Adehader

Package leaflet: 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
Methylphenidati hydrochloridum
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Adehader is and what it is 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 Adehader is and what it is used for

What is this medicine used for?
Adehader is used for the treatment of attention deficit hyperactivity disorder (ADHD).

• It is used in children aged 6 years and older, as well as in adults.
• It is used only after non-pharmacological treatment attempts, such as psychological counselling and behavioural therapy, have proven insufficient.

Adehader is not used in the treatment of ADHD in children under 6 years of age.
How does Adehader work?
Adehader improves the reduced activity of certain areas of the brain. This medicine may help extend attention span, improve concentration, and reduce impulsive behaviours.
It is used as part of a treatment programme, which usually includes psychotherapy, educational interventions, and social therapy.
Treatment with Adehader must be initiated and supervised only by a physician specialized in the treatment of ADHD, such as a paediatrician, child and adolescent psychiatrist, or psychiatrist. A thorough evaluation by such a physician is required. If the patient is an adult who has not been previously treated, the physician will conduct assessments to confirm that ADHD has been present since childhood.
Although there is no cure for ADHD, the condition can be managed effectively with appropriate treatment programmes.
About ADHD
Children and adolescents with ADHD have difficulty:

• sitting still and
• paying attention.

It is not their fault that these activities are so difficult for them.
ADHD may occur in patients with varying severity, with symptoms such as:

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

These may manifest, for example, as:

• difficulty concentrating
• forgetfulness
• excessive talking
• difficulty planning and completing tasks
• acting without thinking
• impatience

ADHD does not negatively affect the patient's intelligence.

2. Important information before using Adehader

When not to use Adehader
If the patient:

• is allergic to methylphenidate or any of the other ingredients of this medicine (listed in section 6);
• has a thyroid disorder;
• has increased intraocular pressure (glaucoma);
• has a tumour of the adrenal gland (pheochromocytoma);
• has eating disorders involving lack of appetite or desire to eat, e.g. anorexia nervosa;
• has very high blood pressure or blood vessel narrowing which may cause pain in arms and legs;
• has ever had heart problems, e.g. heart attack, irregular heartbeat, chest pain or discomfort, heart failure, heart disease or congenital heart defects;
• has cerebrovascular diseases – such as stroke, localized enlargement and weakening of the blood vessel wall (aneurysm), narrowing or blockage of a blood vessel, or inflammation of blood vessels;
• is currently taking or has taken antidepressant medicines (called monoamine oxidase inhibitors) within the last 14 days – see: "Adehader and other medicines";
• has psychiatric problems such as:
  • psychopathic disorders or borderline personality;
  • delusional thoughts or hallucinations, or a condition known as "schizophrenia";
  • significant mood disorder symptoms such as: suicidal thoughts; severe depression, when the patient feels deep sadness, worthlessness and hopelessness; mania, when the patient feels extremely excited, overactive and lacking in inhibition;
  • previously had a severe deficiency of gastric acid (achlorhydria) with pH above 5.5;
  • is taking medicines intended to reduce gastric acid secretion or to treat gastric hyperacidity (H\ receptor antagonists, proton pump inhibitors, or antacids).

If any of the above situations apply to the patient, methylphenidate should not be used.
In case of doubt, consult a doctor or pharmacist before using
methylphenidate. This is important because methylphenidate may worsen the
conditions listed above.

Warnings and precautions
Before taking Adehader, speak with a doctor if:

• the patient has liver or kidney problems;
• the patient has difficulty swallowing or taking whole tablets;
• the patient has had seizures (fits, convulsions, epilepsy) or abnormal brain test results (e.g. EEG);
• the patient has ever abused or been dependent on alcohol, prescription medicines or drugs;
• the patient is a female who has started menstruating (see: "Pregnancy and breastfeeding", below);
• the patient has uncontrollable, repetitive movements of various body parts or repeats sounds and words (tics);
• the patient has high blood pressure;
• the patient has heart diseases not listed in the section "When not to use Adehader", above;
• the patient has psychiatric disorders not listed in the section "When not to use Adehader", above. Other psychiatric disorders include:
  • mood swings (from mania to depression – a condition called "bipolar disorder");
  • emergence of aggressive or hostile behaviours, or increased aggression;
  • seeing, hearing or feeling things that are not real (hallucinations);
  • belief in unreal things (delusions);
  • excessive suspiciousness (paranoia);
  • feelings of restlessness, anxiety or tension;
  • feelings of depression or guilt. Before starting treatment, inform the doctor or pharmacist if any of the above conditions are present. Methylphenidate may worsen them. The doctor will monitor how the medicine affects the patient.

During treatment, unexpected prolonged erections may occur in boys and young men.
This may be painful and can occur at any time. If an erection lasts longer than
2 hours, and especially if it is painful, contact a doctor immediately.
If the patient experiences visual disturbances or other vision problems, contact a
doctor. The doctor may consider discontinuing the use of Adehader.

Medical examination before starting methylphenidate
The purpose of this examination is to determine whether methylphenidate is suitable for the patient. The doctor
will discuss with the patient:

• any other medicines being taken;
• any family history of sudden and unexplained death;
• any other medical conditions (e.g. heart diseases) present in the patient or family members;
• the patient's mental state, e.g. depression or euphoria, unusual thoughts, and whether such conditions occurred in the past;
• presence of tics (uncontrollable, repetitive movements of various body parts or repetition of sounds or words) in the patient's family members;
• any mental health or behavioural problems in the patient or family members.

The doctor will discuss with the patient the risk of mood swings (from mania to depression – so-called
"bipolar disorder"). The doctor will also take a psychiatric history and determine
whether there have been cases of suicide, bipolar disorder or depression in the patient's family.
It is very important to provide the doctor with as complete information as possible. Based on this, the doctor will decide
whether methylphenidate is suitable for the patient. The doctor will also decide whether additional
medical tests are required before starting this medicine.

Drug testing
This medicine may cause a positive result in drug tests.

Adehader and other medicines
Tell the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Do not take methylphenidate if the patient:

• is taking a medicine known as a monoamine oxidase inhibitor (MAOI) used to treat depression, or has taken an MAOI within the last 14 days. Concurrent use of MAOIs with methylphenidate may cause a sudden increase in blood pressure.

If the patient is taking other medicines, methylphenidate may affect their action or cause
unwanted side effects. Tell the doctor or pharmacist if the adult patient or child is taking medicines used to treat:

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

Do not take Adehader together with H\ receptor antagonists, proton pump inhibitors, or antacids
used to reduce gastric acid secretion or counteract gastric hyperacidity, as this may lead to
faster release of the entire active substance into the body.
If there are any doubts whether a medicine being taken is on the list above, ask a doctor or pharmacist before using methylphenidate.

Surgical procedure
Inform the doctor about any planned surgery. Methylphenidate should not be taken on the day of surgery
if a certain type of anaesthesia is to be used. This is due to the risk of sudden increase in
blood pressure during the procedure.

Using methylphenidate with alcohol
Do not consume alcohol while taking this medicine. Alcohol may worsen the
side effects of this medicine. Remember that alcohol is also present in some
food products and medicines.

Pregnancy and breastfeeding
Available data do not indicate an overall increased risk of congenital malformations, although a small increase in the risk of cardiac developmental defects during the first three months of pregnancy cannot be ruled out. The doctor can provide the patient with additional information about this risk. Before using methylphenidate, inform the doctor or pharmacist if the patient:

• is sexually active. The doctor will recommend appropriate contraception.
• is pregnant or may be pregnant. The doctor will decide whether to continue using methylphenidate.
• is breastfeeding or plans to start breastfeeding. Methylphenidate may pass into breast milk. Therefore, the doctor will decide whether breastfeeding is possible during treatment with methylphenidate.

Driving and operating machinery
While taking methylphenidate, dizziness, drowsiness, difficulty focusing vision, blurred vision, hallucinations or other central nervous system side effects may occur. If such symptoms occur, activities such as driving vehicles, operating machinery, cycling, horse riding, or climbing trees may be dangerous.

Adehader contains sucrose
Sucrose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should
consult a doctor before taking this medicine.

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

3. How to take Adehader

Adehader must always be taken exactly as directed by the doctor. If in doubt, consult your doctor or pharmacist.

Dosage

Use in children
The maximum daily dose is 60 mg.

• The doctor usually starts treatment with a low dose and gradually increases it according to need.
• Your doctor will inform you which strength of capsule to take each day.
• The dose contained in the capsule must not be divided. Always take the full content.
• Adehader should not be taken too late in the morning, as it may cause sleep disturbances.

Use in adults
Adult patients previously treated with Adehader

• If the patient has previously taken Adehader as a child or adolescent, the same daily dose (mg/day) may be used. The doctor will regularly monitor the patient's condition to determine whether the dose needs adjustment.
• Adult patients may require a higher daily dose than children, but the doctor will aim to prescribe the lowest effective dose.
• The maximum daily dose is determined based on, among other factors, the patient's body weight (see below).

Adult patients not previously treated with Adehader
The recommended starting dose is 10 mg per day.

• The doctor will increase the patient's dose by 10 mg per day, depending on tolerance and effectiveness of the medication.
• The goal should be the lowest dose effective for the patient.
• The maximum daily dose is determined based on, among other factors, 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 kg of body weight, up to a maximum of 80 mg of methylphenidate per day.

Procedures to be performed by the doctor before and during treatment (for adult or child patients)
The doctor will perform certain examinations

• before starting treatment – to ensure that Adehader is safe and beneficial for the patient;
• after starting treatment – at least every 6 months, but possibly more frequently. Such examinations will also be performed whenever the dose is changed.
• During the examination, the doctor will:
  • ask about the patient's appetite;
  • measure height and weight in children;
  • weigh adult patients;
  • measure blood pressure and pulse;
  • ask about the patient's mood, mental state, or other unusual feelings, and determine whether such problems have worsened during treatment with Adehader.

Method of administration
This medicine is for oral use.
Children should take Adehader in the morning, during or after breakfast.
Adults should take Adehader in the morning and at lunchtime, during a meal or after a meal.
Adehader is a formulation of methylphenidate with "controlled release," meaning the medicine is released into the body gradually over an extended period. Taking the capsule during or after meals is very important to achieve this prolonged, delayed action.
Capsules may be swallowed whole with water. Alternatively, the capsule may be opened, its contents mixed with a small amount (one tablespoon) of applesauce or yogurt, and taken immediately. The contents dispersed from the capsule must not be stored for later use.
Capsules and their contents must not be crushed or chewed.

If the patient's condition does not improve after 1 month of treatment
If there is no improvement in the patient's condition after 1 month of treatment, inform the treating doctor. The doctor may decide to change the treatment approach.

Long-term treatment
There is no need to take Adehader indefinitely. If a patient has been taking Adehader for more than one year, the doctor should interrupt treatment for a short period at least once a year. In children, it is advisable to schedule this break during school holidays. This allows assessment of whether continued treatment is necessary.

Misuse of Adehader
Misuse of Adehader may lead to abnormal behaviors and may result in dependence on the medicine. If the patient has ever abused or been dependent on alcohol, prescription medicines, or drugs, this should be reported to the doctor. This medicine is intended only for the person to whom it was prescribed. Do not give it to others, even if their symptoms are similar.

Taking more than the recommended dose of Adehader
If a patient takes too much medicine, contact a doctor immediately or call emergency services. Inform them of the amount of medicine taken. Treatment may be necessary.
Symptoms of overdose may include: vomiting, feeling of overstimulation, tremors, increased involuntary movements, muscle twitching, seizures (which may lead to coma), intense feelings of happiness, disorientation, seeing, feeling, or hearing things that are not real (hallucinations), sweating, facial flushing, headache, high fever, changes in heart rate (slow, fast, or irregular), high blood pressure, dilated pupils, dryness of the nasal and oral mucosa, muscle cramps, fever, and reddish-brown urine, which may indicate abnormal muscle breakdown (rhabdomyolysis).

Missed dose of Adehader
Do not take a double dose to make up for a missed dose. If a dose is missed, take the next dose at the usual time.

Stopping treatment with Adehader
Suddenly stopping treatment with this medicine may lead to a recurrence of ADHD symptoms or the appearance of unexpected symptoms such as depression. Before completely discontinuing the medicine, the treating doctor will gradually reduce the daily dose. Consult your doctor before stopping treatment with Adehader.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Your doctor will inform you about such adverse effects.
Some adverse effects may be serious. If any of the following occur,
seek medical advice immediately:

Common: may affect up to 1 in 10 people

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

Uncommon: may affect up to 1 in 100 people

• mood swings, changes in mood;
• thoughts of suicide or desire to harm oneself;
• sensing or hearing things that do not exist – these are symptoms of psychosis;
• uncontrolled speech and body movements (Tourette's syndrome) or worsening of existing symptoms;
• 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, shortness of breath, wheezing or difficulty breathing.

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

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

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

• heart attack;
• seizures (epileptic fits, convulsive epilepsy);
• skin peeling or purple-red spots on the skin;
• uncontrollable muscle spasms affecting the eyes, head, neck or other parts of the body, and neurological symptoms associated with transient cerebral ischaemia;
• paralysis or difficulty moving and seeing, speech difficulties (these may be symptoms of problems with blood vessels in the brain), transient lack of sufficient blood and oxygen (ischaemia) supplied to the brain;
• reduction in blood cells (red blood cells, white blood cells and platelets), which may lead to increased susceptibility to infections, as well as increased risk of bleeding and bruising;
• sudden rise in body temperature, very high blood pressure and severe convulsions (neuroleptic malignant syndrome). It is not certain whether this adverse effect is caused by methylphenidate or by other medicines that may be used in combination with methylphenidate.

Unknown: frequency cannot be estimated from available data

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

If any of the above adverse effects occur,
seek medical advice immediately.
Below is a list of other adverse effects. If they become severe, inform your 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 lack of feelings or emotions, or showing excessive interest;
• joint pain;
• high body temperature (fever);
• excessive hair loss or thinning;
• feeling unusually sleepy or sluggish;
• loss of appetite;
• anxiety attacks;
• decreased sexual drive;
• toothache;
• itching, rash or raised, red, itchy skin eruptions (urticaria);
• cough, sore throat or nasal pain and throat irritation, 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, inner restlessness;
• unusual activity;
• aggression, agitation, anxiety, emotional instability, anxiety, depression, stress, irritability, abnormal behaviour, difficulty falling asleep, fatigue;
• abdominal pain, diarrhoea, abdominal discomfort, indigestion, thirst, vomiting. These symptoms usually occur at the beginning of treatment and may be reduced by taking the medicine with food;
• lack of appetite/dislike of food;
• weight loss;
• excessive sweating.

Uncommon: may affect up to 1 in 100 people

• muscle pain, muscle cramps, muscle stiffness;
• constipation;
• chest discomfort;
• inflammation of the gastric and small intestinal mucosa;
• additional heart sound (detected during examinations);
• presence of blood in urine;
• double vision or blurred vision;
• dry eye syndrome;
• elevated liver function test results (in blood tests);
• anger, tearfulness, heightened 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 sexual drive;
• feeling disoriented;
• dilated pupils, difficulty seeing;
• breast enlargement in males;
• skin redness, red raised rash on the skin;
• pain due to insufficient blood flow to the heart;
• problems/changes related to menstruation;
• Obsessive-Compulsive Disorder (OCD) (including irresistible urge to pull out hair, skin picking, repetitive unwanted thoughts, feelings, images or desires (obsessions), performing repetitive behaviours or mental rituals (compulsions)).

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 arterial embolism 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 completed), disturbances in thinking, lack of feelings or emotions;
• lack of energy;
• brief episodes of sadness;
• numbness in fingers of hands and feet, feeling cold, tingling and skin colour changes (from pale to blue, then to red) triggered by cold (Raynaud's phenomenon).

Unknown: frequency cannot be estimated from available data

• migraine;
• very high fever;
• slow, fast or irregular heartbeat;
• increased seizures (major epileptic seizure – "grand mal");
• belief in things that are not true;
• confusion;
• sad/depressed thoughts;
• feeling that the body needs the medicine or feeling its absence;
• problems with blood vessels in the brain (stroke, cerebral arteritis or cerebral artery occlusion);
• erectile dysfunction;
• prolonged erections, sometimes painful or increased number of erections;
• excessive, uncontrollable talking;
• after stopping the medicine: recurrence of ADHD symptoms or occurrence of adverse effects such as depression;
• tingling sensation;
• speech and talking difficulties;
• vomiting reflex;
• attention disturbances;
• flu-like symptoms;
• loss of energy/feeling of weakness;
• feeling thirsty;
• increased activity in blood of thyroid-stimulating hormone;
• pain in the mouth and throat;
• nosebleeds;
• discomfort related to the heart;
• increased intraocular pressure;
• eye diseases that may cause worsening of vision due to damage to the optic nerve (glaucoma);
• tension (stress) in relationships with partner, family tension (stress);
• chest pain;
• hot flushes/flushing of the face;
• "ringing" in the ears (tinnitus);
• misuse of the medicine;
• pancytopenia (reduction in all blood cells);
• inability to control urination (urinary incontinence);
• jaw muscle spasm making it difficult to open the mouth (trismus);
• stuttering.

Effect on growth and body weight
When methylphenidate is used for longer than one year, in some children this medicine
may slow growth. This affects fewer than 1 in 10 children.

• the child may not gain weight or grow at the expected rate.
• the treating doctor will carefully monitor the child's growth, body weight and food intake.
• if the patient does not grow as expected, treatment with methylphenidate may be temporarily interrupted.

Reporting of adverse effects
If any symptoms of adverse effects occur, including any adverse effects not listed
in this leaflet, tell your doctor or pharmacist.
Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions,
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
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Adehader

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton following:
"EXP". The expiry date refers to the last day of the specified month.
Do not store above 30 °C.
Store in the original packaging to protect from moisture.
Medicines must not be disposed of via the sewage system or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures will help
protect the environment.

6. Contents of the pack and other information

What Adehader contains:
The active substance is methylphenidate hydrochloride.
Adehader, 5 mg modified-release hard capsules
Each modified-release hard capsule contains 5 mg of methylphenidate hydrochloride, equivalent to 4.35 mg of methylphenidate.
Adehader, 10 mg modified-release hard capsules
Each modified-release hard capsule contains 10 mg of methylphenidate hydrochloride, equivalent to 8.65 mg of methylphenidate.
Adehader, 20 mg modified-release hard capsules
Each modified-release hard capsule contains 20 mg of methylphenidate hydrochloride, equivalent to 17.30 mg of methylphenidate.
Adehader, 30 mg modified-release hard capsules
Each modified-release hard capsule contains 30 mg of methylphenidate hydrochloride, equivalent to 25.95 mg of methylphenidate.
Adehader, 40 mg modified-release hard capsules
Each modified-release hard capsule contains 40 mg of methylphenidate hydrochloride, equivalent to 34.60 mg of methylphenidate.
Adehader, 50 mg modified-release hard capsules
Each modified-release hard capsule contains 50 mg of methylphenidate hydrochloride, equivalent to 43.25 mg of methylphenidate.
Adehader, 60 mg modified-release hard capsules
Each modified-release hard capsule contains 60 mg of methylphenidate hydrochloride, equivalent to 51.90 mg of methylphenidate.

Other ingredients are:
Capsule contents:
Sucrose, pellets (containing sucrose and maize starch), methacrylic acid and ethyl acrylate copolymer (1:1), talc, triethyl citrate, polyvinyl alcohol, macrogol 3350, polysorbate 80, sodium hydroxide, sodium lauryl sulfate, simethicone, colloidal anhydrous 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 capsule shell of Adehader 10 mg and 20 mg medicinal products:
erythrosine (E 127), patent blue V (E 131).
Additionally in the capsule shell of Adehader 30 mg, 40 mg, 50 mg and 60 mg medicinal products:
erythrosine (E 127), black iron oxide (E 172); indigo carmine (E 132).

What Adehader looks like and contents of the pack
Adehader, 5 mg modified-release hard capsules
White, opaque capsule body/white opaque cap (15.9 mm), the capsule contains white and blue pellets.
Adehader, 10 mg modified-release hard capsules
White, opaque capsule body/pale violet-pink opaque cap (15.9 mm), the capsule contains white and blue pellets.
Adehader, 20 mg modified-release hard capsules
Pale violet-pink, opaque capsule body/pale violet-pink opaque cap (15.9 mm), the capsule contains white and blue pellets.
Adehader, 30 mg modified-release hard capsules
Light grey, opaque capsule body/dark violet opaque cap (15.9 mm), the capsule contains white and blue pellets.
Adehader, 40 mg modified-release hard capsules
Grey, opaque capsule body/dark violet opaque cap (18.0 mm), the capsule contains white and blue pellets.
Adehader, 50 mg modified-release hard capsules
Violet, opaque capsule body/dark violet opaque cap (18.0 mm), the capsule contains white and blue pellets.
Adehader, 60 mg modified-release hard capsules
Dark violet, opaque capsule body/dark violet opaque cap (19.4 mm), the capsule contains white and blue pellets.

Pack sizes:
Adehader, 5 mg modified-release hard capsules
Cardboard boxes containing 20, 24, 27, 30, 36, 45, 48, 50, 54, 60, 90, 96 or 99 modified-release hard capsules in rigid blisters made of PVC/PVdC/Aluminum foil.
Adehader, 10 mg/20 mg modified-release hard capsules
Cardboard boxes containing 20, 24, 27, 28, 30, 36, 45, 48, 50, 54, 60, 90, 96 or 99 modified-release hard capsules in rigid blisters made of PVC/PVdC/Aluminum foil.
Adehader, 30 mg/40 mg modified-release hard capsules
Cardboard boxes containing 20, 24, 27, 28, 30, 36, 45, 48, 50, 54 or 60 modified-release hard capsules in rigid blisters made of PVC/PVdC/Aluminum foil.
Adehader, 50 mg modified-release hard capsules
Cardboard boxes containing 20, 24, 27, 28, 30, 36, 40, 45 or 48 modified-release hard capsules in rigid blisters made of PVC/PVdC/Aluminum foil.
Adehader, 60 mg modified-release hard capsules
Cardbox boxes containing 20, 24, 27, 28, 30, 36 or 40 modified-release hard capsules in rigid blisters made of PVC/PVdC/Aluminum foil.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Humantis GmbH
Kuhloweg 37, 58638 Iserlohn
Germany
Tel.: +48 885 050 178
e-mail: [email protected]

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

This medicinal product is authorised in the European Economic Area countries 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