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. You can help by reporting any side effects you may experience. To find out 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 Adehader and what is it used for
• 2. Important information before taking Adehader
• 3. How to take Adehader
• 4. Possible side effects
• 5. How to store Adehader
• 6. Contents of the pack 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).

• It is used in children aged 6 and over and in adults.
• It is used only if previous attempts at treatment without medication, such as psychological counseling and behavioral therapy, have been insufficient.

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

How does Adehader work?

Adehader improves reduced activity in certain areas of the brain. This medicine may help prolong attention span, improve concentration, and reduce impulsive behavior. This medicine is used as part of a treatment program that usually includes psychotherapy, educational treatment, and social therapy. Treatment with Adehader 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 tests to confirm that ADHD has been present since childhood. 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.

This is not their fault, as these activities are extremely 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 impulse"
• 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 of the other ingredients of this medicine (listed in section 6);
• has a thyroid disease;
• has increased eye 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 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 stroke, aneurysm, or vasculitis;
• is currently taking or has taken monoamine oxidase inhibitors (MAOIs) in the last 14 days - see "Adehader and other medicines";
• 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 agitated, overactive, and uninhibited;
• has a history of significant gastric acid deficiency (achlorhydria) with a pH above 5.5;
• is taking medicines to reduce gastric acid secretion or to 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. If in doubt, 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 Adehader, 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 female who has started menstruating (see "Pregnancy and breastfeeding" below);
• they have uncontrollable repetitive movements of any body part or repeat sounds and words (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 - 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 suspicion (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.

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

This 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 and 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, unusual thoughts, and any history of such conditions;
• any history of tics (uncontrollable repetitive movements of any body part or repetition of sounds and words) in the patient's family;
• any history of mental health or behavioral problems in the patient or their family.

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 tests are necessary before starting treatment with this medicine.

Drug test

This medicine may cause a positive result in drug tests.

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

The patient should not take Adehader at the same time as H2 receptor antagonists, proton pump inhibitors, or antacids used to reduce gastric acid secretion or to 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 methylphenidate treatment.
• they are breastfeeding or plan to breastfeed. Methylphenidate may pass into breast milk. Therefore, 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 their eyes, blurred vision, hallucinations, or other central nervous system side effects. If these symptoms occur, performing activities such as driving, operating machinery, riding a bicycle, or horseback riding, as well as climbing trees, may be dangerous.

Adehader 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 Adehader

Adehader should always be taken as directed by the doctor. If in doubt, 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.
• Adehader should not be taken too late in the morning, as it may cause sleep disturbances.

Use in adults
Adult patients who have previously taken Adehader

• If the patient took 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 give the patient 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 Adehader
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 medicine.
• 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 of the patient (adult or child)

The doctor will perform certain tests

• 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 tests will also be performed when the dose is changed.
• during the test, 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 find out if these problems have worsened during treatment with Adehader.

Method of administration

This medicine is intended for oral use.
Children take Adehader in the morning, during or afterbreakfast.
Adults take Adehader in the morning and at lunchtime, with a mealor after a meal.
Adehader 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 with meals or after meals is very important for achieving this delayed prolonged action.
The capsules can be swallowed whole with water. They can also be opened, and the contents can be sprinkled onto 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 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 beneficial 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 Adehader

Incorrect use of Adehader may lead to unusual behavior. It can also cause the patient to become dependent 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 more than the recommended dose of Adehader

If the patient takes too much of the medicine, they should immediately consult a doctor or call an emergency number. They should say how much medicine was 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 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 medicine may lead to a return 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 Adehader, 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, Adehader can cause side effects, although not everybody gets them.
The doctor will inform the patient about these 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;
• 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

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

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

• heart attack;
• seizures (convulsions, epilepsy);
• skin peeling or reddish-purple 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, difficulties with speech (these may be symptoms of cerebrovascular problems);
• decrease in the 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;

Unknown: frequency cannot be estimated from the available data

• recurring unwanted thoughts;
• loss of consciousness for an unknown reason, shortness of breath (this may be a symptom 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 unemotional or showing too much interest;
• joint pain;
• high temperature (fever);
• excessive hair loss or thinning;
• feeling unusually drowsy or lethargic;
• loss of appetite;
• panic attacks;
• decreased sex drive;
• toothache;
• itching, rash, or raised, red, and itchy patches on the skin (hives);
• cough, sore throat, or nasal 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 tremors, 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, nausea, loss of appetite. 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 tests);
• blood in the urine;
• double vision or blurred vision;
• elevated liver test results (in blood tests);
• anger, tearfulness, excessive awareness of surroundings, tension;
• 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, raised, red rash on the skin;
• chest pain due to insufficient blood flow to the heart;
• problems/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 and blood tests;
• suicide attempts (including successful attempts), thought disorders, emotional numbness, repetitive behaviors, obsessive focus on one thing;
• lack of energy;
• short-term feeling of sadness;
• numbness of fingers on 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 true;
• confusion;
• sad or gloomy thoughts;
• feeling that the body needs the medicine 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 speech;
• after stopping the medicine: return of ADHD symptoms or occurrence 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 of thirst;
• increased levels of thyroid-stimulating hormone in the blood;
• mouth and throat pain;
• nosebleeds;
• heart discomfort;
• 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);
• medicine abuse;
• pancytopenia (decrease in the number of all blood cells);
• inability to control urination (urinary incontinence);
• muscle spasm of the jaw, making it difficult to open the mouth (trismus);
• 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 Drug Safety 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Adehader

The medicine should be stored out of sight and reach of children.
Do not take this medicine after the expiry date stated on the blister pack and carton after "EXP". The expiry date refers to the last day of the month stated.
Do not store above 30°C.
Store in the original package to protect 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 Adehader contains:

The active substance is methylphenidate hydrochloride
Adehader, 5 mgmodified-release capsules, hard
Each modified-release capsule, hard, contains 5 mg of methylphenidate hydrochloride, which corresponds to 4.35 mg of methylphenidate.
Adehader, 10 mgmodified-release capsules, hard
Each modified-release capsule, hard, contains 10 mg of methylphenidate hydrochloride, which corresponds to 8.65 mg of methylphenidate.
Adehader, 20 mgmodified-release capsules, hard
Each modified-release capsule, hard, contains 20 mg of methylphenidate hydrochloride, which corresponds to 17.30 mg of methylphenidate.
Adehader, 30 mgmodified-release capsules, hard
Each modified-release capsule, hard, contains 30 mg of methylphenidate hydrochloride, which corresponds to 25.95 mg of methylphenidate.
Adehader, 40 mgmodified-release capsules, hard
Each modified-release capsule, hard, contains 40 mg of methylphenidate hydrochloride, which corresponds to 34.60 mg of methylphenidate.
Adehader, 50 mgmodified-release capsules, hard
Each modified-release capsule, hard, contains 50 mg of methylphenidate hydrochloride, which corresponds to 43.25 mg of methylphenidate.
Adehader, 60 mgmodified-release capsules, hard
Each modified-release capsule, hard, 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, anhydrous colloidal silica, methylcellulose, sorbic acid (E 200), indigo carmine (E 132)

Capsule shell:

Gelatin, titanium dioxide (E 171), sodium lauryl sulfate, purified water
Additionally, in the shell of Adehader 10 mg and 20 mg capsules:
erythrosine (E 127), patent blue V (E 131)
Additionally, in the shell of Adehader 30 mg, 40 mg, 50 mg, and 60 mg capsules:
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 capsule body/white opaque cap (15.9 mm), the capsule contains white and blue pellets.
Adehader, 10 mgmodified-release capsules, hard
White, opaque capsule body/purple-pink opaque cap (15.9 mm), the capsule contains white and blue pellets.
Adehader, 20 mgmodified-release capsules, hard
Purple-pink, opaque capsule body/purple-pink opaque cap (15.9 mm), the capsule contains white and blue pellets.
Adehader, 30 mgmodified-release capsules, hard
Light gray, opaque capsule body/dark purple opaque cap (15.9 mm), the capsule contains white and blue pellets.
Adehader, 40 mgmodified-release capsules, hard
Gray, opaque capsule body/dark purple opaque cap (18.0 mm), the capsule contains white and blue pellets.
Adehader, 50 mgmodified-release capsules, hard
Purple, opaque capsule body/dark purple opaque cap (18.0 mm), the capsule contains white and blue pellets.
Adehader, 60 mgmodified-release capsules, hard
Dark purple, opaque capsule body/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, in hard blisters of PVC/PVdC/Aluminum foil.
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, in hard blisters of PVC/PVdC/Aluminum foil.
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, in hard blisters of PVC/PVdC/Aluminum foil.
Adehader, 50 mgmodified-release capsules, hard
Cartons containing 20, 24, 27, 28, 30, 36, 40, 45, or 48 modified-release capsules, in hard blisters of PVC/PVdC/Aluminum foil.
Adehader, 60 mgmodified-release capsules, hard
Cartons containing 20, 24, 27, 28, 30, 36, or 40 modified-release capsules, in hard blisters of PVC/PVdC/Aluminum foil.
Not all pack sizes may be marketed.

Marketing authorization holder

Humantis GmbH
Kuhloweg 37, 58638 Iserlohn
Germany
Phone: +48 (22) 370 21 05

Manufacturer

MEDICE Arzneimittel Pütter GmbH & Co. KG
Kuhloweg 37, 58638 Iserlohn
Germany

This medicine 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,
Hard capsules with modified release
Denmark:
Methylphenidate hydrochloride Humantis, 5 mg, 10 mg, 20 mg, 30 mg, 40 mg,
50 mg, 60 mg
Iceland:
Methylphenidate hydrochloride Humantis, 5 mg, 10 mg, 20 mg, 30 mg, 40 mg,
50 mg, 60 mg, hard capsules with modified release
Netherlands:
Methylphenidate HCl Humantis, 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg,
60 mg, capsules with regulated release, hard
Norway:
Methylphenidate Humantis, 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg,
60 mg, Capsules with modified release, 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, Capsules with modified release, hard

Date of last revision of the leaflet: