Adehader

Leaflet attached to 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. See section 4 for how to report side effects.

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 your 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 above and in adults.
• It is used only if previous attempts to treat the disorder without medication, such as psychological counseling and behavioral therapy, have been 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. The medicine may help to prolong attention span, improve concentration, and reduce impulsive behavior. The medicine is used as part of a treatment program that usually includes psychotherapy, educational treatment, and social therapy. Treatment with Adehader should only be initiated and continued by a specialist 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. 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 very 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 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 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 thyroid disease;
• has increased intraocular pressure (glaucoma);
• has a pheochromocytoma (adrenal gland tumor);
• has eating disorders, such as anorexia nervosa;
• has very high blood pressure or narrowing of the blood vessels, which can cause arm and leg pain;
• 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 swings, such as suicidal thoughts, severe depression, mania, or hypomania;
• 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. If in doubt, the patient should consult their 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 discuss the following with their doctor:

• any liver or kidney problems;
• difficulty swallowing or taking whole tablets;
• a history of seizures, convulsions, or abnormal EEG results;
• a history of alcohol, prescription medication, or drug abuse;
• if the patient is a female who has started menstruating (see "Pregnancy and breastfeeding" below);
• if the patient has uncontrollable repetitive movements or sounds (tics);
• if the patient has high blood pressure;
• if the patient has heart problems not listed in the "When not to take Adehader" section above;
• if the patient has 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 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 seek medical attention immediately.

Medical examination before taking Adehader

The examination aims to determine whether Adehader is a suitable medicine for the patient. The doctor will discuss the following with the patient:

• any other medicines being taken;
• any cases of sudden and unexplained death in the patient's family;
• any other medical problems (such as 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;
• 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.

The doctor will discuss the risk of mood swings (from mania to depression - bipolar disorder) with the patient. The doctor will also take a mental health history 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 medicine for the patient and decide if any additional medical examinations are necessary before starting treatment.

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 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 medicines, methylphenidate may affect their action or cause side effects. The patient should tell their doctor or pharmacist if they are taking medicines for:

• depression;
• psychiatric disorders;
• epilepsy;
• blood pressure problems;
• cough and cold. Some of these products contain substances that can affect blood pressure. When buying any of these products, the patient should consult their pharmacist.
• blood-thinning medicines.

Adehader should not be taken with H2 receptor antagonists, proton pump inhibitors, or antacids, as this may lead to faster release of the active substance into the body. If in doubt about whether a medicine is on the above list, 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, 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 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 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 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 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 it 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 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

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 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 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 (for adults or children)

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 medicine is for oral use.

Children take Adehader in the morning, during or afterbreakfast.

Adults take Adehader in the morning and at lunchtime, with or aftera snack or meal.

Adehader is a modified-release form of methylphenidate, which means that the medicine is released into the body slowly over a longer period. Taking the capsule with food or after meals is crucial for achieving this delayed prolonged action.

The capsules can be swallowed whole with water. Alternatively, the capsule can 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 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 for a short period at least once a year. For children, it is beneficial to plan this interruption during school vacations. This will allow for an assessment of whether continued treatment is necessary.

Incorrect use of Adehader

Incorrect use of Adehader may lead to abnormal behavior. It may also cause dependence on the medicine. If the patient has ever abused or been dependent on alcohol, prescription medicines, or drugs, 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 seek medical attention immediately. They should inform their doctor or pharmacist about the amount of medicine taken. Treatment may be necessary.

Symptoms of overdose may include: vomiting, feeling over-stimulated, 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 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 occurrence of unexpected symptoms, such as depression. Before completely stopping the medicine, the doctor will gradually reduce the daily dose. Before stopping 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 seek medical attention immediately:

Common: may affect up to 1 in 10 people

• irregular heartbeat (palpitations)
• changes in personality;
• excessive teeth grinding (bruxism).

Uncommon: may affect up to 1 in 100 people

• mood swings, changes in mood;
• suicidal thoughts or intentions.
• seeing, hearing, or feeling things that do not exist - these are symptoms of psychosis;
• uncontrolled speech and movements and/or 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, or wheezing.

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 with convulsions);
• skin peeling 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, difficulty speaking (these 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 and bleeding;
• sudden increase in body temperature, very high blood pressure, and severe convulsions (malignant neuroleptic syndrome). It is not certain whether this side effect is caused by methylphenidate or other medicines that may be taken in combination with methylphenidate.

Unknown: frequency cannot be estimated from the available data

• recurring unwanted thoughts;
• loss of consciousness for unknown reasons, shortness of breath (these may be symptoms of heart disease).

If the patient experiences any of the above side effects, they should seek medical attention immediately.

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;
• 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, shortness of breath, chest pain;
• 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, excitement, restlessness, emotional instability, anxiety, depression, stress, irritability, abnormal behavior, sleep problems, fatigue;
• stomach pain, diarrhea, discomfort in the abdomen, nausea, thirst, vomiting. These symptoms usually occur at the beginning of treatment and can be reduced by taking the medicine with food;
• loss of appetite/aversion to food;
• weight loss;
• excessive sweating.

Uncommon: may affect up to 1 in 100 people

• muscle pain, muscle spasms, muscle stiffness;
• constipation;
• discomfort in the chest;
• gastritis;
• additional heart sounds (detected by examination);
• blood in the urine;
• double vision or blurred vision;
• elevated liver test results (in blood tests);
• anger, tearfulness, increased 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 and blood tests;
• suicide 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 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;
• 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 talking;
• 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 weak;
• feeling thirsty;
• increased levels of thyroid-stimulating hormone in the blood;
• mouth and throat pain;
• nosebleeds;
• chest discomfort;
• dry eye syndrome;
• increased eye pressure;
• stress in relationships, stress in the family;
• chest pain;
• hot flashes/flushing;
• "ringing" in the ears (tinnitus);
• medicine abuse;
• pancytopenia (reduced blood cell count);
• inability to control urination (urinary incontinence);
• jaw muscle spasm making it difficult to open the mouth (jaw locking);
• stuttering.

Effect on growth and weight

In cases where 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 a normal 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 inform 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

Tel: +48 22 49 21 301

Fax: +48 22 49 21 309

Website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

Reporting side effects will help to gather more information on the safety of this 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:

Capsule contents:

Sucrose, pellets (containing sucrose and cornstarch), methacrylic acid and ethyl acrylate copolymer (1:1), talc, triethyl citrate, polyvinyl alcohol, macrogol 3350, polysorbate 80, sodium hydroxide, sodium lauryl sulfate, simethicone, silica, colloidal anhydrous, methylcellulose, potassium sorbate (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/capsule with white, opaque cap (15.9 mm), the capsule contains white and blue pellets.

Adehader, 10 mgmodified-release capsules, hard

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

Adehader, 20 mgmodified-release capsules, hard

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

Adehader, 30 mgmodified-release capsules, hard

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

Adehader, 40 mgmodified-release capsules, hard

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

Adehader, 50 mgmodified-release capsules, hard

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

Adehader, 60 mgmodified-release capsules, hard

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

Package 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

Tel: +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, 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: