Medicebran 10 mg tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Medicebran 10 mg tablets

Methylphenidate hydrochloride

Package leaflet contents

1. What Medicebran is and what it is used for
2. What you need to know before you or your child start taking Medicebran
3. How to take Medicebran
4. Possible side effects
5. Storage of Medicebran
6. Contents of the pack and other information

1. What Medicebran is and what it is used for

What it is used for

Medicebran is used to treat "attention deficit hyperactivity disorder" (ADHD).

• It is used in children and adolescents aged between 6 and 18 years.
• It is used only after non-medicinal treatments have been tried, such as behavioural therapy and counselling.

Medicebran is not indicated for the treatment of ADHD in children under 6 years of age or in adults. Its safety and benefit in these patients are unknown.

How it works

Medicebran improves the activity of certain brain regions that have low activity. The medicine may help improve attention (level of attention), concentration, and reduce impulsive behaviour.

Medicebran is administered as part of a comprehensive treatment programme, which typically includes:

• psychological therapy
• educational therapy and
• social therapy

Treatment with Medicebran should only be initiated by a specialist in childhood or adolescent behavioural disorders and must be used under their supervision. Although ADHD cannot be cured, it can be managed through comprehensive treatment programmes.

About ADHD

Children and adolescents with ADHD have:

• difficulty staying still and
• difficulty concentrating.

It is not their fault that they cannot do these things.

Many children and adolescents struggle with these tasks. However, patients with ADHD may experience problems in daily life. Children and adolescents with ADHD may have difficulties with learning and completing homework. They may have trouble behaving appropriately at home, at school, and in other settings.

ADHD does not affect the intelligence of the child or adolescent.

2. What you need to know before you or your child start taking Medicebran

Do not take Medicebran if you or your child

• are allergic to methylphenidate or to any of the other ingredients of this medicine (listed in section 6)

• have a thyroid problem

• have high eye pressure (glaucoma)

• have a tumor of the adrenal glands (pheochromocytoma)

• have an eating disorder, lack of appetite, or do not wish to eat, such as in "anorexia nervosa"

• have very high blood pressure or narrowing of blood vessels, which may cause pain in the arms and legs

• have ever had heart problems, such as a heart attack, irregular heartbeat, chest pain or discomfort, heart failure, heart disease, or a congenital heart problem

• have ever had a problem with blood vessels in the brain, such as a stroke, dilation or weakness of part of a blood vessel (aneurysm), narrowing or blockage of blood vessels, or inflammation of blood vessels (vasculitis)

• are taking or have taken within the last 14 days any antidepressant medicine (known as a monoamine oxidase inhibitor), see "Taking Medicebran with other medicines"

• have mental health problems, such as:

• a "psychopathic" disorder or "borderline personality disorder"

• abnormal thoughts or hallucinations, or a condition called "schizophrenia"

• signs of a severe mood disorder, such as:

• suicidal thoughts

• severe depression, feeling very sad, worthless, and hopeless

• mania, feeling unusually elated, more active than normal, and disinhibited.

Do not take methylphenidate if you or your child have any of the above conditions. If you are unsure, inform your doctor or pharmacist before you or your child take methylphenidate. This is because methylphenidate may worsen these conditions.

Warnings and precautions

Consult your doctor before taking Medicebran if you or your child

• have liver or kidney problems

• have difficulty swallowing or trouble swallowing whole tablets

• have ever had seizures (fits, convulsions, epilepsy) or any abnormalities on an electroencephalogram (EEG, a test of brain activity)

• have ever abused alcohol, prescription medicines, or drugs, or have been dependent on them

• are a woman who has started menstruating (see section "Pregnancy and breastfeeding" below)

• have difficulty controlling repetitive movements of certain body parts or repeat sounds and words (tics)

• have high blood pressure

• have a heart problem not listed in the previous "Do not take" section

• have a mental health condition not listed in the previous "Do not take" section. Other mental health problems include:

• mood swings (from manic to depressed states, known as "bipolar disorder")

• experiencing aggressive or hostile behavior, or worsening of aggression

• seeing, hearing, or feeling things that are not there (hallucinations)

• believing things that are not true (delusions)

• feeling unusually suspicious (paranoia)

• feeling restless, anxious, or tense

• feeling depressed or guilty

Inform your doctor or pharmacist if you or your child have any of the above conditions before starting treatment. This is because methylphenidate may worsen these conditions. Your doctor will want to monitor how the medicine affects you or your child.

During treatment, children and adolescents may unexpectedly experience prolonged erections. These erections may be painful and can occur at any time. It is important to contact your doctor immediately if an erection lasts longer than 2 hours, especially if it is painful.

If you or your child experience blurred vision or other visual disturbances, contact your doctor. Your doctor may consider stopping treatment with Medicebran.

Checks your doctor will carry out before you or your child start treatment with methylphenidate

To determine whether methylphenidate is the right medicine for you or your child, your doctor will discuss with you:

• the medicines you or your child are taking
• whether there is a family history of unexplained sudden death
• other illnesses you or your family may have (such as heart problems)
• how you or your child are feeling; for example, if you have mood swings, strange thoughts, or have had such feelings in the past
• whether there is a family history of tics (difficulty controlling repetitive movements of certain body parts or repeated sounds and words)
• any past behavioral or mental health problems in you, your child, or other family members.

Your doctor will specifically explain whether you or your child are at risk of mood changes (from mania to depression, known as bipolar disorder). Your doctor will also review your or your child’s mental health history and check whether any family members have a history of suicide, bipolar disorder, or depression.

It is important to provide as much information as possible. This will help your doctor decide whether methylphenidate is the right medicine for you or your child. Your doctor may decide that you or your child need further medical tests before starting this medicine.

Drug testing

This medicine may give positive results in drug tests.

Athletes should be aware that this medicine may produce a positive result in doping control tests.

Taking Medicebran with other medicines

Inform your doctor or pharmacist if you or your child are taking, have recently taken, or might need to take any other medicines.

Do not take methylphenidate if you or your child:

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

If you or your child are taking other medicines, methylphenidate could affect how these medicines work or cause adverse effects. If you or your child are taking any of the following medicines, consult your doctor or pharmacist before taking methylphenidate:

• other medicines for depression
• medicines for serious mental health conditions
• medicines for epilepsy
• medicines used to lower or raise blood pressure
• some cough and cold remedies whose ingredients may affect blood pressure, so it is important to consult your pharmacist when purchasing such products
• medicines that thin the blood to prevent blood clots.

If you have any doubts about whether any of the medicines you or your child are taking are included in the list above, consult your doctor or pharmacist for advice before taking methylphenidate.

Before surgery

Inform your doctor if you or your child are scheduled for surgery. Methylphenidate should not be taken on the day of surgery when certain types of anesthetics are used, as this may cause a sudden increase in blood pressure during the procedure.

Taking Medicebran with food and drinks

Taking Medicebran with food may help relieve stomach pain, nausea, or vomiting.

Taking methylphenidate with alcohol

Do not drink alcohol while taking this medicine. Alcohol may worsen the adverse effects of this medicine. Remember that some foods and medicines contain alcohol.

Pregnancy and breastfeeding

Available data do not suggest an increased risk of overall congenital malformations, although a small increased risk of cardiac malformations during use in the first three months of pregnancy could not be ruled out. Your doctor will provide further information about this risk.

Consult your doctor or pharmacist before using methylphenidate if you or your daughter:

• are sexually active. Your doctor will discuss contraception with you.
• are pregnant or think you may be pregnant. Your doctor will decide whether you should take methylphenidate.
• are breastfeeding or plan to breastfeed. Methylphenidate may pass into human milk. Therefore, your doctor will decide whether you or your daughter should breastfeed while taking methylphenidate.

Driving and using machines

You or your child may experience dizziness, drowsiness, difficulty focusing, blurred vision, hallucinations, or other adverse effects affecting the central nervous system when taking methylphenidate. If this occurs, it may be dangerous to perform certain activities such as driving, operating machinery, riding a bicycle or horse, or climbing trees.

Medicebran contains lactose

If your doctor has informed you or your child that you have an intolerance to certain sugars, consult with your doctor before taking this medicine.

3. How to take Medicebran

How much to take

Follow exactly the dosing instructions for Medicebran provided by your doctor. Consult your doctor or pharmacist if you have any doubts.

The maximum daily dose is 60 mg.

• Your doctor will usually start treatment with 5 mg of methylphenidate once or twice daily, at breakfast and lunch, and gradually increase the dose if necessary.
• Your doctor will tell you the dose you need to take each day.
• In general, the last dose should not be taken within 4 hours of bedtime, to avoid sleep disturbances.

Your doctor will perform certain tests

• before you or your child start treatment – to ensure that Medicebran is safe and will be beneficial.

• after treatment has started – at least every 6 months, and even more frequently. These tests will also be performed when the dose is changed.

• These tests will include:

• monitoring of appetite

• measurement of height and weight

• measurement of blood pressure and heart rate

• assessment of mood-related issues, mental state, or any unusual feelings, or whether these have worsened while taking Medicebran.

How to take it

This medicine is for oral use.

You or your child should take Medicebran with some water. If necessary, the tablets may be divided into halves. Tablets may be taken with or after food.

If you or your child do not feel better after 1 month of treatment

If you or your child do not feel better after 1 month of treatment, inform your doctor. Your doctor may decide whether you or your child need a different treatment.

Long-term treatment

Medicebran does not need to be taken indefinitely. If you or your child take Medicebran for more than one year, your doctor should interrupt treatment for a short period, such as during school holidays. This allows assessment of whether the medicine is still needed.

Inappropriate use of Medicebran

If Medicebran is not used properly, it may lead to abnormal behavior. It may also mean that you or your child become dependent on the medicine. Inform your doctor if you or your child have ever abused or been dependent on alcohol, prescription medicines, or drugs.

This medicine has been prescribed for you only and should not be given to others, even if they have the same symptoms as you.

If you or your child take more Medicebran than you should

If you or your child take too many tablets, call your doctor, the nearest hospital emergency department, or the Toxicology Information Service, telephone: 91 562 04 20, immediately, and tell them how many tablets have been taken. Medical treatment may be required.

Signs of overdose may include: vomiting, agitation, tremors, increased uncontrolled movements, seizures (sometimes followed by coma), feelings of extreme happiness, confusion, seeing, feeling, or hearing things that are not real (hallucinations), sweating, flushing, headache, high fever, changes in heartbeat (slow, fast, or irregular), high blood pressure, dilated pupils, dryness of the nose and mouth, muscle spasms, and darkening of the urine to a red-brown color, which could be possible signs of abnormal muscle breakdown (rhabdomyolysis).

If you or your child forget to take Medicebran

Do not take a double dose to make up for missed doses. If you or your child forget a dose, wait and take the next dose at the scheduled time.

If you or your child stop taking Medicebran

If you or your child stop taking this medicine suddenly, ADHD symptoms or unwanted effects such as depression may return. Your doctor may want to gradually reduce the daily dose before stopping completely. Consult your doctor before stopping treatment with Medicebran.

If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them. Your doctor will inform you about these adverse effects.

Some adverse effects may be serious. If you or your child experience any of the following effects, 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

• suicidal thoughts or feelings
• seeing or hearing things that are not real, symptoms of psychosis
• uncontrolled speech and body movements (Tourette's syndrome)
• signs of allergy, such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, difficulty or problems breathing
• changes or disturbances in mood

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

• feeling unusually elated, more active than normal and disinhibited (mania)

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

• heart attack
• seizures (fits, epilepsy with convulsions)
• skin peeling or red-purple spots
• uncontrolled muscle spasms affecting the eyes, head, neck, body and nervous system, as a result of reduced blood flow to the brain
• paralysis or movement and vision problems, difficulty speaking (may be signs of blood vessel problems in the brain)
• decrease in blood cell count (red blood cells, white blood cells and platelets), which may increase the risk of infections and cause easier bleeding and bruising
• sudden increase in body temperature, very high blood pressure and severe convulsions ("Neuroleptic Malignant Syndrome"). It is not entirely certain whether this adverse effect is caused by methylphenidate or by other medicines taken in combination with methylphenidate.

Unknown: frequency cannot be estimated from available data

• unwanted thoughts that keep recurring
• unexplained fainting, chest pain, shortness of breath (may be signs of heart problems)

If you experience any of the adverse effects listed above, contact your doctor immediately.

The following additional adverse effects are listed. If they become severe, please consult your doctor or pharmacist:

Very common: may affect up to 1 in 10 people

• decreased appetite
• headache
• feeling nervous
• difficulty sleeping
• feeling unwell
• dry mouth

Common: may affect up to 1 in 10 people

• joint pain
• high temperature (fever)
• abnormal hair loss or reduced thickness (thinner hair)
• unusual drowsiness or drowsiness
• loss of appetite
• panic attack
• decreased sex drive
• toothache
• itching, rash or increased itching of red rashes (urticaria)
• excessive sweating
• cough, sore throat or throat and nose irritation, shortness of breath or chest pain
• changes in blood pressure (usually high blood pressure), rapid heartbeat (tachycardia), cold hands and feet
• restlessness and tremor, dizziness, uncontrolled movements, feeling of inner restlessness, unusual activity
• aggression, agitation, restlessness, anxiety, depression, stress, irritability and abnormal behavior, difficulty sleeping, fatigue
• stomach pain, diarrhea, nausea, feeling unwell, indigestion, thirst and vomiting. These adverse effects usually occur at the beginning of treatment and may be reduced by taking the medicine with food.

Uncommon: may affect up to 1 in 100 people

• constipation
• chest discomfort
• blood in the urine
• double vision or blurred vision
• dry eyes
• muscle pain, muscle jerks, muscle stiffness
• increased liver test results (seen in blood tests)
• anger, feeling tearful, excessive awareness of surroundings, tension

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

• changes or disturbances in sexual desire
• feeling disoriented
• dilated pupils, vision problems
• breast swelling in men
• skin redness, increased redness of skin rashes
• obsessive-compulsive disorder (OCD) (including irresistible urge to pull out body hair, skin picking, repeated unwanted thoughts, feelings, images or impulses in the mind (obsessive thoughts), performing repeated behaviors or mental rituals (compulsions))

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

• heart attack
• sudden death
• muscle cramps
• small red spots on the skin
• inflammation or blockage of arteries in the brain
• abnormal liver function, including liver failure and coma
• changes in test results, including liver and blood tests
• suicidal ideation (including completed suicide), abnormal thinking, absence of feelings or emotions
• numbness, tingling and color change (from white to blue, then red) in fingers and toes in cold conditions ("Raynaud's phenomenon")

Unknown: frequency cannot be estimated from available data

• migraine
• very high fever
• slow or rapid heartbeat, or palpitations
• major epileptic seizure ("grand mal convulsions")
• believing things that are not true, confusion
• severe stomach pain with nausea and vomiting
• problems with blood vessels in the brain (stroke, cerebral arteritis or cerebral occlusion)
• erectile dysfunction
• prolonged, sometimes painful erections, or increased number of erections
• uncontrollable talkativeness
• inability to control urination (incontinence)
• spasm of jaw muscles making it difficult to open the mouth (trismus)
• stuttering
• nosebleeds
• increased eye pressure
• eye diseases that may cause vision loss due to optic nerve damage (glaucoma)

Effects on growth

When used for more than one year, methylphenidate may reduce growth in some children. This affects fewer than 1 in 10 children.

• It may prevent weight or height gain.
• Your doctor will carefully monitor your or your child's height, weight and nutrition.
• If you or your child do not grow as expected, treatment with methylphenidate may be interrupted for a short period.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Medicebran

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

Keep in the original packaging to protect the medicine from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Medicebran

The active substance is: methylphenidate hydrochloride.

Each tablet contains 10 mg of methylphenidate hydrochloride, equivalent to 8.65 mg of methylphenidate.

The other components are:

Microcrystalline cellulose, pregelatinized corn starch, calcium hydrogen phosphate dihydrate, lactose monohydrate, magnesium stearate.

Appearance of Medicebran and pack contents:

Round, white tablets marked with an "M". The tablets may be divided into equal halves.

Each pack contains 20, 28, 30, 50, 56, 98 or 100 tablets.

Cartons containing tablets packaged in aluminum PVC/PVdC blisters.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

MEDICE Arzneimittel Pütter GmbH & Co. KG

Kuhloweg 37

58638 Iserlohn

Germany

Manufacturer:

MEDICE Arzneimittel Pütter GmbH & Co. KG

Kuhloweg 37

58638 Iserlohn

Germany

Local representative:

MEDICE Ibérica, S.L.

Muntaner 179, 3rd floor, office 1A

08036, Barcelona, Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Germany: Medikinet 10 mg Tabletten

Denmark: Medikinet 10 mg

Finland: Medikinet 10 mg

Iceland: Medikinet 10 mg tafla

Luxembourg: Medikinet 10 mg

Netherlands: Medikinet 10 mg

Norway: Medikinet 10 mg

Poland: Medikinet 10 mg

Spain: Medicebran 10 mg

Sweden: Medikinet 10 mg

United Kingdom: Medikinet 10 mg

Date of the most recent review of this leaflet: February 2065

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es.