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 this leaflet before taking this medicine, as it contains important information for you.

• You should keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Table of Contents of the Package 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 only as part of a treatment program including psychological, educational, and social measures.
• It is used when the symptoms are severe and/or when other treatments have failed.

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

How does Adehader work?

Adehader improves the balance of certain natural substances (neurotransmitters) in the brain. It helps to increase attention, reduce impulsivity and hyperactivity, and to improve impulse control and cognitive function.

About ADHD

Children and adolescents with ADHD have difficulty in concentrating and paying attention, and are easily distracted. They are also hyperactive and impulsive.

• They have difficulty sitting still, especially in quiet environments.
• They have difficulty concentrating and paying attention to details.

ADHD can vary from mild to severe and can affect the ability to have relationships with family and friends, and the ability to learn and achieve at school.

2. Important information before taking Adehader

When not to take Adehader

If you:

• are allergic to methylphenidate or any of the other ingredients of this medicine (listed in section 6);
• have a thyroid problem;
• have increased pressure in your eye (glaucoma);
• have a tumor of the adrenal gland (pheochromocytoma);
• have an eating disorder, such as anorexia nervosa;
• have severe high blood pressure or narrowing of the blood vessels;
• have had problems with heart rhythm, heart attack, or other serious heart problems;
• have had problems with blood vessels in the brain, such as a stroke, or abnormal blood vessel formation (e.g. an aneurysm or vascular malformation);
• are taking or have taken in the last 14 days a medicine called an MAOI (used to treat depression);
• have mental health problems, such as:
• psychopathic or borderline personality disorder;
• abnormal thoughts or visions, or schizophrenia;
• severe mood swings, including severe depression, or mania;
• have a history of low stomach acid (achlorhydria) with a pH above 5.5;
• are taking medicines that reduce stomach acid.

If any of these conditions apply to you, do not take Adehader. If you are not sure, talk to your doctor or pharmacist before taking Adehader.

Warnings and precautions

Before taking Adehader, tell your doctor if:

• you have liver or kidney problems;
• you have difficulty swallowing or have a narrowing of the gut;
• you have had fits (seizures), or any abnormal brain scans (e.g. EEG);
• you have ever had problems with alcohol or drug abuse;
• you have a history of mental health problems, including depression, anxiety, or psychosis;
• you have tics (repeated, uncontrollable movements) or Tourette's syndrome;
• you have high blood pressure;
• you have heart problems (e.g. heart failure, heart attack), or have had heart problems in the past;
• you have mental health problems, such as depression, anxiety, or psychosis.

Tell your doctor if you are taking any other medicines, including those you have bought without a prescription.

Interactions with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those you have bought without a prescription.

Do not take Adehader if:

• you are taking a medicine called an MAOI (used to treat depression) or have taken it in the last 14 days.

Adehader may increase the effect of other medicines. Tell your doctor if you are taking any of the following:

• medicines for depression;
• medicines for epilepsy (e.g. phenobarbital, phenytoin, primidone);
• medicines for high blood pressure;
• medicines for coughs and colds (which contain substances that can increase blood pressure);
• medicines that thin the blood to prevent blood clots (e.g. warfarin).

Do not take Adehader with certain medicines that reduce stomach acid, as this may cause the medicine to be released too quickly.

Surgery

Tell your doctor if you are going to have an operation, as you may need to stop taking Adehader for a few days before the operation.

Alcohol

Do not drink alcohol while taking Adehader, as this may increase the risk of side effects.

Pregnancy and breastfeeding

There is limited experience with the use of methylphenidate in pregnancy. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Adehader may cause dizziness, drowsiness, or affect your vision. If this happens, do not drive or use any tools or machines.

Adehader contains sucrose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Sodium

This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially 'sodium-free'.

3. How to take Adehader

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Dosage

For children:

• The maximum daily dose is 60 mg.
• Your doctor will usually start with a low dose and gradually increase it, according to your response.
• Your doctor will tell you which strength of capsule to take and how often.
• Do not divide the capsule or take it in a way that is not prescribed by your doctor.
• Take the capsule in the morning, with or after breakfast.

For adults:

• If you have been taking Adehader as a child or adolescent, your doctor may continue to prescribe the same dose.
• Adults may need a higher dose than children, but your doctor will aim to use the lowest dose that works for you.

Method of administration

This medicine is for oral use only.

• Children should take the capsule in the morning, with or after breakfast.
• Adults should take the capsule in the morning and at lunchtime, with or after food.
• The capsule should be swallowed whole with water.
• Do not crush or chew the capsule.

If you forget to take a dose

Do not take a double dose to make up for a forgotten dose. Take the next dose at the usual time.

Stopping treatment

Do not stop taking this medicine without talking to your doctor first. If you stop taking this medicine suddenly, you may experience withdrawal symptoms, such as depression or anxiety.

4. Possible side effects

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

Common side effects (may affect up to 1 in 10 people)

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

Uncommon side effects (may affect up to 1 in 100 people)

• mood swings;
• thoughts of suicide or attempts to commit suicide;
• hearing, seeing, or feeling things that are not real (psychosis);
• uncontrolled movements, such as twitching or spasms;
• chest pain;
• allergic reactions, such as a rash, itching, or hives.

Rare side effects (may affect up to 1 in 1,000 people)

• mania (excessive excitement or restlessness);

Very rare side effects (may affect up to 1 in 10,000 people)

• heart attack;
• seizures (fits);
• serious allergic reactions, such as angioedema (swelling of the face, lips, tongue, or throat);
• blood disorders, such as a decrease in the number of red blood cells, white blood cells, or platelets;
• neuroleptic malignant syndrome (a rare but serious condition that can cause muscle stiffness, high fever, and confusion);

Unknown frequency (cannot be estimated from the available data)

• repeated thoughts of death or suicide;
• loss of consciousness (syncope);

If you experience any of these side effects, tell your doctor or pharmacist.

Other side effects

Very common side effects (may affect more than 1 in 10 people)

• decreased appetite;
• headache;
• nervousness;
• insomnia;
• dry mouth;
• nausea.

Common side effects (may affect up to 1 in 10 people)

• feeling sad or depressed;
• joint pain;
• fever;
• hair loss;
• feeling unusually weak or tired;
• anxiety;
• decreased sex drive;
• toothache;
• itching or hives;
• cough, sore throat, or cold symptoms;
• changes in blood pressure;
• rapid heartbeat (tachycardia);
• cold hands and feet;
• tremors or twitching;
• restlessness;
• aggression, agitation, or mood swings;
• abdominal pain, diarrhea, or indigestion;
• weight loss;
• excessive sweating.

Uncommon side effects (may affect up to 1 in 100 people)

• muscle pain or cramps;
• constipation;
• chest discomfort;
• inflammation of the stomach or small intestine;
• extra heartbeats (arrhythmia);
• blood in the urine;
• double vision or blurred vision;
• liver problems (e.g. abnormal liver function tests);
• anger, crying, or feeling anxious or agitated;
• feeling unusually calm or sleepy;
• sleep problems;
• fatigue.

Rare side effects (may affect up to 1 in 1,000 people)

• changes in sex drive;
• feeling disoriented or confused;
• dilated pupils;
• breast tenderness or enlargement;
• redness or rash on the skin;
• chest pain or discomfort;
• menstrual problems or changes in menstrual cycle.

Very rare side effects (may affect up to 1 in 10,000 people)

• heart attack;
• sudden death;
• muscle spasms;
• small red spots on the skin;
• inflammation of the blood vessels in the brain;
• liver problems (e.g. liver failure or coma);
• changes in blood test results (e.g. abnormal liver function tests);
• suicidal thoughts or attempts;
• confusion or disorientation;
• feeling weak or tired;
• short-term feelings of sadness;
• numbness or tingling in the fingers or toes;

Unknown frequency (cannot be estimated from the available data)

• migraine;
• very high fever;
• abnormal heartbeat (arrhythmia);
• seizures (fits);
• delusions (believing things that are not true);
• confusion;
• feeling sad or depressed;
• feeling like you need the medicine or feeling like you are missing it;
• problems with blood vessels in the brain (e.g. stroke or inflammation of the blood vessels);
• erectile dysfunction;
• prolonged or painful erections;
• excessive talking;
• stopping treatment and experiencing withdrawal symptoms, such as depression or anxiety;
• tingling or numbness;
• speech problems;
• nausea or vomiting;
• attention problems;
• flu-like symptoms;
• feeling weak or tired;
• feeling thirsty;
• increased levels of a hormone that stimulates the thyroid gland;
• mouth or throat pain;
• nosebleeds;
• chest discomfort;
• dry eye syndrome;
• increased pressure in the eye;
• stress or tension in relationships;
• chest pain;
• hot flashes;
• ringing in the ears (tinnitus);
• drug abuse;
• a decrease in the number of all blood cells (pancytopenia);
• loss of bladder control (incontinence);
• lockjaw (inability to open the mouth);
• stuttering.

Effect on growth and weight

Long-term use of methylphenidate in children may affect their growth and weight. Your doctor will monitor your child's growth and weight and may stop treatment for a short time if necessary.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

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 which is stated on the blister and carton after "EXP".
• Do not store above 30°C.
• Store in the original package in order to protect from moisture.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Adehader contains

The active substance is methylphenidate hydrochloride.

Other ingredients

The capsule contents contain: sucrose, maize starch, methacrylic acid-ethyl acrylate copolymer (1:1), talc, triethyl citrate, polyvinyl alcohol, macrogol 3350, polysorbate 80, sodium hydroxide, sodium lauryl sulfate, simethicone, silicon dioxide, methylcellulose, sorbic acid (E 200), indigo carmine (E 132).

What Adehader looks like and contents of the pack

Adehader 5 mg modified release hard capsules: White, non-transparent body and white non-transparent cap (15.9 mm), containing white and blue pellets.

Adehader 10 mg modified release hard capsules: White, non-transparent body and purple-pink non-transparent cap (15.9 mm), containing white and blue pellets.

Adehader 20 mg modified release hard capsules: Purple-pink, non-transparent body and purple-pink non-transparent cap (15.9 mm), containing white and blue pellets.

Adehader 30 mg modified release hard capsules: Light grey, non-transparent body and dark purple non-transparent cap (15.9 mm), containing white and blue pellets.

Adehader 40 mg modified release hard capsules: Grey, non-transparent body and dark purple non-transparent cap (18.0 mm), containing white and blue pellets.

Adehader 50 mg modified release hard capsules: Purple, non-transparent body and dark purple non-transparent cap (18.0 mm), containing white and blue pellets.

Adehader 60 mg modified release hard capsules: Dark purple, non-transparent body and dark purple non-transparent cap (19.4 mm), containing white and blue pellets.

Pack sizes: 20, 24, 27, 30, 36, 45, 48, 50, 54, 60, 90, 96, or 99 modified release hard capsules in PVC/PVdC/Aluminium blisters.

Marketing Authorisation Holder

Humantis GmbH, Kuhloweg 37, 58638 Iserlohn, Germany.

Manufacturer

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

This medicinal product is authorised 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 package leaflet