Medicebran 5 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Medicebran 5 mg tablets

Methylphenidate hydrochloride

Read the entire patient information leaflet carefully before you or your child start taking this medicine, as it contains important information for you. Keep this leaflet, as you may need to read it again. If you have any questions, consult your doctor or pharmacist. This medicine has been prescribed for you or your child; do not give it to others, even if they have the same symptoms as you, as it may harm them. If you experience any adverse effects, consult your doctor or pharmacist, even if these effects are not listed in this leaflet. See section 4.

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. How to store 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 behavioral therapy and counseling.

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 parts of the brain that have low activity. The medicine may help improve attention (level of attention), concentration, and reduce impulsive behavior.

The medicine is administered as part of a comprehensive treatment program, which usually includes:

• psychological therapy
• educational therapy and
• social therapy

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

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 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 any of the other ingredients of this medicine (listed in section 6)

• have a thyroid problem

• have high intraocular pressure (glaucoma)

• have a tumor of the adrenal glands (pheochromocytoma)

• have an eating disorder, lack of appetite, or do not wish to eat, 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

Talk to 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 or been dependent on alcohol, prescription medicines, or drugs

• 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 condition 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 being manic to depressed, 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 real (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 problems. 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 can be painful and may occur at any time. It is important to contact your doctor immediately if the 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 make before you or your child start treatment with methylphenidate

To decide 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
• any 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
• any family history of tics (difficulty controlling repetitive movements of certain body parts or repeated sounds and words)
• any possible behavioral or mental health problems you or your child, or other family members, may have had.

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 result in a positive finding in doping control tests.

Taking Medicebran with other medicines

Tell 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 a product
• medicines that thin the blood to prevent clotting.

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 anaesthetics are used, as it may cause a sudden increase in blood pressure during the procedure.

Taking Medicebran with food and drink

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 trimester of pregnancy cannot 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 carry out 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 will 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 Medicebran is safe and likely to be beneficial.

• after treatment has started – at least every 6 months, and possibly more frequently. Additional checks will also be performed if 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 split into halves. The 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 continued medication is still needed.

Inappropriate use of Medicebran

If Medicebran is not used appropriately, 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 must 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 immediately at: 91 562 04 20, 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), intense feelings of 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 miss 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 discontinuing treatment with Medicebran.

If you have any further questions about the use of this medicine, ask 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 these adverse effects.

Some adverse effects can be serious. If you or your child experience any of the following adverse effects, contact your doctor 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 problems with movement and vision, difficulty speaking (may be signs of blood vessel problems in the brain)
• decrease in the number of blood cells (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 other medicines taken in combination with methylphenidate.

Not known: frequency cannot be estimated from the 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 contact 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 hair thickness (thinner hair)
• drowsiness or unusual 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 irritation of the throat and nose, 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 eye
• 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 sex drive
• feeling disoriented
• dilated pupils, vision problems
• breast swelling in men
• skin redness, increased redness of skin rashes
• obsessive-compulsive disorder (OCD) (including an irresistible urge to pull out body hair, pinch the skin, have repeated unwanted thoughts, feelings, images or impulses in the mind (obsessive thoughts), or perform 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, lack of feelings or emotions
• numbness, tingling, and color changes in fingers and toes with cold (from white to blue, then red) ("Raynaud's phenomenon")

Not known: frequency cannot be estimated from the available data

• migraine
• very high fever
• slow or fast heartbeat, or palpitations
• major epileptic seizure ("grand mal convulsions")
• believing things that are not true, confusion
• severe stomach pain with feeling unwell 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 of time.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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 container to protect the medicine from moisture.

Medicines should not be disposed of via wastewater drains or household waste. Unused medicines and their containers should be taken to 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 5 mg of methylphenidate hydrochloride, equivalent to 4.35 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 "S". The tablets may be divided into equal halves.

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

Boxes containing tablets packaged in PVC/PE/PVdC-aluminum 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, 3º 1ª
08036, Barcelona, Spain

This medicinal product is authorized in the European Economic Area member states under the following names:

Germany: Medikinet 5 mg Tabletten
Denmark: Medikinet 5 mg
Finland: Medikinet 5 mg
Iceland: Medikinet 5 mg tafla
Luxembourg: Medikinet 5 mg
Netherlands: Medikinet 5 mg
Norway: Medikinet 5 mg
Poland: Medikinet 5 mg
Spain: Medicebran 5 mg
Sweden: Medikinet 5 mg
United Kingdom: Medikinet 5 mg

Date of the most recent review of this leaflet: February 2026

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