Package Insert: Information for the User

Concerta 27 mg prolonged-release tablets

Methylphenidate hydrochloride

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

• Keep this package insert, 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 adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. 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 ConcertaConcerta

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 usedto treat “attention deficit hyperactivity disorder” (ADHD).

• it is used in childrenfrom 6 years oldand in adults.
• it is used only after having tried treatments that do not include medications, such as behavioral therapy and counseling.

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

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 usually includes:

• psychological therapy
• educational therapy and
• social therapy.

Only doctors with experience in behavioral problems in children, adolescents, or adults prescribe it. If you are an adult and have not received treatment before, the specialist will perform tests to confirm that you 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 them. 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 components of this medication (listed in section 6)
• have a thyroid problem
• have high eye pressure (glaucoma)
• have a tumor in the adrenal glands (pheochromocytoma)
• have a feeding 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 an antidepressant (known as a monoamine oxidase inhibitor) in the last 14 days, 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. 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 starting to take Concerta if you or your child:

• have liver or kidney problems
• have trouble swallowing or swallowing 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 a history of alcohol abuse, prescription medications, or drug abuse
• are a woman and have started menstruating (see below the section "Pregnancy and breastfeeding")
• have difficulty controlling movements, 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 (paranoia)
• feeling agitated, anxious, or tense
• feeling depressed or guilty

Inform 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 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 discuss with you:

• the medications you or your child are taking
• if you or your family have a history of sudden, unexplained death
• other health problems you or your family may have, such as heart problems
• how you or your child are doing, 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 sounds and words repeated)
• possible behavior or mental health problems you or your child have ever had or other family members. 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 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. 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) 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 cause 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 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:

• 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 cold and cough remedies that contain medications that can affect blood pressure. It is essential to consult 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 your doctor or pharmacist for advice before taking methylphenidate.

Inform your doctor or pharmacist if you or your child are using or have used 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 give a positive result in drug tests, even in those 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, consult your doctor before using this medication.

The available data do not suggest an increased risk of congenital anomalies, although a small increased risk of cardiac malformations cannot be ruled out during use in the first three months of pregnancy. 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 or horse, 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 1 mmol of sodium (23 mg) 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 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 that you or your child need a different treatment.

Abuse of Concerta

Concerta may cause abnormal behavior if 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 more Concerta than they should

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 were taken. Medical treatment may be necessary.

You can also contact the Toxicology Information Service, Phone 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, you or your child will be tested at least every 6 months and more often if necessary. Testing 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 medicines, this medicine can 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 have any of the side effects listed below, seek immediate medical attention:

Frequent (can affect up to 1 in 10 people)

• Irregular heartbeats (palpitations)
• Mood changes or alterations in personality.

Not common (can affect up to 1 in 100 people)

• Suicidal thoughts or feelings
• Seeing, feeling, or hearing things that are not real, 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 breathing.

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

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

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

• Myocardial infarction
• Sudden death
• Suicidal intent
• Seizures (attacks, convulsions, epilepsy)
• Peeling of the skin or red purpuric spots
• Arterial inflammation or blockage 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 can cause increased risk of infections, and 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 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 reappear
• 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 have 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 (can affect more than 1 in 10 people)

• Headache
• Nervousness
• Difficulty sleeping.

Frequent (can affect up to 1 in 10 people)

• Dyspepsia
• 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
• Difficulty achieving or maintaining an erection
• Itching, rash, or red, itchy spots (hives)
• Excessive drowsiness or drowsiness, feeling tired
• Excessive tooth grinding (bruxism)
• Sensation of panic
• Sensation of tingling, itching, or numbness 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

Not common (can 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 (can 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 behavioral rituals (compulsions)).

Very rare (can 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
• Major seizures (grand mal seizures)
• 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)
• Trismus (spasm of the jaw muscles that makes it difficult to open the mouth)
• 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 the 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 medicine.

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.

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.Deposit the packaging and medications that you no longer need at theSIGREpoint of the pharmacy.Ask your pharmacist how to dispose of the packaging and medications that you no longer need. By doing so, you will help protect the environment.

Concerta Composition

The active ingredient ismethylphenidate hydrochloride

• Concerta contains 27 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), and iron oxide red (E172).
• Film coating:iron oxide black (E172), hypromellose (E464), lactose monohydrate, titanium dioxide (E171), and triacetin.
• Transparent coating:carnauba wax, hypromellose (E464), and macrogol 400.
• Printing ink:iron oxide black (E172), hypromellose (E464), and propylene 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 or 30 prolonged-release tablets.

Only some package sizes may be marketed.

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 medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

AustriaConcerta 27 mg Retardtabletten

BélgicaConcerta 27 mg tabletten met verlengde afgifte

FinlandiaConcerta 27 mg depottabletit

AlemaniaConcerta 27 mg Retardtabletten

GreciaConcerta 27 mgΔισκ?ο παρατεταμ?νηςαποδ?σμευσης

IslandiaConcerta 27 mg forðatöflur

IrlandaConcerta XL 27 mg Prolonged-Release Tablets

LuxemburgoConcerta 27 mg comprimés à libération prolongée

Países bajos Concerta 27 mg tabletten met verlengde afgifte

NoruegaConcerta 27 mg depottabletter

PortugalConcerta 27 mg comprimidos de libertação prolongada

EspañaConcerta 27 mg comprimidos de liberación prolongada

SueciaConcerta 27 mg depottabletter

UK(Irlanda del Norte)Concerta XL 27 mg Prolonged-Release Tablet

Last review date of this leaflet:November 2024.

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).