Concerta

Package Leaflet: Information for the User

Concerta, 18 mg, prolonged-release tablets

Concerta, 36 mg, prolonged-release tablets

Methylphenidate hydrochloride
The medicine is called Concerta and contains the active substance methylphenidate hydrochloride. In this leaflet, the term "methylphenidate" will also be used.

Read this leaflet carefully before taking the medicine, as it contains important information for you.

• Keep this leaflet, as 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 only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• 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 and other information

• 1. What is Concerta and what is it used for
• 2. Before you take Concerta
• 3. How to take Concerta
• 4. Possible side effects
• 5. How to store Concerta
• 6. Contents of the pack and other information

1. What is Concerta and what is it used for

What is Concerta used for

Concerta is used to treat attention deficit hyperactivity disorder (ADHD) in:

• children and adolescents from 6 years of age and adults.
• only after a comprehensive diagnosis of ADHD has been made, and after other treatments have been tried, such as psychological, educational, and social measures (behavioral therapy).

How Concerta works

Concerta improves the function of certain parts of the brain, which are underactive. The medicine may improve attention and reduce impulsivity and hyperactivity. Concerta is part of a comprehensive treatment program, which usually includes psychological, educational, and social measures.

ADHD

Children and adolescents with ADHD have difficulty:

• sitting still for a long time
• focusing their attention. This behavior is not their fault, as they cannot control it.

Many children and adolescents experience these difficulties. However, ADHD can lead to problems in everyday life. Children and adolescents with ADHD may have difficulty learning and doing homework. They may have trouble behaving at home, school, and other places.

2. Before you take Concerta

When not to take Concerta

• if you are allergic to methylphenidate or any of the other ingredients of this medicine (listed in section 6)
• if you have thyroid problems
• if you have increased eye pressure (glaucoma)
• if you have a tumor of the adrenal gland (pheochromocytoma)
• if you have eating disorders, such as anorexia nervosa
• if you have very high blood pressure or narrowing of the blood vessels, which can cause pain in the arms and legs
• if you have ever had heart problems, such as a heart attack, irregular heartbeat, chest pain, or heart failure
• if you have had problems with blood vessels in the brain, such as a stroke, an aneurysm (a bulge in a blood vessel), narrowing or blockage of blood vessels, or inflammation of blood vessels
• if you are taking certain antidepressants (called monoamine oxidase inhibitors) or have taken them in the last 14 days - see "Concerta with other medicines"
• if you have mental health problems, such as:
• psychopathy or borderline personality disorder
• abnormal thoughts or visions, or a condition called schizophrenia
• severe mood swings, with symptoms such as suicidal thoughts or severe depression, mania (when you feel extremely excited, overactive, and uncontrollable), or feelings of aggression

Warnings and precautions

Before taking Concerta, talk to your doctor:

• if you have liver or kidney problems
• if you have difficulty swallowing or swallowing whole tablets
• if you have narrowing or blockage of the digestive tract
• if you have had seizures (fits or convulsions) or abnormal brain wave tests (EEG)
• if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs
• if you have started your menstrual period (see "Pregnancy and breast-feeding")
• if you have movement or verbal tics (involuntary, repetitive movements or sounds)
• if you have high blood pressure
• if you have heart problems other than those mentioned above in "When not to take Concerta"
• if you have mental health problems other than those mentioned above in "When not to take Concerta", including:
• mood swings (from mania to depression, also known as bipolar disorder)
• feeling aggressive or hostile
• seeing, hearing, or feeling things that are not there (hallucinations)
• believing things that are not true (delusions)
• being overly suspicious (paranoia)
• feeling excited, anxious, or tense
• feeling depressed or guilty

During treatment, boys and young men may experience unexpected, long-lasting erections. This can be painful and can occur at any time. If an erection lasts for more than 2 hours, you should seek medical help immediately, especially if it is painful.

Medical history before taking Concerta

The medical history is used to decide whether Concerta is a suitable medicine for you. Your doctor will discuss with you:

• any medicines you are taking
• any sudden, unexplained death in your family
• any other medical conditions you have, such as heart problems
• your overall health, including any mood swings, unusual thoughts, or previous mental health problems
• any history of tics (involuntary, repetitive movements or sounds) in you or your family
• any mental health or behavioral problems you have had, including:

Concerta with other medicines

Tell your doctor about all the medicines you are taking now or have taken recently, and any medicines you plan to take.

• if you are taking a medicine called a monoamine oxidase inhibitor, used to treat depression, or if you have taken it in the last 14 days. Taking this medicine with methylphenidate can cause a sudden increase in blood pressure (see "When not to take Concerta").

Tell your doctor or pharmacist if you are taking any of the following medicines:

• tricyclic antidepressants
• selective serotonin reuptake inhibitors (SSRIs)
• serotonin and noradrenaline reuptake inhibitors (SNRIs). Taking methylphenidate with these medicines can cause a life-threatening increase in serotonin levels in the brain (serotonin syndrome), which can cause confusion, agitation, sweating, shaking, muscle contractions, and rapid heart rate. If you experience these side effects, you should seek medical help immediately.

If you are taking other medicines, methylphenidate may affect their action or cause side effects. Before taking methylphenidate, tell your doctor or pharmacist if you are taking any of the following medicines:

• medicines for severe mental health problems
• medicines for Parkinson's disease (such as levodopa)
• anti-epileptic medicines
• medicines to lower blood pressure
• certain cough and cold medicines that contain ingredients that can affect blood pressure
• blood-thinning medicines to prevent blood clots

Before surgery

Tell your doctor that you are taking Concerta before undergoing surgery. You should not take methylphenidate on the day of surgery if a certain type of anesthetic is used, due to the risk of a sudden increase in blood pressure during surgery.

Drug tests

The medicine may cause a positive result in a drug test. This includes tests performed on athletes.

Concerta with alcohol

Do not drink alcohol while taking Concerta. Alcohol may increase the side effects of the medicine. Remember that some foods and medicines contain alcohol.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or plan to become pregnant, ask your doctor for advice before taking this medicine.

• if you are sexually active. Your doctor will discuss methods of birth control
• if you are pregnant or think you may be pregnant. Your doctor will decide whether methylphenidate should be taken
• if you are breast-feeding or plan to breast-feed. Methylphenidate passes into human milk. Your doctor will decide whether you should continue breast-feeding during treatment with methylphenidate.

Driving and using machines

While taking methylphenidate, you may experience dizziness, difficulty concentrating, and blurred vision. If this happens, it may be dangerous to perform activities such as driving, operating machinery, riding a bike, horse riding, or climbing trees.

Concerta contains lactose

The medicine contains lactose (a type of sugar). If you have been told that you have an intolerance to some sugars, contact your doctor before taking the medicine.

Concerta contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially "sodium-free".

3. How to take Concerta

What dose of Concerta to take

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

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

The goal is to find the lowest dose that works for you. Your doctor will decide on the maximum daily dose for you.

You should take Concerta once a day, in the morning, with a glass of water. The tablet should be swallowed whole. Do not chew, divide, or crush the tablet. The tablet can be taken with or without food.

The tablet does not completely dissolve after releasing the active substance, and you may sometimes see the tablet shell in your stool. This is normal.

Use in children aged 6 years and older

• the recommended starting dose of Concerta is 18 mg once daily for children who have not taken methylphenidate before or for children who are switching from another stimulant medicine to methylphenidate
• the maximum daily dose is 54 mg.

Use in adults

• the maximum daily dose in adults is 72 mg.

For adults who have previously taken Concerta:

• if you took Concerta as a child or adolescent, you can take the same daily dose (mg/day); your doctor will regularly check if the dose needs to be adjusted
• adult patients may need a higher daily dose, but your doctor will aim to give you the lowest dose that works for you.

For adults who have not previously taken Concerta:

• the recommended starting dose is 18 mg once daily.

If you do not feel better after 1 month of treatment

If you do not feel better after 1 month of treatment, tell your doctor, who may decide to use a different treatment.

Misuse of Concerta

Misuse of Concerta can lead to abnormal behavior. It can also be a sign that you are becoming dependent on the medicine. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs. The medicine is for you only. Do not give it to anyone else, even if they have the same symptoms as you.

Taking too much Concerta

If you take too much of the medicine, contact your doctor or go to the hospital immediately. You may need treatment. Symptoms of overdose may include vomiting, feeling overexcited, shaking, muscle twitching, seizures (which can lead to coma), feeling euphoric, disoriented, or hallucinating, increased sweating, flushing, headache, high fever, changes in heart rate (slow, fast, or irregular), high blood pressure, dilated pupils, and dryness of the mouth and nose.

Forgetting to take Concerta

Do not take a double dose to make up for a forgotten tablet. If you forget to take a tablet, wait until it is time for your next dose.

Stopping treatment with Concerta

If you suddenly stop taking the medicine, you may experience a return of ADHD symptoms or side effects, such as depression. Your doctor may recommend gradually reducing the dose of the medicine before stopping it completely. Talk to your doctor before stopping treatment with Concerta.

Tests performed by your doctor during treatment

Your doctor will perform several tests

• before starting treatment - to make sure that Concerta is a safe and suitable medicine for you
• after starting treatment - at least every 6 months, but possibly more often, as well as when changing the dose
• the tests will include:
• checking your appetite
• measuring your height and weight
• measuring your blood pressure and heart rate
• assessing your mood, mental state, or any other abnormalities, and whether they have worsened while taking Concerta.

Long-term treatment

Treatment with Concerta does not have to be lifelong. If you have been taking Concerta for more than a year, your doctor may stop treatment for a short period, for example, during holidays. This will help assess whether the medicine is still needed. If you have any questions about treatment, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Concerta can cause side effects, although not everybody gets them. Despite the side effects, most people's condition improves. Your doctor will discuss these side effects with you.

Some side effects can be serious. You should immediately tell your doctor if you experience any of the following side effects:

Common side effects (may affect up to 1 in 10 people)

• irregular heartbeat (palpitations)
• mood changes or mood swings.

Uncommon side effects (may affect up to 1 in 100 people)

• suicidal thoughts or attempts
• seeing, hearing, or feeling things that are not there (psychosis)
• uncontrollable movements or sounds (Tourette's syndrome)
• allergic reactions, such as a rash, itching, or hives on the skin, swelling of the face, lips, tongue, or other parts of the body, shortness of breath, wheezing, or difficulty breathing.

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

• feeling extremely excited, overactive, and uncontrollable (mania).

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

• heart attack
• sudden death
• suicide attempts
• seizures (fits or convulsions)
• severe skin reactions, such as Stevens-Johnson syndrome or toxic epidermal necrolysis
• inflammation or blockage of blood vessels in the brain (stroke, cerebral vasculitis, or cerebral occlusion)
• temporary paralysis or movement disorders, vision, or speech problems (which can be symptoms of cerebral vasculitis or cerebral occlusion)
• involuntary muscle contractions, especially of the face, head, neck, or body, and neurological symptoms
• reduced number of blood cells (red cells, white cells, and platelets), which can increase the risk of infections, bleeding, and bruising
• a sudden increase in body temperature, very high blood pressure, and severe seizures (malignant neuroleptic syndrome). It is not certain whether this side effect is caused by methylphenidate or other medicines that are taken with it.

Side effects with unknown frequency (frequency cannot be estimated from the available data)

• recurring thoughts
• unexplained fainting, chest pain, or shortness of breath (which can be symptoms of heart problems)
• prolonged erections, sometimes painful, or increased frequency of erections.

You should immediately tell your doctor if you experience any of the above side effects.

Tell your doctor or pharmacist if any of the following side effects get worse:

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

• headache
• nervousness
• insomnia.

Common side effects (may affect up to 1 in 10 people)

• joint pain
• blurred vision
• tension headache
• dry mouth, thirst
• difficulty falling asleep
• high fever
• decreased sex drive
• unusual hair loss or thinning
• muscle tension, muscle spasms
• loss of appetite or decreased appetite
• difficulty getting or maintaining an erection
• itching, rash, or hives
• unusual drowsiness, feeling tired
• grinding of the teeth (bruxism)
• feeling panicked
• tingling, numbness, or prickling sensations (paresthesia)
• increased levels of a liver enzyme (alanine aminotransferase) in the blood
• cough, inflammation or pain in the nose and throat; upper respiratory tract infections, sinusitis
• high blood pressure, rapid heart rate (tachycardia)
• dizziness, feeling weak, involuntary movements (dyskinesia), excessive psychomotor activity
• aggression, feeling overexcited, anxiety, depression, irritability, tension, and behavioral problems
• nausea, stomach pain, diarrhea, vomiting, discomfort in the abdomen, vomiting.
• excessive sweating
• weight loss

Uncommon side effects (may affect up to 1 in 100 people)

• dry eye
• constipation
• chest discomfort
• blood in the urine
• indifference
• tremor
• frequent urination
• muscle pain, muscle spasms
• shortness of breath or chest pain
• feeling hot
• increased liver enzyme levels (in blood tests)
• anger, irritability, crying, talkativeness, excessive alertness, sleep disturbances.

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

• sexual problems
• feeling disoriented or confused
• vision problems or double vision
• breast enlargement in men (gynecomastia)
• rash, hives
• obsessive-compulsive disorder (OCD) (including a strong desire to pull out hair, recurring thoughts, or repetitive behaviors).

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

• muscle spasms
• small, red rash
• liver problems, including liver failure and coma
• changes in test results, including liver and blood tests
• thought problems, lack of emotions
• feeling cold in the hands and feet
• feeling numbness, tingling, and color changes in the skin (Raynaud's phenomenon) when cold.

Side effects with unknown frequency (frequency cannot be estimated from the available data)

• migraine
• pupil dilation
• very high fever
• slow or fast heart rate or extra heartbeats
• grand mal seizures
• delusions
• severe stomach pain, often with nausea and vomiting
• problems with blood vessels in the brain (stroke, cerebral vasculitis, or cerebral occlusion)
• inability to control urination (urinary incontinence)
• muscle spasm of the jaw, which can cause difficulty opening the mouth (trismus)
• stuttering
• nosebleeds.

Effect on physical development

During long-term use of methylphenidate (more than a year), some children may experience slowed physical development. This affects less than 1 in 10 children.

• there may be a lack of weight gain or growth slowdown
• your doctor will closely monitor your growth, weight, and diet
• if your child's development is slower than expected, treatment with methylphenidate may be stopped for a short time.

Reporting side effects

If you experience any side effects, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder.

5. How to store Concerta

Keep the medicine out of the sight and reach of children. Do not use this medicine after the expiry date, which is stated on the packaging after EXP. The expiry date refers to the last day of that month. Store the bottle tightly closed to protect from moisture. Do not store above 30°C. The packaging contains a desiccant (one or two), which is not intended for consumption. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Concerta contains

The active substance is methylphenidate hydrochloride:

• Concerta 18 mg contains 18 mg of methylphenidate hydrochloride
• Concerta 36 mg contains 36 mg of methylphenidate hydrochloride.

The other ingredients are:

• butylhydroxytoluene (E321), cellulose acetate, hypromellose (E464), phosphoric acid, poloxamer 188, polyethylene oxides 200 K and 7000 K, povidone K29-32, sodium chloride, stearic acid, tartaric acid, iron oxide black (E172), iron oxide yellow (E172)
• Colored coating:hypromellose (E464), lactose monohydrate, titanium dioxide (E171), triacetin, iron oxide yellow (E172) (only 18 mg tablets) and stearic acid (only 18 mg tablets)
• Clear coating:carnauba wax, hypromellose (E464) and macrogol 400
• Ink:iron oxide black (E172), hypromellose (E464) and propylene glycol

What Concerta looks like and contents of the pack

Concerta is available in two strengths: 18 mg and 36 mg. Each tablet is differently marked to help distinguish between them:

• 18 mg: yellow, with a black imprint "alza 18" on one side of the tablet
• 36 mg: white, with a black imprint "alza 36" on one side of the tablet

The medicine is available in a bottle containing 30 prolonged-release tablets.

Marketing authorization holder

Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium

Manufacturer and importer responsible for batch release

Janssen Pharmaceutica NV, Turnhoutseweg 30, B-2340 Beerse, Belgium

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

Austria, Germany: Concerta 18 mg, 36 mg, 54 mg Retardtabletten; Belgium: Concerta 18 mg, 36 mg, 54 mg tabletten met verlengde afgifte; Bulgaria: Concerta 18 mg таблетка с удължено освобождаване; Cyprus: Concerta 18 mg, 36 mg, 54 mg Δισκίο παρατεταμένης αποδέσμευσης; Czech Republic: Concerta 18 mg, 36 mg, 54 mg tableta s prodlouženým uvolňováním; Denmark: Concerta 18 mg, 36 mg, 54 mg Depottabletter; Estonia: Concerta 18 mg, 36 mg, 54 mg toimeainet pikaajaliselt vabastav tablett; Finland: Concerta 18 mg, 36 mg, 54 mg depottabletit; France: Concerta LP 18 mg, 36 mg, 54 mg comprimés à libération prolongée; Greece: Concerta 18 mg, 36 mg, 54 mg Δισκίο παρατεταμένης αποδέσμευσης; Spain: Concerta 18 mg, 36 mg, 54 mg comprimidos de liberación prolongada; Netherlands: Concerta 18 mg, 36 mg, 54 mg tabletten met verlengde afgifte; Ireland: Concerta XL 18 mg, 36 mg Prolonged-Release Tablets; Iceland: Concerta 18 mg, 36 mg, 54 mg forðatöflur; Lithuania: Concerta 18 mg, 36 mg, 54 mg pailginto atpalaidavimo tabletė; Luxembourg: Concerta 18 mg, 36 mg, 54 mg comprimés à libération prolongée; Malta: Concerta 18 mg, 36 mg, 54 mg pilloli b’rilaxx imtawwal; Norway, Sweden: Concerta 18 mg, 36 mg, 54 mg depottabletter; Poland: Concerta 18 mg, 36 mg tabletki o przedłużonym uwalnianiu; Portugal: Concerta 18 mg, 36 mg, 54 mg comprimidos de libertação prolongada; Romania: Concerta 18 mg, 36 mg, 54 mg comprimat cu eliberare prelungită; Slovakia: Concerta 18 mg, 36 mg, 54 mg Tableta s predĺženým uvoľňovaním; Slovenia: Concerta 18 mg, 36 mg, 54 mg Tablete s podaljšanim sproščanjem; United Kingdom (Northern Ireland): Concerta XL 18 mg, 36 mg, 54 mg Prolonged-Release Tablets

Date of last revision of the leaflet: 11/2024

Detailed information on this medicine is available on the website of the Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych: http://www.urpl.gov.pl