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.

• You should 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 aged 6 years and older, and adults.
• children and adolescents who have been diagnosed with ADHD and who have been shown to be sensitive to the effects of methylphenidate.

How does Concerta work

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

• psychological treatment
• educational support
• social support. The medicine is prescribed by a specialist in child or adult psychiatry or neurology.

ADHD

Children and adolescents with ADHD have difficulty:

• sitting still for a long time
• concentrating. This behavior is not their fault, as they cannot help 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, at school, and in other places.
Adults with ADHD often have difficulty concentrating. They may feel restless, impatient, and inattentive. They may have trouble organizing their private and professional life.
Not all patients with ADHD need medication.
ADHD does not affect intelligence.

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 pressure in the eye (glaucoma)
• if you have a tumor of the adrenal gland (pheochromocytoma)
• if you have an eating disorder (anorexia)
• 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 schizophrenia
• severe mood swings (from mania to depression, known as bipolar affective disorder)

Warnings and precautions

Before starting treatment with Concerta, discuss the following with 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 gastrointestinal tract
• if you have had seizures (fits or convulsions) or an abnormal EEG (electroencephalogram)
• if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs
• if you have started menstruating (see "Pregnancy and breastfeeding")
• 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". These include:
• mood swings (from mania to depression, known as bipolar affective 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. Before starting treatment, tell your doctor or pharmacist if you have any of these symptoms or illnesses, as methylphenidate may make them worse. Your doctor will want to monitor how the medicine affects you.

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 attention immediately, especially if it is painful.

Medical history before starting treatment with Concerta

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

• any medicines you are taking
• any cases of sudden, unexplained death in your family
• any other illnesses you have (such as heart problems) or have had in the past
• your overall health, such as whether you have mood swings, unusual thoughts, or have had these symptoms in the past
• whether there is a history of tics (involuntary, repetitive movements or sounds) in your family
• any mental health or behavioral problems you have had or have now. Your doctor will assess the risk of mood swings (from mania to depression, known as bipolar affective disorder). This will involve a psychiatric assessment, including questions about any history of suicide in your family, any history of bipolar affective disorder or depression. It is essential to provide as much information as possible. This will help your doctor decide whether methylphenidate is a suitable medicine for you. Before starting treatment, your doctor may decide that you need to have some additional tests. For adult patients who are starting treatment with Concerta for the first time, your doctor may refer you to a heart specialist.

Concerta with other medicines

Tell your doctor about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Do not take methylphenidate if:

• you are taking a medicine called a monoamine oxidase inhibitor (used to treat depression) or 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)
• selective 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, or a fast heart rate. If you experience any of these side effects, you should see a doctor 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 used to treat severe mental health problems
• medicines used to treat Parkinson's disease (such as levodopa)
• antiepileptic medicines
• medicines used to lower blood pressure
• certain cough and cold medicines that contain ingredients that can affect blood pressure
• blood-thinning medicines to prevent blood clots. If you are unsure whether any of your medicines are on this list, ask your doctor or pharmacist before taking methylphenidate.

Before surgery

Tell your doctor that you are taking Concerta if you are going to have an operation. You should not take methylphenidate on the day of the operation if a certain type of anesthesia is used, due to the risk of a sudden increase in blood pressure during the operation.

Drug tests

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

Taking Concerta with alcohol

Do not drink alcohol while taking the medicine. Alcohol may increase the side effects of the 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, ask your doctor for advice before taking this medicine.
Available data do not suggest an increased risk of birth defects overall, although there may be a small increased risk of heart defects during the first three months of pregnancy. Your doctor will be able to provide you with more information about this risk. Before taking any medicine, ask your doctor or pharmacist if:

• you are sexually active. Your doctor will discuss methods of preventing pregnancy
• you are pregnant or think you may be pregnant. Your doctor will decide whether methylphenidate should be taken
• you are breastfeeding or plan to breastfeed. Methylphenidate passes into human milk. Your doctor will decide whether you should continue breastfeeding while taking methylphenidate.

Driving and using machines

While taking methylphenidate, you may experience dizziness, difficulty concentrating, and blurred vision. If this happens, you should not perform activities such as driving a vehicle, operating machinery, riding a bicycle, 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, you should contact your doctor before taking the medicine.

Concerta contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it 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 unsure, 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 aim 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. You can take the tablet with or without food.
The tablet does not dissolve completely after the active substance has been released, and you may see the empty tablet shell in your stool. This is normal.

Taking Concerta 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.

Taking Concerta in adults

• The maximum daily dose in adults is 72 mg.

For adults who have taken Concerta before:

• 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 adults who have not taken Concerta before:

• The recommended starting dose is 18 mg once daily.

If you do not feel better after one month of treatment

If you do not feel better after one 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 and tell them how much you have taken. You may need treatment.
Signs of overdose may include vomiting, feeling over-excited, shaking, muscle twitching, seizures (fits), feeling elated, disoriented, or having hallucinations, excessive sweating, fever, changes in heart rate (slow, fast, or irregular), high blood pressure, dilated pupils, and dryness of the mouth and nose.

Missing a dose of Concerta

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

Stopping treatment with Concerta

If you stop taking the medicine suddenly, you may experience a return of ADHD symptoms or side effects such as depression. Your doctor may advise you to gradually reduce the dose before stopping the medicine completely.
Discuss stopping treatment with your doctor before stopping 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 the dose is changed
• 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 problems, and whether they have got worse while taking Concerta.

Long-term treatment

Treatment with Concerta does not need to be lifelong. If you have been taking Concerta for more than a year, your doctor may stop treatment for a short period, usually during holidays. This will help your doctor decide whether the medicine is still needed.
If you have any questions about your 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 contact your doctor immediately if you experience any of the following:

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

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

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, active, and uncontrolled (mania).

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

• heart attack
• sudden death
• suicide attempts
• seizures (fits)
• exfoliative dermatitis or erythema multiforme
• inflammation or blockage of blood vessels in the brain
• temporary paralysis or problems with movement, vision, or speech (which may be signs of problems with blood vessels in the brain)
• involuntary muscle contractions, especially in the face, head, neck, or arm, and other neurological symptoms
• reduced number of blood cells (red cells, white cells, and platelets), which can increase the risk of infections, bleeding, or bruising
• a sudden increase in body temperature, very high blood pressure, and severe seizures (neuroleptic malignant syndrome). It is not certain whether this side effect is caused by methylphenidate or other medicines that are taken at the same time.

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

• recurring problems with thinking
• unexplained fainting, chest pain, or shortness of breath (which may be signs of heart problems)
• prolonged erections, sometimes painful, or an increased number of erections.

You should contact your doctor immediately 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 temperature (fever)
• reduced 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 sleepiness, feeling tired
• excessive grinding of the teeth (bruxism)
• feeling panicked
• feeling of pins and needles, tingling, or numbness (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 excited, anxious, depressed, irritable, tense, or agitated
• nausea, stomach pain, diarrhea, vomiting, discomfort in the abdomen.
• excessive sweating
• weight loss

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

• dry eye
• constipation
• discomfort in the chest
• 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, patchy rash
• obsessive-compulsive disorder (OCD) (including a strong desire to pull out hair, recurring, unwanted thoughts, images, or urges, or repetitive behaviors or mental acts).

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

• muscle spasms
• fine red rash
• liver problems, including liver failure and coma
• changes in test results, including liver and blood tests
• problems with thinking, lack of feelings or emotions
• feeling cold in the hands and feet
• feeling numbness, tingling, or changes in skin color (from white to blue, then red) when cold (Raynaud's phenomenon).

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, inflammation of blood vessels, or blockage of blood vessels)
• inability to control urination (incontinence)
• muscle spasm in the jaw, making it difficult to open the mouth (trismus)
• stuttering
• nosebleeds.

Effect on physical development

When methylphenidate is used for more than a year, some children may experience a slowing of growth. This affects less than 1 in 10 children.

• There may be a lack of weight gain or a decrease in height.
• Your doctor will closely monitor your height and weight, as well as your diet.
• If your child's growth 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 or pharmacist. Side effects can also be reported to the Medicines and Healthcare products Regulatory Agency (MHRA) using the Yellow Card scheme.

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 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 for 18 mg tablets) and stearic acid (only for 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 a different color and has a distinct marking to help you tell them apart:

• 18 mg: yellow, with "alza 18" printed in black on one side of the tablet.
• 36 mg: white, with "alza 36" printed in black on one side of the tablet.

The medicine is available in bottles 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
For more information about this medicine, contact the local representative of the marketing authorization holder.
Janssen-Cilag Polska Sp. z o.o.
tel. +48 22 237 60 00

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 Medicines and Healthcare products Regulatory Agency (MHRA): http://www.mhra.gov.uk