Package Insert: Information for the User

Medicebran 10 mg Tablets

Methylphenidate Hydrochloride

What it is used for

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

• It is used in children and adolescents aged 6 to 18 years.
• It is only used after trying treatments that do not include medication, such as behavioral therapy and counseling.

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

How it works

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

The medication is administered as part of an integrated treatment program, which typically includes:

• psychological therapy
• educational therapy
• social therapy

Medicebranshould only be initiated by a specialist in childhood or adolescent behavioral disorders and should be used under their supervision. Although ADHD is not curable, it can be controlled using integrated 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 to do them. However, patients with ADHD may experience problems in daily life. Children and adolescents with ADHD may have difficulty learning and doing homework. They have difficulty behaving well at home, school, and other places.

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

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, are not hungry or do not want to eat, such as in "nervous anorexia"
• have very high blood pressure or narrowing of the blood vessels, which can cause pain in the arms and legs
• have had any heart problems, such as a heart attack, irregular heartbeat, chest pain and discomfort, 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 part 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 any antidepressant (known as monoamine oxidase inhibitor), see "Taking Medicebran with other medicines"
• have mental health problems, such as:

-a "psychopathic" disorder or a "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, despised and desperate

-mania, feeling exceptionally excited, more active than normal and uninhibited.

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

Warnings and precautions

Consult your doctor before taking Medicebran if you or your child

• have liver or kidney problems
• have difficulty swallowing orswallowingthewholetablets
• have had seizures (attacks, convulsions, epilepsy) or any alteration in the electroencephalogram (EEG, a brain study)
• have ever abused or been dependent on alcohol, prescription medications or drugs.
• are a woman and have started menstruating (see below the section "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 section "Do not take"
• have a mental health problem not included in the previous section "Do not take". Other mental health problems include:

-bipolar disorder (changes in mood from being manic to being depressed)

-aggressive or hostile behavior, or if aggression worsens

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

-believing things that are not real (delusions)

-feeling strangely suspicious (paranoia)

-feeling agitated, anxious or tense

-feeling depressed or guilty

Inform your doctor or pharmacist if you or your child present 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 experience, unexpectedly, prolonged erections. Erections can be painful and occur at any time. It is essential to contact your doctor immediately if the erection lasts more than 2 hours, especially if it is painful.

Checks your doctor will make before you or your child start taking methylphenidate

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

• the medications you or your child are taking
• if you or your family have a history of sudden, unexplained death
• other health conditions you or your family may have (such as heart problems)
• how you or your child are; for example, if you have mood swings, have strange thoughts or have had feelings of this type in the past
• if there have been cases of tics in your family (difficulty controlling repetitive movements of some parts of the body or repeating sounds and words)
• possible behavior or mental health problems you or your child have ever had or other family members have had.

Your doctor will explain specifically if you or your child are at risk of developing mood swings (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 member has 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 medication for you or your child. Your doctor may decide that you or your child need other medical tests before starting this medication.

Drug analysis

This medication may give positive results in drug tests.

Competitors should be aware that this medication may produce a positive result in doping control tests.

Taking Medicebran with other medicines

Inform your doctor or pharmacist if you or your child aretaking, havetakenrecentlyor may need to take any other medication.

Do not take methylphenidate if you or your child:

• are taking a medication called "monoamine oxidase inhibitor" (MAOI) that is used for depression or have taken an MAOI in the last 14 days. The use of an MAOI with methylphenidate may cause a sudden increase in blood pressure.

If you or your child are taking other medications, methylphenidate may affect the mechanism of action of these medications or cause adverse effects. If you or your child are taking any of the following medications, consult your doctor or pharmacist before taking methylphenidate:

• other medications for depression
• medications for severe mental health problems.
• medications used to reduce or increase blood pressure.
• some cough and cold remedies whose components may affect blood pressure, so it is essential to consult your pharmacist when buying a product of this type.
• medications that thin the blood to prevent clotting.

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

Before surgery

Inform your doctor if you or your child are undergoing surgery. Do not take methylphenidate on the day of surgery with certain types of anesthetics, as it may cause a sudden increase in blood pressure during the procedure.

Taking Medicebran with food and drinks

TakingMedicebranwith food may help alleviate stomach pain, nausea or vomiting.

Taking methylphenidate with alcohol

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

Pregnancy and breastfeeding

The available data do not suggest an increased risk of total congenital anomalies, although a small increase in the risk of cardiac malformations during the first three months of pregnancy cannot 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 birth control methods.
• are pregnant or think they 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, difficulty focusing or blurred vision, hallucinations or other central nervous system effects when taking methylphenidate. If this occurs, it may be hazardous to perform certain activities such as driving, operating machines, riding a bike 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 with them before taking this medication.

How much to take

Follow exactly the administration instructions forMedicebranprescribed 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 a day, in the morning and afternoon, 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 administered within 4 hours of bedtime to prevent sleep disturbances.

Your doctor will perform some tests

• before you or your child start treatment - to ensure thatMedicebranis safe and will be beneficial.
• once treatment has started - you will be tested at least every 6 months and even more frequently. You will also be tested when the dose is changed.

• these tests will include:

• appetite control
• height and weight measurement
• blood pressure and heart rate measurement
• evaluation of mood-related problems, mental state, or any other infrequent feelings. Or if they have worsened while takingMedicebran.

How to take

This medication is for oral administration.

You or your child should takeMedicebranwith a little water. If necessary, the tablets can be divided in half. The tablets can be taken with or after a meal.

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

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

Long-term treatment

Medicebrandoes not need to be taken indefinitely. If you or your child takeMedicebranfor more than a year, your doctor should interrupt treatment for a short period of time, such as during school holidays. This allows to demonstrate if the medication is still needed.

Abuse of Medicebran

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

This medication has been prescribed only to you 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 immediately, the nearest hospital emergency service, or the Toxicological Information Service, phone: 91 562 04 20 and tell them how many tablets have been 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 extremely happy, confusion, seeing, feeling, or hearing things that are not real (hallucinations), sweating, flushing, headache, high fever, changes in heart rate (slow, fast, or irregular), high blood pressure, dilated pupils, dryness of the nose and mouth, muscle spasms, and darkening of urine to a reddish-brown color that may be possible signs of abnormal muscle breakdown (rhabdomyolysis).

If you or your child forget to take Medicebran

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

If you or your child stop taking Medicebran

If you or your child stop taking this medication suddenly, the symptoms of ADHD or unwanted effects such as depression may reappear. Your doctor may want to gradually reduce the amount of medication taken each day before stopping it completely. Consult your doctor before stopping treatment withMedicebran.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. Your doctor will inform you about these side effects.

The following side effects are also indicated, and if they become serious, please seek medical attention or consult your pharmacist:

Very common: may affect up to 1 in 10 people

• Decreased appetite
• Headache
• Nervousness
• Difficulty sleeping
• Nausea
• Feeling sick
• Dry mouth

Common: may affect up to 1 in 10 people

• Joint pain
• Elevated temperature (fever)
• Unusual hair loss or thinning of hair
• Excessive drowsiness or drowsiness
• Loss of appetite
• Panic attack
• Decreased libido
• Dental pain
• Itching, hives, 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
• Restlessness and tremors, feeling of dizziness, uncontrolled movements, feeling of internal unrest, excessive 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 side effects usually occur at the beginning of treatment and may decrease by taking the medication with food.

Uncommon: may affect up to 1 in 100 people

• Constipation
• Chest discomfort
• Blood in the urine
• Dual vision or blurred vision
• Muscle pain, muscle spasms, muscle stiffness
• Increased liver enzyme results (seen in blood tests)
• Irritability, feeling tearful, excessive awareness of surroundings, tension.

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

• Changes or alterations in libido
• Feeling disoriented
• Dilated pupils, vision problems
• Swelling of the chest in men
• Redness of the skin, increased redness of skin rashes.

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

• Heart attack
• Sudden death
• Muscle cramps
• Small red patches on the skin
• Inflammation or blockage of blood vessels in the brain
• Abnormal liver function, including liver failure and coma
• Changes in test results, including liver and blood tests
• Intention to commit suicide (including completed suicide), abnormal thinking, absence of feelings or emotions, doing things repeatedly, obsession with something
• Feeling of numbness in the fingers and toes, tingling, and color change with cold (white to blue, then red) ("Raynaud's phenomenon").

Unknown: frequency cannot be estimated with available data

• Migraine
• Very high fever
• Slow or rapid heartbeat, or palpitations
• Major seizure (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 erections, sometimes painful, or increased number of erections
• Uncontrolled talkativeness
• Inability to control urination (incontinence)
• Spasm of the jaw muscles that makes it difficult to open the mouth (trismus)
• Stuttering
• Nasal bleeding.

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.

• May prevent weight gain or height increase.
• Your doctor will carefully check your or your child's height and weight, as well as their diet.
• If you or your child do not grow as expected, the treatment with methylphenidate may be interrupted for a short period of time.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of this medication.

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

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

Do not store at a temperature above25ºC.

Store in the original packaging to protect the medication from moisture.

Medications should not be disposed of through drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE pointat the pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Medicebran Composition

The active ingredient 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 cornstarch, dihydrate calcium hydrogen phosphate, lactose monohydrate, magnesium stearate.

Appearance of Medicebran and packaging content:

Round tablets, white in color, and marked with an “M”. The tablets can be divided into equal halves.

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

Packages containing tablets packaged in PVC/PVdC aluminum blisters.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

MEDICE Arzneimittel Pütter GmbH & Co. KG

Kuhloweg 37

58638 Iserlohn

Germany

Responsible 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 medicine is authorized in the member states of the European Economic Area with 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

Last review date of this leaflet: September 2022

More detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es.