CONCERTA 27 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Concerta 27 mg prolonged-release tablets

Methylphenidate, hydrochloride

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you or your child only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours or your child's.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Concerta and what is it 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. Storing Concerta
6. Contents of the pack and other information

1. What is Concerta and what is it used for

What is it used for

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

• It is used in children from 6 years of age and in adults.
• It is used only after other treatments that do not involve medication, such as behavioral therapy and counseling, have been tried.

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 are underactive. The medication may help improve attention (level of attention), concentration, and reduce impulsive behavior.

The medication is given as part of a comprehensive treatment program, which usually includes:

• psychological therapy
• educational therapy and
• social therapy.

It is only prescribed by doctors who have experience in behavioral problems in children, adolescents, or adults. If you are an adult and have not been treated before, the specialist will perform tests to confirm that you have had ADHD since childhood. Although ADHD has no cure, it can be controlled using comprehensive treatment programs.

About ADHD

Children and adolescents with ADHD have difficulty:

• staying still and
• focusing

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, at school, and in other places.

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

Not all patients with ADHD need 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 any of the other ingredients of this medicine (listed in section 6)
• have a thyroid problem
• have high eye pressure (glaucoma)
• have a tumor in the adrenal glands (pheochromocytoma)
• have an eating disorder, loss of appetite, or do not want to eat, such as in “anorexia nervosa”
• have very high blood pressure or narrowing of the blood vessels, which can cause pain in the arms and legs
• have had heart problems such as a heart attack, irregular heartbeat, chest pain, heart failure, heart disease, or a heart problem at birth
• 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 a certain type of antidepressant (known as a monoamine oxidase inhibitor), see “Taking Concerta with other medicines”
• have mental health problems such as:

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

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

Warnings and precautions

Tell your doctor before you or your child start taking Concerta if you or your child:

• have liver or kidney problems
• have problems swallowing or swallowing whole tablets
• have a narrowing or blockage in the digestive system
• 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 female and have started having periods (see below the section on “Pregnancy and breastfeeding”)
• have difficulty controlling repetitive movements of some parts of the body or repeated sounds and words
• have high blood pressure
• have a heart problem not included in the previous “Do not take” section
• have a mental health problem not included in the previous “Do not take” section. Other mental health problems include:

• mood changes (from being manic to being depressed, known as “bipolar disorder”)
• feeling aggressive or hostile
• 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.

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

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

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

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

• the medications you or your child are taking
• if you or your child have a family history of sudden unexplained death
• other diseases that you or your family (such as heart problems) may have
• how you or your child are feeling, if you or your child have mood swings, have strange thoughts, or have had such feelings in the past
• if there have been cases of tics in your family (difficulty controlling repetitive movements of some parts of the body or repeated sounds and words)
• possible behavioral or mental health problems that you or your child or other family members have had. Your doctor will explain specifically if you or your child are at risk of experiencing mood changes (from being manic to being depressed, known as bipolar disorder). 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 medicine for you or your child. Your doctor may decide that you or your child need other medical tests before starting to take this medicine. For adults who start taking 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 take any other medicines.

Do not take methylphenidate if you or your child:

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

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

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

Taking methylphenidate with these types of medicines can cause a potentially life-threatening increase in “serotonin” in the brain (serotonin syndrome), which can cause confusion or restlessness, sweating, chills, muscle spasms, or rapid heartbeat. If you or your child experience these side effects, see a doctor immediately.

If you or your child are taking other medicines, methylphenidate can affect how they work or cause side effects. If you or your child are taking any of the following medicines, consult your doctor or pharmacist before taking methylphenidate:

• medicines for severe mental health problems
• medicines for Parkinson's disease (such as levodopa)
• medicines for epilepsy
• medicines used to lower or increase blood pressure
• certain cough and cold remedies that contain medicines that can affect blood pressure. It is essential to consult your pharmacist when purchasing any of these medicines
• medicines that thin the blood to prevent clots.

If you are unsure 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 other medicines, including those obtained without a prescription.

Before an operation

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

Drug tests

This medicine can give a positive result in drug tests, even in tests used in sports.

Concerta with alcohol

Do not drink alcohol while taking this medicine. Alcohol can 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 total congenital anomalies, although a small increase in the risk of cardiac malformations during use in the first three months of pregnancy could not be ruled out. Your doctor will provide more information about this risk. Consult your doctor or pharmacist before using methylphenidate if you or your daughter:

• are having sex. Your doctor will discuss birth control with you
• are pregnant or think you 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 using machines

You or your child may experience dizziness, problems focusing, or blurred vision when taking methylphenidate. If this happens, it can 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 told you that you or your child have an intolerance to certain sugars, consult them before taking this medicine.

Concerta contains sodium

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

3. How to take Concerta

How much to take

Follow the exact instructions for taking this medicine as indicated by your doctor. If you are unsure, 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 sooner 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 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 dissolve completely after all the medicine has been released, and sometimes the tablet may appear in the stool. This is normal.

Use in children from 6 years of age

• The recommended initial dose of Concerta is 18 mg once daily 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) can be used; your doctor will regularly check if any adjustment is needed.
• Adult patients may need a higher daily dose, but the doctor will try to give you the lowest dose that is effective.

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, tell your doctor. Your doctor may decide that you or your child need a different treatment.

Incorrect use of Concerta

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

This medicine is only for you or your child. 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, consult your doctor immediately or go to the emergency department of the nearest hospital and tell them how many tablets were taken. Medical treatment may be necessary.

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

Signs of overdose may include: being sick, agitation, tremors, increased uncontrolled movements, muscle contractions, seizures (which can be followed by coma), feeling very happy, confusion, seeing, hearing, or feeling things that are not there (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 forgotten doses. If you or your child forget a dose, wait and take the next dose at the scheduled time.

If you or your child stop taking Concerta

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

What your doctor will do while 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 even more often. They will also be performed when the dose is changed.
• these tests will include:

• appetite control
• height and weight measurement
• blood pressure and heart rate measurement
• evaluation of mood-related problems, mental state, or any other unusual feeling. 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 interrupt treatment for a short period, such as during school vacations. This allows demonstrating if you or your child still need the medicine.

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 all people suffer from them. Although some people present adverse effects, most people metilfenidato helps. Your doctor will inform you about these adverse effects.

Some adverse effects can be serious. If you or your child have any of the following adverse effects, go to your doctor immediately:

Frequent (may affect up to 1 in 10 people)

• irregular heartbeats (palpitations)
• changes or alterations in mood or personality changes.

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

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

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

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

• heart attack
• sudden death
• suicidal intention
• seizures (attacks, convulsions, epilepsy)
• skin peeling or red purpuric spots
• inflammation or blockage of the arteries in the brain
• temporary paralysis or movement and vision problems, speech difficulties (these signs may be related to problems with blood vessels in the brain)
• uncontrolled muscle spasms that affect the eyes, head, neck, body, and nervous system
• decrease in the number of blood cells (red blood cells, white blood cells, and platelets) that can cause a higher 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 adverse effect is caused by metilfenidato or other medications taken in combination with metilfenidato.

Unknown (frequency cannot be estimated from available data)

• unwanted recurring thoughts
• 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 above adverse effects, go to your doctor immediately.

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

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

• headache
• feeling of nervousness
• difficulty sleeping.

Frequent (may affect up to 1 in 10 people)

• joint pain
• blurred vision
• tension headache
• dry mouth, thirst
• difficulty staying asleep
• fever
• decreased sexual desire
• hair loss or decreased hair thickness (thinner hair)
• muscle tension, muscle cramps
• loss of appetite or decreased appetite
• inability to have or maintain an erection
• itching, rash, or red eruptions that itch (hives)
• excessive drowsiness or drowsiness, feeling tired
• excessive teeth grinding (bruxism)
• panic feeling
• tingling, itching, or numbness of the skin
• increased levels of alanine aminotransferase in blood (liver enzyme)
• cough, sore throat, and irritation of the throat or nose; upper respiratory tract infection; sinusitis
• high blood pressure, rapid heart rate (tachycardia)
• dizziness (vertigo), feeling of weakness, uncontrolled movements, abnormal activity
• aggressiveness, 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

Infrequent (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 twitches
• shortness of breath or chest pain
• feeling of heat
• increased liver test results (seen in a blood test)
• anger reaction (angry), restless, or tearful, excessive awareness of the environment, sleep problems.

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

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

Unknown (frequency cannot be estimated from available data)

• migraine
• dilated pupils
• very high fever
• slow, fast, or irregular heartbeats
• major epileptic seizure ("grand mal" convulsions)
• believing things that are not true
• severe stomach pain with feeling of discomfort and vomiting
• problems with blood vessels in the brain (stroke, cerebral arteritis, or cerebral occlusion)
• inability to control urine elimination (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, metilfenidato may reduce growth in some children. This affects less than 1 in 10 children.

• may prevent weight or height gain.
• your doctor will carefully check the height and weight of you or your child, as well as nutrition.

Reporting Adverse Effects

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

5. Conservation of Concerta

Keep this medicine out of sight and reach of children.

Do not use this medicine after 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 package contains one or two silica gel bags. These bags are used to keep the tablets dry and should not be ingested.

Medicines should not be thrown down the drain or into the trash. Deposit the packages and medicines you no longer need in the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of the packages and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Concerta Composition

The active ingredient is metilfenidato hydrochloride

• Concerta contains 27 milligrams of metilfenidato 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, iron oxide black (E172), iron oxide yellow (E172), and iron oxide red (E172).
• Coating-film: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.

Product Appearance and Package Contents

Concerta is available in 4 doses: 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: gray, with "alza 27" printed in black on one side.
• 36 milligrams: white, with "alza 36" printed in black on one side.
• 54 milligrams: reddish-brown, with "alza 54" printed in black on one side.

The medicine 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.

Paseo del Club Deportivo 1, Edificio 16

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

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:

Austria Concerta 27 mg Retardtabletten

Belgium Concerta 27 mg tabletten met verlengde afgifte

Finland Concerta 27 mg depottabletit

Germany Concerta 27 mg Retardtabletten

Greece Concerta 27 mg Δισκ?ο παρατεταμ?νης αποδ?σμευσης

Iceland Concerta 27 mg forðatöflur

Ireland Concerta XL 27 mg Prolonged-Release Tablets

Luxembourg Concerta 27 mg comprimés à libération prolongée

Netherlands Concerta 27 mg tabletten met verlengde afgifte

Norway Concerta 27 mg depottabletter

Portugal Concerta 27 mg comprimidos de libertação prolongada

Spain Concerta 27 mg comprimidos de liberación prolongada

Sweden Concerta 27 mg depottabletter

UK (Northern Ireland) Concerta XL 27 mg Prolonged-Release Tablet

Date of the last revision of this prospectus:November 2024.

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