MEDICEBRAN 5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Medicebran 5 mg tablets

Methylphenidate hydrochloride

Contents of the package leaflet

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

What is it used for

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

• It is used in children and adolescents from 6 to 18 years old.
• It is used only after non-medication treatments have been tried, such as behavioral therapy and counseling.

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

How it works

Medicebran improves the activity of certain parts of the brain that are underactive. The medication may help improve attention (level of attention), concentration, and reduce impulsive behavior.

The medication is given 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 should be used under their supervision. Although ADHD has no cure, it can be controlled using comprehensive treatment programs.

About ADHD

Children and adolescents with ADHD have:

• difficulty staying still and
• difficulty concentrating.

It's not their fault that they can't do these things.

Many children and adolescents struggle to do these things. However, patients with ADHD may have problems in everyday life. Children and adolescents with ADHD may have difficulty learning and doing homework. They have difficulty behaving well at home, at school, and in other places.

ADHD does not affect the child's or adolescent's intelligence.

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 eye pressure (glaucoma)
• have a tumor in the adrenal glands (pheochromocytoma)
• have an eating disorder, loss of appetite, or do not want to eat, such as in “anorexia nervosa”
• have very high blood pressure or narrowing of the blood vessels, which can cause pain in the arms and legs
• have had heart problems, such as a heart attack, irregular heartbeat, chest pain, heart failure, heart disease, or a congenital heart problem
• have had a problem with the blood vessels in the brain, such as a stroke, dilation or weakness of a blood vessel (aneurysm), narrowing or blockage of the blood vessels, or inflammation of the blood vessels (vasculitis)
• are taking or have taken in the last 14 days a certain type of antidepressant (known as a monoamine oxidase inhibitor), see “Taking Medicebran with other medicines”
• have mental health problems, such as:

• a “psychopathic” or “borderline personality” disorder
• abnormal thoughts or visions or a disease called “schizophrenia”
• signs of a severe mood disorder, such as:
• suicidal thoughts
• severe depression, feeling very sad, worthless, and desperate
• mania, feeling exceptionally elated, more active than usual, and uninhibited.

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

Warnings and precautions

Tell your doctor before you or your child take Medicebran if you or your child

• have liver or kidney problems
• have problems swallowing or swallowing whole tablets
• have had seizures (fits, convulsions, epilepsy) or any alteration in the electroencephalogram (EEG, a brain study)
• have abused or been dependent on alcohol, prescription medications, or drugs.
• are female and have started having periods (see below the section on “Pregnancy and breastfeeding”)
• have difficulty controlling repetitive movements of some parts of the body or repeat sounds and words (tics)
• have high blood pressure
• have a heart problem not included in the previous “Do not take” section
• have a mental health problem not included in the previous “Do not take” section. Other mental health problems include:

• mood changes (from being manic to being depressed, known as “bipolar disorder”)
• experiencing aggressive or hostile behavior, or worsening aggression
• seeing, hearing, or feeling things that are not there (hallucinations)
• believing things that are not real (delusions)
• feeling unusually suspicious (paranoia)
• feeling agitated, anxious, or tense
• feeling depressed or guilty

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

During treatment, children and adolescents may unexpectedly experience prolonged erections. Erections can be painful and occur at any time. It is essential to contact the doctor immediately if the erection lasts more than 2 hours, especially if it is painful.

Checks that your doctor will make before you or your child start treatment with methylphenidate

To decide if methylphenidate is the right medicine for you or your child, your doctor will check with you:

• the medications you or your child are taking
• if you or your child have a family history of sudden unexplained death
• other diseases that you or your family (such as heart problems) may have
• how you or your child are feeling; e.g., if you or your child have mood swings, have unusual thoughts, or have had such feelings in the past
• if there have been cases of tics in your family (difficulty controlling repetitive movements of some parts of the body or repeated sounds and words)
• possible behavioral or mental health problems that you or your child or other family members have had.

Your doctor will explain specifically if you or your child are at risk of experiencing mood changes (from being manic to being depressed, known as bipolar disorder). Your doctor will also check your or your child's mental health history and check if any family members have a history of suicide, bipolar disorder, or depression.

It is essential to provide all the information you can. This will help your doctor decide if methylphenidate is the right medicine for you or your child. Your doctor may decide that you or your child need other medical tests before starting to take this medicine.

Drug tests

This medicine may give positive results in drug tests.

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

Taking Medicebran with other medicines

Tell your doctor or pharmacist if you or your child are taking, have recently taken, or might 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 in the last 14 days. Taking an MAOI with methylphenidate can cause a sudden increase in blood pressure.

If you or your child are taking other medicines, methylphenidate may affect how they work or cause side 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 severe mental health problems.
• medicines for epilepsy.
• medicines used to lower or increase blood pressure.
• some cough and cold remedies whose ingredients may affect blood pressure, so it is essential to consult your pharmacist when buying such a product.
• medicines that thin the blood to prevent clot formation.

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

Before an operation

Tell your doctor if you or your child are going to have an operation. You should not take methylphenidate on the day of the operation with certain types of anesthetics, as it may cause a sudden increase in blood pressure during the procedure.

Taking Medicebran with food and drinks

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

Taking methylphenidate with alcohol

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

Pregnancy and breastfeeding

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

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

• are having sex. Your doctor will discuss contraception with you.
• are pregnant or think you may be pregnant. Your doctor will decide if you should take methylphenidate.
• are breastfeeding or plan to breastfeed. It is possible that methylphenidate may pass into breast milk. Therefore, your doctor will decide if you or your daughter should breastfeed while taking methylphenidate.

Driving and using machines

You or your child may experience dizziness, drowsiness, problems focusing, or blurred vision, have hallucinations, or other effects that affect the central nervous system when taking methylphenidate. If this happens, 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 told you or your child that you have an intolerance to certain sugars, consult them before taking this medicine.

3. How to take Medicebran

How much to take

Follow your doctor's instructions for taking Medicebran exactly. 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 a day, at breakfast and lunch, and gradually increase the dose if necessary.
• Your doctor will tell you what dose you need to take each day.
• Generally, the last dose should not be taken within 4 hours of bedtime to prevent sleep disturbances.

Your doctor will perform some tests

• before you or your child start treatment - to make sure Medicebran is safe and will be beneficial.
• once treatment has started - at least every 6 months and even more often. They will also be performed when the dose is changed.

• these tests will include:

• appetite control
• height and weight measurement
• blood pressure and heart rate measurement
• evaluation of mood, mental state, or any other unusual feelings. Or if they have worsened while taking Medicebran.

How to take

This medicine is for oral use.

You or your child should take Medicebran with a little water. If necessary, the tablets can be divided in half. The tablets can 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, tell your doctor. Your doctor may decide if 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 a year, your doctor should interrupt treatment for a short period, such as during school vacations. This allows your doctor to determine if the medicine is still needed.

Incorrect use of Medicebran

If Medicebran is not used correctly, it may cause abnormal behavior. This may also mean that you or your child start to depend on the medicine. Tell your doctor if you or your child have abused or been dependent on alcohol, prescription medications, or drugs.

This medicine has been prescribed for you only, and you should not give it 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 emergency department of the nearest hospital, or the Toxicology Information Service, phone: 91 562 04 20, and tell them how many tablets were taken. You may need medical treatment.

The signs of overdose may include: vomiting, agitation, tremors, increased uncontrolled movements, muscle contractions, seizures (sometimes followed by coma), feeling very happy, confusion, seeing, feeling, or hearing things that are not real (hallucinations), sweating, flushing, headache, high fever, changes in heartbeats (slow, fast, or irregular), high blood pressure, dilated pupils, dryness of the nose and mouth, muscle spasms, and darkening of the urine to a reddish-brown color, which could be 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 forgotten 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 suddenly stop taking this medicine, ADHD symptoms or unwanted effects such as depression may reappear. Your doctor may want to gradually reduce the amount of medicine you take each day before stopping it completely. Consult your doctor before stopping treatment with Medicebran.

If you have any other 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 all people suffer from 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, go to your doctor immediately:

Frequent: may affect up to 1 in 10 people

• irregular heartbeats (palpitations)
• personality changes
• excessive teeth grinding (bruxism)

Infrequent: may affect up to 1 in 100 people

• suicidal thoughts or feelings
• hearing or seeing things that are not real, symptoms of psychosis
• uncontrolled speech and body movements (Tourette's syndrome)
• allergy signs, 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 breathing
• mood changes or alterations

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

• feeling exceptionally excited, more active than usual, and uninhibited (mania)

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

• heart attack
• seizures (epilepsy with convulsions)
• skin peeling or purple-red spots
• uncontrolled muscle spasms affecting the eyes, head, neck, body, and nervous system, due to lack of blood circulation to the brain
• paralysis or movement and vision problems, difficulty speaking (may be signs of cerebral vascular problems)
• decrease in the number of blood cells (red blood cells, white blood cells, and platelets), which can increase the risk of infection 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 that this adverse effect is caused by methylphenidate or other medications taken in combination with methylphenidate

Unknown: frequency cannot be estimated with available data

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

If you experience any of the above adverse effects, go to your doctor immediately.

Other adverse effects are indicated below, and if they become severe, please consult your doctor or pharmacist:

Very Frequent: may affect up to 1 in 10 people

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

Frequent: may affect up to 1 in 10 people

• joint pain
• high temperature (fever)
• abnormal hair loss or decreased hair thickness (thinner hair)
• excessive sleepiness or drowsiness
• loss of appetite
• panic attack
• decreased sexual desire
• toothache
• itching, rash, or increased itching of red hives (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
• agitation and tremors, feeling dizzy, uncontrolled movements, feeling of inner restlessness, abnormal 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 start of treatment and may decrease when taking the medication with food

Infrequent: may affect up to 1 in 100 people

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

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

• changes or alterations in sexual desire
• feeling disoriented
• dilated pupils, vision problems
• breast swelling in men
• skin redness, increased redness of skin rashes

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 the arteries in the brain
• abnormal liver function, including liver failure and coma
• changes in test results, including liver and blood tests
• suicidal intentions (including completed suicide), abnormal thinking, lack of feelings or emotion, repetitive behavior, obsession with something
• numbness, tingling, and color change in fingers and toes with cold (from white to blue, then red) ("Raynaud's phenomenon")

Unknown: frequency cannot be estimated with available data

• migraine
• very high fever
• slow or rapid heartbeats, or palpitations
• major epileptic seizure ("grand mal" convulsions)
• believing things that are not true, confusion
• severe stomach pain with feeling unwell and vomiting
• cerebral vascular problems (stroke, cerebral arteritis, or cerebral occlusion)
• erectile dysfunction
• prolonged or painful erections, or increased number of erections
• uncontrolled talkativeness
• inability to control urine elimination (incontinence)
• jaw muscle spasms that make it difficult to open the mouth (trismus)
• stuttering
• nosebleeds

Effects on Growth

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

• It may prevent weight or height increase
• Your doctor will carefully check the height and weight of you or your child, as well as their diet
• If you or your child are not growing as expected, the treatment with methylphenidate may be interrupted for a short period

Reporting 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 can also report them directly through the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication

5. Storage of Medicebran

Keep this medication out of sight and reach of children

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated

Do not store above 25°C

Keep in the original packaging to protect the medication from moisture

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment

6. Package Contents and Additional Information

Composition of Medicebran

The active ingredient is:methylphenidate hydrochloride

Each tablet contains 5 mg of methylphenidate hydrochloride, equivalent to 4.35 mg of methylphenidate

Other ingredients are:

Microcrystalline cellulose, pregelatinized cornstarch, calcium hydrogen phosphate dihydrate, lactose monohydrate, magnesium stearate

Appearance of Medicebran and package contents:

Round, white tablets marked with an "S". The tablets can be divided into two equal halves

Each package contains 20, 28, 30, 50, or 56 tablets

Boxes containing tablets packaged in PVC/PE/PVdC aluminum blisters

Only some package 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:

Laboratorios Farmacéuticos ROVI, S.A.

Julián Camarillo, 35

28037 Madrid

This medication is authorized in the member states of the European Economic Area under the following names:

Germany: Medikinet 5 mg Tabletten

Denmark: Medikinet 5 mg

Finland: Medikinet 5 mg

Iceland: Medikinet 5 mg tablets

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 last revision of this leaflet: September 2022

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