Label: Information for the User

Concerta 36 mg prolonged-release tablets

Methylphenidate hydrochloride

Read this label carefully before you or your child start taking this medicine, because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you or your child and should not be given to others even if they have the same symptoms of illness as you or your child, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1. What is Concerta and what it is used for

2. What you need to know before you or your child take Concerta

3. How to take Concerta

4. Possible side effects

5. Storage of Concerta

6. Contents of the pack and additional information

What it is used for

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

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

Concerta is not indicated for the treatment of ADHD in children under 6 years.

How it works

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

The medication is administered as part of a comprehensive treatment program, which typically includes:

• psychological therapy
• educational therapy and
• social therapy.

Only doctors with experience in behavioral problems in children, adolescents, or adults prescribe Concerta. If you are an adult and have not received treatment before, the specialist will perform tests to confirm that you have had ADHD since childhood. Although ADHD does not have a cure, it can be controlled using comprehensive treatment programs.

About ADHD

Children and adolescents with ADHD have difficulty:

• staying still and
• concentrating

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

Many children and adolescents struggle to do these things. However, ADHD can cause 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.

Adults with ADHD often have difficulty concentrating. They often feel restless, impatient, and distracted. They may have difficulty organizing their personal and work life.

Not all patients with ADHD need medication treatment.

ADHD does not affect intelligence.

Do not take Concerta if you or your child:

• are allergic to methylphenidate or any of the other ingredients in this medication (listed in section6)
• 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 “anorexia nervosa”
• 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 any problems with blood vessels in the brain, such as a stroke, dilation or weakness of a blood vessel (aneurysm), narrowing or blockage of blood vessels, or inflammation of blood vessels (vasculitis)
• are taking or have taken in the last 14days an antidepressant (known as a monoamine oxidase inhibitor), see “Taking Concerta with other medications”
• 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 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 starting to take Concerta if you or your child:

• have liver or kidney problems
• have trouble swallowingor swallowingthe whole tablets
• have a narrowing or blockage in the digestive system
• have had seizures or any alteration in the electroencephalogram (EEG, a brain study)
• have abused or been dependent on alcohol, prescription medications, or drugs
• are a woman and have started menstruating (see below the section on “Pregnancy and breastfeeding”)
• have difficulty controlling, repetitive movements of some parts of the body or sounds and words repeated
• 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:

• mood swings (from being manic to being depressed, known as “bipolar disorder”)
• aggressive or hostile feelings
• seeing, hearing, or feeling things that are not there (hallucinations)
• believing things that are not real (delusions)
• feeling suspicious or paranoid
• feeling agitated, 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 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 do before you or your child start taking Concerta

To decide if methylphenidate is the right medication for you or your child, your doctor will talk to you about:

• 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 feeling, if you have mood swings, have had 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 sounds and words repeated)
• any behavioral 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). He/your doctor will 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 medication for you or your child. It is possible that your doctor will decide that you or your child need other medical tests before starting this medication. For adults starting Concerta, your doctor may refer you to a cardiologist.

Other medications and Concerta

Inform your doctor if you or your child are taking, have taken recently, or 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. Taking an MAOI with methylphenidate may cause a sudden increase in blood pressure (see “Do not take Concerta”).

Inform your doctor or pharmacist if you or your child are taking any of the following medications for depression or anxiety:

• tricyclic antidepressant
• selective serotonin reuptake inhibitor (SSRI)
• serotonin and norepinephrine reuptake inhibitor (SNRI)

Taking methylphenidate with these types of medications may produce a potentially fatal increase in “serotonin” in the brain (serotonin syndrome), which can cause confusion or restlessness, sweating, chills, muscle spasms, or rapid heartbeats.If you or your child experience these adverse effects, seek medical attention immediately.

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

• medications for severe mental health problems
• medications for Parkinson's disease (such as levodopa)
• medications for epilepsy
• medications used to lower or raise blood pressure
• some cough and cold remedies that contain medications that can affect blood pressure. It is essential to consult with your pharmacist when purchasing any of these medications
• 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 with your doctor or pharmacist to advise you before taking methylphenidate.

Inform your doctor or pharmacist if you or your child are using or have used recently any other medications, even those purchased without a prescription.

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.

Drug testing

This medication may produce a positive result in drug tests, even in tests used in sports.

Concerta and 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

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication.

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 options
• are pregnant or think they may be pregnant. Your doctor will decide if you should use methylphenidate
• are breastfeeding or plan to breastfeed. Methylphenidate passes into breast milk. Therefore, your doctor will decide if you or your daughter should breastfeed while using methylphenidate

Driving and operating machinery

You or your child may experience dizziness, difficulty focusing, or blurred vision when taking methylphenidate. If this occurs, it may be hazardous to perform certain activities such as driving, operating machinery, riding a bike, horseback riding, or climbing trees.

Concerta contains lactose

This medication contains lactose (a type of sugar). If your doctor has told you or your child that you have an intolerance to certain sugars, consult with them before taking this medication.

Concerta contains sodium

This medication contains less than 1mmol of sodium (23mg) per tablet; that is, it is essentially “sodium-free”.

How much to take

Follow exactly the administration instructions of this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Your doctor will usually start treatment with a low dose and increase the daily dose by 18 mg no more than once a week if necessary.

The goal should be the lowest effective dose for you. Your doctor will decide the maximum daily dose for you or your child.

You or your child should take Concerta once a day in the morning with a glass of water. The tablet should be swallowed whole and not chewed, broken, or crushed. The tablet can be taken with or without food.

The tablet does not completely dissolve after all the medication has been released, and sometimes the tablet may appear in the stool. This is normal.

Use in children aged 6 and above

• The recommended initial dose of Concerta is 18 mg once a day for children who are not currently taking methylphenidate, or for children who are switching from another stimulant to methylphenidate.
• The maximum daily dose is 54 mg.

Use in adults

• The maximum daily dose is 72 mg in adults.

For adults who have taken Concerta before

• If you have already taken Concerta as a child or adolescent, the same daily dose (mg/day) may be used; your doctor will check regularly if any adjustment is needed.
• Adult patients may need a higher daily dose, but your doctor will try to give you the lowest effective dose.

For adults who have not taken Concerta before

• The recommended initial dose is 18 mg per day.

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 that you or your child need a different treatment.

Abuse of Concerta

Concerta may cause abnormal behavior if it is not used properly. 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 ever been dependent on alcohol, prescription medications, or drugs.

This medication is only for you or your child. Do not give this medication to anyone else, even if they have similar symptoms.

If you or your child take too much Concerta

If you or your child take too many tablets, consult your doctor immediately or go to the nearest hospital emergency department and tell them how many tablets have been taken. Medical treatment may be necessary.

You can also contact the Toxicology Information Service, Telephone 91 5620420, indicating the medication and the amount taken. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

The signs of overdose may include: nausea, agitation, tremors, increased uncontrolled movements, muscle contractions, seizures (which may be 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, and dryness of the nose and mouth.

If you or your child forget to take Concerta

Do not take a double dose to compensate for the missed doses. 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 Concerta

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 with Concerta.

What your doctor will do when you or your child are on treatment

Your doctor will perform some tests

• before you or your child start treatment to ensure that Concerta is safe and beneficial
• once treatment has started, at least every 6 months and more often if necessary. These tests will also be done 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 rare feelings. Or if this has worsened while taking Concerta.

Long-term treatment

Concerta does not need to be taken indefinitely. If you or your child take Concerta for more than a year, your doctor should stop treatment for a short period, such as during school holidays. This allows you to demonstrate if you still need the medication.

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

Like all medications, this medication may cause side effects, although not everyone will experience them. Although some people may experience side effects, methylphenidate helps most people. Your doctor will inform you about these side effects.A doctor or pharmacist will inform you about these side effects.

Some side effects can be serious. If you or your child experience any of the following side effects, seek immediate medical attention:

Frequent (may affect up to 1 in 10 people)

• Irregular heartbeats (palpitations)
• Changes or mood swings or changes in personality.

Less frequent (may affect up to 1 in 100 people)

• Thoughts or suicidal feelings
• Seeing, feeling, or hearing things that are not real, which are symptoms of psychosis
• Uncontrolled speech and body movements (Tourette's syndrome)
• Allergic signs such as hives, itching, or urticaria on the skin, swelling of the face, lips, tongue, or other parts of the body, shortness of breath, difficulty or problems breathing.

Rare (may affect up to 1 in 10,000 people)

• Feeling exceptionally excited, more active than normal, and uninhibited (mania).

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

• Myocardial infarction
• Sudden death
• Suicidal intent
• Crisis (seizures, convulsions, epilepsy)
• Peeling of the skin or red purpuric spots
• Inflammation or blockage of the arteries in the brain
• Temporal paralysis or movement and vision problems, speech difficulties (these signs may be due to problems with blood vessels in the brain)
• Uncontrolled muscle spasms affecting the eyes, head, neck, body, and nervous system
• Decreased number of blood cells (red blood cells, white blood cells, and platelets) that may increase the risk of infections and cause easy bruising and bleeding
• Sudden increase in body temperature, very high blood pressure, and severe convulsions ("Neuroleptic Malignant Syndrome"). It is not entirely certain that this side effect is caused by methylphenidate or other medications taken in combination with methylphenidate.

Unknown (frequency cannot be estimated from available data)

• Unwanted thoughts that recur
• Unexplained fainting, chest pain, shortness of breath (may be signs of heart problems)
• Prolonged erections, sometimes painful, or increased number of erections.

If you or your child experience any of the side effects listed above, seek immediate medical attention.

The following side effects are listed below, and if they become serious, please inform your doctor or pharmacist:

Very frequent (may affect more than 1 in 10 people)

• Headache
• Nervousness
• Difficulty sleeping.

Frequent (may affect up to 1 in 10 people)

• Joint pain
• Blurred vision
• Headache due to muscle tension
• Dry mouth, thirst
• Difficulty falling asleep
• High temperature (fever)
• Decreased libido
• Excessive hair loss or thinning of hair (hair becomes finer)
• Muscle tension, muscle cramps
• Loss of appetite or decreased appetite
• Inability to achieve or maintain an erection
• Itching, rash, or red, itchy spots (hives)
• Excessive sleepiness or drowsiness, feeling tired
• Excessive tooth grinding (bruxism)
• Feeling of panic
• Sensation of numbness, itching, or tingling of the skin
• Increased levels of alanine aminotransferase in the blood (liver enzyme)
• Cough, sore throat, and irritation of the throat or nose; upper respiratory tract infection; sinusitis
• High blood pressure, rapid heartbeat (tachycardia)
• Dizziness (vertigo), feeling weak, uncontrolled movements, excessive activity
• Aggression, agitation, anxiety, depression, irritability, tension, nervousness, and abnormal behavior
• Stomach upset or indigestion, stomach pain, diarrhea, feeling dizzy, stomach discomfort, and vomiting
• Excessive sweating
• Weight loss.

Less frequent (may affect up to 1 in 100 people)

• Dry eyes

• Constipation
• Chest discomfort
• Blood in the urine
• Apathy
• Agitation or tremor
• Increased need to urinate
• Muscle pain, muscle spasms
• Shortness of breath or chest pain
• Sensation of heat
• Increased liver enzyme results (seen in a blood test)
• Anger reaction (angry), restless, or tearful, excessive awareness of the environment, difficulty sleeping.

Rare (may affect up to 1 in 10,000 people)

• Sexual desire alterations
• Feeling disoriented or confused
• Vision problems or double vision
• Swelling of the chest in men
• Redness of the skin, increased redness of skin rashes
• Obsessive-compulsive disorder (OCD) (includes the irresistible urge to pull out body hair, unwanted thoughts, feelings, images, or impulses in the mind (obsessive thoughts), and performing mental or ritualistic behaviors (compulsions)).

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

• Muscle cramps
• Small red spots on the skin
• Abnormal liver function, including sudden liver failure and coma
• Changes in test results, including liver and blood tests
• Abnormal thinking, absence of feelings or emotions
• Sensation of cold in arms and legs
• Fingers and toes numb, tingling, and color change with cold (Raynaud's phenomenon).

Unknown (frequency cannot be estimated from available data)

• Migraine
• Dilated pupils
• Very high fever
• Slow, rapid, or irregular heartbeats, palpitations
• Major seizure (grand mal seizure)
• Believing things that are not true
• Severe stomach pain with discomfort and vomiting
• Problems with blood vessels in the brain (stroke, cerebral arteritis, or cerebral occlusion)
• Inability to control urination (incontinence)
• Spasm of the jaw muscles that makes it difficult to open the mouth (trismus)
• Stuttering
• Nosebleed.

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 gain.
• Your doctor will carefully check your or your child's height and weight, as well as 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 Pharmacovigilance 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 usethis medicationafter the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Keep the bottle perfectly closed to protect it from moisture.Do not store at a temperature above 30°C.

The packaging contains one or two packets of silica gel. These packets are used to keep the tablets dry and should not be ingested.

Medications should not bethrown away through drains or in the trash.Dispose of the packaging and medications you no longer need at the SIGREpoint of the pharmacy.Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Concerta Composition

The active ingredient ismethylphenidate hydrochloride

• Concerta contains 36 milligrams of methylphenidate hydrochloride.

The other components are:

• Butilhydroxytoluene (E321), cellulose acetate, hypromellose (E464), concentrated phosphoric acid, poloxamer 188, polyethylene oxide 200K and 7000K, povidone K29-32, sodium chloride, stearic acid, succinic acid, iron oxide black (E172), iron oxide yellow (E172).
• Coating:hypromellose (E464), lactose monohydrate, titanium dioxide (E171), triacetin.
• Transparent coating:carnauba wax, hypromellose (E464), and macrogol 400.
• Printing ink:iron oxide black (E172), hypromellose (E464), andpropylene glycol.

Appearance of the product and contents of the package

Concerta is available in 4 doses: 18milligrams, 27milligrams, 36milligrams, and 54milligrams.

Each capsule-shaped tablet is individually marked for identification:

• 18milligrams: yellow, with “18” printed in black on one face
• 27milligrams: gray, with “27” printed in black on one face.
• 36milligrams: white, with “36” printed in black on one face.
• 54milligrams: reddish-brown, with “54” printed in black on one face.

The medication is presented in bottles containing 28 or30 prolonged-release tablets.

Only some package sizes may be commercially available.

Marketing Authorization Holder

JANSSEN-CILAG S.A

Pº de las Doce Estrellas, 5-7

28042 Madrid

Responsible for manufacturing

JANSSEN PHARMACEUTICA N.V

Turnhoutseweg 30, 2340

Beerse, Belgium.

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

AustriaConcerta 18 mg, 36 mg & 54 mg Retardtabletten

BelgiumConcerta 18 mg, 36 mg & 54 mg tabletten met verlengde afgifte

BulgariaConcerta 18 mg???????? ? ???????? ?????????????

CyprusConcerta 18 mg, 36 mg, 54 mgΔισκ?ο παρατεταμ?νης αποδ?σμευσης

Czech RepublicConcerta 18 mg, 36 mg, 54 mgtableta s prodlouženým uvolnováním

DenmarkConcerta 18 mg, 36 mg, 54 mg Depottabletter

EstoniaConcerta 18 mg, 36 mg, 54 mgtoimeainet prolongeeritult vabastav tablett

FinlandConcerta 18 mg, 36 mg, 54 mg depottabletit

FranceConcerta LP 18 mg, 36 mg, 54 mg comprimés à libération prolongée

GermanyConcerta 18 mg, 36 mg, 54mg Retardtabletten

GreeceConcerta 18 mg, 36 mg, 54 mgΔισκ?ο παρατεταμ?νηςαποδ?σμευσης

IcelandConcerta 18 mg, 36 mg & 54 mg forðatöflur

IrelandConcerta XL 18 mg & 36 mg Prolonged-Release Tablets

LithuaniaConcerta 18 mg, 36 mg, 54 mg pailginto atpalaidavimo tablete

LuxembourgConcerta 18 mg, 36 mg &54 mg comprimés à libération prolongée

MaltaConcerta 18 mg, 36 mg, 54 mgpilloli b’rilaxx imtawwal

NetherlandsConcerta 18 mg, 36 mg & 54 mg tabletten met verlengde afgifte

NorwayConcerta 18 mg, 36 mg & 54 mg depottabletter

PolandConcerta 18 mg, 36 mgTabletka o przedluzonym uwalnianiu

PortugalConcerta 18 mg, 36 mg & 54 mg comprimidos de libertação prolongada

RomaniaConcerta 18 mg, 36 mg, 54 mgcomprimat cu eliberare prelungita

SlovakiaConcerta 18 mg, 36 mg, 54 mgTableta spredlženým uvolnovaním

SloveniaConcerta18 mg, 36 mg, 54 mgTablete s podaljšanim sproščanjem

SpainConcerta 18 mg, 36 mg & 54 mg comprimidos de liberación prolongada

SwedenConcerta 18 mg, 36 mg & 54 mg depottabletter

UK(Northern Ireland)Concerta XL 18mg, 36mg & 54mg Prolonged-Release Tablet

Last review date of this leaflet:November 2024.

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