Package leaflet: Information for the user

Concerta, 18 mg, prolonged-release tablets
Concerta, 36 mg, prolonged-release tablets
Methylphenidati hydrochloridum
The medicine is called Concerta and contains the active substance – methylphenidate hydrochloride. In this leaflet, the name "methylphenidate" will also be used.
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

Keep this leaflet, as you may need to read it again.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

What Concerta is and what it is used for
Important information before taking Concerta
How to take Concerta
Possible side effects
How to store Concerta
Contents of the pack and other information

1. What Concerta is and what it is used for

What Concerta is used for
Concerta is used in the treatment of attention deficit hyperactivity disorder (ADHD):

in children and adolescents aged 6 years and older, as well as in adults.
only after non-pharmacological treatments (without medication), such as psychological counselling or behavioural training (behavioural therapy), have been tried. Concerta is not used to treat ADHD in children under 6 years of age.

How Concerta works
Concerta improves the function of certain parts of the brain that are less active. The medicine may increase the ability to concentrate and reduce impulsive behaviours.
It is used as part of a treatment programme, which usually includes:

psychological
educational
and environmental therapies.
Concerta is prescribed only by a specialist in behavioural disorders in children, adolescents, or adults. In adults who have not been previously treated, the specialist will carry out assessments to confirm that the patient has had ADHD since childhood. Although there is no cure for ADHD, the condition can be managed through therapeutic programmes.

ADHD
Children and adolescents with ADHD have difficulties with:

sitting still for long periods
concentrating.
This behaviour is not their fault, as they have no control over it.

Many children and adolescents experience such disturbances. However, ADHD can lead to problems in daily life. Children and adolescents with ADHD may have difficulties with learning and completing homework. They may struggle to behave appropriately at home, at school, and in other settings.
Adults with ADHD often have concentration difficulties. They may frequently feel restless, impatient, and inattentive. They may have problems organising their personal and professional lives.
Not all patients with ADHD require pharmacological treatment.
ADHD does not affect intelligence.

2. Important information before using Concerta

When not to use Concerta:

if the patient is allergic to methylphenidate or any of the other ingredients of this medicine (listed in section 6)
if the patient has thyroid dysfunction
if the patient has increased intraocular pressure (glaucoma)
if the patient has a tumour of the adrenal medulla (pheochromocytoma)
if the patient has eating disorders – lack of appetite or desire to eat – anorexia
if the patient has very high blood pressure or vascular narrowing that may cause pain in the hands and feet
if the patient has ever had heart problems such as: heart attack, irregular heartbeat, chest pain or discomfort, heart failure, heart disease or significant congenital heart defects
if the patient has had cerebrovascular disorders such as: stroke, aneurysm (localized dilation and weakening of the vessel wall), narrowing or blockage of blood vessels, or vasculitis (inflammation of blood vessels)
if the patient is taking antidepressant medicines (called monoamine oxidase inhibitors) or if such medicines have been taken within the last 14 days – see section "Concerta with other medicines"
if the patient has psychiatric disorders such as:
- psychopathic or emotionally unstable personality (borderline type)
- delusions or hallucinations or schizophrenia
- severe mood disorders with symptoms such as: ✓ suicidal thoughts or tendencies ✓ severe depression, when the patient feels very sad, worthless and hopeless about the future ✓ mania, when the patient is extremely excited, excessively active and uncontrollable in their behaviour. Methylphenidate should not be given if any of the above conditions apply to the patient. In case of doubt, consult a doctor or pharmacist before administering methylphenidate, as the medicine may worsen these conditions.

Warnings and precautions
Before starting treatment with Concerta, discuss the following with your doctor:

if the patient has liver or kidney dysfunction
if the patient has difficulty swallowing or swallowing whole tablets
if the patient has narrowing or obstruction of any part of the gastrointestinal tract
if the patient has had seizures (convulsions, epileptic fits) or abnormal EEG (electroencephalogram) results
if the patient has ever abused or been dependent on alcohol, prescription medicines or drugs
if the patient has started menstruation (see below "Pregnancy and breastfeeding")
if the patient has motor or vocal tics (involuntary, repetitive movements of body parts or repeated sounds or words)
if the patient has hypertension
if the patient has heart diseases other than those listed above under "When not to use Concerta"
if the patient has psychiatric disorders other than those listed above under "When not to use Concerta". These include:
- mood swings (from mania to depression – known as bipolar affective disorder)
- feelings of aggression or hostility
- seeing, hearing or feeling things that are not there (hallucinations)
- believing in things that are not true (delusions)
- unusual suspiciousness (paranoia)
- feelings of restlessness, anxiety and tension
- feelings of sadness or guilt. Before starting treatment, inform the doctor or pharmacist if the patient has any of the above symptoms or conditions, as methylphenidate may worsen them. The doctor will want to monitor how the medicine affects the patient.

If the patient experiences visual disturbances or other vision problems, contact the doctor.
The doctor may consider discontinuing Concerta.
During treatment, unexpected prolonged erections may occur in boys and young men. This may be painful and can occur at any time. If an erection lasts longer than 2 hours, contact a doctor immediately, especially if it is painful.

Medical evaluation before starting Concerta treatment
This evaluation helps determine whether Concerta is the right medicine for the patient.
The doctor will discuss with the patient:

all medicines currently or recently taken
any family history of sudden unexplained death
any other medical conditions (such as heart disease) present in the patient or family
the patient’s emotional state, e.g. whether they experience mood swings, unusual thoughts or such feelings in the past
family history of tics (involuntary, repetitive movements of body parts or repeated sounds or words)
any psychiatric or behavioural disorders ever present in the patient or other family members. The doctor will assess the risk of mood swings (from mania to depression – known as bipolar affective disorder). This will involve a psychiatric interview regarding family history of suicide, bipolar affective disorders and depression. It is important to provide as much information as possible. This will help the doctor decide whether methylphenidate is appropriate for the patient. Before starting treatment, the doctor may decide that further tests are necessary. For adult patients newly starting Concerta, the doctor may refer the patient to a heart specialist.

Concerta with other medicines
Tell the doctor about all medicines the patient is currently taking, has recently taken, or plans to take.
Do not take methylphenidate if the patient:

is taking a medicine known as a "monoamine oxidase inhibitor" used to treat depression, or if such a medicine has been taken within the last 14 days. Taking this medicine together with methylphenidate may lead to a sudden increase in blood pressure (see "When not to use Concerta").

Tell the doctor or pharmacist if the patient is taking any of the following antidepressant or anxiolytic medicines:

tricyclic antidepressants
selective serotonin reuptake inhibitors (SSRI)
serotonin-noradrenaline reuptake inhibitors (SNRI). Taking methylphenidate with these medicines may lead to a life-threatening increase in serotonin levels in the brain (serotonin syndrome), which may manifest as confusion or agitation, sweating, shivering, muscle spasms or rapid heartbeat. If the patient experiences these adverse effects, they must seek medical help immediately.

If the patient is taking other medicines, methylphenidate may affect their action or cause adverse effects. Before taking methylphenidate, inform the doctor or pharmacist if the patient is taking any of the following: medicines used for severe psychiatric disorders
medicines used in Parkinson’s disease (e.g. levodopa)
antiepileptic medicines
medicines used to lower blood pressure
some cough and cold medicines containing ingredients affecting blood pressure. Ask the pharmacist when purchasing such medicines
medicines that thin the blood and prevent clotting.
If in doubt whether any of the medicines taken by the patient are on the above list, consult a doctor or pharmacist before taking methylphenidate.
Inform the doctor or pharmacist about all medicines currently or recently taken, including those available without prescription.

Before surgery
Inform the doctor about any planned surgical procedure. Do not take methylphenidate on the day of surgery if a certain type of anaesthetic is to be used, due to the risk of sudden increase in blood pressure during the operation.

Drug testing
This medicine may cause a positive result in drug tests. This also applies to tests performed on athletes.

Alcohol consumption while taking Concerta
Do not drink alcohol while taking this medicine. Alcohol may worsen the adverse effects of the medicine.
Remember that some food products and medicines contain alcohol.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor before using this medicine.
Available data do not indicate an increased overall risk of congenital malformations, although a small increased risk of congenital heart defects during the first three months of pregnancy cannot be ruled out. The doctor can provide additional information about this risk. Before taking any medicine, consult a doctor or pharmacist if the patient:

is sexually active. The doctor will discuss methods of contraception
is pregnant or suspects she may be pregnant. The doctor will decide whether methylphenidate should be used
is breastfeeding or planning to breastfeed. Methylphenidate passes into human milk. Therefore, the doctor will decide whether breastfeeding should continue during treatment with methylphenidate.

Driving and operating machinery
While taking methylphenidate, dizziness, difficulty concentrating and blurred vision may occur. If this happens, it may be dangerous to perform activities such as: driving, operating machinery, cycling, horse riding or climbing trees.

Concerta contains lactose
This medicine contains lactose (a type of sugar). If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

Concerta contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet; i.e. the medicine is considered "sodium-free".

3. How to take Concerta

What dose of Concerta should be used
This medicine should always be taken exactly as your doctor has instructed. If you are unsure, you should consult your doctor or pharmacist.
Your doctor will usually start treatment with a low dose and then, if necessary, gradually increase the daily dose by 18 mg, no more frequently than once a week.
The goal should be the lowest dose that is effective for the patient. Your doctor will determine the maximum daily dose for the patient.
You should take Concerta once daily in the morning, with a glass of water. The tablet should be swallowed whole. Tablets must not be chewed, divided, or crushed. The tablet may be taken with or without food.
The tablet does not completely dissolve after the active substance has been released, so you may sometimes notice the tablet shell in the stool of patients taking the medicine. This is a normal phenomenon.

Use in children aged 6 years and older

The recommended starting dose of Concerta is 18 mg once daily for children who are not currently taking methylphenidate or for children switching from another stimulant medication 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 the patient has previously taken Concerta as a child or adolescent, the same daily dose (mg/day) may be continued; your doctor will regularly check whether dose adjustment is necessary.
Adult patients may require a higher daily dose, but your doctor will aim to prescribe the lowest effective dose.

For adults who have not previously taken Concerta:

The recommended starting dose is 18 mg per day.

If there is no improvement after one month of treatment
If the patient does not experience improvement after one month of treatment, inform your doctor, who may decide that alternative treatment is necessary.

Misuse of Concerta
Misuse of Concerta may lead to abnormal behaviors. It may also indicate that the patient is becoming dependent on the medicine. Inform your doctor if the patient has ever abused or been dependent on alcohol, prescription medicines, or drugs.
The medicine is intended for use by the individual for whom it was prescribed only. It must not be given to another person, even if they have similar symptoms.

Taking more than the recommended dose of Concerta
If too much medicine is taken, contact your doctor or call emergency services immediately and inform them of the amount taken. Treatment may be necessary.
Symptoms of overdose may include: vomiting, feeling agitated, chills, increased involuntary movements, muscle twitching, seizures (possibly followed by coma), feelings of euphoria, disorientation, seeing, feeling, or hearing things that are not real (hallucinations), excessive sweating, hot flushes, headache, high fever, changes in heart rhythm (slow, fast, or irregular), high blood pressure, dilated pupils, and dryness of the nasal and oral mucous membranes.

Missing a dose of Concerta
Do not take a double dose to make up for a missed tablet. If the patient forgets to take a tablet, wait until it is time to take the next scheduled dose.

Stopping Concerta treatment
If the patient suddenly stops taking the medicine, ADHD symptoms may return or adverse effects such as depression may occur. Your doctor may recommend gradually reducing the dose daily before completely stopping the medicine.
Talk to your doctor before stopping treatment with Concerta.

Examinations performed by the doctor during treatment
Your doctor will carry out several examinations

Before starting treatment – to ensure that Concerta is a safe and beneficial treatment for the patient
After starting treatment – at least every 6 months, but possibly more frequently, and also with any dose change
These examinations will include:
- Checking appetite
- Measuring height and body weight
- Measuring blood pressure and heart rate
- Assessing mood disorders, mental state, or any other abnormalities, and whether they have worsened during treatment with Concerta.

Long-term treatment
Treatment with Concerta does not need to be indefinite. If Concerta is taken for longer than 1 year, your doctor should interrupt treatment for a short period once a year. This may occur during holidays. This break will help assess whether the medicine is still needed.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Despite the occurrence of adverse effects, the condition of most patients improves.
The doctor will discuss these adverse effects with the patient.
Some adverse effects may be serious. Inform the doctor immediately
if any of the following adverse effects occur:
Common adverse effects (may occur in less than 1 in 10 people)

irregular heartbeat (palpitations)
mood changes or mood swings, or changes in personality.

Uncommon adverse effects (may occur in less than 1 in 100 people)

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

Rare adverse effects (may occur in less than 1 in 1,000 people)

feeling of excessive excitement, physical activity and lack of inhibition (mania).

Very rare adverse effects (may occur in less than 1 in 10,000 people)

myocardial infarction (heart attack)
sudden death
suicide attempts
seizures (epileptic fits)
exfoliative dermatitis or erythema multiforme
inflammation or blockage of cerebral arteries
transient paralysis or movement, vision and speech disturbances (these may be symptoms of cerebral vascular disorders)
involuntary muscle contractions of the eyeballs, head, neck, body and neurological symptoms
decreased number of blood cells (red, white and platelets), which may increase susceptibility to infections, bleeding and bruising
sudden increase in body temperature, very high blood pressure and severe seizures (neuroleptic malignant syndrome). It is uncertain whether this effect is caused by methylphenidate or by other medicines taken together with methylphenidate.

Adverse effects with unknown frequency (frequency cannot be determined from
available data)

recurrent disturbances in thinking
unexplained fainting, chest pain, shortness of breath (these may sometimes be symptoms of heart disease)
prolonged erections, sometimes painful, or increased number of erections.

Seek immediate medical advice if any of the above adverse effects occur in the patient.
Inform the doctor or pharmacist if any of the following adverse effects worsen:
Very common adverse effects (may occur in more than 1 in 10 people)

headaches
nervousness
insomnia.

Common adverse effects (may occur in less than 1 in 10 people)

joint pain
blurred vision
tension-type headache
dryness of the oral mucosa, thirst
difficulty falling asleep
high body temperature (fever)
decreased libido
unusual hair loss or thinning of hair
muscle tension, muscle cramps
loss or reduced appetite
difficulty achieving or maintaining erection
itching, rash or hives
unusual drowsiness, feeling of fatigue
excessive teeth grinding (bruxism)
feeling of panic
sensation of pricking, tingling or numbness of the skin (paresthesia)
increased alanine aminotransferase activity (liver enzyme) in blood
cough, inflammation/pain in the nose and throat; upper respiratory tract infections, sinus infection
hypertension, increased heart rate (tachycardia)
dizziness, feeling of weakness, involuntary movements (dyskinesia), excessive psychomotor activity
aggression, agitation, anxiety, depression, irritability, tension, tremor and behavioural disturbances
indigestion, abdominal pain, diarrhoea, nausea, discomfort in the abdominal cavity, vomiting
excessive sweating
weight loss

Uncommon adverse effects (may occur in less than 1 in 100 people)

dry eye syndrome
constipation
discomfort in the chest
haematuria (blood in urine)
apathy
tremor
frequent urination
muscle pain, muscle cramps
shortness of breath or chest pain
feeling of heat
increased liver enzyme activity (in blood tests)
anger, impatience, tearfulness, talkativeness, hyper-vigilance, sleep disturbances.

Rare adverse effects (may occur in less than 1 in 1,000 people)

problems with libido
state of disorientation or confusion
visual disturbances or double vision
breast gland enlargement in males (gynaecomastia)
erythema, macular rash
obsessive-compulsive disorder (OCD) (including irresistible urge to pull out hair, skin picking, recurrent unwanted thoughts, feelings, images or desires (obsessions), performance of repetitive behaviours or mental rituals (compulsions)).

Very rare adverse effects (may occur in less than 1 in 10,000 people)

muscle spasms
small red rash
liver function disorders, including acute liver failure and coma
changes in results of additional tests – including liver function tests and blood tests
thought disturbances, lack of feelings or emotions
feeling of coldness in hands and feet
numbness, tingling and colour change (from white to blue, then to red) in fingers and toes after exposure to cold (Raynaud’s phenomenon).

Adverse effects with unknown frequency (frequency cannot be determined from
available data)

migraine
dilated pupils
increased intraocular pressure
eye diseases which may lead to worsening of vision due to damage of the optic nerve (glaucoma)
very high fever
slow or fast heart rate or extra beats
major seizures (grand mal)
delusions
severe abdominal pain, often with nausea and vomiting
problems with brain blood vessels (stroke, cerebral arteritis or cerebral vessel occlusion)
inability to control urination (urinary incontinence)
jaw muscle spasm making it difficult to open the mouth (trismus)
stuttering
nosebleeds.

Effect on physical development
During treatment with methylphenidate lasting longer than one year, some children may experience a slowing of physical growth. This affects less than 1 in 10 children.

Lack of weight gain or growth has been observed.
The doctor will closely monitor the patient’s growth, weight and diet.
If a child’s development is slower than expected, treatment with methylphenidate may be temporarily interrupted.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform the doctor, pharmacist or nurse. Adverse effects can be reported directly to:
Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

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 stated on the packaging after: EXP.
The expiry date refers to the last day of the stated month.
Store the bottle tightly closed to protect from moisture. Do not store
at temperatures above 30°C.
The packaging contains a desiccant (one or two), which is not intended for consumption.
Medicines must 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 contains 18 mg of methylphenidate hydrochloride
Concerta contains 36 mg of methylphenidate hydrochloride

The other ingredients are:

butylated hydroxytoluene (E321), cellulose acetate, hypromellose (E464), concentrated phosphoric acid, poloxamer 188, polyethylene oxides 200 K and 7000 K, povidone K29-32, sodium chloride, stearic acid, succinic acid, iron oxide black (E172), iron oxide yellow (E172)
Coloured coating: hypromellose (E464), lactose monohydrate, titanium dioxide (E171), triacetin, iron oxide yellow (E172, only in 18 mg tablets), and stearic acid (only in 18 mg tablets)
Clear coating: carnauba wax, hypromellose (E464), and macrogol 400
Printing 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 capsule-shaped tablet is differently marked to facilitate differentiation:

18 mg: yellow tablet with the black marking "alza 18" on one side
36 mg: white tablet with the black marking "alza 36" on one side

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

Marketing Authorisation Holder:
Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium

Manufacturer and Importer where batch release takes place:
Janssen Pharmaceutica NV
Turnhoutseweg 30
B-2340 Beerse
Belgium

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Janssen-Cilag Polska sp. z o.o.
tel. +48 22 237 60 00

This medicine is authorised in the European Economic Area and 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

Detailed information about this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: http://www.urpl.gov.pl