Humantis, 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, capsule met gereguleerde afgifte, hard

Norway:

Methylphenidate Humantis, 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, Kapsel med modifisert frisetting, hard

Poland:

Adehader, 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg

Sweden:

Methylphenidate Humantis, 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, Kapsel med modifierad frisättning, hård

Date of last revision of the leaflet: