Concerta 54 mg prolonged-release tablets

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Concerta 54 mg prolonged-release tablets

Methylphenidate hydrochloride

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

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed only for you or your child. Do not give it to others, even if they have the same symptoms 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 adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Concerta is 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 adverse effects
5. How to store Concerta
6. Contents of the pack and other information

1. What Concerta is and what it is used for

What it is used for

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

• It is used in children aged 6 years and older and in adults.
• It is used only after non-medicinal treatments, such as behavioural therapy and counselling, have been tried first.

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

How it works

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

The medicine is given as part of a comprehensive treatment programme, which usually includes:

• psychological therapy,
• educational therapy, and
• social therapy.

It is prescribed only by doctors experienced in managing behavioural problems in children, adolescents, or adults. If you are an adult who has not previously received treatment, the specialist will carry out tests to confirm that you have had ADHD since childhood. Although ADHD cannot be cured, it can be managed through comprehensive treatment programmes.

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 with these tasks. However, ADHD can cause problems in daily life. Children and adolescents with ADHD may have difficulties learning and completing homework. They may have trouble behaving appropriately at home, at school, and in other settings.

Adults with ADHD often have difficulty concentrating. They often feel restless, impatient, and easily distracted. They may have difficulties organizing their private lives and work.

Not all patients with ADHD require treatment with medication.

ADHD does not affect intelligence.

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

Do not take Concerta if you or your child:

• are allergic to methylphenidate or to any of the other ingredients of this medicine (listed in section 6)

• have a thyroid problem

• have high intraocular pressure (glaucoma)

• have a tumor of the adrenal glands (pheochromocytoma)

• have an eating disorder, lack of appetite, or do not want to eat, such as in "anorexia nervosa"

• have very high blood pressure or narrowing of blood vessels, which may cause pain in arms and legs

• have ever had heart problems such as a heart attack, irregular heartbeat, chest pain or discomfort, heart failure, heart disease, or a congenital heart defect

• have ever had a problem with blood vessels in the brain such as stroke, dilation or weakness of part of a blood vessel (aneurysm), narrowing or blockage of blood vessels, or inflammation of blood vessels (vasculitis)

• are currently taking or have taken within the last 14 days any antidepressant medicine known as a monoamine oxidase inhibitor (MAOI); see “Taking Concerta with other medicines”

• have mental health problems such as:

• a "psychopathic" disorder or "borderline personality disorder"

• abnormal thoughts or hallucinations, or a condition called "schizophrenia"

• signs of a serious mood disorder such as:

  • suicidal thoughts
  • severe depression, feeling very sad, worthless, and hopeless
  • mania, feeling unusually elated, more active than normal, and disinhibited.

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

Warnings and precautions

Talk to your doctor before starting Concerta if you or your child:

• have liver or kidney problems

• have difficulty swallowing or problems swallowing the tablets whole

• have narrowing or blockage in the digestive tract

• have ever had seizures (fits, convulsions, epilepsy) or any abnormalities on electroencephalogram (EEG, a brain test)

• have ever abused or been dependent on alcohol, prescription medicines, or drugs

• are a woman who has started menstruating (see section “Pregnancy and breastfeeding” below)

• have difficulty controlling repetitive movements of certain body parts or repeating sounds and words

• have high blood pressure

• have a heart condition not listed in the previous section “Do not take”

• have a mental health condition not listed in the previous section “Do not take”. Other mental health problems include:

• mood swings (from manic to depressed, known as “bipolar disorder”)

• aggressive or hostile feelings

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

• believing things that are not true (delusions)

• feeling unusually suspicious (paranoia)

• feeling restless, anxious, or tense

• feeling depressed or guilty.

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

If you or your child experience blurred vision or other visual disturbances, contact your doctor. Your doctor may consider stopping treatment with Concerta.

During treatment, children and adolescents may unexpectedly develop prolonged erections. These erections can be painful and may occur at any time. It is important to contact a doctor immediately if an erection lasts longer than 2 hours, especially if it is painful.

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

To determine whether methylphenidate is the right medicine for you or your child, your doctor will discuss with you:

• the medicines you or your child are taking
• whether there is a family history of unexplained sudden death
• other illnesses you or your family may have (such as heart problems)
• how you are feeling, whether you have mood swings, strange thoughts, or have had such feelings in the past
• whether there is a family history of tics (difficulty controlling repetitive movements of certain body parts or repeating sounds and words)
• any possible behavioral or mental health problems you or your child or other family members may have had. Your doctor will specifically explain whether you or your child are at risk of mood changes (from manic to depressed, known as bipolar disorder). He/your doctor will review your or your child’s mental health history and check whether any family members have a history of suicide, bipolar disorder, or depression.

It is important to provide as much information as possible. This will help your doctor decide whether methylphenidate is the right medicine for you or your child. Your doctor may decide that you or your child need further medical tests before starting this medicine. For adults starting Concerta, your doctor may refer you to a cardiologist.

Other medicines and Concerta

Tell your doctor if you or your child are taking, have recently taken, or might need to take any other medicines.

Do not take methylphenidate if you or your child:

• are taking a medicine called a "monoamine oxidase inhibitor" (MAOI) used for depression, or have taken an MAOI within the last 14 days. Using an MAOI with methylphenidate may cause a sudden increase in blood pressure (see “Do not take Concerta”).

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

• tricyclic antidepressants
• selective serotonin reuptake inhibitors (SSRIs)
• serotonin-norepinephrine reuptake inhibitors (SNRIs).

Taking methylphenidate with these types of medicines may cause a potentially fatal increase in "serotonin" in the brain (serotonin syndrome), which may lead to confusion or restlessness, sweating, chills, muscle spasms, or rapid heartbeat. If you or your child experience these side effects, seek medical help immediately.

If you or your child are taking other medicines, methylphenidate may affect how these medicines 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:

• medicines for serious mental health conditions
• medicines for Parkinson’s disease (such as levodopa)
• medicines for epilepsy
• medicines used to lower or raise blood pressure
• some cough and cold remedies containing medicines that may affect blood pressure. It is important to consult your pharmacist when purchasing such medicines
• medicines that thin the blood to prevent clots.

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

Tell your doctor or pharmacist if you or your child are using or have recently used any other medicines, including those obtained without a prescription.

Before surgery

Inform your doctor if you or your child are scheduled for surgery. Methylphenidate should not be taken on the day of surgery when certain types of anesthetics are used, as it may cause a sudden increase in blood pressure during the procedure.

Drug testing

This medicine may give a positive result in drug tests, including those used in sports.

Concerta and 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

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Available data do not suggest an increased risk of overall congenital malformations, although a small increased risk of cardiac malformations during use in the first three months of pregnancy cannot be ruled out. Your doctor will provide further information about this risk. Consult your doctor or pharmacist before using methylphenidate if you or your daughter:

• are sexually active. Your doctor will discuss contraception with you
• are pregnant or think you may be pregnant. Your doctor will decide whether you should use methylphenidate
• are breastfeeding or plan to breastfeed. Methylphenidate passes into breast milk. Therefore, your doctor will decide whether you or your daughter should breastfeed while using methylphenidate.

Driving and using machines

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

Concerta contains lactose

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

Concerta contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; essentially "sodium-free".

3. How to take Concerta

How much to take

Follow exactly the instructions for using this medicine as given 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 frequently than once a week, if necessary.

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

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

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

Use in children aged 6 years and older

• The recommended initial dose of Concerta is 18 mg once daily for children who are not currently taking methylphenidate, or for children 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 previously taken Concerta:

• If you previously took Concerta as a child or adolescent, the same daily dose (mg/day) may be used; your doctor will regularly check whether any adjustments are needed.
• Adult patients may require a higher daily dose, but the doctor will aim to give the lowest effective dose.

For adults who have not previously taken Concerta:

• The recommended starting 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.

Misuse of Concerta

If Concerta is not used properly, it may cause abnormal behavior. This may also mean that you or your child may start to become dependent on the medicine. Inform your doctor if you or your child have ever abused or been dependent on alcohol, prescription medicines, or drugs.

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

If you or your child take more Concerta than you should

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

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

Signs of overdose may include: nausea, agitation, tremors, increased uncontrolled movements, muscle twitching, seizures (which may be followed by coma), feelings of extreme happiness, confusion, seeing, feeling, or hearing things that are not real (hallucinations), sweating, flushing, headache, high fever, changes in heartbeat (slow, fast, or irregular), high blood pressure, dilated pupils, and dryness of the nose and mouth.

If you or your child forget to take Concerta

Do not take a double dose to make up for a missed dose. 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 Concerta

If you or your child stop taking this medicine suddenly, ADHD symptoms or unwanted effects such as depression may return. Your doctor may want to gradually reduce the amount of medicine you take each day before stopping completely. Consult your doctor before stopping treatment with Concerta.

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

Your doctor will carry out some tests

• Before you or your child start treatment, to ensure that Concerta is safe and beneficial

• After treatment has started, at least every 6 months, and even more frequently. These tests will also be performed when the dose is changed.

• These tests will include:

• Monitoring of appetite

• Measurement of height and weight

• Measurement of blood pressure and heart rate

• Assessment of mood-related problems, mental state, or any other unusual feelings, or whether these have 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 one year, your doctor should interrupt treatment for a short period, such as during school holidays. This allows assessment of whether the medicine is still needed.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. Although some people may experience adverse effects, methylphenidate helps most people. Your doctor will inform you about these adverse effects.

Some adverse effects may be serious. If you or your child experience any of the following adverse effects, contact your doctor immediately:

Common (may affect up to 1 in 10 people)

• irregular heartbeat (palpitations)
• changes or disturbances in mood or changes in personality.

Uncommon (may 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 syndrome)
• signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, difficulty or problems breathing.

Rare (may affect up to 1 in 1000 people)

• feeling unusually elated, more active than normal and disinhibited (mania).

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

• heart attack
• sudden death
• suicidal ideation
• seizures (attacks, convulsions, epilepsy)
• skin peeling or purplish red spots
• inflammation or blockage of arteries in the brain
• temporary paralysis or movement and vision problems, speech difficulties (these signs may indicate problems with blood vessels in the brain)
• uncontrollable muscle spasms affecting the eyes, head, neck, body and nervous system
• decrease in blood cell counts (red blood cells, white blood cells and platelets) which may increase the risk of infections and lead to easier bleeding and bruising
• sudden increase in body temperature, very high blood pressure and severe seizures ("Neuroleptic Malignant Syndrome"). It is not entirely certain whether this adverse effect is caused by methylphenidate or by other medicines taken in combination with methylphenidate.

Not known (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 adverse effects listed above, contact your doctor immediately.

The following additional adverse effects are reported. If they become severe, please inform your doctor or pharmacist:

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

• headache
• feeling nervous
• difficulty sleeping.

Common (may affect up to 1 in 10 people)

• joint pain
• blurred vision
• tension headache
• dry mouth, thirst
• difficulty falling asleep
• elevated temperature (fever)
• decreased sex drive
• abnormal hair loss or reduced hair thickness (thinner hair)
• muscle tension, muscle cramps
• loss of appetite or reduced appetite
• inability to achieve or maintain an erection
• itching, rash or itchy red rashes (hives)
• drowsiness or unusual drowsiness, feeling tired
• excessive teeth grinding (bruxism)
• feeling of panic
• tingling, itching or numbness of the skin
• increased levels of alanine aminotransferase in blood (liver enzyme)
• cough, sore throat and throat or nasal irritation; upper respiratory tract infection; sinusitis
• high blood pressure, rapid heartbeat (tachycardia)
• dizziness (vertigo), feeling weak, uncontrolled movements, unusual activity
• aggression, agitation, anxiety, depression, irritability, tension, nervousness and abnormal behavior
• stomach discomfort or indigestion, stomach pain, diarrhea, feeling nauseous, stomach upset and vomiting
• excessive sweating
• weight loss.

Uncommon (may affect up to 1 in 100 people)

• dry eyes
• constipation
• chest discomfort
• blood in the urine
• apathy
• restlessness or tremor
• increased need to urinate
• muscle pain, muscle jerks
• shortness of breath or chest pain
• feeling of warmth
• increased liver test results (seen in blood tests)
• angry outbursts, restlessness or tearfulness, excessive awareness of surroundings, sleep problems.

Rare (may affect up to 1 in 1000 people)

• disturbances in sexual desire
• feeling disoriented or confused
• vision problems or double vision
• breast swelling in males
• skin redness, increased redness of skin rashes
• obsessive-compulsive disorder (OCD) (includes irresistible urge to pull out body hair, skin picking, having unwanted, repeated thoughts, feelings, images or impulses in the mind (obsessive thoughts), performing repeated behaviors or mental rituals (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, lack of feelings or emotion
• sensation of cold in arms and legs
• numbness, tingling and color changes in fingers and toes with cold (from white to blue then red) ("Raynaud's phenomenon").

Not known (frequency cannot be estimated from available data)

• migraine
• dilated pupils
• increased eye pressure
• eye diseases that may cause vision loss due to optic nerve damage (glaucoma)
• very high fever
• slow, fast or irregular heartbeats, palpitations
• major epileptic seizure ("generalized tonic-clonic seizures")
• believing things that are not true
• severe stomach pain with nausea and vomiting
• problems with blood vessels in the brain (stroke, cerebral arteritis or cerebral occlusion)
• inability to control urination (incontinence)
• jaw muscle spasm making it difficult to open the mouth (trismus)
• stuttering
• nosebleeds.

Effects on growth

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

• it may impair weight or height gain.
• your doctor will carefully monitor your or your child's height, weight and nutrition.
• if you or your child do not grow as expected, treatment with methylphenidate may be interrupted for a short period of time.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Concerta

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

Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the month indicated.

Keep the bottle tightly closed to protect it from moisture. Do not store above 30 °C.

The container contains one or two silica gel sachets. These sachets are included to keep the tablets dry and must not be ingested.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Concerta

The active substance is methylphenidate hydrochloride.

• Concerta contains 54 milligrams of methylphenidate hydrochloride.

The other components are:

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

Appearance of the product and contents of the pack

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

Each capsule-shaped tablet is individually marked for identification:

• 18 milligrams: yellow, with "alza 18" printed in black on one side.
• 27 milligrams: grey, with "alza 27" printed in black on one side.
• 36 milligrams: white, with "alza 36" printed in black on one side.
• 54 milligrams: brownish-red, with "alza 54" printed in black on one side.

The medicine is supplied in bottles containing 28 or 30 prolonged-release tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Janssen-Cilag, S.A.
Paseo del Club Deportivo 1, Edificio 16
28223 Pozuelo de Alarcón (Madrid)
Spain

Manufacturer

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:

Austria: Concerta 18 mg, 36 mg & 54 mg Retardtabletten
Belgium: Concerta 18 mg, 36 mg & 54 mg tabletten met verlengde afgifte
Bulgaria: Concerta 18 mg ???????? ? ???????? ?????????????
Cyprus: Concerta 18 mg, 36 mg, 54 mg Δισκ?ο παρατεταμ?νης αποδ?σμευσης
Czech Republic: Concerta 18 mg, 36 mg, 54 mg tableta s prodlouženým uvolnováním
Denmark: Concerta 18 mg, 36 mg, 54 mg Depottabletter
Estonia: Concerta 18 mg, 36 mg, 54 mg toimeainet prolongeeritult vabastav tablett
Finland: Concerta 18 mg, 36 mg, 54 mg depottabletit
France: Concerta LP 18 mg, 36 mg, 54 mg comprimés à libération prolongée
Germany: Concerta 18 mg, 36 mg, 54 mg Retardtabletten
Greece: Concerta 18 mg, 36 mg, 54 mg Δισκ?ο παρατεταμ?νης αποδ?σμευσης
Iceland: Concerta 18 mg, 36 mg & 54 mg forðatöflur
Ireland: Concerta XL 18 mg & 36 mg Prolonged-Release Tablets
Lithuania: Concerta 18 mg, 36 mg, 54 mg pailginto atpalaidavimo tablete
Luxembourg: Concerta 18 mg, 36 mg & 54 mg comprimés à libération prolongée
Malta: Concerta 18 mg, 36 mg, 54 mg pilloli b’rilaxx imtawwal
Netherlands: Concerta 18 mg, 36 mg & 54 mg tabletten met verlengde afgifte
Norway: Concerta 18 mg, 36 mg & 54 mg depottabletter
Poland: Concerta 18 mg, 36 mg Tabletka o przedluzonym uwalnianiu
Portugal: Concerta 18 mg, 36 mg & 54 mg comprimidos de libertação prolongada
Romania: Concerta 18 mg, 36 mg, 54 mg comprimat cu eliberare prelungita
Slovakia: Concerta 18 mg, 36 mg, 54 mg Tableta s predlženým uvolnovaním
Slovenia: Concerta 18 mg, 36 mg, 54 mg Tablete s podaljšanim sprošcanjem
Spain: Concerta 18 mg, 36 mg & 54 mg comprimidos de liberación prolongada
Sweden: Concerta 18 mg, 36 mg & 54 mg depottabletter
United Kingdom (Northern Ireland): Concerta XL 18mg, 36mg & 54mg Prolonged-Release Tablet

Date of the most recent revision of this leaflet: February 2026.

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