Adehader

Package Leaflet: Information for the User

Adehader, 5 mg, Modified Release Hard Capsules

Adehader, 10 mg, Modified Release Hard Capsules

Adehader, 20 mg, Modified Release Hard Capsules

Adehader, 30 mg, Modified Release Hard Capsules

Adehader, 40 mg, Modified Release Hard Capsules

Adehader, 50 mg, Modified Release Hard Capsules

Adehader, 60 mg, Modified Release Hard Capsules

Methylphenidate Hydrochloride
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See section 4 for how to report side effects.

You should carefully read 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) in children aged 6 years and above and in adults.

• It is used when the symptoms are severe and/or the patient has not responded to other treatments such as psychological or behavioral therapy.

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 parts of the brain. This medicine may help to improve attention span, concentration, and reduce impulsive behavior.

About ADHD

Children and adolescents with ADHD have difficulty:

• sitting still and
• focusing their attention.

This is not their fault, as these tasks are very difficult for them.

2. Important information before taking Adehader

When should you not take Adehader?

If you:

• are allergic to methylphenidate or any of the other ingredients of this medicine (listed in section 6);
• have thyroid problems;
• have increased pressure in the eye (glaucoma);
• have a tumor of the adrenal gland (pheochromocytoma);
• have anorexia nervosa;
• have very high blood pressure or narrowing of the blood vessels, which can cause pain in the arms and legs;
• have ever had heart problems, such as a heart attack, irregular heartbeat, chest pain, or heart failure;
• have had problems with blood vessels in the brain, such as a stroke, an aneurysm, or narrowing or blockage of a blood vessel;
• are currently taking or have taken in the last 14 days monoamine oxidase inhibitors (MAOIs), which are medicines used to treat depression (see "Adehader with other medicines");
• have mental health problems, such as:
• psychopathic or borderline personality disorder;
• abnormal thoughts or visions, or schizophrenia;
• severe mood swings, such as thoughts of suicide; severe depression, when you feel very sad, have feelings of worthlessness or guilt, and feel hopeless; mania, when you feel very excited, overactive, and reckless;

If any of the above applies to you, do not take methylphenidate.

Warnings and precautions

Before taking Adehader, talk to your doctor if:

• you have liver or kidney problems;
• you have difficulty swallowing or swallowing whole tablets;
• you have had seizures (fits, convulsions, epilepsy) or abnormal brain wave tests (e.g., EEG);
• you have ever abused or been dependent on alcohol, prescription medicines, or street drugs;
• you are a female and have started your periods (see "Pregnancy and breastfeeding" below);
• you have uncontrollable movements or repeat sounds or words (tics);
• you have high blood pressure;
• you have heart problems not listed in the "Do not take" section above;
• you have mental health problems not listed in the "Do not take" section above. Other mental health problems include:
• mood swings (from mania to depression - also known as "bipolar disorder");
• aggressive behavior or hostility, or increased aggression;
• seeing, hearing, or feeling things that are not there (hallucinations);
• believing things that are not true (delusions);
• excessive suspicion (paranoia);
• feeling excited, agitated, or tense;
• feeling depressed or guilty. Before starting treatment, you should tell your doctor or pharmacist if you have any of these conditions. Methylphenidate may make them worse. Your doctor will monitor how the medicine affects you.

In boys and young men, unexpected long-lasting erections may occur. This can be painful and can happen at any time. If an erection lasts for more than 2 hours, especially if it is painful, you should contact your doctor immediately.

Medical examination before taking Adehader

This examination is to determine if Adehader is a suitable medicine for you. Your doctor will discuss with you:

• any other medicines you are taking;
• any cases of sudden and unexplained death in your family;
• any other medical problems you have or have had, such as heart problems;
• your mood, such as feeling depressed or elated, or any unusual thoughts or feelings you have had;
• any tics you or your family members have had;
• any mental health or behavioral problems you or your family members have had.

Your doctor will discuss with you the risk of mood swings (from mania to depression - also known as "bipolar disorder"). They will also ask about your mental health and whether there have been any cases of suicide, bipolar disorder, or depression in your family.

Drug test

This medicine may give a positive result in drug tests.

Adehader with other medicines

Tell your doctor or pharmacist about all the medicines you are taking or have recently taken, and any you plan to take.

Do not take Adehader if:

• you are taking a medicine called a monoamine oxidase inhibitor (MAOI) for depression or have taken an MAOI in the last 14 days. Taking MAOIs with methylphenidate may cause a sudden increase in blood pressure.

If you are taking other medicines, methylphenidate may affect their action or cause side effects. Tell your doctor or pharmacist if you are taking medicines for:

• depression;
• mental health problems;
• epilepsy;
• high blood pressure;
• coughs and colds. Some of these products contain substances that can affect blood pressure. When buying any of these products, you should consult your pharmacist.
• medicines that thin the blood to prevent blood clots.

Do not take Adehader at the same time as medicines that reduce the production of stomach acid or treat excessive stomach acid, as this may cause the medicine to be released into the body too quickly.

Surgery

Tell your doctor that you are taking Adehader if you are going to have an operation. You should not take methylphenidate on the day of the operation if a certain type of anesthesia is used, as it may cause a sudden increase in blood pressure during the operation.

Taking Adehader with alcohol

Do not drink alcohol while taking this medicine. Alcohol may increase the side effects of this medicine.

Pregnancy and breastfeeding

Available data do not indicate an increased risk of congenital malformations overall, although a slight increase in the risk of heart defects cannot be ruled out. Your doctor will be able to provide you with more information about this risk.

• if you are sexually active, your doctor will discuss contraception with you;
• if you are pregnant or think you may be pregnant, your doctor will decide whether you should continue to take methylphenidate;
• if you are breastfeeding or planning to breastfeed, methylphenidate may pass into breast milk. Your doctor will decide whether you can breastfeed during treatment with methylphenidate.

Driving and using machines

While taking methylphenidate, you may experience dizziness, drowsiness, difficulty focusing, blurred vision, hallucinations, or other effects on the central nervous system. If these effects occur, you should not perform activities such as driving, operating machinery, riding a bicycle, or horse riding, or climbing trees.

Adehader contains sucrose

Sucrose

If you have been told that you have an intolerance to some sugars, you should consult your doctor before taking this medicine.

Sodium

This medicine contains less than 1 mmol (23 mg) of sodium per capsule, which is essentially "sodium-free".

3. How to take Adehader

Adehader should always be taken exactly as your doctor has instructed. If you are unsure, you should consult your doctor or pharmacist.

Dosage

For children:

• The maximum daily dose is 60 mg.
• Your doctor will usually start treatment with a low dose and gradually increase it according to your needs.
• Your doctor will tell you which strength of capsule to take each day.
• The capsule should be swallowed whole with water. Do not divide the dose.
• Adehader should not be taken too late in the morning, as it may cause sleep disturbances.

For adults:

• If you have taken Adehader as a child or adolescent, the same daily dose (mg/day) can be used.
• Adults may require a higher daily dose than children, but your doctor will aim to prescribe the lowest effective dose.
• The maximum daily dose will depend on factors such as your body weight (see below).

For adults who have not taken Adehader before:

• The recommended starting dose is 10 mg per day.
• Your doctor will increase your dose by 10 mg per day, depending on how you tolerate the medicine and how effective it is.
• The aim is to find the lowest effective dose for you.
• The maximum daily dose will depend on factors such as your body weight (see below).
• 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 make sure that Adehader is safe and suitable for you;
• after starting treatment - at least every 6 months, but possibly much more often. These examinations will also be performed when the dose is changed.
• during the examination, the doctor will:
• ask about your appetite;
• measure your height and weight (for children) or weigh you (for adults);
• check your blood pressure and heart rate;
• ask about your mood, mental state, or any unusual feelings or experiences, and whether these have worsened since taking Adehader.

How to take the medicine

This medicine is for oral use only.

Children should take Adehader in the morning, with or afterbreakfast.

Adults should take Adehader in the morning and at lunchtime, with or afterfood.

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 food is important for this slow release to happen.

The capsule can be swallowed whole with water. Alternatively, the capsule can be opened and the contents sprinkled onto a small amount (about 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 your condition does not improve after 1 month of treatment

If your condition does not improve after 1 month of treatment, you should tell your doctor. Your doctor may decide to change your treatment.

Long-term treatment

There is no need to take Adehader indefinitely. If you have been taking Adehader for more than a year, your doctor may stop treatment for a short period, at least once a year, to assess whether it is still needed. For children, this break in treatment is usually planned for the school holidays.

Misuse of Adehader

Misuse of Adehader can lead to abnormal behavior. It can also cause dependence. If you have ever abused or been dependent on alcohol, prescription medicines, or street drugs, you should tell your doctor. This medicine is for you only. Do not give it to others, even if their symptoms are the same as yours.

Overdose of Adehader

If you take too much of this medicine, you should contact your doctor or go to the hospital immediately. You should tell them how much you have taken. Treatment may be necessary.

Missing a dose of Adehader

Do not take a double dose to make up for a forgotten dose. If you forget a dose, take the next dose at the usual time.

Stopping treatment with Adehader

Suddenly stopping treatment with this medicine may cause a return of ADHD symptoms or unexpected effects, such as depression. Before stopping treatment completely, your doctor will gradually reduce your daily dose.

4. Possible side effects

Like all medicines, Adehader can cause side effects, although not everybody gets them.

Some side effects can be serious. If you experience any of the following, you should contact your doctor immediately:

Common: may affect up to 1 in 10 people

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

Uncommon: may affect up to 1 in 100 people

• mood swings, changes in mood;
• thoughts of suicide or self-harm.
• feeling or hearing things that are not there - these are symptoms of psychosis;
• uncontrollable speech or 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, or shortness of breath.

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

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

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

• heart attack;
• seizures (fits, convulsions, epilepsy);
• peeling of the skin or purple-red spots on the skin;
• uncontrollable muscle contractions, affecting the eyes, head, neck, or the rest of the body, and neurological symptoms related to temporary lack of blood flow to the brain;
• paralysis or problems with movement and/or vision, difficulty speaking (these may be symptoms of problems with the blood vessels in the brain), transient lack of blood supply and oxygen to the brain;
• reduced number of blood cells (red blood cells, white blood cells, and platelets), which can increase the risk of infections, bleeding, and bruising;
• sudden increase in body temperature, very high blood pressure, and severe convulsions (neuroleptic malignant syndrome). It is not known whether this side effect is caused by methylphenidate or other medicines that may be taken with it.

Not known: 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 you experience any of the above side effects, you should contact your doctor immediately.

The following is a list of other side effects. If they get worse, you should tell your doctor or pharmacist:

Very common: may affect more than 1 in 10 people

• reduced 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;
• panic attacks;
• reduced sex drive;
• toothache;
• itching, rash, or hives on the skin;
• cough, sore throat, or nasal congestion, and irritation of the throat;
• changes in blood pressure (usually high blood pressure);
• rapid heartbeat (tachycardia), cold hands and feet;
• tremors and twitching, dizziness;
• involuntary movements;
• aggression, excitement, restlessness, emotional instability, anxiety, depression, stress, abnormal behavior, sleep disturbances, fatigue;
• stomach pain, diarrhea, discomfort in the abdomen, nausea, vomiting. These symptoms usually occur at the start of treatment and may be reduced by taking the medicine with food;
• loss of appetite;
• 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 heartbeats (detected on examination);
• blood in the urine;
• double vision or blurred vision;
• abnormal liver function tests (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 reduced 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;
• 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 and toes, feeling cold, tingling, and color change of the skin (from pale to blue to red) in response to cold (Raynaud's phenomenon).

Not known: frequency cannot be estimated from the available data

• migraine;
• very high fever;
• slow, fast, or irregular heartbeat;
• severe seizures (grand mal seizures);
• believing things that are not true;
• confusion;
• depressed or gloomy thoughts;
• feeling that the body needs the medicine or feeling its absence;
• problems with blood vessels in the brain (stroke, inflammation of the blood vessels in the brain, or blockage of a blood vessel);
• erectile dysfunction;
• prolonged erections, sometimes painful, or increased frequency of erections;
• excessive, uncontrolled speech;
• after stopping treatment: return of ADHD symptoms or side effects, such as depression;
• tingling sensation;
• speech and language problems;
• nausea and vomiting;
• attention problems;
• flu-like symptoms;
• lack of energy or 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 pressure in the eye;
• stress in relationships with partners, stress in the family;
• chest pain;
• hot flashes;
• "ringing" in the ears (tinnitus);
• misuse of the medicine;
• reduced number of all blood cells (pancytopenia);
• inability to control urination (urinary incontinence);
• muscle spasm in the jaw, making it difficult to open the mouth (trismus);
• stuttering.

Effect on growth and weight

In children taking methylphenidate for more than a year, this medicine may slow down growth and weight gain. This happens in less than 1 in 10 children.

• the child may not gain weight or grow at the expected rate;
• your doctor will carefully monitor the child's growth and weight, as well as their food intake;
• if the patient is not growing as expected, the doctor may stop treatment with methylphenidate for a short time.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist.

5. How to store Adehader

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the blister pack and carton after "EXP". The expiry date refers to the last day of that month.

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. Ask your pharmacist how to dispose of medicines no longer required. These 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

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

Adehader 10 mg

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

Adehader 20 mg

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

Adehader 30 mg

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

Adehader 40 mg

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

Adehader 50 mg

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

Adehader 60 mg

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

Other ingredients:

Contents of the capsule:

Sucrose, sugar spheres (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

Additional ingredients in the capsule shell of Adehader 10 mg and 20 mg:

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

Additional ingredients in 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 hard capsules

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

Adehader 10 mgmodified-release hard capsules

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

Adehader 20 mgmodified-release hard capsules

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

Adehader 30 mgmodified-release hard capsules

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

Adehader 40 mgmodified-release hard capsules

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

Adehader 50 mgmodified-release hard capsules

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

Adehader 60 mgmodified-release hard capsules

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

Pack sizes:

Adehader 5 mgmodified-release hard capsules

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

Adehader 10 mg/20 mgmodified-release hard capsules

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

Adehader 30 mg/40 mgmodified-release hard capsules

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

Adehader 50 mgmodified-release hard capsules

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

Adehader 60 mgmodified-release hard capsules

Cartons containing 20, 24, 27, 28, 30, 36, or 40 modified-release hard capsules in hard 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 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: